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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 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.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, announced its participation in two upcoming investor conferences in September. The company, which focuses on developing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other diseases involving protein growth factors, will be present at:
1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 5 in New York City, with a fireside chat scheduled for 7:00 a.m. ET.
2. 2024 Wells Fargo Healthcare Conference on September 5 in Boston, where management will engage in one-on-one meetings.
A live webcast of the Morgan Stanley event will be available on Scholar Rock's website, with an archived replay accessible for approximately 90 days.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, has granted inducement equity awards to five newly hired employees. The awards include 48,685 shares of inducement stock options and 36,515 shares of inducement restricted stock units, totaling 85,200 shares of common stock. These awards are part of the company's 2022 Inducement Equity Plan, designed to attract new talent.
The stock options have an exercise price of $9.48, equal to the closing price on August 12, 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 subject to continued employment with Scholar Rock.
Scholar Rock (NASDAQ: SRRK) reported Q2 2024 financial results and business updates. Key highlights include:
1. On track to report topline data from Phase 3 SAPPHIRE trial in Spinal Muscular Atrophy (SMA) in Q4 2024.
2. New data from Phase 2 TOPAZ extension study showed sustained clinical benefit over 48 months in nonambulatory SMA patients.
3. Phase 2 EMBRAZE proof-of-concept trial in obesity enrolling ahead of schedule, topline data expected in Q2 2025.
4. Q2 2024 net loss was $58.5 million or $0.60 per share.
5. Cash, cash equivalents, and marketable securities of $190.5 million as of June 30, 2024, expected to fund operations into the second half of 2025.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, will host a conference call on August 8, 2024, at 8:15am ET to discuss its second quarter 2024 financial results and provide a business update. The call will cover financial performance and advancements in treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases. Interested participants can register for the live audio webcast on the Scholar Rock website under the “Events and Presentations” section. A replay will be available for 90 days.
Scholar Rock (NASDAQ: SRRK) announced the granting of inducement equity awards under Nasdaq Listing Rule 5635(c)(4) to newly hired employees. On July 10, 2024, the company granted awards covering 285,000 shares of common stock, consisting of 162,857 inducement stock options and 122,143 inducement restricted stock units. On July 8, 2024, inducement equity awards covering 48,700 shares of common stock were granted, including 27,829 inducement stock options and 20,871 inducement restricted stock units. The stock options have exercise prices of $8.27 and $7.87, respectively, matching the closing prices on the grant dates. The awards are subject to the Scholar Rock 2022 Inducement Equity Plan. Stock options will vest 25% on the first anniversary of the start date, with the remaining 75% vesting quarterly over three years. Restricted stock units will vest annually over four years, contingent on continued employment.
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