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Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Eli Lilly has expressed interest in participating in the IPO, with the regulatory filing revealing the obesity juggernaut’s plans to buy as much as $100 million worth of Aktis shares.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing director, head of Biotech Private Equity at Ally Bridge Group, about how M &A dynamics, dealmaking and global partnerships are reshaping portfolio valuations and paths to growth in 2026.
A bevy of other companies also brought in money on Thursday, including Alveus Therapeutics, Diagonal Therapeutics, EpiBiologics, Beacon Therapeutics and Protege.
While venture capital funding dipped to a six-year low in 2025, it nevertheless remained above pre-pandemic levels for Massachusetts-based biopharma companies, according to MassBio.
The deals will help Lilly diversify its portfolio that is heavily weighted on the obesity juggernaut tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight loss.
In 2025, made or projected biopharma workforce cuts affected about 42,700 employees, according to BioSpace tallies. BioSpace takes a deep dive into which companies and locations were impacted and speaks to experts about what to expect ahead—and why.
The company announced a $350 million public offering on Monday shortly after revealing positive Phase II results for its investigational congenital adrenal hyperplasia drug, with hopes to one day compete with Neurocrine’s Crenessity.
The cardiovascular biotech was also named as one of BioSpace’s top startups to watch on Wednesday.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
Jazz’s Ziihera and BeOne’s Tevimbra plus chemotherapy led to what Truist Securities dubbed one of the strongest overall survival signals ever reported in a type of gastroesophageal cancer.