Outlook Therapeutics Gains Following FDA Approval of Macular-degeneration Drug

Dow Jones07-25

Shares of Outlook Therapeutics rose as the Food and Drug Administration approved the company's Lytenava for treatment of neovascular age-related macular degeneration.

The stock was up 21%, to $1.60, late Friday. Shares hit a intraday high of $1.75 prior to a trading halt and pared some of the earlier gains once trading resumed.

Outlook said it expects the drug to be available to eligible patients in the U.S. before year-end.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

By Josh Beckerman

Shares of Outlook Therapeutics posted wide swings as the Food and Drug Administration approved the company's Lytenava for treatment of neovascular age-related macular degeneration.

The stock closed up 6% to $1.41 and were recently at $1.40 after hours. Shares hit a intraday high of $1.75 prior to a trading halt and pared some of the earlier gains once trading resumed.

Outlook said it expects the drug to be available to eligible patients in the U.S. before year end. The company anticipates 12 years of market exclusivity under the Biologics Price Competition and Innovation Act.

On Dec. 31, shares closed at $1.58, then fell sharply as the FDA issued a complete response letter for Lytenava. In June, the FDA accepted a resubmitted biologics license application and set a Prescription Drug User Fee Act target action date of July 29.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

July 24, 2026 17:02 ET (21:02 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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Shares hit a intraday high of $1.75 prior to a trading halt and pared some of the earlier gains once trading resumed. \n</p>\n<p>\n  Outlook said it expects the drug to be available to eligible patients in the U.S. before year-end. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n</font><font class=\"NormalMinus1\" face=\"Arial\">\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  By Josh Beckerman \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Shares of Outlook Therapeutics posted wide swings as the Food and Drug Administration approved the company's Lytenava for treatment of neovascular age-related macular degeneration. \n</p>\n<p>\n  The stock closed up 6% to $1.41 and were recently at $1.40 after hours. 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Shares hit a intraday high of $1.75 prior to a trading halt and pared some of the earlier gains once trading resumed. \n\n\n  Outlook said it expects the drug to be available to eligible patients in the U.S. before year-end. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n\n \n\n\n  By Josh Beckerman \n\n\n \n\n\n  Shares of Outlook Therapeutics posted wide swings as the Food and Drug Administration approved the company's Lytenava for treatment of neovascular age-related macular degeneration. \n\n\n  The stock closed up 6% to $1.41 and were recently at $1.40 after hours. Shares hit a intraday high of $1.75 prior to a trading halt and pared some of the earlier gains once trading resumed. \n\n\n  Outlook said it expects the drug to be available to eligible patients in the U.S. before year end. 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