Abiomed Inc. (ABMD: Quote) has enrolled the first patient in RECOVER RIGHT, an Investigational Device Exemption study of Impella RP (Right Peripheral).
The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient’s leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure.
The RECOVER RIGHT clinical study is designed to enroll 30 patients who have signs of right side heart failure, require hemodynamic support, and are being treated in the catheterization lab or cardiac surgery suite.
ABMD closed Monday’s trading at $18.30, down 1.98%.
Shares of Actavis Inc. (ACT: Quote) touched an all time high of $93.13 on Monday following a favorable court ruling in a patent suit related to the company’s generic version of AstraZeneca’s asthma medication Pulmicort RESPULES.
The United States District Court for the District of New Jersey has ruled that Actavis’ generic version of AstraZeneca’s Pulmicort RESPULES 0.25, 0.5 mg, and 1 mg vials do not infringe AstraZeneca’s patents. Actavis intends to launch the 0.25 and 0.5 mg products immediately.
Arena Pharmaceuticals Inc. (ARNA: Quote) announced Monday that its U.S. marketing partner Eisai Inc. has submitted a marketing authorization application for weight-loss drug BELVIQ in Mexico. The MAA submission triggers a milestone payment of $500,000 to Arena from Eisai.
ARNA closed Monday’s trading at $8.02, down 2.31%.
BioCryst Pharmaceuticals Inc. (BCRX: Quote) on Monday received a preliminary comment letter from the FDA outlining a pathway for filing a New Drug Application for Peramivir, the company’s intravenously administered investigational anti-viral agent against influenza A and B viruses.
The company has been asked to request a pre-NDA meeting with the FDA to reach agreement on a complete NDA submission and to address review issues identified in the preliminary comment letter.
BCRX closed Monday’s trading 15.97% higher at $1.38.
Shares of Bovie Medical Corp. (BVX: Quote) touched a new 52-week high of $3.90 on Monday before closing at $3.74 after reporting higher net income and sales for the year ended December 31, 2012 and fourth quarter.
Idera Pharmaceuticals Inc. (IDRA) said Monday that it has completed dosing in its phase I trial of IMO-8400, an investigational drug for the treatment of autoimmune diseases, in healthy subjects. The company’s protocol for a phase II study of IMO-8400 in patients with psoriasis has also been cleared by the Competent Authority of the Netherlands.
IDRA closed Monday’s trading at $0.47, down 6%.
Immunomedics Inc. (IMMU: Quote) on Monday announced that it has settled Financial Industry Regulatory Authority, or Finra, arbitration proceedings relating to its prior investment in certain securities. Pursuant to the settlement, the company expects to receive a net settlement amount of about $16.7 million after payment of expenses and legal fees.
IMMU closed Monday’s trading 1.24% higher at $2.44.
Insmed Inc. (INSM: Quote) has appointed Matthew Pauls as Chief Commercial Officer. Pauls will have full global commercial responsibility for the company’s lead drug candidate ARIKACE, which is under development to treat Pseudomonas aeruginosa lung infections in cystic fibrosis patients and patients with non-tuberculous mycobacteria lung infections.
LipoScience Inc. (LPDX: Quote) announced Monday that its common stock has been selected for inclusion in the Russell 3000(R) Index and its subset, the Russell 2000(R) Index, effective as of March 28, 2013.
LPDX closed Monday’s trading at $9.77, down 7.04%.
MusclePharm Corp. (MSLP.OB) touched a new 52-week high of $11.89 on Monday before closing at $10.03 after reporting record results for the year ended December 31, 2012.
While net loss narrowed to $18.9 million in 2012 from $23.3 million in 2011, the company’s net sales rose 290% to $67.1 million in 2012.
As part of strengthening its management team, Opexa Therapeutics Inc. (OPXA: Quote) has appointed Karthik Radhakrishnan as CFO, Kenny Frazier as Vice President of Clinical Development and Regulatory Affairs and Maryann Murray as Clinical Development Manager.
OPXA closed Monday’s trading at $2.21, down 5.56%.
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