Avolynt Announces Approval for Remogliflozin in Combination With Metformin for Type 2 Diabetes in India

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Avolynt Announces First Marketing Authorization and Commercial Launch of Novel SGLT2 Inhibitor Remogliflozin Etabonate for Type 2 Diabetes

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Avolynt Subsidiary BHV Awarded Over $46 Million in Judgments in Civil Claims against Islet Sciences, Inc. and John F. Steel IV

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Avolynt Subsidiary Brighthaven Ventures LLC Announces Dismissal of Lawsuit on Motion For Summary Judgement

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Avolynt Announces Initiation of Phase 3 to Evaluate Remogliflozin in Patients with Type 2 Diabetes

A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-center, Active-controlled Study to Evaluate Efficacy and Safety of Remogliflozin Etabonate in Subjects With Type-2 Diabetes Mellitus

Avolynt Announces Positive Topline Data for Phase 2b BRID Study of SGLT2 Remogliflozin

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Avolynt To Present at AASLD’s The Liver Meeting 2016

Avolynt Chief Scientific Officer, William Wilkison, Ph.D. will present the poster titled, “Remogliflozin Etabonate Reduces FIB-4 and NAFLD Fibrosis Scores in Type 2 Diabetic Subjects" on Saturday November 12, 2016 during the session titled “Steatohepatitis: Clinical and Therapeutic.”

FDA Acceptance of IND to Commence Pivotal Trial of Remogliflozin for NASH

Avolynt, Inc. to Initiate Pivotal REIN Study for NASH

Avolynt Announces Completion of Phase 2b BRID Study of SGLT2 Inhibitor Remogliflozin-Etabonate

Avolynt Announces Completion of Phase 2b BRID Study of SGLT2 Inhibitor Remogliflozin-Etabonate. Top-line results to be available in the fourth quarter of 2016

Phase 2b BRID Study Fully Enrolled

Avloynt's successfully completed enrollement of 191 patients in its 12-week phase 2b study of biphasic remogliflozin-etabonate in subjects with type 2 diabetes. Top-line results are expected later in 2016.

Avolynt, Inc. Completes Acquisition of BHV Pharma

Avolynt successfully completed the acqusition of BHV Pharma. 

Biphasic Patent Issued in European Union

Patent for combination immediate/delayed release delivery system for short half-life pharmaceuticals including remogliflozin issued in the Europoean Union. 

Avolynt Submits IND for NASH to FDA

On March 9, 2016, Avolynt submitted an IND to the GI division of the FDA in support of its program in NASH.

Avolynt Meets with GI Division of FDA for NASH Indication

On September 2nd 2015 Avolynt met with the FDA for a pre-IND meeting to discuss an IND submission for NASH. 

First Patient Randomized in Phase 2b BRID Study

Avolynt successfully randomized first subject into its phase 2b study in type 2 diabetics. The study is a U.S. based twelve-week multi-site, randomized, double blind, placebo controlled study of 191 subjects with type 2 diabetes. Top-line data is expected in 2016.