RPRX On Track Across The Pond, CERC Gets Funded, Data Gives FOMX A Facelift

(RTTNews) - Celgene Corp.'s (CELG) phase 1b study of oral GED-0301 has demonstrated endoscopic improvement and clinical response and remission at week 12 in patients with active Crohn's disease, according to interim topline data.

The trial, dubbed CD-001, is an ongoing study evaluating three different treatment regimens of GED-0301 in a 12-week treatment phase, followed by an observation phase up to 52 weeks (off treatment). The primary objective of the study is to explore the effect of GED-0301 on endoscopic outcomes. The trial enrolled a total of 63 patients across multiple countries.

CELG closed Monday's trading at $106.85, up 2.28%.

Cerecor Inc. (CERC) has entered into a $15 million common stock purchase agreement and a registration rights agreement with Aspire Capital Fund, LLC, a Chicago-based institutional investor.

Under the terms of the Agreement, Aspire has made an initial purchase of $1 million of Cerecor common stock at $4.00 per share, which represents a 4% premium over the September 8 closing stock price of $3.86. Aspire has committed to purchase the remaining $14 million if and when Cerecor decides to sell shares to Aspire.

CERC closed Monday's trading at $3.99, up 3.64%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has completed subject enrollment in its phase II clinical study of Resunab for the treatment of cystic fibrosis. The company expects to report top-line results from this study early in the first quarter of 2017.

Two other phase II studies of Resunab are underway - one in diffuse cutaneous systemic sclerosis and the other in skin-predominant dermatomyositis. Top-line data from the systemic sclerosis study is expected to be reported in the fourth quarter of 2016, and for dermatomyositis study in the second half of 2017.

CRBP closed Monday's trading at $5.40, up 3.85%.

CytRx Corp. (CYTR) is scheduled to report results from its on-going phase 1b/2 trial of Aldoxorubicin in combination with Ifosfamide/Mesna in patients with advanced sarcomas next month.

The results will be presented at the European Society for Medical Oncology (ESMO) 2016 Congress being held in Copenhagen, Denmark, from October 7-11, 2016.

The phase 1b/2 clinical trial has enrolled 38 patients to date with locally advanced, unresectable, and/or metastatic soft tissue sarcoma, intermediate-grade or high-grade chondrosarcoma or osteosarcoma. The primary endpoint of the study is safety, and secondary endpoints include overall response rates and progression-free survival.

CYTR closed Monday's trading at $0.59, up 2.90%.

Shares of Foamix Pharmaceuticals Ltd. (FOMX) rose over 15% on Monday, following positive topline results from its phase II trial evaluating FMX-103 topical Minocycline foam for moderate-to-severe papulopustular rosacea.

Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone.

Statistically significant differences were demonstrated for improvement in the primary and secondary efficacy endpoints (reduction in the number of inflammatory lesions - papules and pustules and improvement of Investigator Global Assessment score) for FMX103 compared with the vehicle-treated group.

FOMX closed Monday's trading at $10.17, up 15.70%.

Shares of Neuralstem Inc. (CUR) were up over 7% on Monday, following a $20 million strategic investment from Tianjin Pharmaceutical Holding Group.

Neuralstem intends to use the net proceeds from the offering for clinical research and development and general corporate purposes.

The company has completed phase 1a and 1b trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a phase II efficacy study for MDD.

CUR closed Monday's trading at $0.30, up 7.22%.

RespireRx Pharmaceuticals Inc.'s (RSPID.OB) phase IIa trial of CX1739 has demonstrated that the compound is safe and well tolerated, and that it antagonized the respiratory depressive effects of remifentanil, a potent opioid, in clinical models of acute opioid overdose and chronic opioid use.

The next step would be to determine the potential efficacy of CX1739 in the appropriate clinical indications, and future studies are being designed and planned by the company.

RSPID.OB closed Monday's trading at $5.75, down 10.16%.

Repros Therapeutics Inc. (RPRX) has submitted its marketing authorization for Enclomiphene in the treatment of secondary hypogonadism in Europe.

The regulatory decision will be known in 13-16 months from the date of submission and culminates in one authorization being obtained which is valid in all European Union and European Economic Area countries, i.e. 31 in total.

Enclomiphene was turned down by the FDA last December, with the company being asked to conduct an additional phase III study or studies to support approval.

RPRX closed Monday's trading at $2.06, up 1.98%.

Rexahn Pharmaceuticals Inc. (RNN) has initiated stage 2 of the phase Ib/IIa clinical trial with the novel oral anti-cancer agent RX-3117 in relapsed or refractory pancreatic cancer patients.

The FDA has assigned orphan drug status for RX-3117 for pancreatic cancer.

RNN closed Monday's trading at $0.26, up 4.78%.

Shares of Raptor Pharmaceuticals Corp. (RPTP) jumped over 20%, touching a new 52-week high, after the company agreed to be acquired by Horizon Pharma plc (HZNP) for $9.00 per share in cash, equivalent to approximately $800 million.

The acquisition brings in Raptor's PROCYSBI delayed-release capsules and QUINSAIR global rights to Horizon Pharma's portfolio. The deal is also said to diversify Horizon's revenue with 11 medicines across three business units: orphan, rheumatology and primary care.

PROCYSBI is approved in the United States for the treatment of nephropathic cystinosis while QUINSAIR is approved in the European Union and Canada for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

The transaction is expected to close in the fourth quarter of 2016.

RPTP closed Monday's trading at $8.98, up 20.54%.

TESARO Inc. (TSRO) has initiated a rolling submission of a New Drug Application for Niraparib in ovarian cancer to the FDA, and intends to complete this submission during the fourth quarter.

The Marketing Authorization Application for Niraparib is planned for submission to the European Medicines Agency in the fourth quarter.

TSRO closed Monday's trading at $93.19, up 1.74%.