Pharma Phriday (June 12, 2026)

Written by Duncan Emerton, Pharma Phriday is a comprehensive weekly update on the pharmaceutical industry, covering clinical trial results, regulatory approvals, corporate development activity, and other significant developments. Click below to download a PDF version of this week's note.

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Contents

Artificial Intelligence

• Pfizer licenses Chai Discovery’s AI platform for biologics discovery

• Sanofi deepens Owkin AI partnership with five-year K Pro deal

Clinical

• AstraZeneca’s elecoglipron shows 11.8% weight loss in Phase IIb

• Can monthly dosing differentiate Pfizer's berobenatide?

• Gilead/Merck & Co.'s weekly HIV tablet meets Phase III endpoints

• Innovent/Takeda ADC advances in refractory gastric cancer

• Lundbeck's anti-PACAP antibody clears Phase IIb in migraine

• Orforglipron outperforms oral semaglutide across diabetes trials

• Otsuka’s VISIONARY trial shows sibeprenlimab protects kidney function

• Survodutide delivers robust liver fat reductions, but tolerability a concern

• Trodelvy plus Keytruda fails in 1L PD-L1 high NSCLC

• Zasocitinib wins Phase III head-to-head vs. deucravacitinib in psoriasis

• Zealand and Roche report new Phase II data for petrelintide

Regulatory

• Biogen's salanersen gains FDA Breakthrough Designation in SMA

Commercial

• AlzeCure out-licenses ACD680 to Eli Lilly for up to $1 billion

• Engitix lands major GSK fibrosis collaboration

• GSK to acquire Nuvalent for $10.6 billion

• Incyte makes $2 billion move for Vega Therapeutics

• Johnson & Johnson acquires Firefly Bio for $1 billion

• Novartis expands molecular glue pact with Orionis for $1.4bn

• Roche bets up to $2.3 billion on Nurix’s BTK degrader, bexobrutideg

• Wegovy pill hits 3 million prescriptions in five months

In Other News

• Eli Lilly’s Ebglyss approved for Q8W dosing in atopic dermatitis

• FDA grants priority review for Tecentriq in stage III colon cancer

• First golimumab biosimilars approved in US for RA and UC

• Novartis AOC therapy reduces DUX4 activity in FSHD trial

• Pfizer’s Hympavzi approved for children aged 6 and over in haemophilia

• Sanofi's riliprubart stumbles in refractory CIDP trial

• Sanofi’s Sarclisa subQ approved in Europe

• Sensorion files GJB2 gene therapy trials in Canada and France

• Teva launches Eylea biosimilar, Ahzantive, in Europe

• Tango/Revolution combo produces unprecedented early results in PDAC

• US lawmakers target China biotech deals with new legislation

Summary

Artificial Intelligence

Pfizer licensed Chai Discovery's AI platform, including a custom model trained on Pfizer's proprietary data, to accelerate biologics and ADC discovery. Sanofi deepened its Owkin partnership with a five-year K Pro licence, embedding autonomous AI agents across its R&D workflows; the deal is the third evolution of a relationship that began in 2021 and now spans target identification through clinical development.

Clinical

The oral GLP-1 space dominates the clinical section. AstraZeneca's elecoglipron showed 11.8% weight loss in Phase IIb, progressing to Phase III with distinctive renal and cardiovascular outcome trials. Pfizer's berobenatide posted competitive Phase IIb weight loss data with a potential monthly dosing advantage. Zealand and Roche provided further tolerability data for petrelintide, positioning it for patients who prioritise treatment persistence over maximum efficacy. Orforglipron beat oral semaglutide head-to-head across three diabetes trials. In oncology, Innovent/Takeda's CLDN18.2 ADC arcotatug tavatecan met Phase III endpoints in refractory gastric cancer, with an NMPA NDA accepted under priority review. Takeda's zasocitinib delivered a 2.5-fold higher PASI 100 rate vs. deucravacitinib in a direct Phase III comparison. Gilead/Merck's once-weekly HIV tablet ISL/LEN met Phase III non-inferiority endpoints vs. daily regimens. Trodelvy plus Keytruda failed in first-line PD-L1-high NSCLC.

Regulatory

Biogen's salanersen received FDA Breakthrough Therapy Designation in SMA, supported by Phase Ib data showing benefit in patients with a suboptimal response to prior gene therapy.

Commercial

GSK's $10.6 billion acquisition of Nuvalent is the week's largest deal, adding next-generation ROS1 and ALK inhibitors both under FDA review. Roche licensed Nurix's BTK degrader bexobrutideg for $2.3 billion. Incyte acquired Vega Therapeutics for up to $2 billion, bringing a Phase III von Willebrand disease asset into its haematology franchise ahead of Jakafi patent expiry. Novartis expanded its Orionis molecular glue collaboration to $1.4 billion. J&J acquired Firefly Bio's degrader-ADC platform for $1 billion. AlzeCure out-licensed its gamma-secretase modulator ACD680 to Lilly. Wegovy tablets surpassed 3 million US prescriptions in five months, with 80% of new prescriptions going to patients new to GLP-1 therapy.

In Other News

Eli Lilly's Ebglyss gained an every-eight-week maintenance label, making it the least frequently dosed biologic in atopic dermatitis. Roche received Priority Review for atezolizumab in adjuvant stage III dMMR/MSI-H colon cancer. Pfizer's Hympavzi label was expanded to cover haemophilia inhibitor patients and children aged 6 to 11. Sanofi's riliprubart Phase III MOBILIZE trial was stopped for futility in refractory CIDP. Novartis reported positive biomarker data for del-brax in FSHD. Tango/Revolution Medicines reported a 92% response rate in a small PDAC combination study. US lawmakers introduced the BINSA bill, proposing Treasury oversight of American investments in Chinese biotech.

Artificial Intelligence

Pfizer licenses Chai Discovery’s AI platform for biologics discovery

What happened? Chai Discovery has licensed its AI drug discovery platform to Pfizer, giving Pfizer scientists early access to Chai-3, its most advanced model, alongside a custom model trained on Pfizer's proprietary data and tailored to its internal workflows. Financial terms were not disclosed. According to the PR, Chai-3 represents a step-change from its predecessor, doubling success rates in AI-driven antibody design and extending capabilities to multispecific design and broader target generalisation. Chai-2, the prior generation, had already achieved fully de novo antibody design with approximately 20% hit rates from target-plus-epitope prompts. This follows a separate Chai Discovery collaboration with Eli Lilly, making Pfizer and Eli Lilly among the first major pharma companies to deploy Chai's platform at enterprise scale.

What does this mean? As discussed previously in the context of the Incyte/Genesis expansion, there is a critical distinction between applying a general-purpose AI model to a company's problems vs. training a model on that company's experimental data, with the latter producing a progressively calibrated tool rather than a generic one. For Pfizer this deal is aligned with its continuing investment in ADCs and biologics as the next wave of oncology medicines. Chai's generative capabilities in antibody design and multispecific engineering are directly applicable to that portfolio strategy, which is all about designing novel bispecifics and ADC payloads for targets that conventional structure-based methods have struggled to address. Chai-3's doubled success rate places it in direct competition with AlphaFold3, ESMFold2 (Biohub/EvolutionaryScale), and the Genesis/Pearl platform that Incyte is deploying. The rapid succession of Eli Lilly and Pfizer deals signals that Chai is winning enterprise pharma clients at pace, which will only strengthen its commercial position. Further large pharma deals are likely to follow.

Sanofi deepens Owkin AI partnership with five-year K Pro deal

What happened? Owkin and Sanofi have announced a multi-year expansion of their existing partnership, backed by a five-year licence for K Pro, Owkin's AI scientist platform. During the collaboration, Owkin will lead end-to-end development of novel AI-driven biopharma agents purpose-built for Sanofi's workflows, deployed to autonomously perform complex tasks across R&D. K Pro combines multimodal patient data with specialised biological agentic AI systems to support the full pharmaceutical value chain from early discovery through clinical development. Owkin and Sanofi have collaborated since November 2021 through a €90 million strategic partnership initially focused on oncology target identification and patient subgrouping, subsequently expanded to drug positioning for Sanofi's immunology pipeline. This new agreement represents the third evolution of that relationship.

What does this mean? The five-year duration signals genuine institutional commitment rather than a pilot. Sanofi is embedding Owkin into its operating model, not piloting it. The K Pro platform's multimodal design, which combines pathology imaging, genomics, clinical data, and competitive intelligence, is well-suited to Sanofi's therapeutic priorities in immunology and oncology, where patient stratification and biomarker identification are central challenges. The progression from target identification (November 2021) to drug positioning (expansion in March 2024) to autonomous agentic decision-making (this deal) also illustrates how AI relationships with pharma companies tend to deepen as trust and data access accumulate. Owkin is an interesting case study in that trajectory. Owkin also announced an integration with Claude for Healthcare and Life Sciences in January 2026, which connects this deal to Anthropic's growing pharma footprint, including the BMS enterprise deployment covered in Week 21’s note.

Clinical

AstraZeneca’s elecoglipron shows 11.8% weight loss in Phase IIb

What happened? AstraZeneca has announced positive results from the Phase IIb VISTA and SOLSTICE trials of elecoglipron and confirmed progression to an extensive Phase III programme including cardiovascular and kidney outcome trials. In VISTA (N=310), adults with obesity or who were overweight achieved 11.8% mean weight loss at 36 weeks. In SOLSTICE, adults with type 2 diabetes achieved HbA1c reductions of 1.9% at 26 weeks. Elecoglipron is a once-daily oral small molecule GLP-1 receptor agonist discovered by Eccogene and licensed to AstraZeneca globally outside Greater China in 2023, with no food or water restrictions required for dosing.

What does this mean? The 11.8% weight loss at 36 weeks positions elecoglipron below Eli Lilly's orforglipron (approximately 12-15% at 72 weeks) and well below retatrutide, but Phase IIb is more about dose-finding rather than efficacy. The relevant comparison is whether the Phase III programme can identify a dose and duration that delivers competitive weight loss with a differentiated tolerability or convenience profile. The no food or water restriction is the same as Eli Lilly’s orforglipron, so that alone does not distinguish AstraZeneca in this field. The kidney outcome trial is the strategically distinctive element. AstraZeneca already has Farxiga (dapagliflozin) and Lokelma (sodium zirconium cyclosilicate) in its renal franchise and adding an oral GLP-1 with a renal outcomes trial builds a potential multi-mechanism metabolic-renal portfolio that could differentiate it from pure obesity plays. The cardiovascular outcome trial similarly aligns with AstraZeneca's established CVRM positioning. The competitive landscape is becoming increasingly crowded: orforglipron is approved, oral semaglutide is approved, KAI-7535 from Kailera/Hengrui has Phase III T2D data, and Roche's enicepatide Phase II data were recently presented. Elecoglipron needs Phase III data to demonstrate where it fits, and that is still some years away.

Can monthly dosing differentiate Pfizer's berobenatide?

What happened? Pfizer has unveiled detailed Phase IIb data for berobenatide (PF-07976016), an investigational GLP-1 receptor agonist designed for monthly maintenance dosing in obesity. Data from the VESPER programme demonstrated competitive weight-loss efficacy alongside a favourable tolerability profile, supporting Pfizer's planned Phase III development strategy. In the VESPER-1 extension study, patients receiving weekly berobenatide achieved nearly 16% weight loss without evidence of a plateau after 32 weeks of treatment. Across VESPER-1, -2 and -3, the drug demonstrated low gastrointestinal discontinuation rates despite relatively rapid dose escalation and subsequent transition to monthly maintenance dosing. Pfizer highlighted the potential for administration via a low-volume 0.5 mL monthly injection, which could offer meaningful convenience advantages over currently available weekly therapies. The company plans to launch an extensive Phase III programme comprising 10 studies in obesity and obesity-related comorbidities, including obstructive sleep apnoea and knee osteoarthritis, as part of a broader portfolio of more than 20 metabolic disease trials.

What does this mean? As discussed elsewhere in this week’s note, the obesity market has become intensely competitive, and Pfizer is unlikely to win by simply matching the efficacy of market leaders such as Eli Lilly and Novo Nordisk. Instead, berobenatide appears designed to compete on convenience. If approved, it could become the first monthly GLP-1 therapy, potentially reducing the treatment burden associated with weekly injections. The next phase of obesity competition is moving beyond pure efficacy. Companies are increasingly differentiating on convenience, tolerability, adherence, body composition, and disease-specific outcomes. Berobenatide's strongest commercial argument may ultimately be that it offers "good enough" efficacy with a simpler treatment experience. If Phase III data confirm the profile, Pfizer could carve out a meaningful niche despite arriving later than many competitors.

Gilead/Merck & Co.'s weekly HIV tablet meets Phase III endpoints

What happened? Gilead and Merck & Co. have announced that both the Phase III ISLEND-1 and ISLEND-2 trials met their primary endpoints at week 48. ISLEND-1, a double-blind trial, showed islatravir/lenacapavir (ISL/LEN) was statistically non-inferior to Biktarvy in virologically suppressed patients switching from Biktarvy. ISLEND-2, an open-label trial, showed non-inferiority to SoC antiretroviral regimens across a broader population on various daily regimens. Safety was comparable to comparators in both trials. Regulatory submissions are planned globally.

What does this mean? This is a clinically significant milestone for HIV management. Daily oral therapy has been the treatment backbone for people living with HIV for decades, with Biktarvy, the dominant single-tablet regimen, taken once daily. A once-weekly single tablet that maintains virologic suppression non-inferiorly to daily regimens would represent the most meaningful shift in treatment convenience since single-tablet regimens replaced multi-pill combinations in the 2000s. Islatravir is a nucleoside analogue with a distinct mechanism (i.e., reverse transcriptase translocation inhibition) with a long intracellular half-life that enables weekly dosing. Lenacapavir, already approved as a twice-yearly injectable PrEP agent as Sunlenca, is a first-in-class capsid inhibitor acting at multiple stages of the HIV lifecycle. Their combined PK make once-weekly oral dosing pharmacologically viable. The commercial implications are substantial. Biktarvy generated approximately $13 billion in 2025 for Gilead, making it the best-selling treatment for HIV. A successful ISL/LEN approval could, therefore, cannibalise Gilead's own market. Gilead is clearly willing to accept that trade-off rather than cede the once-weekly oral space to competitors. For Merck, ISL/LEN provides a meaningful commercial path for islatravir, which has had a complicated development history after earlier dose-related CD4 count decreases at higher doses limited its progression. Adherence to daily antiretroviral therapy, while generally good, remains imperfect, particularly in populations with irregular schedules, stigma concerns, or pill fatigue. A once-weekly option offers practical benefits of fewer doses to remember, greater discretion and reduced pill burden, benefits that could meaningfully improve real-world adherence outcomes for a proportion of patients.

Innovent/Takeda ADC advances in refractory gastric cancer

What happened? Innovent Biologics has announced that arcotatug tavatecan (IBI343), its CLDN18.2-targeting ADC, met its primary endpoint in the Phase III G-HOPE-001 trial which is evaluating arcotatug tavatecan monotherapy against investigator-selected therapy in patients with previously treated, CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who had received at least two prior systemic therapies. The co-primary endpoints were PFS and OS. Based on the interim analysis results, Innovent's NDA has been accepted by China's NMPA under priority review for this 3L setting. Importantly, Innovent has not yet disclosed the actual PFS or OS figures; full data are expected to be presented at a future academic conference. Arcotatug tavatecan is designed to selectively deliver a high-potency exatecan payload to tumour cells, with the drug optimised to minimise off-tumour toxicities. Beyond gastric cancer, the drug is in a Phase III study in CLDN18.2-positive advanced pancreatic cancer in China and is being explored in Phase I studies in 1L gastric and pancreatic settings. The asset sits at the centre of Innovent's $11.4 billion global collaboration with Takeda, announced in October 2025, under which Takeda received exclusive rights to IBI343 outside Greater China, with Innovent receiving $1.2 billion upfront.

What does this mean? Gastric cancer remains one of the most lethal solid tumours globally, and the 3L setting, where patients have progressed through at least two prior regimens, represents one of the most difficult populations to treat. CLDN18.2 is expressed in normal gastric epithelial cells but becomes accessible to therapeutic antibodies when cell polarity is lost during malignant transformation, making it a genuinely tumour-selective target. Zolbetuximab (Vyloy), the anti-CLDN18.2 mAb developed by Astellas, is currently the only approved therapy in this target class, indicated with chemotherapy in the 1L HER2-negative setting. Arcotatug tavatecan operates on a different mechanism and in a later line. Rather than recruiting immune effector functions as zolbetuximab does, it delivers a cytotoxic TOPO1 inhibitor payload directly to CLDN18.2-expressing tumour cells. The two agents are therefore positioned as potentially sequential rather than directly competing, which expands the addressable treatment continuum for CLDN18.2-positive disease. For Takeda this readout significantly de-risks its investment. The asset now has a positive pivotal trial and an NDA under priority review in China, which substantially strengthens the case for regulatory submissions in Japan, the US, and Europe. Takeda's oncology leadership has described the IBI343 programme as potentially transformative to its portfolio and a driver of growth post-2030. A clean data package at a major congress would convert that expectation into something more concrete. The Phase III programme in pancreatic cancer, where CLDN18.2 is expressed and treatment options are severely limited, may ultimately prove the more commercially significant opportunity.

Lundbeck's anti-PACAP antibody clears Phase IIb in migraine

What happened? Lundbeck has presented primary data from the Phase IIb PROCEED trial of bocunebart (Lu AG09222), an investigational anti-PACAP (pituitary adenylate cyclase-activating polypeptide) mAb being developed as a potential preventative treatment for migraine. PACAP is a neuropeptide involved in migraine through pathways distinct from CGRP. The intravenous part of the PROCEED trial met its primary endpoint, with bocunebart producing a statistically significant reduction in monthly migraine days vs. placebo over weeks 1-12 in patients with one to four prior preventive treatment failures. Patients on bocunebart experienced a mean reduction of 4.24 monthly migraine days vs. 2.86 days on placebo, a treatment difference of 1.38 days (p=0.0178). In a pooled analysis of severe, chronic migraine patients across the Phase II programme, the treatment difference widened to 2.31 days (p<0.001). A pre-defined interim analysis of the subQ part of PROCEED demonstrated futility, triggering enrolment into the intravenous part only. Bocunebart was generally well tolerated, with nasopharyngitis as the most reported adverse event. Lundbeck also presented Phase I data showing no PK interaction when bocunebart was co-administered with ubrogepant, adding to earlier data on co-administration with triptans.

What does this mean? Migraine affects roughly one billion people worldwide, yet a substantial proportion of patients either don’t respond to, or can’t tolerate, available preventive therapies such as anti-CGRP mAbs (e.g., erenumab, fremanezumab, galcanezumab, and eptinezumab) and oral gepants (e.g., atogepant, rimegepant). PACAP inhibition offers a new strategy for the prevention of migraine and based on biology and how the PROCEED trial was designed, bocunebart is most effective in patients that have failed prior preventive treatments, with the pooled chronic migraine subgroup showing a more pronounced treatment difference than the overall population. Two potential wrinkles exist, however. First, the subQ formulation failed a futility analysis mid-trial, which means bocunebart as currently constituted requires IV administration. That’s a meaningful constraint on convenience and how widely it could be used in clinical practice if approved, particularly when patients are already familiar with self-injectable CGRP antibodies. Second, the absolute treatment difference of 1.38 monthly migraine days in the overall PROCEED population is modest, and clinicians will scrutinise how that translates into meaningful benefit for individual patients, even as the chronic migraine subgroup data look more compelling.

Orforglipron outperforms oral semaglutide across diabetes trials

What happened? Eli Lilly (Lilly) has presented detailed Phase III results from three ACHIEVE programme trials at ADA 2026; ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5. In ACHIEVE-3, the first head-to-head trial of two oral GLP-1s in type 2 diabetes, orforglipron (Foundayo) 9 mg reduced HbA1c by 1.9% vs. 1.1% with oral semaglutide 7 mg at 52 weeks. At the highest doses, orforglipron 17.2 mg delivered 2.2% HbA1c reduction vs. 1.4% with oral semaglutide 14 mg, and 73.6% greater relative weight loss. ACHIEVE-2 showed HbA1c reduction of up to 1.7% vs. 0.8% with dapagliflozin at 40 weeks. ACHIEVE-5, in adults on insulin glargine, showed HbA1c reductions of 1.54% to 2.05% vs. 0.77% with placebo. Lilly has submitted Foundayo for T2D regulatory approval.

What does this mean? The ACHIEVE-3 head-to-head vs. oral semaglutide is perhaps the most commercially significant. Foundayo has now demonstrated superiority to oral semaglutide at approved doses in a randomised trial, a direct competitive claim Lilly can use in prescriber communications and payer negotiations once T2D approval follows. The 73.6% greater relative weight loss at the highest dose comparison is a number that will pique the interest of clinicians in an environment where weight management is increasingly recognised as integral to T2D management rather than secondary to glycaemic control. The three-trial package builds a comprehensive evidence base across the major T2D treatment backgrounds. The insulin combination data is particularly useful commercially because basal insulin users represent a large, often poorly controlled population where adding an oral agent that reduces both HbA1c and body weight without hypoglycaemia is a clinically compelling proposition. The T2D regulatory submission positions Foundayo for a second approved indication alongside obesity, materially broadening the addressable market.

Otsuka’s VISIONARY trial shows sibeprenlimab protects kidney function

What happened? Interim data from the Phase III VISIONARY trial presented at ERA Congress 2026 showed sibeprenlimab (Voyxact) produced a mean eGFR change from baseline of +0.7 mL/min/1.73m² vs. a decline of -4.8 mL/min/1.73m² with placebo at 12 months. The annualised eGFR slope was -3.0 vs. -7.6 mL/min/1.73m²/year, a treatment effect of 4.6 mL/min/1.73m²/year. Safety was comparable to placebo.

What does this mean? Voyxact received FDA accelerated approval in November 2025 based on proteinuria reduction. Continued approval is contingent on confirming the eGFR benefit, and Otsuka has initiated a rolling sBLA submission. The 12-month eGFR data are an early read on that confirmatory endpoint, and the signal is positive. A 4.6 mL/min/1.73m²/year treatment effect at 12 months is clinically meaningful in a disease where progressive eGFR decline leads to dialysis and transplant. Competitive activity within IgAN has increased in recent weeks. Povetacicept (Vertex) received BLA acceptance with a November 2026 PDUFA, and the competitive dynamics between APRIL-only inhibition (sibeprenlimab), dual BAFF/APRIL inhibition (povetacicept), and complement pathway targeting (iptacopan, zigakibart) will intensify as full 24-month eGFR data mature. The 24-month final analysis, which is the primary confirmatory endpoint, remains the definitive read, but this interim meaningfully de-risks Otsuka's regulatory path to full approval.

Survodutide delivers robust liver fat reductions, but tolerability a concern

What happened? Boehringer Ingelheim and Zealand Pharma have reported new Phase III data for survodutide, their glucagon/GLP-1 dual agonist in development as a potential treatment for obesity, showing substantial reductions in harmful visceral and liver fat while largely preserving lean body mass. The findings come from a pre-specified MRI sub-study within the Phase III SYNCHRONIZE-1 trial. The analysis found that patients receiving survodutide achieved up to 34% reductions in visceral fat and up to 63% reductions in liver fat over 76 weeks. These effects accompanied previously reported average weight loss of up to 16.6%, suggesting that the drug's benefits extend beyond overall weight reduction to improvements in body composition and metabolic health. Additional analyses highlighted the potential relevance of survodutide for metabolic dysfunction-associated steatotic liver disease (MASLD), with many patients experiencing substantial reductions or normalisation of liver fat.

What does this mean? As I’ve discussed before (when discussing data for Wave Life Sciences’ WVE-007), this data raises some interesting (perhaps philosophical) questions regarding the best outcome for the pharmacological treatment of obesity. Is it better to lose weight (which on GLP-1s includes fat and muscle) or is it better to focus on body composition? Put another way, is it simply about how much weight patients lose, or should they focus more on what kind of weight they lose? As obesity therapies become increasingly effective, differentiation is becoming harder. Weight-loss percentages alone are unlikely to sustain a competitive advantage when multiple drugs can achieve double-digit reductions. Survodutide's emerging profile suggests a different positioning strategy: targeting metabolically harmful fat deposits while preserving muscle mass. If validated in further studies, this could resonate strongly with physicians concerned about sarcopenia, frailty, and long-term metabolic health. However, the data have raised important questions about survodutide’s gastrointestinal tolerability, with discontinuation rates appearing higher than some competing obesity therapies. As a result, the commercial success of survodutide may ultimately depend on whether physicians and payers view its body-composition and liver-health benefits as sufficiently meaningful to offset tolerability concerns. Perhaps these results give some hint as to where the obesity market is heading. The next phase of competition may be less about maximising weight loss and more about demonstrating superior metabolic outcomes, preservation of lean mass, cardiovascular benefit, and disease-specific advantages in conditions such as MASLD/MASH. If that proves true, survodutide could emerge as one of the most differentiated assets in the obesity pipeline despite not being the most potent weight-loss drug on the market.

Trodelvy plus Keytruda fails in 1L PD-L1 high NSCLC

What happened? Gilead and Merck & Co. have announced that the Phase III KEYNOTE-D46/EVOKE-03 trial of Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) vs. Keytruda monotherapy in previously untreated metastatic NSCLC with PD-L1 TPS ≥50% has been discontinued following a DMC recommendation. A numerical PFS improvement was observed but did not reach statistical significance, and OS is unlikely to achieve statistical significance at the planned final analysis. Safety was consistent with known profiles of each agent. Around 620 patients were enrolled. Regulatory authorities have been informed, and data will be presented at a future medical meeting.

What does this mean? This is a significant setback for Gilead's NSCLC ambitions for Trodelvy, and it arrives in the same week as the Gilead/Merck once-weekly HIV success (see Gilead/Merck & Co.'s weekly HIV tablet meets Phase III endpoints). The patient population (PD-L1 TPS ≥50% without driver mutations) is precisely the setting where pembrolizumab monotherapy performs best. Pembrolizumab's KEYNOTE-024 established it as SoC in this population, with a mature and well-characterised efficacy profile. Trying to beat it with an ADC combination in this specific biomarker-enriched group was asking a lot, and the TROP2 ADC strategy in high PD-L1 expressors was always a hypothesis with uncertain biological rationale. For Gilead specifically, this means Trodelvy's NSCLC pathway has narrowed considerably. Trodelvy remains approved in breast cancer (2L TNBC and pre-treated HR+/HER2- metastatic breast cancer) with the Ascent-04 PDUFA in the second half of 2026 for 1L  TNBC plus pembrolizumab potentially providing a near-term positive. But the lung cancer programme, which represented a significant commercial expansion opportunity, will need a fundamental rethink of patient selection and combination strategy before any further pivotal investment.

Zasocitinib wins Phase III head-to-head vs. deucravacitinib in psoriasis

What happened? Takeda has announced that zasocitinib (TAK-279) demonstrated statistically significant superiority over deucravacitinib (Sotyktu; Bristol Myers Squibb) in the Phase III LATITUDE Atlas trial in N=606 adults with moderate-to-severe plaque psoriasis. This is the first prospective randomised trial directly comparing the two oral TYK2 inhibitors. The primary endpoint was PASI 100 (complete skin clearance) at week 16. More than 35% of zasocitinib-treated patients achieved PASI 100, compared with fewer than 14% on deucravacitinib. Zasocitinib also demonstrated statistical superiority for all key secondary endpoints, including PASI 90 and sPGA 0 at week 16, with separation from the deucravacitinib response curve observed as early as week 8. The safety profile was consistent with previous studies, with no new safety signals identified. Recall, Takeda gained rights to zasocitinib via its December 2022 deal with Nimbus Therapeutics.

What does this mean? The clinical data speak for themselves. A 2.5-fold bigger PASI 100 response for zasocitinib vs. deucravacitinib is a clinically meaningful separation on the most demanding skin clearance endpoint. The fact that this divergence was apparent by week 8 suggests the difference is driven by zasocitinib's greater potency at TYK2 (it has more than one-million-fold selectivity for TYK2 over JAK1). The hypothesis has always been that greater TYK2 selectivity and potency could translate into superior efficacy without additional safety trade-offs, and the LATITUDE Atlas result is the first prospective Phase III evidence confirming that hypothesis. A consistent safety profile with no new signals means zasocitinib has not paid an adverse event price for its higher potency, at least over a 16-week treatment period. The combination of strong LATITUDE monotherapy data, a pending NDA, and now a head-to-head win with a large effect size gives zasocitinib one of the more compelling oral immunology data packages in recent years. Phase II studies are also ongoing in Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa, meaning zasocitinib is being positioned as a platform asset across immune-mediated diseases. If that breadth translates into approvals, the commercial opportunity extends well beyond psoriasis.

Zealand and Roche report new Phase II data for petrelintide

What happened? Zealand Pharma and Roche have presented new data from the Phase II ZUPREME-1 trial which further characterises the efficacy and tolerability profile of petrelintide, the once-weekly amylin analogue being developed for weight management. Recall, in March 2026 it was announced that the study showed mean body weight reductions of up to 10.7% at week 42 compared with 1.7% for placebo, while maintaining a favourable tolerability profile. Importantly, 88-98% of participants successfully escalated to their target maintenance dose, suggesting that most patients were able to remain on treatment. This new data highlights low rates of gastrointestinal adverse events and treatment discontinuation, reinforcing the programme's positioning as a potentially well-tolerated alternative to GLP-1-based obesity therapies. At the highest effective dose, investigators reported no vomiting-related discontinuations and no treatment discontinuations due to gastrointestinal side effects. Petrelintide is expected to advance into Phase III development as Zealand and Roche seek to build a differentiated position in the increasingly competitive obesity market.

What does this mean? As the obesity treatment landscape becomes increasingly competitive, developers will need to find ways to differentiate their assets vs. the rest of the field. How? Is it simply via maximising weight loss (see Eli Lilly’s Phase III data for retatrutide)? Should companies target visceral fat (Survodutide delivers robust liver fat reductions, but tolerability a concern)? Or, in the case of Zealand and Roche, is it better to focus on treatment experience? When the ZUPREME-1 data were first released in March 2026, investor reaction was negative because the 10.7% weight-loss result fell below expectations and compared unfavourably with some next-generation obesity therapies from competitors. However, this data reframes the discussion around tolerability, adherence, and long-term treatment persistence. This reflects a growing recognition that obesity is a chronic disease requiring long-term treatment. While therapies from companies such as Eli Lilly and Novo Nordisk can deliver dramatic weight loss, gastrointestinal side effects remain a major reason patients discontinue therapy. Roche appears to be positioning petrelintide for patients who prioritise tolerability and sustained use over maximum efficacy. As the obesity market matures, it’s becoming clear that there will not be a single "winner." Instead, different therapies are likely to serve different patient segments. Some patients will seek maximum weight loss, while others may prefer a therapy that produces more moderate results but is easier to stay on longer-term. Roche executives have explicitly discussed this segmentation strategy.

Regulatory

Biogen's salanersen gains FDA Breakthrough Designation in SMA

What happened? The FDA has granted Breakthrough Therapy Designation to salanersen (BIIB115), Biogen's investigational ASO for SMA. The designation is supported by Phase Ib data showing that children with SMA who had a suboptimal response to prior gene therapy experienced clinically meaningful improvements in motor function and slowed neurodegeneration, measured by reduced neurofilament levels, following once-yearly salanersen. Three Phase III studies are underway: STELLAR-1 in treatment-naïve presymptomatic infants under six weeks old; SOLAR in adolescents and adults aged 15-60 who are treatment-naïve or previously received risdiplam; and STELLAR-2, expected to begin enrolment this month, evaluating salanersen in infants approximately six months after gene therapy.  

What does this mean? The gene therapy rescue angle is quite interesting. Onasemnogene abeparvovec (Zolgensma) transformed SMA outcomes for infants but a meaningful subset don’t achieve optimal motor function following treatment. Until now, those children had limited options. Salanersen's Phase Ib signal, which shows improvements in children who had already received gene therapy, suggests ASO-based SMN2 splicing correction can provide additive benefit on top of an existing gene therapy, which is a novel therapeutic approach. Salanersen is related to but more potent than Biogen's Spinraza (nusinersen), as it requires fewer doses. Its once-yearly intrathecal dosing vs. Spinraza's four loading doses then three-times yearly maintenance is a meaningful practical improvement. The competitive picture in SMA is notable. Roche/PTC's risdiplam is the oral competitor to Spinraza. Salanersen now positions Biogen to defend and expand its SMA franchise with a next-generation ASO that addresses gene therapy non-responders, a population that neither risdiplam nor Zolgensma adequately serves. Breakthrough Designation will accelerate regulatory dialogue and Phase III execution, with the STELLAR-2 post-gene therapy study being the most commercially and clinically consequential readout to watch.

Commercial

AlzeCure out-licenses ACD680 to Eli Lilly for up to $1 billion

What happened? Swedish biotech AlzeCure Pharma has announced that it has entered a collaboration and out-licensing agreement with Eli Lilly (Lilly), granting Lilly global rights to its Alzheimer's candidate Alzstatin (ACD680). AlzeCure will receive a $10 million upfront payment, development and commercial milestones, and tiered mid-single-digit royalties on sales. The total deal value, excluding royalties, may exceed $1 billion. ACD680 is a preclinical small-molecule gamma-secretase modulator designed to reduce production of the toxic amyloid-beta peptide Aβ42 while simultaneously increasing shorter, less aggregation-prone variants Aβ37 and Aβ38. It works by allosterically shifting the cleavage preference of the gamma-secretase enzyme rather than blocking the enzyme outright, a design intended to preserve Notch signalling and avoid the toxicities that caused earlier gamma-secretase inhibitors to fail.

What does this mean? A $10 million cash payment against a potential $1 billion-plus in milestones is heavily backloaded, meaning the headline figure reflects a best-case commercial outcome many years away. That said, $10 million upfront for a preclinical asset is not unusual, and Lilly's willingness to attach a ten-figure milestone structure signals genuine interest. Gamma-secretase has a difficult history in Alzheimer's disease. Earlier attempts to block the enzyme outright, including Lilly's own semagacestat, failed in Phase III after showing an unfavourable risk-benefit profile. The underlying problem was that gamma-secretase processes several proteins beyond amyloid-beta, including the Notch receptor, which regulates cell development and tissue maintenance. Broad inhibition disrupted these normal biological functions. ACD680 takes a modulator rather than inhibitor approach, allosterically shifting the enzyme's cleavage preference to reduce Aβ42 production while preserving Notch signalling, which is a mechanistically distinct design intended to capture the therapeutic benefit without the toxicity profile that doomed earlier agents.

Engitix lands major GSK fibrosis collaboration

What happened? Engitix has entered a strategic research collaboration and option agreement with GSK to identify and validate novel therapeutic targets involved in liver fibrosis regression. The partnership combines Engitix's proprietary extracellular matrix (ECM) platform and multi-omics datasets with GSK's drug discovery and development capabilities. Unlike many fibrosis programmes that focus on slowing disease progression, the collaboration is specifically designed to uncover mechanisms that actively drive the reversal of liver fibrosis. Under the agreement, Engitix is eligible to receive up to £44.5 million in upfront and near-term payments, with potential milestone payments of up to £118 million per target, plus royalties on any commercialized products. GSK will have options to license targets, datasets and assays emerging from the collaboration and will lead subsequent development and commercialization activities.

What does this mean? The deal further expands GSK's growing hepatology portfolio, which already includes the late-stage MASH candidate efimosfermin and the company's broader investment in liver disease. For Engitix, the partnership provides significant validation of its ECM-focused discovery platform and strengthens its position as a specialist in fibrosis biology. Most fibrosis drug discovery efforts focus on preventing additional scarring. This collaboration instead focuses on understanding how scar tissue disappears, which is a potentially important shift in strategy. If researchers can identify mechanisms that actively drive fibrosis regression, they may be able to develop therapies capable of restoring organ function rather than merely slowing decline. For GSK, the agreement reinforces a growing conviction that liver disease will become one of the next major therapeutic markets. The company has already invested heavily in MASH and hepatitis B, and this collaboration broadens its approach from treating metabolic liver disease to addressing the underlying fibrotic process that drives progression to cirrhosis and liver failure.

GSK to acquire Nuvalent for $10.6 billion

What happened? GSK has agreed to acquire Nuvalent for $10.6 billion. The deal includes three pipeline assets being investigated as potential treatments for NSCLC: zidesamtinib (NVL-520), a next-generation ROS1 inhibitor under FDA review with a PDUFA date of 18 September 2026; neladalkib (NVL-655), a next-generation ALK inhibitor under FDA review with a PDUFA date of 27 November 2026; and NVL-330, an early-stage HER2 inhibitor in Phase I. Both lead assets have FDA Breakthrough Therapy and Orphan Drug designations.

What does this mean? This is GSK's biggest acquisition in over a decade and its third major deal of 2026 (following acquisitions of 35Pharma and RAPT Therapeutics). Nuvalent's two lead assets are next-generation inhibitors designed to address the core limitations of approved first-generation ROS1 and ALK drugs (e.g., crizotinib, lorlatinib, alectinib, brigatinib), specifically resistance mutations, CNS penetration, and tolerability. Analysts have modelled combined peak revenue of approximately $3.5 billion for zidesamtinib and neladalkib, which would represent genuine blockbuster status and go a significant way to justifying the $10.6 billion price. Interestingly, GSK also frames this as a platform for expansion with Ris-Rez, its B7-H3 ADC, into lung cancer, suggesting the intent is to build combination strategies around the Nuvalent assets rather than treating them as standalone products.

Incyte makes $2 billion move for Vega Therapeutics

What happened? Incyte has agreed to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, in a deal worth up to $2 billion. The transaction includes $1.25 billion upfront and up to $750 million in future sales-based milestone payments. The acquisition brings VGA039, a Phase III mAb for von Willebrand disease (VWD), into Incyte's portfolio and expands the company's haematology franchise into bleeding disorders. VGA039 targets Protein S, a natural anticoagulant, to improve blood clotting and reduce bleeding episodes. The therapy is being developed as a once-monthly subQ injection, offering a potentially more convenient alternative to existing treatments that often require frequent IV administration. The programme has received multiple FDA expedited designations and is currently in pivotal Phase III development. The acquisition comes at a time when investors are increasingly focused on Incyte’s ability to offset future revenue losses from its flagship product, Jakafi, as patent protection begins to erode later this decade.

What does this mean? Specifically, this deal is about preparing for life after Jakafi. Jakafi generated more than $3 billion in 2025 and remains Incyte's largest product, but patent expirations beginning in 2028 have created pressure on management to identify new growth drivers. Rather than pursuing an early-stage platform acquisition, Incyte has chosen a relatively de-risked, late-stage asset that could reach the market shortly after Jakafi faces generic competition. The acquisition also signals a strategic broadening of Incyte's haematology franchise. Historically, the company has been strongest in hematologic malignancies and inflammatory diseases. VGA039 gives Incyte entry into inherited bleeding disorders, a specialised market where its existing haematology infrastructure and physician relationships may provide commercial advantages. While many recent biotech acquisitions have focused on oncology, obesity, or immunology, Incyte is targeting a rare disease opportunity with a clearly differentiated product profile. The monthly subQ administration could make VGA039 attractive both to patients and physicians if efficacy and safety are confirmed in Phase III. Broadly, this may be the first indication of how CEO Bill Meury intends to deploy capital. The deal appears consistent with a strategy of acquiring late-stage or near-commercial assets that can generate meaningful revenue within the next five years rather than making higher-risk technology platform bets. If successful, it could serve as a template for further BD&L activity in haematology, immunology, and oncology as Incyte seeks to reshape its portfolio for the post-Jakafi era.

Johnson & Johnson acquires Firefly Bio for $1 billion

What happened? Johnson & Johnson (J&J) has agreed to acquire Firefly Bio for $1 billion in cash, adding the company's proprietary Firelink degrader antibody conjugate (DAC) platform to its oncology portfolio. The acquisition is intended to strengthen J&J's capabilities in developing targeted therapies for KRAS-driven cancers and other difficult-to-treat solid tumours. Firefly's technology combines the tumour-targeting precision of ADCs with targeted protein degradation, enabling delivery of protein-degrading payloads directly to cancer cells. The approach is designed to overcome some limitations of conventional ADCs by selectively eliminating disease-driving proteins while minimizing exposure to healthy tissue. The deal provides J&J with preclinical programmes focused on pan-KRAS and other high-value oncology targets.

What does this mean? ADCs have become intensely competitive, with virtually every major pharma company building or buying ADC capabilities. However, the industry is already searching for the "next wave" beyond traditional cytotoxic payloads. Enter Firefly's DAC platform. Strategically, the deal reinforces J&J's ambition to remain a leader in solid tumours by investing earlier in emerging technologies rather than waiting for clinical PoC. The focus on KRAS is particularly notable. While KRAS was once considered undruggable, recent success (e.g., daraxonrasib in pancreatic cancer) suggests progress is finally being made. Firefly's platform could potentially broaden the range of KRAS-driven cancers that can be addressed.

Novartis expands molecular glue pact with Orionis for $1.4bn

What happened? Orionis Biosciences (Orionis) and Novartis have expanded a strategic research collaboration that began in 2020, signing a new multi-year agreement to discover and develop molecular glue medicines across multiple disease areas. Orionis will receive $40 million upfront and is eligible for up to $1.4 billion in development and commercial milestones, plus tiered royalties on any resulting products. The collaboration centres on Orionis' Allo-Glue small molecule platform and its AI-driven discovery engine, which together enable systematic target and ligase profiling, molecular glue candidate identification, and compound optimisation. Molecular glues are small molecules used to stabilise the interaction between two proteins that don’t typically interact, offering a route to targets that have historically proved difficult to drug with conventional small molecules. The agreement gives Novartis access to a discovery platform capable of generating multiple drug candidates across different targets and disease areas, rather than licensing a single clinical asset.

What does this mean? This is a renewal of the original 2020 agreement, which means that Novartis has seen enough from the first collaboration to commit at a higher level. Molecular glues have emerged as one of the most active areas in targeted protein degradation and induced-proximity drug discovery, with the potential to address disease-driving proteins that have proved resistant to conventional small molecule approaches. The competitive landscape is active, and Novartis has other deals in place focused on the same area. In September 2025, Novartis announced a collaboration with Monte Rosa Therapeutics which is focused on VAV1-directed molecular glue degraders in immune-mediated diseases.

Roche bets up to $2.3 billion on Nurix’s BTK degrader, bexobrutideg

What happened? Roche has entered an exclusive global licensing and collaboration agreement with Nurix Therapeutics for bexobrutideg (NX-5948), an oral BTK degrader. Nurix receives $700 million upfront and up to $1.6 billion in milestones, for total potential deal value of $2.3 billion. Development costs are split 60%/40% Roche/Nurix, with 50/50 US profit sharing and low-to-high-teen royalties for Nurix outside the US. Phase III initiation in second-line CLL is planned for summer 2026. The collaboration also covers chronic spontaneous urticaria in immunology and multiple sclerosis in neurology.

What does this mean? BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib) are among the most commercially important drugs in haematology, but resistance mutations, particularly C481S in the BTK binding site, limit their durability in CLL. Bexobrutideg is a brain-penetrant oral small molecule that degrades the BTK protein entirely rather than inhibiting it, which is the key differentiator. Degrading the protein sidesteps resistance mutations affecting the binding site, because the drug does not need to bind where a mutation has occurred and it recruits an E3 ligase to destroy BTK regardless of mutations. That mechanism has significant implications for the large and growing population of patients who have progressed on covalent BTK inhibitors. Nurix also has existing BTK-related partnerships with Gilead, Sanofi, and Seagen (now Pfizer). The $700 million upfront from Roche, which caused Nurix’s share price to surge as much as 70% in pre-market trading, reflects how seriously the field is taking targeted protein degradation as the next generation of kinase-targeted therapy. The CSU and MS indications are strategically meaningful additions. BTK plays a role in mast cell signalling relevant to CSU and in B-cell activity relevant to MS, and a brain-penetrant BTK degrader is particularly well-suited to neuroinflammatory indications where CNS exposure is essential. This cross-therapeutic ambition (i.e., one molecule, multiple indications) mirrors the approach AbbVie has taken with Brukinsa and Calquence, except with the protein degradation mechanism providing a potential durability advantage.

Wegovy pill hits 3 million prescriptions in five months

What happened? Novo Nordisk has announced that Wegovy (semaglutide) tablets 25 mg have surpassed three million prescriptions in just over five months since launch on 5 January 2026, describing it as one of the strongest US pharmaceutical launches by volume on record. The three million milestone corresponds to one prescription filled roughly every five seconds. More than 80% of new Wegovy pill prescriptions are for people new to GLP-1 therapy, indicating the oral formulation is expanding the market rather than replacing existing injectable therapies. This year, more patients starting a new weight management therapy have filled prescriptions for Wegovy than any other available obesity medication. Novo Nordisk has also recently launched Wegovy HD (semaglutide injection 7.2 mg), which has shown strong early uptake.

What does this mean? What’s perhaps most interesting about this announcement is the 80% new-to-GLP-1 figure. It suggests that oral Wegovy is not cannibalising Novo Nordisk's injectable Wegovy franchise, or drawing patients away from Zepbound, but expanding the addressable population. Injection aversion, access barriers, and the psychological burden of self-administering a weekly jab have long been cited as reasons why eligible patients don’t start or persist with GLP-1 therapy. A pill removes those barriers, and the prescription data appear to confirm that effect in practice. It’s also impressive considering that Eli Lilly’s Foundayo (orforglipron) has been on the market during this time, meaning that patients and physicians have had a choice of oral treatments for obesity. Both Wegovy pill and Foundayo are priced at comparable entry points, with savings cards allowing patients to access either product for as little as $25 per month. Price parity means the competition will likely be fought on formulary positioning, access programmes, dosing convenience, and real-world weight loss outcomes as evidence accumulates.

In Other News

Eli Lilly’s Ebglyss approved for Q8W dosing in atopic dermatitis

The FDA has approved a Q8W maintenance dosing regimen for Ebglyss (lebrikizumab) in adults and adolescents aged 12 and older weighing at least 40 kg with moderate-to-severe atopic dermatitis. Ebglyss was already approved for once-monthly maintenance. The approval was supported by data from the Phase III ADjoin extension trial, which enrolled participants from the ADvocate 1/2, ADore, and ADopt-VA trials. No new safety signals were identified and no patients discontinued due to adverse events during the extension period. Notably, Lilly obtained this label expansion through PK modelling rather than a new head-to-head clinical trial comparing the two maintenance intervals from the outset. The expanded label makes lebrikizumab the only approved biologic for atopic dermatitis that offers as few as six maintenance injections per year without mandatory concomitant topical therapy from treatment initiation. 

FDA grants priority review for Tecentriq in stage III colon cancer

The FDA has accepted Roche's sBLA for atezolizumab (Tecentriq and Tecentriq Hybreza) in combination with chemotherapy as adjuvant treatment for stage III dMMR/MSI-H colon cancer, granting Priority Review with a PDUFA date of October 9, 2026. The filing is based on the Phase III Alliance ATOMIC trial which showed that adding atezolizumab to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% vs. chemotherapy alone. The 36-month disease-free survival rate was 86% for the combination vs. 76% for chemotherapy alone. The safety profile was consistent with previous Tecentriq and FOLFOX6 studies.

First golimumab biosimilars approved in US for RA and UC

The FDA has approved Immgolis (golimumab) and Immgolis Intri (golimumab), both developed by Bio-Thera Solutions, as interchangeable biosimilars to Simponi (subQ) and Simponi Aria (IV) respectively. Both are the first biosimilars to either reference product. Immgolis is approved for adults with moderate to severe active RA in combination with methotrexate and for moderately to severely active UC; Immgolis Intri for RA with methotrexate. Commercialisation in the US will be handled by Accord BioPharma.

Novartis AOC therapy reduces DUX4 activity in FSHD trial

Novartis has announced that the biomarker cohort (cohort C) of the Phase I/II FORTITUDE trial has met its primary and secondary endpoints. The primary endpoint was change in plasma concentration of KHDC1L, a DUX4-regulated circulating biomarker. The key secondary endpoint was change from baseline in creatine kinase, a marker of muscle damage. Cohort C assessed delpacibart braxlosiran (del-brax) 2 mg/kg every six weeks vs. placebo for 12 months in 51 FSHD patients aged 16-70. Del-brax is an antibody oligonucleotide conjugate which uses a transferrin receptor 1-targeting antibody to deliver siRNA directly to skeletal muscle cells, suppressing DUX4 mRNA, the aberrant transcription factor that drives FSHD pathology. It’s one of three late-stage AOC therapies Novartis gained through its acquisition of Avidity Biosciences completed in February 2026. 

Pfizer’s Hympavzi approved for children aged 6 and over in haemophilia

The FDA has approved an expanded indication for Hympavzi (marstacimab) to include patients with haemophilia A or B aged 12 years and older with inhibitors, and paediatric patients aged 6 to 11 years with or without inhibitors. Prior to this action, Hympavzi had only been indicated for patients aged 12 years and older without inhibitors. Hympavzi is now indicated in the US for routine prophylaxis to prevent or reduce bleeding episodes in adults and paediatric patients aged 6 years and older with haemophilia A or B, regardless of inhibitor status. The approval makes Hympavzi the first subcutaneous non-factor therapy available for children aged 6 to 11 years with haemophilia B.

Sanofi's riliprubart stumbles in refractory CIDP trial

Sanofi has announced that the Phase III MOBILIZE trial of riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to SoC treatment will be stopped. An IDMC conducted an interim analysis and determined that the study is unlikely to provide sufficient evidence of efficacy. No safety signals were identified. Riliprubart (SAR445088, BIVV020) is an IgG4 humanised mAb that selectively inhibits activated C1s in the classical complement pathway. By blocking C1s, it was designed to inhibit inflammatory mechanisms that drive demyelination and axonal damage in CIDP.

Sanofi’s Sarclisa subQ approved in Europe

Following the EMA CHMP’s positive endorsement in March 2026, the EC has approved Sarclisa (isatuximab) subQ for multiple myeloma, making it the first anticancer therapy in the EU that can be administered via an on-body injector (OBI). The approval covers all currently approved indications for intravenous Sarclisa and allows administration either through the wearable CirCLIQ injector or by manual subQ injection. The approval was supported by data demonstrating comparable efficacy, PK, and safety between the new subQ formulation and the existing intravenous version. Results from the Phase III IRAKLIA trial showed the OBI-delivered formulation was non-inferior to IV administration while offering a significantly simplified treatment experience. Four other studies supported the decision; GMMG-HD8, IZALCO, ISASOCUT and a Phase I study. For patients with multiple myeloma, the new formulation has the potential to reduce time spent in infusion centres and expand access to treatment in outpatient and home settings.

Sensorion files GJB2 gene therapy trials in Canada and France

Sensorion has announced that it has selected SENS-601, its gene therapy for GJB2-related hearing loss, as its lead programme. Clinical Trial Applications have been filed in Canada and France to evaluate the safety, tolerability, and efficacy of intra-cochlear administration of SENS-601 in paediatric patients with GJB2 gene-mediated hearing loss. The French medicines agency (ANSM) has granted Fast Track designation. IND submission in the US and a submission in Australia are targeted by year-end 2026. GJB2 mutations are responsible for approximately 50% of autosomal recessive non-syndromic hearing loss, making this the single largest genetic cause of congenital deafness. The GJB2 gene encodes connexin 26, a gap junction protein that maintains the ionic balance required for sound transduction in the inner ear; loss-of-function mutations abolish this process, causing severe-to-profound hearing loss from birth. SENS-601 uses an AAV-based gene therapy approach developed in collaboration with the Institut Pasteur.

Teva launches Eylea biosimilar, Ahzantive, in Europe

Teva has launched Ahzantive (aflibercept), its biosimilar to Regeneron and Bayer's Eylea, across France, Germany, Spain, and the Netherlands, with further European market launches planned later in 2026. The product received EC approval in 2025 and is indicated for neovascular age-related macular degeneration, diabetic macular oedema, myopic choroidal neovascularisation, and macular oedema following retinal vein occlusion. The commercialisation is conducted under a semi-exclusive agreement with Klinge Biopharma and Formycon.

Tango/Revolution combo produces unprecedented early results in PDAC

Tango Therapeutics has reported striking early clinical data for its PRMT5 inhibitor vopimetostat in combination with Revolution Medicines' pan-RAS inhibitor daraxonrasib in patients with MTAP-deleted, RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). Among 12 evaluable patients with at least 14 weeks of follow-up, the combination achieved a 92% objective response rate (11 of 12 patients), a 100% disease control rate, and a 90% six-month progression-free survival rate. Median progression-free survival has not yet been reached. The results come in a heavily pre-treated patient population, with many participants receiving second- or third-line therapy and a high proportion presenting with liver metastases. The combination appears to outperform historical results seen with either agent alone, suggesting a potentially synergistic effect between PRMT5 inhibition and RAS pathway blockade.

US lawmakers target China biotech deals with new legislation

Republican Congressman John Moolenaar and Democrat Debbie Dingell have introduced the Biotech Investment National Security Act (BINSA), which would bring US pharmaceutical licensing deals, joint ventures, and equity investments with Chinese entities under Treasury Department review, thereby applying the same outbound investment screening framework already proposed for semiconductors and AI to biotechnology. The bill covers pharmaceutical development, biologics manufacturing, and clinical R&D. It explicitly names Pfizer and Bristol Myers Squibb as examples of companies making deals that it characterises as threatening American pharmaceutical production. Treasury would have one year to issue implementing regulations, and the Secretary of Defence would have 60 days to assess whether US capital flows into Chinese biotech negatively affect national security.

About the Author

Duncan Emerton is a pharmaceutical industry professional with a background spanning clinical R&D, medical affairs, and strategic consulting. He brings a commercially minded perspective to complex scientific and market developments, with experience in competitive intelligence, business analysis, and portfolio strategy across the life sciences sector. Through Pharma Phriday, Duncan provides concise, insight-driven commentary on the stories shaping the pharmaceutical and biotech landscape, helping readers filter out the noise to understand what really matters for companies, competitors, and patients alike.