Ardelyx Inc. shares fell on news that its kidney disease drug resulted in a higher incidence of diarrhea than anticipated.
What's happening with Ardelyx stock?
Jul 20, 2021 · Shares of the small-cap biotech Ardelyx (ARDX-7.82%) fell by a whopping 73.2% in pre-market action Tuesday morning. The drugmaker's stock is tanking today in response to a July 13 letter from the ...
Why did the FDA reject Ardelyx's NDA?
Jul 20, 2021 · The ARDX stock hit rock bottom on Monday after the company broke the negative outcome about its NDA for Tenapanor. ARDX stock can further go down in the coming days because it was a massive setback for the company and the company needs to address the issues as soon as possible to stop its decline in the stock market.
How much did Ardelyx get for Tenapanor?
Apr 30, 2021 · Shares of Ardelyx (NASDAQ: ARDX) were sinking 13% lower as of 11 a.m. EDT on Friday. The decline came after the company announced Thursday evening that the U.S. Food and Drug Administration (FDA ...
Is a complete response letter on the way for Ardelyx?
Jul 20, 2021 · Ardelyx Stock Collapses After FDA Rejects Its Kidney Disease Candidate Pitch. Vandana Singh, Benzinga. Jul. 20, 2021, 05:12 AM. Three months after revealing that the FDA had asked for more ...
Is ardelyx a good buy?
Is ARDX gonna go up?
The 6 analysts offering 12-month price forecasts for Ardelyx Inc have a median target of 4.50, with a high estimate of 12.00 and a low estimate of 1.00. The median estimate represents a +455.49% increase from the last price of 0.81.
Why is ARDX stock dropping?
Is ALDX stock a good buy?
Is ARDX a good company?
Ardelyx facing legal battles after FDA setback
After the FDA letter, Ardelyx has to face legal actions, soon after the news on July 19, 2021, Labaton Sucharow, a nationally ranked and award-winning shareholder rights firm, announced that it is investigating potential securities violations and breach of fiduciary duty claims against Ardelyx, Inc.
Participation in the recent conferences
Ardelyx, Inc recently did two presentations at new tenapanor data at the European Renal Association, European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021, which took place on June 5-8, 2021.
Recent financial results announcement
On May 6, 2021, Ardelyx, Inc announced its financial results for the first quarter ended March 31, 2021.
Q1 2021 financial highlights
Ardelyx reported revenue of $6.6 million in Q1 2021 compared to $1.2 million in Q1 2020.
Conclusion
The ARDX stock hit rock bottom on Monday after the company broke the negative outcome about its NDA for Tenapanor. ARDX stock can further go down in the coming days because it was a massive setback for the company and the company needs to address the issues as soon as possible to stop its decline in the stock market.
Investors appear to be taking profits off the table after the biotech announced a key FDA approval
Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights
What happened
Shares of Ardelyx ( NASDAQ:ARDX) were sinking 11.5% as of 10:58 a.m. EDT on Friday. The drop appears to be a case of "buy the rumor, sell the news." The biotech stock has soared in recent weeks in anticipation of Food and Drug Administration approval of Ibsrela (tenapanor) in treating irritable bowel syndrome with constipation (IBS-C).
So what
Investors' reaction the day after the FDA approval isn't all that unusual for a small biotech stock. Some opt to take profits off the table after a milestone development.
Now what
While investors watch how Ardelyx's launch of Ibsrela in treating IBS-C goes, the company should have more big news on the way relatively soon. It hopes to file for U.S. approval of the drug in treating hyperphosphatemia next year. If all goes well, the biotech will have two approved indications for Ibsrela by 2021.
The clinical-stage biotech's stock gave back about half of Tuesday's big gain in Wednesday morning trading
Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights
What happened
Shares of Ardelyx ( NASDAQ:ARDX) were down 16.8% as of 11:42 a.m. EDT on Wednesday. The drop came after the biotech stock soared Tuesday following its announcement of positive results from a late-stage study evaluating its lead experimental drug candidate, tenapanor.
So what
High volatility comes with the territory when investing in biotech stocks, especially clinical-stage biotechs like Ardelyx. But in many cases, the up-and-down swings don't really mean much. It's nearly always best to focus on the reasons for buying (or not buying) a stock in the first place, and ignore the short-term share price fluctuations.
Now what
While the results from the Amplify study certainly present good news for Ardelyx, the company still has more hurdles to jump. The biotech expects to announce results from its second late-stage study of tenapanor as a monotherapy in the fourth quarter. If those results are also positive, Ardelyx plans to file for U.S.
The company's Japanese partner initiated pivotal late-stage studies of Ardelyx's lead candidate
Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights
What happened
Shares of Ardelyx ( NASDAQ:ARDX) were soaring 8.9% as of 2:57 p.m. EDT on Wednesday.
So what
Kyowa Kirin's initiation of multiple phase 3 studies is good news for Ardelyx in a couple of ways. For one thing, it triggered a $5 million milestone payment. More importantly, it gets the two collaboration partners even closer to potential regulatory approval for tenapanor in Japan.
Now what
While the start of Japanese clinical studies is good news for Ardelyx, a more important milestone for the biotech stock is only a couple of weeks away. By April 29, the Food and Drug Administration should announce its approval decision for tenapanor in controlling phosphorus levels in adult patients with chronic kidney disease.
