Pharma Phriday (April 17, 2026)

Pharma Phriday is a comprehensive weekly update on the pharmaceutical industry, covering clinical trial results, regulatory approvals, corporate development activity, and other significant developments.

In this week’s note:

Clinical

• BioNTech/DualityBio’s trastuzumab pamirtecan posts Phase II EC win

• Boehringer Ingelheim partners with Zai Lab on oncology R&D

• Cosmo Pharma reports positive Phase III data for clascoterone in AGA

• Eli Lilly’s Jaypirca extends PFS in previously treated CLL/SLL

• GSK presents positive data for B7‑H4‑targeted ADC

• IDEAYA and Servier post positive data for darovasertib in mUM

• Revolution Medicines posts positive Phase III data for daraxonrasib

• Spyre posts positive Phase II data for SPY001 in ulcerative colitis

• SynOx posts positive Phase III data for emactuzumab in TGCT

Regulatory

• BeOne wins China approval for Amgen’s lung cancer drug, Imdelltra

• Dupixent receives EU approval for CSU in young children

Commercial

• AbbVie licenses acute pain treatment duo from China’s Haisco

• Beeline Medicines announces funding, pipeline and leadership

• BMS partners with Oxford Biotherapeutics on TCEs

• Eli Lilly acquires CrossBridge Bio for $300 million

• Novo Nordisk and OpenAI partner on AI transformation

• Regeneron and Telix to collaborate on radiopharmaceuticals

• Tempus partners with Gilead on advanced oncology R&D

In Brief

• AbbVie’s Elahere succeeds in Phase II PSOC trial

• Bayer wins MHRA approval for Kerendia in heart failure

• Genmab posts updated Phase I/II data for rinatabart sesutecan

• GSK completes acquisition of 35Pharma Inc.

• GSK pulls application for leucovorin…again

• Ifinatamab deruxtecan granted FDA priority review for ES‑SCLC

• McKinsey to pay $125 million as part of Purdue's bankruptcy settlement

• MHRA releases new portal for reporting defective medicines

• Obsidian and Galera announce $350 million merger agreement

• Samsung Bioepis’ nectin‑4 targeting ADC, SBE303, enters Phase I trials

• Vir Biotechnology’s VIR‑5500 hits Phase I dose escalation cohort

Summary

This week's edition of Pharma Phriday covers key developments across clinical, regulatory, and commercial activity. The overall picture is one of continued momentum in oncology, selective expansion in immunology and rare disease, and a pharma sector increasingly willing to place larges bets on both next-generation biologics and AI partnerships.

The week's most significant clinical readout came from Revolution Medicines’ daraxonrasib which roughly doubled mOS in 2L pancreatic cancer compared to standard chemotherapy (13.2 months versus 6.7 months). IDEAYA/Servier also reported a compelling Phase II/III win for darovasertib plus crizotinib in HLA-A*02:01-negative mUM, an indication with no currently approved targeted therapy, more than doubling PFS over immunotherapy. Elsewhere, Eli Lilly's pirtobrutinib extended PFS in relapsed CLL when combined with venetoclax and rituximab, its fourth positive Phase III dataset in the disease. BioNTech/DualityBio reported Phase II data for trastuzumab pamirtecan across all HER2 expression levels in EC, supporting what would be BioNTech's first oncology regulatory filing. SynOx Therapeutics added a positive Phase III result for emactuzumab in TGCT, positioning it as a short-course alternative to pexidartinib.

Regulatory progress was also reported by several companies. Sanofi/Regeneron’s Dupixent received EU approval for CSU in children aged 2-11 years, the first targeted medicine for this age group in the EU and an extension of an already substantial franchise. Amgen's tarlatamab (Imdelltra) won approval in China for ES-SCLC, opening access to roughly 15% of global cases. GSK presented early but striking Phase I data for its B7-H4 targeting ADC mocertatug rezetecan, with confirmed response rates above 60% in platinum-resistant ovarian and endometrial cancer; five Phase III trials are planned for 2026.

Deal activity reflected three running themes. ADCs continued to attract large investment, with Eli Lilly acquiring CrossBridge Bio for up to $300 million to add a TROP2-targeting dual-payload ADC. Radiopharmaceuticals drew further attention via a Regeneron/Telix collaboration combining antibody expertise with radiopharmaceutical manufacturing across four initial programmes. And AI partnerships continued to broaden in scope, with Novo Nordisk's enterprise-wide transformation deal with OpenAI a prime example. Other deals include AbbVie’s $30 million upfront licencing deal for two NaV1.8 inhibitors from China's Haisco, entering a class validated by Vertex's suzetrigine. Beeline Medicines, the BMS and Bain Capital immunology spin-out, officially launched with a $300 million Series A and five BMS-originated assets.

Clinical

BioNTech/DualityBio’s trastuzumab pamirtecan posts Phase II EC win

What happened? BioNTech has announced positive results from the primary analysis of a Phase II cohort evaluating trastuzumab pamirtecan (BNT323/DB-1303) in patients with HER2-expressing, advanced endometrial cancer (EC) whose disease progressed on or after first-line chemotherapy with or without prior checkpoint inhibitor treatment. This cohort is part of a global Phase I/IIa clinical trial investigating the HER2-targeted ADC in multiple solid tumours. The data demonstrated clinically meaningful efficacy and a manageable safety profile for trastuzumab pamirtecan monotherapy across all HER2 immunohistochemistry (“IHC”) expression levels (IHC1+, IHC2+, IHC3+). Outcomes were consistent among patients regardless of prior checkpoint inhibitor treatment. The confirmatory Phase III Fern-EC-01 trial evaluating trastuzumab pamirtecan monotherapy compared to chemotherapy in previously treated patients with HER2-expressing, recurrent EC is ongoing.

What does this mean? For BioNTech, this readout is strategically significant as the results will form the basis for a planned BLA submission in 2026 and would mark the company's first ever oncology regulatory filing. Quite a milestone as it works to build a commercial pipeline beyond its COVID-19 franchise. However, this is a single-arm Phase II cohort, not a randomised trial, so the absence of a direct comparator limits any conclusions that can be made. The confirmatory Phase 3 Fern-EC-01 trial will be decisive for full approval. On balance, this is a robust data package that positions BioNTech credibly in the HER2-targeted gynaecological oncology space.

Boehringer Ingelheim partners with Zai Lab on oncology R&D

What happened? Boehringer Ingelheim and Zai Lab have announced a clinical collaboration focused on assessing a dual DLL3-targeting combination. The Phase Ib/II study will assess the safety, tolerability, and initial clinical activity of combining obrixtamig, Boehringer Ingelheim’s DLL3/CD3 T-cell engager, with zocilurtatug pelitecan, Zai Lab’s DLL3-targeting ADC. The study will enroll patients with poorly differentiated neuroendocrine carcinomas (NECs) and extensive stage SCLC (ES-SCLC). Both obrixtamig (DAREON-Lung-1) and zocilurtatug pelitecan (DLLEVATE) are being assessed in individual Phase III studies. Under the terms of the agreement, Zai Lab will supply zocilurtatug pelitecan, while Boehringer Ingelheim will sponsor and oversee day‑to‑day clinical operations. Each company retains the rights to its respective assets.

What does this mean? The hypothesis is that these two assets might work synergistically, with the ADC killing tumour cells directly while the T-cell engager activates an immune response. For Boehringer Ingelheim the deal with Zai Lab represents another way of finding the optimal combo partner for obrixtamig. Only last week Boehringer Ingelheim announced would be partnering with BioNTech and assessing the combo of obrixtamig with BioNTech’s pumitamig (PD-L1/VEGF-A bsAb) in ES-SCLC.

Cosmo Pharma reports positive Phase III data for clascoterone in AGA

What happened? Cosmo Pharmaceuticals has announced positive 12-month Phase III results for clascoterone 5% topical solution in men with mild-to-moderate androgenetic alopecia (AGA). The data confirm long-term safety, continued efficacy with ongoing use, and a novel mechanism designed to target the underlying biology of hair loss. The Phase III program, composed of SCALP 1 and SCALP 2 pivotal studies, enrolled 1,465 subjects across 51 study centres in the US and Europe, thereby making it the largest Phase III clinical program ever conducted for a topical treatment in male AGA. The 12 month extension evaluated long-term safety and durability of effect in patients who were responders in the first 6-month study period (Part 1) and could therefore participate in Part 2, where they were re-randomized to either continue clascoterone 5% solution or switch to vehicle for the additional 6-month treatment period. Clascoterone 5% topical solution leverages the same active ingredient used in Winlevi, Cosmo’s FDA and EMA approved topical acne treatment.

What does this mean? Current treatments for androgenetic alopecia (pattern hair loss) focus on slowing hair loss and promoting regrowth. Options include topical minoxidil foam/liquid (either as Rogaine or generics) and oral finasteride (Propecia). Key R&D focus areas include non-hormonal approaches (e.g., PP405 from Pelage Pharmaceuticals), thyromimetics (e.g., TDM-105795 from TechnoDerma Medicines), and multiple new pathways (e.g., Wnt signalling agonists (e.g., Biosplice Therapeutics’ dalosirvat) and cGMP-enzyme regulation (Topadur Pharma's TOP-M119). Veradermics’ is also developing VDPHL01, an orally dosed, extended-release minoxidil tablet.

GSK presents positive data for B7-H4-targeted ADC

What happened? GSK has announced positive findings from its Phase I BEHOLD-1 clinical trial for mocertatug rezetecan (Mo-Rez), a novel ADC targeting the B7-H4 antigen. At the highest doses evaluated, Mo-Rez monotherapy achieved confirmed objective response rates (cORR) of 62% in platinum-resistant ovarian cancer (PROC) and 67% in recurrent or advanced endometrial cancer (EC). Currently, there are limited treatment options with modest response rates for patients with PROC and advanced EC. B7-H4 is an immune checkpoint that is widely expressed in ovarian and endometrial cancers and is low in normal tissues, providing potential for a differentiated precision-therapy. The response to Mo-Rez observed across a range of B7-H4 expression levels reinforces its broad potential in gynaecologic cancers and further validates the relevance of targeting B7-H4. Recall, GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to Mo-Rez from Hansoh Pharma in October 2023.

What does this mean? Targeting the B7-H4 antigen has emerged as a promising strategy in cancer treatment because it’s a key immune checkpoint molecule that cancers exploit to evade immune surveillance, specifically by shutting off the anti-tumour activity of T cells. By blocking B7-H4, therapies can reverse this immunosuppression, reactivating the body's immune system to recognize and destroy cancer cells. According to GSK’s PR, Mo-Rez will advance to five pivotal global Phase III trials in 2026, starting with BEHOLD-Ovarian01 (PROC) and BEHOLD-Endometrial01 (2L EC). Additional Phase III studies will evaluate Mo‑Rez in PSOC, 1L maintenance settings for OC without homologous recombination deficiency (BEHOLD-Ovarian03) and mismatch‑repair–proficient endometrial cancer (BEHOLD-Endometrial02). Other companies developing B7-H4 targeting assets in similar treatment settings include AstraZeneca (puxitatug samrotecan), Day One Bio (emiltatug ledadotin), while Pfizer discontinued the development of felmetatug vedotin in February 2025.

IDEAYA and Servier post positive data for darovasertib in mUM

What happened? IDEAYA Biosciences and Servier have announced positive topline results from their Phase II/III OptimUM-02 trial, evaluating darovasertib in combination with crizotinib (Xalkori) in patients with 1L HLA-A*A2:01-negative metastatic uveal melanoma (mUM). The darovasertib/crizotinib combo met the trial's primary endpoint of a statistically significant improvement in median PFS relative to the investigator choice of therapy arm (which included 76% ipilimumab/nivolumab combo, 24% pembrolizumab mono) as assessed by blinded independent central review. The secondary endpoints in the study include ORR and DOR. The darovasertib/crizotinib combo arm of the trial (n=210) achieved mPFS of 6.9 months (p<0.0001) vs. 3.1 months in the ICT arm (n=103). The secondary endpoint of ORR by BICR in the darovasertib/crizotinib combo arm was 37.1% (p<0.0001) vs. 5.89% for the ICT arm. The combo arm also achieved 5 CRs and mDOR of 6.8 months. OS data appear to be positive but are not mature enough yet, and there were no surprises on safety.

What does this mean? While there is an approved treatment for HLA-A*02:01-positive mUM (tebentafusp; Immunocore), there are currently no FDA-approved targeted or immune-systemic therapies specifically indicated for HLA-A*02:01-negative mUM, representing a high unmet need. Treatment for this cohort often relies on clinical trials, as in the case of the OptimUM-02 trial, or standard, less effective options like immunotherapy (e.g., ipilimumab, nivolumab or pembrolizumab) and liver-directed therapies (e.g., percutaneous hepatic perfusion with melphalan, transarterial chemoembolization, or radioembolization). During a conference call to discuss the data, Dr Meredith McKean (Sarah Cannon Research Institute) said that “this is just a huge day for patients with metastatic uveal melanoma. I think darovasertib is going to be an exciting option for those patients.”

Eli Lilly’s Jaypirca extends PFS in previously treated CLL/SLL

What happened? Eli Lilly has announced positive topline results from the Phase III BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL). Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy until their disease progresses. The study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in PFS, as assessed by an independent review committee (IRC). Results were consistent across clinically relevant subgroups and regardless of whether patients were previously treated with a covalent BTK inhibitor. OS, a key secondary endpoint, was not yet mature at this analysis. The overall safety profile of this regimen was consistent with the known safety profile of each medicine. Rates of adverse events were similar across the study arms, with low rates of treatment regimen discontinuations, also similar between arms.

What does this mean? Pirtobrutinib has now generated four positive Phase III datasets in CLL, covering post-covalent BTK inhibitor patients, treatment-naïve patients, a head-to-head comparison with ibrutinib, and now this data in combination with venetoclax and rituximab in the relapsed or refractory setting. Taken together, Eli Lilly is covering all major treatment paradigms, including continuous monotherapy, frontline, post-BTKi, and fixed-duration combinations. This data will now put pressure on AstraZeneca which had its Calquence (acalabrutinib) plus venetoclax combo approved by the in February 2026 as the first all-oral, fixed-duration combination regimen for first-line CLL. Both events show that there’s a growing preference for fixed-duration regimens as patients and clinicians weigh the convenience and reduced toxicity burden of time-limited approaches against the durability of continuous BTK inhibitor monotherapy. More colour is needed before any firm conclusions can be made, however. OS data are not yet mature, which limits the strength of clinical conclusions for now. The safety profile was described as consistent with the known profile of each individual agent, but the cumulative toxicity burden of a multi-drug regimen deserves scrutiny.

Revolution Medicines posts positive Phase III data for daraxonrasib

What happened? Revolution Medicines has announced positive topline results from its Phase III RASolute 302 clinical trial evaluating daraxonrasib in 2L metastatic pancreatic ductal adenocarcinoma (PDAC). Daraxonrasib works by suppressing RAS signalling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. Daraxonrasib taken orally once daily demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care cytotoxic chemotherapy delivered intravenously. In the overall (ITT) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). Daraxonrasib was generally well tolerated, with a manageable safety profile and with no new safety signals.

What does this mean? Data interpretation and nuance aside, this is a significant outcome in the treatment of PDAC. While PDAC trials have historically struggled to push median OS much beyond 12 months, daraxonrasib’s 13.2 month OS in a 2L setting represents one of the most impressive survival signals seen in this disease, particularly given the magnitude of benefit vs. standard chemotherapy. One potential question, however, is why earlier daraxonrasib datasets (reported in September 2025) hinted at OS up to ~15–16 months in later-line settings? This drop likely reflects normalisation from small, enriched cohorts to a global ITT population, rather than a loss of efficacy. Other developments to watch in the PDAC space include Immuneering which reported updated data on atebimetinib in 1L PDAC that suggested a 64% OS rate at 12 months.

Spyre posts positive Phase II data for SPY001 in ulcerative colitis

What happened? Spyre Therapeutics has announced positive 12-week induction data from Part A of the Phase II SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 mAb being investigated for the treatment of moderate-to-severely active ulcerative colitis (UC). The company described a 40% clinical remission rate and a 51% endoscopic improvement rate as clinically meaningful and claimed they supported SPY001’s potential best-in-class profile. SPY001 was well tolerated with a safety profile consistent with the α4β7 class. There were six subjects with TEAEs during the induction treatment period, with one SAE, deemed not drug related. The most common AE (occurring in ≥ 2 patients) was back pain (n=2).

What does this mean? Despite SPY001 targeting the same epitope as vedolizumab (Entyvio; Takeda), Spyre claims that due to SPY001 having a 3-fold greater half-life compared to vedolizumab it could potentially be dosed subQ on a quarterly or biannual basis compared to Entyvio’s fortnightly dosing. This would be significant because patients treated with Entyvio IV need to attend hospital every couple of weeks for initial treatment (induction) then every 6-8 weeks for maintenance, depending on if being treated with IV or subQ Entyvio. Spyre has not yet advanced SPY001 into Phase III, instead prioritising Phase II trials to identify the optimal monotherapy or combinations. This suggests the company is less focused on rapid progression of a single asset and more on selecting the best regimen/combo before committing to pivotal development.

SynOx posts positive Phase III data for emactuzumab in TGCT

What happened? SynOx Therapeutics has announced positive topline results from the pivotal Phase III TANGENT study of emactuzumab in adult patients with tenosynovial giant cell tumour (TGCT). Emactuzumab is a targeted CSF-1R inhibitor being developed as a short-course treatment for patients with TGCT, which is designed to deliver rapid and durable disease control without the need for continuous treatment. Results across the primary and key secondary endpoints demonstrated clinically meaningful and statistically significant benefit of emactuzumab treatment, including measures of tumour volume reduction and patient-reported and functional outcomes, including PROMIS-PF, physical function, pain, range of motion, and stiffness. Importantly, these benefits were achieved rapidly in the short-course treatment cycle, were durable and were observed across clinically relevant patient segments. Emactuzumab also demonstrated a manageable safety profile, consistent with prior clinical experience.

What does this mean? Despite being a benign disease, diffuse TGCT represents a significant unmet need due to high recurrence rates and the morbidity associated with repeated synovectomies. The FDA approval of pexidartinib (Turalio; Daiichi Sankyo) in August 2019 based on data from the Phase III ENLIVEN trial validated CSF1R as a target, but safety constraints have limited its broad adoption. This created a clear opportunity for next-generation inhibitors to expand the market by offering safer, more durable, and potentially earlier-line treatment options. While pexidartinib and emactuzumab both target CSF1R, they reflect fundamentally different treatment paradigms. Pexidartinib was developed as a continuous therapy requiring sustained pathway inhibition, with efficacy assessed during ongoing treatment. In contrast, emactuzumab is positioned as a short-course intervention designed to induce durable tumour control after treatment cessation, with trial design explicitly incorporating an off-treatment observation period. As such, the key question is if TGCT can be managed as a chronic disease requiring continuous suppression or as a condition amenable to finite, disease-modifying therapy. Data from the Phase III TANGENT study suggest the latter.

Regulatory

BeOne wins China approval for Amgen’s lung cancer drug, Imdelltra

What happened? Amgen's lung cancer drug tarlatamab (Imdelltra; DLL-3/CD3 targeted bispecific T-cell engager) has won ‌approval from China's National Medical ‌Products Administration (NMPA) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) that has progressed after platinum-based chemotherapy. There’s no mention of what data supported the approval, but it’s assumed to come from the Phase III DeLLphi-304 trial, a multicenter, randomised, open-label trial in patients with SCLC with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody. 

What does this mean? With ~160,000 new cases of SCLC annually, China represents roughly 15% of global cases, creating a critical growth market for Imdelltra. Recall, the NMPA accelerated the approval using priority review and conditional market authorisation mechanisms, reflecting the high unmet need for hard-to-treat small cell lung cancer in China. Imdelltra’s approval in China follows other western pharmas gaining approvals in China, including Exdensur (GSK; asthma), Enhertu (Daiichi Sankyo/AstraZeneca; HER2+ GEJ), and Nucala (GSK; COPD).

Dupixent receives EU approval for CSU in young children

What happened? The European Commission (EC) has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2-11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-IgE therapy (e.g., omalizumab) for CSU. The approval in the EU is based on data from the LIBERTY-CUPID clinical study programme. This includes an extrapolation of efficacy data in adults from two Phase III studies (Study A and Study C; NCT04180488) complemented by PK, safety, and efficacy data from the single-arm Phase III CUPIDKids study in children aged two to 11 years with CSU (NCT05526521). Data from the LIBERTY-CUPID clinical study programme has been published.

What does this mean? Never in doubt following the CHMP’s positive recommendation in February 2026, and Dupixent’s November 2025 approval in adults and adolescents aged 12 years and older. Moreover, Dupixent is now the first and only targeted medicine in the EU for this vulnerable young population who do not respond to standard antihistamines. This expansion of biologics into younger age groups sets the stage for a step-change in how CSU is managed, with the next phase in CSU treatment likely to be defined by increased potency and extended duration of action. Companies such as GSK and Novartis have both made big bets on longer-acting anti-IgE assets, which is another modality used in the treatment of CSU. GSK’s January 2026 acquisition of RAPT Therapeutics included ozureprubart, a long-acting anti-IgE mAb, which demonstrated comparable efficacy with less frequent dosing, and similar safety and tolerability compared with omalizumab (Xolair). And in March 2026, Novartis acquired Excellergy to gain access to EXL-111, a half-life extended, high-affinity anti-IgE mAb currently in Phase I trials.

Commercial

AbbVie licenses acute pain treatment duo from China’s Haisco

What happened? In an April 13 release (Chinese, translated using Claude), Haisco Pharmaceutical Group has announced that AbbVie has agreed to pay $30 million upfront for ex-China rights to two non-opioid pain treatment candidates, HSK55718 and HSK51155, which are both NaV1.8 sodium channel blockers. The deal includes $10 million in near-term milestones and up to $705 million in additional milestone payments. It grants AbbVie rights to develop, manufacture, and commercialise the assets outside Greater China. According to the release, HSK55718 is being developed as an IV formulation and is currently in Phase I clinical trials in China. HSK51155 is being developed as an oral formulation and is currently in pre-clinical development.

What does this mean? Very early days, so very little to comment on. As a category, this is AbbVie’s first move into conventional pain. Before this, its pain interest was more opportunistic via its May 2020 acquisition of Allergan which include Botox and two CGRP inhibitors (Ubrelvy and Aquipta/Qulipta), all approved for migraine. AbbVie will be looking to join Vertex Pharmaceuticals in the NaV1.8 inhibitor market. Vertex’s suzetrigine (Journavx) targets NaV1.8 and was approved as a treatment for acute pain by the FDA in January 2025. Other companies interested in the MOA include Eli Lilly which acquired SiteOne Therapeutics (including its Phase II ready Nav1.8 inhibitor, STC-004) in May 2025.

Beeline Medicines announces funding, pipeline and leadership

What happened? Beeline Medicines has announced its official debut with a focus on developing novel treatments for autoimmune and inflammatory diseases. Originally formed in July 2025, Beeline’s initial portfolio is comprised of five programmes in-licensed from BMS. The company is backed by a $300 million Series A financing led by Bain Capital. Beeline’s lead programme is afimetoran, a small-molecule TLR7/TLR8 proteins. Phase Ib PoC data in cutaneous lupus erythematosus (CLE) showed afimetoran's potential as a once daily oral treatment for patients with CLE and suggest a possibly therapeutic benefit. The other four assets include BMS-986326 (IL-2-CD25 fusion protein in Phase Ib development for atopic dermatitis and CLE and SLE), lomedeucitinib (TYK2 inhibitor that achieved positive PoC in a placebo-controlled Phase II study in plaque psoriasis) and two IND-stage biologics focused on the IL-18 and IL-10 pathways.

What does this mean? Beeline will hope to be able to optimise the development of these five assets provided by its big pharma backer, BMS, and achieve similar levels of success to other spin-outs, such as SpringWorks (spun out from Pfizer in September 2017). SpringWorks provides the inspiration as it has had commercial success with two products that were originally part of the 2017 spin-out, including nirogacestat (Ogsiveo) for desmoid tumours and mirdametinib (Gomekli) for NF1-associated plexiform neurofibromas.

BMS partners with Oxford Biotherapeutics on TCEs

What happened? Oxford BioTherapeutics (OBT) has announced a multi-year, selective target collaboration with Bristol Myers Squibb (BMS) focussed on the discovery and development of novel T-cell engager therapies (TCE) for solid tumours. OBT will leverage its proprietary OGAP-Verify target discovery and validation platform, to identify novel, tumour-selective targets for solid cancers and generate next-generation T-cell engager molecules. The collaboration extends beyond discovery, with OBT assuming responsibility for the design and delivery of development candidates, highlighting the company’s expanding evolution into a fully integrated discovery and preclinical development platform. Under the terms of the agreement, OBT will receive an upfront inclusive of research funding and the potential for significant downstream milestone payments and royalties on commercialised products from BMS. Financial terms were not disclosed.

What does this mean? Not much to say as details are thin on the ground, but it does continue the trend of TCEs attracting significant big pharma interest. Recent deals including Astellas and Vir Biotechnology partnering on TCEs in prostate cancer, Sanofi signing a $1.2 billion deal with Kali Therapeutics for autoimmune asset KT-501, a CD19/BCMA/CD3 tri-specific T-cell engager and UCB obtaining worldwide exclusive rights to develop, manufacture and commercialise ATG-201, a CD19/CD3 bispecific TCE antibody, targeting B cell-related autoimmune diseases. This collaboration with BMS is also OBT’s third partnership with a big pharma company since the beginning of 2025, following strategic partnerships with GSK (December 2025) and Roche (March 2025). This provides additional validation of OBT’s capabilities and extends the company’s sphere of operations beyond pure discovery.

Eli Lilly acquires CrossBridge Bio for $300 million

What happened? ADC discovery and development specialist CrossBridge Bio has announced a definitive agreement to be acquired by Eli Lilly. CrossBridge Bio is focused on advancing next-generation ADCs. Its lead candidate, CBB-120, is a TROP2-targeting TOP1i/ATRi dual-payload ADC for cancer treatment. It’s designed to enhance the therapeutic index and generate more durable responses compared to current TROP2-targeting ADCs (e.g., Trodelvy, Datroway) while also addressing key resistance mechanisms. CBB-120 is expected to enter clinical trials in 2026. Under the terms of the agreement, Eli Lilly will pay up to $300 million in cash, inclusive of an upfront payment and a subsequent payment upon achieving a specified development milestone.

What does this mean? Considering Eli Lilly has already made ADCs a meaningful part of its oncology strategy, acquiring CrossBridge is likely to be an ADC portfolio optimisation play, as none of Eli Lilly’s other ADCs target TROP2. These include sofetabart mipitecan (LY4170156), a novel FRα-targeting ADC in Phase III trials for advanced ovarian cancer, two nectin-4 ADCs, both in Phase I trials, including LY4101174 (which came from Eli Lilly's June 2023 acquisition of Emergence Therapeutics) and LY4052031 (which uses linker technology licensed from Immunogen in February 2022), and PTK7 ADC (currently in Phase I trials). Eli Lilly is not alone in pursuing additional ADC assets, with Gilead paying $3.1 billion upfront for Tubulis in early April 2026, Daiichi Sankyo partnering with BostonGene on the AI-driven discovery of novel ADCs in February 2026 and GSK acquiring an ADC for prostate cancer from Syndivia in October 2025.

Novo Nordisk and OpenAI partner on AI transformation

What happened? Novo Nordisk has announced a strategic partnership with OpenAI that will place Novo Nordisk at the forefront of AI transformation in healthcare and help the company bring new and better treatment options to patients faster. The partnership will apply advanced AI capabilities to data analysis, drug candidate identification and reducing the time required to move from research to patient. OpenAI will assist Novo Nordisk in upskilling the company’s workforce and enhancing AI literacy. The partnership will also apply OpenAI’s capabilities to improve efficiency in manufacturing, supply chain and distribution and corporate operations. Pilot programmes will launch across R&D, manufacturing and commercial operations, with full integration by the end of 2026.

What does this mean? Details are thin on the ground, other than what OpenAI’s technology will be applied to. But that’s the interesting part, as the scope of this deal is far broader than traditional pharma/AI collaborations. All of Novo’s AI deals thus far have focused on discovery/R&D (e.g., Vivtex, Valo Health, Deep Apple, NVIDIA), but this deal with OpenAI covers manufacturing, supply chain, commercial operations, and workforce upskilling, as well as discovery. That's more of an enterprise-wide transformation strategy. Questions will be asked about OpenAI's general-purpose large language model capabilities and if they are well suited to the nitty gritty of R&D, including protein structure, molecular design, and clinical trial optimisation, or whether those are better addressed by more specialised tools from NVIDIA. My take is that nobody, including Novo Nordisk, knows if any of this will translate into approved drugs or meaningful efficiency gains. The industry is essentially running a large, expensive, uncontrolled experiment.

Regeneron and Telix to collaborate on radiopharmaceuticals

What happened? Regeneron and Telix Pharmaceuticals (Telix) have announced a collaboration to jointly develop and commercialise next generation radiopharmaceutical therapies. The collaboration combines Regeneron’s biologics expertise, including bsAb discovery, with Telix’s radiopharmaceutical development platform, global manufacturing capabilities and supply chain infrastructure. The collaboration will include multiple solid tumour targets from Regeneron’s portfolio of antibodies. Under the terms of the agreement, Telix will receive an upfront cash payment of $40 million from Regeneron for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programmes, with Regeneron having the option to expand to include four additional programmes with additional upfront payments. Telix could potentially be paid up to $2.1 billion if it decides against the cost-sharing model for all four programmes, assuming each hits their milestones.

What does this mean? The radiopharmaceutical space has seen an extraordinary concentration of M&A and partnership activity over the past 2-3 years. Starting with Novartis gaining FDA approval for Pluvicto for mCRPC in March 2022, there has since been a scramble by large pharma to gain access to the market. In February 2024, BMS acquired RayzeBio for $4.1 billion, gaining RYZ101, an actinium-225 SSTR2-targeting radiopharmaceutical. AstraZeneca followed in March 2024 with a $2.4 billion acquisition of  Fusion Pharmaceuticals adding radioconjugate assets and actinium-225 manufacturing expertise. Then in May 2024 Novartis acquired Mariana Oncology for $1.75 billion, expanding its radioligand therapy capabilities with actinium-225 assets including a programme in small cell lung cancer. BMS has since continued building on its RayzeBio base with its June 2025 acquisition of Philogen's OncoACP3, a radiopharmaceutical and diagnostic targeting ACP3 which is overexpressed in prostate cancer. One way that the Regeneron/Telix deal differs from the others is that it focuses on antibodies, as opposed to small molecules/peptides.

Tempus partners with Gilead on advanced oncology R&D

What happened? Tempus AI has announced an expanded, multi-year collaboration with Gilead Sciences aimed at building and advancing Gilead’s oncology pipeline. To date, Gilead has leveraged Tempus’ repository of de-identified multimodal data to inform a range of oncology R&D initiatives, including trial design, indication selection, biomarker strategy, health outcomes analysis and clinical real world evidence. The expanded agreement provides Gilead with enterprise-wide access to Tempus’ AI-driven Lens platform, unlocking access to broader datasets across multiple indications and integrating dedicated Tempus analytical services. No deal terms were provided.

What does this mean? This collaboration allows Gilead to analyse real-world patient data, including genomic, imaging, and clinical records, to better design trials, identify biomarkers, and improve cancer treatment success rates. Similar deals have been announced, including Regeneron partnering with TriNetX, BMS partnering with Faro Health on protocol design for clinical trials, and Citizen Health collaborating with UCB on the development of novel treatments for rare diseases and epilepsy using patient insights and advocacy networks.

In Brief

Anthropic appoints Novartis CEO Vas Narasimhan to Board of Directors

Novartis CEO Vas Narasimhan has been appointed to Anthropic's Board of Directors by the Anthropic Long-Term Benefit Trust. Dr. Narasimhan joins Dario Amodei, Daniela Amodei, Yasmin Razavi, Jay Kreps, Reed Hastings, and Chris Liddell on the Board of Directors.

AbbVie’s Elahere succeeds in Phase II PSOC trial

AbbVie has announced positive results from the Phase II IMGN853-0420 trial which evaluated the efficacy and safety of mirvetuximab soravtansine-gynx (Elahere) in combination with carboplatin followed by maintenance of mirvetuximab soravtansine-gynx monotherapy, in patients with folate receptor alpha (FRα)-expressing, recurrent platinum‑sensitive ovarian cancer (PSOC). The primary endpoint of the study was a confirmed objective response rate (ORR) in the ≥50% FRα subgroup after six cycles of combination therapy. Key secondary endpoint was ORR after six cycles in the overall population (FRα ≥25%) and additional secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS). Elahere is a first-in-class ADC comprising a FRα-binding antibody, cleavable linker and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Elahere is currently indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Bayer wins MHRA approval for Kerendia in heart failure

PharmaTimes reports that Bayer has received MHRA approval for Kerendia (finerenone) for adults with symptomatic chronic heart failure and a left ventricular ejection fraction of 40% or above. The decision covers both heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction, two phenotypes that together account for around half of all UK heart failure cases. This approval comes after Kerendia’s FDA and EMA approval in July 2025 and March 2026, respectively.

Genmab posts updated Phase I/II data for rinatabart sesutecan

Genmab has posted new data demonstrating that rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor ADC, evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase I/II RAINFOL-01 study. Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials in other indications, including platinum-resistant ovarian cancer (PROC), recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy and non-small cell lung cancer (NSCLC).

GSK completes acquisition of 35Pharma Inc.

GSK has announced the completion of its acquisition of 35Pharma. The acquisition includes HS235, a molecule in development for the treatment of pulmonary hypertension (PH). HS235 targets the activin receptor signalling pathway, a clinically validated therapeutic target in PH. HS235 is designed with enhanced selectivity providing the potential to lower the risk of bleeding, pericardial effusion and dose-limiting increases in haemoglobin, addressing key limitations in current pulmonary arterial hypertension (PAH) treatment. The underlying mechanism of HS235 also offers the potential for broad metabolic benefits, as observed in early clinical studies, including fat-selective weight loss, preservation of lean mass, and improved insulin sensitivity.

GSK pulls application for leucovorin…again

GSK has withdrawn an approval application for Wellcovorin (leucovorin), a decades-old drug that late last year gained renewed attention after the members of the Trump administration publicly suggested it has the potential to treat autism symptoms. GSK requested to terminate the new drug application because “the drug products were no longer marketed,” according to a Federal Register notice on Thursday. The withdrawal of the application was procedural and not linked to any safety or efficacy issues, a GSK spokesperson told The Wall Street Journal on Thursday, noting that the company had never intended to revive the drug.

Health Canada approves Apotex’s denosumab biosimilar, Denoza

Apotex has announced that Health Canada has approved Denoza (denosumab), a biosimilar to Prolia (Amgen), for its authorized indications. These include the treatment of postmenopausal women with osteoporosis at high risk for fracture and the treatment of osteoporosis in men at high risk for fracture. Denoza is also authorised for the remaining indications of the reference biologic, as outlined in the Product Monograph. The product will be available in a prefilled syringe format.

Ifinatamab deruxtecan granted FDA priority review for ES-SCLC

Daiichi Sankyo and Merck & Co.’s BLA for ifinatamab deruxtecan has been accepted and granted priority review by the FDA for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The PDUFA date is October 10, 2026. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed ADC. The BLA is based on results from the IDeate-Lung01 Phase II trial, with support from the IDeate-PanTumor01 Phase I/II trial. Ifinatamab deruxtecan was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

McKinsey to pay $125 million as part of Purdue's bankruptcy settlement

McKinsey will pay $125 million to Purdue Pharma's bankruptcy settlement for helping the company "turbocharge" OxyContin sales during the peak years of the opioid epidemic. The firm does not admit wrongdoing, stopped advising opioid-related businesses in 2019, and says it’s "deeply sorry." This isn't McKinsey's first payment toward the settlement. The firm has already agreed to pay $1.6 billion across settlements with the DOJ, states, and local governments. The running total is now north of $1.7 billion for a company that sells advice.

MHRA releases new portal for reporting defective medicines

Licence holders can now report potentially defective medicines through a new secure online platform, replacing email submissions. Available via the MHRA’s existing ICSR submission portal, the system supports improved data quality through structured reporting, faster processing via automatic routing, enhanced security with encrypted submissions and case tracking for greater transparency. This update supports the MHRA’s wider digital transformation, enabling more efficient and secure reporting of defective medicinal products. More information can be found via the Guide to Defective Medicine Products.

Obsidian and Galera announce $350 million merger agreement

Galera Therapeutics and Obsidian Therapeutics have announced that they have entered into a definitive merger agreement to combine in an all-stock transaction. Upon completion of the transaction, the combined company plans to operate under the name Obsidian Therapeutics. Obsidian’s lead product candidate, OBX-115, is a genetically engineered, autologous tumour infiltrating lymphocyte (TIL) cell therapy currently in a Phase II clinical trial for the treatment of advanced melanoma and a Phase I clinical trial for the treatment of NSCLC.

Samsung Bioepis’ nectin-4 targeting ADC, SBE303, enters Phase I trials

Samsung Bioepis has announced the initiation of a Phase I clinical trial for SBE303, Samsung Bioepis’ first novel ADC candidate engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumour cells, including urothelial cancer, lung cancer, and breast cancer. The trial is an open‑label, multi-center, first‑in‑human trial to evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumours.

Vir Biotechnology’s VIR-5500 hits Phase I dose escalation cohort

Vir Biotechnology has announced that the first patient has been dosed in one of three expansion cohorts in the Phase I trial evaluating VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked T-cell engager (TCE) for metastatic castration resistance prostate cancer (mCRPC). The trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), in early-line mCRPC and mHSPC. Recall, Astellas Pharma and Vir Biotechnology announced a global strategic collaboration to accelerate the development VIR-5500. Under the terms of the agreement, Vir Biotechnology received $335 million in upfront and near-term payments, including $240 million in cash, a $75 million equity investment and a near-term $20 million milestone.

About the Author

Duncan Emerton is a pharmaceutical industry professional with a background spanning clinical research and development, 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.