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.
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Vaxart Announces Initiation of Bivalent Norovirus Vaccine Phase 1b Clinical Trial
Posted yesterday in Clinical Trials
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Mar. 19, 2019-- Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced the initiation of a Phase 1b bivalent norovirus vaccine clinical trial. “The initiation of the bivalent norovirus vaccine Phase 1b trial marks a significant step towards our goal of developing ... Read more...
Data From GARNET Study Indicates Robust Activity of Dostarlimab in Patients with Advanced or Recurrent Endometrial Cancer
Posted yesterday in Clinical Trials
London UK - 19 March 2019 -- TESARO, an oncology-focused business acquired by GlaxoSmithKline plc (LSE/NYSE: GSK), announced today the presentation of data from the Phase 1/2 GARNET study evaluating dostarlimab in women with recurrent or advanced endometrial cancer who progressed on or after a platinum-based regimen. These data were presented at the 2019 Society for Gynecologic Oncology (SGO) Annual Meeting on... Read more...
Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder
Posted yesterday in Clinical Trials
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Mar. 19, 2019-- Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced positive topline results from EMPOWUR, an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of... Read more...
Biohaven Enrolls First Patient In Phase 3 Spinocerebellar Ataxia Clinical Trial Of Troriluzole
Posted 6 days ago in Clinical Trials
NEW HAVEN, Conn., March 14, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that it has enrolled the first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in Spinocerebellar... Read more...
Atossa Genetics Announces FDA Approval of Oral Endoxifen for "Expanded Access" as Post-Mastectomy Treatment for a U.S. Breast Cancer Patient
Posted 7 days ago in Clinical Trials
SEATTLE, March 14, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that the FDA has issued a "Safe to Proceed" letter under their "expanded access" program permitting the use of Atossa's oral Endoxifen as a post-mastectomy treatment in a... Read more...
Esperion Announces Publication of Bempedoic Acid Study 1 Results in The New England Journal of Medicine
Posted 7 days ago in Clinical Trials
ANN ARBOR, Mich., March 13, 2019 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced that results from the 2,230 patient, 52-week, Phase 3 long-term safety study of bempedoic acid (CLEAR Harmony, also known as Study 1 or 1002-040) were published today in The New England Journal of Medicine (NEJM). Bempedoic acid is being developed as a complementary, cost-effective, convenient, once-daily, oral therapy for the... Read more...
DermBiont Begins Phase 2 Clinical Trial for Athlete's Foot with a Live Bacterial Topical Probiotic
Posted 7 days ago in Clinical Trials
BOSTON, March 13, 2019 /PRNewswire-PRWeb/ -- DermBiont, an early stage biopharmaceutical company dedicated to the discovery and development of live bacterial products for the treatment of skin diseases has initiated a clinical trial with its lead bacterial therapeutic DBI-001 for the treatment of athlete's foot (T. pedis). The trial will evaluate the safety and tolerability as well as microbiologic and clinical... Read more...
Moleculin Files with FDA for Expedited Approval Pathway for Annamycin
Posted 7 days ago in Clinical Trials
HOUSTON, TX / ACCESSWIRE / March 13, 2019 / Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or... Read more...
Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant
Posted 7 days ago in Clinical Trials
NEW HAVEN, Conn., March 13, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the Company concluded its pre-New Drug Application ("NDA") meetings with the U.S. Food and Drug... Read more...
Theravance Biopharma Announces First Patient Dosed in Phase 2b/3 Study of TD-1473 in Patients with Ulcerative Colitis
Posted 9 days ago in Clinical Trials
DUBLIN, March 12, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced dosing of the first patient in a Phase 2b/3 study of TD-1473 in patients with moderately to severely active ulcerative colitis. TD-1473 is a novel, orally administered and gut-selective pan-Janus kinase (JAK) inhibitor in clinical development as a treatment for multiple... Read more...
Trevena Announces Publication of APOLLO-1 Results in The Journal of Pain Research Highlighting Oliceridine’s Potential for Management of Moderate-to-Severe Acute Pain
Posted 9 days ago in Clinical Trials
March 11, 2019 -- Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of innovative treatment options that target and treat diseases affecting the central nervous system, or CNS, today announced publication of APOLLO-1 (Phase 3) results in The Journal of Pain Research on the effects of oliceridine (TRV130) for management of moderate-to-severe acute pain... Read more...
Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies
Posted 2 weeks ago in Clinical Trials
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 7, 2019-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced findings from two studies that support the further development of GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function, for potential future use as part of long-acting HIV combination therapy. Interim blinded data from a Phase 1 study in healthy trial participants demonstrated that... Read more...
Marinus Pharmaceuticals Initiates Phase 3 Study in Children with PCDH19-Related Epilepsy
Posted 2 weeks ago in Clinical Trials
RADNOR, Pa., March 06, 2019 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) (“Marinus” or “Company”), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that it is initiating a single global pivotal Phase 3 clinical study (Violet Study) evaluating oral ganaxolone in children with PCDH19-related epilepsy ... Read more...
The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI
Posted 2 weeks ago in Clinical Trials
Daix (France), March 05, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation (RPDD) to odiparcil, the Company’s product candidate in dev... Read more...
Phase 2 Clinical Trial of Bermekimab Shows Potential New Standard of Care for Treatment of Hidradenitis Suppurativa, Including Significant Pain Reduction without Antibiotics
Posted 2 weeks ago in Clinical Trials
AUSTIN, Texas, March 05, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) today released findings for its Phase 2 clinical study for bermekimab presented at the American Academy of Dermatology’s annual meeting which concluded today. Held at the Walter E. Washington Convention Center in Washington, D.C., the presentation titled, “Bermekimab Shows Efficacy for Treating Hidradenitis Suppurativa (HS), Including Marked Re... Read more...
Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study
Posted 2 weeks ago in Clinical Trials
Brussels, Belgium – 2 March 2019 – UCB, a global biopharmaceutical company, presented positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. The results are the longest-term data so far inv... Read more...
First Human Study of "Robotic" RaniPill™ Capsule to Replace Injections Announced by Rani Therapeutics
Posted 2 weeks ago in Clinical Trials
SAN JOSE, Calif., Feb. 28, 2019 /PRNewswire/ -- The first human study of a pill designed to replace injections of biologics is today being announced by Rani Therapeutics, the inventor of the RaniPill™ capsule. The human study follows more than 100 animal studies testing the RaniPill capsule's delivery of drugs such as insulin and Humira into the wall of the small intestine, where Rani has demonstrated 100% e... Read more...
Zosano Announces Completion of the Final Milestone in the Long-Term Safety Study of Qtrypta for the Acute Treatment of Migraine Disease
Posted 3 weeks ago in Clinical Trials
FREMONT, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the completion of the second and final goal of the long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period. The long-term data generated in this trial reinforced the well-tolerated safety profile and strong efficacy... Read more...
Biohaven Enrolls First Patient In Phase 3 Generalized Anxiety Disorder (GAD) Trial Of Troriluzole
Posted 4 weeks ago in Clinical Trials
NEW HAVEN, Conn., Feb. 20, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neuropsychiatric diseases, today announced that it has enrolled its first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in generalized anxiety disorder... Read more...
Immunomedics Announces Publication of Triple-Negative Breast Cancer Data With Sacituzumab Govitecan in the New England Journal of Medicine
Posted 4 weeks ago in Clinical Trials
MORRIS PLAINS, N.J., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that updated data from the Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC) were published on NEJM.org as part of the February 21 print issu... Read more...
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