Mannkind Corp. Will Wait until Mid-July for FDA Review and FuelCell Energy Awarded $3M by U.S. Department of Energy

MannKind Corp. (NASDAQ: MNKD) reported recently that the U.S. Food and Drug Administration plans to take until mid-July to review its inhaled diabetes treatment. “We view an approval [of Afrezza] as the most likely outcome, given the overwhelmingly positive vote, but continue to see some risk in the decision,” Cowen & Co. analyst Simos Simeonidis said in a note to clients, adding that it appears the FDA sees the drug as a “real need” for patients who can’t or shouldn’t use injectable insulin. MannKind Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of therapeutic products for diabetes and cancer in the United States. Its lead product candidate is AFREZZA inhalation powder, an insulin that is in late-stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. The company is also developing MedTone and Dreamboat inhaler devices.

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FuelCell Energy Inc. (NASDAQ: FCEL) has been awarded by the U.S. Department of Energy $3M to accelerate the development of fuel cells being used for heat and power. The money is for a project to improve performance, increase lifespan and decrease cost of stationary fuel cells, as well as to reduce manufacturing costs, according to the report. The project will focus on developing "an innovative carbonate fuel cell electrolyte matrix."

FuelCell Energy, Inc., together with its subsidiaries, designs, manufactures, sells, installs, operates, and services stationary fuel cell power plants for distributed baseload power generation. It offers Direct FuelCell power plants that electrochemically produce electricity and heat using various fuels, including natural gas, methanol, diesel, biogas, coal gas, coal mine methane, and propane.

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