Bevacizumab

Merck KGaA, Darmstadt, Germany, Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Retrieved on: 
Thursday, January 4, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Phase, SLC6A8, Science, Merck Group, CRC, ESMO, Survival, Health care, Colorectal cancer, FOLFIRI, Progression-free survival, Disease, Congress, Randomized controlled trial, Bevacizumab, Merck, Patient, Safety, Head, Pharmaceutical industry

Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

Key Points: 
  • Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).
  • The collaboration with Inspirna builds on Merck KGaA, Darmstadt, Germany’s long-standing commitment to the colorectal cancer community.
  • “The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr™.
  • Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights.

Merck Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Retrieved on: 
Thursday, January 4, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Phase, SLC6A8, ESMO, CRC, Survival, Health care, Colorectal cancer, FOLFIRI, Progression-free survival, Disease, Congress, Randomized controlled trial, Bevacizumab, Patient, Safety, Head, Pharmaceutical industry

Merck, a leading science and technology company, today announced a licensing agreement with Inspirna, Inc. (New York, NY) for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds.

Key Points: 
  • Merck, a leading science and technology company, today announced a licensing agreement with Inspirna, Inc. (New York, NY) for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds.
  • Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).
  • The collaboration with Inspirna builds on Merck’s long-standing commitment to the colorectal cancer community.
  • Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights.

Inspirna Partners with Merck KGaA, Darmstadt, Germany, to Accelerate Global Development of Ompenaclid (RGX-202)

Retrieved on: 
Thursday, January 4, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, SLC6A8, Merck Group, CRC, ESMO, Survival, Rasm, Health care, Colorectal cancer, FOLFIRI, Progression-free survival, Congress, Randomized controlled trial, Bevacizumab, Creatine, Merck, RAS, Patient, Safety, Head, Therapy, Pharmaceutical industry

“The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr™.

Key Points: 
  • “The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr™.
  • Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights.
  • Ompenaclid was well-tolerated, with no dose-limiting toxicities observed in the dose-escalation cohort and combination safety profile comparable to FOLFIRI plus bevacizumab backbone treatment.
  • Inspirna has initiated a Phase 2 double-blind randomized controlled trial in 2L RAS mutant advanced or metastatic mCRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Outlook Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – OTLK

Retrieved on: 
Tuesday, January 2, 2024
Food, Agency, BLA, Outlook, LLP, FDA, Action Replay, CMC, Ext, AMD, Court, Person, Therapy, News, Complaint, Pomerantz, Bevacizumab, Prior, Safety, District court

NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and certain officers.

Key Points: 
  • NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and certain officers.
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

OUTLOOK SHAREHOLDER NOTICE: Faruqi & Faruqi Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Outlook To Contact Him Directly To Discuss Their Options

Retrieved on: 
Wednesday, December 27, 2023
Agency, LLP, FDA, CMC, Court, News, Bevacizumab, Advertising, Safety, Woman, BLA, Cryptocurrency

NEW YORK, Dec. 27, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and reminds investors of the January 2, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

Key Points: 
  • If you suffered losses exceeding $50,000 investing in Outlook securities between August 3, 2021 and August 29, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
  • On August 30, 2023, Outlook issued a press release announcing that the FDA had issued a complete response letter to the ONS-5010 BLA.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Outlook’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

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: 
Friday, December 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.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Outlook Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – OTLK

Retrieved on: 
Friday, December 22, 2023
Food, Agency, BLA, Outlook, LLP, FDA, Action Replay, CMC, Ext, AMD, Court, Person, Therapy, News, Complaint, Pomerantz, Bevacizumab, Safety, District court

NEW YORK, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and certain officers.

Key Points: 
  • NEW YORK, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and certain officers.
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

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

Retrieved on: 
Tuesday, December 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 ONGOING DEADLINE ALERT: Faruqi & Faruqi Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Outlook To Contact Him Directly To Discuss Their Options

Retrieved on: 
Tuesday, December 19, 2023
Agency, LLP, FDA, CMC, Court, News, Bevacizumab, Advertising, Safety, Woman, BLA, Cryptocurrency

NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and reminds investors of the January 2, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

Key Points: 
  • If you suffered losses exceeding $50,000 investing in Outlook securities between December 29, 2022 and August 29, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
  • On August 30, 2023, Outlook issued a press release announcing that the FDA had issued a complete response letter to the ONS-5010 BLA.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Outlook’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

OTLK STOCK ALERT: Robbins LLP Reminds Investors of January 2, 2024, Lead Plaintiff Deadline in the Class Action Filed Against Outlook Therapeutics, Inc.

Retrieved on: 
Saturday, December 16, 2023
Agency, Efficacy, LLP, FDA, CMC, AMD, Person, Complaint, SAN, Therapy, News, Viability, Bevacizumab, Safety, BLA

Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications.

Key Points: 
  • Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Outlook Therapeutics, Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.