Opus Genetics Announces Successful FDA Meeting Supporting Advancement of OPGx-LCA5 Toward Pivotal Trial for LCA5-Related Inherited Retinal Disease
Opus Genetics, Inc. (IRD)
Company Research
Source: GlobeNewswire
Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides the potential for an accelerated regulatory pathway to approval of OPGx-LCA5First participant enrolled in run-in period for planned adaptive Phase 3 trialCompany intends to apply for the FDA’s new Rare Disease Evidence Principles (RDEP) review processOPGx-LCA5 has the potential to be the first gene therapy and one-time treatment for Leber congenital amaurosis (LCA) type 5Recent $23 million financing led by Perceptive Advisors and Balyasny Asset Management to advance LCA5 and BEST1 programs and fund current operating plans into second half of 2027 RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases (IRDs) and small-molecule therapies for other ophthalmic disorders, today announced the successful completion of a Type B Regenerative
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News
- Opus Genetics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Opus Genetics (NASDAQ:IRD) was upgraded by analysts at Brookline Capital Management to a "strong-buy" rating.MarketBeat
- Piper Sandler Initiates Coverage on Opus Genetics, Inc. (IRD) With “Overweight” Rating and $7 PT [Yahoo! Finance]Yahoo! Finance
- Opus Genetics (NASDAQ:IRD) was upgraded by analysts at Piper Sandler to a "strong-buy" rating.MarketBeat
- Opus Genetics (NASDAQ:IRD) is now covered by analysts at Piper Sandler. They set an "overweight" rating on the stock.MarketBeat
IRD
Sec Filings
- 11/12/25 - Form 10-Q
- 11/12/25 - Form 8-K
- 11/6/25 - Form 8-K
- IRD's page on the SEC website