OUTLOOK THERAPEUTICS, INC.


Associated tags: Retina, AMD, DME, Bevacizumab, FDA, BLA, Outlook, Food, Therapy, Pharmaceutical industry, BRVO, Patient, PHSA

Locations: CANADA, SWITZERLAND, IRELAND, ISELIN, NJ, US, UNITED STATES

Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

Retrieved on: 
пятница, марта 22, 2024
Retina, Civil service commission, Committee, EMA, European Medicines Agency, Bevacizumab, European, Outlook, Therapy, European Commission, AMD, Marketing, CHMP, Pharmaceutical industry

Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Key Points: 
  • Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
  • “The CHMP positive opinion for ONS-5010/LYTENAVA™ represents a significant milestone for Outlook Therapeutics and advancement in the treatment of wet AMD in the EU.
  • If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA™.
  • The CHMP’s positive opinion supports the grant of marketing authorization by the European Commission (EC) for Outlook Therapeutics’ application for ONS-5010.

Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million

Retrieved on: 
понедельник, марта 18, 2024
Retina, GMS, Sale, Visium Asset Management, Bevacizumab, Schonfeld Strategic Advisors, Bank of America, Therapy, Security (finance)

ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting placement agent fees and offering expenses.

Key Points: 
  • ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting placement agent fees and offering expenses.
  • Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.
  • The private placement was led by Great Point Partners, LLC, with participation from existing investor GMS Ventures as well as new investors Altium Capital, Armistice Capital, Caligan Partners LP, Schonfeld Strategic Advisors, Sphera Healthcare, Velan Capital, Woodline Partners LP, and an undisclosed life sciences dedicated investor.
  • BofA Securities and BTIG acted as co-placement agents in connection with the financing.

Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split

Retrieved on: 
вторник, марта 12, 2024
Retina, Bevacizumab, FDA, CUSIP, Exercise, Therapy, Security (finance)

The Company’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on March 14, 2024.

Key Points: 
  • The Company’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on March 14, 2024.
  • Following the reverse stock split, the Company’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “OTLK” with the new CUSIP number 69012T 305.
  • The number of authorized shares of the Company’s common stock will be proportionately reduced at the same ratio as the reverse stock split, for a total of 60,000,000 authorized shares of common stock following the reverse split.
  • The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 260.3 million to approximately 13.0 million.

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update

Retrieved on: 
среда, февраля 14, 2024
AmerisourceBergen, EMA, Injection, Committee, Fiscal, CRL, Outlook, MAA, Ranibizumab, FDA, Calendar, Completion, Bevacizumab, Symantec Endpoint Protection, Chemistry, Therapy, CHMP, European Medicines Agency, AMD, Patient, SPA, Retina, CMC

ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.

Key Points: 
  • ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.
  • Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer.
  • In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol from the FDA under a SPA for NORSE EIGHT.
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Retrieved on: 
среда, января 31, 2024
Injection, CMC, Calendar, AMD, Clinical trial, Patient, CRL, FDA, Chemistry, Retina, Ranibizumab, SPA, Bevacizumab, Therapy, Symantec Endpoint Protection, BLA, Pharmaceutical industry

Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Key Points: 
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
  • The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010.
  • Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT.
  • Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

Retrieved on: 
вторник, января 23, 2024
Aggregate, CRL, Patient, Therapy, Injection, Chemistry, Symantec Endpoint Protection, Bevacizumab, Retina, Schonfeld Strategic Advisors, Visium Asset Management, BofA Securities, Regulation D, Sale, The Act, AMD, Calendar, SPA, FDA, Ranibizumab, BLA, Clinical trial, Act, Outlook

Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

Key Points: 
  • Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
  • Outlook Therapeutics is working to address the open items and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
  • The private placement is expected to provide up to $60 million in gross proceeds at closing, before deducting placement agent fees and offering expenses.

Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU

Retrieved on: 
пятница, декабря 22, 2023
SPA, Ranibizumab, Partnership, Food, Outlook, FDA, MAA, EMA, Completion, Retina, AMD, Injection, Trial of the century, Therapy, Bevacizumab, Calendar, Protocol, European Medicines Agency, Feedback, AmerisourceBergen, Committee, Patient, Food and Drug Administration, CHMP, Pharmaceutical industry

Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback.

Key Points: 
  • Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback.
  • The FDA has already provided written feedback on the protocol, which Outlook Therapeutics has incorporated.
  • As of September 30, 2023, Outlook Therapeutics had cash and cash equivalents of $23.4 million.
  • On December 21, 2023, Outlook Therapeutics reached an agreement with the holder of its outstanding convertible promissory note to extend the maturity until April 1, 2024.

Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

Retrieved on: 
вторник, декабря 19, 2023
SPA, Ranibizumab, Food, U.S. FDA, Outlook, Symantec Endpoint Protection, FDA, Retina, Type, CMC, AMD, Injection, Therapy, Clinical trial, Bevacizumab, Calendar, Protocol, Feedback, Patient, BLA, Pharmaceutical industry

Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback.

Key Points: 
  • Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback.
  • The FDA has since provided written feedback on the protocol, which Outlook Therapeutics has incorporated.
  • “We have been working closely with FDA to meet the remaining requirements provided by the Agency to support approval of ONS-5010.
  • Based on our ongoing discussions with FDA, we believe we have agreement on a clinical trial protocol.

Outlook Therapeutics® Announces Strategic Organizational Realignment

Retrieved on: 
среда, декабря 6, 2023
Senior, SPA, Ranibizumab, Partnership, Food, Senior advisor, Symantec Endpoint Protection, Marketing, FDA, MAA, EMA, Acquisition, Type, Retina, CMC, Therapy, Bevacizumab, Calendar, European Medicines Agency, CRL, Committee, Patient, Food and Drug Administration, CHMP, BLA

Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A.

Key Points: 
  • Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A.
  • Previously, Outlook Therapeutics announced the addition of Jedd Comiskey as Senior Vice President – Head of Europe to focus on potential commercial launch and commercial partnership opportunities for ONS-5010 in the EU, if approved.
  • As previously reported, Outlook Therapeutics is working with the FDA to design an additional adequate and well-controlled clinical trial to support the planned ONS-5010 BLA resubmission.
  • Outlook Therapeutics also submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022.

Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Retrieved on: 
понедельник, ноября 27, 2023
SPA, Ranibizumab, Food, Division, Outlook, Symantec Endpoint Protection, FDA, Retina, Type, CMC, AMD, Biologics license application, Therapy, Clinical trial, Bevacizumab, Calendar, CRL, Patient, BLA, Pharmaceutical industry

As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.

Key Points: 
  • As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.
  • As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements.
  • The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.
  • Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023.