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TOP STORIES
IPO
If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
FDA
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.
While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share.
UPCOMING EVENTS
Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
AstraZeneca remains “very much on track” to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said during the company’s Q2 earnings presentation on Monday.
Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
The star of the takeover is Forte Biosciences’ investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
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