New Drug Application

Journey Medical Corporation Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 21, 2024
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SCOTTSDALE, Ariz., March 21, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2023.

Key Points: 
  • ET to discuss the financial results and provide a business update
    SCOTTSDALE, Ariz., March 21, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2023.
  • Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “2023 was a year of growth and development for Journey Medical.
  • In December 2023, Journey Medical entered into a $20.0 million credit facility with SWK Holdings Corporation (“SWK”), a specialized finance company with a focus on the global healthcare sector.
  • In July 2023, Journey Medical announced positive topline results from the two DFD-29 Phase 3 clinical trials (MVOR-1 & MVOR-2) for the treatment of rosacea.

ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
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SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under nasal allergen challenge conditions.
  • R&D Expenses: Research and development expenses were $3.4 million and $20.3 million for the quarter and year ended December 31, 2023, respectively.
  • G&A Expenses: General and administrative expenses were $6.8 million and $47.3 million for the quarter and year ended December 31, 2023, respectively.
  • Net Loss: Net loss was $7.2 million and $54.4 million for the quarter and year ended December 31, 2023, respectively.

Context Therapeutics Reports Full Year 2023 Operating and Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Conference, Cancer, Immunotherapy, New Drug Application, Integral, CLDN6, Insurance, Society, Trial of the century, IND, CD3, SITC, Context, Annual general meeting, Food

PHILADELPHIA, March 21, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the year ended December 31, 2023, and reported on recent and upcoming business highlights.

Key Points: 
  • “During the fourth quarter of 2023, Context continued to advance our lead clinical candidate, CTIM-76, a Claudin 6 ("CLDN6”) x CD3 bispecific antibody, toward a first-in-human clinical study.
  • The preclinical data further support CTIM-76’s differentiated product profile, including its potential to address limitations of first-generation CLDN6-targeted clinical-stage therapies,” said Martin Lehr, CEO of Context.
  • In November 2023, Context presented preclinical data at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in xenograft models of CLDN6-positive cancer.
  • Context reported a net loss of $24.0 million for 2023, as compared to $14.8 million for the same period in 2022.

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Letter, Arrhythmia, Refusal, Offering, Paroxysmal supraventricular tachycardia, Safety, Atrial fibrillation, New Drug Application, Patient, Shanda, NDA, Aes, Science, Net, RTF, Investment, AHA, Milestone, Revera, FDA, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.

Key Points: 
  • - FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024
    MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.
  • There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022.
  • Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period.
  • For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period.

X4 Pharmaceuticals Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Security (finance), WHIM, WHIM syndrome, Conference call, Conference, RPD, New Drug Application, Ageing, Orphan, Wart, NDA, Priority review, Research and development, Immune system, File, ID, FDA, X4, PDUFA, Pharmaceutical industry

BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted key 2023 events and expected upcoming milestones.

Key Points: 
  • “Following an incredibly productive 2023, we are expecting a transformative year in 2024,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.
  • X4 will host a conference call and webcast today at 8:30 am ET to discuss these financial results and business highlights.
  • The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com .
  • Following the completion of the call, a webcast replay of the conference call will be available on the company website.

Silo Pharma Exercises Option for Exclusive License Agreement for First-in-Class PTSD and Stress-Induced Anxiety Therapeutic

Retrieved on: 
Wednesday, March 20, 2024
Exercise, New Drug Application, Research, Anxiety, Columbia University, IND, SILO, Therapy, FDA, PTSD, Administration, Pharmaceutical industry

SARASOTA, FL, March 20, 2024 (GLOBE NEWSWIRE) --  Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has exercised its option to license SPC-15, a prophylactic treatment for stress-induced affective disorders including anxiety and PTSD, from Columbia University, pursuant to a sponsored research and option agreement established in 2021. Under the terms of the license agreement currently in process, Silo will be granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide. The Company expects to finalize and enter into the exclusive license agreement in the first half of 2024.

Key Points: 
  • Under the terms of the license agreement currently in process, Silo will be granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
  • The Company expects to finalize and enter into the exclusive license agreement in the first half of 2024.
  • In contrast, SPC-15’s differentiated method of action is designed to increase stress resilience in high-risk populations.
  • Silo has identified clinical development of lead asset SPC-15 as the Company’s top strategic priority in 2024.

Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer

Retrieved on: 
Monday, March 18, 2024
Sickle cell disease, University, Medicine, Doctor of Philosophy, Albireo, New Drug Application, Patient, SVP, Research, Losmapimod, Senior, Homocystinuria, Facioscapulohumeral muscular dystrophy, Therapy, DRS, Hereditary angioedema, Drug development, Interim, Boston, Fulcrum, PFIC, DSM-IV codes, Pharmaceutical industry

CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Patrick Horn, M.D., Ph.D., as chief medical officer, effective immediately. Dr. Horn is a seasoned executive with over 20 years of end-to-end drug development experience spanning multiple therapeutic areas, with an emphasis on rare diseases, across both large pharmaceutical and biotech companies. Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development. Together, Drs. Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.

Key Points: 
  • Interim chief medical officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum’s executive leadership team as SVP of early development.
  • Horn and Fraser will be responsible for leading clinical development and overseeing regulatory strategy and execution.
  • His most recent role was as the Chief Medical Officer at HemoShear Therapeutics, specializing in rare metabolic diseases.
  • Prior to transitioning to industry, Dr. Horn was a practicing pediatrician at major academic institutions in Chicago.

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

Retrieved on: 
Friday, March 15, 2024
Symantec Endpoint Protection, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals 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.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

Retrieved on: 
Monday, April 1, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lung cancer, BMY, NMPA, Development, NSCLC, Cetuximab, Progression-free survival, New Drug Application, Patient, Neoplasm, Shanda, NDA, Cancer, Bristol Myers Squibb, Pancreatic cancer, CRC, Safety, PFS, FDA, PDUFA, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
  • Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.