Akebia Therapeutics Inc (AKBA) Quote

Starting to remind me of a “pump and dump” stock. Spikes up but always comes back down to where it started.

Starting to remind me of a “pump and dump” stock. Spikes up but always comes back down to where it started.

I'm in at 33 cents so I'm not going anywhere, just gonna let it ride wherever it goes

Thanks, I’m hanging onto it . With actual revenues of 40-60 mill the last 5 quarters, one would think this stock price should rise. I wouldn’t mind seeing them bought out.

Classic sell the news. Probable offering coming next week to dilute on the good news.

Something just isnt right here. How do you get FDA approval for a drug and your stock price tank? Is there some bads news getting ready to come out on this company??

Long solid position here!

Long term play. Congrats all!

Something didn’t look good , I guess!

AKBA should see 3 bucks

AKBA...FDA EXPLOSION ...WE LOADED THIS BEAUTY....KOCKED AND LOADED!!!!

AKBA...................................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783

AKBA new 52 hi

$AKBA looking good damn! she fine.

AKBA.................................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783

$AKBA from stocktwits FDA’S THREE ALARM FIRE- (a)FDA issued CRL to FibroGen & Roxadustat (Aug. 2021); (b)FDA issued CRL to Akebia & Vadadustat (March 2022); (c)FDA’s Cardiovascular & Renal Drugs Advisory Committee supported GSK’s Daprodustat for dialysis dependent patients w/ anaemia of CKD w/ 13-3 vote (Oct. 2022); (d)Akebia submitted FDRR w/ FDA’s Senior Advisor in agency’s Office of New Drugs (OND) (Nov. 2022); (e)CKD community & key opinion leaders such as Dr. Jay Wish criticize FDA decision making concerning HIF-PHI drugs (March 2022 - present). (FDA knows from data that Daprodustat is inferior to Vadadustat.) FDA’S RESPONSE TO FIRE - (a)FDA met w/ Akebia to discuss appeal & subsequently requested “additional clarifying information” (not ADCOM, not clinical trial, not denial) (Nov. 2022); (b)FDA assigned Dr. Peter Stein, M.D., Director of OND as deciding authority for appeal (Feb. 2023); (c)Dr. Stein provided Akebia/Vadadustat w/ clear path forward to approval (May 2023). GLTA

AKBA 10Q March 4

Excellent chart. Thank you for posting.

Found myself studying it for quite a bit.

As it really is a dream chart for both swing traders AND long term buy & hold investors alike.

AKBA..............................................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783

$AKBA

$AKBA reversal incoming?

CAMBRIDGE, Mass., Jan. 30, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it has closed a loan facility with funds and accounts managed by BlackRock. The loan provides Akebia with up to $55.0 million of borrowing capacity available in three tranches.

At the closing, Akebia drew the first tranche of $37.0 million and used the proceeds to pay down $35.0 million of principal outstanding from a loan agreement with Pharmakon Advisors, LP (Pharmakon), the investment manager of the BioPharma Credit funds, plus interest and fees. The new agreement substantially extends the interest-only period in the event of vadadustat approval by the U.S. Food and Drug Administration (FDA) without requiring any principal repayment until December 31, 2025, with an option for Akebia to extend until December 31, 2026.

$AKBA profit taking! hope you took some off the table!

PDUFA explanation https://www.fool.com/terms/p/pdufa-date/

What percentage of PDUFA are approved?
Characteristic Percentage of drugs approved in 2023
Met PDUFA goal date* 89%
First cycle of review 84%
Approved in the United States before receiving approval in any other country 64%
Priority review 56%

From

$AKBA via stocktwit @Bidzill @fresh10 fresh - We have PDUFA date scheduled for March 27, 2024 concerning Vadadustat DD USA. Approval is de-risked and highly likely, IMO. We have product launch date first half of year for Vadadustat DD EU/Australia. We have phase 2 trial for AKB 9090 for second half of 2024. We have Auryxia all time/near all time high sales 2024. Good luck 🍀 to you and us.

https://www.tradingview.com/x/6Ykwijbc/

$AKBA from stocktwits

MORE GOOD NEWS - FDA Fast Track Designation is process designed to facilitate development & expedite drug review to treat serious conditions & fill UNMET MEDICAL NEED. Determining whether condition is serious enough for designation is matter of judgment … ARDS is life threatening & acute, diffuse, inflammatory form of lung injury in seriously ill patients characterized by poor oxygenation, pulmonary infiltrates, acute onset. Unadjusted hospitalization mortality was reported to be 35% among those w/ mild ARDS, 40% w/ moderate disease, 46% for patients w/ severe ARDS. AKB 9090 is Akebia’s ARDS drug. Filling an unmet need is defined as providing therapy where none exists or which may be potentially better than available therapy. Drug that receives Fast Track is eligible for accelerated approval/priority review. August of 2022, CEO Butler said Vadadustat was in trials for Covid-19/ARDS which was an “unmet medical need.” Butler was signaling intention to go after Fast Track status.
https://stocktwits.com/buythehornz127/message/559186953

John P. Butler, President and Chief Executive Officer of Akebia Therapeutics, Inc. (the “Company”), plans to present the information in the presentation attached hereto as Exhibit 99.1 (the “Presentation”) at the 42 Annual J.P. Morgan
Healthcare Conference on January 11, 2024 at 11:15 a.m. PST, which includes preliminary unaudited net product revenue for Auryxia® cumulative and for the fiscal year ended December 31, 2023. Spokespersons of the Company also plan
to present the information in the Presentation at various meetings beginning on January 8, 2024, including investor and analyst meetings that coincide with the J.P. Morgan Healthcare Conference

https://ir.akebia.com/static-files/0be66d7f-9988-43fa-bcab-e587260e1dc0

easy money https://schrts.co/JdqbEsCN wait till the real news drops!

$AKBA shabba https://schrts.co/bYSHjBzF

this is looking good. if the RSI ever resets i'm going all in!

end of year. double top forming or is it slow and steady?

AKBA...........................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783

AKBA full out weekly trend in place

AKBA MONSTER BREAK OUT

AKBA...........................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783

here we go...break out!!!

AKBA IN PLAY...WEEKLY SETTING UP FOR A BIG POP!!!

Nice hits premarket

AKBA: Might Close today way UP, behind that news!!

Nice rise from .50s past few weeks. Pump over??
4/25 news Akebia Receives European Commission Approval for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

Source: PR Newswire (US)
CAMBRIDGE, Mass., April 25, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the European Commission (EC) has granted marketing authorisation for 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 approval is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Vadadustat is now approved in 32 countries.

Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)

"We're extremely pleased the EC has approved Vafseo, an important milestone for Akebia but even more impactful for the hundreds of thousands of Europeans diagnosed with anaemia associated with CKD on dialysis," said John P. Butler, Chief Executive Officer of Akebia. "We believe patients receiving chronic maintenance dialysis would benefit from additional therapeutic options. With approval, we're eager to select a European partner who can quickly bring Vafseo to those patients."

Anemia associated with CKD, common in patients on dialysis, is a debilitating condition which may be associated with many adverse clinical outcomes. Vafseo, approved in 150 mg, 300 mg and 450 mg film-coated tablets, provides a once-daily oral treatment option for dialysis dependent patients with symptomatic anaemia associated with CKD. Throughout Europe, more than 200,000 dialysis patients are currently treated for anemia associated with CKD.

The approval follows the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) positive opinion issued in February 2023 recommending the EC approve Vafseo. The approval is based 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, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events, which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies.

John Butler added, "We are grateful for the patients, physicians, investigators, and site coordinators who participated in our clinical trials that led to this important approval. I want to also express my deep appreciation for our team at Akebia as the approval is a culmination of years of work and a demonstration of their commitment to bettering the lives of people impacted by kidney disease."

Bought a lot here today.

two hedge funds competing to be largest AKBA stake holder AWESOME

Nice find G2G. :)

AKBA 2NEWS 2DAY

https://finance.yahoo.com/m/d467c3e1-c5b5-3419-8f7d-a3b3ad6ab3e4/the-petri-dish%3A-blindness.html

https://finance.yahoo.com/news/akebia-receives-positive-chmp-opinion-210500420.html

https://finviz.com/quote.ashx?t=AKBA&p=d

Awesome news. Market cap of $136 million.....absolute joke!

Panic selling because of that huge short position that just opened...bastardos

Panic selling.

1,05~~ ANT

touched one dollar pm, lookin' for volume again, ANT