FDA Lifts Clinical Hold On ADXS, CPRX Awaits Next Catalyst, All Is Well For ACST

(RTTNews) - Shares of Acasti Pharma Inc. (ACST) surged more than 56% on Wednesday on encouraging response from the FDA for the proposed 505(b)(2) pathway for CaPre clinical development.

Last September, the company reported successful top-line results from its phase II safety and efficacy study of CaPre for the treatment of patients with hypertriglyceridemia.

A 1-for-10 reverse stock split was implemented on October 15, 2015. The stock closed Wednesday's trading at $2.52, up 56.91%.

Aduro Biotech Inc. (ADRO) has received a milestone payment from its license partner Janssen Biotech Inc. for the acceptance of an Investigational New Drug Application by the FDA for ADU-741, an investigational treatment of prostate cancer.

The company is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $345.5 million, as per the terms of the agreement with Janssen.

Janssen plans to initiate a multi-center phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 by the end of 2015.

ADRO closed Wednesday's trading at $33.63, up 8.00%.

Shares of Advaxis Inc.(ADXS) were up over 31% on Wednesday as the FDA lifted the clinical hold on its three Listeria-based cancer vaccine candidates - Axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2.

The three investigational cancer thereapies were put on clinical hold in October of this year after a patient who received Axalimogene filolisbac in early 2013 in an investigator-initiated trial tested positive for Listeria monocytogenes in late July 2015 and passed away the following month.

Now that the clinical hold has been removed, Advaxis will resume all clinical trials with Axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

The company said it will implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.

ADXS closed Wednesday's trading at $10.92, up 31.57%.

The last patient has completed dosing in Aldeyra Therapeutics Inc.'s (ALDX) phase II trial of NS2 in patients with allergic conjunctivitis.

The company expects to provide data from this trial in the first quarter of 2016.

ALDX closed Wednesday's trading 2.21% higher at $6.98.

Array BioPharma's (ARRY) ongoing phase III clinical trial of Binimetinib in patients with advanced NRAS-mutant melanoma has met the primary endpoint - achieving statistically significant progression free survival compared to chemotherapy Dacarbazine.

In the trial, dubbed NEMO, the mdian progression free survival on the Binimetinib arm was 2.8 months and that on of Dacarbazine arm was 1.5 months.

Binimetinib is also being studied in a phase III trial for patients with BRAF-mutant melanoma and in a phase III trial for patients with low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.

ARRY closed Wednesday's trading 20.63% higher at $4.62.

Catalyst Pharmaceuticals Inc.'s (CPRX) product candidate CPP-115 has shown significant increases in brain levels of the surrogate marker for potential efficacy, gamma-aminobutyric acid in normal healthy volunteers in a phase 1(b) trial.

CPP-115 is being explored as a treatment for epilepsy, including infantile spasms, and addiction.

The company expects to receive the full results of the study early next year, including additional data from laboratory safety tests, pharmacokinetic modeling, and brain levels of CPP-115 as determined from MRS (magnetic resonance spectroscopy) data of the patients.

CPRX closed Wednesday's trading at $2.62, up 5.65%.

Celsion Corp. (CLSN) has received clearance from Chinese regulatory body to conduct the ongoing phase III OPTIMA Study at clinical sites in China.

The OPTIMA Study is the company's global pivotal, double-blind, placebo-controlled trial, evaluating ThermoDox in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat patients with primary liver cancer, also known as hepatocellular carcinoma.

The pivotal trial is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. The clearance from the Chinese regulatory authority will allow Celsion to enroll patients at up to 25 additional clinical sites in China.

The enrollment in the OPTIMA Study is expected to be completed by the end of 2017.

CLSN closed Wednesday's trading at $1.79, up 0.56%.

Marinus Pharmaceuticals Inc. (MRNS) has completed patient recruitment for the phase III clinical trial of its product candidate Ganaxolone in adults with drug-resistant focal onset seizures.

In the study, about 350 patients will be randomized to receive either 1,800 mg/day of Ganaxolone or placebo for 12 weeks. The primary endpoint of the study is percent change in seizure frequency per 28 days relative to the baseline, noted the company.

Marinus anticipates announcing top-line results from the study in mid-2016.

MRNS closed Wednesday's trading at $6.14, up 0.33%.