The following five healthcare stocks made headlines on Tuesday following company releases.
Medtronic (MDT) after hours released a statement from its CEO on a series of articles that questioned the company's recombinant human Bone Morphogenetic Protein-2 (rhBMP-2). "While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold. Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in applications not covered by FDA labeling." The stock rose 1.1% during the day but fell after hours.
Amgen (AMGN) rose 1.3% after it announced the submission of a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone. The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating Xgeva versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.
Pfizer (PFE) jumped 1.9% after it announced that the FDA accepted Pfizer’s filing for standard review of axitinib for patients with advanced renal cell carcinoma. This submission was based on Phase 3 data from the AXIS 1032 trial, comparing axitinib with sorafenib in patients with previously treated advanced RCC.
Abiomed (ABMD) tumbled 5% after it received a warning letter from the FDA. The FDA noted that it has learned that the firm is marketing the IMPELLA RECOVER LP 2.5 Percutaneous Cardiac Support System device in the United States without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The Office of Compliance requests that ABIOMED immediately cease marketing the IMPELLA RECOVER LP 2.5 for unapproved uses.
AdCare Health Systems (ADK) rallied 10% after it signed a definitive agreement to acquire, lease or become the manager of 15 skilled nursing facilities in South Carolina, North Carolina, Virginia and Tennessee for $38.5 million. Two of the facilities are to be purchased, nine leased, and four managed by AdCare. The facilities have an aggregate of 1,995 beds and generate an estimated $93 million in gross annualized revenues according to their most recent financials. They are expected to be immediately accretive to AdCare's earnings after the transaction closes as planned in the fall. The company plans to fund the transaction with a combination of cash, shares of AdCare common stock, and seller notes.