Biotech Stocks Facing FDA Decision In June 2020

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Menlo Therapeutics
Menlo Therapeutics

The FDA decision on Menlo Therapeutics Inc’s (MNLO) FMX103, proposed for the treatment of papulopustular rosacea, is expected on June 2, 2020.

Developed by Foamix Pharmaceuticals, FMX103 is topical 1.5% minocycline foam, came under Menlo’s fold when the former was acquired on March 9, 2020.

Papulopustular rosacea, a subtype of rosacea, is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin, and forehead.

Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States.

Oral antibiotics like Minocycline, Doxycycline, Erythromycin, Clarithromycin, and Clindamycin and topical agents like Metronidazole and Ivermectin are used to treat papulopustular rosacea.

Menlo needs a bit of good news at least on the regulatory front because on the clinical trial front, the Company has experienced only disappointment over the trial results of its itching drug Serlopitant since February of this year.

On February 26, Menlo announced that its phase II trial of Serlopitant in chronic itching (pruritus) failed to meet the key endpoints. Last month, the Company disclosed that the compound failed two late-stage studies in prurigo nodularis.

MNLO closed Friday’s (May 22, 2020) trading at $2.24, up 1.82%.