Symantec Endpoint Protection

Supernus Provides Regulatory Update for SPN-830

Retrieved on: 
Monday, April 8, 2024
Symantec Endpoint Protection, PD, Central nervous system, Patient, CNS, Food and Drug Administration, CRL, NDA, FDA, Food

ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.

Key Points: 
  • ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.
  • The FDA has issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for SPN-830.
  • The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.
  • We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” said Jack Khattar, President & CEO of Supernus.

IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

Retrieved on: 
Friday, April 5, 2024
Symantec Endpoint Protection, CRL, IGX, Chronic pain, Buprenorphine, TSX, FDA, Food, Pharmaceutical industry

SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

Key Points: 
  • SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
  • The CRL includes a request for additional Pharmaceutical Quality information.
  • Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
  • Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

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: 
Thursday, April 4, 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 .

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024

Retrieved on: 
Thursday, April 4, 2024
Symantec Endpoint Protection, CLL, Safety, RT, Patient, EBMT, NHL, Euronext, Efficacy, Abstract, CD19, Pharmaceutical industry

ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.

Key Points: 
  • ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.
  • The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study.
  • GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
  • “We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.

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.

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.

Molecular Templates, Inc. Reports Fourth Quarter 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 29, 2024
Multiple myeloma, Private placement, Symantec Endpoint Protection, EGFR, CD8, Exercise, Disease, AML, HNSCC, CMV, Patient, Common, Tom Clancy's Ghost Recon, Neoplasm, Immunoglobulin A, Tumor microenvironment, Sale, Bristol Myers Squibb, Form 10-K, Cancer, MHC, PD-L1, Antibody, Interim, Therapy, MTD, Poster, Total, ETB, UPR, Pharmaceutical industry

The net loss attributable to common shareholders for the fourth quarter of 2023 was $3.9 million, or $0.73 per basic and diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the fourth quarter of 2023 was $3.9 million, or $0.73 per basic and diluted share.
  • Revenues for the fourth quarter of 2023 were $7.0 million, compared to $2.6 million for the same period in 2022.
  • Revenues for the fourth quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol-Myers Squibb and grant revenue.
  • For more details on MTEM’s financial results for 2023, refer to Form 10-K filed with the SEC.

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.

Cellectar Biosciences Reports Financial Results for Year Ended 2023 and Provides a Corporate Update

Retrieved on: 
Wednesday, March 27, 2024
Research, NCI, AON, Development, Sarcoma, Disease, Neuroblastoma, Shareholder, Patient, CNS, Fast Track, Cash, SBIR, NDA, Syndrome, Cancer, MRR, CLR, BNS, University, Head, External beam radiotherapy, Cure, Wisconsin Alumni Research Foundation, WAM, HERE, Completeness, Safety, Tat, Intellectual property, Patent, PLE, WARF, Symantec Endpoint Protection, Tranche, UW, Pharmaceutical industry

FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the year ended December 31, 2023, and provided a corporate update.
  • Net cash used in operating activities during the twelve months ended December 31, 2023, was approximately $32.4 million.
  • General and Administrative Expense: G&A expense for the year ended December 31, 2023, was $10.7 million, compared to $9.6 million for the year ended December 31, 2022.
  • Cellectar management will host a conference call for investors today, March 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions.