BRIDGEWATER, N.J., June 05, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (“Menlo”) (Nasdaq: MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced the pricing of an underwritten public offering of 27,050,000 shares of common stock at a price to the public of $1.85 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $50,042,500, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares of common stock to be sold in the offering will be offered by Menlo. In addition, Menlo has granted the underwriters a 30-day option to purchase up to an additional 4,057,500 shares of its common stock. The offering is expected to close on June 9, 2020, subject to customary closing conditions.
BRIDGEWATER, N.J., June 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year.
BRIDGEWATER, N.J., April 23, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics (HK) Limited, an affiliate of Cutia Therapeutics (“Cutia”) for AMZEEQ™ (minocycline) topical foam, 4% as well as its other topical minocycline product candidates, once approved, on an exclusive basis in Greater China.
Shares in Menlo Therapeutics had dropped nearly 50% in pre-market trading as investors shrank back on news of a Phase III failure of serlopitant.
Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.
Using bioluminescent protein to map tooth decay, Calcivis nets FDA blessing
Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage biopharmaceutical company, today announced results from its Phase 2 clinical trial evaluating the safety and efficacy of once daily oral serlopitant for the treatment of chronic pruritus (itch) of unknown origin (CPUO). The trial, which included 233 patients, did not meet its primary endpoint to show a statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. In the trial, 37.9% of patients in the serlopitant group (N=116) achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10 compared to baseline (primary efficacy endpoint) versus 39.3% of patients treated with placebo (N=117). There were no meaningful differences observed between the serlopitant and placebo groups in the prospectively-defined secondary endpoints.