Scholar Rock stock downgraded at Barclays (SRRK:NASDAQ)

Bristol Myers Squibb (BMY) awaits an FDA decision on Sept. 30 for expanding Camzyos to adolescents with obstructive hypertrophic cardiomyopathy. Egetis Therapeutics (EGTX) faces a Sept. 28 decision for Emcitate for MCT8 deficiency. Scholar Rock (SRRK), Biofrontera (BFRI), and Mirum Pharmaceuticals (MIRM) received early FDA approvals for their respective drugs. Mirum's shares rose 3% in pre-market trading.

Bristol Myers Squibb (BMY) and Egetis Therapeutics (EGTX) await FDA decisions on drug expansions. Biofrontera (BFRI), Scholar Rock (SRRK), and Mirum Pharmaceuticals (MIRM) received early approvals. BMY's Camzyos, if approved, would be the first cardiac myosin inhibitor for adolescents with oHCM. EGTX's Emcitate could be the first FDA-approved treatment for MCT8 deficiency. SRRK and BFRI shares declined post-approval, while MIRM shares rose.

The weight-loss drug market is growing rapidly, with analysts projecting $100B in annual sales in the next decade. Novo Nordisk and Eli Lilly lead the sector, but other companies like Pfizer, Viking Therapeutics, and AstraZeneca are developing new treatments. Key drugs include Novo's amycretin and CagriSema, Pfizer's PF-3944, and Lilly's retatrutide, with varying degrees of success in clinical trials.

Ultragenyx (RARE) gained FDA approval for FAYUVI, a treatment for Sanfilippo syndrome Type A, closing at $14.50, up 12.58%. Nuvation Bio (NUVB) expanded IBTROZI's label with new lung cancer data, closing at $6.07, up 5.02%. Bayer (BAYRY) won FDA approval for Kerendia in type 1 diabetes-related CKD, closing at $14.13, up 0.57%. Biogen (BIIB) and Eisai (ESALY.PK) received Japan approval for LEQEMBI Pen, closing at $219.05, up 1.41%. Telix (TLX) got FDA approval for Pixclara, a PET imaging agent fo

Scholar Rock Holding (SRRK) received FDA approval for ISEMBYLD, a treatment for spinal muscular atrophy in patients aged 2+. The drug showed a 2.2-point advantage over placebo in motor ability tests. The company is launching the product in the U.S., with support programs for insurance and infusions. Commercial success depends on patient access and treatment persistence, with safety concerns and reimbursement terms being key factors.

Scholar Rock (SRRK) shares fell 14% after Barclays downgraded it to Equal Weight, citing concerns about its pipeline despite FDA approval for Isembyld. The stock's P/S ratio is high, reflecting growth expectations, but profitability remains weak. Insider activity is balanced, and the GF Score™ is 29/100.