AIMT Is Nothing To Sneeze At, AGRX Secured, TiGenix Admired, ICPT Gets FDA Date

(RTTNews) - Agile Therapeutics Inc. (AGRX) has completed patient recruitment in its phase III clinical trial of Twirla, its investigational contraceptive patch. The trial, dubbed SECURE, is on track to complete enrollment by the end of the third quarter 2015.

The SECURE study will enroll approximately 2,100 female subjects who will receive treatment for up to one year. The study will assess the effectiveness of the patch in preventing pregnancy using the Pearl Index as the primary contraceptive efficacy measure. Safety and tolerability will also be evaluated, noted the company.

AGRX closed Monday's trading at $8.83, down 3.60%.

Aimmune Therapeutics Inc. (AIMT) plans to initiate an international phase III registrational trial of AR101 in children and adults with peanut allergy in early 2016.

In June of this year, the company announced positive results from a phase II study of AR101, which met its primary endpoint and additional endpoint of desensitizing patients to cumulative amounts of peanut protein of 443 mg and 1,043 mg, respectively.

Peanut allergy is a serious and growing health problem that affects more than 5 million people in the United States and Europe, including more than two million children.

Aimmune went public as recently as August 6, 2015, offering its shares at a price of $16.00. The stock closed Monday's trading at $21.09, down 0.09%.

Atara Biotherapeutics Inc. (ATRA) has completed enrollment in its phase II trial of PINTA in end-stage renal disease patients with Protein Energy Wasting. The company expects to report preliminary top-line data by the end of the fourth quarter of 2015.

ATRA closed Monday's trading at $40.53, up 0.77%.

Corbus Pharmaceuticals Holdings, Inc. (CRBP) has commenced patient enrollment in its phase II study of its investigational drug Resunab for the treatment of diffuse cutaneous systemic sclerosis. This study is designed to enroll up to 36 individuals with systemic sclerosis who will be treated for 84 days with a follow up period of 28 days.

A phase II study of Resunab in dermatomyositis was launched last quarter. Data from these studies are expected at the end of 2016.

CRBP closed Monday's trading at $1.91, down 0.52%. In after hours, the stock was up 4.71% at $2.00.

Intercept Pharmaceuticals Inc.'s (ICPT) New Drug Application for obeticholic acid for the treatment of primary biliary cirrhosis has been accepted for Priority Review by the FDA - with a decision date set for February 29, 2016.

ICPT closed Monday's trading at $189.76, up 0.43%.

Lipocine Inc. (LPCN) has submitted a 505(b)(2) New Drug Application to the FDA for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for hypogonadism, a condition associated with a deficiency or absence of endogenous testosterone.

In clinical trials, LPCN 1021 successfully restored testosterone levels to the normal range in 88% of hypogonadal men with low testosterone.

LPCN closed Monday's trading 6.36% higher at $14.72.

NeuroMetrix Inc. (NURO) has reported positive preliminary results from a pilot study of its wearable pain relief technology in subjects with restless leg syndrome.

Of the total nine subjects were evaluated in the pilot study, two-thirds were responders to the therapy according to the Clinical Global Impression of improvement (CGI-I) scale. Overall, restless leg syndrome severity decreased by 32%, as assessed by the International Restless Leg Syndrome (IRLS) scale, which was statistically significant. Similarly, several sleep related outcomes measures (MOS Sleep Scale) showed statistically significant (or a trend towards) improvement, according to the company.

NURO closed Monday's trading at $0.90, down 2.20%.

OncoMed Pharmaceuticals Inc. (OMED) has completed patient enrollment in its phase II clinical trial of Tarextumab for the treatment of pancreatic cancer - more than eight months ahead of schedule.

The study, dubbed ALPINE, whose primary endpoint is overall survival, has enrolled 177 patients with advanced pancreatic cancer who had not received prior treatment. Data from this trial are expected in the second half of 2016.

OMED closed Monday's trading at $19.59, down 3.69%.

Sanofi and the life sciences team at Google (GOOG) are collaborating to improve care and outcomes for people with type 1 and type 2 diabetes.

The collaboration will bring together Sanofi's leadership in diabetes treatments and devices and Google's expertise in analytics, miniaturized electronics and low power chip design.

SNY closed Monday's trading at $48.92, down 0.73%.

Theratechnologies Inc. (TH.TO) has finalized a 10-year agreement with privately held BL&H Co., LTD for the distribution and commercialization of EGRIFTA for the treatment of HIV-associated lipodystrophy in South Korea.

EGRIFTA, which is approved in the U.S., Europe, Canada and Mexico, is not approved in South Korea. Under the terms of this agreement, BL&H will be responsible to conduct all regulatory activities required to obtain marketing approval for EGRIFTA in South Korea.

TH.TO closed Monday's trading at C$2.20, down 3.51%.

Shares of Trevena Inc. (TRVN) were up more than 41% in extended trading on Monday, following positive results from its phase 2b trial of TRV130 in moderate to severe acute postoperative pain after abdominoplasty surgery.

According to the company the study achieved its primary endpoint of statistically greater pain reduction than placebo over 24 hours. In addition, TRV130 was superior to morphine in pre-specified secondary measures, exhibiting significantly reduced nausea, vomiting, and hypoventilation events.

TRVN closed Monday's trading at $6.00, down 0.66%. In after hours, the stock was up 41.33% at $8.48.

TiGenix NV's (TGXSF.OB) lead compound Cx601 has met the primary endpoint in a phase III trial in Crohn's disease patients with complex perianal fistulas.

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally.

In the trial, dubbed ADMIRE-CD, a single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs.

Based on the positive phase III results, TiGenix will submit a Marketing Authorisation Application to EMA early 2016.

Last month, the company reached an agreement with the FDA on a Special Protocol Assessment for its phase III registration trial of Cx601 in the U.S. for the treatment of complex perianal fistulas in Crohn's disease patients. The phase III trial of Cx601 in the U.S. is scheduled to commence in the second half of 2016.

TGXSF.OB closed Monday's trading 26.50% higher at $1.48.