Last $1.36 USD
Change Today +0.01 / 0.74%
Volume 82.5K
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As of 8:10 PM 02/27/15 All times are local (Market data is delayed by at least 15 minutes).

biodel inc (BIOD) Key Developments

Biodel Inc. Reports Unaudited Consolidated Financial Results for the First Quarter Ended December 31, 2014

Biodel Inc. reported unaudited consolidated financial results for the first quarter ended December 31, 2014. For the quarter, the company reported a net loss of $2.443 million or $0.12 per basic and diluted share compared to a net loss of $4.7 million or $0.20 per basic and diluted share a year ago. Loss before tax provision was $2.44 million against $4.7 million a year ago.

Biodel Inc. to Report Q1, 2015 Results on Feb 12, 2015

Biodel Inc. announced that they will report Q1, 2015 results at 5:00 PM, US Eastern Standard Time on Feb 12, 2015

Biodel Inc., Q1 2015 Earnings Call, Feb 12, 2015

Biodel Inc., Q1 2015 Earnings Call, Feb 12, 2015

Biodel Inc. - Special Call

To discuss the positive preliminary results from Study 3-151, a Phase 2a clinical trial

Biodel Inc. Announces Positive Preliminary Results from Study 3-151

Biodel Inc. announced positive preliminary results from Study 3-151, a Phase 2a clinical trial comparing Biodel’s proprietary, concentrated insulin formulation BIOD-531 to Humalog Mix 75/25 and Humulin R U-500 in patients with type 1 and type 2 diabetes with severe insulin resistance who use at least 150 units of insulin per day or at least 100 units of insulin in a single injection. Many type 2, and some type 1, diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog Mix 75/25, in order to receive both basal and prandial insulin in single injections. Pre-mixed insulin is commonly dosed before breakfast and before dinner and is usually used in patients who are not candidates for an intensive basal-bolus insulin regimen which often requires four or more injections per day. Humulin R U-500 is used most commonly to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin—typically greater than 150 units per day. Humulin R U-500 is currently the only concentrated insulin available in the U.S. BIOD-531 is an ultra-rapid-acting formulation of recombinant human insulin (RHI) at a concentration of 400 units/ml (U-400) combined with EDTA, citrate and magnesium sulfate. In the Phase 1 Study 3-150, the results of which were released in February 2014, BIOD-531 administered to non-diabetic, obese volunteers demonstrated ultra-rapid absorption and onset of action compared to Humalog Mix 75/25 and Humulin R U-500, and had an extended duration of action expected to be suitable for basal insulin needs. The Phase 2a Study 3-152, which completed in August 2014, demonstrated that a single dose of BIOD-531 conferred better postprandial glucose control for two consecutive meals compared to Humalog Mix 75/25 or Humulin R U-500 when administered to type 2 diabetes patients with moderate insulin resistance (insulin dose requirement between 50-150 units/day). Postprandial glucose control with BIOD-531 dosed after the standardized meal was also superior to the control provided by the comparators dosed prior to the standardized meal. The results of this recently completed Phase 2a Study 3-151 demonstrate that BIOD-531 may confer similar clinically meaningful benefits of superior mealtime coverage and adequate basal duration for diabetes patients with higher degrees of insulin resistance and insulin dose requirements.

 

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