GLOBAL RESEARCH ARCHIVE
Investor Day: Q4 NDA Single Trial Submission Timeline Balances Speed And Risk
Research evidence excerpt
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
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