Key Factors
Akebia Therapeutics is a biotech specializing in therapies for power kidney illnesses (CKD).
Its lead drug, Vafseo, obtained 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 accredited in 37 international locations.
5 shares we like higher than Akebia Therapeutics
Akebia Therapeutics Inc. NASDAQ: AKBA is a biopharmaceutical firm specializing in creating therapies for power kidney illnesses (CKD) and anemia administration for sufferers with CKD. The medical sector firm addresses unmet wants within the phase. It obtained 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 as a consequence of CKD. Vafseo is an oral pill competing with present therapies like Jesduvroq from GSK plc NYSE: GSK and blood transfusions in extreme instances.
Get Akebia Therapeutics alerts:Signal UpWhat is Anemia?
Anemia is a situation triggered by the deficiency of hemoglobin within the purple blood cells. Hemoglobin is the protein that transports oxygen from the lungs to the physique. A scarcity of hemoglobin leads to organs not receiving sufficient oxygen, which may trigger signs like fatigue, pale pores and skin, weak point, dizziness, shortness of breath and speedy heartbeat.
Many kinds of anemia, like iron and vitamin-deficiency anemia, are attributable to a scarcity of iron to supply purple blood cells. Hemolytic anemia varieties from the untimely destruction of purple blood cells from an underlying situation like infections or autoimmune issues. Aplastic anemia is attributable to injury to the bone marrow stopping it from producing purple 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 purple blood cells in bone marrow. This will happen from kidney illness, inflammatory issues or most cancers. This leads to sufferers having a lot decrease than regular purple blood cells, resulting in anemia.
The Vafseo Capsule Remedy
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 medicine known as hypoxia-inducible issue (HIF) prolyl hydroxylase inhibitors (HIF-PHIs). HIF-PHIs are enzymes which are 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 purple 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) accredited 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 approval as a consequence of security issues. This approval makes Vafseo accredited in 37 international locations as a once-daily HIF-PH inhibitor tablet. This was backed by Akeba’s international Part 3 INNO2VATE program and post-marketing security information from Japan. Japan accredited it in 2000.
The Founder and President of the Renal Assist 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 every day lives. It’s promising to see the introduction of modern therapy choices for individuals preventing anemia.”
Vafseo Receives FDA Approval
The FDA approval permits Akebia to commercialize Vafseo in the US 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 accredited in February 2023 and is Japan’s main HIF-PHF drug.
Akebia CEO John Butler said, “With the approval of Vafseo within the U.S., we’re proud to ship another therapy choice for the a whole lot of hundreds of Individuals on dialysis who’re identified with anemia as a consequence of CKD.” Butler concluded, “At Akebia we’re dedicated to kidney sufferers, a dedication that has pushed our workforce 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 normal 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 obtained a $55 million time period mortgage facility and $26 million in gross proceeds from at-the-market (ATM) inventory gross sales.

 Every day Bearish Engulfing Sample
The every 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 could be considered as bearish. The every day relative power 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 wish to hear this.MarketBeat retains monitor of Wall Road’s top-rated and finest performing analysis analysts and the shares they suggest to their purchasers every day. MarketBeat has recognized the 5 shares that prime analysts are quietly whispering to their purchasers to purchase now earlier than the broader market catches on… and Akebia Therapeutics wasn’t on the record.Whereas Akebia Therapeutics at present has a “Purchase” ranking amongst analysts, top-rated analysts consider these 5 shares are higher buys.View The 5 Shares Right here MarketBeat simply launched its record of 10 low cost shares which were neglected by the market and could also be significantly undervalued. Click on the hyperlink under to see which corporations made the record.Get This Free Report