Biomimetic Receives FDA Clarification Request and 4 Stocks Hitting 52-Week Highs

Biomimetic Therapeutics (NASDAQ:BMTI): Closing Price $7.74

BioMimetic Therapeutics said that it has received an informal request for clarification from the FDA comprised of six questions, some with multiple subparts, linked to the Augment Bone Graft Pre-Market Approval review. The firm explained that “These questions focused on the specific characteristics and etiology of the bone defects treated in the pivotal trial, an assessment of the medical relevance, or lack thereof, of certain protocol deviations, further information relating to the recently supplied operative notes and specific statistical clarifications. BioMimetic said it is supplying a response to individual questions as each response is completed and that the responses “will further support the safety and efficacy of Augment.” Shares closed up 1.84 percent on the day at $7.74, having been traded in a 52-week range of $1.87 to $7.85.

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Celgene Corporation (NASDAQ:CELG): Closing Price $85.73

Celgene International reported that statistical significance for the primary endpoint of PASI 75 at week 16 was met for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 phase III studies. ESTEEM 1 & 2 are the two pivotal phase III, randomized, placebo-controlled studies which are evaluating apremilast, the firm’s oral small-molecule inhibitor of phosphodiesterase 4 in patients suffering from moderate to severe chronic plaque psoriasis. Patients taking apremilast also achieved a statistically significant benefit compared to placebo in the major secondary endpoint, Static Physician Global Assessment. An NDA submission for psoriasis, based on ESTEEM 1 & 2 data, is anticipated in the second half of the current year. Celgene previously said that it expects to file an NDA for psoriatic arthritis in the first quarter and a combined MAA for psoriasis and psoriatic arthritis in Europe in the second half of the year. Shares closed up 4.43 percent on the day at $85.73, and have been traded in a 52-week range of $58.53 to $83.17.

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Acorda Therapeutics (NASDAQ:ACOR): Closing Price $28.34

Acorda estimates other revenue of $25 million (FAMPYRA and Zanaflex), which includes $9.1 million in amortized license revenue. The numbers are from slides that will be presented at the 31st Annual JP Morgan Healthcare Conference. Shares closed up 2.13 percent on the day at $28.34, having been traded in a 52-week range of $21.04 to $27.89.

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Alliance Data System (NYSE:ADS): Closing Price $154.41

Alliance Data reported that its Canadian coalition loyalty division has reached a new agreement with General Motors Company of Canada Limited (NYSE:GM), to issue Air Miles reward miles during key promotional periods for new vehicle purchase and leases at Canadian dealerships, effective in January. Shares closed up 2.19 percent on the day at $154.41, and have been traded in a 52-week range of $102.37 to $152.48.

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Astro-Med (NASDAQ:ALOT): Closing Price $10.45

Astro-Med and Natus Medical Incorporated (NASDAQ:BABY) have agreed that Natus will purchase the Grass Technologies Product Group from Astro-Med. The Group includes clinically differentiated neurodiagnostic and monitoring products, among which include a portfolio of polysomnography and electroencephalography systems for both clinical and research use and related accessories and proprietary electrodes. The transaction should close on January 31st. The buyer will pay for the approximate $18.6 million cash purchase price with existing cash and borrowings under its credit facility. The seller reported revenue from the Grass segment of $18.5 million for the fiscal year ended January 31st. Astro-Med will keep its Grass manufacturing facility and the parties have made an agreement whereby Astro-Med will continue to manufacture the Grass products and supply other transition services for a period of time, after which Natus will buy any remaining inventory. Shares closed up 2.35 percent on the day at $10.45, having been traded in a 52-week range of $7.50 to $10.40.

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