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: 
Thursday, December 14, 2023
Food, Agency, BLA, Outlook, LLP, FDA, Action Replay, CMC, Ext, AMD, Court, Person, Therapy, News, Complaint, Pomerantz, Bevacizumab, Prior, Safety, District court

NEW YORK, Dec. 14, 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. 14, 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.

Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM

Retrieved on: 
Wednesday, December 13, 2023
Diamond, Patient, Conference, Lung cancer, AACR, Temozolomide, PR, Neoplasm, Diarrhea, EGFR, Dana–Farber Cancer Institute, Neuro-Oncology (journal), Brain, Therapy, Clinical trial, PD, Bevacizumab, CNS, Cancer, GBM, Diagnosis, Safety, PFS, NSCLC, Rash, Pharmaceutical industry

BDTX-1535, a fourth-generation, brain-penetrant, covalent EGFR inhibitor, is under investigation in a Phase 1 clinical trial for the treatment of patients with non-small cell lung cancer (NSCLC) or GBM.

Key Points: 
  • BDTX-1535, a fourth-generation, brain-penetrant, covalent EGFR inhibitor, is under investigation in a Phase 1 clinical trial for the treatment of patients with non-small cell lung cancer (NSCLC) or GBM.
  • Clinical data as of November 2023 reflect 27 patients with recurrent GBM who received a range of doses spanning 15mg to 400mg once daily (QD) in the dose escalation cohort.
  • Of the 27 patients with recurrent GBM, 22 were started at or escalated to a dose of 100mg QD or greater and reached at least one post baseline tumor assessment.
  • Black Diamond plans to submit results from the dose escalation GBM cohort for presentation at a medical meeting in the second quarter of 2024.

Kirby McInerney LLP Reminds Investors That a Class Action Lawsuit Has Been Filed on Behalf of Outlook Therapeutics, Inc. (OTLK) Investors and Encourages Investors to Contact the Firm Before January 2, 2024

Retrieved on: 
Tuesday, December 12, 2023
Food, FDA, AMD, Court, Therapy, News, Bevacizumab, District court, BLA, Pharmaceutical industry

Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications.
  • On August 30, 2023, Outlook announced that the FDA had issued a complete response letter to the ONS-5010 BLA.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.

OUTLOOK INVESTOR DEADLINE APPROACHING: 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: 
Thursday, December 7, 2023
Agency, LLP, FDA, CMC, Court, News, Bevacizumab, Advertising, Safety, Woman, BLA, Cryptocurrency

NEW YORK, Dec. 07, 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.

Outlook Therapeutics® Announces Strategic Organizational Realignment

Retrieved on: 
Wednesday, December 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.

IGM Biosciences Announces Strategic Pipeline Prioritization and Cash Runway Extension

Retrieved on: 
Tuesday, December 5, 2023
Workforce, DR5, Sanofi, IND, Antibody, FDA, Colorectal cancer, FOLFIRI, CD20, SLE, IGM, Clinical trial, Rheumatoid arthritis, Inflammation, Investigational New Drug, Lupus, CD38, Bevacizumab, Myopathy, Myositis, Patient, Immunoglobulin M, Vaccine

In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.

Key Points: 
  • In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.
  • As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.
  • “IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • As a part of this strategic refocusing, the Company will halt the following clinical development activities:

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: 
Monday, December 4, 2023
Food, Agency, BLA, Outlook, LLP, FDA, Action Replay, CMC, Ext, AMD, Court, Person, Therapy, News, Complaint, Pomerantz, Bevacizumab, Prior, Safety, District court

NEW YORK, Dec. 04, 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. 04, 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 SHAREHOLDER 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: 
Saturday, December 2, 2023
Agency, LLP, FDA, CMC, Court, News, Bevacizumab, Advertising, Safety, Woman, BLA, Cryptocurrency

NEW YORK, Dec. 02, 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.

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

Retrieved on: 
Monday, November 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.

OTLK INVESTOR NOTICE: Robbins Geller Rudman & Dowd LLP Announces that Outlook Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Case

Retrieved on: 
Monday, November 27, 2023
Food, Agency, Outlook, FDA, CMC, AMD, SAN, Therapy, News, Bevacizumab, Safety, BLA

), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics as well as certain of its top executive officers with violations of the Securities Exchange Act of 1934.

Key Points: 
  • ), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics as well as certain of its top executive officers with violations of the Securities Exchange Act of 1934.
  • A lead plaintiff acts on behalf of all other class members in directing the Outlook Therapeutics class action lawsuit.
  • The lead plaintiff can select a law firm of its choice to litigate the Outlook Therapeutics class action lawsuit.
  • An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Outlook Therapeutics class action lawsuit.