LJPC Climbs 76%, VTVT On Track, Eventful October Awaits ACRX, ATRS

(RTTNews) - AcelRx Pharmaceuticals Inc.'s (ACRX) New Drug Application, submitted under section 505(b)(2), for DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting has been accepted for review by the FDA.

The U.S. regulatory agency is scheduled to announce its decision on DSUVIA on October 12, 2017.

ACRX closed Monday's trading at $3.20, up 6.67%.

Antares Pharma Inc.'s (ATRS) New Drug Application for QuickShot Testosterone, a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, has been accepted for standard review by the FDA.

QuickShot Testosterone, or QST, was developed to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism.

The FDA's decision on QST is expected to be announced on October 20, 2017.

ATRS closed Monday's trading at $2.47, up 2.49%.

BioCryst Pharmaceuticals Inc.'s (BCRX) interim results from its phase II trial of BCX7353 in hereditary angioedema are encouraging.

In the trial, dubbed APeX-1, 28 subjects were randomized equally to receive BCX7353 350 mg QD or placebo for 28 days. According to the interim analysis, there was a reduction of 63% in overall attack rate in HAE patients with severe disease.

A pre-planned analysis of peripheral and abdominal attacks showed reductions of 88% and 24%, respectively, for BCX7353 compared with placebo, added the company.

BCRX closed Monday's trading at $5.51, up 0.36%.

Shares of La Jolla Pharmaceutical Co. (LJPC) climbed more than 76% on Monday, following positive results from its phase III trial of LJPC-501 in patients with catecholamine resistant hypotension.

Catecholamine-resistant hypotension or CRH is an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is unresponsive to current treatments.

In the phase III trial, dubbed ATHOS-3, the percentage of LJPC-501-treated patients achieving a pre-specified target blood pressure response, was highly statistically significant. In addition, a trend toward longer survival was observed namely, a 22% reduction in mortality risk through day 28 for LJPC-501-treated patients, noted the company.

La Jolla plans to submit the NDA for LJPC-501 in the second half of this year.

LJPC touched a new 52-week high of $37.64 on Monday, before closing the day's trading at $35.12, up 76.75%.

Ligand Pharmaceuticals Inc. (LGND) has completed enrollment in its phase II clinical trial of LGD-6972 for the treatment of type 2 diabetes mellitus. The top line results from this trial are expected to be reported in September 2017.

LGND closed Monday's trading at $107.38, up 6.97%.

Revance Therapeutics Inc.'s (RVNC) phase III program of RT002 for the treatment of frown lines, which includes two pivotal trials and a long-term safety trial, is underway. The company plans to report top line results from both pivotal trials in the fourth quarter of 2017.

A phase II trial of RT002 for the treatment of cervical dystonia is ongoing - with 24-week results scheduled to be announced in the second quarter of 2017.

The company is also exploring the potential of RT002 in reducing the signs and symptoms of plantar fasciitis in a phase II trial. The trial is actively enrolling and Revance expects to report results in the second half of 2017.

RVNC closed Monday's trading at $21.10, up 3.94%.

vTv Therapeutics Inc. (VTVT) expects to complete enrollment in Part B of its phase III study of Azeliragon in Alzheimer's disease by mid-year of 2017.

Enrollment of Part A of the study, dubbed STEADFAST, was completed last September. Top line data from this part of the study are expected in early 2018.

VTVT closed Monday's trading at $6.14, up 7.91%.