AKBA - What Does 75% Institutional Ownership Signal For a Pharma Company? Let's Find Out

Summary Vadadustat passed efficacy endpoints but did not meet safety endpoints and Shares plummeted In the process of re-submitting to FDA in the next few weeks and month Significant institutional buying in the last few weeks might signal upcoming news 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. https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-approval-vadadustat-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 https://ir.akebia.com/news-releases/news-release-details/akebia-reports-third-quarter-2020-financial-results-and-recent 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 Trading at 60% below estimate of its fair value Earnings are forecast to grow 56% per year Upcoming Earnings February 25th, 2021 Target of (0.4) Current Consensus (0.43) Analyst Price Target $10.29 from 7 Analysts Ownerhsip Have had 53 institutional investors invest since October. Only 18.5% of the float is for public purchase. Institutions own 75% of the total float. 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%