Ardelyx Inc (ARDX)

[Johnstonj27]

It sure is going to look a lot better when the FDA drops the final approval letter sometime before 2nd week of Dec.

[TommyBoyTrader9460]

$ARDX Beauty of a chart here..and great news gave this an extra boost..

https://stockcharts.com/c-sc/sc?s=ARDX&p=D&b=5&g=0&i=0&r=1668860456062

[Johnstonj27]

[Johnstonj27]

Best Guess FDA was protecting their kickback stream... why wouldn't they want more tools for doctors... this drug is easy to swallow... competitor currently is huge horse size pills... big pill burden..

[Johnstonj27]

Fill that Gap $8 last year before CRL... Now more drugs and more to offer shareholders.... larger OS now but ohwell would have climbed double with the approved XPHOZAH last year anyways...

[Cosa]

Ty Sub and Johnston. Go baby go!! ARDX to the moon

[crudeoil24]

I am not in. Too many potential roadblocks.

[ErnieBilco]

So if the drug is already approved for IBS why would the FDA deny it for the additional indication? If it is safe for one indication how would they justify denying it for another indication?

Approval odds are about 70% IMO

[crudeoil24]

A kidney disease drug that seemed to have little likelihood of receiving Food and Drug Administration approval received an unexpected boost late Thursday, when a committee of the agency's outside advisors voted in favor of the proposition that the drug's benefits outweigh its risks.

The drug, Ardelyx's (ARDX) tenapanor, is under consideration for FDA approval as a treatment for elevated levels of serum phosphorus in the blood of chronic kidney disease patients receiving dialysis. The drug is already approved as a treatment for constipation in patients with irritable bowel syndrome, and marketed under the name Ibsrela.

The FDA's advisors voted nine to four in favor of the risk-benefit profile of tenapanor administered alone to treat high serum phosphorus levels, and 10 to two in favor of its risk-benefit profile in combination with a drug known as a phosphate binder.

Investors had attributed low odds to the drug receiving FDA approval, and the agency isn't required to follow the advisory committee's guidance. What's more, given the lengthy and unusual path the drug has taken so far through the FDA's approval process, the path ahead for the drug is complicated, and somewhat hazy.

Still, shares of Ardelyx surged 45% to $1.77 in recent Thursday morning trading, after spiking more than 50% before the market open. The stock saw at least one upgrade Thursday morning.

That upgrade came from Piper Sandler analyst Christopher Raymond, who raised his rating on Ardelyx to Overweight from Neutral. Raymond set a target price of $8, up from his previous target of $3.

"While we found the vote itself remarkable, more meaningful was the fact that the vote was not split along 'party lines,'" Raymond wrote. "Three nephrologists, three cardiologists and both biostatisticians on the panel voted in favor of the monotherapy benefit/risk."

Ardelyx shares were trading at $1.94 before the market opened on Thursday, up from its previous closing price of $1.22. Trading was suspended much, if not all, of the day on Wednesday.

Shares had traded in the $7 to $8 range until July of last year, when the FDA unexpectedly rejected Ardelyx's application for tenapanor's approval, sending the stock down 74% in a single day. At the time, the agency told Ardelyx that while the drug did reduce serum phosphorus levels in the chronic kidney disease patients, the actual effect was "small and of unclear clinical significance."

The rejection took investors by surprise, and analysts suggested that the agency's position was unfair. Piper Sandler's Raymond wrote at the time that the FDA seemed to have "moved the goal posts" by raising questions about the clinical significance at the last minute, after the agency guided the design of Ardelyx's trial.

Ardelyx appealed the decision once and was rejected, but in April of this year, the company said a second appeal had resulted in the FDA agreeing to schedule an advisory committee meeting. The FDA's briefing documents, released on Monday, reiterated the FDA reviewers' questions about the drug's clinical benefit.

"The clinical significance of the magnitude of the treatment effect is unclear," the reviewers wrote in the briefing document. "While there is well established precedent for accepting serum phosphorus as a surrogate endpoint and basis for approval in this therapeutic area, there is no precedent for accepting treatment effects of the magnitude seen in this development program."

Expectations for a new outcome were low going into Thursday's meeting, and the advisors' overwhelming support for the drug's risk-benefit profile, in the face of the agency's skepticism, took analysts by surprise. A positive vote by the advisors, however, doesn't necessarily guarantee FDA approval.

"This is somewhat uncharted territory as it's rare for an appeal to be granted an [advisory committee hearing]; even more rare for the [advisory committee] to resoundingly reject FDA's rationale," Piper Sandler's Raymond wrote.

Now, the FDA's Office of New Drugs, the entity to which Ardelyx had submitted its second appeal, will make a decision within 30 days on that appeal. If the office finds in Ardelyx's favor, the company would then need to resubmit its application for approval of tenapanor. Raymond wrote that he expected approval of the drug in the new indication at the end of next year.

Write to Josh Nathan-Kazis at [e-mail]


(END) Dow Jones Newswires

[crudeoil24]

$weet RUN !!!!!

[subslover]

Loving this beautiful followthrough!!!!!!!!!!!!!!!!!!!!

[Johnstonj27]

Form 4 Dropped at close Million dollar insider buy.

https://ir.ardelyx.com/node/11836/html

[subslover]

Here you go, bro
https://www.otcmarkets.com/filing/html?id=16209976&guid=xW_-kHwwSFTsB3h

[Cosa]

What? I didn't see anything on SEC Edgar

[Pt3]

Anybody thought this run today...well nope Insider is buying after hour

[Cosa]

I thought we would run higher. Closed all my calls for a penny. Took some profits. Maybe next week, need to get past opex tomorrow.

[Jess070283]

Great News!$$$

[Johnstonj27]

We have a RUNNER $2.32 Right now Conference Call
https://ir.ardelyx.com/events/event-details/fda-advisory-committee-update-call

[subslover]

Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis
November 16 2022 - 06:29PM
PR Newswire (US)
Alert
Print
Share On Facebook
The Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders

The Office of New Drugs is expected to provide a response to Ardelyx's appeal within thirty (30) days

If approved, XPHOZAH will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily

Conference call to be held tomorrow, November 17, 2022, at 8:00 AM ET

WALTHAM, Mass., Nov. 16, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The CRDAC voted nine to four that the benefits of treatment with XPHOZAH outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy and voted ten to two, with one abstention, that the benefits of treatment with XPHOZAH in combination with phosphate binder treatment outweigh its risks.

Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx)

"Today's vote by the CRDAC is a promising development for the chronic kidney disease community, as patients continue to struggle to control serum phosphorus levels despite use of currently available therapies, which are all limited to the phosphate binder class," said Mike Raab, president and chief executive officer of Ardelyx. "We are confident that the data from three Phase 3 clinical trials involving more than 1,200 patients support the approval of XPHOZAH in the U.S. for the control of serum phosphorus in adult patients with CKD on dialysis. We want to thank the patients, physicians and the advocacy community who shared their valuable insights today and throughout the development program. We are hopeful following today's discussion that the data, the opinion of the advisory committee, the needs of patients, and the compelling voice of the broader nephrology community will be reflected in the FDA's decision on our appeal."

Sharon Moe, M.D., chief of the division of nephrology and hypertension, Indiana University School of Medicine, added, "XPHOZAH is a novel treatment that provides a clinically meaningful effect on serum phosphate. I am encouraged by the committee's vote. The nephrology community is enthusiastic to have access to this therapy with its novel mechanism of action to help our patients."

The CRDAC review of XPHOZAH for the control of serum phosphorus in adult patients with CKD on dialysis was based on findings from a comprehensive development program including more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY).

The CRDAC's recommendations, while not binding, will be considered by the Office of New Drugs (OND), Center for Drug Evaluation and Research of the FDA, when making its decision on Ardelyx's second level appeal of the Complete Response Letter received on July 28, 2021, for XPHOZAH. The OND is expected to provide a response to Ardelyx's appeal within thirty (30) days.

About XPHOZAH (tenapanor) for Hyperphosphatemia
XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI). XPHOZAH, with its unique blocking mechanism of action, acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30 mg tablet BID (twice) daily dosing regimen. The most common side effect with tenapanor in clinical trials was diarrhea.

About Hyperphosphatemia
Elevated levels of serum phosphorus in the blood, or hyperphosphatemia (HP), is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect

[Cosa]

I think this can rocket up pretty quickly. Shorts will need to cover, naked call sellers will need to buy shares. Could be an epic day tomorrow! Will see if MM can control this...Fill that gap!

[Johnstonj27]

Adcom Vote Approved ARDELYX

https://endpts.com/in-surprise-turn-fda-adcomm-votes-in-favor-of-ardelyx-ckd-drug-as-monotherapy-despite-agency-questions/

[Cosa]

Fingers crossed. Good luck to all!

[StonewallPatriot]

Price prediction: higher
XPHOZAH can indeed
help good folks in need

[Cosa]

This is going to XPLODAH either up or down.

[Cosa]

ARDX big day tomorrow. Will they add another revenue stream or are they just stuck with what they have.

[Johnstonj27]

$ARDX NEWS OUT TODAY...

https://www.etrade.wallst.com/v1/stocks/news/search_results.asp?ChallengeUrl=https://idp.etrade.com/idp/SSO.saml2&reinitiate-handshake=0&AuthnContext=authenticated&env=PRD&symbol=ARDX&docKey=309-IN20221031080738ARDX_live-05GGF4GIQ8Q12H7STC3RJIOG61&DMSourceID=BRIEFING&Source=Briefing.com&DisplayName=Briefing.com&docDate=2022-10-31%2012%3A07%3A38&headline=Ardelyx%20partner%20sumbmits%20NDA%20for%20Tenapanor%20for%20Hyperphosphatemia%20in%20Japan%3B%20Ardelyx%20to%20receive%20an%20aggregate%20of%20%2435%20million%20in%20milestone%20payments%20

[Cosa]

It was $0.60 three months ago. It looks fine. Just waiting on news.

[Bigb3]

Going wrong way

[Cosa]

The premium on those November $2.50 call got the life sucked out of them. I think those going to $0, way too heavy. MM's won't let it get there.

[Master Stocktrader]

But a good one today.

[Luckysevens]

XBI

[Master Stocktrader]

Bad chart today

[Cosa]

Why is the open interest on November $2.50 calls so heavy?

[Cosa]

That is a monster position. And that would be sick

[Luckysevens]

Imagine buying $15mil in shares and having it tank to new lows

[Cosa]

Wrote some November calls. Either way I think its a win win, unless this tanks to new lows.

[Johnstonj27]

It's been so far one of the most manipulated stocks I have seen. There is so many strong fundamentals at play that the company is absolutely keeping silent. Ones doing the real good DD are also probably shocked how cheap this is right now.

I can't believe they have been able to keep the PPS crushed like this.

[Master Stocktrader]

This will go as a a rocket

[Luckysevens]

Nice dip leading into October

[Master Stocktrader]

O man this will fly

[Johnstonj27]

Volume Massive Today

[Cosa]

Nice slow climb back up from lows

[Master Stocktrader]

We have time till November

[Johnstonj27]

Big Volume today 7.1 mil so far without news...

[Master Stocktrader]

I guess 8 dollars

[Johnstonj27]

Going to keep climbing now till Nov FDA Adcom.

[Master Stocktrader]

Incredible gap with $8.

[Master Stocktrader]

That is not so much

[TheFinalCD]

even with 140M float?

https://finviz.com/quote.ashx?t=ARDX&ty=c&ta=1&p=d

[TheFinalCD]

+11% slow grind but HOD and getting more attention https://finviz.com/quote.ashx?t=ARDX&ty=c&ta=1&p=d