FENC On Fast Track, SPHS To Report Data In Q2, REGN, ALNY Team Up For NASH

(RTTNews) - Today's Daily Dose brings you news about the collaboration inked between Regeneron and Alnylam; progress in Edwards Lifesciences' PARTNER 3 trial; Sophiris Bio's near-term clinical trial catalyst; FDA approval of Lucentis 0.3 mg prefilled syringe and Fast Track designation for Fennec's investigational drug PEDMARK.

Read on…

Cronos Group Inc. (CRON) (CRON.V) has entered into an agreement with a syndicate of underwriters co-led by GMP Securities L.P. and BMO Capital Markets to sell 10.42 million common shares on a "bought deal" basis, at a price of $9.60 each.

The gross proceeds from the offering are expected to be approximately $100.0 million ($115.0 million if the over-allotment option is exercised in full). The offering is expected to close on or about April 6, 2018.

Cronos Group is a Canadian licensed producer and distributor of medical cannabis.

On March 19, 2018, Cronos Group and MM Enterprises USA, LLC, a leading U.S. cannabis company with facilities in California, Nevada, and New York, entered into an agreement to form a first-of-its-kind cross border joint venture. The joint venture, called MedMen Canada Inc. will develop branded cannabis products and open stores across Canada by year's end.

CRON closed Wednesday's trading at $8.00, down 2.32%.

Edwards Lifesciences Corp. (EW) has completed enrollment in the computed tomography imaging sub-study within the PARTNER 3 trial of the SAPIEN 3 valve.

This randomized sub-study is examining leaflet mobility of both the SAPIEN 3 valve and surgical heart valves in low-risk patients undergoing valve replacement for the treatment of severe aortic stenosis.

Data from the PARTNER 3 main study of the SAPIEN 3 valve in low-risk patients is expected to be presented at the American College of Cardiology Scientific Sessions 2019, and expects to receive FDA approval for the indication late that year.

EW closed Wednesday's trading at $139.07, down 1.61%.

Fennec Pharmaceuticals Inc.'s (FENC) (FRX.TO) investigational drug PEDMARK has been granted Fast Track designation by the FDA for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).

PEDMARK, a unique formulation of sodium thiosulfate, has successfully completed phase III testing. The Company plans to pursue regulatory approvals with FDA and EMA this year.

There are currently no drugs approved in the US for cisplatin-related hearing loss. Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

FENC closed Wednesday's trading at $10.35, up 6.70%.

Regeneron Pharmaceuticals Inc. (REGN) and Alnylam Pharmaceuticals, Inc. (ALNY) have teamed up to identify RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases.

Under the discovery collaboration, Regeneron will contribute research on the hepatocyte-expressed, genetically-validated HSD17B13 target, and Alnylam will leverage its RNAi therapeutics platform to identify compounds directed to this target. Regeneron and Alnylam intend to enter into a separate, fifty-fifty collaboration to further research, co-develop and commercialize any therapeutic product candidates that emerge from these discovery efforts.

REGN closed Wednesday's trading at $334.87, up 0.30%.

The FDA has approved Roche's (RHHBY.OB) Lucentis 0.3 mg prefilled syringe as a new method of administering the medicine to treat all forms of diabetic retinopathy. The Lucentis 0.3 mg PFS is expected to be available in the second quarter of 2018.

Lucentis 0.3 mg vial was approved by the FDA in April 2017 to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME), a complication of the eye disease that causes swelling in the back of the eye.

The Lucentis 0.5 mg PFS received FDA approval in October 2016 for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).

Roche's subsidiary Genentech holds the rights to commercialize Lucentis in the US, and Novartis holds the rights to commercialize the product outside of the U.S. For the full year 2017, Lucentis' US sales were about $1.5 billion, and sales of the drug outside the US totaled $1.9 billion.

RHHBY.OB closed Wednesday's trading at $28.74, up 0.21%.

Streamline Health Solutions Inc. (STRM) has signed a contract with Washington Regional Medical Center to offer its eValuator technology, a new cloud-based automated pre-bill coding analysis technology.

Ashley Moser, RHIT, Director of Revenue Integrity, Washington Regional Medical Center, said, "We were looking for an innovative new way to help us improve our revenue integrity and came across Streamline Health's eValuator. Our goal in deploying eValuator is to improve our coding accuracy by analyzing every patient record before we bill them. An analysis of some of our previously billed records clearly showed opportunities we could improve upon, both in capturing more revenue for the care we had provided, and in helping us mitigate revenue risk."

STRM closed Wednesday's trading at $1.65, down 2.37%.

Sophiris Bio Inc. (SPHS) has an important catalyst to watch out for in the second quarter.

The Company's phase 2b study of Topsalysin in treating men with clinically significant localized prostate cancer has completed enrollment, and a total of 38 patients have been treated with the drug candidate.

The Company expects biopsy data from all patients in the phase II study receiving the first dose of Topsalysin to be available by the end of the second quarter of 2018, and final biopsy data in the fourth quarter of 2018 from all patients who receive a second administration of Topsalysin.

SPHS closed Wednesday's trading at $2.16, up 0.93%.