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

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…

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