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Biotech Stocks Facing FDA Decision In August 2020

Bausch Health
Bausch Health

The FDA decision on EM-100, an over-the-counter preservative-free formulation of ketotifen ophthalmic solution, proposed for the treatment of ocular itching associated with allergic conjunctivitis is expected on August 10, 2020.

Developed by Eton Pharmaceuticals Inc. (ETON), EM-100 was out-licensed to Bausch Health Companies Inc. (BHC) in 2019.

This is EM-100’s second go-around with the FDA. The eye drop was denied regulatory approval in July 2019.

BHC closed Friday’s (Jul.24, 2020) trading at $17.05, up 0.18%.