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Intercept Pharmaceuticals, Inc. (ICPT) announced that REVERSE, a phase 3 study evaluating the safety and efficacy of Obeticholic Acid in patients with compensated cirrhosis due to nonalcoholic steatohepatitis or NASH, did not meet its primary endpoint. REVERSE is one of the company's two phase 3 studies...

Gamida Cell Ltd. (GMDA) reported long term follow-up data and health-related quality of life scores of patients treated with omidubicel in patients with blood cancers. The data showed an overall survival and disease-free survival of 63% and 56% at three years, respectively, as well as durable long-term...

Axcella Therapeutics (AXLA) reported interim results from the ongoing global phase 2b randomized, double-blind, placebo-controlled, dose ranging EMMPACT study to evaluate the safety, tolerability, and efficacy of AXA1125 for the treatment of Nonalcoholic Steatohepatitis or NASH. At 24-weeks, the study...

Avidity Biosciences, Inc. (RNA) announced the FDA has placed a partial clinical hold on new participant enrollment in the phase 1/2 MARINA clinical trial of AOC 1001 in adults with myotonic dystrophy type 1. The partial clinical hold is in response to a serious adverse event reported in a single participant...

Ocular Therapeutix Inc. (OCUL), a biopharmaceutical company focused on eye diseases, announced Tuesday positive interim results from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration...

Artivion, Inc. (AORT), a cardiac and vascular surgery company focused on aortic disease, announced Friday that it has stopped the PROACT Xa clinical trial following recommendation of the independent Data and Safety Monitoring Board or DSMB. The study was evaluating the use of apixaban in patients treated...

DBV Technologies' (DBVT) phase III study of modified Viaskin Peanut 250 µg patch, dubbed VITESSE, has been slapped with a partial clinical hold by the FDA.

Pacira BioSciences, Inc. (PCRX) announced Wednesday positive topline results from its Phase 3 study of EXPAREL as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy. EXPAREL achieved the study's primary endpoint by demonstrating...

MyMD Pharmaceuticals, Inc. (MYMD) announced a dosing update on phase 2 clinical trial of MYMD-1, an orally available next-generation TNF-alpha inhibitor, as a therapy for chronic inflammation associated with sarcopenia and frailty. The company stated that, to date, the trial has completed dosing for...

Merck (MRK) said it will initiate a phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. The new phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir. The FDA has reviewed and agreed with the company's...

Immunic, Inc. (IMUX) reported positive unblinded safety, tolerability and pharmacokinetic results from single and multiple ascending dose parts of phase 1 trial of IMU-856 in healthy human subjects. IMU-856 is a small molecule modulator targeting restoration of intestinal barrier function and regeneration...

Shares of Synairgen plc (SNG.L) were gaining more than 5 percent in the morning trading in London after the respiratory company developing SNG001 reported positive findings from the analysis of data from 60 and 90-day follow-up visits from the Phase 3 SPRINTER trial in patients hospitalised with COVID-19. SNG001...

Seagen Inc. (SGEN) said FDA has accepted for Priority Review the supplemental New Drug Application seeking accelerated approval for TUKYSA in combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable...

Virios Therapeutics, Inc. (VIRI), a development-stage biotechnology company focused on chronic diseases, including fibromyalgia or FM, Monday said topline results from its Phase 2b Study of oral IMC-1 for the treatment of FM failed to meet primary efficacy endpoint. In pre market activity on Nasdaq,...

Trevi Therapeutics, Inc. (TRVI) reported positive results from the full set of subjects in phase 2 Cough And NALbuphine trial of Haduvio for the treatment of chronic cough in idiopathic pulmonary fibrosis. The company said the data was statistically significant for the primary efficacy endpoint of daytime...

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