RGLS Up After Hours, GLYC Has Some Good News, Panther On The Prowl

(RTTNews) - Cytori Therapeutics Inc.'s (CYTX) lead drug candidate ECCS-50 has been designated as an orphan medicinal product for the treatment of scleroderma by the European Commission.

The company is currently working with leading scleroderma centers in France led by the Assistance Publique des Hôpitaux de Marseille to begin a 40 patient EU pivotal trial called SCLERADEC-II. The trial is a follow-up controlled trial to the first SCLERADEC trial published last August If successful, this trial would potentially lead to EMA approval of ECCS-50 in the EU, as an ATMP or Advanced Therapy Medicinal Product.

In the U.S, the company plans to enroll patients in a phase 3 clinical trial of ECCS-50 in patients with scleroderma associated hand dysfunction this year.

CYTX closed Tuesday's trading at $1.35, up 2.27%.

GlycoMimetics Inc. (GLYC) may finally see a phase III clinical trial of Rivipansel being initiated by Pfizer Inc. (PFE) in mid-2015 as the clinical supply issue which has delayed the start of this trial has been discussed with the FDA.

Rivipansel for the treatment of vaso-occlusive crisis of sickle cell disease is being developed in partnership with Pfizer - with the pharma giant being responsible for ongoing clinical development of the compound.

The phase III trial of Rivipansel was supposed to have commenced before the end of 2014, but has been delayed due to a manufacturing development issue impacting formulated drug supply.

Under the terms of the license agreement between the two companies, Pfizer is scheduled to make a $20 million milestone payment to GlycoMimetics once the first patient is dosed in the phase III clinical trial. This milestone is the second of two scheduled milestone payments totaling $35 million upon initiation of the phase III clinical trial. Pfizer previously paid GlycoMimetics $15 million in May 2014.

GLYC closed Tuesday's trading at $8.26, down 0.06%.

Nanosphere Inc. (NSPH) has decided to implement a 20-to-1 reverse split of its common stock at 5:00 p.m. EDT on April 8, 2015. The reverse stock split will reduce the number of shares of Nanosphere's outstanding common stock from approximately 117.2 million to approximately 5.9 million.

NSPH closed Tuesday's trading 0.54% higher at $0.24.

Panther Biotechnology Inc. (PBYA.PK) is all set to acquire the pharmaceutical technology assets of privately held Faulk Pharmaceuticals Inc.

The transaction is expected to boost Panther's pipeline to include multiple new drug candidates in cancer and antiviral diseases. The lead development program that will come under Panther's fold is a ligand-drug conjugate, TRF-DOX. Panther plans to submit applications for a phase II study of TRF-DOX in ovarian cancer and a phase 1a / 1b study in lung cancer.

PBYA.PK closed Tuesday's trading 15.11% higher at $8.00.

Shares of Regulus Therapeutics Inc. (RGLS) were up more than 10% in extended trading on Tuesday after the company announced that its preclinical drug candidate RG-125 (AZD4076), a microRNA therapeutic for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has been selected for clinical development by AstraZeneca plc (AZN).

In August 2012, Regulus and AstraZeneca formed a strategic alliance to discover and develop microRNA therapeutics for cardiovascular diseases, metabolic diseases and oncology. RG-125 (AZD4076) is the first compound from the alliance to be selected for clinical development by AstraZeneca.

AstraZeneca has already paid $28.0 million to Regulus under the terms of the strategic alliance, and in connection with the candidate selection, AstraZeneca will pay Regulus $2.5 million and will assume development of the program following acceptance of an Investigational New Drug application. In addition to these payments, Regulus is eligible to receive up to $495.5 million in future milestone payments.

RGLS closed Tuesday's trading at $15.95, down 2.68%. In after-hours, the stock was up 10.66% at $17.65.