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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) has appointed Tracey M. Sacco as Chief Commercial Officer. Sacco, with nearly two decades of biopharmaceutical experience, will lead all commercial activities, focusing initially on the potential launch of apitegromab, a Phase 3 candidate for spinal muscular atrophy (SMA). Dr. Jay Backstrom, CEO of Scholar Rock, expressed confidence in Sacco's expertise in building commercial organizations, which is critical as the company advances its Phase 3 SAPPHIRE trial. Sacco's background includes significant roles at notable companies like Acceleron Pharma and Genzyme, underscoring her capacity to drive successful product launches.
Scholar Rock (NASDAQ: SRRK) provided updates on its clinical programs, indicating pivotal Phase 3 SAPPHIRE trial enrollment completion expected in 2023. The DRAGON trial of SRK-181 is also advancing, showing early efficacy signals. The company anticipates sufficient cash runway into 2025, supported by a $205 million equity raise completed in June 2022, with current cash reserves around $315 million. Upcoming milestones include 36-month data from the Phase 2 TOPAZ trial and progress on preclinical assets targeting fibrosis and iron-restricted anemia.
Scholar Rock (NASDAQ: SRRK) has announced that management will present at the J.P. Morgan 41st Annual Healthcare Conference on January 10, 2023, at 1:30 p.m. PT (4:30 p.m. ET). Investors can watch the live webcast through the Scholar Rock website, with an archived version available for 90 days afterward. Scholar Rock focuses on developing innovative treatments for serious diseases influenced by protein growth factors, targeting conditions like neuromuscular disorders, cancer, and fibrosis.
Scholar Rock (NASDAQ: SRRK) granted equity awards to a new employee, Jing L. Marantz, as part of its 2022 Inducement Plan. Dr. Marantz received a stock option for 250,000 shares at an exercise price of $8.59, which will vest in increments starting on November 9, 2023. The Inducement Plan aims to attract new employees following a period of non-employment, complying with Nasdaq's requirements. This strategic move underscores Scholar Rock's growth initiatives in the biopharmaceutical sector focused on innovative treatments for serious diseases.
Scholar Rock (SRRK) reported its Q3 2022 financial results, revealing a net loss of $43.3 million or $0.55 per share, compared to a net loss of $37.5 million or $1.02 per share in Q3 2021. Revenue fell to $0 from $5.5 million in the previous year. Notable updates include positive 24-month TOPAZ trial data for apitegromab in spinal muscular atrophy and ongoing enrollment for the Phase 3 SAPPHIRE trial. The company amended its debt facility, adding $25 million in capacity and extending loan terms. Cash reserves stand at $343.7 million, expected to fund operations into 2025.
Scholar Rock (NASDAQ: SRRK) has released early data from its Phase 1 DRAGON trial of SRK-181, a selective TGFβ1 inhibitor targeting advanced cancer resistance to checkpoint therapy. Key findings include:
- All doses were well tolerated with no significant toxicities.
- Biomarker data showed consistent target engagement.
- Two confirmed partial responses were observed in patients with anti-PD-1 resistant clear cell renal cell carcinoma.
Enrollment in the trial's Part B is ongoing, with further data expected next year.
Scholar Rock (NASDAQ: SRRK) appointed Dr. Jing L. Marantz as Chief Medical Officer, bringing over 20 years of experience in neurology, hematology/oncology, and rare diseases. Dr. Marantz, previously of Krystal Biotech, will oversee clinical development including the Phase 1 DRAGON trial for SRK-181 and Phase 3 SAPPHIRE trial for apitegromab in spinal muscular atrophy (SMA). CEO Jay Backstrom noted her expertise will enhance the company’s innovative approach to targeting TGFβ growth factors.
Scholar Rock (NASDAQ: SRRK) announced its participation in two upcoming investor conferences. The first is the Guggenheim 4th Annual Neuro/Immunology Conference on November 15, 2022, from 2:10-2:35 p.m. ET. The second is the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, from 8:00-8:25 a.m. ET. Live webcasts can be accessed on the Scholar Rock website, with archived replays available for 90 days post-event. Scholar Rock focuses on innovative treatments for serious diseases involving protein growth factors.
Scholar Rock (NASDAQ: SRRK) has announced new quality-of-life data from its Phase 2 TOPAZ trial extension, indicating sustained improvements in daily activities, fatigue, and muscle endurance for non-ambulatory patients with spinal muscular atrophy (SMA) over 24 months. Data presented in Barcelona suggest apitegromab may offer significant benefits, particularly for patients receiving nusinersen. No safety concerns were reported, with the majority of patients opting to continue treatment into a 36-month extension.
Scholar Rock (NASDAQ: SRRK) announced the upcoming presentation of data from the DRAGON Phase 1 clinical trial of SRK-181 at the SITC Annual Meeting in Boston, from November 8-12. The study focuses on patients with advanced solid tumors, showcasing safety, efficacy, and biomarker results from Part A and an update on Part B.
SRK-181 is designed to overcome resistance to checkpoint inhibitors, with potential benefits in tumor response and survival rates. The trial continues to enroll patients across multiple cancer types, demonstrating a promising path for future cancer therapies.
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