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Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

New England Journal of Medicine Publishes Positive Results of the Pivotal Trial of Cablivi (caplacizumab) for Rare Blood Clotting Disorder

Posted yesterday in Clinical Trials

PARIS, Jan. 9, 2019 /PRNewswire/ -- The New England Journal of Medicine (NEJM) today published positive results of the Phase 3 trial of Cablivi® (caplacizumab) in adults with acquired thrombotic thrombocytopenic purpura (aTTP). aTTP is a rare, life-threatening autoimmune blood disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low ... Read more...

Sound Pharmaceuticals Advances Phase 2 Hearing Loss Clinical Trial in Cystic Fibrosis

Posted 2 days ago in Clinical Trials

Seattle, WA and Charleston, S.C. -- January 14, 2019 -- Sound Pharmaceuticals (SPI) is pleased to announce that first-patient-in has been achieved in the STOP Ototoxicity Phase 2 clinical trial. This novel interventional study with SPI-1005 is aimed to prevent and treat ototoxicity in Cystic Fibrosis (CF) patients undergoing intravenous (IV) tobramycin for the treatment of acute pulmonary exacerbation. Ototoxicity... Read more...

miRagen Announces New Clinical Data in Patients With Three Different Types of Blood Cancers Treated With Cobomarsen

Posted 6 days ago in Clinical Trials

BOULDER, Colo., Jan. 10, 2019 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced data from its Phase 1 clinical trial evaluating the safety, tolerability and efficacy of cobomarsen, an inhibitor of microRNA-155, in cutaneous T-cell lymphoma (CTCL) and in adult T-cell... Read more...

Novartis Investigational Therapy Crizanlizumab (SEG101) Receives FDA Breakthrough Therapy Designation for the Prevention of Vaso-Occlusive Crises in Sickle Cell Disease

Posted 8 days ago in Clinical Trials

Basel, January 8, 2019 - Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic... Read more...

MediciNova Announces Initiation of Enrollment in a Clinical Trial of MN-166 (ibudilast) in Glioblastoma

Posted 8 days ago in Clinical Trials

LA JOLLA, Calif., Jan. 08, 2019 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the first glioblastoma patient has enrolled in the clinical trial of MN-166 (ibudilast) in combination with temozolomide (TMZ, Temodar‑®) for the treatment of recurrent gl... Read more...

UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)

Posted 8 days ago in Clinical Trials

NEW YORK--(BUSINESS WIRE)--Jan. 8, 2019-- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract... Read more...

Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata

Posted 11 days ago in Clinical Trials

January 3, 2019 -- Pfizer Inc. (NYSE: PFE) announced today the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies.1,2 “We are proud to start this global pivotal Phase 2b/3 trial for P... Read more...

Reata Announces Clinical Trial Design for FALCON, a Phase 3 Trial of Bardoxolone Methyl for the Treatment of Autosomal Dominant Polycystic Kidney Disease

Posted 11 days ago in Clinical Trials

IRVING, Texas, Jan. 03, 2019 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced that it has completed a successful end-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease... Read more...

Epizyme Announces Registration Path for Tazemetostat for Follicular Lymphoma and Provides Pipeline Updates and 2019 Guidance

Posted 12 days ago in Clinical Trials

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 4, 2019-- Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL), both with and without EZH2 activating... Read more...

Verrica Achieves Positive Topline Results from Two Pivotal Phase 3 Clinical Trials of VP-102 in Patients with Molluscum Contagiosum

Posted 13 days ago in Clinical Trials

WEST CHESTER, Pa., Jan. 03, 2019 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a pharmaceutical company focused on identifying, developing and commercializing innovative pharmaceutical products for the treatment of skin diseases with significant unmet needs, today announced positive topline results from its Phase 3 CAMP-1 and CAMP-2 pivotal trials with VP-102 for the treatment of... Read more...

Kiniksa Announces Active U.S. Investigational New Drug Application for Mavrilimumab

Posted 13 days ago in Clinical Trials

HAMILTON, Bermuda, Jan. 03, 2019 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of five product candidates across various stages of development, today announced an active investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for a clinical study of mavrilimumab in subjects with giant cell arteritis (GCA). ... Read more...

Catabasis Pharmaceuticals Phase 3 PolarisDMD Clinical Trial For Edasalonexent In Duchenne Muscular Dystrophy Progress Update

Posted 13 days ago in Clinical Trials

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 3, 2019-- Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today shared an update on clinical trial sites in the United States and recent international clinical trial application approvals to perform the Phase 3 PolarisDMD trial for edasalonexent (CAT-1004) in Duchenne muscular dystrophy (DMD). PolarisDMD clinical trial sites in the... Read more...

Onconova Submits Special Protocol Assessment (SPA) To FDA For Phase 3 Trial Of Oral Rigosertib In Combination With Azacitidine (Vidaza®) For First-Line Myelodysplastic Syndromes (MDS)

Posted 2 weeks ago in Clinical Trials

NEWTOWN, Pa., Jan. 02, 2019 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on MDS, today announced that it has submitted a Special Protocol Assessment request to the U.S. Food and Drug Administration (FDA) for a Phase 3 study of oral rigosertib combination therapy with... Read more...

BioCryst Initiates Phase 1 Clinical Trial of Galidesivir

Posted 2 weeks ago in Clinical Trials

RESEARCH TRIANGLE PARK, N.C., Jan. 02, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the dosing of the first subject in a randomized, placebo-controlled phase 1 clinical trial to evaluate intravenous (IV) galidesivir in healthy volunteers. The main goals of this trial are to evaluate the safety, tolerability and pharmacokinetics of escalating doses of galidesivir in healthy... Read more...

BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin

Posted 2 weeks ago in Clinical Trials

NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead asset, Plinabulin. The focus of this meeting was the content of the chemistry, manufacturing and... Read more...

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation

Posted 2 weeks ago in Clinical Trials

NEW HAVEN, Conn., Dec. 27, 2018 -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), today announced that the U.S. FDA has granted Fast Track Designation for its investigational drug BXCL501, a proprietary sublingual film of dexmedetomidine, for the treatment of acute agitation. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify t... Read more...

Opiant Pharmaceuticals Licenses Novel CB-1 Receptor Antagonist for Treatment of Acute Cannabinoid Overdose from Sanofi

Posted 2 weeks ago in Clinical Trials

SANTA MONICA, Calif., Dec. 26, 2018 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, today announced that it has entered into an exclusive global licensing agreement with Sanofi (NYSE:SNY) for the development and commercialization of drinabant for the treatment of acute cannabinoid overdose (ACO). Opiant intends... Read more...

Valneva Awarded FDA Fast Track Designation for Chikungunya Vaccine Candidate

Posted 3 weeks ago in Clinical Trials

Saint-Herblain (France), December 21, 2018 - Valneva SE ("Valneva"), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its chikungunya vaccine candidate, VLA1553. Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, "Chikungunya is a... Read more...

Viriom to Report Results from Phase 1b Clinical Trial of Once Weekly Oral HIV Treatment

Posted 3 weeks ago in Clinical Trials

SAN DIEGO, Dec. 21, 2018 /PRNewswire/ -- Viriom (San Diego, CA) announced today that it plans to report results from its Phase 1b clinical trial of once weekly dosing of oral elsulfavirine (Elpida®, VM1500), a potent long acting nonnucleoside reverse transcriptase inhibitor (NNRTI) in HIV-uninfected volunteers in March 2019. This trial is designed to evaluate the safety and pharmacokinetics of elsulfavirine dosed ... Read more...

Loxo Oncology Announces Initiation of Phase 1/2 Clinical Trial for Highly Selective, Non-Covalent BTK Inhibitor, LOXO-305

Posted 3 weeks ago in Clinical Trials

STAMFORD, Conn., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers, today announced that it has initiated a Phase 1/2 clinical trial of LOXO-305. LOXO-305 is an investigational, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) i... Read more...

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