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48 stories matching this filter · ← front page

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  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 6d agoRegulatoryPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 9d agoDealPositive↗ source
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Infectious Disease346
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 10d agoDealPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 14d agoDealPositive↗ source
  • Wall Street reacts negatively to AstraZeneca-Bristol Myers merger talks, shares tumble
    A report in the Financial Times, followed by Reuters, said AstraZeneca and Bristol Myers Squibb have been discussing a possible combination in recent months. The news triggered a sharp sell-off. A…
    BioPharma Dive · 16d agoDealNegative↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 19d agoNegative readoutNegative↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 20d agoEarningsNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 22d agoEarningsPositive↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 21d agoRegulatoryNegative↗ source
  • Eli Lilly to file FDA application for obesity drug retatrutide after Phase 3 trial results
    Eli Lilly announced that two additional Phase 3 trials of its experimental obesity medicine retatrutide met their primary goals, and the company plans to submit an FDA application for the drug next…
    BioPharma Dive · 28d agoRegulatoryPositive↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 29d agoDealPositive↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 28d agoRegulatoryPositive↗ source
  • Summit Therapeutics' ivonescimab shows improved survival trend in extended follow-up, easing investor doubts
    A new analysis of Summit Therapeutics and Akeso's dual‑acting cancer immunotherapy ivonescimab indicates that the drug's impact on overall survival has grown with longer observation. The extended d…
    BioPharma Dive · 29d agoPositive readoutPositive↗ source
  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 1mo agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Attovia Therapeutics and Braveheart Bio announce plans for biotech IPOs amid market upswing
    Attovia Therapeutics and Braveheart Bio disclosed on Tuesday that they intend to go public, joining a recent wave of large biotech offerings. Attovia, which was spun out of Alamar Biosciences in 2…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Q32 Bio’s alopecia drug bempikibart meets Phase 2 goal, driving shares up 80%
    Q32 Bio reported that its experimental alopecia areata therapy, bempikibart, achieved the primary endpoint in the second part of a Phase 2 trial. Two‑fifths of participants grew enough hair to cove…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca and Ionis report failure of eplontersen in ATTR-CM trial
    AstraZeneca and Ionis said their nucleic‑acid drug eplontersen did not meet the primary goal in a large study of patients with transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM). Over a 140‑we…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 1mo ago↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 2mo ago↗ source