Apitegromab

Eli Lilly and Laekna collaborate on an obesity drug, LAE102, targeting weight loss and muscle preservation. This move intensifies competition in the $150B obesity treatment market, dominated by Lilly and Novo Nordisk. Other companies like Regeneron and Scholar Rock are also developing muscle-preserving treatments, reflecting a growing focus on maintaining muscle mass during weight loss.

Scholar Rock announced successful Phase 3 SAPPHIRE study results for apitegromab in treating SMA, showing significant motor function improvement. Plans include filing regulatory applications in Q1 2025 and a U.S. commercial launch in Q4 2025. The company raised $345 million, boosting its cash balance to $463 million, and is preparing for apitegromab's potential $1 billion revenue.

Scholar Rock Holding Corp's Q3 2023 Form 10-Q reports increased operating expenses, net loss, and loss per share. Key business highlights include positive Phase 3 SAPPHIRE trial results for apitegromab in SMA, ongoing ONYX extension study, and initiation of SRK-439 Phase 2 EMBRAZE trial for obesity. The company plans to submit regulatory applications for apitegromab in Q1 2025, with potential U.S. and European launches in 2025. Challenges include product development risks, reliance on third parties, and financial condition.

Apitegromab met primary endpoint in phase 3 SAPPHIRE trial, showing significant motor function improvement in SMA patients. Scholar Rock plans to submit a BLA for FDA and EU approval in Q1 2025.

BMO Capital Markets raised Scholar Rock's stock target to $38, citing positive Phase 3 SAPPHIRE trial results for apitegromab in SMA treatment, increasing approval probability to 95%. Scholar Rock plans FDA and EMA submissions in early 2025, with strong market momentum and analyst optimism supporting its outlook.

Apitegromab, an experimental SMA drug, showed promising results in a phase 3 trial, with 30% of patients achieving a 3-point improvement in motor function. The therapy targets myostatin to enhance muscle growth alongside existing treatments. Scholar Rock plans to submit applications to the FDA and EMA in Q1 2025.

Scholar Rock's experimental drug apitegromab, designed to block myostatin activation, showed significant muscle function improvement in SMA patients in a Phase 3 study, leading to a $300 million stock offering. The company plans FDA and EMA submissions for 2025 commercial launch, and is exploring apitegromab's use in preserving muscle mass during weight loss treatment.

Apitegromab, an antibody designed to block myostatin's inactive form, showed significant motor function improvements in SMA type 2 or 3 patients after a year of treatment in the Phase 3 SAPPHIRE study. The results align with earlier Phase 2 TOPAZ study findings and support plans for U.S. and EU approval submissions in Q1 2025. Apitegromab was well-tolerated, with no new safety issues reported.

Scholar Rock's stock surged 362% following positive Phase III results for its SMA candidate, apitegromab, which met primary endpoint in improving motor function. The company plans to file for US and EU approval in Q1 2025. Apitegromab, a muscle-targeted treatment, demonstrated clinical proof-of-concept in SMA, with significant improvement in HFMSE scores and a well-tolerated safety profile.

Scholar Rock's apitegromab, a myostatin blocker, showed significant motor function improvement in SMA patients in Phase III SAPPHIRE trial, with a 1.8-point increase on HFMSE at 52 weeks (p-value 0.0192). The company plans regulatory submissions in Q1 2025.