Sepracor (SEPR) says it received an "approvable" letter from the FDA for its New Drug Application for Estorra brand eszopiclone. Deutsche Bank upgraded the stock to buy from hold.
Analyst David Steinberg says the company's insomnia drug Estorra is critical to its profit outlook over the next several years. He notes several positive factors: 1) no further clinical/preclinical trials are needed for final approval; 2) no ST limitation in usage as there is with market leader Ambien; 3) inclusion of company's six month chronic use study in draft label; 4) approval of 3 dosage strengths vs. expectation of two.
Steinberg says Estorra's approvability creates a near-term pathway to profits, reducing concerns over the company's debt. He sees $2.31 loss per share in 2004. He ups $28 12-month price target to $39.