Key Factors
Akebia Therapeutics is a biotech specializing in therapies for power kidney ailments (CKD).
Its lead drug, Vafseo, acquired FDA approval for treating anemia in grownup CKD sufferers who’ve at the least 3 months of dialysis.
Vafseo is an oral pill that has been authorised in 37 international locations.
5 shares we like higher than Akebia Therapeutics
Akebia Therapeutics Inc. NASDAQ: AKBA is a biopharmaceutical firm specializing in growing therapies for power kidney ailments (CKD) and anemia administration for sufferers with CKD. The medical sector firm addresses unmet wants within the section. It acquired FDA approval for its lead candidate, Vafseo, which is used to deal with anemia in grownup sufferers on dialysis affected by power kidney illness (CKD). This is applicable to a complete addressable market (TAM) of 500,000 grownup sufferers on dialysis affected by anemia attributable to CKD. Vafseo is an oral pill competing with present therapies like Jesduvroq from GSK plc NYSE: GSK and blood transfusions in extreme circumstances.
Get Akebia Therapeutics alerts:Signal UpWhat is Anemia?
Anemia is a situation triggered by the deficiency of hemoglobin within the crimson blood cells. Hemoglobin is the protein that transports oxygen from the lungs to the physique. An absence of hemoglobin ends in organs not receiving sufficient oxygen, which may trigger signs like fatigue, pale pores and skin, weak spot, dizziness, shortness of breath and fast heartbeat.
Many forms of anemia, like iron and vitamin-deficiency anemia, are brought on by a scarcity of iron to provide crimson blood cells. Hemolytic anemia kinds from the untimely destruction of crimson blood cells from an underlying situation like infections or autoimmune problems. Aplastic anemia is brought on by injury to the bone marrow stopping it from producing crimson blood cells.
Anemia in CKD Sufferers
Anemia in CKD sufferers happens when the kidneys cannot produce sufficient erythropoietin (EPO), a hormone that stimulates the manufacturing of crimson blood cells in bone marrow. This could happen from kidney illness, inflammatory problems or most cancers. This ends in sufferers having a lot decrease than regular crimson blood cells, resulting in anemia.
The Vafseo Tablet Therapy
Akebia’s lead therapeutic, Vafseo (vadadustat), treats anemia by mimicking the pure response to low oxygen ranges by the physique. It belongs to a category of medication referred to as hypoxia-inducible issue (HIF) prolyl hydroxylase inhibitors (HIF-PHIs). HIF-PHIs are enzymes which might be usually produced by wholesome kidneys to assist regulate HIF. Vafseo will increase HIF ranges are inhibiting HIF-PH enzymes. Rising HIF ranges set off the pure manufacturing of EPO, and as extra EPO is produced the bone marrow additionally will increase crimson blood cell manufacturing, which improves hemoglobin ranges to alleviate anemia signs.
Vafseo Receives FDA Approval
On March 28, 2024, the U.S. Meals and Drug Administration (FDA) authorised Vafseo tablets for treating anemia with CKD for grownup sufferers with at the least 3 months of dialysis. This overturns an earlier denials for advertising and marketing approval attributable to security issues. This approval makes Vafseo authorised in 37 international locations as a once-daily HIF-PH inhibitor capsule. This was backed by Akeba’s international Section 3 INNO2VATE program and post-marketing security knowledge from Japan. Japan authorised it in 2000.
The Founder and President of the Renal Help Community, Lori Hartwell, has been affected by CKD since she was a baby and expressed her help, “Anemia is a debilitating situation that considerably impacts our day by day lives. It’s promising to see the introduction of revolutionary remedy choices for folks combating anemia.”
Vafseo Receives FDA Approval
The FDA approval permits Akebia to commercialize Vafseo in the USA with its companion CSL Restricted OTCMKTS: CSLLY. CSL holds the unique license to promote Vafseo to third-party dialysis organizations and Fresenius Kidney Care dialysis facilities. It competes with GSK plc-owned Jesduvroq, which was authorised in February 2023 and is Japan’s main HIF-PHF drug.
Akebia CEO John Butler acknowledged, “With the approval of Vafseo within the U.S., we’re proud to ship another remedy choice for the a whole bunch of 1000’s of People on dialysis who’re recognized with anemia attributable to CKD.” Butler concluded, “At Akebia we’re dedicated to kidney sufferers, a dedication that has pushed our crew to attain this milestone. We consider this dedication uniquely positions the corporate to execute a profitable launch designed to drive towards a possible new oral customary of look after dialysis sufferers.”
Outcomes for This fall 2023
Previous to the FDA approval, Akebia launched its This fall 2023 earnings report on March 14, 2024. The corporate reported EPS of breakeven, which was 4 cents higher than consensus estimates. Revenues grew 1.84% YoY To 56.2 million. The corporate acquired a $55 million time period mortgage facility and $26 million in gross proceeds from at-the-market (ATM) inventory gross sales.

 Day by day Bearish Engulfing Sample
The day by day candlestick chart on PATH illustrates a bearish engulfing candle sample. Shares of AKBA surged over 20% on the FDA approval information to $2.48 however fashioned a spot and crap response to shut at $1.83, down 18% on the day. The bearish engulfing candle swallowed the vary of the 7 previous candles, which might be considered as bearish. The day by day relative energy index (RSI) took a pointy drop, rejecting the 70-band to fall to the 52-band. Pullback help ranges are at $1.82, $1.60, $1.34 and $1.05.Earlier than you think about Akebia Therapeutics, you may need to hear this.MarketBeat retains monitor of Wall Avenue’s top-rated and finest performing analysis analysts and the shares they suggest to their shoppers every day. MarketBeat has recognized the 5 shares that high analysts are quietly whispering to their shoppers to purchase now earlier than the broader market catches on… and Akebia Therapeutics wasn’t on the checklist.Whereas Akebia Therapeutics presently has a “Purchase” score amongst analysts, top-rated analysts consider these 5 shares are higher buys.View The 5 Shares Right here Click on the hyperlink beneath and we’ll ship you MarketBeat’s information to pot inventory investing and which pot firms present probably the most promise. Get This Free Report