BIOD Plans Overhaul, Stellar To Uplist, AERI To File NDA, Time To Follow NXTM

(RTTNews) - Anika Therapeutics Inc. (ANIK) has received approval in Canada to market CINGAL, a medical device to treat pain associated with osteoarthritis of the knee.

The company has also sought approval for CINGAL in the U.S. and European Union, and regulatory filings in this regard were submitted in February of this year.

CINGAL is the first and only approved combination viscosupplement formulated with the company's proprietary cross-linked sodium hyaluronate (currently marketed as the single-injection viscosupplement MONOVISC) and triamcinolone hexacetonide, an FDA-approved steroid to treat inflammation.

ANIK closed Tuesday's trading at $38.43, up 0.52%.

Aerie Pharmaceuticals Inc. (AERI) expects to file its NDA for once-daily glaucoma therapy Rhopressa in the third quarter of 2016 based on results from two phase III trials, dubbed Rocket 1 and Rocket 2.

Another phase III trial of Rhopressa, known as Rocket 4, is underway and is designed to provide adequate six-month safety data for regulatory filing in the EU, and also provide additional clinical data on this product candidate.

The NDA filing in the U.S. is not contingent upon receipt of any Rocket 4 results, including the 90-day efficacy results which are expected in approximately one year, noted the company.

AERI closed Tuesday's trading at $23.55, down 3.29%.

Biodel Inc. (BIOD) has initiated a phase IIa clinical trial to evaluate patient-friendly BIOD-531 based regimens against a state-of-the-art basal-bolus insulin regimen and in combination with a GLP-1 analog in patients with type 2 diabetes. The topline data from this trial, dubbed Study 3-157, are expected towards the end of the first calendar quarter of 2016.

A corporate restructuring is also in the works - with the company planning to focus on later stage clinical development programs and restructure research, quality assurance/quality control (QA/QC) and facilities activities to save approximately $2 million annually.

BIOD closed Tuesday's trading at $0.36, down 0.68%.

Shares of NxStage Medical Inc. (NXTM) soared 13% on Tuesday following better-than-expected third quarter results and rosy outlook.

For full-year 2015, the company now expects revenue to be between $332 million and $333 million, versus its previously increased guidance for revenue to be at the high end of its range of $324 million to $328 million.

Net loss for the year is anticipated to be between $15 million and $16 million, versus its previous guidance of $18 million to $20 million, which was revised from its original guidance of $20 million to $24 million.

NXTM closed Tuesday's trading at $19.10, up 13.02%.

Rigel Pharmaceuticals Inc. (RIGL) expects topline data from its first phase III trial of Fostamatinib in immune thrombocytopenic purpura in the middle of 2016 - with the second trial anticipated shortly thereafter.

RIGL closed Tuesday's trading at $2.95, up 4.98%.

A phase III trial evaluating ViiV Healthcare's investigational antiretroviral drug Cabotegravir plus Janssen's approved antiretroviral drug Edurant has demonstrated that the two-drug injectable regimen were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational Cabotegravir and two nucleoside reverse transcriptase inhibitors.

ViiV Healthcare is a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Ltd. as shareholders.

Stellar Biotechnologies Inc. (SBOTF.OB) is all set to begin trading on Nasdaq under the symbol "SBOT" at market open on Thursday, November 5, 2015.

The company implemented a 1 for 10 reverse stock split, effective September 2, 2015 to support the requirements of uplisting.

SBOTF.OB closed Tuesday's trading at $7.40, down 7.18%.