AEGR Lays Off 25% Staff, INCY Discontinues Ruxolitinib Trials, ZBH Gets FDA Nod

(RTTNews) - Aegerion Pharmaceuticals Inc. (AEGR) is reducing approximately 25% of its global workforce, as part of the company's broad program to rein in operating expenses and extend its cash position.

Moreover, not all is well with the company's lead product Juxtapid as its sales are being impacted by the introduction of competitive therapies. Juxtapid is approved to treat high cholesterol in adults with homozygous familial hypercholesterolemia.

For the fourth quarter 2015, the company's preliminary, unaudited net product sales of Juxtapid are expected to range between $37.5 million and $39.5 million. This is sharply down from net product sales of $58.8 million reported in the third quarter of 2015.

Following the workforce reduction, Aegerion expects to have approximately 230 employees globally.

AEGR closed Thursday's trading at $6.18, down 3.44%.

Collegium Pharmaceutical Inc. (COLL) will soon request FDA to convert tentative approval granted to its abuse-deterrent Xtampza ER, for the management of chronic pain last November, to final approval, now that the patent litigation related to the drug has been resolved.

At issue in the dispute that has now been resolved is Purdue Pharma's three Orange Book-listed patents asserted against Collegium that were the cause of the 30 month stay imposed on the New Drug Application for Xtampza ER.

With the final judgment coming in favor of Collegium, the company said that there is additional clarity on the timing for the potential commercial launch of Xtampza.

COLL closed Thursday's trading at $18.95, up 7.49%.

Genocea Biosciences Inc. (GNCA) has a couple of catalysts to watch out for in the coming months.

The company's lead drug candidate is GEN-003, an immunotherapy for the treatment of genital herpes, which is under phase II development.

Later in the first quarter of 2016, Genocea expects to report 12-month durability data from the ongoing phase II dose optimization trial. Positive results, if achieved, would represent an improvement to the already-attractive 6-month durability of effect which was confirmed in the fourth quarter of 2015, noted the company.

A phase IIb clinical trial for GEN-003 for the treatment of genital herpes, which was initiated late last month, is underway - with virologic efficacy data anticipated in the middle of 2016 and clinical efficacy data in the second half of 2016.

GNCA closed Thursday's trading at $3.01, up 9.45%.

Shares of Incyte Corp. (INCY) dropped to a new 52-week low on Thursday as the company decided to pull the plug on its phase III study of Ruxolitinib in advanced or metastatic pancreatic cancer following lacklustre interim analysis results.

The phase III study, dubbed JANUS 1 was evaluating Ruxolitinib or placebo in combination with approved anticancer drug Capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer. The interim analysis revealed that Ruxolitinib plus Capecitabine did not show a sufficient level of efficacy to warrant continuation.

Consequently, the ongoing Incyte-sponsored trials of Ruxolitinib in solid tumors will be discontinued, including the phase III JANUS 2 study in pancreatic cancer, the phase II sub-study in patients with metastatic colorectal cancer and low CRP and the phase II studies in breast and lung cancer, added the company.

Incyte said that its dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer will also be discontinued.

INCY closed Thursday's trading at $65.51, down 9.40%.

Kindred Biosciences Inc.'s (KIN) investigational drug Zimeta for the control of pyrexia (fever) in horses is one step closer to approval, with the company submitting the Effectiveness Technical Section of the New Animal Drug Application to the FDA.

The Chemistry, Manufacturing, and Controls technical section for Zimeta was submitted in December 2015 and all remaining technical sections of the New Animal Drug Application are planned for submission by the end of the first quarter of 2016, according to the company.

KIN closed Thursday's trading at $3.31, up 0.30%.

Neurocrine Biosciences Inc.'s (NBIX) drug candidate Valbenazine is under two phase II trials in Tourette syndrome in adults and pediatrics, dubbed T-Forward study and T-Force GREEN study, respectively.

Data from both of these Tourette studies is expected around year-end 2016.

The company has initiated a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. Top-line data from this phase I study is expected in the first-half of 2016.

NBIX closed Thursday's trading 4.96% higher at $35.37.

RedHill Biopharma Ltd. (RDHL) has successfully completed a first-in-man pharmacokinetic study of BEKINDA 12 mg formulation to support the planned phase II study for the treatment of diarrhea-predominant irritable bowel syndrome.

The company has submitted to the FDA the protocol for the phase II diarrhea-predominant irritable bowel syndrome study and plans to initiate the study in the coming weeks.

A phase III study with BEKINDA 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in the second half of 2016.

RDHL closed Thursday's trading at $8.60, down 1.32%.

Zimmer Biomet Holdings (ZBH) has received FDA clearance for its Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery.

According to the company, the Unite3D Bridge Fixation System represents an alternative to traditional surgical plates, screws and staples for a range of foot and ankle fusion procedures.

ZBH closed Thursday's trading at $91.68, down 1.32%.