Welcome to our dedicated page for Scholar Rock Holding news (Ticker: SRRK), a resource for investors and traders seeking the latest updates and insights on Scholar Rock Holding stock.
News about Scholar Rock Holding Corporation (NASDAQ: SRRK) focuses on its progress as a late-stage biopharmaceutical company in neuromuscular diseases, particularly spinal muscular atrophy (SMA). Company announcements highlight clinical, regulatory, financial, and corporate developments tied to its myostatin biology platform and lead investigational therapy, apitegromab.
Investors and followers of SRRK can expect regular updates on the regulatory path for apitegromab, including interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Recent press releases describe a Biologics License Application (BLA) for apitegromab, a Complete Response Letter related to a third-party fill-finish facility, a subsequent Type A meeting with the FDA, and ongoing EMA review of a Marketing Authorisation Application. News items also cover disease awareness and launch readiness activities in the United States and Europe.
Scholar Rock’s news flow also includes clinical trial milestones across its pipeline. Examples include dosing in the Phase 2 OPAL study in infants and toddlers with SMA, plans for the FORGE Phase 2 trial in facioscapulohumeral muscular dystrophy (FSHD), completion of a subcutaneous apitegromab Phase 1 study, and initiation of a Phase 1 trial of SRK-439 in healthy volunteers. These updates provide insight into the company’s broader anti-myostatin program and expansion into additional rare, severe, and debilitating neuromuscular diseases.
Financial and corporate news for SRRK features quarterly financial results, cash runway commentary, equity offerings under at-the-market programs, and inducement equity grants to new employees under the 2022 Inducement Equity Plan. Scholar Rock also issues announcements about participation in major healthcare conferences and investor events. For readers tracking SRRK stock and the company’s evolution as a late-stage biopharmaceutical organization, this news page aggregates these developments in one place.
Scholar Rock (NASDAQ: SRRK) has granted inducement equity awards to four new employees, including stock options for 57,429 shares and restricted stock units for 43,071 shares. The stock options, priced at $28.15 per share, will vest 25% after one year and the remaining 75% in quarterly installments. The restricted stock units will vest in four equal annual installments. These grants, made under the company's 2022 Inducement Equity Plan, are designed to attract new talent to the late-stage biopharmaceutical company, which focuses on treatments for spinal muscular atrophy and cardiometabolic disorders.
Scholar Rock (SRRK) reported positive Phase 3 SAPPHIRE trial results for apitegromab in Spinal Muscular Atrophy (SMA), achieving its primary endpoint with statistically significant motor function improvement. The company plans to submit BLA and MAA applications in Q1 2025. The Phase 2 EMBRAZE obesity trial enrollment is complete with data expected in Q2 2025. Financial highlights include completion of a $345M public offering and Q3 2024 net loss of $64.5M ($0.66/share). Cash position stands at $139.1M, with pro forma balance of $463.5M including October offering, extending runway into Q4 2026.
Scholar Rock (NASDAQ: SRRK) announced new preclinical data for SRK-439, showing significant lean mass increase and enhanced fat mass loss when combined with metformin. In young mice, the combination treatment demonstrated a 31.6% increase in lean mass compared to 15.1% in controls, while older mice showed a 10.2% increase versus 0.2% in controls. The study also revealed lower fat mass gain in young mice receiving the combination treatment (68.2% increase) compared to metformin alone (114% increase). These results support the potential of selective myostatin inhibition in improving body composition for obesity treatment. The company's Phase 2 EMBRAZE trial is on track for readout in Q2 2025.
Scholar Rock (NASDAQ: SRRK) announced it will host a conference call to discuss third quarter 2024 financial results and provide a business update on Tuesday, November 12, 2024, at 8:15am ET. The company, which focuses on developing treatments for spinal muscular atrophy, cardiometabolic disorders, and other diseases involving protein growth factors, will make the audio webcast available on their investor relations website. Participants can register online to join via telephone or web.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focusing on treatments for spinal muscular atrophy, cardiometabolic disorders, and diseases involving protein growth factors, has announced its participation in three upcoming investor conferences. The company will present at the Truist Securities BioPharma Symposium on November 7, the Jefferies London Healthcare Conference on November 20, and the Piper Sandler Healthcare Conference on December 4. Live webcasts will be available on Scholar Rock's website, with replays accessible for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) announced it will present new data from the Phase 1 DRAGON trial of SRK-181, an investigational selective inhibitor of latent TGFβ1 activation, at the SITC 39th Annual Meeting. The presentation will include updated safety, efficacy, and biomarker results for SRK-181 in anti-PD-1 resistant patients with advanced solid tumors from the expansion phase (Part B) of the trial. The company reports observing durable responses in heavily pretreated patients, with some patients remaining on therapy after the trial completed enrollment last year.
Scholar Rock Holding (Nasdaq: SRRK) announced on October 16, 2024, that the underwriters of its previously announced public offering exercised their option to purchase an additional 1,592,920 shares at $28.25 per share. This resulted in additional gross proceeds of approximately $45 million. The closing of this additional purchase occurred on October 18, 2024.
The original offering, which closed on October 10, 2024, included common stock and pre-funded warrants. J.P. Morgan Securities , Jefferies, and Piper Sandler & Co. acted as joint book-running managers, while BMO Capital Markets Corp., Wedbush Securities Inc., and Raymond James & Associates, Inc. served as co-managers for the offering.
An automatically effective shelf registration statement on Form S-3 was filed with the SEC on October 7, 2024. The final prospectus supplement and accompanying prospectus were filed on October 9, 2023.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, has announced the granting of inducement equity awards to two newly hired employees. The awards include inducement stock options to purchase 13,429 shares of common stock and inducement restricted stock units covering 10,071 shares, totaling 23,500 shares. These awards are subject to the terms and conditions of the Company's 2022 Inducement Equity Plan.
The inducement stock options have an exercise price of $28.52, equal to the closing price of Scholar Rock's common stock on October 14, 2024. They will vest 25% after one year, with the remaining 75% vesting in 12 quarterly installments. The restricted stock units will vest in four equal annual installments. All vesting is contingent on continued employment with the Company.
Scholar Rock Holding (Nasdaq: SRRK) has announced the pricing of an upsized public offering of 10,265,488 shares of common stock at $28.25 per share and 353,983 pre-funded warrants at $28.2499 per warrant. The gross proceeds are expected to be approximately $300 million. The offering is set to close on October 10, 2024, with underwriters having a 30-day option to purchase up to an additional 1,592,920 shares.
The company plans to use the net proceeds to support the commercialization of apitegromab, advance ongoing and future clinical programs, develop its technology platform, and for working capital. J.P. Morgan Securities , Jefferies, and Piper Sandler & Co. are acting as joint book-running managers for the offering.
Scholar Rock Holding (Nasdaq: SRRK) has announced a proposed public offering of $275 million in common stock and pre-funded warrants. The biopharmaceutical company, focused on treatments for spinal muscular atrophy and other diseases, intends to use the proceeds for commercialization of apitegromab, advancing clinical programs, developing its technology platform, and general corporate purposes. J.P. Morgan Securities , Jefferies , and Piper Sandler & Co. are acting as joint book-running managers. The company will grant underwriters a 30-day option to purchase additional shares up to 15% of the offered securities. An automatically effective shelf registration statement has been filed with the SEC, and a preliminary prospectus supplement will be available soon.