What happened
Shares of Outlook Therapeutics (OTLK -1.45%) jumped on Tuesday after the biotech announced positive clinical trial results for its investigational treatment for neovascular age-related macular degeneration (wet AMD). By the close of trading, its stock price was up 6.6% after rising as much as 44.7% earlier in the day.
So what
Outlook Therapeutics' treatment for wet AMD, which is known as ONS-5010/Lytenava (bevacizumab), reached its primary efficacy endpoint in a phase 3 study. A statistically significant 41% of the patients who were treated with bevacizumab gained at least 15 letters in the best-corrected visual acuity (BCVA) at 11 months.
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Outlook Therapeutics said the successful completion of the phase 3 trial would allow it to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2022.
"Currently there are a vast number of off-label injections of bevacizumab to treat retinal disease in the United States, and we want to offer an alternative for patients and retinal surgeons that is approved and formulated and packaged specifically for wet AMD," CEO C. Russell Trenary said in a press release.
Now what
These promising trial results prompted H.C. Wainwright analyst Douglas Tsao to repeat his buy rating on Outlook Therapeutics' stock and boost his share-price forecast from $5 to $6. Tsao posits that bevacizumab's superior effectiveness compared to that of other wet AMD treatments puts its odds of commercial success at 80%. If he's correct and Outlook Therapeutics hits his price target, investors could enjoy gains of nearly 150% from the stock's current price near $2.41.
