Akebia Therapeutics Inc (NASDAQ: AKBA) is an exciting low priced Nasdaq biotech advancing Vadadustat; an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor currently in phase-III development for the treatment of anaemia due to chronic kidney disease (CKD). The Company believes vadadustat has the potential to address limitations of injectable ESAs, and become the new oral standard of care for the treatment of anemia due to CKD. Severeal weeks ago Akebia received a second interim response from the FDA to its Formal Dispute Resolution Request regarding the Complete Response Letter for Vadadustat received in March 2022. Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that the deciding authority for the appeal will now be Peter Stein, M.D., Director, OND. Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing the discussions and any required follow up.  

With $144 millioin in the treasury and fully funded moving forward AKBA already has a commercial product Auryxia® (ferric citrate) is approved and marketed in the United States for two indications: (1) the control of serum phosphorus levels in adult patients with DD-CKD, or the Hyperphosphatemia Indication, and (2) the treatment of iron deficiency anemia, or IDA, in adult patients with NDD-CKD, or the IDA Indication. Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of patients with IDA, under the trade name Riona (ferric citrate hydrate). The Comapnys growth in revennues has been exponnential with Akebia reecntly announcing $42.2 million in revenues for the 3 months ended September 30, and $127.2 million in revenues for the 9 months ended September 30, 2022 up from $100 million for the same period in 2021. Akebia will release its financial results for the fourth quarter and full-year ended December 30, 2022 on Thursday, March 9 prior to the open. The Comapny will also hold a conference call at 8:30 a.m. ET. A live webcast of the conference call will be available via the Investors section of Akebia’s website at: https://ir.akebia.com/. We will be updating on AKBA when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below. 

Akebia Therapeutics Inc (NASDAQ: AKBA) is a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. Akebia has a commercial product Auryxia® approved and marketed in the United States, Japan and Taiwan, and a late-stage product candidate. Akebia’s lead product candidate, Vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).  

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia’s New Drug Application for Vadadustat for the treatment of anemia due to chronic kidney disease (CKD). In November 2022, Akebia submitted a Formal Dispute Resolution Request focused on the favorable balance of the benefits and risks of Vadadustat for the treatment of anemia due to CKD in adult patients on dialysis.  

Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. In Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. 

In June of 2020, Akebia announced the first regulatory approval of Vadadustat for the treatment of anemia due to CKD in DD-CKD and NDD-CKD adult patients in Japan. Akebia’s collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation, or MTPC, commenced commercial sales of vadadustat in Japan under the trade name, VafseoTM, in August 2020. In addition, MTPC filed a new drug application for Vadadustat for the treatment of anemia due to CKD in adult patients in Taiwan in January of 2022. 

Auryxia® (ferric citrate) is approved and marketed in the United States for two indications: (1) the control of serum phosphorus levels in adult patients with DD-CKD, or the Hyperphosphatemia Indication, and (2) the treatment of iron deficiency anemia, or IDA, in adult patients with NDD-CKD, or the IDA Indication. Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of patients with IDA, under the trade name Riona (ferric citrate hydrate). Since 2018, Auryxia product revenue has grown at a compounded annual growth rate of 14% due to market share gains and improved net price per pill, while total prescriptions for phosphate binders in the United States have declined 8%.  

Akebia believes Vadadustat has the potential to treat other serious or life-threatening conditions, including preventing and lessening the severity of acute respiratory distress syndrome, or ARDS, a complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or COVID-19, infection. More specifically, in July of 2020, the Company announced an investigator-sponsored clinical study by The University of Texas Health Science Center at Houston, or UTHealth, in Houston, Texas, evaluating the use of Vadadustat as a potential therapy to prevent and lessen the severity of ARDS adult patients who have been hospitalized due to COVID-19. With the support of its data monitoring committee, UTHealth decided to expand the study beyond the initial 400 patients, an enrollment target they have now surpassed. Within this randomized, double-blind, placebo-controlled study, patients will be dosed with Vadadustat or a placebo starting within 24 hours of hospital admission and continuing for up to 14 days. This study is being conducted under an Investigational New Drug application, or IND, with UTHealth as the study sponsor and is currently enrolling patients. In January of 2021, UTHealth announced that it had been awarded $5.1 million in funding from the U.S. Department of Defense, or DOD, to expand this clinical trial at its facilities. 

$AKBA EU approval writ large within 2 months. Why is it only worth pennies? I see a transformational year for $AKBA after formal appeal with FDA succeeds. Similar case to $ARDX, a new life after an odyssey.

— Nick zheng (@pick1998_2) March 1, 2023

To Find out the inside Scoop on AKBA Subscribe to newsytrends.com Right Now by entering your Email in the box below

If Akebia obtains FDA approval of Vadadustat, the Company plans to commercialize Vadadustat in the United States with its well-established, nephrology-focused commercial organization, while also leveraging its collaboration with Otsuka and its U.S. nephrology commercial organization. In addition, Akebia continues to explore additional development opportunities to expand our pipeline and portfolio of novel therapeutics through both internal research and external innovation. The Company’s development pipeline includes several earlier stage opportunities, including Praliciguat, an investigational oral soluble guanylate cyclase, or sGC, stimulator. Further, Akebia internal innovation efforts include several preclinical opportunities, both in the HIF pathway, leveraging its learnings from the research and development of Vadadustat, as well as new areas of focus it is currently exploring. 

In February Akebia reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo™ (Vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. The EC will review the CHMP recommendation and deliver a final decision in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. 

The CHMP based its positive opinion on data from a comprehensive development program that included over 7,500 patients, including the global Phase 3 clinical program of Vadadustat for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE). In the study of adult patients on dialysis, vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved the primary safety endpoint of the INNO2VATE program. 

Akebia received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for Vadadustat received in March 2022. Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that due to agency resource constraints and staffing needs the deciding authority for the appeal will now be Peter Stein, M.D., Director, OND. The appeal was originally assigned to a Senior Advisor within the OND. 

Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. Dr. Stein indicated that he will do all he can to facilitate the appropriate meetings and discussions given the delay resulting from the staffing change. Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing the discussions and any required follow up. 

$AKBA broke the short downttrend now need to go back over the uptrendline look at the blue area pic.twitter.com/KDJ0n6XaHi

— chartsignals (@signaljumper) February 26, 2023

 We have something big coming Subscribe Right Now!

Currently trading at a $177 million market valuation Akebia os is 183,962,083. The Company is well funded moving forward with $144.7 million in cash in the treasury. While AKBA used to trade at much higher prices ($20 in 2017 and over $10 in 2021) and many investors have lost a lot of money on this stock, from current levels AKBA is a compelling setup; trading just under $1 the Company is well funded moving forward with $144 million in the treasury and has growing sales recently reporting $127.2 million in revenues for the 9 months ended September 30, 2022 up from $100 million for the same period in 2021 due to the rapid growth in sales of Auryxia. Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that the deciding authority for the appeal will now be Peter Stein, M.D., Director, OND. Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing the discussions and any required follow up.We will be updating on AKBA when more details emerge so make sure you are subscribed to Newsytrends.com by entering your email below. 

Disclosure: we hold no position in AKBA either long or short and we have not been compensated for this article.