Cynosure, Inc. (NASDAQ:CYNO): CEO Michael Davin commented: “With Cellulaze now FDA cleared, we are in the process of establishing several U.S. physician training centers and completing launch preparations,” Davin said. “We expect to begin introducing the product in North America by the end of Q1, and accelerate production as we move through 2012.”
The shares closed at $16.44, up $2.55, or 18.36%, on the day. Its market capitalization is $206.57 million.
LCA-Vision Inc. (NASDAQ:LCAV): Reports Q4 total procedure volume up 30% to 14,205 procedures
The shares closed at $6.68, up $0.78, or 13.22%, on the day. Its market capitalization is $125.91 million.
LHC Group, Inc. (NASDAQ:LHCG) is exploring M&A options, DealReporter says.
The shares closed at $17.13, up $1.76, or 11.45%, on the day. Its market capitalization is $322.19 million.
Vanda Pharmaceuticals Inc (NASDAQ:VNDA): Reports Q4 revenue $8.37M vs. consensus $8.2M. (One analyst estimate)
The shares closed at $4.80, down $0.31, or 6.07%, on the day. Its market capitalization is $134.96 million.
Johnson & Johnson (NYSE:JNJ): In an oral hearing that took place yesterday, Johnson & Johnson (NYSE:JNJ) attempted to ease EU concerns that its planned $21.3B purchase of medical devices maker Synthes would hurt competition, reported Reuters, citing an European Commission spokesperson.
The shares closed at $64.61, down $0.07, or 0.11%, on the day. Its market capitalization is $176.44 billion.
Gilead Sciences, Inc. (NASDAQ:GILD) announced that the U.S. FDA has accepted the supplemental New Drug Application, or sNDA, and granted a six-month Priority Review for once-daily Truvada – emtricitabine/tenofovir disoproxil fumarate – for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the U.S. The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists. Gilead submitted the Truvada for PrEP sNDA on Dec. 15, 2011. The FDA has set a target review date for Truvada for PrEP under the Prescription Drug User Fee Act, or PDUFA, of June 15. The agency has also indicated that Truvada for PrEP will be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May. If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV.
The shares closed at $54.56, down $0.35, or 0.63%, on the day. Its market capitalization is $41.09 billion.
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