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  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 3d agoApprovalPositive↗ source
  • RevMed's pancreatic cancer drug Rasonque generates $198M in Q3, far exceeding forecasts
    RevMed reported $198 million in revenue from its newly launched pancreatic cancer therapy Rasonque during the third quarter, roughly ten times the $19 million estimate from Truist Securities. The…
    BioSpace · 3d agoPositive readoutPositive
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  • AstraZeneca reportedly bids $10 billion for metabolic biotech Rhythm Pharmaceuticals
    AstraZeneca is said to have made a $10 billion offer to acquire Rhythm Pharmaceuticals, a biotech that develops treatments for rare neuroendocrine disorders. The proposal values Rhythm at $124 per…
    BioSpace · 3d agoDealPositive↗ source
  • Novartis reports nine tumor cases in patients treated with Zolgensma gene therapy
    Novartis has confirmed that nine cases of tumors have been reported in patients who received its spinal muscular atrophy gene therapy, Zolgensma. The company says two cases are confirmed and seven…
    BioSpace · 3d agoNegative↗ source
  • British biotech T-Therapeutics raises $133 million Series B to advance bispecific T-cell engagers
    T-Therapeutics, a British biotech, announced a $133 million Series B financing to advance its next-generation T-cell engager therapeutics. The round was co-led by Advent Life Sciences and the Brit…
    BioSpace · 3d agoDealPositive↗ source
  • Evommune pays $30 million upfront to license Hinova’s oral molecular glue degrader for autoimmune pipeline
    Evommune announced a deal with Hinova Pharmaceuticals to license an oral molecular glue degrader aimed at autoimmune diseases. The agreement includes a $30 million upfront payment, split into $20…
    BioSpace · 3d agoDealPositive↗ source
  • Novartis Lp(a) drug pelacarsen shows no cardiovascular benefit, raising doubts on Amgen and Lilly programs
    Novartis disclosed that its phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide partnered with Ionis, failed to demonstrate any reduction in major cardiovascular events. The drug…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Rezera targets $181 million IPO to fund phase-3 trial of NLRP3 inhibitor for peripheral artery disease
    Boston-based biotech Rezera, which rebranded from NodThera last September, said it will seek an initial public offering to raise about $181 million. The proceeds are intended to move its brain-pene…
    Fierce Biotech · 3d agoDealPositive↗ source
  • MetaVia's GLP-1/glucagon agonist cuts liver fat and weight in phase 1, eyes phase 2 in alcohol-related liver disease
    MetaVia reported that its dual GLP‑1/glucagon receptor agonist, DA‑1726, lowered liver fat and body weight in a small phase‑1 study of obese adults. After 16 weeks of once‑weekly dosing, the drug…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • AstraZeneca proposes $10 billion purchase of Rhythm Pharmaceuticals, sparking possible bidding war
    AstraZeneca has reportedly made an offer of about $10 billion to buy Rhythm Pharmaceuticals, a company focused on rare obesity disorders. Analysts from at least three research groups say the propo…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Madrigal’s 2024 MASH drug sparks new wave of diagnosis and personalized treatment approaches
    The article argues that the field of metabolic dysfunction‑associated steatohepatitis (MASH) is entering a period of rapid innovation, and that the industry must broaden efforts in diagnosis, monit…
    BioSpace · 4d agoPositive↗ source
  • Evommune pays $30 million to Hinova for rights to develop oral VAV1 molecular glue degrader EVO570 outside China
    Evommune announced a licensing agreement with Chinese firm Hinova Pharmaceuticals, paying $30 million upfront for access to a preclinical molecular glue program. The agreement gives Evommune the r…
    Fierce Biotech · 4d agoDealPositive↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 3d agoNeutral↗ source
  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 3d agoDealPositive↗ source
  • Novo names former Galderma exec as new CFO as eight-year finance chief departs; Alnylam and Amgen also seek senior replacements
    Novo's chief financial officer, who has served for eight years, will step down at the end of the year. The company has selected an executive from Galderma to take over the CFO role, signaling a le…
    Fierce Biotech · 3d agoNeutral↗ source
  • Merck reports positive mid-stage results for Hanmi-licensed MASH drug
    Merck announced Thursday that its dual GLP-1/glucagon agonist, which it licensed from South Korea’s Hanmi Pharmaceutical in 2020, has met its primary endpoints in a mid-stage trial for metabolic dy…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
  • One in Five Biopharma Workers Have Been Laid Off Multiple Times, Survey Shows
    A recent BioSpace LinkedIn poll found that 64% of biotech and pharma professionals have been laid off in the past five years, and 22% have experienced job loss at least twice. Those who have faced…
    BioSpace · 4d agoLayoffsNegative↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 3d agoPositive↗ source
  • Generate Biomedicines CEO touts AI-driven shrinkage of CAR-T cell engines as huge opportunity
    Generate Biomedicines' chief executive highlighted a "huge opportunity" after the company applied Anthropic's Claude AI platform to make its CAR‑T cell engines smaller. The Flagship‑founded biotec…
    Fierce Biotech · 4d agoPositive↗ source
  • Agios to cut over 202 R&D positions as it awaits FDA decision on sickle cell drug
    Agios Pharmaceuticals said it will eliminate more than 100 research and development positions by the end of 2026, cutting its R&D workforce by roughly 35% from 2025 levels. The company entered the…
    Fierce Biotech · 4d agoLayoffsNegative↗ source
  • Cloudbreak Pharma’s Phase 3 Eye Drop Shows Significant Benefit in Pterygium Trial
    Cloudbreak Pharma reported that its phase 3 trial of CBT-001, a multi‑kinase inhibitor eye drop for pterygium, met both co‑primary endpoints. The study compared two doses of CBT-001 given twice da…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • AAFP chief urges Congress to add oversight to CDC vaccine advisory panel
    Shawn Martin, CEO of the American Academy of Family Physicians, said the CDC’s Advisory Committee on Immunization Practices (ACIP) has faced more than a year of turmoil. He is urging Congress to e…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Vivoryon reclaims Chinese rights to kidney disease drug amid cash crunch
    Vivoryon Therapeutics, a Munich-based biotech, has taken back the rights to develop its kidney disease candidate in China after a licensing arrangement with Simcere Pharmaceuticals. The original 2…
    Fierce Biotech · 4d agoDealNeutral↗ source