Pre-market explanation of increase of more than 8%
- Scholar Rock’s (NASDAQ: SRRK) share price rose more than 8% before market launch. That’s why it happened.
The share price of Scholar Rock (NASDAQ: SRRK) – a clinical-stage biopharmaceutical company focused on treating serious conditions in which protein growth factors play a fundamental role – rose more than 8% before the marketing. Investors have responded positively to the company’s announcement that the US Food and Drug Administration (FDA) has granted Fast Track designation for apitegromab, a selective myostatin activation inhibitor, for the treatment of patients with the disease. of spinal muscular atrophy (SMA).
The purpose of the Fast Track designation is to facilitate the development and expedite the review of drugs to treat serious conditions and to provide new drugs to patients earlier. And through Fast Track, Scholar Rock is eligible to submit a Biologic License Application (BLA) for apitegromab if the relevant criteria are met.
Fast Track is expected to meet an unmet medical need defined as providing treatment where none exists or improving available therapies and is based on the fact that a drug will have impact on factors such as survival, daily functioning or, if left untreated, progression to a more serious condition. And in addition to the Fast Track designation, apitegromab had previously received orphan drug and rare pediatric disease designations from the FDA and the PRIME and orphan drug product designations from the EMA for the treatment of SMA.
“We are delighted to receive the Fast Track designation and look forward to working closely with the FDA in furthering our goal of establishing apitegromab as the first muscle-directed therapy for patients with ADS. We believe that the recently announced breakthrough data from the TOPAZ Phase 2 trial has shown the transformational potential of apitegromab for patients with SMA.
– Tony Kingsley, President and CEO of Scholar Rock
“The recent Fast Track and PRIME designations granted by regulatory agencies highlight the persistent unmet medical needs of patients with ADS. The majority of non-ambulatory patients in our TOPAZ trial experienced increases in Hammersmith scores, underscoring the therapeutic potential of apitegromab to treat motor function disorders in this patient population. “
– Yung Chyung, MD, Chief Medical Officer of Scholar Rock
Disclaimer: This content is intended for informational purposes. Before you make an investment, you need to do your own analysis.