bevacizumab was approved by the FDA on July 24, 2026 for neovascular Age-related Macular Degeneration.
Verified against: FDA action day July 24, 2026 (BLA 761320 ORIG-1) · Announcement July 24, 2026 (sponsor announcement) · Goal date July 29, 2026 (Outlook Therapeutics 8-K).
LYTENAVA (bevacizumab-vikg), also known as ONS-5010, approved as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of neovascular (wet) age-related macular degeneration (nAMD) (Jul 24 2026). The approval followed a resubmitted BLA (Class 1 review) after a successful appeal of the December 2025 Complete Response Letter; the FDA acted ahead of the July 29 2026 PDUFA target date.
Gray = run-up into the FDA decision; gold dot & dashed line = the decision day (Jul 24 2026); colored line = the day-of reaction and after. Day-of move: +6% (decision-day close vs prior close). Daily closes via Polygon. Not a prediction.
Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Outlook Therapeutics, "LYTENAVA FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD" (Jul 24 2026).
FDA record of the action: the FDA approved on July 24, 2026, per BLA 761320 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 3,139,216 | $5.0 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for LYTENAVA (bevacizumab-vikg, ONS-5010) on July 24, 2026, per the FDA's own record. The primary source is linked on this page.
LYTENAVA (bevacizumab-vikg, ONS-5010) is an Outlook Therapeutics, Inc. (OTLK) program. The FDA decision came on July 24, 2026; the FDA's own record of the decision is linked on this page.