NEW YORK, January 1, 2026, 04:59 ET — Market closed
- FDA issued a complete response letter on Outlook’s Lytenava wet-AMD application.
- OTLK closed at $1.58 on Dec. 31 and traded around $0.58 after hours.
- Focus turns to what “confirmatory” efficacy evidence the FDA will require next.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) shares fell sharply in after-hours trading on Dec. 31 after the U.S. Food and Drug Administration again declined to approve its ONS-5010/LYTENAVA (bevacizumab-vikg) filing for wet age-related macular degeneration. The stock closed down 15.51% at $1.58 and slid to $0.58 after hours.
The decision is the third complete response letter the company has received on the application, following earlier FDA letters in August 2023 and August 2025, Ophthalmology Times reported. The drug is already authorized in the European Union and the UK and has been commercially available in Germany and the UK since June 2025, the publication said.
A complete response letter is the FDA’s formal notice that it will not approve an application in its current form. For investors, it usually signals a longer and costlier path, because the sponsor must address the agency’s concerns before trying again.
The FDA said additional mechanistic and natural history data in the resubmission did not change its prior conclusion that confirmatory evidence of efficacy is needed, and it did not spell out what evidence would be acceptable, HCPLive reported. HCPLive said the NORSE EIGHT study met a non-inferiority bar versus ranibizumab (Lucentis) at week 12 but not at week 8, while CEO Bob Jahr reiterated the push for an on-label alternative to compounded Avastin. “We are disappointed and disagree with this decision, but we remain fully committed to taking all necessary steps to receive approval in the United States,” Jahr said. HCPLive
Non-inferiority trials test whether a new drug is not worse than an existing treatment by more than a pre-set margin. “Off-label” use means doctors prescribe an approved drug for a condition not listed on the label, while compounded medicines are prepared by pharmacies rather than manufactured as a fully approved product.
U.S. stock markets are closed Thursday for New Year’s Day and will reopen Friday, giving investors their first chance to price the FDA decision in regular trading.
The next scheduled corporate readout on the calendar is Outlook’s earnings report, which Nasdaq estimates for Feb. 13; the company has not confirmed the date.
Traders will be watching for any follow-up from Outlook that clarifies the FDA’s request for confirmatory evidence and whether it will require a new trial. A fresh study would likely raise costs and extend timelines, while an agency path based on existing data would be faster but is now uncertain.
With the stock last indicated near $0.58 after hours, the $0.50 level is likely to be an early sentiment gauge. On the upside, Wednesday’s $1.58 close is the first reference point if the shares attempt to stabilize.
The FDA’s demand for more evidence has rattled other biotech names, too: Corcept Therapeutics slid after the agency declined to approve its relacorilant drug for a rare hormonal disorder, citing insufficient evidence of effectiveness, Reuters reported.
