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  • MapLight shifts focus to schizophrenia drug after mixed Phase 2 results, raises $150 million
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the muscarinic agonist ML-007C-MA. A twice‑daily dose achieved the study’s primary endpoint with notable reductions in…
    Fierce Biotech · 9h agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 3h agoNeutral↗ source
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  • MapLight presses the pause button; ADC Therapeutics considers what to do with Zynlonta
    ⏸️ MapLight Therapeutics pauses preclinical and discovery work: The biotech said it will instead focus its resources on advancing its lead candidate, ML-007C-MA, for schizophrenia and Alzheimer’s d…
    Endpoints · 30m ago↗ source
  • Capricor soars on plan to amend DMD filing after adcomm setback
    Capricor Therapeutics has bounced back from a bruising FDA advisory committee meeting by securing a green light to file an amendment to its approval application, raising hopes that the biotech can…
    Fierce Biotech · 5h ago↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
    The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
    Endpoints · 17h agoApprovalPositive↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 20h agoRegulatoryNegative↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 20h agoRegulatoryPositive↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 23h agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 1d agoDealPositive↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 1d agoDealNeutral↗ source
  • PDS Biotechnology pauses phase 3 head-and-neck trial to prioritize colorectal cancer immunotherapy
    PDS Biotechnology announced it is stopping work on its phase 3 head and neck cancer therapy, Versamune HPV (PDS0101), in order to reallocate resources to a different drug program. The halted trial…
    Fierce Biotech · 1d agoNeutral↗ source
  • PTC Therapeutics acquires Sangamo’s Fabry gene therapy program for $111 million upfront
    PTC Therapeutics announced it has purchased the Fabry disease gene-therapy program (ST-920) from Sangamo Therapeutics. The deal provides $111 million in upfront cash and includes up to $100 millio…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Versa Vascular appoints former Medtronic heart franchise leader Bill Shields as CEO
    Bill Shields, who spent 15 years leading Medtronic’s structural heart franchise, is leaving the medtech giant to become chief executive of Versa Vascular, a startup developing tricuspid valve repai…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 1d agoRegulatoryNeutral↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 1d agoDealPositive↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
    The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…
    raps · 1d agoRegulatoryNeutral↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 20h agoDealNeutral↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 1d agoNeutral↗ source
  • Chutes & Ladders—Former Legend CEO lands at K2
    Just weeks after Legend Biotech announced the departure of its CEO, Ying Huang, K2 Therapeutics has announced that Wang will now lead the startup, which was founded in 2024 with a $50 million seed…
    Fierce Biotech · 1d ago↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 2d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 1d agoDealPositive↗ source