NOVN Moves Ahead, PTCT Finally Achieves It, TGTX Gets GENUINE Reaction

(RTTNews) - ARCA biopharma Inc. (ABIO) has randomized the 175th patient in GENETIC-AF - its phase 2B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation.

The Data Safety Monitoring Board (DSMB) will conduct a Phase 2B interim efficacy, safety and futility analysis of evaluable data from at least 150 patients. The Company expects the outcome of this interim analysis in the third quarter of 2017.

ABIO closed Monday's trading at $2.60, up 1.96%.

GlaxoSmithKline plc's (GSK) phase IIIb study of Nucala, dubbed MUSCA, has demonstrated significant improvement in the quality of life and lung function in severe asthma patients with an eosinophilic phenotype.

The exploratory endpoints were the annual rate of exacerbations (asthma attacks), which was reduced by 58%, and the number of exacerbations requiring emergency room visits or hospitalisation, which was reduced by 68% for people treated with Nucala compared with placebo, added the company.

GSK closed Monday's trading at $41.82, down 0.40%.

Novan Inc. (NOVN) has decided to proceed with its SB204 development program.

On January 27, 2017, the company reported top-line results from its two, replicate phase III pivotal clinical trials for SB204 in the treatment of acne vulgaris.

In one of those trials, dubbed NI-AC302, SB204 demonstrated statistical significance compared to vehicle on all three co-primary endpoints, but in another trial, named NI-AC301, the topical acne product candidate demonstrated statistical significance on only one of three co-primary endpoints. Following the results, the stock shed 74% of its value that day to $4.86.

The company now intends to pursue a pre-submission meeting with the FDA to discuss the entirety of the SB204 development program in the third quarter of 2017. The New Drug Application for SB204 is expected to be submitted in the first quarter of 2018.

NOVN closed Monday's trading at $6.95, up 8.76%.

PTC Therapeutics Inc.'s (PTCT) New Drug Application for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy has finally been accepted for standard review by the FDA - with a decision date set for October 24, 2017.

Last February, the FDA refused to even review the application saying that the application was not sufficiently complete to permit a substantive review.

Translarna was approved in the European Union in August 2014 and is now available in over 25 countries. The drug brought home sales of $56 million in the nine months ended September 30, 2016. For full year 2016, the company expects sales of Translarna to range between $65 million and $85 million.

The company is scheduled to report Q4 and full-year 2016 results on March 14, 2017.

PTCT closed Monday's trading at $10.22, up 4.18%.

Supernus Pharmaceuticals Inc. (SUPN) has entered into a settlement agreement with Zydus Pharmaceutical Inc. and Cadila Healthcare Limited on Trokendi XR patent litigation.

Supernus' Trokendi XR is an antiepileptic drug indicated for the treatment of epilepsy, and it was approved by the FDA in 2013. The patent protection for Trokendi XR expires no earlier than 2027.

Meanwhile, Zydus Pharmaceutical and Cadila Healthcare are seeking approval to market generic versions of Trokendi XR. Supernus sued Zydus and Cadila in November 2014, alleging that the companies infringed Trokendi XR patents by submitting to the FDA an Abbreviated New Drug Application seeking to market a generic version of Trokendi XR prior to the expiration of Supernus' patents.

Now, that the dispute has been settled, Zydus and Cadila are permitted to begin selling a generic version of Trokendi XR on January 1, 2023, or earlier under certain circumstances.

Trokendi XR recorded sales of $158.4 million in 2016, up $110.3 million in 2015.

SUPN closed Monday's trading at $29.75, up 3.48%.

Shares of TG Therapeutics Inc. (TGTX) soared as much as 116% to touch a new 52-week high of $11.60 on Monday, following positive results from its phase III trial of TG-1101 in patients with high risk Chronic Lymphocytic Leukemia.

In the trial, dubbed GENUINE, TG-1101 in combination with Ibrutinib increased the Overall Response Rate by more than 70% over Ibrutinib alone.

A full analysis of the GENUINE data along with detailed efficacy and safety results will be submitted for presentation at a medical meeting in the first half of 2017.

TGTX closed Monday's trading at $10.20, up 90.65%.