FDA Pre-NDA Meeting Confirms AXPAXLI Path for Wet AMD, NDA on Track for Q4
OCUL sits 73% above its 52-week low of $6.23.
Summary
Ocular Therapeutix completed a positive Pre-NDA meeting with the FDA for AXPAXLI in wet AMD, confirming alignment on the NDA package and keeping submission on track for Q4 2026. The FDA agreed to the 505(b)(2) pathway, which could shorten review by up to 60 days, and the submission will include repeat-dosing data from multiple injections. This follows the positive Type C meeting in May and the SOL-1 Phase 3 superiority win in February. The company is now positioned to potentially be the first TKI approved for wet AMD, with commercial launch targeted for 2027. The next key milestone is the interim SOL-R safety analysis and NDA submission in Q4 2026.
At the time of this announcement, OCUL was trading at $10.76 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.4B. The 52-week trading range was $6.23 to $16.44. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.