CRL

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
Wednesday, April 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

CHARLES RIVER ALERT: Bragar Eagel & Squire, P.C. is Investigating Charles River Laboratories International, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, April 3, 2024
Risk, Telephone, Primate, Defendant, Complaint, CRL, Research, P.C

NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Charles River Laboratories International, Inc. (NYSE: CRL) on behalf of long-term stockholders following a class action complaint that was filed against Charles River on May 19, 2023 with a Class Period from May 5, 2020 to February 21, 2023.

Key Points: 
  • NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Charles River Laboratories International, Inc. (NYSE: CRL) on behalf of long-term stockholders following a class action complaint that was filed against Charles River on May 19, 2023 with a Class Period from May 5, 2020 to February 21, 2023.
  • Our investigation concerns whether the board of directors of Charles River have breached their fiduciary duties to the company.
  • According to the complaint, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.
  • There is no cost or obligation to you.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Retrieved on: 
Sunday, March 31, 2024
Symantec Endpoint Protection, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, March 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, Symantec Endpoint Protection, Prejudice, SPA, Patient, CRL, NDA, G&A, CMC, Disclosure, Insurance, Senior, Woman, Investment, Infection, Therapy, Urinary tract infection, ATM, FDA, ITRM, Food, Pharmaceutical industry

DUBLIN, Ireland and CHICAGO, March 28, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Iterum reported positive top-line data in January 2024 and plans to resubmit its NDA early in the second quarter of 2024.
  • In connection with this strategic process, Iterum has engaged a financial advisor to assist management and the board in evaluating strategic alternatives.
  • In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Royalty-Linked Notes.
  • Iterum will host a conference call today, Thursday, March 28, 2024 at 8:30 a.m. Eastern Time.

AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, March 26, 2024
Symantec Endpoint Protection, Telephone, CRL, News, NDA, CMC, Migraine, Myenteric plexus, Chemistry, P.C, Therapy, FDA, Food, Pharmaceutical industry

Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.
  • However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
  • Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome .

Charles River Announces Rare Disease Gene Therapy Collaboration with Axovia Therapeutics

Retrieved on: 
Tuesday, April 9, 2024
Research, Medical Devices, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Deafness, CDMO, Obesity, Syndrome, Infertility, Entrepreneurship, Disease, Diabetes, Ciliopathy, Patient, CRL, DNA, Display resolution, Kidney disease, GMP, Tecmar, Therapy, Paratriathlon, BBS, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) today announced a plasmid DNA contract development and manufacturing organization (CDMO) collaboration with Axovia Therapeutics Ltd .

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today announced a plasmid DNA contract development and manufacturing organization (CDMO) collaboration with Axovia Therapeutics Ltd .
  • Charles River will manufacture High Quality (HQ) gene of interest plasmid to support the development of Axovia’s gene therapies for ciliopathies, including Bardet-Biedl Syndrome (BBS), a condition with limited treatment options and no cure.
  • Dysfunctional cilia can cause blindness, deafness, chronic respiratory infections, kidney disease, heart disease, infertility, obesity and diabetes.
  • In recent years, Charles River has significantly broadened its cell and gene therapy portfolio to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services.

Pomerantz Law Firm Announces the Filing of a Class Action Against Checkpoint Therapeutics, Inc. and Certain Officers - CKPT

Retrieved on: 
Saturday, April 6, 2024
Radiation, Biologics license application, District court, Patient, Defendant, CRL, News, Ext, Acquisition, LLP, Complaint, Pomerantz, CMO, Action Replay, Food, FDA, BLA, Court, Person

NEW YORK, April 5, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Checkpoint Therapeutics, Inc. ("Checkpoint" or the "Company") (NASDAQ: CKPT) and certain officers.

Key Points: 
  • NEW YORK, April 5, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Checkpoint Therapeutics, Inc. ("Checkpoint" or the "Company") (NASDAQ: CKPT) and certain officers.
  • To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Retrieved on: 
Saturday, March 23, 2024
Symantec Endpoint Protection, Prior, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.