secwatch.observer — SEC 8-K summary
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Issuer:     Opus Genetics, Inc. (IRD)
CIK:        0001228627
Form:       8-K
Filed at:   2026-03-10T23:59:59+00:00
Accession:  0001140361-26-008621
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Opus Genetics reports FY2025 net loss $49.6M; cash $70.1M; PDUFA date Oct 2026
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- Net loss $49.6M ($0.80/sh) vs $57.5M ($2.15/sh) in 2024; revenue $14.2M from Viatris collab.
- Cash $45.1M at Dec 31, 2025; raised $25M in private placement to $70.1M; runway into H1 2028.
- BEST1 gene therapy: sentinel patient showed 12-letter BCVA gain and 23% CST decrease; three-month data from full cohort expected mid-2026.
- FDA set PDUFA date Oct 17, 2026 for Phentolamine Ophthalmic Solution 0.75% for presbyopia.
- Phase 3 LCA5 trial enrolling; RDEP review submission planned Q1 2026; MERTK funding secured from Abu Dhabi fund.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126008621/0001140361-26-008621-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126008621/ef20067388_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-008621

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer