Data Boosts AERI, FDA Panel Snubs SPPI, D-Day For ACRX Today, VTAE Abuzz

(RTTNews) - Shares of Acasti Pharma (ACST)(APO.V) surged 123% on Wednesday, following positive data from its bioavailability study of CaPre for the treatment of patients with severe hypertriglyceridemia.

The bioavailability study compared CaPre given as a single dose of 4 grams in fasting and fed states with the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers.

The results support Acasti's strategy to pursue the FDA's 505(b)(2) regulatory pathway to gain marketing approval of CaPre.

ACST closed Wednesday's trading at $2.81, up 123.02%.

AcelRx Pharmaceuticals Inc. (ACRX) is all set to announce the results of its phase III clinical study of ARX-04 in patients who have moderate-to-severe acute pain following a surgical procedure on September 15, 2016.

Last month, the company reported positive topline results from a phase III trial of ARX-04 in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury.

ACRX closed Wednesday's trading at $3.28, up 1.86%.

Shares of Aerie Pharmaceuticals Inc. (AERI) were up 61% in extended trading on Wednesday, following positive topline data from the first phase III trial of its investigational glaucoma drug Roclatan.

Roclatan is a fixed dose combination of Aerie's most advanced drug candidate Rhopressa and Latanoprost, a widely prescribed prostaglandin analog for glaucoma.

In the trial, known as Mercury 1, Roclatan demonstrated statistical superiority over Rhopressa and Latanoprost.

Another phase III trial of Roclatan, named Mercury 2, is underway, and topline data readout from this trial is expected in the second quarter of 2017.

AERI closed Wednesday's trading at $21.13, up 7.53%. In after hours, the stock was up 61% to $34.02.

Aviragen Therapeutics Inc. (AVIR) has completed 90% enrollment in the SPIRITUS phase 2b trial of Vapendavir for the treatment of human rhinovirus infections in moderate and severe asthmatic patients. The top-line data from the trial are expected around the end of the year.

The company has resumed enrollment in its phase 2a challenge study of BTA585, being developed for respiratory syncytial virus (RSV) infections. The top-line viral load data are expected to be available around the end of the year.

AVIR closed Wednesday's trading at $1.42, up 0.71%.

Lexicon Pharmaceuticals Inc. (LXRX) will now have to wait till February 28, 2017 to know the FDA decision on telotristat etiprate, its oral drug proposed for the treatment of carcinoid syndrome.

The FDA's decision date was originally set for November 30, 2016. However, following the company's submission of additional clinical data analyses, the decision date has been postponed by 3 months.

LXRX closed Wednesday's trading at $18.83, up 2.06%.

The FDA advisory committees have recommend removal of boxed warning regarding serious neuropsychiatric adverse events from the label of Pfizer inc.'s (PFE) smoking cessation therapy, Chantix.

Chantix was approved in the U.S. in 2006. Following reports of unusual changes in behavior in people using Chantix, the FDA in 2009, required Pfizer to add a Boxed warning to the product labeling about the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking the drug.

The FDA panels' recommendation to remove the boxed warning regarding serious neuropsychiatric adverse events is based on the results of post-marketing requirement study of Chantix, dubbed EAGLES.

The EAGLES study, conducted at the request of the FDA and EMA, compared the neuropsychiatric safety of Chantix and bupropion with placebo and nicotine replacement therapy patch in adult smokers with and without a history of psychiatric disorders. The EAGLES study, the results of which were published in April of this year, demonstrated that there was no significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with Chantix or bupropion compared to placebo and nicotine patch.

Now that the FDA panels have given their views, it is now for the FDA to take a call on Chantix's boxed warning regarding serious neuropsychiatric adverse events.

Sales of Chantix have declined ever since it was slapped with a black box warning. Sales, which were $883 million in 2008, were down to $671 million in 2015.

PFE closed Wednesday's trading at $33.94, down 0.29%.

Shire plc (SHPG) has received FDA approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution], for treatment of adult and pediatric patients two years of age and older with primary immunodeficiency.

Primary immunodeficiency refers to a group of more than 300 genetic disorders in which part of the body's immune system is missing or functions improperly. It affects up to six million people worldwide.

Shire expects to launch CUVITRU in the U.S. in the coming weeks. CUVITRU was approved in 17 European countries in June of 2016.

SHPG closed Wednesday's trading at $193.32, up 1.14%.

Spectrum Pharmaceuticals' (SPPI) Qapzola, proposed for immediate intravesical instillation post-transurethral resection of bladder tumors, has been voted down by an FDA panel, citing lack of substantial evidence of a treatment effect.

The FDA's final decision is scheduled for December 11, 2016.

SPPI closed Wednesday's trading 8.20% down at $5.04. In after hours, the stock gained 3.77% to $5.23.

Shares of Vitae Pharmaceuticals Inc. (VTAE) jumped more than 157% on Wednesday as the company agreed to be acquired by Allergan plc (AGN) for $21.00 per share, in cash, which equates to a total transaction value of $639 million.

The acquisition adds Vitae's VTP-43742, a potential treatment of psoriasis and other autoimmune disorders, and VTP-38543, a potential treatment of atopic dermatitis, both of which are phase II compounds, to Allergan's pipeline.

Allergan anticipates closing the transaction by the end of 2016.

VTAE closed Wednesday's trading at $20.85, up 157.41%.