Scholar Rock’s Apitegromab Application Declined by FDA Due to Manufacturer Issues
Scholar Rock’s potential new SMA treatment, Apitegromab, received a delay from the FDA due to manufacturing site issues, not the drug's safety or effectiveness.
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HeartFlow Gets FDA Approval for Next-Gen Heart Plaque Detection Technology; Cigna Coverage 2025
HeartFlow receives FDA clearance for advanced AI-powered plaque analysis technology with 3D visualization, now covered by Cigna insurance starting October 2025.
Kodiak Sciences Gets 'Buy' Rating: What Investors Need to Know
Kodiak gets a "Buy" rating and $15 target. Final results for its 3 eye drugs are due 2026. Watch for rival Roche's data soon.
MBX Biosciences Advances Hypoparathyroidism Treatment to Phase 3
Once-weekly canvuparatide for hypoparathyroidism met its Phase 2 goal. 63% of patients achieved stable calcium and cut daily supplements. It was well tolerated and is advancing to Phase 3.
Goldman Sachs Initiates Immunome Coverage: Buy Rating
Goldman Sachs gave Immunome a "Buy" rating ($26 target). The company creates potentially best-in-class cancer drugs, including Varegacestat, which is seen as "differentiated." Key trial results are expected at the end of 2025.
Premier Acquired by Patient Square Capital in $2.6 Billion Deal
Premier, a healthcare tech firm, is being bought by Patient Square Capital for $2.6B ($28.25/share). Premier will go private, getting new capital to boost its tech and services for hospitals and health systems. Expected to close by early 2026.