$SRRK

Scholar Rock Holding (SRRK) has two manufacturing facilities ready for regulatory review for its lead SMA therapy, apitegromab, reducing supply risk. The company projects $538.3M revenue and $92.4M earnings by 2029, but faces high launch costs and regulatory risks. Analysts' fair value estimates for SRRK range from $70 to $220.

Scholar Rock Holding (SRRK) reported Q2 2026 results, highlighting $492M in cash and preparations for the U.S. launch of apitegromab by September 30th. The company has two fill-finish facilities ready for approval and is advancing its anti-myostatin pipeline, including Phase 2 trials for SMA and FSHD. Positive interactions with FDA and EMA were noted, with plans for a European launch starting in Germany.

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.

Scholar Rock COO Keith Woods gifted 48,034 shares to a trust on September 24, 2026. Post-transfer, Woods holds 0 common shares, 122,021 time-based RSUs, and 450,000 performance- and time-based RSUs. The transfer was made for no consideration, with Woods' spouse as trustee.

Scholar Rock (SRRK) was added to Wedbush's Best Ideas List with an Outperform rating. Wedbush cited its position in the neuromuscular space and set a $70 price target, implying 44% upside from the Sept. 24 close.

Scholar Rock CEO David Hallal transferred 36,652 shares to a family trust on September 21, 2026. Post-transaction, Hallal's position includes 1,602,382 shares, comprising common stock and RSUs. The Hallal Family Irrevocable Trust-2021 now holds 36,652 shares, while another family trust holds 205,000 shares.

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 received FDA approval for Isembyld, a drug targeting muscle loss in spinal muscular atrophy (SMA). The approval follows successful clinical trials showing improved motor skills in patients. The drug is approved for use with existing SMA therapies. Scholar Rock, valued at $6.8B, addressed manufacturing issues before resubmission. Pricing details are pending.

Analysts downgraded several stocks: HSBC cut Banco Santander Brasil (BSBR) to Hold with a $6.2 target; Rosenblatt downgraded Ribbon Communications (RBBN) to Neutral with a $2.2 target; Citizens downgraded Cellectis (CLLS) to Market Perform; Barclays downgraded Scholar Rock (SRRK) to Equal-Weight with a $58 target; Raymond James downgraded Ascendis Pharma (ASND) to Outperform with a $287 target.