Scholar Rock Surges Amid Regeneron Eylea Update

Scholar Rock's stock price jumped following an update from Regeneron Pharmaceuticals regarding the manufacturing of a new pre-filled syringe version of Eylea HD. Both companies utilize contract drug manufacturer Catalent, which was acquired by Thermo Fisher Scientific in 2018. The update may have inadvertently boosted Scholar Rock's stock due to increased attention and speculation about potential collaborations or investments in the company.

Scholar Rock Holding Corporation's (SRRK) stock price experienced a notable increase following an update from Regeneron Pharmaceuticals regarding the manufacturing of a new pre-filled syringe version of Eylea HD. The update, which may have inadvertently boosted SRRK's stock, comes as both companies utilize contract drug manufacturer Catalent, which was acquired by Thermo Fisher Scientific in 2018.

Regeneron announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. This includes a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe and a supplemental Biologics License Application (sBLA) seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA extended the review periods after determining that information provided since the initial submissions required additional evaluation [2].

The update from Regeneron may have sparked increased attention and speculation about potential collaborations or investments in SRRK. The company's stock price has been volatile in recent months, with significant movements following clinical trial results and regulatory decisions. For instance, SRRK's stock rallied after Biogen's dual myostatin and activin receptor inhibitor taldefgrobep alfa failed its Phase 3 study in November 2024, and further increased following the successful placebo-controlled Phase 3 trial (SAPPHIRE) of its lead program, apitegromab [1].

SRRK's lead program, apitegromab, is an intravenously administered monoclonal antibody that inhibits the activation of growth factor myostatin in skeletal muscle, targeting spinal muscular atrophy (SMA). The company is awaiting a decision from the FDA for the treatment of SMA, with a PDUFA date of September 22, 2025. If approved, management places the global revenue potential of apitegromab at over $2 billion.

While the exact reason for the recent stock price jump is unclear, the update from Regeneron could be seen as a positive development for SRRK, as it suggests increased attention and potential opportunities in the biopharmaceutical industry. However, it is essential to note that SRRK's stock price has been influenced by various factors, including clinical trial results and regulatory decisions, and the company's overall financial performance remains to be seen.

References:
[1] https://seekingalpha.com/article/4813307-scholar-rock-holding-upcoming-milestone-approaches
[2] https://www.globenewswire.com/news-release/2025/08/20/3136582/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Applications-for-Expanded-U-S-Label-and-Prefilled-Syringe-Receive-FDA-Review-Period-Extension.html