FDA Panel To Review PTCT's Translarna, CTIC Plunges On Offering, NNVC Abuzz

(RTTNews) - Today's Daily Dose brings you news about Acasti Pharma's progress with CaPre; FDA approval of Alkermes' two-month dosing option of ARISTADA for the treatment of schizophrenia; CTI BioPharma's public offering; NanoViricides' inhibitory effects of its topical shingles treatment candidates against varicella-zoster virus in multiple cell culture studies and PTC Therapeutics' upcoming regulatory catalyst.

Read on...

Acasti Pharma Inc. (ACST) expects to initiate a phase III program of CaPre in patients with severe hypertriglyceridemia in the second half of 2017.

The phase III program will comprise of two pivotal, double-blind, placebo-controlled studies and a total of roughly 400 patients.

ACST closed Tuesday's trading at $1.29, up 3.20%.

The FDA has approved Alkermes plc's (ALKS) supplemental New Drug Application for two-month dosing option of ARISTADA for the treatment of schizophrenia.

ARISTADA, an injectable drug with once-monthly and once-every-six-weeks dosing options, was approved by the FDA to treat adults with schizophrenia in October 2015. The newly approved two-month offering expands the range of ARISTADA dosing intervals to include a third option for patients with schizophrenia.

The annual net sales of ARISTADA were $47.2 million in 2016 compared to $4.59 million in 2015.

ALKS closed Tuesday's trading at $58.99, up 1.67%.

Shares of CTI BioPharma Corp. (CTIC) dropped over 20% on Tuesday after it priced its underwritten public offering of $45 million of convertible preferred stock.

The Company has offered to sell 22,500 shares of its Series N-3 Preferred Stock at a price of $2,000 per share of Series N-3 Preferred Stock.

Each share of Series N-3 Preferred Stock is convertible at the option of the holder, at any time subject to certain limitations, into shares of its common stock at a conversion price of $3.00 per share of common stock, for a total of about 15.0 million shares of common stock. The offering is expected to close on or about June 9, 2017.

CTIC closed Tuesday's trading at $3.25, down 20.15%.

Exact Sciences Corp. (EXAS) has agreed to sell 7 million shares of its common stock to Jefferies LLC, BofA Merrill Lynch and Robert W. Baird & Co. Inc. in an underwritten public offering, pursuant to an effective shelf registration statement filed with the SEC on Form S-3.

The underwriters have an option to purchase up to 1.05 million additional shares.

EXAS closed Tuesday's trading at $36.59, down 1.29%. In after-hours, the stock fell 2.02% to $35.85.

Shares of NanoViricides Inc. (NNVC) were up over 38% in extended trading on Tuesday after reporting that its topical shingles treatment candidates have demonstrated excellent inhibition of varicella-zoster virus, the causative virus, with practically no cytotoxicity in cell culture assays using multiple cell lines.

The Company noted that two of the nanoviricide drug candidates in the HerpeCide program demonstrated almost complete inhibition of the varicella-zoster virus at the highest drug doses, whereas FDA-approved Acyclovir at the same drug dose exhibited only partial inhibition of the virus.

The antiviral effect of its herpecide drug candidates was almost five times superior to that of Acyclovir, added the Company.

NNVC closed Tuesday's trading at $1.27, up 3.25%. In after-hours, the stock was up 37.80% to $1.75.

PTC Therapeutics Inc.'s (PTCT) new drug application for Translarna, a treatment for nonsense mutation Duchenne muscular dystrophy, is all set to be reviewed by an FDA panel on September 28, 2017.

The FDA's final decision on Translarna is slated for October 24, 2017.

In the European Union, Translarna has been available for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older in since December 2014. Translarna was given conditional approval by the European Medicines Agency in August 2014.

Translarna generated net product sales of $81.4 million in 2016 compared to $33.7 million in the prior year.

PTCT closed Tuesday's trading at $14.31, up 5.61%.