Good News For GNVC, ACRS On Track, TBRA Tanks, FDA Says No To OCUL

(RTTNews) - AbbVie's (ABBV) once-daily formulation of VIEKIRA PAK to treat genotype 1 chronic hepatitis C virus infection has won FDA approval.

Initially approved in December 2014, VIEKIRA PAK has all along been taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

The newly approved dosing means VIEKIRA PAK can be taken as three oral tablets once daily with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients.

VIEKIRA PAK contains a fixed dose combination of antiviral medicines Ombitasvir, Paritaprevir and Ritonavir co-packaged with Dasabuvir tablets.

VIEKIRA PAK clinched in sales of $1.64 billion in 2015, and is expected to rake in $2 billion in sales this year.

ABBV closed Monday's trading at $64.32, up 0.80%.

Aclaris Therapeutics Inc. (ACRS) has completed patient enrollment in its two phase III pivotal clinical trials, dubbed SEBK-301 and SEBK-302, and its phase III open-label safety trial, known as SEBK-303, evaluating its lead candidate, A-101 Topical Solution for the treatment of seborrheic keratosis.

In the trials named SEBK-301 and SEBK-302, Aclaris is evaluating the safety and efficacy of A-101 (40% concentration) in subjects with seborrheic keratosis on the trunk, extremities and face.

Aclaris expects to report initial results from the SEBK-301, SEBK-302 and SEBK-303 trials in the fourth quarter of 2016.

A phase II trial evaluating A-101 for the treatment of common warts, dubbed Wart-201, is also completely enrolled, and initial results are expected in the third quarter of 2016.

ACRS closed Monday's trading at $19.72, down 5.69%.

Alder BioPharmaceuticals Inc.'s (ALDR) top-line 24-week data from its phase 2b study of ALD403 in patients with chronic migraine has demonstrated persistent migraine prevention.

In March 2016, Alder reported that the Phase 2b study met both the primary efficacy endpoint, a 75% reduction in migraine days over 12 weeks, and the secondary efficacy endpoint of mean reduction in migraine days from baseline.

The company's second planned pivotal trial of ALD403, dubbed PROMISE 2, is on track to start later this year.

ALDR closed Monday's trading at $28.72, up 6.13%.

Alnylam Pharmaceuticals Inc.'s (ALNY) phase 1 study with Fitusiran, an investigational RNAi therapeutic targeting antithrombin for the treatment of hemophilia A and B, and rare bleeding disorders, has produced encouraging results.

Fitusiran achieved median estimated annualized bleeding rate of zero in patients without inhibitors.

One of the most serious and costly complications of hemophilia is developing an inhibitor. Approximately 15-20% of people with hemophilia will develop an antibody—called an inhibitor—to the product used to treat or prevent bleeding episodes.

In an initial low dose cohort of patients with inhibitors, Fitusiran achieved antithrombin lowering, increased thrombin generation, and preliminary evidence for reduced bleeding.

The company plans to initiate its phase III studies of Fitusiran in patients with and without inhibitors in early 2017.

ALNY closed Monday's trading at $66.20, up 1.08%.

Shares of GenVec Inc. (GNVC) rose over 50% in extended trading on Monday after being notified that the FDA has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.

CGF166, which is GenVec's lead product candidate, is licensed to Novartis (NVS).

On January 11, 2016, GenVec plunged more than 60% as Novartis paused enrollment in the clinical trial of CGF166 based on a review of data by the trial's Data Safety Monitoring Board.

Now that the clinical hold has been lifted, GenVec looks forward to the near-term enrollment of new patients and believes that the trial will be completed sometime in 2017 as previously expected.

GNVC closed Monday's trading at $0.59, down 1.67%. In after hours, the stock was up 52.54% to $0.90.

Shares of Ocular Therapeutix Inc. (OCUL) plunged over 14% on Monday, following FDA's Complete Response Letter for DEXTENZA, the company's product candidate for the treatment of post-surgical ocular pain.

In its Complete Response Letter, the FDA has raised concerns pertaining to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility. The FDA's letter did not provide any details as to which manufacturing deficiencies identified during the facility inspection remain open since the last response submitted by the company.

OCUL lost 14.51% on Monday to close at $4.42.

PTC Therapeutics Inc. (PTCT) has been informed by the European Medicines Agency that the company's request for renewal of its current conditional marketing authorization for Translarna for nonsense mutation Duchenne muscular dystrophy cannot be completed by mid-year 2016.

Translarna was given conditional approval by the European Medicines Agency in 2014 for the treatment of nonsense mutation Duchenne muscular dystrophy, subject to annual renewal and certain conditions.

The company expects that Translarna's current marketing authorization status will remain valid until a decision is adopted by the European Commission.

PTCT closed Monday's trading at $6.76, down 5.85%.

Aesthetic device company Syneron Medical Ltd. (ELOS) has received FDA clearance for a new ultra-short 785nm wavelength for PicoWay, a picosecond laser that is used for tattoo removal and pigmented lesions.

The wavelengths of 532nm and 1064nm are already in use in PicoWay. The new wavelength will be available to new and existing PicoWay customers in the U.S. market in the fourth quarter of 2016.

The addition of PicoWay's third wavelength completes the PicoWay laser platform, allowing for the comprehensive removal and treatment of all colors of tattoos and pigmented lesions, says the company.

ELOS closed Monday's trading at $7.21, up 1.12%.

Shares of Tobira Therapeutics Inc. (TBRA) tanked over 60%, following the failure of the company's phase IIb trial of Cenicriviroc, dubbed CENTAUR, to meet the primary endpoint.

Cenicriviroc is being developed for the treatment of non-alcoholic steatohepatitis in adults with liver fibrosis.

Although the study did not meet its primary endpoint of a two-point reduction in the NAFLD Activity Score, CENTAUR did demonstrate 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, noted the company.

TBRA closed Monday's trading at $4.50, down 60%.

Zosano Pharma Corp. (ZSAN) has dosed the first subject in its pivotal efficacy trial of M207 patch, formerly known as ZP-Triptan, for the treatment of acute migraine. Till date, 136 subjects have enrolled in the trial. The company is on track to report results from the trial in the first quarter of 2017.

ZSAN closed Monday's trading at $1.75, up 25%.