FDA Clears IND for Third Gene Therapy Program, Phase 1/2 Trial Slated This Quarter
IRD has more than doubled off its 52-week low of $1.7.
Summary
The FDA cleared Opus Genetics' IND for OPGx-RDH12, a gene therapy for RDH12-associated Leber congenital amaurosis, a childhood blindness affecting an estimated 30,900 people globally. This is the company's third pipeline program to reach the clinic, and management plans to start a Phase 1/2 trial this quarter. The program is backed by the Global RDH12 Alliance, which committed up to $1.6 million toward development, with costs reimbursed as milestones are met. The clearance is a genuine pipeline expansion but modest in scale next to the lead OPGx-BEST1 and OPGx-LCA5 programs that have driven recent news flow, including the positive Cohort 1 data reported September 9. The company ended Q2 with $88.8 million in cash, funding operations into 2029, and has a $125 million ATM in place. The next concrete checkpoint is trial initiation, guided to this quarter.
At the time of this announcement, IRD was trading at $4.09 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $333.6M. The 52-week trading range was $1.70 to $7.07. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.