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  • ARPA-H launches SPECTRA program to advance autism diagnosis and precision care
    ARPA-H announced the launch of the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a new effort aimed at transforming autism diagnosis and precisio…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Lisata Therapeutics merges with Marea Therapeutics in reverse merger after failed Kuva deal
    Lisata Therapeutics, a solid tumor biotech, announced a stock-for-stock merger with cardiovascular specialist Marea Therapeutics after a previous merger attempt with Kuva Labs collapsed. The trans…
    Fierce Biotech · 1mo agoDealNeutral↗ source
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  • Rare inherited EGFR mutation raises lung cancer risk 62-fold in never-smokers, 25-fold in smokers
    Researchers examined genotyping data from 23andMe covering 3.37 million individuals and found the T790M germline mutation in about one out of every 15,850 people. The study reported that carriers…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Novo signs $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo, which recently rebranded from Novo Nordisk, announced a partnership with Copenhagen‑based Orbis Medicines. The agreement could provide up to $1.4 billion in upfront payments and milestone pay…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Novartis halts ALS drug VHB937 after phase 2 trial fails to meet endpoints
    Novartis announced it is stopping development of its ALS candidate VHB937 after the phase 2 Astrals trial did not meet its primary or secondary endpoints. The study enrolled 251 patients with earl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Senator Todd Young urges White House to appoint biotech leader amid rising Chinese innovation
    Senator Todd Young, chair of the National Security Commission on Emerging Biotechnology, told Fierce he is concerned about China’s expanding role in biopharma. The commission notes that Chinese co…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novartis pays $125 million to acquire Sironax’s brain-delivery platform
    Novartis has exercised an option to buy Sironax’s platform for delivering large molecules across the blood‑brain barrier, with a $125 million payment due at closing. The technology is intended to…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • 'Still a bull': Novo's CEO on honoring heritage and planning for the future amid corporate rebrand
    Novo CEO Mike Doustdar—tapped to breathe new life into the Danish drugmaker last year after losing GLP-1 marketing ground to chief rival Eli Lilly—isn’t one to make changes for the sake of change.
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug into Phase 3
    Sling Therapeutics announced a $123 million Series C financing round aimed at moving its oral therapy for thyroid eye disease into a late‑stage trial and eventual market launch. The company has be…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • FDA opens pilot to accelerate phase 1 trials with fast IND reviews
    The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research inst…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Mayo Clinic and Thermo Fisher launch Precure to build large biomedical data set
    Mayo Clinic has partnered with Thermo Fisher Scientific to form Precure LLC, a new group focused on creating one of the largest biomedical data sets using human multi‑omics data. Precure will inte…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Eli Lilly partners with QurCan Therapeutics, pledging up to $237 M per CNS genetic-medicine program
    Eli Lilly announced a collaboration with Canadian biotech QurCan Therapeutics to advance genetic medicines aimed at the central nervous system. Under the deal, Lilly will provide up to $237 millio…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Sionna Therapeutics cuts 46% of staff after cystic fibrosis trial miss
    Sionna Therapeutics announced it will lay off roughly half of its employees as it reassesses its strategy following a recent setback in its cystic fibrosis program. The company’s lead candidate, S…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • Connect Biopharma's asthma drug rademikibart misses primary endpoint in Phase 2 trial
    Connect Biopharma reported that its IL-4/IL-13 blocker rademikibart failed to meet the primary endpoint in a Phase 2 study in asthma patients with type-2 inflammation. The trial enrolled 160 patie…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Novo abandons $285 million partnership with Ascendis for monthly GLP-1 obesity drug
    Novo Nordisk, which recently rebranded, has terminated a licensing agreement with Ascendis Pharma that was originally valued at up to $285 million. The collaboration, signed in November 2024, was…
    Fierce Biotech · 1mo agoDealNegative↗ source