Food and Drug Administration

ROSEN, NATIONAL TRIAL COUNSEL, Encourages bluebird bio Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – BLUE

Retrieved on: 
Monday, April 1, 2024
Titan, Patient, Class, Food and Drug Administration, Advertising, Bluebird, FDA, Court, Bluebird bio, Tobacco

WHAT TO DO NEXT: To join the bluebird class action, go to https://rosenlegal.com/submit-form/?case_id=23717 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the bluebird class action, go to https://rosenlegal.com/submit-form/?case_id=23717 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

ReShape Lifesciences® Reports Year Ended December 31, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024
Commitment, Research, Obesity, PTE, Exercise, Bariatrics, Patent, Patient, Food and Drug Administration, Weight loss, Travel, Acquisition, FLEX, Prescription, NYU, Food, Security (finance), Insurance, Marketing, Surgeon, C-peptide, Annual report, PMA, NYU Langone Health, Division, United States patent law, FDA, Advertising, Bariatric surgery

IRVINE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a corporate strategic update.

Key Points: 
  • Specifically, it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/370,819.
  • December 2023: Engaged Maxim Group LLC, to act as the company’s exclusive financial advisor to help identify potential synergistic merger and acquisition partnerships.
  • December 2023: Received U.S. Food and Drug Administration (FDA) PMA supplement approval for its next-generation Lap-Band® 2.0 FLEX, designed to improve the patient experience.
  • Participants using this feature are requested to dial into the conference call fifteen minutes ahead of time to avoid delays.

INMODE LTD. (NASDAQ: INMD) DEADLINE ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against InMode Ltd.

Retrieved on: 
Monday, April 1, 2024
District court, Food and Drug Administration, Dermatology, News, Complaint, Action Replay, Dentist, Court, Advertising

If you purchased or acquired InMode common stock, and/or would like to discuss your legal rights and options please visit InMode Ltd.

Key Points: 
  • If you purchased or acquired InMode common stock, and/or would like to discuss your legal rights and options please visit InMode Ltd.
  • If you wish to serve as lead plaintiff, you must move the Court no later than April 15, 2024.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

Retrieved on: 
Monday, April 1, 2024
Harvard Medical School, Investigational device exemption, Human, Obesity, Cardiovascular disease, Exercise, Risk, Patient, Food and Drug Administration, Weight loss, IDE, MD, Diet, Pharmacotherapy, Duodenum, Hospital, T2D, Wellness, Pathology, Therapy, BMI, FDA, Endoscopy, Food, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a critical precursor to various highly morbid and expensive chronic conditions such as type 2 diabetes, metabolic dysfunction-associated fatty liver disease, and cardiovascular disease.

Key Points: 
  • The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024.
  • Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
  • It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.
  • The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024
Research, Conference, Lupus, Inflammation, Patient, Food and Drug Administration, CTA, Doctor of Philosophy, SLE, Insurance, GRI, IPF, Fibrosis, Oxygen, Immune system, Injury, NKT, Food, Movement, Lupus nephritis, Autoimmune disease, Natural killer T cell, Medication, Pharmaceutical industry

LA JOLLA, CA, April 01, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported its financial results for the fiscal year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells.
  • Research and development expenses were $3.2 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively.
  • General and administrative expenses were $8.2 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against NYCB, Amylyx, Xponential, and InMode and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, March 30, 2024
SSS, Signature, Vii, Apoptosis, ALS, Patient, AUV, Bloomberg Businessweek, ACL, Food and Drug Administration, Defendant, AMX0035, Amyotrophy, Sale, News, Dermatology, Prescription, New York Community Bank, NYCB, IBD, Complaint, P.C, Geisler, Investor's Business Daily, Assumption, Confidentiality, Amylyx Pharmaceuticals, Injury, Category, Dentist, FDA, BBC World Service, Evercore, Food, Pharmaceutical industry

NYCB is a large commercial-real estate lender in the New York City market area, where it specializes in rent-regulated, non-luxury apartment buildings.

Key Points: 
  • NYCB is a large commercial-real estate lender in the New York City market area, where it specializes in rent-regulated, non-luxury apartment buildings.
  • NYCB is engaged in several national businesses, including multi-family lending, mortgage originations and servicing, and warehouse lending.
  • On January 31, 2024, before the market opened, NYCB announced its fiscal fourth quarter 2023 financial results.
  • For more information on the InMode class action go to: https://bespc.com/cases/INMD

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 29, 2024
Research, Data monitoring committee, Cirrhosis, Disease, Metabolism, AASLD, Safety, Patient, Food and Drug Administration, Liver, Mortality, Liver transplantation, Hope, Hepatology, Fibrosis, Clinical trial, Annual report, Therapy, GALT, Pharmacokinetics, Data, DSMB, NASH, Food, Esophageal varices

NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.

Key Points: 
  • NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.
  • Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH) cirrhosis program.
  • Dr. Jamil’s extensive experience in advanced liver disease, specifically for late-stage cirrhotic patients, is a tremendous asset to our program.
  • These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov .

Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma

Retrieved on: 
Thursday, March 28, 2024
SOC, Survival, Fast track (FDA), Safety, Patient, Food and Drug Administration, Standard of care, Doctor of Philosophy, MD, Clinical trial, Therapy, Injection, FDA, Drug development, CADL, Food, Serology, Pharmaceutical industry

“Dosing patients with multiple injections represents the next step forward in the development of CAN-3110 for rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “The observed data suggest that repeated injections of CAN-3110 are well tolerated, supporting the design of a future phase 2 clinical trial in this indication. We’re excited by our recent progress -- as illustrated by the publication in Nature, CAN-3110’s recent FDA Fast Track designation, and the collaboration with Batavia Biosciences -- to accelerate the development and production of CAN-3110, along with our update presented today. Together, we hope this will help to accelerate the development of a better treatment for patients with high unmet need.”

Key Points: 
  • The first cohort of patients were treated with multiple injections of CAN-3110 in the ongoing phase 1b clinical trial.
  • A second cohort is being planned for enrollment in the ongoing phase 1b clinical trial of CAN-3110.
  • The data were presented today during the 5th Glioblastoma Drug Development Summit in Boston, Massachusetts.
  • Results from the ongoing phase 1b clinical trial were published in Nature in Q4 2023.

ArriVent BioPharma Reports Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, EGFR, Conference, Breakthrough therapy, NSCLC, Patient, Food and Drug Administration, Lung cancer, Therapy, PACC, Safety, ADC, FDA, SHP2, Food, Pharmaceutical industry

In September 2023, ArriVent and its partner, Shanghai Allist Pharmaceuticals Company, Ltd. ("Allist”), presented interim Phase 1b results at the World Conference on Lung Cancer.

Key Points: 
  • In September 2023, ArriVent and its partner, Shanghai Allist Pharmaceuticals Company, Ltd. ("Allist”), presented interim Phase 1b results at the World Conference on Lung Cancer.
  • In January 2024, ArriVent appointed Winston Kung as Chief Financial Officer and Treasurer, bringing over 20 years of extensive leadership experience, most recently as Chief Financial Officer and Chief Operating Officer at PMV Pharmaceuticals.
  • Research and development expenses were $64.9 million and $30.4 million for the years ended December 31, 2023 and 2022, respectively.
  • Net loss was $69.3 million and $37.0 million for the years ended December 31, 2023 and 2022, respectively.

ROSEN, A LEADING LAW FIRM, Encourages InMode Ltd. Investors to Secure Counsel Before Important Deadline in Securities Class Action – INMD

Retrieved on: 
Thursday, March 28, 2024
Titan, Food and Drug Administration, Class, Advertising, FDA, Court, Food

WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.