The Latest
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Kendall Davis/BioPharma Dive
Tracker10 clinical trials to watch in the first half of 2026
After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and many rare conditions could help it continue.
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Gene editingPrime to test FDA flexibility with 2-patient gene editing submission
The planned filing comes amid heightened scrutiny of the FDA’s rare disease stance and a year after Prime deprioritized the program for economic reasons.
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Courtesy of Kyowa Kirin
Kyowa Kirin abandons touted eczema drug following safety review
A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug’s mechanism to the onset of a type of skin cancer.
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China competitionDrugs from China are reshaping biotech. Track the licensing deals here.
Sanofi reached a deal for rights to a drug already on the market in China, while UCB is the latest to bet on the ability of T cell engagers to treat autoimmune conditions.
Updated March 4, 2026 -
Alamy
Pierre Fabre seeks to revive US approval chances for spurned cell therapy
Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has surprised some companies and frustrated investors.
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Permission granted by Candid Therapeutics
Candid, in a reverse merger with RallyBio, to go public
Candid, which is making bispecifics for immune diseases, has also raised $505 million in a private financing for the newly formed company.
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UniQure says FDA wants another study of Huntington’s gene therapy
Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
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News roundupFDA again targets GLP-1 compounders; Intellia to restart heart disease trial
The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.
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Bhagavatheeshwaran, Govind. (2016). "MRI Scan" [Image]. Retrieved from Flickr.
Roche pill succeeds in another MS study, but approval questions linger
Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared Phase 3 studies in multiple forms of the disease.
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Safety concerns spur Aardvark to halt key Prader-Willi drug trial
The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.
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Ascendis wins FDA approval of dwarfism drug
Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.
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UniQure falls further on Makary comments
Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is accelerating. Track the deals that are happening here.
Esperion Therapeutics is paying $75 million upfront, and potentially $180 million more, for Corstasis Therapeutics, the developer of an FDA-approved nasal spray used to treat edema.
Updated March 2, 2026 -
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Startup launchesAtrium spins out of Avidity, aiming to target rare heart diseases with RNA
Four months after Avidity’s $12 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its predecessor’s work in cardiovascular disease.
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IPO windowGenerate caps a strong month for biotech IPOs with $400M offering
The AI drug discovery specialist is the fifth biotechnology company to go public in February and priced the sector’s largest new stock offering in nearly three years.
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Courtesy of Sarepta
Sarepta CEO Doug Ingram to retire, with company at a crossroads
Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling Elevidys sales and emerging competitors to its core business.
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Obesity drugsLilly’s GLP-1 pill tops Novo’s Rybelsus in head-to-head trial
Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates.
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Adeline Kon/BioPharma Dive
Deep Dive // IPO windowBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
Generate Biomedicines’ $400 million offering is the biotech sector’s largest by total proceeds since Acelyrin’s $540 million IPO in May 2023.
Updated Feb. 26, 2026 -
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VaccinesModerna’s combination flu, COVID shot wins over European drug regulators
In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for Moderna’s vaccine in the U.S.
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News roundup
Boehringer drug approved in 44 days; BioMarin shelves Roctavian
Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval. Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid dividends.
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Bristol Myers says ADC licensed from China hits mark in aggressive breast cancer
The study result is the latest step forward for a drug Bristol could eventually pay more than $8 billion for and has spotlighted as important to its future growth.
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Obesity drugsWith Vivtex deal, Novo gains a chance at better oral obesity drugs
The potentially $2.1 billion collaboration gives Novo access to technologies that are meant to help optimize the delivery of oral biologic medicines.
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Courtesy of GSK
GSK to acquire 35Pharma in $950M deal for cardiovascular drug
The deal hands GSK a drug it views as a potentially “best-in-class” therapy for blood pressure diseases like pulmonary arterial hypertension — the target of Merck’s fast-selling Winrevair.
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Permission granted by Karissa Waddick
Alkermes’ Richard Pops to step down after three-decade run as CEO
One of biotech’s longest-tenured leaders, Pops steered Alkermes through several reinventions, the latest of which has made it a frontrunner in developing a new narcolepsy drug.
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Elijah Nouvelage via Getty Images
Vaccines15 states sue HHS over changes to childhood vaccine schedule
The lawsuit seeks to reverse the abrupt overhaul of the U.S. immunization schedule as well as the federal government’s allegedly “unlawful” reformation of a key vaccine panel.
