Scholar Rock Holding Stock Price, News & Analysis

Scholar Rock (NASDAQ: SRRK) announced the publication of pivotal Phase 3 SAPPHIRE trial results for apitegromab in The Lancet Neurology. The trial demonstrated statistically significant motor function improvements in SMA patients receiving SMN-targeted treatment. Key findings include a 1.8-point mean improvement in HFMSE scores (p=0.019) versus placebo, with 30.4% of patients showing ≥3-point improvement compared to 12.5% on placebo.

The FDA has accepted apitegromab's BLA under priority review with a PDUFA date of September 22, 2025. Scholar Rock plans to launch commercially in the U.S. in 2025 and Europe in 2026, pending regulatory approvals. The treatment demonstrated consistent benefits across age groups and was well-tolerated, maintaining its established safety profile.

Scholar Rock (NASDAQ: SRRK) reported significant progress in Q2 2025, highlighted by the FDA's acceptance of apitegromab's BLA under priority review with a PDUFA date of September 22, 2025. The company's lead candidate for spinal muscular atrophy (SMA) also received EMA validation for its Marketing Authorisation Application, with European launch anticipated in 2026.

The company reported positive results from the Phase 2 EMBRAZE trial in obesity, demonstrating significant lean mass preservation with apitegromab during tirzepatide-induced weight loss. Financial results showed a net loss of $110 million ($0.98 per share) for Q2 2025. With $295 million in cash and equivalents, Scholar Rock expects to fund operations into 2027.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy (SMA) and other neuromuscular diseases, will host a conference call to discuss Q2 2025 financial results on August 6, 2025, at 8:00am ET.

Investors can access the call by registering online or dialing 800-715-9871 (domestic) or 646-307-1963 (international) with conference ID 3205013. A webcast replay will be available for approximately 90 days on the company's investor relations website.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy (SMA), has granted inducement equity awards to 6 new employees. The awards include 128,057 stock options at an exercise price of $38.59 and 96,043 restricted stock units.

The awards are part of the Company's 2022 Inducement Equity Plan, designed for new hires. The stock options will vest 25% after one year, with remaining 75% vesting quarterly over three years. Restricted stock units will vest in four equal annual installments, subject to continued employment.

Scholar Rock (SRRK) will present comprehensive data from its successful Phase 3 SAPPHIRE trial of apitegromab at the 2025 Cure SMA Meeting. The trial demonstrated statistically significant and clinically meaningful improvements in motor function for SMA patients, measured by HFMSE. The FDA has accepted apitegromab's BLA with priority review, setting a PDUFA date of September 22, 2025. Additionally, the EMA has validated the Marketing Authorisation Application for apitegromab. Dr. Basil T. Darras will present detailed efficacy and safety data for Type 2 and Type 3 SMA patients on June 27, while Dr. Jena M. Krueger will present a systematic review of long-term SMN-targeted therapy effectiveness on June 25.

Scholar Rock (SRRK) announced positive Phase 2 EMBRAZE trial results for apitegromab combined with tirzepatide for weight loss. The study showed that apitegromab preserved 54.9% more lean mass (+4.2 lbs) compared to tirzepatide alone (p=0.001). Patients receiving the combination therapy lost 12.3% body weight with better quality weight loss (85% fat mass/15% lean mass) versus tirzepatide alone (70% fat mass/30% lean mass). The combination resulted in 18.8 lbs fat mass loss compared to 17.7 lbs with tirzepatide alone. The drug demonstrated a favorable safety profile with no serious adverse events related to apitegromab treatment. While promising for the platform, the company remains focused on apitegromab's potential approval for spinal muscular atrophy (SMA) and plans to file an IND for SRK-439 in H2 2025.

Scholar Rock (SRRK) announced equity inducement grants to 11 new employees, including stock options for 176,963 shares and restricted stock units for 132,737 shares under its 2022 Inducement Equity Plan. The stock options have an exercise price of $34.07, equal to the closing price on June 9, 2025. The options vest 25% after one year and the remaining 75% quarterly over three years, while restricted stock units vest in four equal annual installments. These grants are specifically designed for new hires as employment incentives under Nasdaq Rule 5635(c)(4). Scholar Rock is a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy and other neuromuscular diseases.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company specializing in apitegromab development for spinal muscular atrophy (SMA) and other neuromuscular diseases, announced its participation in the 46th Annual Goldman Sachs Global Healthcare Conference. CEO David L. Hallal and management team members will engage in a fireside chat on June 11, 2025, at 9:20 a.m. ET in Miami, Florida. The presentation will be accessible via live webcast through the company's Investors & Media section, with replay availability for approximately 90 days.

Scholar Rock (SRRK) has appointed Rebecca McLeod as Chief Brand Officer and U.S. General Manager to lead the anticipated U.S. commercial launch of apitegromab for spinal muscular atrophy (SMA) patients. McLeod, a 25-year industry veteran, previously served as argenx U.S. General Manager where she successfully led the launch of VYVGART for gMG and CIDP. In her new role, she will be responsible for establishing global brand strategy and market positioning for apitegromab across Europe, Asia-Pacific, and Latin America. McLeod's extensive experience includes leadership positions at Alexion Pharmaceuticals and Takeda Pharmaceuticals, with her most recent achievement being one of the most successful biopharmaceutical franchise launches with VYVGART at argenx.