Apr 11, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks Buzz: Amicus Therapeutics, Inc (NASDAQ:FOLD), Radius Health Inc (NASDAQ:RDUS), VIVUS Inc (NASDAQ:VVUS)

Stocks Buzz: Amicus Therapeutics, Inc (NASDAQ:FOLD), Radius Health Inc (NASDAQ:RDUS), VIVUS Inc (NASDAQ:VVUS)

Amicus Therapeutics, Inc (NASDAQ:FOLD) stock is at $8.11, down -1.70 percent from its previous close of $8.25. The stock opened the session at $8.47 and touched its highest price point at $8.47. The company’s stock’s lowest price point for the session stood at $7.96. Its yesterday’s volume is 1.98 million shares in comparison to its usual trading volume of 3.06 million shares.

Amicus Therapeutics, Inc (NASDAQ:FOLD) on April 1, 2016 announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to approve the oral small molecule pharmacological chaperone migalastat as a first line therapy for Fabry disease in all patients who have an amenable genetic mutation. A final decision from the European Commission (EC) is expected in the second quarter of 2016, after which the Company will begin the country-by-country reimbursement processes. The label approved by the CHMP includes 269 Fabry causing mutations which represent up to half of all patients with Fabry disease.

The CHMP based its opinion on clinical data from Phase 3 pivotal studies in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT), as well as ongoing long-term extension studies.

Based on the positive CHMP opinion, the company expects to increase net cash spend in support of commercialization activities. This increase in net cash spend on a go-forward basis is expected to be 10-15% over the company’s initial full-year 2016 net cash spend guidance of between $135 million and $155 million.

Radius Health Inc (NASDAQ:RDUS) stock is at $35.44, down -4.42 percent from its previous close of $37.08. Its yesterday’s volume is 1.86 million shares in comparison to its usual trading volume of 1.53 million shares. Previous 5 days graph demonstrated a positive move of 2.22%. Its quarterly performance remained red with the percentage of -29.79, while its year to date performance showed that the stock plunged overall -43.25%.

Radius Health Inc (NASDAQ:RDUS) on April 1, 2016 announced results from pre-specified subgroup analyses from its Phase 3 ACTIVE trial. The results demonstrate that Radius’ investigational drug, abaloparatide-SC injection, reduced the risk of vertebral and nonvertebral fractures and increased bone mineral density (BMD) consistently in postmenopausal women with osteoporosis regardless of baseline patient characteristics. These data were presented at the Endocrine Society (ENDO) 2016 Annual Meeting in Boston. Radius will also present an update at the Meeting on investigational drug RAD1901, a novel oral estrogen receptor ligand being studied at low doses for potential treatment of moderate to severe hot flashes (vasomotor symptoms) associated with menopause.

The Phase 3 ACTIVE trial is a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of the investigational drug abaloparatide-SC 80 mcg in the reduction of risk of vertebral and nonvertebral fractures.

VIVUS Inc (NASDAQ:VVUS) traded in the range of $1.64 and $1.79 in its previous trading session. The stock recorded the volume of 1.82 million shares so far, in comparison its average daily trading volume of 1.26 million shares. Company’s year to date performance remained quiet optimistic with the rise of 66.34%. The stock opened at $1.79 and its closing price for the day was $1.79, down -4.00 percent from its previous close.

VIVUS Inc (NASDAQ:VVUS) on March 9, 2016 reported its financial results for the fourth quarter and year ended December 31, 2015. The net loss for the 2015 fourth quarter was $12.2 million as compared to $25.4 million in 2014. The net loss for the twelve months ended December 31, 2015 was $93.1 million as compared to $82.6 million in 2014. Cash, cash equivalents and available-for-sale securities was $241.6 million at December 31, 2015.

Total revenue, net for the quarter and year ended December 31, 2015 was $15.3 million and $95.4 million, respectively, compared to $21.7 million and $114.2 million in the same periods in 2014, respectively. Approximately 132,000 and 566,000 Qsymia prescriptions were dispensed in the quarter and year ended December 31, 2015, respectively, compared to 136,000 and 534,000 in the same periods in 2014, respectively.

Total cost of goods sold, excluding inventory impairment, was $2.6 million and $34.2 million in the quarter and year ended December 31, 2015, respectively, compared to $9.6 million and $33.4 million in the same periods of 2014, respectively. Total selling, general and administrative expense was $13.7 million and $79.4 million for the quarter and year ended December 31, 2015, respectively, compared to $26.8 million and $111.5 million in the same periods in 2014, respectively. Selling and marketing expense for the commercialization of Qsymia totaled $8.6 million and $53.0 million in the quarter and year ended December 31, 2015, respectively, compared to $17.8 million and $72.3 million in the same periods in 2014, respectively.

 

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