Apr 22, 2016

Posted by in Biotech Stocks | 0 Comments

Traders Alert: Amgen Inc (NASDAQ:AMGN), ACADIA Pharmaceuticals Inc (NASDAQ:ACAD), Amicus Therapeutics Inc (NASDAQ:FOLD)

Traders Alert: Amgen Inc (NASDAQ:AMGN), ACADIA Pharmaceuticals Inc (NASDAQ:ACAD), Amicus Therapeutics Inc (NASDAQ:FOLD)

Amgen Inc (NASDAQ:AMGN) surged +0.98% and ended at $164.35. The total traded volume was 2.35 million shares and market capitalization arrived at $123.77 billion. The stock has a 52-week high price of $181.81 and its 52-week low was recorded at $130.09, while during last trade its minimum price was $162.03 and it gained the highest price of $164.54.

On April 1, 2016, Amgen Inc (NASDAQ:AMGN) and UCB (UCB) announced detailed Phase 3 results showing the investigational agent romosozumab demonstrated a statistically significant increase in hip bone mineral density (BMD) and strength compared with teriparatide in postmenopausal women with osteoporosis transitioning from bisphosphonate treatment. The data, from the randomized, open-label, international, multi-center STRUCTURE study (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy), were presented during an oral session at ENDO 2016, the Endocrine Society’s 98th Annual Meeting & Expo in Boston.

The trial included 436 women, averaging 72 years of age, with postmenopausal osteoporosis, a history of non-vertebral fracture after the age of 50, or vertebral fracture and treatment with bisphosphonate therapy for a minimum of three years prior to transitioning to romosozumab or teriparatide therapy. The women were randomly assigned to receive either subcutaneous romosozumab 210 mg once monthly (n=218) or subcutaneous teriparatide 20 mcg daily for 12 months (n=218).

The results showed that the percent change from baseline in BMD at the total hip through month 12 (the primary endpoint, an average of the percent change from baseline at month six and 12), was significantly greater with romosozumab compared with teriparatide: 2.6 percent versus –0.6 percent, respectively (pp

ACADIA Pharmaceuticals Inc (NASDAQ:ACAD) reported the increase of +1.02% to close at $33.69 with the overall traded volume of 2.27 million shares. Its market capitalization on last close reached to $3.76 billion. Its beta value stands at 3.72 times. The company has the total of 112.64 million outstanding shares. Its intraday-low price was $33.00 and its hit its day’s highest price at $34.22.

ACADIA Pharmaceuticals Inc (NASDAQ:ACAD) on March 29, 2016 announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease outweigh the risks of treatment.

The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID New Drug Application (NDA) is May 1, 2016. The FDA has granted the NUPLAZID NDA Priority Review status and designated NUPLAZID for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.

The Advisory Committee provides the FDA with independent expert advice and recommendations on the safety and efficacy of potential new medicines. The FDA is not bound by the Committee’s recommendation, but takes its advice into consideration when reviewing new drug applications.

Amicus Therapeutics Inc (NASDAQ:FOLD) moved up +2.95% to settle at $8.03. Its total traded volume during last trading session was 2.20 million shares. The overall market worth of this company is about $1.03 billion. The 52 week range of the stock remained $4.99 – $18.83, while its day’s lowest price was $7.74 and its hit its day’s highest price at $8.10. The beta of this stock currently stands at 1.79.

Amicus Therapeutics Inc (NASDAQ:FOLD), a biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines for various rare and orphan diseases. Its principal product is the migalastat HCl, a small molecule, which has completed Phase III studies that can be used as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease. The company is also developing SD-101, which is in Phase III clinical study for the treatment of the genetic connective tissue disorder epidermolysis bullosa; ATB200 that is in Phase II studies to treat pompe disease; AT2221, which is in Phase II studies for the treatment of pompe disease; and AT3375 to treat Parkinson’s disease.


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