Scholar Rock NASDAQ: SRRK CEO David Hallal said the company is preparing for a September 30 FDA decision date for apitegromab, its investigational treatment for spinal muscular atrophy, or SMA, following a resubmitted biologics license application supported by an alternate fill-finish manufacturing facility.
Scholar Rock NASDAQ: SRRK said its resubmitted biologics license application for apitegromab remains on track for a U.S. Food and Drug Administration decision by its Sept. 30 PDUFA date, as the company prepares for a potential launch of the muscle-targeted treatment for spinal muscular atrophy, or SMA.
Scholar Rock Holding Corporation (SRRK) Q2 2026 Earnings Call Transcript
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
Curtis Ellergodt Rothschild Investment LLC | 204 | $6,742.37 | $9,749.16 | $3,006.79 | 44.6% |
| NA Nizar Araji National Bank Of Canada /FI/ | 292 | $15,270.85 | $15,461.4 | $190.55 | 1.25% |
| BG Bart Gancher Intech Investment Management LLC | 25,782 | $885,652.16 | $1.37M | $479,504.74 | 54.14% |
Anthony Scaramucci SkyBridge Capital II LLC | 278,000 | $12.95M | $14.6M | $1.65M | 12.78% |
Jeff Ameen Spire Wealth Management | 6,303 | $118,496.4 | $298,100.38 | $179,603.98 | 151.57% |
| Biotechnology Industry | Healthcare Sector | David L. Hallal CEO | NASDAQ (NGS) Exchange | 80706P103 CUSIP |
| US Country | 289 Employees | - Last Dividend | - Last Split | 24 May 2018 IPO Date |
Scholar Rock Holding Corporation is a pioneering biopharmaceutical company deeply engaged in the research and development of innovative treatments aimed at severe diseases where protein growth factor signaling plays a critical role. Founded in 2012 and based in Cambridge, Massachusetts, Scholar Rock is committed to advancing the field of biopharmaceuticals through its cutting-edge scientific research and development initiatives. The company’s strategic focus is not only on unveiling novel therapeutic candidates but also on pushing the boundaries of medical research to potentially revolutionize treatment paradigms for patients afflicted with a myriad of grave conditions. Through its rich pipeline and strategic partnerships, such as the collaboration with Gilead Sciences, Inc., Scholar Rock seeks to address unmet medical needs in areas including neuromuscular disorders, cancer, fibrosis, and iron-restricted anemia.
An innovative therapeutic in development by Scholar Rock, Apitegromab targets the inhibition of latent myostatin activation. It has successfully completed Phase 3 clinical trials, signifying a promising step forward in the treatment of spinal muscular atrophy (SMA). As a disease that devastates muscle strength and movement, SMA represents a critical area in need of effective treatments. Apitegromab's progression into late-stage development underscores Scholar Rock's commitment to addressing this debilitating condition and its potential to significantly impact patient care.
Embarking on a journey to conquer cancer resistance, Scholar Rock’s SRK-181 is at the forefront of the company's oncological pipeline. Currently in Phase 1 clinical trials, SRK-181 is designed to target tumors resistant to existing checkpoint inhibitor therapies, including those that engage anti-PD-1 or anti-PD-L1 antibodies. This innovative approach highlights the company’s dedication to tackling one of the key hurdles in oncology - the evasion of immune response by certain cancers, with the aim of providing new hope and options for patients facing limited treatments.
In its quest to combat fibrotic diseases, Scholar Rock has entered into a strategic partnership with Gilead Sciences, Inc. This collaboration is dedicated to the discovery and development of specialized inhibitors targeting transforming growth factor beta (TGFβ) activation. Fibrotic diseases, characterized by the damaging buildup of scar tissue in organs, represent a significant challenge in medical treatment. Through this partnership, Scholar Rock and Gilead Sciences aim to unlock novel therapeutic avenues, potentially improving outcomes for patients across the globe suffering from these debilitating conditions.