Pumitamig

iStock, Afry Harvy BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers. The collapse of AstraZeneca’s reported merger talks with Bristol Myers Squibb extended the long wait for a deal between two major drugmakers and deprived BMS of one possible solution to growth problems that could be compounded soon if a key upcoming readout does not meet expectations. Analysts saw merging with AstraZeneca as a way for BMS to manage its patent cliff. About 80% of the company’s revenue base will face generic or biosimilar competition by 2031, Raghuram Selvaraju, senior healthcare equity research analyst at H.C. Wainwright & Co., told BioSpace via email. Unless the oral FXIa inhibitor milvexian succeeds in the clinic and offsets lost sales, Selvaraju believes BMS may face challenges that could have implications across the Big Pharma landscape. “We think that consolidation among the weaker large-cap companies is inevitable. If BMS blows up with milvexian, there may be a feeding frenzy once the carnage is over and the dust settles,” Selvaraju said. “Other companies that could be the subject of takeover speculation include the weakest of the traditional large-caps, namely GSK and Pfizer.” M&A No deal between AstraZeneca and BMS, senior source insists: Reuters Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal in pharma history. August 5, 2026 · 1 min read · Gabrielle Masson Read more BMS’ binary event Selvaraju sees LIBREXIA AF, a Phase 3 trial of milvexian in atrial fibrillation, as the key readout for BMS’ future, regardless of whether the company delivers positive results elsewhere in its portfolio. BMS expects to report LIBREXIA AF data next year. Milvexian has become a risky prospect, given the previous failure of the LIBREXIA ACS pivotal program for reducing cardiovascular risk and prior setbacks in stroke, Selvaraju said. Bayer’s rival oral FXIa inhibitor, asundexian, also failed to reduce the risk of stroke in atrial fibrillation, leading the German drugmaker to end the trial in 2023. Noting the readthrough from Bayer’s failure, Selvaraju said it is “not totally clear” why there remains “significant faith in milvexian.” In an email to BioSpace , Seamus Fernandez, senior managing director at Guggenheim Securities, put milvexian’s chances of success in the atrial fibrillation trial at 60%. Milvexian has a 70% chance of succeeding in a secondary stroke prevention study, Fernandez said. BMS does not currently have sufficient backup programs to weather the possibility of milvexian failing in Phase 3, Selvaraju said. If milvexian is totally written off, BMS’ share price could fall 40% to 50% from its current levels, the analyst added. “If milvexian fails in atrial fibrillation, that leaves a gaping hole in the portfolio and a revenue base void that could prove impossible to fill, with significant top-line sales attrition likely to occur in 2029 through the early 2030s,” Selvaraju said. BMS reported Eliquis and Opdivo revenues of $8.6 billion and $4.6 billion, respectively, in the first half of 2026. The drugs accounted for more than half of BMS’ sales. Selvaraju predicts the entire Eliquis revenue base could be erased by 2030, reflecting expectations that generics will start to erode sales quickly when the patent expires later this year. The company is working to hold on to a larger share of Opdivo sales for longer. Not only does Opdivo have a couple extra years of exclusivity, going off patent in 2028, but biosimilars typically take longer to win market share than generics. BMS aims to further dull the impact of biosimilars by driving uptake of its subcutaneous product, Opdivo Qvantig. H.C. Wainwright analysts model Opdivo sales falling from about $11 billion in 2027 to less than $5 billion by 2030. Biosimilars “are likely to eat into Opdivo sales relatively quickly,” Selvaraju said, because BMS lacks “a clear life cycle management strategy” and Qvantig will only partly cushion the blow. Selvaraju added that “Opdivo has been getting creamed by Keytruda in the checkpoint inhibitor wars for years.” Life beyond milvexian BMS’ LPA1 antagonist admilparant is widely seen as another important R&D program. The pulmonary fibrosis drug candidate is “probably the most exciting and high-probability prospect” in the company’s clinical pipeline, Selvaraju said. BMS aims to publish Phase 3 data for the asset in idiopathic pulmonary fibrosis this year, with results in progressive pulmonary fibrosis due in 2027. Boehringer Ingelheim’s Jascayd has set the bar in these indications. Selvaraju predicts that BMS can dominate the markets if admilparant matches Jascayd’s “relatively low” efficacy benchmark and meets the “readily achievable” goal of improving on the drug’s safety and tolerability. In that scenario, peak annual sales of admilparant could exceed $3 billion. Fernandez is bullish on the drug candidate, telling investors to “watch the extraordinary launch of Jascayd as a benchmark for just how poorly served the market is.” The Guggenheim analyst sees the U.S. market growing to “well over” $30 billion at peak and values the admilparant opportunity at more than $5 billion. Admilparant could join Camzyos and Breyanzi among BMS’ key commercial products. Heart disease drug Camzyos “has particularly strong long-term sales potential given its first-in-class status and favorable positioning following recent label expansions,” Selvaraju said. The H.C. Wainwright analyst said the cell therapy Breyanzi is an underappreciated asset and an “eminently defensible” franchise. Selvaraju is more downbeat on Cobenfy, the schizophrenia treatment that BMS acquired in its $14 billion takeover of Karuna Therapeutics. Turning Cobenfy into a blockbuster will be challenging, the analyst said, and “label expansion into the elderly Alzheimer’s disease population shall be difficult due to the well-documented side effects of the drug.” BMS’ struggles to grow Cobenfy, sales of which totaled $119 million in the first half of 2026, are dialing up the pressure on the rest of the business. Drug candidates such as lymphoma prospect golcadomide and PD-L1/VEGF-A bispecific antibody pumitamig could take some of the slack. Yet the magnitude of the patent cliff means Selvaraju believes milvexian will be key to securing BMS’ future. Its failure, Selvaraju said, could leave BMS “hanging by a thread.” Neurodegenerative disease BMS’ neuro renaissance was built on back of Celgene mega-merger Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset. August 31, 2026 · 7 min read · Heather McKenzie Read more

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squamous non-small cell lung cancer following prior immunotherapy BioNTech is advancing a diversified development program in lung cancer treatment spanning more than 16 ongoing clinical trials across subtypes, biomarkers and treatment settings, including five ongoing Phase 3 clinical trials and two novel-novel combination trials August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer. “Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.” Highlights from BioNTech’s presentations at WCLC 2026: Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”): Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”): 2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer (“NSCLC”) who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer. BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. The content above comes from the network. if any infringement, please contact us to modify.