Thu, Jan. 7, 9:15 AM
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Dec. 14, 2015, 9:21 AM
Dec. 14, 2015, 8:20 AM
- Thinly traded micro cap Akebia Therapeutics (NASDAQ:AKBA) and Mitsubishi Tanabe Pharma (OTCPK:MTZPY)(OTC:MTZXF)(OTC:MTZXY) enter into a collaboration agreement that grants Mitsubishi exclusive development and commercialization rights to Akebia's lead product candidate, vadadustat (AKB-6548), in Japan and 22 other countries in Asia (excluding China).
- Under the terms of the agreement, Mitsubishi will make payments up to $100M to fund the vadadustat global Phase 3 program, including $40M upfront. Akebia is eligible to receive up to $250M in additional milestones and tiered royalties from low teens up to 20%.
- The companies will form a joint steering committee to oversee development and commercialization activities. The contract will be in effect on a country-by-country basis until the later of the expiration of the last-to-expire patent in the particular country, the expiration of marketing or regulatory exclusivity in the particular country or ten years after the first commercial sale of vadadustat in the particular country.
- Vadadustat is an inhibitor of hypoxia inducible factor (HIF)-prolyl hydroxylase, an enzyme that promotes the breakdown of HIF proteins. HIF is the primary regulator of the production of red blood cells. The body's natural response to anemia is to increase the level of HIF proteins. It is being developed for the treatment of anemia related to chronic kidney disease.
- Akebia is up 24% premarket on light volume.
- Previously: Akebia set to begin Phase 3 development of lead product candidate vadadustat (Oct. 6)
Sep. 11, 2015, 12:44 PM
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Sep. 8, 2015, 5:25 PM
- A 94-subject Phase 2 clinical trial evaluating Akebia Therapeutics' (NASDAQ:AKBA) lead product candidate vadadustat (formerly AKB-6548) in dialysis patients with anemia related to chronic kidney disease (CKD) met its primary endpoint of maintaining hemoglobin levels throughout the 16-week treatment period following conversion from recombinant erythropoiesis-stimulating agent (rESA) therapy [e.g., Amgen's Epogen (epoetin alfa)]. Mean hemoglobin levels were comparable from baseline through week 16 for three dose cohorts (300 mg daily, 450 mg daily, 450 mg 3x/week).
- Vadadustat is an inhibitor of hypoxia inducible factor (HIF)-prolyl hydroxylase, an enzyme that promotes the breakdown of HIF proteins. HIF is the primary regulator of the production of red blood cells. The body's natural response to anemia is to increase the level of HIF proteins.
- The company intends to proceed to Phase 3 development as soon as feasible.
- Complete results will be presented at an upcoming medical conference.
- Shares are up 59% after hours on robust volume.
Jun. 29, 2015, 5:35 PM
Jun. 23, 2015, 5:34 PM
Jun. 22, 2015, 12:58 PM| Jun. 22, 2015, 12:58 PM
Jun. 22, 2015, 12:45 PM
Akebia Therapeutics, Inc. is a biopharmaceutical company, which focuses on development of novel proprietary therapeutics based on hypoxia-inducible factor biology and the commercialization of these products for patients with kidney disease. Its lead product candidate, AKB-6548, is in a Phase 2b... More
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