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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.

Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer

Posted 13 days ago in Clinical Trials

WALTHAM, Mass., Jan. 10, 2018 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced a new clinical collaboration with Genentech, a member of the Roche Group. As part of the collaboration, the two companies will evaluate the combination of Syndax's...

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AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

Posted 2 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic...

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Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients

Posted 2 weeks ago in Clinical Trials

Cambridge, Mass. – January 4, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy. By targeting a...

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Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia

Posted 2 weeks ago in Clinical Trials

WESTON, Fla., January 3, 2018 -- Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to CX-01 for the treatment of acute myeloid leukemia (“AML”). CX-01 is an investigational agent...

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FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

Posted 4 weeks ago in Clinical Trials

December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing r...

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Rhizen Pharmaceuticals S.A. Receives FDA Orphan-Drug Designation for Tenalisib (RP6530) for Treatment of Peripheral T-Cell Lymphoma (PTCL)

Posted 4 weeks ago in Clinical Trials

La Chaux-de-Fonds, Switzerland, Dec. 22, 2017 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the active moiety of Tenalisib (RP6530), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of peripheral T-cell lymphoma (PTCL). “We are pleased to receive US FDA orp...

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AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

Posted 4 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis...

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Blueprint Medicines Announces New Data from Ongoing Phase 1 Clinical Trial of Avapritinib (BLU-285) in Patients with Advanced Systemic Mastocytosis Showing Evidence of Strong Clinical Activity

Posted 4 weeks ago in Clinical Trials

CAMBRIDGE, Mass., Dec. 10, 2017 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced new data from its ongoing Phase 1 clinical trial of avapritinib (formerly known as BLU-285), a potent and highly selective KIT and PDGFRα inhibitor in development for patients with advanced ...

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Asklepion Pharmaceuticals Announces Special Protocol Assessment (SPA) Agreement with FDA for Phase 3 Program of Intravenous Citrulline

Posted 5 weeks ago in Clinical Trials

BALTIMORE, Dec. 19, 2017 (GLOBE NEWSWIRE) — Asklepion Pharmaceuticals, LLC (“Asklepion” or “the Company”) announced 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 a pivotal Phase 3 trial for intravenous citrulline. This SPA provides agreement that the Phase 3 protocol design, notably clinical endpoints, trial population ...

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Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy

Posted 5 weeks ago in Clinical Trials

BOSTON – December 18, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy (LHON). “We are pleased with the FDA’s decision to gran...

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Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Posted 5 weeks ago in Clinical Trials

London: Friday, December 15, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of co...

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FDA Grants Fast Track Designation to Renova Therapeutics’ RT-100 AC6 Gene Transfer for the Treatment of Heart Failure

Posted 5 weeks ago in Clinical Trials

San Diego, CA - December 14, 2017 – Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead product candidate, RT-100 AC6 gene transfer (Ad5.hAC6), for the treatment of heart failure with reduced ejection fraction (HFrE...

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Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer

Posted 5 weeks ago in Clinical Trials

December 8, 2017 -- Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 EMBRACA trial in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC) demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy. Median PFS was 8.6 months (95% C...

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Sanofi and Regeneron Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma

Posted 5 weeks ago in Clinical Trials

Paris, France & Tarrytown, N.Y. – December 13, 2017 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), the second deadliest skin cancer after melanoma.i ii, Cemiplimab, an investigational human antibody targeting PD-1 (programmed cell death pro...

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Loxo Oncology Announces Updated Larotrectinib Pediatric Clinical Trial Data Demonstrating Continued Durability of Response in TRK Fusion Cancers

Posted 6 weeks ago in Clinical Trials

STAMFORD, Conn., Dec. 04, 2017 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced updated clinical data from the larotrectinib pediatric Phase 1 SCOUT clinical trial. These data are being presented today at the American Association for Cancer Research (AACR) Special...

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TapImmune Announces Enrollment of First Patient in Phase 2 Clinical Trial for Treating Triple-Negative Breast Cancer Funded by U.S. Department of Defense

Posted 6 weeks ago in Clinical Trials

JACKSONVILLE, Florida, December 12, 2017 / TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that the first patient has been enrolled in a Phase 2 randomized, multi-center, double-blinded, placebo-controlled clinical trial of TapImmune’s novel therapeutic vaccine candidate TPIV200. The 280-patient trial, s...

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Clementia Initiates Pivotal Phase 3 MOVE Trial for Palovarotene in Patients with Fibrodysplasia Ossificans Progressiva

Posted 6 weeks ago in Clinical Trials

MONTREAL, Dec. 12, 2017 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (NASDAQ:CMTA), a clinical-stage biopharmaceutical company innovating new treatments for people with ultra-rare bone disorders and other diseases, today announced the start of the MOVE Trial, its Phase 3 registration study evaluating the safety and efficacy of palovarotene for the treatment of patients with fibrodysplasia ossificans...

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Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Posted 6 weeks ago in Clinical Trials

ATLANTA--(BUSINESS WIRE)--Dec. 11, 2017-- Kite, a Gilead Company (Nasdaq: GILD), announced updated results from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy, which is investigational for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). With a minimum of eight weeks of follow-up, 71 percent of ALL patients...

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Novartis Drug Crizanlizumab Shown to Prolong Time to Patients' First Sickle Cell Pain Crisis in Subgroup Analysis of SUSTAIN Study

Posted 6 weeks ago in Clinical Trials

Basel, December 11, 2017 - Results from a post hoc subgroup analysis of the Phase II SUSTAIN study show that crizanlizumab, an investigational humanized anti-P-selectin monoclonal antibody, delayed the time to first sickle cell pain crisis (SCPC) in patients vs. placebo in key subgroups of adult patients with sickle cell disease[1]. Findings were featured during an oral session at the 59th American Society of...

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Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma

Posted 6 weeks ago in Clinical Trials

South San Francisco, CA -- December 10, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the randomized Phase II GO29365 study that compared polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) against BR alone in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for ...

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