Welcome to our dedicated page for Akebia Therapeut news (Ticker: AKBA), a resource for investors and traders seeking the latest updates and insights on Akebia Therapeut stock.
Akebia Therapeutics, Inc. develops and commercializes therapeutics for people impacted by kidney disease. Company news commonly covers Vafseo® (vadadustat), an oral HIF-PH inhibitor indicated for anemia due to chronic kidney disease in adults receiving dialysis, and Auryxia® (ferric citrate), a U.S.-marketed therapy for chronic kidney disease-related conditions.
Recurring updates also address product revenue, dialysis-market access, clinical data publications, and kidney disease pipeline programs, including praliciguat in focal segmental glomerulosclerosis, AKB-097 in rare kidney diseases, and AKB-9090 for cardiac surgery-associated acute kidney injury. Akebia also reports Nasdaq inducement grants, board changes, investor presentations, and quarterly financial results.
Akebia Therapeutics (AKBA) reported a net loss of $83.0 million for Q2 2021, an improvement from a loss of $175.8 million in Q2 2020. Total revenue decreased to $52.9 million from $90.1 million year-over-year, primarily due to lower collaboration revenue, which fell to $20.0 million from $59.4 million. Net product revenue for Auryxia rose to $33.0 million, a 7.4% increase. Akebia announced FDA acceptance of the vadadustat NDA with a PDUFA date of March 29, 2022, indicating potential market opportunities in treating anemia due to chronic kidney disease.
Akebia Therapeutics granted stock options to 14 newly-hired employees, totaling 95,000 shares at an exercise price of $2.47 per share, equivalent to the stock’s closing price on the grant date, July 30, 2021. The stock options will vest over four years, with 25% vesting after the first year and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), reflecting Akebia's commitment to attracting talent in the biopharmaceutical sector focusing on kidney disease treatment.
Akebia Therapeutics, Inc. (Nasdaq: AKBA) has announced that it will release its financial results for the second quarter ended June 30, 2021, on August 5, 2021, before markets open. The company will also host a conference call at 9:00 a.m. ET on the same day to discuss the results and recent business developments. Interested parties can listen live by calling (877) 458-0977 domestically or (484) 653-6724 internationally. A replay will be available after the call until August 11, 2021.
Akebia Therapeutics (Nasdaq: AKBA) announced on July 1, 2021, that it granted stock options to 25 new employees, totaling 210,000 shares. These options, priced at $3.79 per share, are in accordance with Nasdaq Listing Rule 5635(c)(4). The options vest over four years, with 25% unlocking after the first anniversary and the remainder vesting quarterly, contingent upon the employees' continued service. Akebia is dedicated to improving the lives of individuals affected by kidney disease.
Akebia Therapeutics (Nasdaq: AKBA) announced upcoming presentations of data from its Phase 3 program for vadadustat at the ERA-EDTA Virtual Congress 2021 from June 5-8, 2021. The abstracts are available online in Nephrology Dialysis Transplantation. Key presentations will focus on the hematologic efficacy of vadadustat for anemia in both dialysis-dependent patients and those with non-dialysis-dependent chronic kidney disease. Vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved in Japan but not yet in the U.S.
On June 2, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 15 new employees totaling 121,000 shares. The options were issued as inducements for employment and have an exercise price of $3.51, equivalent to the stock's closing price on the grant date. Vesting occurs over four years, with 25% vesting after one year and the remainder quarterly, contingent on continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4).
Akebia Therapeutics (Nasdaq: AKBA) and Otsuka Pharmaceutical have announced the FDA's acceptance of their New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD). This application targets adult patients both on and off dialysis. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) action date of March 29, 2022. The companies emphasize their commitment to bringing this new oral treatment option to patients, with ongoing collaborations for commercial launch preparations.
Akebia Therapeutics® (Nasdaq: AKBA) reported Q1 2021 financial results, showing total revenue of $52.3 million, a decline from $88.5 million in Q1 2020. Collaboration revenue fell to $21.9 million from $59.3 million last year, while net product revenue increased by 4% to $30.4 million. The net loss widened to $69.6 million from $60.7 million. Notably, the NDA for vadadustat was submitted to the FDA, a key milestone for the company. Cash reserves remain strong at $272.8 million, expected to fund operations beyond the anticipated U.S. launch of vadadustat.
On May 4, 2021, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to 9 new employees. A total of 197,200 shares were offered, each with an exercise price of $3.19, equal to the stock's closing price on April 30, 2021. The options will vest over four years, with 25% vesting on the first anniversary, and the remainder vesting quarterly. These grants comply with Nasdaq Listing Rule 5635(c)(4), intended to incentivize new hires.
Akebia Therapeutics (Nasdaq: AKBA) announced the publication of its Phase 3 clinical program results for vadadustat in the New England Journal of Medicine. The program evaluated vadadustat's effectiveness in treating anemia due to chronic kidney disease (CKD) in patients on and not on dialysis. A New Drug Application (NDA) was submitted to the FDA for vadadustat recently. The program demonstrated that vadadustat is noninferior to darbepoetin alfa for cardiovascular safety in dialysis patients, but did not meet the same for non-dialysis patients.