BLA

CytoDyn’s Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at the World Antiviral Congress 2021

Tuesday, September 21, 2021 - 1:00pm

Dr. Kelly will speak on Wednesday, November 30, 2021, at 2:55pm PDT about emerging approaches to antivirals, specifically focusing on leronlimab.

Key Points: 
  • Dr. Kelly will speak on Wednesday, November 30, 2021, at 2:55pm PDT about emerging approaches to antivirals, specifically focusing on leronlimab.
  • Dr. Kelly stated, It is an exceptional honor to be asked to present at the World Antiviral Congress and a testament to the incredible potential the medical community sees with leronlimab.
  • The Congress brings together thought leaders and representatives of the largest pharmaceutical companies and the most prestigious academic institutions from around the world to discuss the future of antiviral therapy.
  • The World Antiviral Congress 2021 agenda is available here: https://www.terrapinn.com/conference/world-antiviral-congress/agenda.stm .

SHAREHOLDER ALERT: Robbins LLP Reminds Investors that Sesen Bio, Inc. (SESN) is Being Sued for Misleading Shareholders

Tuesday, September 21, 2021 - 12:49am

Its most advanced product candidate is Vicineum, a treatment for bacillus Calmette-Gurin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC").

Key Points: 
  • Its most advanced product candidate is Vicineum, a treatment for bacillus Calmette-Gurin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC").
  • If you suffered a loss due to Sesen Bio, Inc.'s misconduct, click here .
  • During the relevant period, defendants expressed its "significant commercial progress" and ramped up operations in anticipation that Vicineum would be granted FDA approval.
  • On August 13, 2021, the Company announced that the FDA declined to approve its BLA for Vicineum in its current form.

Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab)

Monday, September 20, 2021 - 3:23pm

Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is deferring action on the application for AVT02, the companys proposed biosimilar to Humira, until facility assessments can be completed.

Key Points: 
  • Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is deferring action on the application for AVT02, the companys proposed biosimilar to Humira, until facility assessments can be completed.
  • Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.
  • Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products.
  • AVT02 is a monoclonal antibody and a proposed biosimilar to Humira (adalimumab).

CytoDyn Announces Resolution of Federal Litigation with Rosenbaum/Patterson Activist Group

Monday, September 20, 2021 - 3:18pm

Specifically with respect to the resolution of the Federal Lawsuit, the Activist Group took the following steps, which were conveyed in its public filings made after the close of the market on Friday, September 17, 2021:

Key Points: 
  • Specifically with respect to the resolution of the Federal Lawsuit, the Activist Group took the following steps, which were conveyed in its public filings made after the close of the market on Friday, September 17, 2021:
    The Activist Group dissolved its Schedule 13D group and filed an exit Schedule 13D.
  • The Activist Group maintains its narrative that these individuals and entities decided to gift the group with at least hundreds of thousands of dollars.
  • Moreover, the Activist Group has now created a new category of financial supporters called the "Contributing Persons."
  • To reiterate, CytoDyn urges shareholders to ignore any further emails or mailings from the Activist Group.

Brunswick Corporation’s Advanced Systems Group Acquires SemahTronix

Monday, September 20, 2021 - 2:20pm

METTAWA, Ill., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Brunswick Corporation (NYSE: BC) today announced that it has acquired SemahTronix, a global supplier of high-complexity electrical wiring harnesses for advanced products in the marine, mobile, and defense industries.

Key Points: 
  • METTAWA, Ill., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Brunswick Corporation (NYSE: BC) today announced that it has acquired SemahTronix, a global supplier of high-complexity electrical wiring harnesses for advanced products in the marine, mobile, and defense industries.
  • The company will become part of Brunswicks Advanced Systems Group (ASG) which consists of leading P&A brands in advanced batteries, electrical power management, digital control & monitoring, and networked systems & devices for the marine, RV, specialty vehicle, and other industries.Financial terms of the deal were not disclosed.
  • "The acquisition of SemahTronix immediately enhances our integrated systems offerings by providing our ASG Connect organization and our global customers with access to high-quality, large, complex electrical wire harnessing systems that further enable our end-to-end systems solutions and capabilities,said Brett Dibkey, Advanced Systems Group president.Adding SemahTronix will allow us the ability to vertically integrate, offering a higher degree of quality control and faster lead time, and aligns with our mission to expand within the rapidly growing system integration market and create opportunities for further growth in adjacent markets.
  • A key growth strategy for the Advanced Systems Group and our ASG Connect organization is to provide turnkey solutions that offer superior quality and fully integrated systems to reaffirm our position as the go-to trusted partner in the marketplace, said Daniel Clarkson, General Manager, ASG Connect.

BioCryst Appoints Dr. Amy McKee to Board of Directors

Monday, September 20, 2021 - 12:00pm

Dr. McKee currently serves as vice president of regulatory consulting services for Parexel, a leading global clinical research organization.

Key Points: 
  • Dr. McKee currently serves as vice president of regulatory consulting services for Parexel, a leading global clinical research organization.
  • Prior to joining Parexel in 2019, Dr. McKee spent more than a decade at the FDA in leadership roles of increasing responsibility.
  • I am excited to bring this experience to BioCryst as the company advances BCX9930 into pivotal trials in PNH and other complement-mediated diseases.
  • Amys strategic regulatory perspective and substantial FDA experience, especially related to novel approaches to drug development programs to meet serious and unmet needs, represent an exciting addition to the BioCryst board, said Robert Ingram, chairman of BioCryst.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Alerts Sesen Bio (SESN) Investors to Lead Plaintiff Opportunity in Securities Class Action, Advises Investors with Significant Losses to Contact Firm’s Attorneys Now

Saturday, September 18, 2021 - 4:24pm

Then, on Aug. 16, 2021, the company revealed it needed to conduct an additional clinical trial to provide the FDA with additional efficacy and safety data.

Key Points: 
  • Then, on Aug. 16, 2021, the company revealed it needed to conduct an additional clinical trial to provide the FDA with additional efficacy and safety data.
  • Finally, on Aug. 18, 2021, STAT published an article entitled Sesen Bio trial of cancer drug marked by misconduct and worrisome side effects, documents show.
  • If you invested in Sesen and have significant losses, or have knowledge that may assist the firms investigation, click here to discuss your legal rights with Hagens Berman .
  • Hagens Berman is a national law firm with eight offices in eight cities around the country and over eighty attorneys.

DEADLINE ALERT for VIEW, SESN, KPLT, HYRE: Law Offices of Howard G. Smith Reminds Investors of Class Actions on Behalf of Shareholders

Friday, September 17, 2021 - 6:00pm

BENSALEM, Pa, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • BENSALEM, Pa, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors have until the deadlines listed below to file a lead plaintiff motion.
  • Investors suffering losses on their investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in these class actions at 888-638-4847 or by email to howardsmith@howardsmithlaw.com .
  • Law Offices of Howard G. Smith

VBL Therapeutics Announces Independent Data Safety Monitoring Committee Provides Clearance to Continue the OVAL Phase 3 Registration-Enabling Study of VB-111 in Ovarian Cancer

Friday, September 17, 2021 - 12:00pm

The OVAL trial is planned to enroll approximately 400 adult patients globally and more than 320 patients (>80 percent) have already been recruited.

Key Points: 
  • The OVAL trial is planned to enroll approximately 400 adult patients globally and more than 320 patients (>80 percent) have already been recruited.
  • VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer ( NCT01229865 ) and platinum-resistant ovarian cancer ( NCT01711970 ).
  • VB-111 is currently being studied in a Phase 3 registration-enabling trial for recurrent platinum-resistant ovarian cancer.
  • To learn more about VBL Therapeutics, please visit vblrx.com or follow the company on LinkedIn , Twitter , YouTube or Facebook .

Junshi Biosciences and Coherus to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squ

Friday, September 17, 2021 - 1:19am

SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive interim results from the pivotal study “JUPITER-06” (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

Key Points: 
  • We believe toripalimab could be a potential new treatment choice where patients truly need better options.
  • The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma.
  • We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously.
  • Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.