Biologics license application

Polaris Group Announced the Acquisition of Genovior Biotech, Initiating Dual-Engine Growth

Retrieved on: 
Friday, December 22, 2023
Mesothelioma, Workforce, Leiomyosarcoma, Hepatocellular carcinoma, Acquisition, Semaglutide, MIT, Diabetes, Chemical engineering, SAN, Biologics license application, HCC, Glioblastoma, Dicarboxylic acid, Doctor of Philosophy, GBM, LMS, Growth, Escherichia coli, BLA

TAIPEI, Taiwan and SAN DIEGO, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550) announced that its board approved to increase the acquisition of Genovior Biotech's shares to 100%.

Key Points: 
  • TAIPEI, Taiwan and SAN DIEGO, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550) announced that its board approved to increase the acquisition of Genovior Biotech's shares to 100%.
  • Additionally, Dr. Steve Hsu, Chairman of Genovior Biotech Corporation, has been appointed as the CEO of Polaris Group.
  • These two highly prospective product lines will serve as the dual engines propelling Polaris Group's future growth.
  • Consequently, Genovior Biotech fills critical gaps for Polaris Group, providing not just high-quality manufacturing capabilities but also a substantial entry into the market for peptide products.

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc. (BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Thursday, December 21, 2023
Telephone, NEXT, Food, LLP, Court, CLASS, Biologics license application, COST, Cryptocurrency

NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Wednesday, December 20, 2023
NEXT, Fraud, Food, Biologics license application, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

Retrieved on: 
Tuesday, December 19, 2023
Growth hormone, Endocrine gland, GHD, Ageing, Tissue, Biologics license application, Week, Patient, Safety, SDS, Dietary supplement

COPENHAGEN, Denmark, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).

Key Points: 
  • The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH and daily hGH.
  • For patients with IGF-1 SDS levels ≤ 1.75 at Week 38:
    Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily hGH -2.59%)
    TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily hGH.
  • “TransCon hGH, our once-weekly growth hormone, is designed to deliver unmodified somatropin, thereby preserving the same overall endocrine benefits inherent in endogenous and daily hGH,” said Jan Mikkelsen, Ascendis Pharma’s President and CEO.
  • “Next year, we plan to submit a supplemental Biologics License Application to the U.S. FDA for the adult GHD indication and look forward to reporting data from our Phase 2 program in Turner syndrome.”

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc. (BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Monday, December 18, 2023
Telephone, NEXT, Food, LLP, Court, CLASS, Biologics license application, COST, Cryptocurrency

NEW YORK, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Robbins LLP Reminds Brainstorm Cell Therapeutics Inc. Investors of Upcoming Lead Plaintiff Deadline in Class Action Against BCLI

Retrieved on: 
Friday, December 15, 2023
Cellular, Food, ALS, Biotechnology, Efficacy, LLP, FDA, Person, Complaint, SAN, Gene, Biologics license application, News, Viability, BLA, Pharmaceutical industry

SAN DIEGO, Dec. 15, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.

Key Points: 
  • SAN DIEGO, Dec. 15, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.
  • Brainstorm Cell is a biotechnology company that develops and commercializes autologous cellular therapies for the treatment of neurodegenerative diseases.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Brainstorm Cell 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.

AC Immune’s Targeted Anti-pTau Active Immunotherapy for Alzheimer’s Disease Advances into Phase 2b Trial

Retrieved on: 
Friday, December 15, 2023
Partnership, AC, Deficit spending, Johnson & Johnson, Janssen Pharmaceuticals, Function (mathematics), Biomarker, FDA, Janssen, Injection, Biologics license application, Clinical trial, CHF, Dementia, JAMA, Pathology, Neurotoxicity, Patient, MCI, Memory, Tauopathy, BLA, Vaccine

ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).

Key Points: 
  • ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).
  • Studies have shown that pTau correlates with AD progression and the trial aims to show that ACI-35.030 can prevent or slow down the progression of tau pathology and onset of clinical symptoms.
  • The partnership with Janssen aims to develop and commercialize therapeutic anti-Tau active immunotherapies for the treatment of AD and potentially other Tauopathies.
  • It is sensitive enough to detect early changes in cognitive function, even before the first clinical signs of mild cognitive impairment (MCI) are apparent2.

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Thursday, December 14, 2023
NEXT, Fraud, Food, Biologics license application, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc.(BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Wednesday, December 13, 2023
Telephone, NEXT, Food, LLP, Court, CLASS, Biologics license application, COST, Cryptocurrency

NEW YORK, Dec. 13, 2023 (GLOBE NEWSWIRE) -- , December 13, 2023 – Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Dec. 13, 2023 (GLOBE NEWSWIRE) -- , December 13, 2023 – Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Humacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel™ (HAV™) for the Treatment of Vascular Trauma

Retrieved on: 
Tuesday, December 12, 2023
Food, Priority review, Infection, HUMA, Injury, FDA, File, HAV, Tissue, MD, Doctor of Philosophy, Biologics license application, Defense, Amputation, Public law, Patient, Food and Drug Administration, BLA, Pharmaceutical industry

DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

Key Points: 
  • The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine.
  • The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
  • Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date.
  • In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma.