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

(RTTNews) - 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.

Commenting on the interim results, Arthur Bertolino, President and Chief Medical Officer at Cellceutix said, "These interim results suggest the potential for an even greater effective therapeutic response as formulation and dosing is further optimized. There currently is no existing preventative treatment available for OM patients in this population, with only limited therapies focusing on symptom relief. The use of Brilacidin to prevent the onset of OM could even lead to an entirely new standard of care in this area as we strive to bring this drug to market."

CTIX.OB closed Monday's trading at $0.98, up 3.46%.

Eagle Pharmaceuticals' (EGRX) New Drug Application for Ryanodex, submitted under 505(b)(2) regulatory pathway, for the treatment of exertional heat stroke (EHS) has been accepted for filing and granted a priority review designation by the FDA - with a decision date set for July 23, 2017.

EGRX closed Monday's trading at $82.92, up 3.81%.

Shares of Foamix Pharmaceuticals Ltd. (FOMX) plunged more than 41% on Monday after the company reported that only one of the two phase III clinical trials investigating FMX101 in patients with moderate-to-severe acne, dubbed Trial 05, showed significance in both primary endpoints.

The two co-primary endpoints were the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients achieving success at week 12, as defined by an IGA score of "clear" or "almost clear" and at least a two-grade improvement from baseline at week 12.

The other phase III trial, known as Trial 04, did not meet significance for the IGA score endpoint.

FOMX closed Monday's trading at $5.30, down 41.76%.

Neurotrope Inc.'s (NTRP.OB) application to list its common stock on the NASDAQ Capital Market has been approved by The NASDAQ Stock Market.

The Company's common stock is expected to begin trading on the NASDAQ Capital Market at the opening of trading on March 29, 2017 under the ticker symbol "NTRP".

The company's lead candidate is Bryostatin-1, under Phase 2 clinical trial, for the treatment of moderate to severe Alzheimer's dementia. Topline data from this trial are expected next month.

Selecta Biosciences Inc.'s (SELB) new data from its ongoing phase II study of SEL-212 shows persistent clinical activity after repeat administration in symptomatic gout patients.

The company noted that as of March 23, 2017, a total of 38 patients had been dosed in the phase II study of SEL-212 at 10 active U.S. clinical sites. In the ongoing phase II study, patients are being enrolled in multiple ascending dose cohorts to identify the optimal dose ratio of SVP-Rapamycin and pegsiticase, the minimal effective dose level of SEL-212 for repeat monthly administration, and the dose regimen to take forward into Phase 3.

The recruitment for two higher dose cohorts of patients began in March 2017, and the company plans to present initial data from this trial at a medical meeting by the end of June 2017.

SELB closed Monday's trading at $11.92, down 1.00%. In after-hours, the stock was up 16.28% to $13.86.

Sophiris Bio Inc.'s (SPHS) phase II open-label study of Topsalysin for localized prostate cancer is underway. The Company expects to receive the six-month biopsy data for all patients in the trial in late 2017 or early 2018.

The final biopsy data on all patients who receive a second dose are expected by the third quarter of 2018.

SPHS closed Monday's trading at $2.84, down 1.05%.

The FDA has approved TESARO Inc.'s (TSRO) ZEJULA for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. The drug is expected to be launched in the U.S. in late April.

The FDA decision on ZEJULA, previously known as niraparib, was originally slated for June 30, 2017.

ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing, noted the company.

AstraZeneca's Lynparza and Clovis Oncology's Rubraca are the other approved drugs to treat advanced ovarian cancer. But these two drugs require patients to undergo testing for a BRCA mutation before they can receive it.

TSRO closed Monday's trading at $156.56, down 2.15%. In after-hours, the stock was up 5.91% to $166.00.