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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.

ARCA Biopharma Announces Completion of Enrolment for GENETIC-AF Phase 2B Clinical Trial Evaluating Gencaro (bucindolol hydrochloride)

Posted 3 days ago in Clinical Trials

WESTMINSTER, Colo., Aug. 16, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced the completion of enrolment for GENETIC-AF, a Phase 2B, double-blind, superiority clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential...

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Spectrum Pharmaceuticals Announces Initiation of the Registrational Phase 3 Trial of Qapzola (apaziquone) in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

Posted 5 days ago in Clinical Trials

HENDERSON, Nev.--(BUSINESS WIRE) August 14, 2017 -- Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today the Company has enrolled the first patient in a Phase 3 trial of Qapzola, a potent tumor-activated drug being investigated for low and intermediate risk non-muscle...

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Anthera Announces FDA Orphan Drug Designation for Blisibimod for the Treatment of IgA Nephropathy

Posted 10 days ago in Clinical Trials

HAYWARD, Calif., Aug. 09, 2017 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals (Nasdaq:ANTH) today announced that blisibimod has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A nephropathy (IgAN). Blisibimod targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including...

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Amylyx Pharmaceuticals Doses First Patient in Phase II Clinical Trial of AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

Posted 11 days ago in Clinical Trials

Cambridge, MA, August 8, 2017 – Amylyx Pharmaceuticals, Inc., in collaboration with The ALS Association, ALS Finding a Cure®, and the Massachusetts General Hospital, today announced that the first patient was dosed in the CENTAUR study, a Phase II clinical trial assessing the efficacy and safety of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The Neurological Clinical Research Institute (NCRI) at...

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Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma

Posted 11 days ago in Clinical Trials

SANTA MONICA, Calif.--(BUSINESS WIRE) August 8, 2017 -- Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human trial of KITE-585, a CAR-T cell therapy engineered to target B-cell maturation antigen (BCMA) in patients with relapsed/refractory...

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Zynerba Pharmaceuticals Announces Top-Line Results from Phase 2 STAR 1 Trial of ZYN002 in Adult Epilepsy Patients with Focal Seizures

Posted 11 days ago in Clinical Trials

Devon, PA, August 7, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal pharmaceutically-produced cannabinoid treatments, today announced top-line results from its double-blind placebo controlled Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial e...

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Rebiotix Announces First Patient Enrolled in Phase 3 Clinical Trial of RBX2660 for the Prevention of Recurrent Clostridium difficile Infection

Posted 11 days ago in Clinical Trials

ROSEVILLE, MN (August 07, 2017) — Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that it has enrolled the first patient in a Phase 3 clinical trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 is Rebiotix’s most clinically advanced drug product developed from the ...

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Gemphire Announces Top-Line Data from ROYAL-1 Phase 2b Clinical Trial in Hypercholesterolemic Patients

Posted 11 days ago in Clinical Trials

LIVONIA, Mich., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP) today announced top-line data based upon the Company’s preliminary review of the limited top-line data set from the completed double-blind, placebo-controlled, randomized Phase 2b ROYAL-1 trial. ROYAL-1 evaluated the efficacy, safety, and tolerability of oral gemcabene 600 mg dosed once daily. ROYAL-1 enrolled patients who ...

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Polaryx Therapeutics Receives Orphan Drug Designation From the U.S. FDA for PLX-200 for Rare Pediatric Disease

Posted 12 days ago in Clinical Trials

PARAMUS, N.J., Aug. 7, 2017 /PRNewswire/ -- Polaryx Therapeutics, Inc, a biotech company developing oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and for other forms of NCL, commonly known as Batten disease, has been granted Orphan Drug Designation from the U.S. FDA for PLX-200 to treat LINCL. LINCL, which qualifies as a rare pediatric disease under Section 529 of the...

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Lilly Announces Positive Results For Second Phase 3 Study Of Lasmiditan For The Acute Treatment Of Migraine

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, Aug. 4, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, met its primary endpoint in SPARTAN, a second Phase 3 study. At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. These results were...

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Theravance Biopharma Announces Positive Top-Line Results from Phase 2b Study of Velusetrag (TD-5108) in Patients with Gastroparesis

Posted 2 weeks ago in Clinical Trials

DUBLIN, Ireland, Aug. 2, 2017 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced positive results from a 12-week, Phase 2b study of velusetrag (TD-5108), an oral investigational drug in development for the treatment of patients with diabetic and idiopathic gastroparesis. Top-line results from the study demonstrated statistically significant...

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Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5)

Posted 2 weeks ago in Clinical Trials

SANTA MONICA, Calif.--(BUSINESS WIRE) August 2, 2017 -- Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, today announced that patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma (iNHL) are now being treated in its Phase 2 ZUMA-5 trial with its lead investigational candidate, axicabtagene ciloleucel (axi-cel). This study builds upon early clinical results using the same axi-cel...

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Acalabrutinib Granted Breakthrough Therapy Designation by US FDA for the Treatment of Patients with Mantle Cell Lymphoma

Posted 2 weeks ago in Clinical Trials

August 1, 2017 -- AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton...

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TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement with the FDA for a Phase 3 Program of TG-1101 (ublituximab) for Patients with Multiple Sclerosis (MS)

Posted 2 weeks ago in Clinical Trials

NEW YORK, Aug. 01, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX) announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), the Company's glycoengineered anti-CD20 monoclonal antibody, for the treatment of relapsing forms of Multiple Sclerosis...

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Diffusion Pharmaceuticals Selects Contract Research Organization for Phase 3 Clinical Trial of Lead Compound TSC for Inoperable GBM Brain Cancer

Posted 2 weeks ago in Clinical Trials

CHARLOTTESVILLE, Va., July 31, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals, Inc. (NASDAQ:DFFN), a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, announced today that it has selected a premier Clinical Research Organization (CRO) to conduct a Phase 3 clinical trial of Diffusion's lead molecule, trans sodium crocetinate (TSC), in...

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Soligenix Initiates Pivotal Phase 3 Clinical Trial of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Head and Neck Cancer Patients

Posted 3 weeks ago in Clinical Trials

PRINCETON, NJ – July 27, 2017 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 (dusquetide) as a tre...

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Tetraphase Announces Positive Top-line Results From Phase 3 IGNITE4 Clinical Trial In Complicated Intra-Abdominal Infections

Posted 3 weeks ago in Clinical Trials

WATERTOWN, Mass., July 25, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE4, the Company's phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous (IV) eravacycline compared...

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Neuralstem Announces Top-line Phase 2 Data of NSI-189 for Major Depressive Disorder

Posted 3 weeks ago in Clinical Trials

GERMANTOWN, Md., July 25, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced top-line results from its exploratory Phase 2 clinical trial examining the efficacy of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID) compared to placebo for the treatment of major depressive disorder (MDD). The study,...

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Biohaven Enrolls First Patient In Pivotal Phase 3 Clinical Trial of Oral Rimegepant for the Acute Treatment of Migraine

Posted 3 weeks ago in Clinical Trials

NEW HAVEN, Conn., July 24, 2017 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced enrollment in the first of its two registrational Phase 3 clinical trials to evaluate the safety and efficacy of orally-dosed rimegepant (BHV-3000) for the acute treatment of migraine. Biohaven expects to begin enrollment in the second Phase 3 clinical trial this summer and...

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Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15

Posted 3 weeks ago in Clinical Trials

Lyon (France), July 24, 2017 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15. Fast Track designation is granted by the FDA to products that are under development for...

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