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Stock Market & Financial Investment News

News Breaks
July 28, 2014
06:11 EDTBIODBiodel enters into $15M equity commitment with Lincoln Park Capital
Biodel announced that it has entered into a stock purchase agreement with Lincoln Park Capital Fund, or LPC, a Chicago-based institutional investor. Under the terms of the purchase agreement, Biodel will have the right to sell to LPC, and LPC will be obligated to purchase, up to $15M in shares of Biodel's common stock, subject to the limitations and conditions set forth in the agreement. Biodel intends to use any proceeds that it receives from the sale of shares under the purchase agreement for general corporate purposes and working capital requirements. Under the terms of the purchase agreement and related registration rights agreement, Biodel has agreed to file with the SEC a registration statement covering the shares that may be issued to LPC under the purchase agreement. Sales under the purchase agreement may take place over the 36-month period after the registration statement is declared effective by the SEC.
News For BIOD From The Last 14 Days
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March 19, 2015
16:59 EDTBIODBiodel files to sell $30M of common stock
March 16, 2015
07:27 EDTBIODBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.

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