CERC's Woes Continue, TXMD Replenished By Trial Data, NDRM Abuzz, SRNE On Watch

(RTTNews) - Shares of Cerecor Inc. (CERC) plunged over 13% on Monday on disappointing top-line clinical results from its phase II clinical trial of CERC-501 for smoking cessation.

The trial failed to achieve its objectives of improvement on symptoms of tobacco withdrawal and smoking behaviors, as measured by improvement in time to start smoking and number of cigarettes smoked following abstinence, according to the company.

On November 29, 2016 too, the company suffered a setback - with its phase II clinical trial of adjunctive treatment of CERC-301 missing the primary endpoint.

Cerecor has lost 70% of its share price over the last 5 trading days alone. The stock closed Monday's trading at $1.52, down 13.14%.

Seeking to regain compliance with the minimum bid price requirement for continued listing on The NASDAQ Capital, GTx Inc. (GTXI) has implemented a reverse stock split of its shares of common stock at a ratio of one-for-ten that will come into effect on December 6, 2016.

The number of shares of GTx's common stock outstanding will decrease from approximately 159.2 million pre-split shares to approximately 15.9 million post-split shares.

GTXI closed Monday's trading at $0.67, down 12.99%.

Lipocine Inc. (LPCN) plans to initiate a dosing validation study for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The company expects top-line results from the dosing validation study in the second quarter of 2017.

LPCN closed Monday's trading at $3.72, up 7.35%.

NeuroDerm Ltd. (NDRM) gained as much as 41% to touch a new 52-week high on Monday on being allowed by the FDA to replace two large, phase III efficacy trials of its lead product candidate ND0612, with small pharmacokinetic trials.

ND0612 is the company's continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson's disease.

Accordingly, the company has decided to discontinue preparations to initiate its phase III clinical efficacy trial of *ND0612H and suspend its other ongoing phase III trial for ND0612L. (ND0612H refers to high dose ND0612 and ND0612L refers to low dose ND0612).

NDRM closed Monday's trading at $19.65, up 26.37%.

Sientra Inc. (SIEN) has received FDA clearance for four new breast implant styles in both shaped and round as well as additional profile and sizing options for nine existing implant offerings.

The company, which went public in October 2014, offering its shares at a price of $15 apiece, received its first FDA approval in March 2012 for its Silimed-brand portfolio of round and shaped silicone breast implants.

Sientra, along with its partner Vesta, has completed the build-out of a manufacturing facility for its breast implants and expects to submit its FDA pre-market approval supplement for the implants manufactured at this new facility by the end of the first quarter 2017.

In the third quarter ended September 30, 2016, the company's total net sales declined to $6.5 million from $9.9 million for the same period in 2015, due to the voluntary hold on the sale and implanting of all Sientra devices manufactured by Silimed between October 9, 2015 and March 1, 2016 over contamination fears.

Silimed is a breast implant manufacturer located in Brazil in South America.

SIEN closed Monday's trading at $8.52, up 6.37%.

Sorrento Therapeutics Inc.'s (SRNE) subsidiary SCILEX Pharmaceuticals Inc. has announced that its pivotal bioequivalence study for lead investigational product ZTlido has met the primary and secondary endpoints.

In the trial, ZTlido has proved its bioequivalence to the reference product, Lidoderm, developed by Endo Pharmaceuticals Inc., which is approved to treat the pain associated with postherpetic neuralgia.

The company plans to re-submit the ZTlido NDA under the 505(b)(2) regulatory pathway in mid-2017.

SRNE closed Monday's trading at $5.30, up 2.91%.

Shares of TherapeuticsMD Inc. (TXMD) were up over 20% in after-hours on Monday, following positive top-line results from its pivotal phase 3 trial of TX-001HR for the treatment of moderate to severe vasomotor symptoms due to menopause in post-menopausal women with an intact uterus.

The trial, dubbed Replenish, met the co-primary efficacy endpoints of the change from baseline in the number and severity of hot flashes at weeks 4 and 12 and primary safety endpoint of the incidence of endometrial hyperplasia with up to 12 months of treatment.

The company looks forward to submitting a New Drug Application for TX-001HR to the FDA as early as the third quarter of 2017.

TXMD closed Monday's trading at $6.17, up 0.65%. In after-hours, the stock was up 20.75% to $7.45.