MSTX Crashes On EPIC Data, MIRN Ditches MRX34, More Good News From SRPT

(RTTNews) - Seeking to take a lead R&D position in non-alcoholic steatohepatitis, Allergan plc (AGN) is acquiring Tobira Therapeutics Inc. (TBRA) and privately-held Akarna Therapeutics Ltd.

Tobira Therapeutics is to be acquired by Allergan for a total potential consideration of up to $1.695 billion.

As per the agreement terms, Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones.

The acquisition of Tobira adds Cenicriviroc (CVC) and Evogliptin, two differentiated, complementary development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan's global Gastroenterology R&D pipeline.

On July 25, 2016, Tobira reported negative results from its Phase 2b clinical trial of Cenicriviroc, dubbed CENTAUR, which sent the stock down 60%. The trial did not meet its primary endpoint of a two-point reduction in the NAFLD (non-alcoholic fatty liver disease) Activity Score, but there was a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after only one year of treatment.

Allergan has made an up-front payment of $50 million to acquire Akarna Therapeutics. The acquisition adds AKN-083, a preclinical compound in development for the treatment of NASH, to Allergan's pipeline.

AGN closed Tuesday's trading at $238.67, down 2.70%.

Amgen's (AMGN) phase III study of Repatha on coronary artery disease has met its primary and secondary endpoints. The phase III study, known as GLAGOV, evaluated whether Repatha modified atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimized statin therapy.

The primary endpoint was change in percent atheroma volume (PAV) from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). IVUS is a high-resolution imaging tool that allows for the quantification of coronary atheroma in the coronary arteries.

Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV, said the company.

Repatha was approved by FDA last August for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease (ASCVD), such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Repatha recorded sales of $27 million in Q2, 2016, compared to $16 million in Q1, 2016.

AMGN closed Tuesday's trading at $173.38, up 1.17%.

Shares of Mast Therapeutics Inc. (MSTX) were down over 83% in extended trading on Tuesday after the company announced that its phase III study of Vepoloxamer in sickle cell disease did not meet the primary efficacy endpoint.

The hallmark of sickle cell disease is recurring episodes of severe, debilitating pain commonly known as sickle cell crisis or vaso-occlusive crisis.

In the study, dubbed EPIC, there was no statistically significant reduction in the mean duration of vaso-occlusive crisis in sickle cell disease patients treated with Vepoloxamer compared to placebo group.

Based on the results, the company has decided to terminate all clinical development of Vepoloxamer.

MSTX closed Tuesday's trading at $0.59, up 0.22%. In after-hours, the stock was down 83.31% to $0.10.

Mirna Therapeutics Inc. (MIRN) was down more than 27% in after-hours on Tuesday, following its decision to pull the plug on the ongoing Phase 1 study of MRX34, its investigational microRNA therapy for multiple cancers.

The company decided to close the trial after multiple immune-related severe adverse events were observed in patients dosed with MRX34 over the course of the study.

MRNA closed Tuesday's trading at $2.47, unchanged from the previous day's close. In after-hours, the stock was down 27.13% to $1.80.

Puma Biotechnology Inc.'s (PBYI) New Drug Application for its lead product candidate PB272 has been accepted for review by the FDA.

The company is seeking approval of PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.

The FDA decision on PB272 can be expected in July 2017.

PBYI closed Tuesday's trading at $65.16, up 10.53%.

A day after gaining FDA approval for its Duchenne muscular dystrophy drug EXONDYS 51, Sarepta Therapeutics Inc. (SRPT) has released some more good news.

The company has received favorable decisions from the United States Patent and Trademark Office in the composition of matter patent interference cases against BioMarin Pharmaceutical (BMRN). However, the decisions are subject to appeal.

The composition of matter patent interferences relate to exon 51 and exon 53. Sarepta's EXONDYS 51 is designed to skip exon 51 and the company's candidate for exon 53 skipping is SRP-4053, which is in clinical development. The USPTO has refused all of BioMarin's claims in the exon 51 and exon 53 composition of matter interferences.

The favorable decision facilitates commercialization of EXONDYS 51 in the U.S., the company said.

SRPT touched an all-time high of $56.80 on Tuesday before closing the day's trading at $55.73, up 13.87. In after-hours, the stock was up another 1.74% to $56.70.

VBI Vaccines Inc. (VBIV) (VBV.TO) has completed enrollment and initial dosing of all participants in the phase I clinical study evaluating its preventative cytomegalovirus vaccine candidate.

The study is enrolled with 128 healthy CMV-negative adults. Preliminary results are anticipated in the first half of 2017.

VBIV closed Tuesday's trading at $3.65, down 6.17%.