IMGN Marches Forward, FDA Nod For ZLTQ, Knight Lends Shine To PLX

(RTTNews) - ImmunoGen Inc. (IMGN) announced that the first patient has been dosed in its phase III clinical trial of Mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer.

The study, dubbed FORWARD I, is designed to enroll 333 patients who will be randomized 2:1 to receive either Mirvetuximab soravtansine or the physician's choice of single-agent chemotherapy. The primary endpoint of this study is progression free survival (PFS).

FORWARD I is being conducted by ImmunoGen in partnership with GOG Foundation Inc., a non-profit organization promoting research in gynecologic malignancies.

IMGN closed Thursday's trading at $2.42, down 3.97%.

Opiant Pharmaceuticals Inc.'s (OPNT.OB) commercialization partner Adapt Pharma has received FDA approval for its 2mg formulation of NARCAN Nasal Spray.

NARCAN Nasal Spray in 4mg formulation was approved by the FDA in November 2015 for the emergency treatment of known or suspected opioid overdose.

The new 2mg formulation of NARCAN Nasal Spray provides an important new dosing option for patients at risk of severe opioid withdrawal, noted Opiant.

OPNT.OB closed Thursday's trading at $8.05, up 6.62%.

Pfizer Inc.'s (PFE) C. difficile vaccine candidate has produced positive data in a phase II study in healthy adults 65 to 85 years of age. The vaccine candidate is designed to help prevent C. difficile infection, which can include life-threatening diarrhea and pseudomembranous colitis.

The company plans to move the C. difficile vaccine candidate into phase III testing in the first half of 2017.

PFE closed Thursday's trading at $31.28, down 0.03%.

Canada-based Knight Therapeutics Inc. (GUD.TO) has acquired 6.3 million common shares of Protalix BioTherapeutics Inc. (PLX) at an average price of US$0.57 per share.

Knight now owns roughly 5% of the outstanding common shares of Protalix.

Protalix has one FDA approved marketed product, Elelyso for the treatment of Gaucher disease, and three clinical drug candidates. Protalix has licensed to Pfizer Inc.(PFE) the worldwide development and commercialization rights for Elelyso, excluding Brazil, where Protalix retains full rights.

The clinical drug candidates include Pegunigalsidase alfa for the treatment of Fabry disease under phase III testing; OPRX-106 for the treatment of inflammatory diseases under phase II trial, and Alidornase alfa for the treatment of Cystic Fibrosis, also under phase II testing.

Enrollment in the phase III trial of Pegunigalsidase alfa is expected to be completed this year - with interim data analysis anticipated in 2018 to support EMA and other regulatory filings outside of the United States.

The company expects to report full results for the phase II efficacy and safety study of Alidornase alfa during the first quarter of 2017 and full results for the phase II efficacy and safety study of OPRX-106 during the second half of 2017.

PLX closed Thursday's trading at 0.55, down 3.48%. In after-hours, the stock was up 11.71% to $0.64.

ZELTIQ Aesthetics Inc.'s (ZLTQ) fat freezing method CoolSculpting has now received FDA clearance to address another body area - upper arms.

The company also announced that it will be launching the CoolAdvantage Petite applicator for the CoolSculpting system in order to optimize the performance of CoolSculpting in the upper arms, with full commercial release targeted for the middle part of the year.

In the U.S., the CoolSculpting procedure is already FDA-cleared for the treatment of visible fat bulges in the submental area, thigh, abdomen and flank, along with bra fat, back fat, and underneath the buttocks (also known as banana roll). Over 3.5 million treatments have been performed to date in over 80 countries around the world, says the company.

The company is slated to report Q4 and full year 2016 financial results on February 27, 2017. For the fourth quarter revenue is expected to be approximately $104.5 million, up 34% year-over-year and representing the highest revenue quarter in company history.

ZLTQ closed Thursday's trading at $42.86, down 1.06%.