Outlook Therapeutics Inc - OTLKW STOCK NEWS

Outlook Therapeutics, Inc. (OTLK) has closed a private placement with Syntone Ventures, , securing $5.0 million in upfront gross proceeds. The company may receive up to $8 million more upon full cash exercise of warrants. This funding will support the development of an ophthalmic formulation of bevacizumab for retinal diseases in the US and the EU.

Outlook Therapeutics (OTLK) receives positive opinion from CHMP for ONS-5010/LYTENAVA™ in the EU, a significant milestone in treating wet AMD.

Outlook Therapeutics, Inc. (OTLK) closed a private placement, raising $60 million upfront with potential for $99 million more. Great Point Partners led the investment, joined by existing and new investors. BofA Securities and BTIG were co-placement agents.

Outlook Therapeutics, Inc. (OTLK) announces a 1-for-20 reverse stock split to regain compliance with Nasdaq listing requirements. The reverse split will reduce outstanding shares from 260.3 million to 13.0 million, with no change in par value per share.

Outlook Therapeutics, Inc. (OTLK) announces progress in NORSE EIGHT trial with first subject dosed and financial results for Q1 FY2024. Anticipates resubmission of ONS-5010 BLA by end of CY2024 and EU regulatory decision in first half of CY2024. Secures financing for regulatory efforts.

Outlook Therapeutics, Inc. (OTLK) announced the start of patient enrollment in the NORSE EIGHT clinical trial for ONS-5010, a potential treatment for neovascular age-related macular degeneration. The trial aims to support the resubmission of the Biologics License Application (BLA) by the end of 2024. If successful, it would fulfill FDA's requirements for approval. The company also received written agreement from the FDA under a Special Protocol Assessment (SPA) for NORSE EIGHT, indicating positive progress in the development pathway. Outlook Therapeutics is optimistic about the potential FDA approval and launch of ONS-5010, with the primary endpoint being the mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 8.

Outlook Therapeutics, Inc. has received FDA agreement for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration subjects. The company also entered into securities purchase agreements to raise up to $172 million to fund the development of ONS-5010. The financing is expected to take ONS-5010 through potential FDA approval and fund commercial launch. The company has also reached an agreement to extend the maturity of its outstanding convertible promissory note until July 1, 2025.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the commencement of ONS-5010 NORSE EIGHT clinical trial in the first quarter of 2024, reaffirming potential European approval for ONS-5010 with the MAA decision date expected in the first half of 2024. The resubmission of the ONS-5010 BLA is anticipated by the end of 2024. The company reported a net loss attributable to common stockholders of $59.0 million for the fiscal year ended September 30, 2023, with cash and cash equivalents of $23.4 million as of that date.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the submission of a Special Protocol Assessment (SPA) request for the NORSE EIGHT study, with plans to commence in Q1 2024. The company expects to resubmit the ONS-5010 Biologics License Application (BLA) in the U.S. by the end of 2024, based on the results of the study and additional work to address FDA concerns.