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Clinical Trials

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia
SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and...
View Pub Date: Thu, 19 Dec 2024 01:12:09 +0000

Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)
TARRYTOWN, N.Y., December 19, 2024 – Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer...
View Pub Date: Thu, 19 Dec 2024 01:12:05 +0000

Reported Use of Most Drugs Among Adolescents Remained Low in 2024
December 17, 2024 -- New NIH-funded data show lower use of most substances continues following the COVID-19 pandemic. If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat at 988lifeline.org. To learn...
View Pub Date: Tue, 17 Dec 2024 22:12:44 +0000

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis
SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and...
View Pub Date: Tue, 17 Dec 2024 01:12:26 +0000

Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab
RAHWAY, N.J.--(BUSINESS WIRE) December 16, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and...
View Pub Date: Mon, 16 Dec 2024 22:12:24 +0000

Findings from Minzasolmin Proof-of-Concept ORCHESTRA Study Shape Next Steps in UCB Parkinson’s Research Program
Brussels, Belgium – 16 December 2024 -- UCB today announced the ORCHESTRA proof-of-concept study of minzasolmin - an investigational, oral small molecule, alpha-synuclein misfolding inhibitor - developed in partnership with Novartis for early...
View Pub Date: Mon, 16 Dec 2024 22:12:14 +0000

FDA Revokes Emergency Use Authorization (EUA) for Bebtelovimab for the Treatment of COVID-19
December 13, 2024 -- On December 5, 2024, Lilly requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bebtelovimab since all lots of bebtelovimab manufactured and labeled for use under EUA 111 have expired...
View Pub Date: Fri, 13 Dec 2024 21:12:25 +0000

FDA Revokes EUA for Sotrovimab for the Treatment of COVID-19
December 13, 2024 -- On November 22, 2024, GSK requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for sotrovimab since all lots of sotrovimab manufactured and labeled for use under EUA 100 have expired. At...
View Pub Date: Fri, 13 Dec 2024 21:12:24 +0000

FDA Revokes EUA for REGEN-COV (casirivimab and imdevimab) for the Treatment of COVID-19
December 13, 2024 -- On November 25, 2024, Regeneron requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for REGEN-COV (Casirivimab and Imdevimab) since all lots of REGEN-COV manufactured and labeled for use...
View Pub Date: Fri, 13 Dec 2024 21:12:08 +0000

FDA Revokes EUA for Evusheld (tixagevimab co-packaged with cilgavimab) for the Treatment of COVID-19
December 13, 2024 -- On November 21, 2024, AstraZeneca requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) since all lots of Evusheld distributed under...
View Pub Date: Fri, 13 Dec 2024 20:12:00 +0000

Tolebrutinib Designated Breakthrough Therapy by the FDA for Non-Relapsing Secondary Progressive Multiple Sclerosis
Paris, December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This is based on...
View Pub Date: Fri, 13 Dec 2024 03:12:59 +0000

Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta
SAN FRANCISCO--(BUSINESS WIRE) December 12, 2024 -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines...
View Pub Date: Thu, 12 Dec 2024 04:12:43 +0000

Repare Therapeutics Announces Positive Results of the Lunresertib and Camonsertib Combination from the MYTHIC Phase 1 Gynecologic Expansion Clinical Trial
CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)--Dec. 12, 2024-- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported positive data from its...
View Pub Date: Thu, 12 Dec 2024 03:12:04 +0000

Pilatus Biosciences Inc. Receives Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer
December 12, 2024 -- Pilatus Biosciences Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for the treatment of liver and intrahepatic bile duct...
View Pub Date: Thu, 12 Dec 2024 00:12:00 +0000

Lilly's Imlunestrant, an Oral SERD, Significantly Improved Progression-Free Survival as Monotherapy and in Combination with Verzenio® (abemaciclib) in Patients with ER+, HER2- Advanced Breast Cancer
INDIANAPOLIS, Dec. 11, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 EMBER-3 study of imlunestrant, an investigational, oral selective estrogen receptor degrader (SERD), in patients with estrogen...
View Pub Date: Wed, 11 Dec 2024 22:12:41 +0000

Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Dec. 11, 2024-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and...
View Pub Date: Wed, 11 Dec 2024 03:12:45 +0000

NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution or Pain
December 10, 2024 -- The antiviral drug tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data...
View Pub Date: Tue, 10 Dec 2024 23:12:33 +0000

Acelyrin, Inc. Announces Topline Results From Phase 2b/3 Study of Izokibep for the Treatment of Uveitis
LOS ANGELES, Dec. 10, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that its Phase 2b/3...
View Pub Date: Tue, 10 Dec 2024 22:12:32 +0000

Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza
GAITHERSBURG, Md., Dec. 10, 2024. Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone...
View Pub Date: Tue, 10 Dec 2024 22:12:26 +0000

Zealand Pharma Announces First Participant Enrolled in Phase 2b ZUPREME-1 Trial of Petrelintide in People with Overweight or Obesity
Copenhagen, Denmark, December 10, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that...
View Pub Date: Tue, 10 Dec 2024 02:12:56 +0000

uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
LEXINGTON, Mass. and AMSTERDAM, Dec. 10, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company reached...
View Pub Date: Tue, 10 Dec 2024 01:12:19 +0000

Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End
DURHAM, N.C., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that...
View Pub Date: Mon, 09 Dec 2024 18:12:57 +0000

Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
TARRYTOWN, N.Y., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab were presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in...
View Pub Date: Mon, 09 Dec 2024 03:12:43 +0000

Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
9 December 2024 -- Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small...
View Pub Date: Mon, 09 Dec 2024 00:12:57 +0000

Merck’s Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrates Complete Response Rate of 100% at 1.75 mg/kg Dose in Phase 2 Trial of Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
RAHWAY, N.J.--(BUSINESS WIRE) December 8, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin...
View Pub Date: Sun, 08 Dec 2024 04:12:04 +0000