Biotech

  • Intellia Therapeutics
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    Gene editing

    FDA places formal hold on two Intellia CRISPR trials

    Two days after Intellia voluntarily paused dosing due to safety concerns, the regulator stepped in with an official hold that makes a longer halt more likely. 

    By • Oct. 30, 2025
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    BridgeBio chalks up another win for its rare disease research

    The company reported its second late-stage study success, this time with a drug that could become a new treatment standard for an uncommon endocrine disease.

    By • Oct. 29, 2025
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    Trendline

    Emerging biotech

    New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

    By BioPharma Dive staff
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    GSK adds to COPD drug push with Empirico deal

    GSK is shelling out $85 million up front, and possibly $745 million overall, for an RNA-based therapy it sees helping a "broad spectrum" of people with the chronic lung condition. 

    By Kristin Jensen • Oct. 28, 2025
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    News roundup

    Incyte trims pipeline; Zenas surges on MS drug results

    Incyte axed three prospects to focus on “high-value programs,” its CEO said. Elsewhere, MapLight priced an IPO during the federal government shutdown and GSK picked up a cancer drug.

    By BioPharma Dive staff • Oct. 28, 2025
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    Zag Bio emerges with plans to treat immune disease by targeting the thymus

    With $80 million in funding from a list of high-profile backers, the startup is developing bifunctional antibodies that drag “tolerizing” antigens to the thymus.

    By • Oct. 28, 2025
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    BioMarin, following sluggish sales, to offload hemophilia gene therapy

    The company intends to divest Roctavian and “remove it from our portfolio,” CEO Alexander Hardy said, after nearly three years of slow uptake for a medicine once viewed as a future blockbuster.

    By • Oct. 27, 2025
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    Courtesy of Intellia Therapeutics
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    Gene editing

    Intellia pauses two CRISPR drug studies after safety scare

    A study volunteer receiving Intellia’s transthyretin amyloidosis treatment was hospitalized due to severe signs of liver stress, prompting the company to pause enrollment and dosing while evaluating a new safety protocol. 

    By • Oct. 27, 2025
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    BridgeBio to seek approval of limb-girdle drug following new study data

    The company intends to meet with the FDA to discuss results that showed a level of improvement on a marker of muscle stability that one executive described as a “home run.”

    By • Oct. 27, 2025
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    Emerging biotech

    Hemab collects another $157M to go after ‘underserved’ blood diseases

    The startup, which has a pair of medicines in testing and others in development, aims to build the “ultimate coagulation disorders company,” its CEO said. 

    By • Oct. 27, 2025
  • A sign with Biogen's logo sits outside the company's Cambridge, Massachusetts, headquarters on Sept. 5, 2024.
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    Biogen licenses a possible immune drug from OrbiMed-backed biotech

    The preclinical drug from Vanqua Bio is designed to inhibit “C5aR1,” a part of the immune system that regulates inflammation.

    By • Oct. 24, 2025
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    Ventyx shares soar after study suggests cardiovascular benefits for experimental drug

    The drug’s effects on cardiovascular and inflammation markers outshined its failure to spur weight loss, analysts wrote.

    By Kristin Jensen • Oct. 23, 2025
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    Vaccines

    Moderna says CMV vaccine once seen as future blockbuster fails key study

    A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.

    By • Oct. 22, 2025
  • A pair of scientists work in Electra Therapeutics' lab.
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    Emerging biotech

    Electra nabs $183M for its rare disease drug ambitions

    The San Francisco-area biotech has a therapy in mid-stage testing for secondary hemophagocytic lymphohistiocytosis, a rare inflammatory condition.

    By • Oct. 22, 2025
  • Two people work in the laboratory at Expedition Medicines.
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    Courtesy of Expedition Medicines
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    Startup launches

    Flagship bets again on AI with Expedition

    The prolific company creator is staking $50 million on AI drug discovery for cancer and immune diseases, launching a biotech that already has a partnership with Pfizer.

    By • Oct. 22, 2025
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    News roundup

    Iambic partners with Jazz; Merck breaks ground on $3B plant

    The biotechs will assess a combination of two drugs against HER2-positive breast cancer. Elsewhere, Merck unveiled the latest piece of its more than $70 billion domestic manufacturing investment.

    By BioPharma Dive staff • Oct. 21, 2025
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    Courtesy of Galapagos
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    Galapagos to wind down cell therapy business after failed attempt at sale

    The plans, if implemented, would result in the layoff of about 365 employees. Galapagos said it will still entertain acquisition offers as it works to close the unit.

    By Kristin Jensen • Oct. 21, 2025
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    Alto shares double on plans to speed depression drug’s development

    Investors reacted positively to news that the company was using a $50 million private placement to help fund a Phase 3 study.

    By • Oct. 20, 2025
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    Summit’s dual-acting drug scores lung cancer win

    A closely watched trial in Chinese patients is raising hope that ivonescimab will outperform Keytruda in a large global study that could reshape first-line treatment regimens.

    By • Oct. 20, 2025
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    News roundup

    I-Mab morphs into ‘hub-and-spoke’ biotech; Astellas passes on Taysha gene therapy

    I-Mab is rebranding as a company that will form individual drugmaking subsidiaries. Elsewhere, Sanofi cut an immune drug deal and investors poured $140 million into a new hair loss treatment.

    By BioPharma Dive staff • Oct. 17, 2025
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    Brain drug revival

    A longshot bet on a tremor drug pays off

    Shares of Praxis Precision Medicines more than tripled Thursday, peaking at $200 apiece, after the company disclosed positive data from a pair of late-stage clinical trials.

    By • Oct. 16, 2025
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    Emerging biotech

    A regenerative therapy for hair loss attracts a mega-fundraising round

    Backed by GV and Arch Venture Partners, Pelage Pharmaceuticals is advancing a first-of-its-kind topical gel designed to activate dormant hair follicle stem cells.

    By • Oct. 15, 2025
  • This image depicts the podcast series cover image for Pearson's BioPharma Dive series, "The Progress Profile: Alzheimer’s Research in Focus"
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    William Walker/BioPharma Dive
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    Sponsored by Pearson

    [Podcast] The Progress Profile: Alzheimer’s Research in Focus

    Discover the latest breakthroughs in Alzheimer's research, diagnosis, and prevention in this expert-led podcast series.

    By BioPharma Dive's studioID • Oct. 15, 2025
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    Emerging biotech

    Cancer drug startup Tubulis raises $361 million for ADCs

    The German biotech banked one of the larger funding rounds this year to support an ovarian and non-small cell lung cancer drug that’s currently in early-stage testing.

    By • Oct. 15, 2025
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    News roundup

    AstraZeneca cuts US drug pricing deal; FDA declares Novo plant out of compliance

    AstraZeneca followed the blueprint of a deal Pfizer recently cut with the White House. Elsewhere, Novo is shuttering its cell therapy division and an investor wants Novavax to sell itself.

    By BioPharma Dive staff • Oct. 14, 2025
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    Obesity drugs

    Kailera nets $600M more to advance Zepbound-like obesity drug

    Among the largest private biotech funding rounds this year, the financing will support global trials of an obesity shot that just succeeded in late-stage testing in China.

    By • Oct. 14, 2025