Scholar Rock(US:SRRK)2025-07-03 08:09Apitegromab in SMA - Positive Phase 3 SAPPHIRE data was presented at MDA, showing that 30% of apitegromab patients achieved ≥3-point improvement in HFMSE compared to 12.5% on placebo[19] - Apitegromab demonstrated a 1.8 point improvement (p=0.0192) in HFMSE versus placebo[19] - The FDA has accepted the BLA for Apitegromab under Priority Review, with a PDUFA date of September 22[22] - The company anticipates a commercial launch of Apitegromab in Q3, pending regulatory approval[37] - The company anticipates EU approval in 2026[10] Pipeline Development - The company plans to file the IND application for SRK-439 in Q3[26] - An exploratory Phase 2 EMBRAZE POC study in Obesity readout is on track for June[10] - The company plans to initiate Ph 2 OPAL Trial in Q3 2025 for SMA patients <2 years old[32] Financial Status - The company reported $364.4 million in cash as of March 31, 2025[10]