Biodel Inc.’s (BIOD) shares are up 4.13% following the company’s first quarter of fiscal 2014 (ending Dec 2013) earnings report. Biodel reported a loss of 12 cents per share, narrower than the year-ago loss of 26 cents and the Zacks Consensus Estimate of a loss of 19 cents per share.
Biodel did not generate any revenues in the reported quarter and also in the year-ago comparable quarter.
Quarter in Details
Research and development (R&D) expenses decreased 21.3% to $3.7 million because the decline represented the completion of the phase II study on BIOD-123.
General and administrative expenses remained flat at $1.4 million.
Biodel finished dosing patients in the phase I study (3-150) being conducted on lead candidate BIOD-531. The study is comparing BIOD-531 to Eli Lilly’s (LLY) Humulin R U-500 and Humalog Mix 75/25. Topline results are expected later this month.
Meanwhile, Biodel is progressing with the development of the EZMix GEM program for the rescue treatment of severe hyperglycemia. The company intends to complete a dose-ranging study so that a toxicology study can commence and file an Investigational New Drug (IND) application in the third quarter of calendar 2014. Pivotal studies should commence in the fourth quarter of calendar 2014. Biodel intends to file an NDA for GEM next year.
Biodel carries a Zacks Rank #2 (Buy). We expect investor focus to remain on pipeline updates.
Some better-ranked stocks in the same sector include Endocyte, Inc. (ECYT) and Forest Laboratories Inc. (FRX), with both carrying a Zacks Rank #1 (Strong Buy).
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