AGRX Secure, NEOS Facing Tense Moments, Oprah Effect On WTW, ZGNX On Watch

(RTTNews) - Agile Therapeutics Inc. (AGRX) has reached the enrollment target of over 2,000 subjects in its phase III clinical trial of Twirla, its investigational combined hormonal contraceptive patch.

The trial, dubbed SECURE, assesses the efficacy of Twirla, a once-weekly transdermal contraceptive patch, in preventing pregnancy using the widely accepted Pearl Index as the primary endpoint.

The company expects that the results of the SECURE study will address all of the clinical issues raised in the complete response Letter, which was issued by the FDA to Twirla NDA in 2013. The SECURE study is anticipated to be completed in the second half of 2016, following which the company will be submitting its response to FDA's complete response letter in the first half of 2017.

AGRX closed Monday's trading at $7.08, down 2.75%.

Shares of Dehaier Medical Systems Ltd. (DHRM) were up over 36% on Monday after winning a medical device distribution bid for a new rural healthcare construction project supported by China Development Bank Corp.

According to the agreement, Dehaier will provide its proprietary C-arm X-Ray machine and defibrillator monitor to Dongsheng Hospital of Ordos, Inner Mongolia. The procurement project is funded by CDB, one of China's three national policy banks.

DHRM closed Monday's trading at $1.94, up 36.62%.

Karyopharm Therapeutics Inc. (KPTI) has initiated a phase 1b/2 study evaluating its drug candidate Selinexor in combination with other standard therapies in patients with multiple myeloma.

The phase 1b/2 study, dubbed STOMP, will evaluate the safety and efficacy of Selinexor and low-dose Dexamethasone at 60mg and 20mg, respectively, twice weekly or 80mg and 40mg, respectively, once weekly in separate combinations with Bortezomib, Lenalidomide or Pomalidomide.

The study is designed to enroll about 220 patients with multiple myeloma whose disease has relapsed after one or more prior therapies. The primary endpoint of the study is overall response rate.

KPTI closed Monday's trading at $13.83, up 8.81%.

La Jolla Pharmaceutical Co. (LJPC) has initiated a phase 1 clinical trial of LJPC-401 in patients at risk of iron overload due to conditions such as hereditary hemochromatosis, beta thalassemia and sickle cell disease. The preliminary results from this clinical trial are anticipated by the end of 2015.

LJPC closed Monday's trading at $25.64, up 7.39%.

Luminex Corp. (LMNX) has received CE-IVD marking for its NxTAG Respiratory Pathogen Panel, which detects 21 clinically-relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila.

The NxTAG Respiratory Pathogen Panel is the only respiratory assay that easily enables laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, such as during flu season, the company noted.

LMNX closed Monday's trading at $17.93, down 0.28%.

Shares of Neos Therapeutics Inc. (NEOS) were down more than 13% in afterhours on Monday, following FDA's notification of the deficiencies in the company's NDA for Cotempla XR-ODT 10 mg, 20mg, and 30 mg tablets for the treatment of attention deficit hyperactivity disorder, or ADHD.

The FDA has stated that this notification does not reflect a final decision on Cotempla XR-ODT NDA, currently under review - with a decision slated for November 9, 2015.

Meanwhile, the company's resubmitted New Drug Application for NT-0202 for the treatment of ADHD has been assigned a decision date of January 27, 2016. NT-0202 was issued a complete response letter last September.

NEOS closed Monday's trading at $18.59, up 0.27%. In after hours, the stock was down 13.66% at $16.05.

Protalix BioTherapeutics Inc. (PLX) has reported promising long term efficacy and safety data from its phase I/II clinical trial of PRX-102 for Fabry disease.

PRX-102 is a recombinant plant cell expressed, chemically modified version of the human alpha-Galactosidase-A enzyme.

According to the trial results, PRX-102 significantly improved pharmacokinetic characteristics demonstrating higher active enzyme quantities, induced Immune tolerance, and meaningful clinical benefit across all key disease parameters.

Protalix has scheduled an end of phase II meeting with the FDA to be held during the month of November to discuss the design of the pivotal phase III trial which the company expects to start in early 2016.

PLX closed Monday's trading at $0.98, down 3.92%.

Shares of Weight Watchers International Inc. (WTW) soared more than 100% on Monday, with Oprah Winfrey taking a 10% stake in the company and joining the Board of Directors.

Ray Debbane, Chairman of the Board of Directors, said, "Weight Watchers and Oprah Winfrey make a powerful combination. Oprah is a force of nature in connecting with people on a very personal level to live inspired lives. This partnership will accelerate our transformation and will meaningfully expand our ability to impact many millions of people worldwide."

WTW closed Monday's trading at $13.92, up 105.01%.

Zogenix Inc. (ZGNX) has been asked by the FDA to provide additional information related to its proposed phase III program for ZX008 for the treatment of Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.

ZX008 previously received orphan drug designation from the FDA, and the company has been planning to move ZX008 into phase III clinical studies during the fourth quarter of 2015.

The company has responded with the requested information required to initiate the clinical program and is confident that it has adequately addressed the FDA's information requests.

ZGNX closed Monday's trading at $13.72, up 1.40%. In after hours, the stock was down 7.43% to $12.70.