Watch Out For CTRV, FDA Delays Decision On EGLT, OGXI In Low Spirits

(RTTNews) - Shares of ContraVir Pharmaceuticals Inc. (CTRV) jumped over 21% on Thursday, following encouraging data from a phase IIa study comparing its investigational CMX157 to Gilead's (GILD) Viread in chronically infected hepatitis B patients.

According to the interim data, the CMX157 treated patients showed an average 99% reduction in HBV viral load from the baseline. And what is significant is that the observed antiviral activity for CMX157 is comparable to that observed in Viread-treated patients, but at 1/12th the dose (25 mg CMX157 vs. standard 300 mg Viread), noted the company.

CTRV closed Thursday's trading at $1.36, up 21.43%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has completed its phase 2 study of Resunab for the treatment of diffuse cutaneous systemic sclerosis. The topline data from this study are expected in the fourth quarter of 2016.

The study's primary efficacy endpoint is the American College of Rheumatology Provisional Composite Response Index for diffuse cutaneous Systemic Sclerosis which predicts the probability (0-1 or 0-100% score) of improvement from baseline in randomized controlled trials in systemic sclerosis.

CRBP closed Thursday's trading at $9.34, down 1.68%.

Shares of Egalet Corp. (EGLT) fell more than 8% in extended trading on Thursday after being notified by the FDA that the decision on pain drug candidate ARYMO ER will not be announced on October 14, 2016.

The company is seeking approval of ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

ARYMO ER won the backing of a panel of U.S. regulatory advisers in August, and the FDA's final decision was slated for October 14, 2016. But, with the regulatory agency still working on the product label, more time has been sought to announce the decision on ARYMO ER.

EGLT closed Thursday's trading at $7.52, up 1.48%. In after-hours, the stock was down 8.11% to $6.91.

Just when Lipocine Inc. (LPCN) thought that its legal troubles over its drug candidate LPCN-1021 are over, its opponent Clarus Therapeutics Inc. has vowed to refile its patent infringement lawsuit if LPCN-1021 is approved.

LPCN 1021 is Lipocine's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The FDA had issued a Complete Response Letter for Lipocine's LPCN 1021 in June of this year.

Last November, Clarus Therapeutics filed a lawsuit against Lipocine for infringing a Clarus patent. On October 7, 2016, the U.S. District Court in Delaware dismissed a patent infringement lawsuit related to LPCN 1021 filed by Clarus Therapeutics.

Clarus on Thursday said that the Court dismissed the lawsuit due to lack of FDA approval for LPCN-1021 and not on merits of case.

Robert Dudley, President and CEO of Clarus and co-inventor of the patent in question, stated, "We remain strong in our belief that LPCN-1021 infringes Clarus' '428' patent and it is particularly noteworthy that the court did not rule on this central fact. If LPCN-1021 were to be approved by the FDA, our plan would be to vigorously pursue all avenues to keep Lipocine's LPCN-1021 from entering the market and protect the intellectual property, accompanying financial investment and years of work we have invested in JATENZO - our oral TRT product. We continue to advance the development of JATENZO which is being evaluated in a new Phase 3 study that is near completion."

LPCN closed Thursday's trading at $4.15, down 9.78%.

Shares of OncoGenex Pharmaceuticals Inc. (OGXI) dropped over 10% on Thursday on news that the company's phase III trial of Custirsen in patients with non-small cell lung cancer failed to meet the primary endpoint.

The trial, dubbed ENSPIRIT evaluated Custirsen in combination with Docetaxel against Docetaxel alone in patients whose non-small cell lung cancer progressed following initial treatments.

According to the trial results, the study did not demonstrate a statistically significant improvement in overall survival for patients treated with Custirsen in combination with Docetaxel compared to Docetaxel alone.

In August, the company said that its phase III trial of Custirsen in men with metastatic castrate-resistant prostate cancer, dubbed AFFINITY, did not meet the trial goal.

OGXI closed Thursday's trading at $0.40, down 10.71%.

Pernix Therapeutics Holdings Inc. (PTX) has effected a 1-for-10 reverse stock split to regain compliance with the minimum $1.00 continued listing requirement for the listing of its common stock on The NASDAQ Global Market.

The reverse stock split became effective as of the close of business on October 13, 2016, and the shares will trade on the post-split basis on NASDAQ commencing at the open of the stock market on October 14, 2016.

Following the reverse stock split, the number of outstanding common shares will be reduced to approximately 9.5 million, the company noted.

PTX closed Thursday's trading at $0.41, down 25.81%.

TG Therapeutics Inc. (TGTX) has filed with the FDA an amended protocol for the ongoing phase III study of TG-1101 that will accelerate the trial to a rapid conclusion.

The trial, dubbed GENUINE, is evaluating TG-1101 in combination with *Imbruvica in previously treated Chronic Lymphocytic Leukemia patients with high-risk cytogenetic features.

Prior to the amendments, the GENUINE study consisted of two parts namely, Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival in all study patients, say 330, to support a filing for full approval of TG-1101.

Following the amendment, the Part II of the study has been eliminated, and accordingly, the study's sole primary endpoint will be overall response rate as originally contemplated in Part I; and target enrollment has been reduced to approximately 120 randomized patients.

If all goes well as planned, the company expects to file a Biologics License Application for TG-1101 in the first half of 2018.

TGTX closed Thursday's trading at $6.85, down 16.97%.