Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
AKBA BEASTING LONG...FDA APPROVED DRUG COMES TO MARKET IN JAN
AKBA BUILDING 1.79 BREAK IS COMING
AKBA BACK IN PLAY UNTIL JAN 2025...FDA COMING
AKBA.....................................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783
AKBA................................https://stockcharts.com/h-sc/ui?s=ARKB&p=W&b=5&g=0&id=p86431144783
AKBA......................................https://stockcharts.com/h-sc/ui?s=AKBA&p=W&b=5&g=0&id=p86431144783
I believe the current news releases may have answered your question. GLTA
Why do you say we have a gold mine here ?
Toofuzzy
There's no doubt we have a gold mine here, and at some point it will be load up time. Figuring out when is the big question!
https://journey.ct.events/view/a825b116-e5ee-4e76-ad8d-2e9e9116aa21 tomorrows web cast
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??
Something didn’t look good , I guess!
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.................................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
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
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.
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 <https://www.google.com/search?q=pdufa+explantion&oq=pdufa+explantion&gs_lcrp=EgZjaHJvbWUyBggAEEUYOTIGCAEQLhhA0gEINDc5MGowajGoAgCwAgA&sourceid=chrome&ie=UTF-8>
$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.
$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!
Followers
|
43
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
405
|
Created
|
04/17/15
|
Type
|
Free
|
Moderators |
We are a fully integrated biopharmaceutical company. Our team works to address complications of kidney disease. We have both a commercially available medicine and a late stage oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat. Vadadustat and other HIF-PHIs are based on Nobel Prize-winning science.
VAFSEO® (vadadustat)is approved for use in 34 countries. Vadadustat has not been approved by the U.S. Food & Drug Administration.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |