Biotech
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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 Delilah Alvarado • Oct. 30, 2025 -
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 Ben Fidler • Oct. 29, 2025 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging 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 -
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 -
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 -
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 Gwendolyn Wu • Oct. 28, 2025 -
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 Ben Fidler • Oct. 27, 2025 -
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 Jonathan Gardner • Oct. 27, 2025 -
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 Ben Fidler • Oct. 27, 2025 -
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 Ben Fidler • Oct. 27, 2025 -
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 Jacob Bell • Oct. 24, 2025 -
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 -
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 Delilah Alvarado • Oct. 22, 2025 -
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 Gwendolyn Wu • Oct. 22, 2025 -
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 Gwendolyn Wu • Oct. 22, 2025 -
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 -
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 -
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 Jacob Bell • Oct. 20, 2025 -
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 Jonathan Gardner • Oct. 20, 2025 -
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 -
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 Jacob Bell • Oct. 16, 2025 -
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 Jacob Bell • Oct. 15, 2025 -
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 -
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 Gwendolyn Wu • Oct. 15, 2025 -
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 -
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 Jonathan Gardner • Oct. 14, 2025