FDA Nod For TSRO, Déjà Vu For ARQL, FOMX Plunges On Trial Data, SELB Abuzz

Allergan plc (AGN) and Paratek Pharmaceuticals Inc. (PRTK) announced positive results from two phase III trials of Sarecycline for the treatment of moderate to severe acne.

The trials, SC1401 and SC1402, have met their 12 week primary efficacy endpoints.

Based on the encouraging data, Allergan plans to file a New Drug Application to the FDA in the second half of this year.

Paratek has licensed rights to Sarecycline for the treatment of acne in the United States to Allergan, while retaining rights in the rest of the world.

PRTK closed Monday’s trading at $17.30, up 9.15%.

It seems like it is deja vu for ArQule Inc.’s (ARQL) hepatocellular carcinoma candidate Tivantinib.

A phase III trial of Tivantinib in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma, dubbed JET-HCC, did not meet its primary endpoint of progression free survival, said ArQule’s co-development partner, Kyowa Hakko Kirin.

In February of this year, ArQule and Daiichi Sankyo announced that a phase III study of Tivantinib in hepatocellular carcinoma, dubbed METIV-HCC, did not meet its primary endpoint of improving overall survival.

ArQule has a licensing, co-development and co-commercialization agreement with Daiichi Sankyo for Tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea, and Taiwan where ArQule is partnered with Kyowa Hakko Kirin.

ARQL closed Monday’s trading at $1.10, down 4.35%.

Cellceutix Corp. (CTIX.OB) has reported encouraging results from its ongoing phase II study of Brilacidin in the prevention and control of Oral Mucositis in patients receiving chemoradiation for treatment of Head and Neck Cancer.

In a preliminary interim analysis, a marked reduction in incidence of Severe OM was observed in patients treated with Brilacidin who received at least 55 Gy cumulative units of radiation, noted the company.

The trial is expected to be completed before this year-end.

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