FOLD Shrinks, JAZZ On Right Track, NVLS Choked Up, AAAP On Watch, NVRO Sues BSX

(RTTNews) - Shares of Advanced Accelerator Applications S.A. (AAAP) were down more than 10% on Monday as the company announced that the FDA decision on its experimental drug Lutathera originally scheduled for December 28, 2016, is unlikely to be announced that day as only last week did the regulatory agency identify certain issues related to data format in the New drug Application.

The company has to resolve the issues before the FDA can announce its decision.

Lutathera is a Lu-177-labeled somatostatin analogue peptide that is being developed for the treatment of gastroenteropancreatic neuroendocrine tumors.

AAAP closed Monday's trading at $30.40, down 10.35%.

Shares of Amicus Therapeutics (FOLD) were down over 26% in extended trading on Monday as the FDA has ruled that accelerated approval of Migalastat for Fabry Disease is not possible based on existing data related to GL-3 reduction, a key biomarker of disease.

The company plans to collect additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation. Accordingly, a 12-month, placebo-controlled pivotal "cross-over" study in treatment naïve Fabry patients who have an amenable mutation and GI symptoms is scheduled to be initiated next year, with data expected in 2019.

Migalastat, under the trade name Galafold was granted full approval by the European Commission as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

FOLD closed Monday's trading at $8.32, down 6.52%. In after hours, the stock was down another 26.68% to $6.10.

Aimmune Therapeutics Inc. (AIMT) has completed global enrollment of its phase III trial of AR101 for the treatment of peanut allergy, meeting the target of 540 patients.

The topline results from the study, dubbed PALISADE, are expected to be available in the fourth quarter of 2017, followed by regulatory submissions for marketing approval of AR101 in 2018 in both the United States and Europe.

AIMT closed Monday's trading at $24.53, down 1.49%.

Foamix Pharmaceuticals Ltd. (FOMX) has completed patient enrollment in its two phase III clinical trials evaluating FMX101, a topical 4% minocycline foam, in the treatment of moderate-to-severe acne.

The two phase III pivotal trials are being conducted simultaneously, and top-line results are anticipated in the first half of 2017.

If approved, FMX101 is expected to be the first FDA-approved topical antibiotic treatment for moderate-to-severe acne.

FOMX closed Monday's trading $9.06, down 3.21%.

Gemphire Therapeutics Inc. (GEMP) has enrolled its first patients in a phase 2b trial of Gemcabene in the treatment of patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy.

The trial, dubbed ROYAL-1, is designed to enroll up to 104 adult patients at clinical sites in the United States. The topline data readout from the trial is anticipated in the second half of 2017.

GEMP closed Monday's trading at $9.42, down 2.89%.

Jazz Pharmaceuticals plc's (JAZZ) phase 3 study evaluating JZP-110 in excessive sleepiness associated with narcolepsy is now fully enrolled, with 240 patients. The top-line results from this narcolepsy study are expected in the second quarter of 2017.

Meanwhile, two phase III studies evaluating JZP-110 in excessive sleepiness in adult patients with obstructive sleep apnea are underway, and results from these two studies are expected in the first quarter of 2017.

JAZZ closed Monday's trading at $108.04, down 2.65%. In after hours, the stock was up 1.24% to $109.38.

Medical device company Nevro Corp. (NVRO) has filed a lawsuit alleging that Boston Scientific (BSX) is infringing its patents covering inventions relating to Senza system and HF10 therapy.

Nevro's Senza spinal cord stimulation system, which delivers proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The lawsuit seeks preliminary and permanent injunctive relief against further infringement as well as damages and attorney's fees.

Nevro derives revenue from sales of Senza to customers in Australia, Europe and the U.S. The company's revenue in Q3, 2016 was $60.92 million compared to $15.40 million in the year-ago quarter.

NVRO closed Monday's trading at $84.75, down 1.68%.

Shares of Nivalis Therapeutics Inc. (NVLS) cratered over 52% in extended trading on Monday, following the failure of its first phase II study evaluating Cavosonstat for treatment of cystic fibrosis patients, who have two copies of the F508del mutation, when added to Vertex Pharmaceuticals' Orkambi.

The primary endpoint of the trial was change in absolute percent predicted FEV1 from baseline to week 12, and this was not met. The FEV1 (forced expiratory volume 1) is defined as the volume of air forcefully exhaled in 1 second.

Another phase II study in which Cavosonstat is being evaluated as add-on therapy to Vertex Pharma's Kalydeco in adult patients who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein is underway. The topline results from the second study are expected in the first quarter of next year.

NVLS closed Monday's trading at $6.25, down 0.48%. In after hours, the stock was down 52.96% to $2.94.