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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
FEATURED STORIES
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?
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.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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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.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
Arrowhead heralded the results as proof of concept that inhibiting the Activin E pathway can improve body composition and enhance weight loss as compared to tirzepatide alone, particularly in patients with type 2 diabetes.
Eli Lilly kicked off a pivotal 2026 campaign with a multi-year collaboration with current partner Nimbus Therapeutics worth a potential $1.3 billion for a preclinical obesity therapeutic. The deal follows a 2022 partnership struck by the companies to target the AMPK protein in cardiometabolic diseases.
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.
The agreement, which BMO Capital Markets called a “mild positive” for Structure, appears to address Roche’s concerns about the composition of investigational weight loss drug CT-996.