Odyssey Hits The Mark, SPHS Awaits Data In Q2, TEVA Breathes Easy

(RTTNews) - Aclaris Therapeutics Inc. (ACRS) is one stock to watch out for this year as the company has a couple of catalysts coming its way.

The company expects to report phase III results for A-101 Topical Solution for the treatment of seborrheic keratosis in the third quarter of this year and, if the data is positive, an NDA will be submitted the following quarter.

A phase II trial of A-101 Topical Solution for the treatment of common warts is underway, and results from this trial are anticipated in the third quarter of this year.

ACRS closed Wednesday's trading at $15.00, down 2.41%.

BioLineRx Ltd. (BLRX) has initiated a phase II trial for BL-8040 as a novel approach for the mobilization and collection of bone marrow stem cells from the peripheral blood circulation.

The trial will enroll up to 24 donor/recipient pairs, aged 18-70, and will evaluate the ability of BL-8040, as a single agent, to promote stem cell mobilization for allogeneic transplantation.

The company expects partial results from the trial by the end of 2016 and topline results by the end of 2017.

BLRX closed Wednesday's trading at $1.15, down 2.54%.

Lannett Co. Inc. (LCI) has lowered its sales forecast for fiscal 2016 on account of the softness being experienced in the generic drug market and anticipated temporary delay of its product launches.

Consequently, the company now expects net sales for fiscal 2016 to be in the range of $555 million to $565 million, down from its prior outlook of $585 million to $595 million. The company now sees adjusted gross margin to range between 60.5% and 61.5% compared to its prior forecast of 62% to 63%.

LCI closed Wednesday's trading at $20.36, up 0.15%.

Otonomy Inc. (OTIC) has initiated patient enrollment in its phase III clinical trial of OTO-104 in Ménière's disease patients, dubbed AVERTS-2, in the European Union. A phase III clinical trial of OTO-104 in Ménière's disease patients in the U.S. is ongoing, and it is named AVERTS-1.

The company expects results from the two identical trials to be available in the second half of 2017.

OTIC closed Wednesday's trading at $14.29, down 5.86%.

The European Medicines Agency has accepted for review Pfizer Inc.'s (PFE) Marketing Authorization Application for XELJANZ for the treatment of patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

XELJANZ is already approved in more than 45 countries around the world for the treatment of moderate to severe rheumatoid arthritis as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs. In the U.S., it was approved in 2012. Last year, XELJANZ recorded sales of $523 million.

PFE closed Wednesday's trading at $30.19, down 0.63%.

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) phase III trial of cholesterol-lowering treatment Praluent in patients undergoing LDL *apheresis therapy has met the primary endpoint.

(*Apheresis is a procedure where bad (LDL) cholesterol is removed from the blood, in a process similar to kidney dialysis).

In the trial, dubbed ODYSSEY ESCAPE, when patients whose cholesterol levels required chronic, weekly or bi-weekly *apheresis therapy added Praluent to their existing treatment regimen, the frequency of their apheresis therapy was significantly reduced by 75 percent, compared to placebo. Sixty-three percent of patients treated with Praluent no longer required apheresis, compared to zero percent of placebo patients.

Praluent, a PCSK9 inhibitor monoclonal antibody, was approved by the FDA for the treatment of heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol, last July. The net sales of Praluent were $11 million in 2015. This drug is caught up in a patent fight with Amgen Inc. (AMGN).

Amgen sued Sanofi and Regeneron in October 2014 charging that Praluent violated patents on Amgen's cholesterol reducing drug Repatha. Last week, a Delaware jury delivered a verdict in Amgen's favor. What comes next in the near future is a hearing by a judge to consider a permanent injunction.

However, Sanofi and Regeneron disagree with the jury verdict and plan to appeal the judgment.

REGN closed Wednesday's trading at $365.38, down 3.42%.

Sophiris Bio Inc. (SPHS), which reported encouraging preliminary data from its phase 2a proof of concept study of Topsalysin in localized prostate cancer early this year, expects final data on all patients to be available by the end of second quarter of 2016.

SPHS closed Wednesday's trading at $1.65, down 1.79%.

Stellar Biotechnologies Inc. (SBOT) (KLH.V) has applied for voluntary delisting of its common shares from the TSX Venture Exchange. However, the company's shares will continue to trade on the Nasdaq.

The decision to voluntarily delist from the TSX-V was based on the very limited trading volume of the company's shares on the TSX-V, the costs and resources required to maintain TSX-V listing, and the liquid market for the company's Shares on Nasdaq.

The company believes that the voluntary delisting from TSX-V will help in reducing listing fees, costs, and administrative burden associated with listing its shares on two separate stock exchanges.

As you may know, Stellar Biotechnologies was uplisted to the Nasdaq on November 5, 2015, following a 1 for 10 reverse stock split that was effected on September 2, 2015.

SBOT closed Wednesday's trading at $5.11, down 1.73%. In after hours, the stock was up 15.26% to $5.89.

Teva Pharmaceutical Industries Ltd.'s (TEVA) CINQAIR has received FDA approval as an add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

Last December, an FDA panel recommended approval of CINQAIR.

CINQAIR, whose chemical name is Reslizumab, is designed to be administered iintravenously once every four weeks. It is expected to become commercially available to patients, by prescription, during the second quarter of 2016.

TEVA closed Wednesday's trading at $54.05, down 1.33%.