FDA Reportedly Reverses Rejection of REGENXBIO's Rare-Disease Drug
Summary
The FDA is reportedly reversing its earlier rejection of a rare-disease therapy from REGENXBIO. This news, if confirmed, is a significant positive development for the company, directly addressing a prior regulatory setback. It could materially improve the company's pipeline value and future revenue prospects, especially given its small market cap and previous 'going concern' doubts mentioned in recent filings. This follows the company's positive Phase III results for its Duchenne gene therapy, RGX-202, announced in May, which was tempered by Q1 losses. Traders will be watching for an official FDA announcement.
At the time of this announcement, RGNX was trading at $8.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $403.2M. The 52-week trading range was $5.46 to $16.19. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.