Feb 11, 2021
general Analysis
[3 min Read]
Summary
Company
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts.
Main Drug
Vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD).
June 29, 2020 - Approval of Vadadustat in Japan
Akebia's collaboration partner in Japan for vadadustat, obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare. An estimated 13 million people in Japan have advanced stages of CKD. Anemia is common in patients with CKD and its prevalence increases as CKD progresses. Injectable erythropoiesis-stimulating agents (ESAs) are currently the standard of care. Vadadustat provides adult patients with a convenient, once-daily oral therapeutic for the treatment of anemia due to CKD in Japan.
Sept 3, 2020 - What Happened?
Share price tanked 73% in after saying its Vadadustat drug candidate did not achieve the primary safety endpoint during phase III testing in adult patients with anemia due to chronic kidney disease who are not on dialysis. Vadadustat did meet the primary and key secondary efficacy endpoints of the study, however, and Akebia said it plans on submitting a new drug application to US regulators "as early as possible" in 2021.
Nov 5, 2020 - Update from Recent Shareholders Meeting
"We recently completed our pre-NDA meeting with the FDA. This was an important milestone for our vadadustat development program, and we remain on track to submit an NDA to the FDA as early as possible next year. A key component of this NDA is the positive data from our global Phase 3 INNO2VATE program for the treatment of anemia due to CKD in adult patients on dialysis, which we shared most recently at ASN Kidney Week
Jan 13, 2021 - Funding from DOD for Vadadustat for COVID patients
Researchers evaluating whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients were awarded $5.1 million in funding from the U.S. Department of Defense (DOD) to expand the Phase II clinical trial at The University of Texas Health Science Center at HoustonQ (UTHealth).
https://www.eurekalert.org/pub_releases/2021-01/uoth-dfh011321.php
Key Financials
Upcoming Earnings
Analyst Price Target
Ownerhsip
File Date |
Form |
Security |
Current Shares |
Ownership |
2/11/2021 |
13G |
STATE STREET CORP |
22,476,534 |
15.6% |
2/10/2021 |
13G |
VANGUARD GROUP INC |
8,434,759 |
5.8% |
2/3/2021 |
13G/A |
WELLINGTON MANAGEMENT GROUP LLP |
12,590,463 |
8.7% |
1/29/2021 |
13G/A |
BlackRock Inc. |
11,397,548 |
7.9% |
10/9/2020 |
13G/A |
BAUPOST GROUP LLC/MA |
0 |
0.0% |
2/13/2020 |
13G |
Nantahala Capital Management, LLC |
6,737,120 |
5.7% |
2/14/2019 |
13G/A |
ABRAMS CAPITAL MANAGEMENT, L.P. |
|
0.0% |
1/11/2019 |
13D/A |
Satter Muneer A |
3,067,043 |
2.6% |
1/7/2019 |
13G/A |
Novo Holdings A/S |
3,100,000 |
0.0% |
8/31/2018 |
13G/A |
EAGLE ASSET MANAGEMENT INC |
0 |
0.0% |
11/7/2017 |
13G/A |
Novartis Bioventures Ltd |
2,312,403 |
4.9% |
8/10/2017 |
13D/A |
Vifor Pharma Ltd. |
3,571,429 |
7.6% |
2/14/2017 |
13G/A |
FMR LLC |
931,855 |
2.4% |
2/12/2016 |
13G/A |
Venture Investors Early Stage Fund IV LP |
1,000,092 |
3.3% |
1/20/2016 |
13D/A |
Kearny Venture Partners LP |
1,590,309 |
4.2% |
4/29/2014 |
13G |
TRIATHLON MEDICAL VENTURES FUND LP |
1,114,080 |
5.8% |
75% |