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The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.
FEATURED STORIES
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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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.
Cartography will hunt for novel tumor antigens, which Pfizer can opt into and advance into clinical development.
The acquisition is centered on Dark Blue Therapeutics’ small-molecule degrader of the MLLT1 and MLLT3 proteins, which is being tested for acute myeloid leukemia.
Novo Nordisk follows Christmas oral Wegovy approval with quick launch; Eli Lilly is headed for $94.3 billion in annual revenue by 2027, analysts predict; nine more pharmas strike Most Favored Nation deals but half remain unsigned; experts call for stability and rare disease action at FDA, and all eyes are on M&A ahead of the J.P. Morgan Healthcare conference next week.
After a prolonged funding chill, investors say 2026 is shaping up for continued dealmaking and diversified bets beyond oncology and immunology.
From biotech veterans to embattled modalities to a new wave of RNAi therapeutics, BioSpace’s NextGen Class of 2026 emerged during a tough fundraising environment in 2025. Check out the 15 battle-tested companies that caught our eye.