These stocks saw increased downside pressure on Monday, despite the broad market closing higher.
Pain Therapeutics (PTIE) and Durect (DRRX) tumbled for the second day in a row, after Pain Therapeutics released additional information on the Remoxy FDA Complete Response Letter received last week. The company said that the FDA's Complete Response Letter raised concerns related to, among other matters, the Chemistry, Manufacturing, and Controls section of the NDA for Remoxy. Certain drug lots showed inconsistent release performance during in vitro testing. In the opinion of Pain Therapeutics, potential regulatory approval of Remoxy in the U.S. is unlikely to occur in less than one year, and could be delayed significantly longer than a year. Durect fell 9% while Pain Therapeutics fell 26%.
Universal Forest Products (UFPI) fell nearly 10% after announcing measures to align its costs with its current business, primarily due to significantly weaker-than-expected sales in the first five months of the year. Specifically, from the same period of 2010, year-to-date net sales through May 2011 were down 9.5% to $765 million, including a decline of 15.0% in net sales to retail customers. In addition, contrary to typical seasonal trends, the lumber market declined for 11 consecutive weeks from March 2011 through the end of May 2011. That decline, coupled with significantly higher fuel prices, contributed to a decline in gross margin to 10.5%, or a year-to-date decline of 2.2% in May 2011 from the same period of 2010. The decline in year-over-year net sales was due, in part, to lower lumber prices in 2011. The company has identified cost reductions that will result in annualized savings of $10 million, before one-time charges for severances related to the reductions.
Columbia Laboratories (CBRX) closed down 5% after announcing the withdrawal for its request for a priority review for the Prochieve NDA. First, Watson Pharmaceuticals (WPI) announced that the FDA accepted for filing Columbia's NDA for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Second, Columbia noted that it has voluntarily withdrawn its request for priority review. Following discussions with FDA, the companies determined that a standard review would afford the agency the appropriate timeframe necessary to complete its review of the application, including empaneling an agency advisory committee, if necessary.
These stocks saw increased downside pressure on Tuesday, going against the tide of the stock market rally.
Cellcom Israel (CEL) fell 4% after it announced that Discount Investment Corporation (DIC) announced it is considering selling up to 5% of the company's issued share capital. DIC also said that it entered into an agreement with a financial institution to sell 3,260,870 shares of Company stock, constituting approximately 3.3% of the Company's issued share capital, for a total consideration of NIS 300 million in cash.
Spectrum Brands Holdings (SPB) closed 2% lower after it filed a Form S-3 registration statement with the SEC under which 1,000,000 shares of its common stock and 5,495,489 shares of the Company’s common stock held by Harbinger Capital Partners Master Fund I, will be offered to the public.
Penn Virginia (PVA) fell 3% after provided an update of its activity in the Marcellus Shale. The company said that peak 24-hour production rates from its first three Marcellus horizontal wells, the Risser #A-1H, Risser #A-2H and Dunn #A-1H, were approximately 3.1, 2.8 and 4.0 million cubic feet (MMcf) per day, with an average rate over a 72-hour test period of 2.1, 1.7 and 2.7 MMcf per day, respectively. Pipeline construction is in progress with sales expected to begin by early August. The CEO added that the Marcellus Shale test wells had initial production rates which fell short of the company’s expectations.
Abiomed (ABMD) tumbled 5% after it received a 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.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.