CRMD Awaits Makeover, INSY In Crosshairs, Plandaí On A High, SNTA Enchants

(RTTNews) - An FDA panel has voted 13-1 recommending the approval of Dapagliflozin, developed by Bristol-Myers Squibb Co. (BMY) in partnership with AstraZeneca (AZN), for the treatment of type 2 diabetes in adults.

The regulatory agency's final decision on Dapagliflozin is slated for Jan. 11, 2014.

CorMedix Inc. (CRMD), which announced the first sales of Neutrolin in the European Union today, believes that 2014 could be a transformational year for the company as it continues working to grow the business in Europe, the Middle East and other geographies and create shareholder value.

Neutrolin, a broad-spectrum antimicrobial/antifungal and anticoagulant combination that reduces the incidence of catheter-related bloodstream infections by working as a catheter lock solution, received CE mark approval early in the second half of 2013.

CRMD closed Thursday's trading at $0.80, up 14.29%.

Insys Therapeutics Inc. (INSY) plunged more than 20 percent to $35.87 in extended trading on Thursday after the company announced that its sales and marketing practices relating to Subsys will be probed by the Office of Inspector General of the Department of Health and Human Services.

Subsys, a Fentanyl product in sublingual spray formulation for the management of breakthrough pain in cancer patients 18 years of age and older, was approved by the FDA last January and has been available since March 2012.

In the third quarter ended September 30, 2013, revenues from Subsys were $28.4 million, up 1,002% over third quarter of 2012 levels and up 53% compared with the second quarter of 2013.

Myriad Genetics, Inc. (MYGN) said that its multi-gene diagnostic test known as myRisk Hereditary Cancer significantly improves detection of women at risk for hereditary breast and ovarian cancer by 51 percent compared to testing for the BRCA1 and BRCA2 genes alone.

myRisk Hereditary Cancer, which represents the next generation of hereditary cancer testing, was launched in September of this year. The test analyzes 25 genes associated with eight major cancers including: breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.

MYGN closed Thursday's trading at $24.25, up 0.87%.

Plandaí Biotechnology's (PLPL) said that its subsidiary, Cannabis Biosciences Inc., will be developing and testing a botanical extract derived from cannabis. The company noted that the phytonutrients in cannabis show excellent potential for treating and preventing a host of neuron and injury related brain diseases including Parkinson's, Alzheimer's, ALS, MS, and post-concussion syndrome.

Plandaí will undertake the profiling of the Phytofare Cannabinoid Complex with in-vitro testing starting within six months and begin animal trials within twelve months. If all goes well as planned, the company expects to eventually gain FDA approval for human clinical trials specifically aimed at a number of neural disorders.

PLPL.OB closed Thursday's trading 4.76% higher at $0.44.

Synta Pharmaceuticals Corp. (SNTA) today announced positive interim results from a phase II study, dubbed ENCHANT-1, evaluating Ganetespib, its lead drug candidate, administered as monotherapy for the treatment of metastatic breast cancer.

The ENCHANT-1 trial has 3 subgroup of breast cancer patients namely, HER2+, triple-negative and ER/PR+/HER2- patients.

A breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells, is HER2+. This type of cancer is said to be more aggressive than the other types. A breast cancer lacking the three receptors commonly found on breast cancer cells namely estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2 is known as triple negative breast cancer. If there are significant number of receptors for either estrogen or progesterone in the breast cancer cells, it is known as ER/PR+.

According to the trial results, Ganetespib monotherapy resulted in objective response (change in tumor size) in 75% of HER2+ patients and achieved disease control in 64% of the triple negative breast cancer patients. The third cohort of ER/PR+/HER2- patients was only recently added to the trial.

Another event to watch out for are the final overall survival results from a phase 2b/3 trial known as GALAXY-1, evaluating Ganetespib in patients with advanced non small cell lung cancer, by early 2014.

VIVUS Inc. (VVUS) has entered into a License and Commercialization Agreement with Sanofi to commercialize erectile dysfunction drug SPEDRA on an exclusive basis in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia. The drug is marketed as Spedra outside the U.S.

The agreement entitles VIVUS to receive up to $61 million in upfront payments, regulatory and sales milestones. The company will also receive escalating royalties based on net sales over the life of the agreement.

VVUS closed Thursday's trading 6.03% higher at $10.03.