Outlook Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

Rhea-AI Summary

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced it has regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at $1.00 or greater for 10 consecutive trading days. This achievement comes as the company advances ONS-5010/LYTENAVA™, its ophthalmic formulation of bevacizumab, aimed at obtaining FDA approval for retinal diseases such as wet AMD, DME, and BRVO. Outlook is set to file for a new BLA under the 351(a) pathway for ONS-5010 initially targeting wet AMD.

Positive

• Regained compliance with Nasdaq's minimum bid price requirement.
• Common stock closing at $1.00 or greater for 10 consecutive trading days.
• Advancing ONS-5010 toward FDA approval, targeting multiple retinal indications.

Negative

• None.

MONMOUTH JUNCTION, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced today that it has received notification from Nasdaq that it has regained compliance with the minimum bid price for continued listing on the Nasdaq Capital Market, as the closing bid price of Outlook Therapeutics’ common stock has been at $1.00 or greater for 10 consecutive trading days. Accordingly, this matter is now closed.

About Outlook Therapeutics, Inc. 

Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan, China and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.

CONTACTS:

Media Inquiries: 
Harriet Ullman
Assistant Vice President
LaVoieHealthScience
T: 617-669-3082 
hullman@lavoiehealthscience.com

Investor Inquiries: 
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247 
OTLK@jtcir.com

FAQ

What does Outlook Therapeutics' compliance with Nasdaq mean for OTLK stock?

Outlook Therapeutics has regained compliance by maintaining a bid price of $1.00 or greater, which secures its listing on the Nasdaq Capital Market.

When does Outlook Therapeutics plan to file for FDA approval of ONS-5010?

Outlook Therapeutics expects to file for FDA approval of ONS-5010 as a new BLA under the PHSA 351(a) pathway.

What indications is ONS-5010 targeting for FDA approval?

ONS-5010 is targeting retinal diseases, including wet AMD, DME, and BRVO, for FDA approval.

What is the significance of ONS-5010 for Outlook Therapeutics?

If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, potentially expanding treatment options in multiple markets.