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Outlook Therapeutics Inc. Announces Date for Upcoming Annual Stockholders Meeting Outlook Therapeutics Inc. will hold its 2026 Annual Meeting of Stockholders on March 10, 2026. During the meeting, stockholders will vote on the election of three directors, the ratification of the selection of KPMG LL
01-27 06:02
Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug
01-01 05:16
FDA issued a Complete Response Letter (CRL) for Outlook Therapeutics' resubmitted ONS-5010/LYTENAVA™ BLA for wet AMD treatment. The agency noted that additional data did not alter its previous conclusion, requiring confirmatory efficacy evidence. Bob Jahr, CEO, expressed disappointment but reaffirmed commitment to securing U.S. approval. The company's efforts include exploring alternative approval pathways and expanding into Europe, where LYTENAV...
2025-12-31 21:15
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that its Compensation Committee granted stock options to purchase 150,000 shares of common stock with an exercise price of $2.01 per share to two new employees, effective December 19, 2025. These awards were made as inducements for the employees to join the company, in accordance with NASDAQ Listing Rule 5635(c)(4). The company focuses on enhancing care for retina diseases using bevacizumab, wit...
2025-12-26 22:00
Ascendiant Capital analyst Edward Woo maintains Outlook Therapeutics (NASDAQ:OTLK) with a Buy and raises the price target from $8 to $10.
2025-12-22 18:40
Outlook Therapeutics reported a net loss of $62.4M ($1.79 per share) for fiscal year 2025, with $1.4M in revenue from initial sales of LYTENAVA™ in Germany and the UK. The company saw reduced R&D expenses and increased SG&A costs due to the product launch. Cash reserves totaled $8.1M as of September 30, 2025. The FDA PDUFA date for ONS-5010 is December 31, 2025, and the company is expanding commercially in Europe and preparing for potential U.S. ...
2025-12-19 13:05
Outlook Therapeutics' CEO, Bob Jahr, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, at 10:00 AM ET. A live webcast of the chat will be available on the company's website, with a replay archived for 90 days. Management will also host one-on-one meetings with investors. Outlook Therapeutics focuses on developing LYTENAVA™ for treating retinal diseases, which is the first approved opht...
2025-11-24 14:05
Gainers Mersana Therapeutics (NASDAQ:MRSN) stock increased by 205.0% to $27.05...
2025-11-14 01:06
Outlook Therapeutics announced that the FDA has accepted the resubmission of the BLA for ONS-5010 (bevacizumab-vikg) for wet AMD treatment. The PDUFA goal date is set for December 31, 2025. If approved, ONS-5010 will be marketed as LYTENAVA™, the first FDA-approved ophthalmic bevacizumab formulation in the U.S. The company addressed feedback from the August 2025 CRL and expects a 60-day review period. LYTENAVA™ is already authorized in Europe and...
2025-11-13 13:30
Outlook Therapeutics has resubmitted its BLA to the FDA for ONS-5010, an ophthalmic formulation of bevacizumab aimed at treating wet AMD, following feedback from a September 2025 Type A meeting. The company believes this action addresses the issues highlighted in the August 2025 CRL. CEO Bob Jahr emphasized the importance of this step in achieving U.S. approval and highlighted ongoing European commercialization efforts. ONS-5010, branded as LYTEN...
2025-11-03 13:35