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TOP STORIES
Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the indication.
Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma’s second quarter earnings call—though major pickups aren’t completely off the table.
The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Therapeutics’ exon-skipping therapy Exondys 51, the current standard of care, according to Oppenheimer.
Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.”
Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for their recently approved IgAN therapies Fabhalta and Trutakna.
After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape with innovative approaches—and experts say there’s room for all of them.
PRESS RELEASES
Ad hoc announcement pursuant to Art. 53 LR • The next phase of the greenfield project in Sisslerfeld (Eiken, Switzerland) will be implemented as part of a strategic collaboration. • Total investment amounts to more than CHF 500 million. • Start of commercial production at the new site is expected in 2030.