Outlook Therapeutics® Confirms It Has No Exposure to Silicon Valley Bank

Rhea-AI Summary

Outlook Therapeutics (Nasdaq: OTLK) announced it is unaffected by the Federal Deposit Insurance Corporation's control of Silicon Valley Bank (SVB), as it holds no deposits or investments at SVB. The company focuses on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab, targeting retinal diseases such as wet AMD, DME, and BRVO. The FDA has set a PDUFA goal date of August 29, 2023, for its BLA submission. Outlook Therapeutics partnered with AmerisourceBergen to enhance distribution and logistics services in anticipation of potential FDA approval.

Positive

• FDA has set a PDUFA goal date of August 29, 2023, for ONS-5010.
• Strategic partnership with AmerisourceBergen for enhanced distribution.

Negative

• None.

ISELIN, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it is aware that the Federal Deposit Insurance Corp. has taken control of Silicon Valley Bank (“SVB”).

Outlook Therapeutics does not hold any deposits or investments at SVB.

About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023. The submission is supported by Outlook Therapeutics’ wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company’s multi-year commercial planning process, and in anticipation of potential FDA approval in August 2023, Outlook Therapeutics and AmerisourceBergen have entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. AmerisourceBergen will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services in the United States. For more information, please visit www.outlooktherapeutics.com.

CONTACTS:
Media Inquiries:
Harriet Ullman
Vice President
LaVoie Health Science
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 is the significance of the FDA's PDUFA goal date for Outlook Therapeutics?

The FDA's PDUFA goal date of August 29, 2023, is crucial for Outlook Therapeutics as it marks the timeline for potential approval of ONS-5010, which could be the first FDA-approved ophthalmic formulation of bevacizumab.

How does Outlook Therapeutics plan to commercialize ONS-5010?

Outlook Therapeutics is partnering with AmerisourceBergen to enhance distribution and logistics services as part of its commercialization strategy for ONS-5010.

Is Outlook Therapeutics affected by the situation with Silicon Valley Bank?

No, Outlook Therapeutics has stated that it does not hold any deposits or investments at Silicon Valley Bank and is therefore unaffected.

What retinal indications is ONS-5010 intended to treat?

ONS-5010 is being developed to treat retinal indications including wet AMD, DME, and BRVO.

What is the current status of the ONS-5010 BLA submission?

The BLA submission for ONS-5010 has been accepted by the FDA, with a goal date for approval set for August 29, 2023.