Mannkind Corp’s Afrezza Diabetes Device Raises Concerns and Idera Pharmaceuticals Announces Positive Phase 2 Trial Results
MannKind Corp. (NASDAQ: MNKD) shares dipped on Friday after a report from FDA staff raised some questions about the company’s diabetes device Afrezza. An FDA committee said it was concerned about certain pharmacology issues that could impact Afrezza’s safety and effectiveness. Concerns included the drug’s potential risks related to bronchospasms and pulmonary function decline in patients with underlying lung disease. The committee also said that available data from studies do not “conclusively support” use in patients with underlying lung disease. The committee issued their report before a meeting on April 1 of outside advisers to the FDA who will discuss clinical trial data and advise on whether the product should be approved.
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.
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Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) shares moved higher after the company announced positive top-line data from its randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. IMO-8400, which is Idera’s lead clinical candidate, is an antagonist of Toll-like receptors (TLRs) 7, 8, and 9. The company’s strategy is to develop IMO-8400 for the treatment of genetically defined forms of B-cell lymphoma and orphan autoimmune diseases.
The trial met its primary objective as all treatments were well tolerated with no treatment related discontinuation, serious adverse events or dose reductions. IMO-8400 treatment met the secondary objective of demonstrating clinical activity in patients with psoriasis, as assessed by Psoriasis Area and Severity Index (PASI).
Idera Pharmaceuticals, Inc., a clinical stage biotechnology company, engages in the discovery and development of novel synthetic DNA- and RNA- based drug candidates. It is developing drug candidates designed to modulate immune responses mediated through Toll-like Receptors (TLRs); and evaluating gene silencing oligonucleotides (GSOs), which inhibit the production of disease-associated proteins by targeting RNA. The company focuses on developing products for the treatment of autoimmune and inflammatory diseases.
Get more information on Idera Pharmaceuticals, Inc. and free access to the in depth equity report at: www.TrendingWallStreet.com/stockquote/IDRA
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