Roche Reports 43.1% Proteinuria Reduction For Sefaxersen, Extending Its IgA Nephropathy Push
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Biopharmaceutical Industry
Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.
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Roche Licenses Zymeworks’ ZW209 In Deal Worth Up To $813 Million, Extending Its Lung Cancer Deal Run
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Roche Ends RG6540 Development After Poseida Buyout, While Keeping Its CD19xCD20 CAR T Strategy Intact
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AbbVie Posts 31.4% HS Response For Lutikizumab In Phase 3, But Misses Prior Bar From Mid-Stage Data
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Pfizer Ends PF-06835375 Phase 2 In ITP, Leaving CXCR5 Program Direction Unclear
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Roche Expands Hansoh ADC Alliance To More Than $15 Billion, Deepening Its China Oncology Sourcing
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Merck And Moderna Expand Intismeran Autogene Strategy Beyond Melanoma After Phase 3 Success
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Bausch + Lomb Replaces Brent Saunders Again, As Paragon And Verastem Reset Leadership
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Oct 22, 2026Celltrion Adds Kaigene’s KG013 In Deal Worth Up To $580.5 Million, Deepening Its Autoimmune Shift
KG013 is a monoclonal antibody designed to target a proliferation-inducing ligand involved in plasma cell survival and immunoglobulin production, with IgA nephropathy as the initial indication. The deal follows last November’s Kaigene agreement with Celltrion, suggesting the South Korean company is building a repeatable sourcing model for early autoimmune assets rather than making a one-off diversification bet.
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Oct 22, 2026Roivant And Priovant Post More Than 48 Weeks To Treatment Failure For Brepocitinib In Non-Infectious Uveitis
The Clarity-1 and Clarity-2 studies also showed 40 weeks without requiring steroids in the treatment arm, while pooled data found 62% of patients on brepocitinib remained steroid-free at 48 weeks versus 20% on placebo. Priovant plans to file a supplemental application in the first half of 2027.
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Oct 22, 2026Roche Advances Fenebrutinib With 16% CDP Reduction, Building A Broader MS Case Ahead Of FDA Review
At the MSToronto2026 conference, Roche presented additional data linking fenebrutinib to effects on chronic active lesions, disability progression and brain volume loss. The update matters because physicians and investors increasingly view confirmed disability progression as a key differentiator for the next wave of MS medicines.
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Oct 21, 2026GSK Wins FDA Approval For Hibsago In Chronic Hepatitis B, Opening A Six-Month Functional-Cure Option
Hibsago is designed to reduce hepatitis B viral messenger RNA so some patients can stop treatment after up to 24 weeks and maintain viral control afterward. The decision gives GSK a first-in-class product, while also providing a commercial and technical validation point for Ionis’ antisense platform.
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Oct 20, 2026Pfizer Ends PF-06835375 Phase 2 In ITP, Leaving CXCR5 Program Direction Unclear
Pfizer confirmed that its phase 2 trial of PF-06835375 in primary immune thrombocytopenia has been terminated after enrolling 61 patients, according to the federal trials register. The company said the decision was business-based rather than safety-related, leaving investors and partners with an incomplete read on whether the asset or the CXCR5 mechanism still has a future inside the company.
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Oct 20, 2026Genmab Faces A Darzalex Revenue Cliff As Petosemtamab And Rina-S Readouts Approach
Genmab executives and investors are framing the company’s next phase around a narrow set of oncology assets ahead of U.S. Darzalex patent expiry in 2029. The near-term question is less whether the cliff exists than whether upcoming data can compress the revenue gap fast enough to keep Genmab growing beyond it.
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Oct 19, 2026Merck KGaA Buys Silence Therapeutics For $1.1 Billion Enterprise Value, Adding A Phase 3-Ready PV siRNA Program
Merck KGaA said it will acquire Silence Therapeutics for $20 per share, with the companies describing the transaction as about $1.1 billion in enterprise value and about $1.3 billion in equity value. The strategic centerpiece is divesiran, which Silence is using as a springboard into Phase 3 in polycythemia vera after mid-stage data that put it near the front of an increasingly competitive field.
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Oct 19, 2026Roche Expands Hansoh ADC Alliance To More Than $15 Billion, Deepening Its China Oncology Sourcing
The new agreement comes a year after Roche licensed ex-China rights to Hansoh’s CDH17-targeted ADC HS-20110. Taken together, the two deals point to a more deliberate strategy of sourcing oncology assets from Chinese developers with established ADC platforms rather than treating such transactions as one-off bets.
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Oct 18, 2026Allswell Raises $7 Million Seed Round, Expanding LGBTQ+ Behavioral Health Care
The company combines one-on-one virtual therapy, group programs and trauma-informed care with a network model built around LGBTQ+ clinicians or therapists screened for experience serving the community. Its pitch to investors is not only unmet need, but a reimbursement structure based on commercial insurance and Medicaid rather than cash-pay behavioral health.
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Oct 17, 2026Bausch + Lomb Replaces Brent Saunders Again, As Paragon And Verastem Reset Leadership
Bausch + Lomb said Saunders’ departure was mutually agreed with the board, with Thomas Appio stepping in as interim CEO. Elsewhere, Paragon recruited several former Apogee leaders, while Verastem set a CEO transition for the new year after advancing VS-7375 into phase 2.
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Oct 16, 2026Merck And Moderna Expand Intismeran Autogene Strategy Beyond Melanoma After Phase 3 Success
At the STAT Summit, Moderna President Stephen Hoge and Merck R&D chief Dean Li described a development plan that builds on adjuvant melanoma and extends into lung, kidney and bladder cancer, while keeping the vaccine paired with Keytruda in settings where checkpoint inhibition has worked best. The strategic question is no longer whether the program can generate one positive study, but whether Merck and Moderna can translate that result into a broader oncology franchise without overreaching into settings where immunotherapy has historically struggled.
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Compass Pathways Plans Slow COMP360 Rollout, As Phase 3 Response Rates Meet REMS Reality
At the STAT Summit, CEO Kabir Nath said Compass aims to launch early next year if approved and expects COMP360 to come with an FDA risk evaluation and mitigation strategy. The strategic message was that the first commercial psilocybin launch cannot afford avoidable safety, training, or reimbursement failures because a bad start would damage the wider field, not just one product.
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