It's One Up For AKBA, CYNA Under Close Watch, Busy Days Ahead For APRI

(RTTNews) - Akebia Therapeutics Inc. (AKBA) has prevailed in the opposition proceedings in the European Patent Office brought against its rival Fibrogen Inc. (FGEN), which owns patents on the use of certain chemical compounds to treat anemia.

The Opposition Division of the European Patent Office has ruled that the patent '823 as granted to FibroGen did not meet the requirements for patentability under the European Patent Convention. Accordingly, the patent '823 has been revoked in its entirety.

AKBA closed Wednesday's trading 4.53% higher at $8.30.

Busy times are ahead for Apricus Biosciences Inc. (APRI) this year. The company expects to complete its phase 2b clinical trial of Fispemifene in patients with symptomatic secondary hypogonadism - with top-line data expected by the end of this quarter.

The company expects to resubmit the NDA for Vitaros, a topical cream for the treatment of erectile dysfunction, in the second half of 2016.

A phase 2b clinical trial of RayVa, a topical treatment in patients with scleroderma-related Raynaud's phenomenon, is anticipated to be initiated in the second half of 2016.

APRI closed Wednesday's trading 2.97% higher at $1.04.

Cynapsus Therapeutics Inc. (CYNA) sees 2016 as an important year as the company has a couple of make or break events coming its way.

The company's lead product candidate is APL-130277, an easy-to-administer, sublingual thin film formulation of Apomorphine. As you may know, Apomorphine is a drug that is used to control "off" episodes in people with Parkinson's disease. An off episode is a period of time during which the Parkinson's symptoms reemerge despite taking the medications.

A phase III efficacy study of APL-130277 is underway, and top-line data are expected in the second or third quarter of 2016.

A phase III safety study of APL-130277 is ongoing, and top-line data are expected in the fourth quarter of 2016 or the first quarter of 2017.

If all goes well as planned, the company intends to submit a New Drug Application for APL-130277 under the abbreviated Section 505(b)(2) regulatory pathway in the United States near the end of 2016 or in early 2017.

A pre-submission meeting with the EMA related to APL-130277 is expected to occur in the second quarter of 2016.

CYNA closed Wednesday's trading at $13.60, up 0.93%.

Mirati Therapeutics Inc. (MRTX) expects preliminary data from its phase Ib dose expansion clinical trial for MGCD516 in genetically selected patients with advanced solid tumor malignancies in the second half of 2016. Recruitment is underway in the study, which is designed to enroll 120 patients.

The company is slated to provide initial data from its phase II trial of MGCD265 in NSCLC patients with activating genetic changes of the MET gene by the end of 2016.

MRTX closed Wednesday's trading at $21.23, down 2.17%.

OncoGenex Pharmaceuticals Inc. (OGXI), which is evaluating its drug candidate Custirsen in combination with cabazitaxel as second-line chemotherapy in a phase III trial in castrate-resistant prostate cancer patients, expects final analysis for the intent-to-treat population in the third quarter of 2016. This phase III trial is known as AFFINITY.

Another phase III study, dubbed ENSPIRIT, evaluating Custirsen in combination with Docetaxel as second-line chemotherapy in non-small cell lung cancer, is also underway. The final survival analysis is expected in the first half of 2017.

An investigator-sponsored, randomized phase II trial evaluating Apatorsen in combination with Docetaxel treatment compared to Docetaxel treatment alone in patients with advanced or metastatic bladder cancer, dubbed Borealis-2, is ongoing, and final results are expected in the second half of 2016.

Apatorsen is also being explored in the indication of non-squamous non-small cell lung cancer. An investigator-sponsored, randomized, placebo-controlled phase II trial evaluating Apatorsen with carboplatin and pemetrexed chemotherapy in patients with previously untreated advanced non-squamous NSCLC is also underway, and results are expected in the second half of 2016.

OGXI closed Wednesday's trading at $0.77, down 1.42%. In after hours, the stock was up 11.69% to $0.86.