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Last $1.18 USD
Change Today 0.00 / 0.00%
Volume 122.8K
BIOD On Other Exchanges
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As of 8:10 PM 03/30/15 All times are local (Market data is delayed by at least 15 minutes).

biodel inc (BIOD) Snapshot

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04/2/14 - $2.94
52 Week Low
03/24/15 - $1.14
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biodel inc (BIOD) Details

Biodel Inc., a specialty biopharmaceutical company, focuses on the development and commercialization of treatments for diabetes in the United States. Its lead product candidate is a glucagon emergency management (GEM) device that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. The company is conducting a Phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of BIOD-961, the reconstituted glucagon formulation intended for use in the GEM device. It also develops ultra-rapid-acting proprietary insulin formulations, such as BIOD-123, which has been evaluated in a Phase 2 clinical trial combining recombinant human insulin with its proprietary combination of excipients; and BIOD-531, a concentrated ultra-rapid-acting insulin formulation. The company was founded in 2003 and is headquartered in Danbury, Connecticut.

30 Employees
Last Reported Date: 12/19/14
Founded in 2003

biodel inc (BIOD) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $688.4K
Chief Medical Officer
Total Annual Compensation: $437.0K
Chief Administrative Officer, Vice President ...
Total Annual Compensation: $334.2K
Compensation as of Fiscal Year 2014.

biodel inc (BIOD) Key Developments

Biodel Mulls Acquisitions

Biodel Inc. (NasdaqCM:BIOD) is looking for acquisitions. Biodel Inc. has filed a follow-on equity offering and intends to use the net proceeds from this offering for operating costs, capital expenditures and for general corporate purposes, including working capital. Biodel Inc. may also use a portion of the net proceeds to invest in or acquire businesses or technologies that are complementary to their own.

Biodel Inc. Approves Amendment to the Second Amended and Restated Certificate of Incorporation

Biodel Inc. at its annual meeting of stockholders 2015 held on March 17, 2015, approved the amendment to the company's Second Amended and Restated Certificate of Incorporation, as amended, to effect an increase in the number of shares of authorized common stock, par value $0.01 per share, from 62,500,000 shares to 200,000,000 shares.

Biodel Inc. Announces Positive Preliminary Results from Study 6-101, a Phase 1 Clinical Trial

Biodel Inc. 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 (GEM) auto-reconstitution device, to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM), 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 (SC) and intramuscularly (IM) in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic (PK) profiles, the pharmacodynamic (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. Overall, PK and PD (glucose response) profiles among all three glucagon formulations were statistically indistinguishable. Although this study was designed as an exploratory comparison of PK and PD profiles, standard regulatory criteria for PK and PD bioequivalence were satisfied when comparing BIOD-961 to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen(R) HypoKit(TM). As expected, nausea was the most common adverse event for all glucagon formulations. The incidence of adverse events was similar among treatments. Biodel formulated BIOD-961 for use in a user-friendly injection device, referred to as the Glucagon Emergency Management (GEM) system. The GEM device is a customized version of an auto-reconstitution syringe developed by Unilife Corporation. The device is specifically designed to address and expand an underserved market currently wrestling with cumbersome glucagon kits that are especially difficult to use and operate during an emergency for the treatment of severe hypoglycemia. This is the first glucagon formulation in development for the treatment of severe hypoglycemia which has demonstrated comparable pharmacokinetic and pharmacodynamic profiles to marketed glucagon formulations. In addition to the pivotal clinical trial, a human factors study is planned for the first half 2015 to compare the usability of the GEM device to the existing manually reconstituted commercial glucagon kits in the hands of representative caregivers, with the final pivotal human factors study expected to be completed by the end of 2015. The company plans to request an end-of-Phase 2 meeting with the FDA in the second calendar quarter of 2015 and submit the NDA in mid-2016.


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