Menlo Therapeutics Inc (NASDAQ:MNLO) Reports Positive Data From Phase 2 Clinical Study Of FCD 105 To Treat Moderate To Severe Acne Vulgaris

Menlo Therapeutics Inc (NASDAQ:MNLO) achieved a breakthrough to cure moderate to severe acne vulgaris. It is evident from positive data reported in Phase 2 clinical study of FCD105.

Going forward, the company expects to reap rich dividends by offering the best in class treatment for people suffering from acne. Menlo strengthened its balance sheet with equity offering recently.

Maintains leadership in dermatology

CEO of Menlo, Dave Domzalski, said the company strengthened its leadership in the dermatology space with the recent approval of ZILXI by the US FDA. In early 2020, Menlo unveiled AMZEEQ, which is used to treat moderate to severe acne in pediatric patients aged nine years and above and adults.

David said AMZEEQ, which is developed by Menlo using its MST (Molecule Stabilizing Technology) platform, accounts for 60% of the commercial lives in the US. Millions of people suffering from acne will get access to this innovative medicine for better treatment.


Topical foam – minocycline – ZILXI received the FDA’s approval to treat inflammatory lesions caused by rosacea in adults. Menlo will commercialize ZILXI in Q4 2020. Also, FCD105 demonstrated a significant improvement in Phase 2 clinical study to treat acne.

The company will present clinical data obtained from the Phase 2 trial of FCD105 to the FDA along with the planned Phase 3 program by the end of this year.

Menlo also entered a pact with a China-based Cutia Therapeutics affiliate to sell its products – FCD105, ZILXI, and AMZEEQ in Greater China on receiving the approval. The company mobilized funds of $54 million through a public placement of its shares.

Menlo recorded total revenues of $11.7 million in Q2 2020. AMZEEQ, which is introduced in January 2020, contributed revenues of $1.5 million in Q2 2020. The company generated funds of $10 million as upfront payment by signing a license agreement with an affiliate of Cutia. It also received $0.2 million as royalty revenue from Finacea. The company resumed sales of this innovative formulation in the US.

Spending on R&D

Menlo’s spending on R&D is surged by 4% to $13.1 million in Q2 2020. The manufacturing and clinical expenses associated with serlopitant rose by $4.1 million.