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OSUR Surges On Strong Results, Zika Continues To Make Headlines, HTBX Loses Heat


Arch Biopartners Inc. (ACH.V) (FOIFF.OB) has submitted an application for orphan drug designation to the European Medicines Agency for AB569 in the treatment of Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis.

AB569 has successfully completed pre-clinical in vivo and in vitro validation studies.

The Committee for Orphan Medicinal Products is expected to provide an opinion on the application by the end of May 2016.

ACH.V closed Wednesday's trading at C$0.47, up 11.76%.

Conatus Pharmaceuticals Inc.'s (CNAT) drug candidate Emricasan has been granted Fast Track status for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis, or NASH.

The company recently initiated a phase 2b trial of Emricasan in patients with NASH fibrosis, dubbed ENCORE-NF, and results from this study are expected in 2018.

CNAT closed Wednesday's trading at $1.96, up 22.50%.

Corium International Inc.'s (CORI) phase I clinical study of Corplex Donepezil transdermal delivery system in healthy volunteers supports advancing the product candidate into further clinical development as a potential treatment of Alzheimer's disease.

The purpose of the phase 1 study was to evaluate the pharmacokinetics, safety and tolerability of once-weekly, single-dose Corplex Donepezil in healthy volunteers aged 50-80, compared to Eisai's Aricept once-daily oral tablet taken for seven consecutive days.

CORI closed Wednesday's trading at $5.38, down 0.55%.

Another company that has joined the bandwagon against the dreaded mosquito-borne Zika virus is GeoVax Labs Inc. (GOVX.OB).

The company has begun a program to develop a vaccine for the prevention of Zika virus infections using its novel MVA-VLP vaccine platform. GeoVax has also entered into a Collaborative Research Agreement with the University of Georgia to accelerate the development of vaccine.

Last month, Inovio Pharmaceuticals (INO) entered into a collaborative research program with Korea-based GeneOne Life Science to test and advance a DNA-based vaccine preventing and treating Zika virus infection.

Meanwhile, an Indian company Bharat Biotech claims that it has 2 promising vaccine candidates against the Zika virus. According to the company, one is a Recombinant Vaccine and another is an inactivated vaccine that has reached the stage of pre-clinical testing in animals.

Zika is fast spreading its wings across the globe, becoming a real threat. According to WHO, there are now 23 countries affected by this virus - with Brazil being the worst-hit, where there have been over 3,530 cases of children born with 'microcephaly', a birth defect linked to Zika virus.

GOVX.OB closed Wednesday's trading at $0.09, up 12.50%.

Heat Biologics Inc.'s (HTBX) phase II clinical trial HS-410 in bladder cancer has been placed on partial clinical hold by the FDA after being informed by the company that the cell line on which HS-410 is based had been previously misidentified.

The partial clinical hold does not relate to concerns regarding the safety of HS-410, noted the company.

As previously announced, Heat completed enrollment for the trial's randomized, combination arms in October 2015 and continues to expect to report top line efficacy, immune-response and safety data in the fourth quarter of 2016.

HTBX closed Wednesday's trading at $2.05, down 16.23%. In after hours, the stock was down 10.35% to $1.84.

Shares of OraSure Technologies Inc. (OSUR) were up more than 22% in extended trading on Wednesday, following record Q4 results.

For the fourth quarter of 2015, the company's consolidated net income was $4.6 million or $0.08 per share on revenue of $32.4 million. This compares with a consolidated net loss of $2.7 million or $0.05 per share and revenue of $28.7 million in the year-ago quarter.

Analysts polled by Thomson Reuters expected the company to earn $0.03 per share on revenue of $29.73 million in Q4 2015.

Looking ahead to Q1, 2016, the company expects net income per share range of $0.01 to $0.02 and consolidated net revenues to range from $28.5 million to $29.0 million.

OSUR closed Wednesday's trading 2.04% higher at $5.50. In after-hours, the stock was up another 22.73% to $6.75.

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