Pharma Phriday (May 22, 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

• BMS expands clinically focused AI collaboration with Tempus AI.

• BMS to deploy Anthropic’s Claude Enterprise company wide.

• Incyte, Edison partner on AI-driven R&D.

• Incyte expands AI collaboration with Genesis.

• QIAGEN taps NVIDIA to accelerate AI drug discovery.

Clinical

• AstraZeneca notches up crucial bladder cancer win for Imfinzi.

• BioMarin’s BMN401 flops in Phase III ENPP1 deficiency trial.

• Eli Lilly posts pivotal win for retatrutide in obesity.

• Meiji Seika’s nacubactam delivers in Phase III infection study.

• Merck & Co.’s sacituzumab tirumotecan delivers in Phase III EC trial.

• Pfizer’s next-gen pneumococcal vaccine hits mark in Phase II trial.

• Regeneron’s fianlimab flops in Phase III advanced melanoma trial.

• Relay Therapeutics posts Phase II data for zovegalisib.

• Sanofi’s efdoralprin alfa hits mark in Phase II AATD trial.

• Vincentage reports Phase III data for VCT220 in obesity.

Regulatory

• AstraZeneca’s Baxfendy gets FDA nod for uncontrolled hypertension.

• Chugai’s alectinib gains tumour-agnostic approval in Japan.

• Pressure mounts on Amgen as Tavneos linked to 20 deaths in Japan.

Commercial

• Eli Lilly acquires Engage Biologics for up to $202 million.

• Eton Pharma gains US commercial rights to Impavido.

• Regeneron, Parabilis ink antibody-peptide conjugate R&D pact.

In Other News

• AstraZeneca’s Fasenra gets FDA nod for hypereosinophilic syndrome​

• Boehringer Ingelheim’s Jascayd gets MHLW nod for IPF and PPF.

• Dr Reddy’s Labs launches generic semaglutide in Canada.

• EC approves Sandoz’s insulin lispro and insulin aspart biosimilars.

• Enhertu set to reshape early HER2+ breast cancer treatment.

• Exelixis, Merck & Co. collaborate on a Phase III CRC trial.

• FDA approves first golimumab biosimilar.

• Formycon launches two aflibercept biosimilars in Europe.

• GSK’s Arexvy gets MHLW nod for high risk 18-49 year olds.

• Microbiotica posts positive Phase I data for MB097 in melanoma.

• Samsung Bioepis launches its ustekinumab biosimilar in Japan.

Summary

Artificial Intelligence. Enterprise AI deployment in pharma accelerated this week, with BMS announcing two separate deals. First, an expanded collaboration with Tempus AI to apply RWD and AI to optimise clinical trial design across five initial programmes spanning solid tumour oncology and Alzheimer's disease. Second, a company-wide deployment of Anthropic's Claude Enterprise platform across 30,000 employees, covering R&D, manufacturing, commercial, and corporate functions. Both deals reflect pharma's shift from AI pilots to enterprise-wide operational integration. Incyte also announced two AI partnerships in the same week, including a collaboration with Edison Scientific to deploy the Kosmos AI scientist across target discovery and translational biology and an expansion of its existing Genesis Molecular AI collaboration. The latter adds at least five new targets and grants Genesis access to Incyte's proprietary experimental data to train its GEMS platform. Not to be outdone, QIAGEN announced a collaboration with NVIDIA to integrate GPU-accelerated GraphRAG with its curated IPA bioinformatics knowledge base, targeting improved target identification and biomarker discovery.

Clinical. AstraZeneca's Phase III VOLGA trial demonstrated statistically significant improvements in EFS and OS for perioperative durvalumab plus enfortumab vedotin in cisplatin-ineligible MIBC, though durvalumab faces a stiff commercial challenge from the already-approved pembrolizumab plus enfortumab vedotin combination. Lilly's Phase III TRIUMPH-1 trial of retatrutide in 2,339 morbidly obese adults met all primary and secondary endpoints at 80 weeks. The 12mg dose produced 28.3% average weight loss, with 30.3% at 104 weeks and no plateau. The 4mg dose achieved 19.0% weight loss with a discontinuation rate below placebo. Merck & Co.'s sacituzumab tirumotecan met both OS and PFS endpoints in post-platinum, post-immunotherapy endometrial cancer, the first TROP2 ADC to do so in this setting. Regeneron's fianlimab failed to demonstrate superiority over pembrolizumab in first-line advanced melanoma, continuing a difficult run for LAG-3 inhibitors. Pfizer's 25-valent pneumococcal vaccine candidate delivered a 9-15 fold improvement in serotype 3 immunogenicity over Prevnar 20 in infants, addressing a longstanding gap. BioMarin's BMN401 met its biomarker endpoint in ENPP1 deficiency but failed to show any radiological improvement. Sanofi's efdoralprin alfa demonstrated superiority over plasma-derived AAT augmentation therapy in AATD, with less frequent dosing. Meiji Seika's nacubactam delivered positive Phase III data in complicated UTIs, with its dual PBP2 and beta-lactamase inhibition mechanism offering a scientifically credible differentiator in the AMR space.

Regulatory. AstraZeneca's baxdrostat received FDA approval as the first aldosterone synthase inhibitor for uncontrolled hypertension, addressing an estimated 23 million US patients inadequately controlled on existing agents. Chugai's alectinib received the world's first tumour-agnostic approval for an ALK inhibitor in Japan, including paediatric patients. Safety concerns around Amgen's Tavneos intensified, with 20 deaths reported in Japan, most linked to vanishing bile duct syndrome, and Kissei actively discouraging new prescriptions.

Commercial. Eli Lilly acquired Engage Biologics for up to $202 million, gaining access to the Tethosome non-viral DNA delivery platform, which aims to address nuclear localisation and immune sensing limitations that have historically constrained non-viral gene therapy. Regeneron entered a multi-target collaboration with Parabilis Medicines to develop antibody-helicon conjugates, paying $50 million up front with up to $2.2 billion in milestones. Eton Pharmaceuticals secured US commercialisation rights to Impavido (miltefosine) from a Knight Therapeutics affiliate, acquiring an orphan drug with an established FDA approval for leishmaniasis and a complex commercial history.

In Other News. Enhertu received FDA approval in two early-stage HER2-positive breast cancer settings, reinforcing its position as the standard of care across the HER2 spectrum. Generic semaglutide launched in Canada via Dr. Reddy's and Apotex, with direct-to-patient access priced from $124.99 per month. Fasenra received FDA approval for hypereosinophilic syndrome. The first golimumab biosimilars were approved in the US, and Formycon launched its aflibercept biosimilars across key European markets.

Artificial Intelligence

BMS expands clinically focused AI collaboration with Tempus AI

What happened? Building on a previous collaboration, Tempus AI has announced an expansion of its collaboration with Bristol Myers Squibb (BMS) which will aim to leverage AI, RWD and data science techniques to optimise clinical trial designs and enhance PTRS across five initial clinical trial programmes. This collaboration will combine large-scale RWD with emerging AI techniques to stress test assumptions, characterise patient populations, validate control group assumptions, and identify the best patient segments most likely to benefit from investigational therapies. It will support the development of assets in solid tumour oncology, including lung, colon, and prostate cancers. Beyond oncology, the collaboration will extend to Alzheimer’s disease.

What does this mean? BMS partnered with Faro Health in March 2026 in a similar area (i.e., protocol design), so this deal aligns with BMS’ overarching strategy. Using a large real-world dataset to stress-test Phase III design assumptions (e.g., patient population, endpoints, etc.) before committing to a Phase III trial is sensible risk management, and it's not surprising that BMS is investing here given the raft of late-stage failure across their oncology and neuroscience portfolios (e.g., Opdualag, Camzyos, Reblozyl, milvexian, and Cobenfy). That said, there are some things that need more information. Alzheimer’s is notable because it's a harder domain for this approach than oncology. Tempus built its data moat in cancer, but the multimodal data relevant to Alzheimer's is different in character: cognitive assessments, imaging, biomarkers, care pathway data. It would be good to know how deep and how comprehensive the Tempus dataset is in that indication. In terms of PTRS improvements, this will be challenging to validate prospectively using RWD because RWD is observational and retrospective. Tempus will need to show that trials designed with this approach succeed at higher rates than those without it, and that comparison is difficult to make cleanly.

BMS to deploy Anthropic’s Claude Enterprise company wide

What happened? BMS is deploying Claude Enterprise as its shared AI platform across the entire company, including R&D, manufacturing, commercial, and corporate functions. The deployment covers more than 30,000 employees. Priorities include Claude Code to accelerate software and data science development; embedding Claude agents into priority workflows across the value chain; and connecting Claude to BMS' institutional knowledge base through secure integrations with existing systems and repositories. The specific workflow applications cited drafting clinical study reports and patient safety narratives, supporting regulatory submissions, root-cause investigation in manufacturing, corrective and preventive action (CAPA) documentation, batch release decisions, and turning field insights into structured intelligence for medical affairs. The collaboration builds on more than three years of AI investment at BMS, where the company has given employees unlimited access to leading frontier models through a proprietary internal platform. No deal terms were provided.

What does it mean? Pharma’s AI focus continues to shift from pilots and discovery tools toward enterprise-wide operational infrastructure. Like Novo Nordisk’s April 2026 collaboration with OpenAI, BMS is betting that the biggest near-term value from AI will come from accelerating knowledge work across multiple functions, including discovery, clinical, regulatory, competitive intelligence, manufacturing and internal decision-making. If successful, this could become a competitive advantage that other companies might struggle to replicate. If not, it risks becoming another expensive enterprise tech deployment that never fully changes how the organisation operates.

Incyte, Edison partner on AI-driven R&D

What happened? Incyte and Edison Scientific (Edison) have announced a strategic collaboration to employ Kosmos, Edison’s AI scientist, for Incyte’s discovery and development work. Kosmos will be embedded across the Incyte discovery and development lifecycle, enabling continuous learning from translational and clinical data, real-time synthesis of evidence and predictive models of therapeutic performance. The initial deployment will be focused on use cases in target discovery and validation and translational biology. The companies will work together to measure impact on decision quality and long-term pipeline productivity as the system evolves. No deal terms were provided.

What does this mean? Most AI-pharma deals announced in the past two years are essentially data licensing arrangements, where a pharma company provides proprietary datasets and an AI company runs analysis on them, producing target lists or compound suggestions. The Incyte/Edison collaboration is different in one specific way, as it’s suggested that Kosmos will improve its capability as it ingests more of Incyte's experimental and clinical data over time. If that feedback loop works as described, the model becomes progressively better calibrated to Incyte's specific biology and therapeutic areas. On that note, Incyte has a relatively focused pipeline built largely around haematology, oncology, and inflammation, with ruxolitinib (Jakafi) as its leading commercial asset. They have proprietary experimental data from years of clinical programmes across JAK inhibitors, PD-1/LAG-3 combinations, and other mechanisms. That accumulated dataset is exactly the kind of structured, domain-specific input that a system like Kosmos is designed to exploit. Using it to improve hypothesis generation and experimental design in early discovery, rather than starting from scratch with public data, is a sensible use of both the AI platform and the data asset.

Incyte expands AI collaboration with Genesis

What happened? Incyte and Genesis Molecular AI (Genesis) have announced an expansion of their February 2025 strategic collaboration which focuses on using AI to discover novel molecules for targets selected by Incyte. The expanded agreement broadens the deployment of Genesis’ AI platform, GEMS (Genesis Exploration of Molecular Space), which includes foundation models for protein-ligand structure and property prediction, across a broader variety of targets in Incyte’s portfolio. Incyte will also share proprietary experimental data with Genesis to enhance GEMS’ capabilities. Under the terms of the deal, Genesis receives $120 million upfront, structured as $80 million in cash plus a $40 million equity investment. Incyte will also provide ongoing research funding to cover AI model training and compute costs. Milestones of up to $232 million per programme are available, with over $1 billion in aggregate milestones across the five initial targets if all are achieved and aggregate peak sales hit specified thresholds.

What does it mean? As the PR alludes to, this is not the first pharma-AI collaboration to power large-scale foundation model training with a partner's proprietary experimental data. Other examples include Eli Lilly and Chai Discovery (January 2026), Eli Lilly and TuneLab (September 2025) and Sanofi, Formation Bio and OpenAI (May 2024). In the original deal, Genesis was applying GEMS to Incyte-selected targets by using a general-purpose AI platform on Incyte's R&D objectives. In this expansion, Incyte is feeding Genesis its own experimental data to train the underlying foundation models. This is very different arrangement and means GEMS will become progressively tuned in to Incyte's specific chemistry, biology, and assay outputs. GEMS will evolve. The arrangement does create a question about data exclusivity, however. When Incyte's proprietary experimental data trains Genesis' foundation models, does it remain Incyte-exclusive, or does it generalise into improvements that benefit Genesis' other partners (e.g., Gilead) and any future collaborators?

QIAGEN taps NVIDIA to accelerate AI drug discovery

What happened? QIAGEN's Digital Insights bioinformatics business will integrate NVIDIA accelerated computing and the NVIDIA BioNeMo platform with its curated biomedical knowledge bases, with the goal of helping pharmaceutical and biotechnology researchers better understand disease biology, identify therapeutic targets, and uncover biomarkers. The technical implementation will use graph-based retrieval AI built on frameworks including PyTorch Geometric and GPU-accelerated GraphRAG systems, delivered via BioNeMo. The system is designed to let researchers ask natural language questions directly against biomedical knowledge graphs. Initial pilot programmes will be available to select pharma and biotech partners, with broader availability following validation. No deal terms were provided.

What does this mean? QIAGEN's IPA knowledge base has been manually curated over decades by domain scientists who have read the primary literature and encoded the directional, causal relationships between biological entities in a structured form. That is an expensive and slow thing to produce. The aim here is that combining this curated data with NVIDIA's GPU-accelerated compute and the GraphRAG architecture (which is designed to retrieve and reason over graph-structured knowledge rather than just flat text) produces something more reliable than retrieval-augmented generation over raw literature. Pilot programmes with select partners, broader availability following validation and no committed timeline acknowledge the validation risk. The question now becomes, can the AI-augmented graph retrieval produce better scientific decisions than researchers using IPA directly in its current form?

Clinical

AstraZeneca notches up crucial bladder cancer win for Imfinzi

What happened? AstraZeneca has released high-level results from a planned interim analysis of the three-arm, Phase III VOLGA trial. Results show that in patients treated with Imfinzi (durvalumab) perioperatively in combination with neoadjuvant enfortumab vedotin (Padcev; Astellas/Pfizer) (ARM A) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and OS in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm (ARM C) had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment. Perioperative Imfinzi plus Imjudo (tremelimumab; AstraZeneca) in combination with neoadjuvant Padcev (ARM B) demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS. However, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. The safety and tolerability of Imfinzi with or without Imjudo plus Padcev was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

What does this mean? Padcev plus pembrolizumab is already approved by the FDA for perioperative treatment of cisplatin-ineligible MIBC patients and is under priority review for cisplatin-eligible patients regardless of eligibility, with a PDUFA date of August 2026. The KEYNOTE-905/EV-303 trial showed that Padcev plus pembrolizumab significantly extended EFS and OS versus surgery alone in the cisplatin-ineligible population. s such, VOLGA is arriving into a space where Padcev plus pembrolizumab has already established itself, and pembrolizumab's broader approval in MIBC regardless of cisplatin eligibility could follow within months. That creates a difficult position for AstraZeneca. They have a positive trial, but the Padcev backbone is the same, and durvalumab now must compete with pembrolizumab as the immunotherapy partner. Pembrolizumab has deeper market penetration, a larger evidence base, and broader oncology brand recognition. VOLGA is a positive result that matters for patients and strengthens AstraZeneca's bladder cancer franchise. The strategic challenge is that without comparative data against Padcev plus pembrolizumab, it's hard to know where durvalumab sits in a setting that Merck & Co./Pfizer are likely to dominate commercially.

BioMarin’s BMN401 flops in Phase III ENPP1 deficiency trial

What happened? BioMarin has announced data from the Phase III ENERGY 3 trial of BMN401 in paediatric patients aged 1-12 years old with ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) deficiency. BMN 401 (formerly INZ-701) is a subQ enzyme replacement therapy in development as a potential treatment for ENPP1 deficiency. The trial had two co-primary endpoints: plasma inorganic pyrophosphate concentration (PPi) and Radiographic Global Impression of Change (RGI-C) score. BMN401 met the PPi endpoint, showing statistically significant increases in plasma PPi through Week 52, but failed to show any corresponding improvement in RGI-C scores. No positive trends were observed across any secondary endpoints, including Rickets Severity Score, growth Z-score, or height and weight. BMN 401 was generally well-tolerated with no new safety signals reported.

What does it mean? The disconnect between the biomarker endpoint and the clinical outcome mirrors a pattern seen elsewhere in rare metabolic bone disease (e.g., X-linked hypophosphataemia). ENPP1 is designed to raise PPi, which inhibits pathological calcification. However, raising a surrogate biomarker that’s mechanistically connected to the disease does not guarantee clinical benefit if the downstream biology is more complex than the model predicts, if treatment is initiated too late in the disease course to reverse established pathology, or if biomarker normalisation alone is insufficient to restore normal bone mineralisation. The history of rickets treatment has several examples where correction of biochemical parameters (e.g., phosphate levels, ALP, PTH) did not fully predict radiological or functional improvement in the timeframe measured. What next? Detailed results from the ENERGY 3 study will be presented at an upcoming medical meeting, but development is likely to be terminated based on these data.

Eli Lilly posts pivotal win for retatrutide in obesity

What happened? Eli Lilly has announced positive results from its Phase III TRIUMPH-1 trial. This is the primary registrational trial for retatrutide in obesity: N=2,339 adults, 80 weeks, three active doses versus placebo, in a population without diabetes and with at least one weight-related comorbidity. Mean baseline BMI at randomisation was 40.0 kg/m², so this was a morbidly obese population. Recall, retatrutide is an investigational first-in-class glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon receptor agonist. All three doses met the primary endpoint and all key secondary endpoints. At 80 weeks, the 12mg dose produced average weight loss of 28.3% (70.3 lbs); the 9mg dose 25.9% (64.4 lbs); and the 4mg dose 19.0% (47.2 lbs) versus 2.2% on placebo. 65.3% of participants on 12mg fell below a BMI of 30 at 80 weeks, crossing back under the clinical threshold for obesity. In the pre-specified 104-week extension for participants with BMI ≥35, those continuing the 12mg dose reached average weight loss of 30.3% (85.0 lbs), with no plateau observed. The safety profile was broadly consistent with TRIUMPH-4 and with the incretin class generally: nausea (42%), diarrhoea (32%), constipation (26%), vomiting (25%) at 12mg. Dysesthesia occurred in 12.5% at 12mg versus 0.9% on placebo. Discontinuation rates due to adverse events were 11.3% at 12mg, 6.9% at 9mg, and 4.1% at 4mg, with the 4mg arm discontinuation rate below the 4.9% placebo rate.

What does this mean? Cross-trial comparison caveats aside, this is as strong a pivotal obesity trial readout as the field has seen. Semaglutide (Wegovy) produced approximately 15% weight loss in STEP-1 at 68 weeks, and tirzepatide (Zepbound) produced approximately 22.5% in SURMOUNT-1 at 72 weeks. Retatrutide at 12mg produced 28.3% at 80 weeks, at a slightly longer duration. Patients in the 104-week extension phase reaching 30.3% weight loss is the number that will draw the most attention. This is the level of weight loss historically associated with bariatric surgery, achieved pharmacologically. Data for the 4mg dose also deserve some attention. 19% weight loss from a single dose escalation step, with a discontinuation rate below placebo, creates a patient-friendly dosing option. For the substantial proportion of patients who do not tolerate higher doses of incretin therapy,  or who don’t want to escalate, a 4mg maintenance dose achieving nearly 20% weight loss is clinically meaningful and commercially differentiated. Eli Lilly's framing of retatrutide as complementing rather than replacing Zepbound (tirzepatide) and orforglipron (Foundayo) makes clear commercial sense: 4mg retatrutide slots between orforglipron (oral, convenient, ~15-17% weight loss) and high-dose Zepbound, while 12mg retatrutide addresses the highest unmet need at the severe obesity end. The dysesthesia signal at 12.5% for 12mg remains worth watching. It was lower here than in TRIUMPH-4 (where it reached 20.9% at 12mg), which is reassuring, but the mechanism is poorly understood, and regulators will want to see it characterised carefully in the label. The 104-week extension demonstrates that weight loss continues to build beyond the standard trial endpoint rather than plateauing, which has been a persistent criticism of GLP-1 class agents where weight is regained on discontinuation. The extension data does not address durability when treatment is stopped, but it does establish that on-treatment benefit continues to build. TRIUMPH-2 (type 2 diabetes) and TRIUMPH-3 (established cardiovascular disease) are the remaining pivotal readouts. The cardiovascular outcomes data will determine whether retatrutide can access the same kind of guideline positioning that semaglutide achieved with SELECT.

Meiji Seika’s nacubactam delivers in Phase III infection study

What happened? Meiji Seika Pharma (Meiji Seika) has announced positive results from the Phase III Integral-1 study, one of two Phase III clinical trials assessing the efficacy and safety of nacubactam (b-lactamase inhibitor; diazabicyclooctane class). Integral-1 assessed the efficacy and safety of nacubactam co-administered with either cefepime (cephalosporin) or aztreonam (monobactam) versus imipenem (carbapenem) plus cilastatin (renal dehydropeptidase inhibitor). The study met its primary endpoint of composite clinical and microbiological response seven days after the end of treatment, demonstrating non-inferiority of cefepime-nacubactam to imipenem-cilastatin. Superiority of cefepime-nacubactam over imipenem-cilastatin and non-inferiority of aztreonam-nacubactam versus the same comparator were also demonstrated. With respect to safety, the incidence of adverse events was comparable between groups, and no new safety concerns were identified. These data were also published in The Lancet. Although not covered in this article, positive results were also observed in Integral-2, the other Phase III trial that enrolled patients with infections caused by carbapenem-resistant Enterobacterales (CRE).

What does this mean? Carbapenem-resistant Gram-negative bacteria are on the WHO’s priority pathogen list precisely because carbapenems have been the last-resort option for serious infections, and resistance to them leaves clinicians with very limited alternatives. The existing approved agents in this space (i.e., ceftazidime-avibactam and Emblaveo) are effective but face a growing resistance problem of their own. Most b-lactamase inhibitors work purely by inactivating the resistance enzyme and thereby restoring the potency of the antibiotic partner. Nacubactam also hits penicillin-binding protein 2 (PBP2), which is involved directly in bacterial cell wall synthesis. This dual action (enzyme inhibition plus direct antibacterial activity) is theoretically more difficult for bacteria to evolve resistance around, because they would need to simultaneously adapt to two different mechanisms of attack. Whether that advantage holds up in long-term clinical use remains to be seen, but it’s a scientifically sound basis for differentiation. While this is great news, the development of novel antibiotics has suffered from huge scientific, economic and regulatory challenges over the years. This has been addressed by various incentives that have been put in place, including the UK’s antibiotic subscription model and the PASTEUR Act in the US, both of which are Netflix-style subscription models that decouple revenue from sales volume. Despite these being in place, the economics remain challenging, and smaller companies like Meiji Seika often need to find a larger partner for wider commercialisation. Notwithstanding, the combination of two positive Phase III trials, a Lancet publication, and a regulatory submission in Japan puts nacubactam in a stronger position than most AMR programmes at this stage.

Merck & Co.’s sacituzumab tirumotecan delivers in Phase III EC trial

What happened? Merck & Co. has announced that the Phase III TroFuse-005 trial of sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech, met both primary endpoints of OS and PFS, plus the key secondary endpoint of ORR, versus chemotherapy in patients with advanced or recurrent endometrial cancer who had previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. The trial enrolled 776 patients randomised to sac-TMT versus physician's choice of doxorubicin or paclitaxel. No new safety signals were observed.

What does this mean? This is the first Phase III trial in endometrial cancer to demonstrate statistically significant improvements in both OS and PFS versus chemotherapy in this post-platinum, post-immunotherapy setting, and the first TROP2 ADC to do so in any endometrial cancer population. That is a genuinely meaningful clinical benchmark in a disease that is increasing in both incidence and mortality globally. The TROP2 ADC field has been dominated by sacituzumab govitecan (Trodelvy; Gilead) in breast and bladder cancer and datopotamab deruxtecan (Dato-DXd; AstraZeneca/Daiichi Sankyo) across multiple solid tumours. Sac-TMT's bifunctional linker design, which aims to maximise payload delivery while minimising systemic payload loss, is Merck & Co.'s principal differentiating claim versus those competitors. Demonstrating a statistically significant OS benefit alongside PFS at an interim analysis is a high bar and strengthens the case for regulatory approval and clinical adoption. The breadth of the TroFuse programme is also worth noting. With 17 ongoing Phase III trials across more than nine tumour types including breast, bladder, cervical, gastric, NSCLC and ovarian cancers, this first positive readout substantially de-risks the broader programme and sets a positive precedent for the remaining trials. The ongoing TroFuse-033 trial in first-line mismatch repair proficient endometrial cancer is particularly worth watching given the larger patient population it targets.

Pfizer’s next-gen pneumococcal vaccine hits mark in Phase II trial

What happened? Pfizer has posted positive Phase II data for its 25-valent pneumococcal conjugate vaccine candidate (25vPnC; PF-07872412) in infants demonstrated robust immunogenicity across all 25 serotypes, with a particularly notable finding on serotype 3. PF-07872412 produced approximately 9-15 times higher serotype 3 immune responses after doses 3 and 4 compared to Prevnar 20. The vaccine was well-tolerated with no safety concerns. Based on these Phase II results and discussions with regulators, Pfizer has now initiated its Phase III programme for 25vPnC in children. The 25vPnC is designed to achieve around 90% coverage of the pneumococcal serotypes circulating in the paediatric population, which is a meaningful step up from the 20 serotypes covered by Prevnar 20. In parallel, Pfizer has advanced its adult programme to a fifth-generation 35-valent vaccine candidate.

What does this mean? Serotype 3 has been a persistent problem across the entire development history of pneumococcal conjugate vaccines. Despite being included in Prevnar 13 and Prevnar 20, it continues to cause residual invasive disease, even in countries with high vaccine coverage. Though there are various factors that contribute to this, enhancing the immune response to serotype 3 specifically may have a meaningful impact on the remaining burden of disease. The 9-to-15-fold improvement over Prevnar 20 on serotype 3 immunogenicity in infants addresses a known and longstanding gap. From a commercial perspective, Prevnar 20 currently dominates the US paediatric and adult pneumococcal vaccine market. Merck & Co.’s Capvaxive (21-valent), which introduces eight serotypes absent from legacy formulations, received FDA approval in June 2024 and has moved quickly in the adult segment. In terms of novel vaccines, Vaxcyte’s VAX-31, a 31-valent candidate, is being developed in infants and adults and has delivered some robust Phase II data. While VAX-31 shares 20 serotypes with Prevnar 20 (including serotype 3), 11 are unique. VAX-31 is in Phase III trials so could come to market before PF-07872412. In terms of Pfizer’s 35-valent adult candidate (35vPnC), Pfizer’s PR implies prior generations of adult vaccine development have not been successful. Very little information exists for this programme, and it’s not included in Pfizer’s pipeline (as of May 5, 2026).

Regeneron’s fianlimab flops in Phase III advanced melanoma trial

What happened? Regeneron has announced results from a Phase III trial evaluating two dose levels of fianlimab (LAG-3 inhibitor) in combination with cemiplimab (PD-1 inhibitor) as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in PFS compared to pembrolizumab (Keytruda; Merck & Co.) monotherapy. No new safety signals were identified with the fianlimab combination. The trial enrolled 1,546 patients who were randomized to receive either: (1) 1,600 mg fianlimab and 350 mg cemiplimab (high-dose combination) every 3 weeks; (2) 400 mg fianlimab and 350 mg cemiplimab (low-dose combination) every 3 weeks; (3) placebo and 200 mg pembrolizumab every 3 weeks; or (4) placebo and 350 mg cemiplimab every 3 weeks.

What does this mean? Not the first time a pembrolizumab comparator arm has demonstrated superiority vs. the investigational regimen in solid tumour trials. In July 2024 Roche reported that the addition of tiragolumab (TIGIT; MTIG7192A) to atezolizumab (Tecentriq) and chemotherapy failed to improve PFS and OS compared with pembrolizumab plus chemotherapy in 1L locally advanced, unresectable or metastatic non-squamous NSCLC, missing the primary end points of the Phase II/III SKYSCRAPER-06 trial.  Pembrolizumab is the market-leading PD-1 inhibitor in first-line melanoma (along with a number of other indications), with a well-established efficacy profile. The trial used cemiplimab (Libtayo, Regeneron's own PD-1 inhibitor) as the combination partner but pembrolizumab as the comparator. Cemiplimab monotherapy produced a median PFS of 6.3 months (essentially the same as pembrolizumab's 6.4 months) which at least validates the control arm and confirms cemiplimab and pembrolizumab perform similarly in this setting. But it also means the trial was testing whether adding a LAG-3 antibody to a PD-1 inhibitor adds benefit over PD-1 alone, in a population where PD-1 inhibitors already work well. A separate Phase III HARMONY HEAD-TO-HEAD trial of the high dose fianlimab combination versus Opdualag (nivolumab plus relatlimab) is ongoing in the same setting. This is now the make-or-break study. If fianlimab/cemiplimab can beat Opdualag, which, as noted above, has a slightly weaker PFS hazard ratio versus its own comparator in its pivotal trial, there might still be a commercial story to tell. But that trial is some way off completion, and the failed PFS trial against pembrolizumab will cast a shadow over interpretation when those results eventually arrive. This failure continues a difficult pattern for LAG-3. Multiple companies have failed to build on the BMS precedent set by Opdualag, and the field is increasingly asking whether Opdualag's success reflects something specific about the relatlimab molecule or the nivolumab combination, rather than LAG-3 inhibition as a class. The near-miss here is particularly frustrating because it doesn't cleanly answer that question. For Regeneron, this is a blow to cemiplimab's commercial ambitions in oncology.

Relay Therapeutics posts Phase II data for zovegalisib

What happened? Relay Therapeutics has released data from its Phase II ReInspire trial of zovegalisib (RLY-2608) in patients with PIK3CA-driven vascular anomalies (i.e., abnormal development of blood vessels or lymphatic vessels), most commonly PIK3CA-related overgrowth spectrum (PROS), lymphatic malformations, and venous malformations. N=32 patients were enrolled across three dose cohorts (100mg BID, 300mg BID, 400mg BID), and 72% had previously received sirolimus and/or alpelisib, meaning this was largely a pre-treated population. In the Part 1 dose randomisation portion of the study for adults and adolescents aged 12 and over, 60% of patients achieved a volumetric response at the earliest assessment point of 12 weeks, and nearly all patients reported symptomatic improvement at that same timepoint. Investigator- and patient-reported outcome data showed 89% and 79% of patients respectively had clinical improvement at week 12. Importantly, no patients discontinued due to adverse events, and the expansion cohorts at 400mg once daily and 300mg BID cohorts are now open and enrolling. The overall tolerability profile was generally as expected and consistent with mutant-selective PI3Kα inhibition.

What does this mean? Existing approved PI3Kα inhibitors (e.g., Piqray and Itovebi) are limited by off-target toxicity from inhibiting wild-type PI3Kα, causing significant side effects including hyperglycaemia and rash. This is one of the reasons Novartis paid up to $3 billion for SNV4818, a pan-mutant‑selective PI3Kα inhibitor, from Synnovation Therapeutics in March 2026. Like SNV4818, zovegalisib targets a different site on the protein and is selective for the mutant form, which is the theoretical basis for a cleaner tolerability profile. Zero discontinuations due to adverse events in this early cohort, if it holds up, is meaningful. The Phase III ReDiscover-2 trial is where the rubber will really hit the road, with zovegalisib plus fulvestrant being tested head-to-head against capivasertib plus fulvestrant in PIK3CA-mutant HR+/HER2- breast cancer.

Sanofi’s efdoralprin alfa hits mark in Phase II AATD trial

What happened? Sanofi has announced that the Phase II ElevAATe trial has demonstrated superiority of efdoralprin alfa over standard-of-care therapy in achieving and maintaining normalised functional alpha-1 antitrypsin (fAAT) levels in adult patients with alpha-1 antitrypsin deficiency (AATD)-related emphysema. Efdoralprin alfa is a recombinant human AAT-Fc fusion protein engineered to restore protective protein levels in the blood, helping shield lung tissue from inflammatory destruction by inhibiting neutrophil elastase. The ElevAATe trial randomised N=97 patients with AATD-related emphysema 2:2:1 to efdoralprin alfa Q3W, efdoralprin alfa Q4W, or standard-of-care plasma-derived AAT augmentation therapy QW. At steady state at Week 32, the Q3W efdoralprin alfa arm achieved a mean increase in functional AAT trough levels of 24.1 μM versus 7.6 μM for plasma-derived therapy, representing superiority. All key secondary endpoints were also met.

What does it mean? Plasma-derived augmentation therapy has been the only available treatment for AATD since 1987. It requires weekly IV infusions, is manufactured from pooled human plasma which constrains supply, and does not reliably maintain patients in the normal functional AAT range even with compliant weekly dosing. This mid-stage trial suggests that efdoralprin alfa (a recombinant protein with an extended half-life) has the potential to improve clinical outcomes and compliance via less frequent dosing. Other avenues of investigation include gene therapy (e.g., Beam Therapeutics’ BEAM-302, YolTech’s YOLT-302) and RNA-editing approaches (e.g., Airna’s AIR-001). However, efdoralprin alfa is being positioned as an improved protein replacement across the broader eligible population and could reach the market sooner.

Vincentage reports Phase III data for VCT220 in obesity

What happened? Vincentage Pharma, a Chengdu-based biotech founded in 2021, has reported positive Phase III results for VCT220, an oral non-peptide small-molecule GLP-1 receptor agonist, in 840 overweight or obese Chinese adults. At 52 weeks, both the 120mg and 160mg doses achieved approximately 12.2-12.4% mean body weight reduction versus 1.3% on placebo. Discontinuation rates due to treatment-related adverse events were 1.8% in both active arms, and no hepatic safety signal or severe nausea and vomiting events were observed.

What does this mean? These data are pretty good for a Chinese company with a five-year history, and the 12% weight loss is broadly consistent with orforglipron's (Foundayo) 14.7% in ATTAIN-1 and with oral semaglutide's (Wegovy) 17% in OASIS-4, though cross-trial comparisons are unreliable given different populations and BMI cut-offs. Practically, VCT220 could have an edge as it’s described as requiring no food restrictions, fixed dosing timing, refrigeration, or light protection, with a six-week titration period. Oral semaglutide (Wegovy pill) requires administration on an empty stomach with specific water requirements, which has real-world adherence implications. Corxel Pharmaceuticals acquired ex-Greater China rights to VCT220 (previously called CX11) in December 2024 and is running a Phase II study in the US. Whether Corxel has the commercial infrastructure and capital to compete with Eli Lilly and Novo Nordisk remains to be seen, but VCT220 has genuine scientific credibility.

Regulatory

AstraZeneca’s Baxfendy gets FDA nod for uncontrolled hypertension

What happened? The FDA has approved Baxfendy (baxdrostat) as the first aldosterone synthase inhibitor for the treatment of hypertension in adults not adequately controlled on existing antihypertensive medications. The approval is based on the Phase III BaxHTN trial, published in the NEJM, in which baxdrostat 2mg produced an absolute reduction from baseline in seated systolic blood pressure of 15.7 mmHg and a placebo-adjusted reduction of 9.8 mmHg at 12 weeks in patients with uncontrolled or resistant hypertension on two or more medications. Both the 2mg and 1mg doses met the primary endpoint with high statistical significance. Data from the Phase III Bax24 trial, published in The Lancet, also demonstrated a statistically significant reduction in 24-hour ambulatory systolic blood pressure in resistant hypertension. Recall, AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma in February 2023.

What does this mean? The existing tool kit for treating hypertension (e.g., ACE inhibitors, ARBs, renin inhibitors, CCBs, beta blockers, and thiazide diuretics) is well established but leaves a substantial proportion (about 23 million US patients, according to the PR) of patients uncontrolled. Baxdrostat addresses a specific and well-validated upstream driver of treatment-resistant hypertension (i.e., excess aldosterone production) in a way that existing drug classes do not. The near-double-digit placebo-adjusted SBP reduction of 9.8 mmHg is clinically meaningful. As cited in the press release and supported by published meta-analyses, a 10 mmHg reduction in systolic blood pressure is associated with approximately 20% lower risk of major adverse cardiovascular events. In addition to uncontrolled hypertension, baxdrostat is being studied in combination with dapagliflozin for CKD and hypertension in the Phase III BaxDuo-Pacific outcomes trial, and in the Prevent-HF trial for prevention of heart failure. If these studies succeed, AstraZeneca will have an asset with applications spanning hypertension, resistant hypertension, CKD, and heart failure prevention, which is a very substantial cardiorenal franchise built around a single mechanism. The one notable absence from the press release is an EU regulatory timeline. A UAE approval was previously reported, but no EMA submission date or anticipated EU decision is mentioned.

Chugai’s alectinib gains tumour-agnostic approval in Japan

What happened? Japan's MHLW has approved alectinib (Alecensa; Chugai/Roche) for a new tumour-agnostic indication covering advanced or recurrent ALK fusion gene-positive solid tumours in both adult and paediatric patients. This is the world's first tumour-agnostic approval for an ALK inhibitor and, notably, the first tumour-agnostic therapy anywhere to explicitly cover paediatric patients. The approval is based on the Phase II TACKLE study, an investigator-initiated Japanese study evaluating alectinib across rare cancers harbouring ALK gene abnormalities. In the ALK fusion gene-positive subpopulation across all cohorts (the key basis for approval) the response rate was 76.5% (13/17 patients, 95% CI: 50.1-93.2%). FoundationOne CDx is approved as the companion diagnostic.

What does this mean? The concept of treating cancer based on molecular alteration rather than tissue of origin is not new and has been validated by entrectinib (Rozlytrek; Roche) and larotrectinib (Vitrakvi; Bayer) in NTRK fusions and by pembrolizumab in MSI-H/TMB-H tumours. Alectinib's approval extends this model to ALK, a target already well validated in NSCLC, and demonstrates that ALK fusions in rarer tumour types respond to the same inhibitor at clinically meaningful rates. The paediatric dimension is important as ALK fusions occur in paediatric cancers including inflammatory myofibroblastic tumours, and children with ALK-positive rare cancers have historically had very limited targeted treatment options. This approval is a meaningful advance for a patient population that rarely features in oncology approvals. Alecensa is already approved in over 100 countries for ALK-positive NSCLC. A tumour-agnostic label, beginning in Japan with broader submissions likely to follow, extends the addressable population to ALK fusion-positive cancers beyond NSCLC, including breast, colorectal, and inflammatory myofibroblastic tumours, without requiring new development programmes for each tumour type individually. The caveat is that the TACKLE dataset is small (n=26 patients total, 17 evaluable in the ALK fusion-positive pooled population) which is consistent with the rarity of these tumours but means the evidence base will need to grow through post-marketing data collection.  

Pressure mounts on Amgen as Tavneos linked to 20 deaths in Japan

What happened? Citing a Japanese safety alert from Kissei Pharmaceutical, Amgen’s Japanese partner in charge of distributing Tavneos, BioSpace has reported that 20 patients on Tavneos have died since the drug’s Japanese launch in 2022. Most of the deaths were linked to vanishing bile duct syndrome (VBDS), a complication of drug-induced liver injury (DILI). It’s not clear if Tavneos was the direct cause of the deaths, but Kissei has discouraged doctors from giving the drug to new patients and recommended informing patients already on treatment of the liver risks potentially linked to the product. In its own statement, Amgen sought to provide context to these deaths. Kissei’s report flagged 20 deaths “from over 8,500 patients who have been treated with Tavneos in Japan,” Amgen said. “These figures include cases for which a causal relationship with the product could not be determined.” Amgen also confirmed that “there have been no known deaths in the US linked to serious liver injury, including VBDS, in the more than 8,000 patients in the US treated with Tavneos.”

What does this mean? Cumulatively, things seem to be stacking up against Tavneos. Alleged data manipulation underpinning the original approval, an FDA proposal to withdraw the drug from the US market, the FDA identifying 76 cases of VBDS and eight deaths in US patients with reasonable evidence of causal association with Tavneos, and now 20 deaths in Japan prompting Kissei to actively discourage new prescriptions. Amgen's position, that Tavneos "demonstrates effectiveness and a favorable benefit-risk profile," is becoming increasingly difficult to defend. More broadly, this is a case study in the critical importance of post-marketing safety monitoring, and why the regulatory system's ability to act on those signals after approval is as important as the pre-approval review process.

Commercial

Eli Lilly acquires Engage Biologics for up to $202 million

What happened? Eli Lilly has acquired Engage Biologics (Engage), a preclinical biotechnology company pioneering non-viral DNA delivery, for up to $202 million, which includes an upfront payment and milestone payments. Engage is developing the Tethosome platform, a novel non-viral DNA delivery system designed to overcome key limitations in DNA delivery, including potency, tolerability, and redosability. The platform combines engineered DNA payloads with lipid nanoparticle delivery and an mRNA-encoded proprietary Tethosome technology designed to enhance localisation and increase expression. Engage’s DNA payloads are further engineered to improve tolerability while retaining key advantages of DNA-based therapies, including durability and programmability.

What does this mean? The non-viral DNA delivery space has been the promised land of genetic medicine for years and consistently disappoints in practice. Viral vectors (e.g., AAV) have been the vehicle of choice for gene therapy because they’re efficient at getting DNA into cells and into the nucleus, but they carry significant limitations (e.g., manufacturing complexity, immunogenicity, limited payload capacity, and the near impossibility of redosing once the patient has developed antibodies to the vector). Non-viral approaches (e.g., lipid nanoparticles, naked DNA plasmids, or electroporation) have largely solved the delivery-to-cell problem but consistently struggled with the nuclear localisation step for DNA specifically. This is why non-viral delivery has been far more successful for mRNA (which works in the cytoplasm) than for DNA therapies. If the mRNA-encoded Tethosome component improves nuclear localisation, that addresses a specific technical bottleneck that has prevented the field from evolving. The redosability angle is also compelling. If you’re not using a viral vector, there is no antibody response to the delivery vehicle, so in principle you can dose repeatedly. For chronic diseases this will support long-term treatment. The Cystic Fibrosis Foundation's involvement is telling because CF has been one of the most active proving grounds for non-viral pulmonary gene therapy, partly because the lung is accessible.

Eton Pharma gains US commercial rights to Impavido

What happened? Eton Pharmaceuticals (Eton) has entered into a supply and distribution agreement for the US commercialisation rights to Impavido (miltefosine) from an affiliate of Knight Therapeutics (Knight), most likely Profounda (see below for why). Impavido is an orphan drug indicated for the treatment of visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species in adults and adolescents over the age of 12 and weighing more than 30kg. Miltefosine is an oral alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. According to Tradingview, Eton will pay $4.25 million in fixed fees through March 31, 2032, plus up to $4 million in sales milestones, and will remit 55% of annual net sales up to $7.0 million and 50% above that. 

What does this mean? Originally developed as a treatment for cancer in the 1990s, miltefosine’s route to market has been controversial. Scientifically, it was considered a breakthrough in the treatment of leishmaniasis. Commercially and politically, it became an example of how a drug can be successfully developed yet still fail to reliably reach the patients who need it most. Miltefosine was originally launched as a treatment for leishmaniasis in India in 2002. Its availability made it feasible to eliminate a regional disease. As a result of its importance, miltefosine was included on the WHO’s Essential Medicines List in 2011. Fast-forward a few years, miltefosine was approved by the FDA in March 2014. As part of that approval, Knight received an FDA priority review voucher (PRV) which it could use to gain expedited review for any new drug application. The FDA PRV scheme, a target of significant criticism in recent years, is an incentive that aims at rewarding R&D for new treatments for neglected diseases, including tropical diseases. In November 2014, Knight sold the PRV to Gilead for $125 million. What’s perhaps worth highlighting at this point is that the R&D for miltefosine was largely funded from private and public sources (e.g., WHO/TDR). As Knight did not invest any significant resources into the development of miltefosine, it begs a moral (and perhaps ethical) question as to how Knight could benefit to the tune of $125 million after selling its PRV to Gilead. Thoughts on a postcard, please. In September 2015 Knight entered into an exclusive distribution agreement with Profounda to commercialise miltefosine in the US. Profounda launched miltefosine in the US in March 2016. Profounda is likely to be the affiliate Knight talks about in its PR. One would hope that new ownership brings fresh perspectives on pricing and patient access. Fingers crossed this isn’t another Turing Pharmaceuticals.

Regeneron, Parabilis ink antibody-peptide conjugate R&D pact

What happened? Regeneron has entered a multi-target research collaboration with Parabilis Medicines to discover and develop Antibody-Helicon Conjugates (AHCs). Parabilis receives $50 million upfront and a $75 million equity commitment from Regeneron, with up to approximately $2.2 billion in milestone payments across five initial targets plus tiered royalties up to low double digits. Regeneron takes responsibility for development, manufacturing, and worldwide commercialisation of any resulting candidates. Additional targets can be added via option payments.

What does this mean? This deal comes at a moment when one of Regeneron’s near-term clinical programmes has disappointed (see Regeneron’s fianlimab flops in Phase III advanced melanoma trial). The AHC concept takes ADC delivery logic and replaces the cytotoxic payload with a Helicon designed to modulate a specific intracellular protein rather than kill the cell. If it works, it could open an entirely new category of druggable targets rather than compete in existing spaces. The caveat is the same one that applies to all platform deals at this stage. Helicons have not yet demonstrated clinical PoC, and the history of novel delivery mechanisms, including many that sounded compelling at the research collaboration stage, is littered with programmes that worked in preclinical models but failed to translate (e.g., cell penetrating peptides, stapled peptides, SMAC mimetics, etc.). The $50 million upfront is a credible validation signal, but the $2.2 billion headline figure is entirely back-end loaded on clinical and commercial success that is years away at best.

In Other News

AstraZeneca’s Fasenra gets FDA nod for hypereosinophilic syndrome​

AstraZeneca’s Fasenra (benralizumab; anti-IL-5) has been approved by the FDA for the treatment of adult and paediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. The approval was based on positive results from the Phase III NATRON trial that evaluated the efficacy and safety of benralizumab in patients with HES. In the trial, treatment with benralizumab delayed the time to first HES flare and significantly reduced the risk of first HES flare compared to placebo by 65%.

Boehringer Ingelheim’s Jascayd gets MHLW nod for IPF and PPF

Japan's MHLW has approved nerandomilast (Jascayd; Boehringer Ingelheim) for the treatment of adults with IPF and PPF, making Japan the fourth market to approve it after the US, China, and the UAE. The approval is supported by the Phase III FIBRONEER-IPF and FIBRONEER-ILD trials. In FIBRONEER-IPF, nerandomilast 18mg produced a 68.8mL improvement in absolute FVC change versus placebo at 52 weeks, and in FIBRONEER-ILD the equivalent figure was 67.2mL for the 18mg dose. The most common adverse event was diarrhoea, occurring in 41.3% of the 18mg group versus 16.0% on placebo in the IPF trial. Importantly, the key secondary composite endpoint of acute exacerbation, hospitalisation, or death was not met in either trial. However, a pooled analysis across both trials showed a 59% reduction in risk of death in the 18mg group without existing treatment versus placebo, with a nominally significant difference. Recall, nerandomilast is an oral PDE4B inhibitor with antifibrotic and immunomodulatory effects.

Dr Reddy’s Labs launches generic semaglutide in Canada

Dr. Reddy’s Labs has announced the launch of generic semaglutide injection in Canada. Dr. Reddy’s launch comes after Apotex launched its generic version of semaglutide injection earlier in May 2026. Soon after the launch, digital health providers Phoenix and Raven announced the launch of generic semaglutide for direct-to-patient access in Canada. Prices will start at $124.99. Ozempic is currently priced between $200-$450 per month, depending on where a patient lives and the pharmacy they select.

EC approves Sandoz’s insulin lispro and insulin aspart biosimilars

Sandoz has announced that the EC has approved Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, were developed by Gan & Lee Pharmaceuticals. Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults and children, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more. Both biosimilar insulins have equivalent efficacy and comparable safety to their respective reference medicines, Humalog and NovoRapid.

Enhertu set to reshape early HER2+ breast cancer treatment

The FDA has approved AstraZeneca/Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan) for two additional, early-stage HER2-positive breast cancer indications. Approval was based on data from the based on DESTINY-Breast11 and DESTINY-Breast05. In the neoadjuvant setting, Enhertu followed by taxane, trastuzumab, and pertuzumab achieved a pathological complete response rate of 67.3% versus 56.3% with standard AC followed by THP in high-risk Stage II/III disease. In the adjuvant setting, Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 in patients with residual invasive disease after neoadjuvant HER2-targeted therapy, with three-year IDFS of 92.4% versus 83.7%.

Exelixis, Merck & Co. collaborate on a Phase III CRC trial

Exelixis and Merck & Co. have announced that the companies will collaborate on the Phase III STELLAR-316 trial which will evaluate zanzalintinib, Exelixis’ novel oral kinase inhibitor, with and without pembrolizumab (Keytruda; Merck & Co.), in patients with resected stage II/III colorectal cancer (CRC). Under the terms of the collaboration, Exelixis is sponsoring the STELLAR-316 pivotal trial, and Merck & Co. will supply Keytruda QLEX (pembrolizumab and berahyaluronidase alfa). The primary endpoint of STELLAR-316 is disease-free survival, with key secondary endpoints including circulating tumour DNA clearance. Exelixis expects to initiate STELLAR-316 in mid-2026.

FDA approves first golimumab biosimilar

The FDA has approved Immgolis (golimumab, subQ) and Immgolis Intri (golimumab, IV) as the first biosimilars to Simponi and Simponi Aria, respectively. Both carry interchangeable designation for their approved indications. Immgolis is approved for moderately to severely active rheumatoid arthritis in combination with methotrexate and for moderately to severely active ulcerative colitis. Immgolis Intri is approved for moderately to severely active rheumatoid arthritis in combination with methotrexate. Commercial launch is planned for Q4 2026. The biosimilar was developed by China’s Bio-Thera Solutions and Accord BioPharma, the US specialty division of India's Intas Pharmaceuticals. Accord BioPharma holds exclusive US commercialisation rights.

Formycon launches two aflibercept biosimilars in Europe

Formycon and its licensing partner Klinge Biopharma GmbH (Klinge) have announced the launch of its aflibercept biosimilar, FYB203, in the European Union. The market launch of the Ahzantive and Baiama pre-filled syringes through multiple commercialisation partners began on May 15, 2026, in key European markets such as Germany, France, and Italy. The rollout in additional Central and Eastern European countries will take place step by step over the coming weeks and months. In March 2026, Formycon entered into a settlement and licensing agreement with Regeneron and Bayer, ensuring the market launch in Europe. Formycon launched its aflibercept biosimilar in the US in October 2025.

GSK’s Arexvy gets MHLW nod for high risk 18-49 year olds

Japan's MHLW has expanded the approved indication for Arexvy to include adults aged 18-49 at increased risk for RSV disease, having previously approved it for all adults aged 60 and older and for adults aged 50-59 at increased risk. The prescribing information has also been updated to explicitly include immunocompromised patients as a recognised increased risk group. The expansion was supported by a Phase IIIb immunogenicity bridging study demonstrating non-inferior immune response in the 18-49 at-risk population versus adults aged 60 and older, rather than a new efficacy trial. Vaccine efficacy rests on the earlier Phase III AReSVi-006 programme.

Microbiotica posts positive Phase I data for MB097 in melanoma

Microbiotica, a company developing a pipeline of oral microbiome medicines, has announced that all primary and secondary objectives were met in its Phase Ib MELODY-1 trial. MELODY-1 was an open-label study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab (Keytruda, Merck & Co.) in patients with advanced melanoma who demonstrated primary resistance to anti-PD-1 therapy. MB097 is a once daily, orally administered therapy consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors. 

Samsung Bioepis launches its ustekinumab biosimilar in Japan

Samsung Bioepis has launched Ustekinumab BS 45 mg Syringe for S.C. Injection (NIPRO), a biosimilar referencing Stelara (ustekinumab; J&J), marking its first product launch in Japan under the partnership with Nipro Corporation. The launch follows the Official Gazette announcement on May 19 regarding the product’s listing under the National Health Insurance (NHI) Drug Price Standard.

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.