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  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 26d agoApprovalPositive↗ source
  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 26d agoDealPositive↗ source
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  • Azalea Therapeutics wins Endpoints 11 award, combines gene editing with CAR-T and raises $82 million
    Azalea Therapeutics was named the winner of the Endpoints 11 2026 competition, highlighting its innovative approach in the biotech space. The company’s platform merges precise gene‑editing techniq…
    Endpoints · 26d agoDealPositive↗ source
  • Carvykti shows 5-year survival in half of multiple myeloma patients in Phase 2 study
    Johnson & Johnson and Legend Biotech reported that 10 of the 20 multiple myeloma patients treated with a single dose of Carvykti remained alive after a median follow‑up of 60.7 months, representing…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • FDA approves Mirum's Atebrioz for ultra-rare disease that hardens muscle and connective tissue
    The U.S. Food and Drug Administration has granted approval for Mirum Pharmaceuticals' new therapy for an ultra-rare genetic disorder that causes muscle and connective tissue to turn into bone. The…
    Endpoints · 25d agoApprovalPositive↗ source
  • Experts say expanding beyond rare disease markets can make ultra-rare therapies financially viable
    The piece highlights that investment in ultra‑rare disease treatments remains limited, and experts argue the answer is not to focus solely on the rare condition itself. They propose that drugmaker…
    Endpoints · 25d agoPositive↗ source
  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 25d agoNeutral↗ source
  • NewLimit raises $682M to pursue new class of anti-aging drugs
    NewLimit, a biotech startup based in South San Francisco, announced it secured $682 million in funding. The round was led by venture firms including Kleiner Perkins, Founders Fund, Dimension Capit…
    Endpoints · 26d agoDealPositive↗ source
  • SonoThera secures $186 million to advance non-viral gene-therapy platform
    SonoThera, the winner of the Endpoints 11 2026 competition, announced a fresh financing round to push its non-viral gene-therapy technology forward. The company raised a total of $186 million, wit…
    Endpoints · 26d agoDealPositive↗ source
  • ADARx raises $446 million in one of 2026's largest biotech IPOs as City Therapeutics plans its own listing
    ADARx Pharmaceuticals completed an initial public offering that raised about $446.3 million, exceeding the company’s original target. The shares were priced at $17 each, with 26.25 million shares…
    BioSpace · 26d agoDealPositive↗ source
  • ADARx prices $446.3 million Nasdaq debut, boosting biotech IPO wave
    ADARx Pharmaceuticals, a RNA interference focused biotech, announced pricing of its initial public offering at $446.3 million on Nasdaq. The offering was upsized, reflecting strong investor demand…
    Endpoints · 26d agoDealNeutral↗ source
  • Pharma groups urge FDA to clarify criteria for approving drugs based on a single pivotal trial
    Pharmaceutical companies and industry associations are asking the U.S. Food and Drug Administration for more detailed guidance on when a single pivotal clinical trial, supported by additional confi…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • Anew Labs, ByteDance’s biotech spinout, raises $290M to build a China AI bio rival
    Anew Labs, a biotech spinout from ByteDance, announced it has secured $290 million in funding. The capital came from a mix of Chinese investors such as HSG, IDG Capital and Hillhouse Investment, a…
    Endpoints · 26d agoDealPositive↗ source
  • Vivodyne’s Human Tissue Factory Wins Endpoints 11 2026, Promising Faster Drug Testing
    Vivodyne was announced as the winner of the Endpoints 11 2026 competition for its human tissue factory technology. The platform creates human tissue constructs that can be used in preclinical drug…
    Endpoints · 26d agoPositive↗ source
  • Jury awards Nektar $90 million in lawsuit against Eli Lilly over licensing dispute
    A federal jury in a US District Court awarded Nektar Therapeutics $90 million after finding Eli Lilly breached a licensing agreement. The verdict ends a dispute that began when the parties' licens…
    Endpoints · 25d agoPositive↗ source
  • Medici wins Endpoints 2026 award, touts personalized cancer therapy
    Medici was announced as the winner of the Endpoints 2026 competition. The company said its approach focuses on tailoring cancer treatments to individual patients. The award highlights growing int…
    Endpoints · 26d agoPositive↗ source
  • Endpoints 11 showcases top biotech startups, signaling renewed optimism and funding
    The Endpoints 11 awards highlight the most promising biotech startups of 2026, offering a snapshot of emerging trends in the sector. According to the summary, the awards illustrate that biotech ap…
    Endpoints · 26d agoPositive↗ source
  • Jury awards Nektar $90 million in damages after lawsuit over broken rezpeg partnership with Eli Lilly
    A jury in a US court has ordered Eli Lilly to pay Nektar Therapeutics $90 million after finding the pharma giant breached their collaboration on the experimental autoimmune drug rezpeg. Nektar and…
    BioSpace · 26d agoNegative↗ source
  • Kali Therapeutics pivots from Chinese drug acquisitions to focus on its own growing pipeline
    Kali Therapeutics, the winner of the Endpoints 11 2026 competition, initially explored the possibility of purchasing drug candidates from China. The company ultimately chose to rely on its own res…
    Endpoints · 26d agoPositive↗ source
  • Stipple Bio wins Endpoints 2026 award for precision pancreatic cancer therapy
    Stipple Bio was announced as the winner of the Endpoints 2026 competition, recognized for its work in precision medicine. The company’s approach focuses on developing targeted treatments for pancr…
    Endpoints · 26d agoPositive↗ source
  • Medra, 2026 Endpoints 11 winner, aims to build self-driving labs
    Medra, the recent winner of the Endpoints 11 2026 competition, announced plans to develop autonomous laboratory systems. The company's founder, who just completed a PhD in robotics, said the goal…
    Endpoints · 26d agoPositive↗ source
  • Corsera wins Endpoints 11 2026 award, marking a major bet by veteran biotech leaders Meanwell and Maraganore
    Corsera was announced as the winner of the Endpoints 11 2026 competition, a recognition of its scientific progress. The win highlights the involvement of veteran biotech executives Clive Meanwell…
    Endpoints · 26d agoPositive↗ source
  • Travere names former Amicus CEO Bradley Campbell as new leader; Roche eyes board seat for ex‑Takeda chief Alex Hoffman
    Travere Therapeutics announced that its long‑time chief executive Eric Dube will step down at the start of December, ending an almost eight‑year tenure. The board has selected Bradley Campbell, wh…
    Endpoints · 26d agoNeutral↗ source
  • Novo signs development deal with Swedish biotech Nanexa to license long-acting delivery technology
    Novo Nordisk has entered a new development agreement with the Swedish biotech Nanexa. Under the pact, Nanexa will license its long-acting drug delivery platform to Novo, expanding the larger compa…
    Endpoints · 26d agoDealNeutral↗ source
  • Legend's five-year data suggests Carvykti could be a cure; Addex, Indivior split
    Plus news about Amberstone, Henlius and Boehringer Ingelheim. Legend adds to argument for Carvykti as a cure: J&J and Legend Biotech said Friday that 10 of 20 relapsed/refractory multiple myeloma p…
    Endpoints · 26d agoNeutral↗ source