New Outlook For NEO, Busy Days Ahead For OASM, OPK's Rayaldee Gets 2nd Chance

(RTTNews) - Shares of Aeterna Zentaris Inc. (AEZS) (AEZ.TO) were up over 9% in extended trading on Wednesday, with the company acquiring exclusive U.S. promotional rights for APIFINY from Armune BioScience Inc.

APIFINY is the only cancer specific, non-PSA blood test to assess the risk for the presence of prostate cancer.

In less than one year on the market, APIFINY has been ordered over 5,000 times as clinicians move beyond PSA-based testing to further assess the risk for the presence of prostate cancer, says Armune.

AEZS closed Wednesday's trading at $4.06, down 2.40%. In after hours, the stock was up 9.85% to $4.46.

Shares of NeoGenomics Inc. (NEO) were up more than 9% on Wednesday, following stellar results for the first quarter of 2016.

The company reported revenue of $59.7 million, reflecting 159% growth, and adjusted EBITDA of $8.2 million, which is an increase of 442%, driven by Clarient acquisition and strong volume gains.

Looking ahead, the company now expects full year 2016 revenue to be in the range of $242 million to $252 million, adjusted EBITDA to be in the range of $35 million to $40 million, adjusted net income to be in the range of $8 million to $13 million, and adjusted Diluted EPS to be in the range of $0.08 - $0.13 per share.

The company's previous forecast for full year 2016 was as follows - revenue in the range of $240 million to $250 million, Adjusted EBITDA in the range of $33 million to $38 million, Adjusted Net Income in the range of $7 million to $12 million, and Adjusted Diluted EPS in the range of $0.07 - $0.12 per share.

NEO closed Wednesday's trading at $8.20, up 9.92%.

Oasmia Pharmaceutical AB's (OASM) phase III study of Paclical/Apealea in ovarian cancer has demonstrated positive results.

The results showed non-inferiority between the two treatment groups of Paclical/Apealea in combination with Carboplatin versus Taxol in combination with Carboplatin, according to the company.

While the overall survival was 25.7 months in patients that had received the Paclical/Apealea combination, it was 24.8 months in patients that had received the Taxol combination.

Oasmia plans to submit an application to the FDA for approval of Apealea for treatment of ovarian cancer in the end of 2016 or early 2017.

The company's American Depositary Shares, or ADSs, began trading on the Nasdaq on October 23, 2015 at an offering price of $4.06 per ADS. OASM closed Wednesday's trading at $4.59, up 4.99%.

Ocular Therapeutix Inc. (OCUL) is all set to initiate the first of two phase III clinical trials of OTX-TP for the treatment of glaucoma and ocular hypertension during the third quarter of 2016.

The two phase III trials will include an OTX-TP treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot. The trials will not include a Timolol comparator or validation arm.

The primary efficacy endpoint will be statistically superior and clinically meaningful reduction of intraocular pressure (IOP) from baseline with OTX-TP compared to placebo at 60 and 90 days. The FDA has also indicated that they will take into consideration the risk-reward profile of OTX-TP relative to currently available therapies in their evaluation of the phase III trial results.

OCUL closed Wednesday's trading at $12.50, up 1.38%.

The New Drug Application for RAYALDEE, resubmitted by OPKO Health Inc. (OPK), has been accepted for review by the FDA, and a decision is scheduled for October 22, 2016.

RAYALDEE is intended for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

This is RAYALDEE's second try to gain approval. Last month, the FDA turned down the NDA for RAYALDEE on concerns related to third-party manufacturing observations.

OPK closed Wednesday's trading at $10.89, down 2.94%.

Theratechnologies Inc. (TH.TO) said that enrollment in a phase III study of Ibalizumab, in combination with optimized background regimen (patients' current therapy), for patients infected with multi-drug resistant HIV-1 has been completed.

With 36 patients having been enrolled, the trial has exceeded the minimum target of 30 patients proposed by the FDA. The primary end point is the proportion of patients achieving a viral load reduction of at least 0.5 log10 at Day 14.

Top-line results of the primary end point are expected to be available by the end of May 2016.

TH.TO closed Wednesday's trading at C$2.16, up 8.54%.