PepGen Inc. (NASDAQ: PEPG) witnessed a notable surge of 14.68% in its stock valuation during the preceding trading session, concluding at $16.95 by the session’s end. This ascent in PepGen’s stock value occurred amidst a lack of immediate news, triggering speculation regarding recent developments propelling the surge.
PepGen (PEPG) recently disclosed that the U.S. Food and Drug Administration (FDA) accorded Fast Track designation to PGN-EDODM1, an investigational contender aimed at addressing myotonic dystrophy type 1 (DM1). Acquiring Fast Track designation from the FDA for PGN-EDODM1 stands as a noteworthy milestone in PEPG’s endeavors to furnish a potentially revolutionary therapy to the DM1 community.
With the FDA’s Fast Track designation process, drug candidates intended to treat severe conditions and meet unmet medical needs are expedited in order to provide crucial new drugs to patients sooner rather than later, in order to facilitate the advancement and expedite the evaluation process.
In the process of drug development and regulatory review, the FDA cultivates early and recurrent communication with the pharmaceutical company once a drug candidate has been granted Fast Track designation. By communicating frequently, patients’ concerns and queries are promptly addressed, often resulting in faster drug approval and accessibility.
Individuals afflicted with DM1 presently lack treatment options targeting the fundamental cause of the disease, resulting in progressive neuromuscular symptoms and a decline in life expectancy. Building upon robust preclinical data, the evaluation of PGN-EDODM1 is underway in the ongoing FREEDOM-DM1 Phase 1 trial, with preliminary data anticipated to be disclosed later this year.
There is confidence that PGN-EDODM1 harbors the potential to alter the course of the disease and enhance outcomes for individuals grappling with DM1. PGN-EDODM1 is presently undergoing assessment in the ongoing FREEDOM-DM1 Phase 1 clinical trial, catering to individuals afflicted with DM1.
The Company anticipates releasing preliminary data from the trial in 2024. It was previously announced by the Company that the FDA conferred Orphan Drug Designation upon PGN-EDODM1 in September 2023.
