Investor Day: Q4 NDA Single Trial Submission Timeline Balances Speed And Risk

研报英文原文证据摘录

Investor Day: Q4 NDA Single Trial Submission Timeline Balances Speed And Risk

Biotechnology

Ocular Therapeutix

TD SECURITIES (USA) LLC QUICK TAKE: COMPANY UPDATE

June 18, 2026

Price: $9.64 (06/17/2026) Investor Day: Q4 NDA Single Trial Submission

Price Target: $20.00 Timeline Balances Speed And Risk

BUY (1)

ESG SCORE: 53/100

Tara Bancroft, Ph.D. THE TD COWEN INSIGHT

646 562 1410

Ocular offered a clear timeline and case for Axpaxli's single trial NDA submission in Q4 that

tara.bancroft@tdsecurities.com

optimizes both speed and risk. The Type C meeting established that the NDA package should

Sam Rollenhagen require SOL-1 efficacy/safety + SOL-R safety + confirmatory evidence. We believe this derisks

212 468 7785 potential approval in 2027, along with the SPA, highly stat sig superiority outcome, and

samuel.rollenhagen@tdsecurities.com

favorable public FDA commentary.

Nicholas Lorusso

646 562 1390 Ocular Outlines Clear Plan For Axpaxli Single Trial Submission In Q4, With Confidence

nick.lorusso@tdsecurities.com Bolstered From In-Person And Written Type C Feedback

Greg W. Torres, Ph.D. Ocular's Investor Day focused on regulatory matters and the potential for Axpaxli to be

646 562 1351

approved on the SOL-1 trial. Prior to the event, the company reported that it aligned with

gregory.wiessner@tdsecurities.com

the FDA in a Type C meeting on what constitutes a complete NDA package in May. Per

Ikenna Okafor, Ph.D. management, the Agency supported the combination of SOL-1 and confirmatory evidence to

646 562 1395 establish efficacy, leading Ocular to announce that the NDA would be submitted in Q4 (note

ikenna.okafor@tdsecurities.com here).

Key Data

The gating item for the Q4 submission is the need to conduct a new interim analysis of SOL-R

Symbol NASDAQ: OCUL