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Scholar Rock Holding Corporation (SRRK) is a biotechnology company dedicated to pioneering a novel class of biologic therapies known as 'niche modulators'. These therapies selectively target the activation of growth factors within the disease microenvironment, offering a groundbreaking approach to treating serious medical conditions. Scholar Rock's initial proprietary and partnered drug discovery programs focus on specific growth factors, particularly members of the TGF-beta superfamily, which are critical in regulating cell growth and differentiation. These growth factors are notably present in the microenvironments of significant diseases like fibrosis, musculoskeletal disorders, and autoimmune diseases.
The company’s innovative therapeutic strategy stems from the foundational scientific discoveries of its founders, Professors Timothy Springer, PhD, and Leonard Zon, MD, from Children's Hospital Boston and Harvard Medical School. These discoveries illuminate the molecular mechanisms of growth factor activation, empowering Scholar Rock to advance its ground-breaking treatments.
Scholar Rock is backed by a consortium of top-tier life sciences investors, including Polaris Partners and Arch Venture Partners. Its flagship product candidate, Apitegroma, is a selective, fully human, monoclonal antibody that inhibits the activation of the growth factor myostatin in skeletal muscle. This innovative mechanism holds promise for treating neuromuscular disorders. Another key product in the company's pipeline is SRK-181, which targets the activation of latent transforming growth factor beta-1 (TGFβ1) and is being developed to treat cancers that are resistant to existing anti-PD-(L)1 antibody therapies.
With its operations based in the United States, Scholar Rock continues to make significant strides in the biopharmaceutical industry, pushing the envelope of medical science and offering hope for effective treatments against some of the most challenging diseases.
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.
Scholar Rock announced positive topline results from the Phase 3 SAPPHIRE clinical trial evaluating apitegromab, an investigational muscle-targeted therapy, in patients with Spinal Muscular Atrophy (SMA). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor function as measured by the Hammersmith Functional Motor Scale Expanded (HFMSE).
Key findings include:
- 30.4% of patients receiving apitegromab had >3 point improvement in HFMSE versus 12.5% on placebo
- Early motor function improvement observed from 8 weeks, with benefit expanding at 52 weeks
- Clinically meaningful benefit across all age groups (2-21 years)
- Favorable safety profile consistent with long-term data from Phase 2 TOPAZ trial
Scholar Rock plans to submit regulatory applications in the U.S. and EU in Q1 2025.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, has granted inducement equity awards to three new employees. The awards include 232,571 inducement stock options and 174,429 inducement restricted stock units, totaling 407,000 shares of common stock. These grants are part of the company's 2022 Inducement Equity Plan, designed to attract new talent.
The stock options have an exercise price of $8.49, equal to the closing price on September 9, 2024. They will vest 25% after one year, with the remaining 75% vesting quarterly over three years. The restricted stock units will vest in four equal annual installments. All vesting is subject to continued employment.
Scholar Rock (NASDAQ: SRRK) has completed enrollment in the Phase 2 EMBRAZE trial, evaluating apitegromab, a selective myostatin inhibitor antibody, for preserving lean muscle mass in obese individuals on GLP-1 receptor agonist therapy. Topline results are expected in Q2 2025. The trial will inform the development of SRK-439, a novel myostatin inhibitor for cardiometabolic disorders. EMBRAZE is assessing the primary endpoint of change in lean mass at 24 weeks. Scholar Rock will present new preclinical SRK-439 data at ObesityWeek® in November. The company plans to file an IND for SRK-439 in 2025. Additionally, Scholar Rock is developing apitegromab for spinal muscular atrophy (SMA), with topline data from the Phase 3 SAPPHIRE trial expected in Q4 2024.
Scholar Rock (NASDAQ: SRRK) has appointed Beth Shafer, Ph.D., as Chief Business Officer, a newly created role. With over 20 years of biopharmaceutical industry experience, Dr. Shafer will drive the company's long-term corporate and business development strategy. She joins from Voyager Therapeutics, where she served as Chief Business Officer. Previously, she held leadership positions at Takeda, Novartis, and Roche.
Scholar Rock is a late-stage biopharmaceutical company focusing on innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other diseases where protein growth factors play a key role. The appointment comes at a transformative time for the company as it aims to build an integrated biopharmaceutical company and advance its pipeline of therapies in high-value areas.
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