MSTX Study Crosses Halfway Mark, VASC Blooms, ALL Is Well With PFE

(RTTNews) - ERBA Diagnostics Inc. (ERB) has been notified that it is not in compliance with NYSE MKT continued listing standards for failing to timely file its Annual Report on Form 10-K for the year ended December 31, 2014 with the SEC.

The company must, by May 1, 2015, submit a plan of compliance addressing how it intends to regain compliance.

ERB closed Tuesday's trading at $3.34, down 3.16%.

Juno Therapeutics Inc.'s (JUNO) phase I study evaluating JCAR017 in pediatric patients with relapsed/refractory acute lymphoblastic leukemia has demonstrated encouraging results - with 91% of patients achieving a complete remission as documented by flow cytometry.

Based on the positive results, the company intends to begin testing of JCAR017 in adult patients with B cell malignancies, including non-Hodgkin lymphoma, later this year.

Juno Therapeutics went public as recently as December 19, 2014, priced at $24 per share. The stock closed Tuesday's trading at $56.40, up 0.89%.

Loxo Oncology Inc. (LOXO) is all set to begin a phase 1b study of LOXO-101, examining proof of concept exclusively in patients with NTRK alterations, in the second half of 2015. The alterations in the NTRK genes are said to drive tumor growth.

The ongoing phase 1a dose escalation study of LOXO-101 in patients with advanced solid tumors has demonstrated encouraging initial results that support the therapeutic potential of this compound.

Loxo Oncology went public on August 1, 2014 priced at $13.00 per share. The stock closed Tuesday's trading 1.50% higher at $13.22.

Mast Therapeutics Inc. (MSTX) has surpassed the halfway point in its pivotal study of its lead product candidate, Vepoloxamer (MST-188), in sickle cell disease.

The study, dubbed EPIC, is designed to enroll a total of 388 patients, ages four to 65, and 205 patients have been randomized so far. The company anticipates reporting top-line results from this trial in the first quarter of 2016.

MSTX closed Tuesday's trading at $0.49, up 0.24%.

Pfizer Inc.'s (PFE) phase III study of its investigational antibody-drug conjugate Inotuzumab Ozogamicin in adult patients with relapsed or refractory Acute Lymphoblastic Leukemia, or ALL, has met the primary endpoints.

In the study, dubbed INO-VATE ALL, Inotuzumab ozogamicin was compared with a defined set of chemotherapy choices in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia. The primary endpoints of the study were complete hematologic remission rate and overall survival.

PFE closed Tuesday's trading at $34.89, down 0.34%.

Sanofi's (SNY)subsidiary Genzyme has initiated a phase 2a clinical trial of GZ/SAR402671, a new oral substrate reduction therapy, for the treatment of Fabry disease. The company plans to enroll nine treatment-naïve male adult patients with Fabry disease in this international, multicenter study.

Fabry disease is a rare lysosomal storage disorder that results in abnormal tissue deposits of a particular fatty substance (called globotriaosylceramide, also referred to as GL-3 or Gb3) throughout the body.

The company already has an approved drug for Fabry disease called Fabrazyme, a version of the human form of the natural enzyme produced by recombinant DNA technology, which is given intravenously. Fabrazyme generated sales of €460 million in 2014, reflecting a growth of 23% over the prior year.

SNY closed Tuesday's trading at $51.56, up 0.37%.

Vascular Solutions Inc. (VASC) was up more than 6% in after-hours trading on Tuesday following better-than-expected first quarter results and rosy outlook for 2015.

On an adjusted basis, non-GAAP operating earnings for the first quarter ended March 31, 2015 were $5.86 million or $0.21 per share on total revenue of $34.61 million. This compares with adjusted non-GAAP operating earnings of $4.88 million or $0.18 per share and revenue of $29.91 million in the comparable quarter. Analysts polled by Thomson Reuters were looking for earnings of $0.18 per share and revenue of $33.38 million.

Looking ahead to full year of 2015, Vascular Solutions has raised its adjusted earnings guidance to a range of $0.93-$0.97 per share from its prior outlook range of $0.88-$0.92. The company has also boosted its net revenue outlook for the year to a range of $140 million to $144 million from its previous forecast range of $139 million to $143 million.The analysts' consensus estimates for EPS is $0.89 and that of revenue is $139.80 million for 2015.

VASC closed Tuesday's trading at $29.24, down 0.75%. In after hours, the stock was up 6.87% at $31.25.