PTIE Surges After-hours, Valeant Gets FDA Date, JAZZ Hits Right Notes

(RTTNews) - Shares of Aevi Genomic Medicine Inc. (GNMX) got pounded on Monday after it announced that the phase 2/3 efficacy study of AEVI-001 in adolescent patients with ADHD (attention-deficit/hyperactivity disorder) who have genetic disorders impacting the mGluR network did not meet primary endpoint.

The study, dubbed SAGA, did not meet the primary endpoint of reduction on the ADHD rating scale (ADHD-RS) compared to placebo.

GNMX closed Monday's trading at $2.21, down 59.38%.

Corium International Inc.'s (CORI) Corplex Donepezil candidate, a once-weekly transdermal patch for delivery of the most commonly prescribed treatment for the symptoms of Alzheimer's disease, continues to be well tolerated, with favorable skin safety and gastrointestinal side effect profiles in its pilot bioequivalence study.

The pilot study is on track for completion of the third and final treatment period in April and results from the entire study are expected to be reported in May.

CORI closed Monday's trading at $3.63, down 1.89%.

Jazz Pharmaceuticals plc (JAZZ) has reported positive efficacy results from two phase III studies of its investigational drug JZP-110 in adult patients with excessive sleepiness associated with obstructive sleep apnea, dubbed TONES 3 and TONES 4.

The TONES 3 study, or 14-003, is a 5-arm, parallel-group study evaluating four doses of JZP-110 (300 mg, 150 mg, 75 mg and 37.5 mg) and placebo for a 12-week period. The TONES 4 study, or 14-004, is a six-week phase III study comprising a two-week flexible-dose titration phase followed by two weeks at stable dose, and then a two-week, placebo-controlled, double-blind randomized withdrawal phase.

The Company expects to announce preliminary results from its phase III TONES 2 study evaluating JZP-110 in excessive sleepiness associated with narcolepsy in the second quarter of 2017. The NDA submission is anticipated to occur in late 2017.

JAZZ closed Monday's trading at $144.08, up 6.91%.

Neothetics Inc.'s (NEOT) phase II proof of concept trial, LIPO-202-CL-31, for the reduction of submental subcutaneous fat has completed patient enrollment.

The trial has enrolled approximately 150 subjects at 12 sites across the United States. The top-line data from the study are expected to be reported in June 2017.

NEOT closed Monday's trading at 1.47, up 4.26%.

Shares of Nektar Therapeutics (NKTR) rose more than 40% on Monday, following positive results from its Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic.

The study, dubbed SUMMIT-07, compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy (opioid-naïve).

The trial met the primary efficacy endpoint in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo. Key secondary endpoints of the study were also met with high statistical significance.

NKTR closed Monday's trading 42.65% higher at $22.11.

Shares of Pain Therapeutics Inc. (PTIE) soared more than 60% in extended trading on Monday, following positive regulatory guidance from a recent meeting with the FDA regarding REMOXY ER, its lead drug candidate.

Remoxy ER is a long-acting abuse-resistant narcotic analgesic formulation intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The New Drug Application for Remoxy ER has been rejected thrice by the FDA before - in December 2008, June 2011 and September 2016.

In the recent meeting with the FDA, an agreement was reached on additional studies that are needed for REMOXY's approval. The company expects to complete these studies by year-end 2017, at a cost of approximately $3-4 million.

PTIE closed Monday's trading at $0.68, down 2.26%. In after-hours, the stock was up 60.29% to $1.09.

The FDA decision date on the New Drug Application for Vesneo is set for August 24, 2017.

Vesneo was licensed by Nicox to Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) wholly owned subsidiary, Bausch + Lomb.

Vesneo is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

This is Vesneo's second go-around with the FDA. It was turned down by the regulatory agency last July on concerns of Current Good Manufacturing Practice at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA.

VRX closed Monday's trading at $10.64, down 3.54%.