EGLT Gets Long Awaited FDA Approval, PTCT Breathes Easy, GLMD On Track

(RTTNews) - The FDA, which missed the deadline of October 14, 2016 in deciding the fate of Egalet Corp.'s (EGLT) ARYMO ER C-II for treatment of chronic pain, has given the thumbs up to the pain pill.

While an FDA panel, which reviewed Arymo ER last August, had supported the company's claim of labeling the pain pill as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse, the FDA is not so generous.

The FDA in a statement has said that "abuse of Arymo ER by injection difficult. However, abuse by the intravenous, intranasal, and oral routes is still possible".

ARYMO ER has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg, and the U.S. commercial launch is planned for the first quarter 2017.

EGLT closed Monday's trading at $8.38, up 6.08%. In after-hours, the stock was down 5.73% to $7.90.

Fluidigm Corp. (FLDM) has announced preliminary revenue for the fourth quarter and full year ended December 31, 2016, which has come in short of analysts' expectations.

The company expects total revenue to be in the range of approximately $24.7 million to $25.2 million for the fourth quarter of 2016 and $104.1 million to $104.6 million for the full year of 2016.

The consensus forecast among analysts polled by Thomson Reuters is $26.25 million for Q4 and $105.61 million for the full year of 2016.

The company is scheduled to report the financial results on February 2017.

FLDM closed Monday's trading at $8.33, up 3.48%.

Galmed Pharmaceuticals Ltd. (GLMD) has completed recruitment in its Phase IIb study of Aramchol in non-alcoholic steatohepatitis, or NASH.

The study, dubbed ARREST, has enrolled 240 patients with biopsy proven NASH who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Results from this study are anticipated to be announced in Q2 2018.

GLMD closed Monday's trading at $4.05, down 0.49%.

Kite Pharma (KITE) has entered into a strategic partnership with Daiichi Sankyo Co., Ltd. to develop and commercialize Axicabtagene ciloleucel in Japan.

Axicabtagene ciloleucel, or KTE-C19, is Kite's lead product candidate investigated as a potential treatment for B-cell lymphomas and leukemias.

Under the terms of the partnership agreement, Kite will receive an upfront payment of $50 million and future payments totaling up to $200 million for development and commercial milestones from Daiichi Sankyo. Kite is also entitled to receive sales royalties in the low to mid double digit range.

A rolling submission of the Biologics License Application for KTE-C19 as a treatment for patients with refractory aggressive non-Hodgkin lymphoma to the FDA was initiated by Kite last month. The submission is expected to be completed by the end of Q1 2017.

KITE closed Monday's trading at $51.99, up 1.46%.

Shares of PTC Therapeutics Inc. (PTCT) rose over 10% on Monday, following the European Commission's positive decision granting annual renewal of the conditional marketing authorization for its treatment of nonsense mutation Duchenne muscular dystrophy, Translarna.

Translarna was given only conditional approval by the European Medicines Agency for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older in August 2014. Conditional marketing authorizations are subject to annual reassessment and renewal.

The net sales of Translarna in the first nine months of 2016 were $56 million, an increase of 125% over the year-ago quarter. Translarna net sales for 2016 are expected to range between $65 million and $85 million.

PTCT closed Monday's trading at $14.29, up 10.35%.

ProNAi Therapeutics Inc. (DNAI) has changed its corporate name to Sierra Oncology Inc. and its shares will trade on the NASDAQ under the symbol 'SRRA', effective on January 10th.

DNAI closed Monday's trading at $1.56, down 4.29%.

Syros Pharmaceuticals (SYRS) plans to present initial clinical data from an ongoing Phase 2 clinical trial of SY-1425 in subsets of acute myeloid leukemia and myelodysplastic syndrome in the fall of 2017.

The company expects to initiate a phase 1 clinical trial of SY-1365 in patients with transcriptionally driven solid tumors, including ovarian, triple negative breast and small cell lung cancers, in the first half of 2017.

SYRS closed Monday's trading at $11.89, down 9.03%.

Vital Therapies Inc. (VTL) has so far enrolled 38 subjects in its phase III trial evaluating its ELAD System in subjects with severe acute alcoholic hepatitis.

The company continues to expect to announce topline results in mid-2018.

VTL closed Monday's trading at $4.95, down 1.98%.