Biologics license application

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

Retrieved on: 
Wednesday, November 15, 2023
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NEW YORK, Nov. 15, 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, Nov. 15, 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.

Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023
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SAN DIEGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Next steps for Cohort A:
    Plan to report the outcome from the interim futility analysis in the fourth quarter of 2023.
  • Held a positive Type-B clinical meeting with FDA in the third quarter of 2023.
  • Next steps for Cohort B:
    Expect to commence enrollment for Cohort B in the fourth quarter of 2023.
  • Revenues for the third quarter of 2023 were approximately $6.2 million compared with approximately $1.6 million for the third quarter of 2022.

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: 
Monday, November 13, 2023
NEXT, Fraud, Biologics license application, Food, Holding company, 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.

KALA BIO Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
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ARLINGTON, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research and development of innovative therapies for rare and severe diseases of the eye, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Cash Position: As of September 30, 2023, KALA had cash and cash equivalents of $56.1 million, compared to $70.5 million as of December 31, 2022.
  • R&D Expenses: For the quarter ended September 30, 2023, research and development (R&D) expenses were $5.6 million, compared to $5.4 million for the same period in 2022.
  • Operating Loss: For the quarter ended September 30, 2023, loss from operations was $8.8 million, compared to $14.6 million for the same period in 2022.
  • The weighted average number of shares used to calculate net loss/income per share was 2.6 million for the quarter ended September 30, 2023 and 1.5 million for the quarter ended September 30, 2022.

aTyr Pharma Announces Third Quarter 2023 Results and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023
NRP2, Research, Safety, SAN, Neuropilin, PST, D, BLA, Sarcoidosis, ILD, Scleroderma, International, Investment, Systemic scleroderma, ERS, Clinical trial, Patient, European Respiratory Society, DSMB, Rheumatoid arthritis, ATyr Pharma, American College, American College of Rheumatology, Small RNA, The Journal, Frontiers, Skin, ACR, Poster, Biologics license application, Pharmaceutical industry, Pharmacology, Kyorin

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.

Key Points: 
  • Ended the third quarter of 2023 with $105.6 million in cash, cash equivalents and investments.
  • SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.
  • Based on current enrollment projections, the Company expects to complete enrollment in the study early in the second quarter of 2024.
  • G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2023.

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

Retrieved on: 
Thursday, November 9, 2023
Telephone, Food, LLP, CASE, COST, CLASS, NEXT, Court, Biologics license application, Cryptocurrency

NEW YORK, Nov. 09, 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, Nov. 09, 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.

Appili Therapeutics Announces Issuance of Patent for ATI-1701 Biodefense Vaccine Candidate to Protect Against Tularemia and Provides Update on Bridge Loan

Retrieved on: 
Friday, December 15, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Bridge loan, Safety, GMP, Engineering, Therapy, Technology transfer, Toxicology, Acceleration, Tularemia, National Research Council, FDA, Francisella tularensis, Infection, NRC, CMC, Biologics license application, Patent, TSX, Pharming, State, Drug development, Pharmaceutical industry

16/982,322 filed on September 18, 2020 and titled “A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis”.

Key Points: 
  • 16/982,322 filed on September 18, 2020 and titled “A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis”.
  • The patent covers the composition and preparation methods for the vaccine through 2039.
  • Appili licensed the biodefense vaccine candidate ATI-1701 from NRC in December 2017.
  • Under the amended terms, the Bridge Loan will now mature on March 31, 2024, subject to acceleration in connection with certain corporate events.

Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease

Retrieved on: 
Sunday, December 10, 2023
Health, Surgery, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Fascia, Safety, Kaplan–Meier estimator, Food, Head, Esophagus, BLA, ASH, Lipase, Liver, Disease, Macrophage, Patient, Multimedia, Abstract, FDA, Joint, GVHD, CRS, GI, SNDX, ORR, Chocolate liquor, Development, Death, Mouth, Society, Skin, Biologics license application, Inflammation, Fibrosis, Pharmaceutical industry

The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.

Key Points: 
  • The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.
  • Organ-specific responses, including complete responses (CRs), were seen across all organs involved at baseline, including lower gastrointestinal (GI), upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin.
  • Additionally, responses were notable in fibrosis-dominated organs, including the esophagus (78%), joints and fascia (76%), lungs (47%) and skin (27%).
  • "Full results from the AGAVE-201 trial show rapid durable responses documented in all organs and patient subgroups, with significant symptom burden reduction reported by most of these heavily-pretreated patients.

Brainstorm Cell Therapeutics Inc. (BCLI) Investors: Shareholders with Large Losses Should Contact Robbins LLP Regarding the BCLI Class Action

Retrieved on: 
Tuesday, November 14, 2023
Class Action Lawsuit, Professional Services, Legal, Efficacy, Food, Gene, BLA, LLP, ALS, Complaint, Cellular, Viability, Biotechnology, FDA, Person, Biologics license application, News, Pharmaceutical industry

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: 
  • 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.
  • 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 Brainstorm Cell Therapeutics Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.

CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

Retrieved on: 
Thursday, December 14, 2023
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KING OF PRUSSIA, Penn., Dec. 14, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab. If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).

Key Points: 
  • The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab.
  • If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).
  • Orphan-drug designation for garadacimab as a therapy for hereditary angioedema has been granted by both the FDA and the EMA.
  • The ongoing open-label extension of the VANGUARD study evaluates the long-term safety and efficacy of garadacimab (200 mg monthly) in patients with HAE.