Harmony BioSciences, LLC
Approach: histamine 3 receptor antagonist/inverse agonist
Status: FDA approved for excessive daytime sleepiness. The company is running a Phase 2 trial in myotonic dystrophy patients.
July 27, 2020 S-1 statement for IPO: "We are now planning to include both patients with DM1 and patients with DM2 in our trial, subject to feedback from the FDA and receiving authorization to proceed under an IND, which we plan on submitting in the second half of 2020."
Aug. 15, 2019 Press Release announcing FDA approval of WAKIX
Aug. 15, 2019 Article discussing Harmony's intent to test WAKIX in myotonic dystrophy patients
July 27, 2020 S1 filed in conjunction with IPO
Sept. 2020 Presentation at Myotonic Dystrophy Foundation annual conference (starts at 19:30)
June 29, 2021 Press Release on Phase 2 trial.