Outlook Therapeutics, INC 8-K filings

Outlook Therapeutics, Inc. announced the pricing of its public offering of common stock and accompanying warrants, raising approximately $55 million.

Outlook Therapeutics announced third quarter fiscal year 2026 financial results and highlighted the FDA approval of LYTENAVA, positioning it for a U.S. launch with significant sales potential.

Outlook Therapeutics announced preliminary cash reserves of $11.2 million as of June 30, 2026, while also highlighting substantial capital needs and ongoing litigation risks following LYTENAVA's FDA approval.

Outlook Therapeutics announced the FDA approval of LYTENAVA (bevacizumab-vikg) as the first and only FDA-approved ophthalmic formulation for treating wet age-related macular degeneration (AMD).

Outlook Therapeutics' stockholders approved an increase in authorized common stock and the potential issuance of shares related to warrant exercises, alongside a potential reverse stock split.

Outlook Therapeutics has officially regained compliance with Nasdaq's minimum bid price requirement after maintaining a share price of $1.00 or greater for ten consecutive business days.

Outlook Therapeutics announced the FDA has accepted its resubmitted Biologics License Application for ONS-5010 (bevacizumab-vikg) for wet AMD, with a PDUFA goal date set for July 29, 2026.

Outlook Therapeutics announced the resubmission of its Biologics License Application (BLA) for ONS-5010/LYTENAVA to the U.S. FDA for the treatment of neovascular age-related macular degeneration (nAMD).

Outlook Therapeutics, Inc. has entered into a securities purchase agreement for a registered direct offering of 8,539,709 shares of common stock.

Outlook Therapeutics, Inc. has entered into a securities purchase agreement for a $5 million registered direct offering of common stock.

Outlook Therapeutics announced the FDA granted its appeal regarding the Complete Response Letter for ONS-5010/LYTENAVA, paving the way for a resubmission.

Outlook Therapeutics, Inc. has entered into an At The Market Offering Agreement to sell up to $100 million of its common stock through H.C. Wainwright & Co., LLC.

Outlook Therapeutics has entered into a securities purchase agreement to raise approximately $5 million in gross proceeds through a registered direct offering and concurrent private placement.

Outlook Therapeutics has completed a Federal Dispute Resolution meeting with the FDA regarding its ONS-5010 BLA, with a formal decision expected in May 2026.

Outlook Therapeutics announced the FDA accepted its formal dispute resolution request regarding the BLA for ONS-5010/LYTENAVA, with a meeting scheduled for April 2026.

Outlook Therapeutics, Inc. completed a public offering of common stock and warrants, generating approximately $4.0 million in net proceeds.

Outlook Therapeutics, Inc. has entered into a new $18.36 million unsecured promissory note with Atlas Sciences, LLC, using the $17 million proceeds to partially repay and extend the maturity of its existing convertible note with Avondale Capital, LLC.

Outlook Therapeutics held a Type A meeting with the FDA to discuss the Complete Response Letter for ONS-5010, seeking clarity on effectiveness evidence and future approval pathways.

Outlook Therapeutics reported increased European LYTENAVA sales and expansion plans, alongside a significant net loss and a U.S. FDA Complete Response Letter for ONS-5010.

Outlook Therapeutics has requested a Type A meeting with the FDA to discuss the Complete Response Letter for its ONS-5010 BLA for wet AMD, citing disagreement with the FDA's determination.

Outlook Therapeutics received a Complete Response Letter from the FDA for its ONS-5010 BLA resubmission for wet AMD, delaying U.S. approval despite European market authorization.

Outlook Therapeutics announced its fiscal year 2025 financial results, reporting initial LYTENAVA sales and awaiting a crucial FDA decision for ONS-5010.

Outlook Therapeutics announced the FDA acknowledged its ONS-5010 BLA resubmission, setting a PDUFA goal date of December 31, 2025, for a Class 1 review.

Outlook Therapeutics, Inc. announced the resubmission of its Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration for the treatment of wet age-related macular degeneration.

Outlook Therapeutics completed a Type A meeting with the FDA and plans to resubmit its BLA for ONS-5010 by year-end 2025.

Outlook Therapeutics, Inc. announced the immediate departure of Chief Commercial Officer Jeff Evanson, effective September 5, 2025.

Outlook Therapeutics announced the FDA issued a Complete Response Letter for its ONS-5010 BLA resubmission for wet AMD, citing a lack of substantial evidence of effectiveness.

Outlook Therapeutics reported a net loss of $20.2 million for Q3 FY2025, with initial European sales of LYTENAVA and a U.S. FDA PDUFA date set for August 27, 2025.

Outlook Therapeutics, Inc. announced the appointment of Robert Charles Jahr, a seasoned biopharmaceutical executive, as its new President and Chief Executive Officer, effective July 1, 2025.

Outlook Therapeutics, Inc. announced the commercial launch of LYTENAVA (bevacizumab gamma) in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD).