FDA Panel Backs ACAD, AUPH Awaits Data In Q3, CTRV Abuzz

(RTTNews) - Shares of ACADIA Pharmaceuticals Inc. (ACAD) were up 24% in after-hours on Tuesday, following positive vote from an FDA panel for the company's NUPLAZID for the treatment of psychosis associated with Parkinson's disease.

The panel voted 12 to 2 recommending approval of NUPLAZID. The FDA's final decision is slated for May 1, 2016.

If approved, NUPLAZID will be the first and only drug approved in U.S. for Parkinson's disease psychosis.

Trading of ACAD was halted on Tuesday. In after-hours, the stock was up 24.32% to $29.60.

Argos Therapeutics Inc. (ARGS) expects the third review of data from its phase III trial of AGS-003 in metastatic renal cell carcinoma, dubbed ADAPT, by the Independent Data Monitoring Committee to take place in June of this year.

The ADAPT trial successfully navigated two data analyses by the IDMC in June and December of 2015.

ARGS closed Tuesday's trading at $6.79, up 11.13%. In after-hours, the stock was down 8.69% to $6.20.

As part of an ongoing strategic review, ARIAD Pharmaceuticals Inc. (ARIA) is reducing approximately 25 percent of its headquarter positions.

The reduction includes approximately 90 positions in the U.S. and Europe. No customer-facing positions within ARIAD's commercial or medical affairs organizations are included in this action, the company noted.

In addition to workforce reduction, the review also includes an evaluation of commercial maximization initiatives, geographical presence, R&D portfolio, and business development opportunities to support the overall strategic direction.

ARIAD plans to provide further details on the progress of the strategic review, which is aimed at increasing patient and shareholder value, in the second quarter of 2016.

ARIA closed Tuesday's trading at $6.16, up 2.33%.

Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) expects the release of primary endpoint data from its phase 2b clinical study of Voclosporin in Lupus Nephritis, known as AURA, in the third quarter of 2016.

AUPH closed Tuesday's trading at $2.99, down 1.32%.

BioLineRx's (BLRX) phase II clinical trial of BL-8040 with chemotherapy drug Cytarabine in relapsed or refractory acute myeloid leukemia has demonstrated encouraging response rate.

According to the trial results, BL-8040, as a single agent and in combination with Cytarabine was safe and well tolerated at all doses tested up to and including the highest dose level of 2.0 mg/kg, with no major adverse events.

BLRX closed Tuesday's trading at $1.08, down 8.49%.

Shares of ContraVir Pharmaceuticals Inc. (CTRV) rose more than 12% on Tuesday after the company announced that its drug candidate CMX157 has outperformed Gilead's Tenofovir AF (TAF) against Hepatitis B Virus in an independent head-to-head in vitro study.

Tenofovir alafenamide fumarate was approved recently by the FDA as part of a four-drug combination therapy for HIV-1 (Genvoya), and is currently under development by Gilead for treating chronic hepatitis B infection.

ContraVir recently initiated a phase 1/2a clinical study of CMX157, which is currently enrolling healthy volunteers and is anticipated to begin enrolling hepatitis B patients in the second quarter 2016.

CTRV closed Tuesday's trading at $1.67, up 12.08%.

Mirna Therapeutics Inc. (MIRN) expects to provide a further clinical update from its ongoing phase 1 trial of MRX34 in multiple advanced cancers in mid-2016 and top-line data in mid-2017.

By the end of this year, the company expects to initiate two phase 2 clinical studies of MRX34 in patients with melanoma and renal cell carcinoma. Each Phase 2 trial is expected to enroll approximately 30 patients to further characterize the safety and efficacy of MRX34 in these cancer types. Mirna currently plans to provide a clinical update from these studies in the second half of 2017.

A phase Ib study of MRX34, which is expected to include serial tumor biopsies and aims to develop deeper insights into the mechanism of action of MRX34 in melanoma patients, will begin in late 2016.

MRNA closed Tuesday's trading at $4.98, up 6.87%.

Pain Therapeutics (PTIE) has resubmitted the New Drug Application for REMOXY to the FDA.

REMOXY is an investigational extended-release oral formulation of oxycodone for patients with moderate-to-severe chronic pain.

Pain Therapeutics has stated that they expect to be notified by the FDA of a Prescription Drug User Fee Act action date within 30 days.

REMOXY has been at the FDA altar twice, and it was issued a complete response letter on both the occasions - in December 2008 and in June 2011.

PTIE closed Tuesday's trading at $2.15, up 2.87%.

Rexahn Pharmaceuticals Inc. (RNN) has initiated a phase Ib/IIa clinical trial of RX-3117 in patients with relapsed and refractory pancreatic cancer and advanced bladder cancer.

The study will follow a two-stage design. In the initial stage, 10 patients with relapsed or refractory pancreatic cancer and 10 patients with advanced bladder cancer will be enrolled. If responses are observed within the first 10 response-evaluable subjects, 40 additional subjects could be enrolled, noted the company.

The primary endpoint is an assessment of the progression free survival rate or an objective clinical response rate and reduction in tumor size. Secondary endpoints include time to disease progression, overall response rate and duration of response, as well as pharmacokinetic assessments and safety parameters.

RNN closed Tuesday's trading at $0.32, up 2.53%.

VBL Therapeutics (VBLT) expects interim analysis from its pivotal phase III trial of VB-111 in recurrent Glioblastoma, dubbed GLOBE, to occur in the first half of 2017.

The company expects to provide updated results from its phase 1/2 study of VB-111 in platinum-resistant ovarian cancer, including data from tumor biopsies as well as survival data, and a full report on phase 2 trial of VB-111 in advanced radioiodine-refractory differentiated thyroid cancer this year.

VBLT closed Tuesday's trading at $3.20, down 8.09%.