Akebia Therapeutics, Inc.(AKBA)- NASDAQ
  • Mon, Aug. 8, 4:55 PM
    • Akebia (NASDAQ:AKBA): Q2 EPS of -$0.95 misses by $0.38.
    • Cash and equivalents of $188.64M
    • Press Release
    | Mon, Aug. 8, 4:55 PM | 1 Comment
  • Thu, May 5, 5:40 PM
    • Akebia (NASDAQ:AKBA): Q1 EPS of -$0.70 misses by $0.27.
    • Press Release
    | Thu, May 5, 5:40 PM
  • Mon, Mar. 14, 4:11 PM
    | Mon, Mar. 14, 4:11 PM | 3 Comments
  • Wed, Mar. 9, 1:11 PM
    • Akebia Therapeutics (AKBA +2%) prevails in its vadadustat-related patent fight in Europe by virtue of the total revocation of competitor FibroGen's (FGEN -2.2%) European patent EP 1 463 823 ('823) by the European Patent Office's (EPO) Opposition Division (OD). In an oral session, the OD ruled that the '823 patent did not meet the requirements for patentability under the European Patent Convention. A written decision should be issued within the next several months.
    • The company filed its opposition to the '823 patent in December 2013 after the EPO granted the patent in June 2013.
    • Vadadustat (AKB-6548), under initial development for the treatment of anemia in patients with chronic kidney disease, is an inhibitor of hypoxia inducible factor (HIF)-prolyl hydroxylase (PH), 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.
    • FibroGen's HIF-PH inhibitor is a similar compound called roxadustat.
    | Wed, Mar. 9, 1:11 PM
  • Thu, Jan. 7, 9:15 AM
    | Thu, Jan. 7, 9:15 AM | 20 Comments
  • Thu, Jan. 7, 7:04 AM
    • Akebia Therapeutics (NASDAQ:AKBA) prices its public offering of 7.25M shares of common stock at $9 per share. Underwriters over-allotment is an additional 1,087,500 shares. Closing date is January 12.
    • Net proceeds will be ~$61M.
    • Shares are down 13% premarket on increased volume.
    | Thu, Jan. 7, 7:04 AM
  • Wed, Jan. 6, 5:39 PM
    • Top gainers, as of 5.25 p.m.: ZUMZ +12.1%. M +3.5%. EARS +3.5%. OSUR +2.0%. OME +2.0%.
    • Top losers, as of 5.25p.m.: PER -11.8%. ARDX -7.1%. GMED -5.8%. AKBA -5.1%. EPZM -4.5%.
    | Wed, Jan. 6, 5:39 PM
  • Tue, Jan. 5, 12:40 PM
    | Tue, Jan. 5, 12:40 PM | 5 Comments
  • Mon, Jan. 4, 5:02 PM
    • Akebia Therapeutics (NASDAQ:AKBA) commences a $75M public offering of common stock. Volume, price and terms have yet to be announced.
    • Net proceeds will fund the continued development of vadadustat in anemic patients with chronic kidney disease, the PRO2TECT program, the INNO2VATE Phase 3 study, the advancement of AKB-6899 through Phase 1, working capital and general corporate purposes.
    | Mon, Jan. 4, 5:02 PM
  • Mon, Jan. 4, 4:31 PM
    • The first patient has been dosed in Akebia Therapeutics' (NASDAQ:AKBA) Phase 3 program, PRO2TECT, assessing lead product candidate vadadustat (AKB-6548) in non-dialysis patients with anemia related to chronic kidney disease (NDD-CKD).
    • PRO2TECT includes two separate trials that will enroll a total of 3,100 NDD-CKD patients across 500 sites worldwide. The first study, PRO2TECT correction, will enroll anemic patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The second, PRO2TECT conversion, will enroll patients currently receiving rRDAs who will be converted to either vadadustat or active control. Both studies are open-label and are designed to demonstrate non-inferiority (no worse than) to active control. The primary endpoints include an assessment of efficacy related to hemoglobin response and cardiovascular safety as measured by major cardiovascular events.
    • The results from both trials will support global regulatory submissions. Enrollment should be completed in late 2017.
    • 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.
    • Previously: Akebia set to begin Phase 3 development of lead product candidate vadadustat (Oct. 6, 2015)
    | Mon, Jan. 4, 4:31 PM
  • Dec. 14, 2015, 9:21 AM
    | 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)
    | Dec. 14, 2015, 8:20 AM
  • Nov. 9, 2015, 8:46 AM
    • Akebia (NASDAQ:AKBA): Q3 EPS of -$0.68 misses by $0.16.
    | Nov. 9, 2015, 8:46 AM | 1 Comment
  • Oct. 6, 2015, 10:22 AM
    • Based on the completion of its End-of-Phase 2 Meeting with the FDA and the Scientific Advice Process with the European Medicines Agency (EMA), Akebia Therapeutics (AKBA +0.9%) has set the key elements of its Phase 3 program for lead product candidate vadadustat (AKB-6548) for the treatment of patients with anemia related to non-dialysis-dependent chronic kidney disease (NDD-CKD).
    • The program, called PRO2TECT, includes two separate studies that will enroll ~3,100 subjects across 500 sites globally. The correction study will enroll anemia patients not currently being treated with recombinant erythropoiesis-stimulating agents (rESAs) while the conversion study will enroll patients currently receiving rESA therapy who will be converted to either vadadustat or active control with the goal of maintaining baseline hemoglobin levels. Both trials will include a 1:1 randomization and an open-label, active-control, non-inferiority design. Efficacy endpoints will include hemoglobin response.
    • The Phase 3 program will be finalized after the company presents its completed Phase 2 results to the both the FDA and EMA.
    • 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.
    • Previously: Akebia's lead product candidate successful in mid-stage study; shares up 59% AH (Sept. 8)
    | Oct. 6, 2015, 10:22 AM
  • Sep. 11, 2015, 12:44 PM
    | Sep. 11, 2015, 12:44 PM
  • Sep. 10, 2015, 12:44 PM
    | Sep. 10, 2015, 12:44 PM | 4 Comments
Company Description
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
Sector: Healthcare
Industry: Biotechnology
Country: United States