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Enrollment has started in RegeneRx Biopharmaceuticals’ $RGRX 500-participants Phase 3 clinical trial, ARISE-2, evaluating lead product candidate RGN-259 (Thymosin beta 4) for the treatment of patients with dry eye syndrome, neurotrophic Keratopathy and other corneal disorders. The primary endpoints are the alteration in ocular discomfort from baseline to the end of treatment (Day 29) and the change in inferior corneal staining from baselines to Day 29 of the trial. The top-line data should be available by Q4, 2017.

Intrexon’s field trial study on Zika dengue using genetically modified mosquitoes in jeopardy-Intrexon’s $XON U.S. filed trial of subsidiary Oxitec’s genetically modified mosquitoes, OX513A, to evaluate their ability to decrease the spread of disease like Zika, dengue,  chikungunyaand Yellow fever, has hit a roadblock. Locals are opposing the trails. The proposed trial will be conducted in Florida’s Key Haven, an island in the lower keys with roughly 1000 residents, most of which are not convinced with the proposal. In a ballot vote on Tuesday, almost 2/3rd of the votes opposed it. However, in a country-side referendum, about 58% of the voters approved it.

 Alexion defers 10-Q on internal Sales Investigation-Alexion Pharmaceuticals’ $ALXN trading got briefly halted on Wednesday in response to its announcement that it has delayed 10-Q as it probes internal sales. The drug-maker submitted a notification of late filing with the SEC as it investigates into sales practices around its product, Soliris (eculizumab). The Audit and Finance Committee has appointed an outside counsel and is probing the practices due to allegations from a former employee.

 Novavax cuts around 1/3 of workforce-Novavax $NVAX shares got hammered in afterhours on Wednesday after it announced downsizing its workforce by 30%. The company recently had a setback after its Phase 3 study of its RSV F-Protein nanoparticle vaccine candidate failed. It has also initiated cost-saving measures in R&D, administration, capex and pre-commercialization activities.  The management expects to cut cash burn by $70M - 100M next year compared to this year.

No approvals to report.

Can-Fite BioPharma $CANF got awarded with a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application for A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction (ED).  The patent relates to methods for treating ED with different A3AR ligands including its candidate CF602, which has a similar mechanism of action to Pfizer's $PFE Viagra (sildenafil).

Bristol-Myers Squibb $BMY and Infinity Pharmaceuticals $INFI will jointly conduct a clinical program evaluating the combination of Opdivo (nivolumab) and Infinity's IPI-549 in patients with advanced solid tumors. The dose escalation phase investigating the combination should commence soon. IPI-549: It is an orally available inhibitor of phosphoinositide-3-kinase (PI3K)-gamma.

No secondary offerings to report.

No IPOs to report.

Keryx Biopharmaceuticals $KERX reported Q3 revenues of $6.3 million, a growth of 50%, Y-o-Y. Operating loss for the quarter was $41.8 million. Net loss was $41.7 million. EPS was -$0.39.

Ionis Pharmaceuticals $IONS reported Q3 revenues of $110.9 million, a growth of 125.9%. Operating income was $16.1 million, an increase of 133.5%, Y-o-Y. Net income for the quarter was $7.4 million, a growth of 120.7%. EPS was $0.06, an increase of 120%, Y-o-Y.

Inovio Pharmaceuticals $INO reported Q3 revenues of $12.5 million, a drop of 48.3%, Y-o-Y. Operating loss was $20.2 million and net loss was $20.8 million. EPS was -$0.28.

Aquinox Pharma $AQXP reported Q3 EPS of -$0.46, beating the guidance by $0.12. Cash, cash equivalents, short-term and long-term investments were at $162.6 million.

XOMA $XOMA reported Q3 EPS of -$2.08, beating the guidance by $0.32. Revenue was $0.64 million, a drop of 69.1%, Y-o-Y, missing the guidance by $0.52 million.

Kite Pharma $KITE reported Q3 EPS of -$1.10, beating the estimate by $0.52. Revenue was $7.34 million, a growth of 44.2%, Y-o-Y, and beating the guidance by $2.4 million.

Aeglea BioTherapeutics $AGLE reported Q3 EPS of -$0.47, beating the guidance by $0.08. Revenue was $1.15 million, an increase by 7.5%, Y-o-Y; but missing the guidance by $0.75 million.

Protalix BioTherapeutics $PLX posted Q3 EPS was -$0.07, beating the guidance by $0.03. Revenue was $4.67 million, a growth of 248.5%, Y-o-Y; and beating the estimate by $2.97 million.

BioDelivery Sciences $BDSI reported Q3 EPS pf -$0.30, missing the guidance by $0.05. Revenue was $3.57 million, a growth of 187.9%, Y-o-Y, missing the estimate by $0.01 million.

Sucampo $SCMP reported Q3 EPS of $0.28, beating the guidance by $0.01. Revenue was $57.87 million, a growth of 73%, Y-o-Y, and beating the estimate by $6.51 million.

MannKind $MNKD reported Q3 EPS of $0.26. Revenue was $162.35 million.

Kadmon Holdings $KDMN (pending) reported Q3 EPS of -$4.23. Revenue was $5.7 million, a drop of 49.5%, Y-o-Y.

MEI Pharma $MEIP posted FQ1 EPS of -$0.12, beating the guidance by $0.03. Revenue was $1.1 million, beating the estimate by $0.47 million.