Below are seven companies from the
<font> BioMedReports.com FDA Calendar </font> database of over 200 entries, which have pending new drug decision(s) at the FDA combined with a stock price that is below its 200-day moving average (200-DMA). The list includes a balanced mix of two large-caps, two mid-caps, and three small-cap stocks which have been laggards in the overall market rally with looming regulatory catalysts in the form of FDA new drug decisions serving as potential upside catalysts. Data Source: Yahoo! Finance on 6/17/09 during late day trading.
1.) Abbott Labs (NYSE:ABT): Price $46.00, 200-DMA $48.53
On 6/4/09, ABT and AstraZeneca (NYSE:AZN) announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL (bad) cholesterol, high triglycerides and low HDL (good) cholesterol. The NDA submission for this investigational compound, containing the active ingredients of CRESTOR (rosuvastatin) and TRILIPIX (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD. The estimated PDUFA decision date is 4/4/10 for a standard, 10-month review by the FDA.
2.) Eli Lilly (NYSE:LLY): Price $33.46, 200-DMA $34.63
On 6/3/09, LLY announced that it resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain to the FDA. Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Lilly originally submitted the sNDA in the second quarter of 2008 but withdrew the application in November 2008 following discussions with the FDA primarily about statistical methodology and study design.
LLY is also awaiting an overdue decision for its pending EFIENT (prasugrel) NDA - acute coronary syndrome (ACS) - 2/3/09 unanimous FDA panel recommendation for approval - 2/23/09 announcement of approval in Europe for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI).
3.) OSI Pharma (NASDAQ:OSIP): Price $28.65, 200-DMA $35.61
Supplemental new drug application (sNDA) to expand the labeled use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Both the U.S. and EU submissions are based on a pivotal Phase 3 placebo-controlled, randomized, double-blind trial known as SATURN. On 5/30/09, OSIP announced that median progression-free survival was 4.8 months for the combination therapy of Tarceva (erlotinib) and Avastin (bevacizumab) versus 3.7 months for the placebo group in a 768-patient Phase 3 ATLAS study of patients with advanced cases of lung cancer. Tarceva is co-marketed by OSIP and Roche (OTC:RHHBY). The estimated PDUFA action date for a possible FDA decision on the sNDA is 1/18/10.
4.) Dyax Corp. (NASDAQ:DYAX): Price $2.03, 200-DMA $2.51
On 6/8/09, DYAX announced today that the FDA accepted the Company’s submission in response to the FDA’s March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.
5.) XenoPort (NASDAQ:XNPT): Price $20.56, 200-DMA $21.14
Solzira (gabapentin enacarbil) NDA - treatment of moderate to severe restless leg syndrome. NDA Accepted 3/16/09 Solzira (gabapentin enacarbil) Extended Release Tablets in the United States as a potential treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). In accordance with XenoPort’s collaboration agreements with GSK and Astellas Pharma, the FDA’s acceptance of the NDA triggers milestone payments to XenoPort of $23 million in the aggregate.
6.) GTx Inc. (NASDAQ:GTXI): Price $8.60, 200-DMA $11.60
Toremifene 80 mg NDA (standard 10-month review) for bone loss due to prostate cancer. Toremifene 80 mg is an oral selective estrogen receptor modulator which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT). ADT is primary treatment for advanced prostate cancer. In the United States, approximately 700,000 men with prostate cancer are being treated with ADT and an estimated 100,000 initiate ADT each year.
7.) Endo Pharma (NASDAQ:ENDP): Price $17.38, 200-DMA $19.54
On 3/12/09, Endo Pharma’s majority-owned subsidiary Indevus Pharma announced that the FDA accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting 9/2/09 as the PDUFA action date for a possible decision on the NDA. Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.
Disclosure: No positions.
$33.43 (06/17/09)
