Monday, August 19, 2019 11:20:52 AM
ARDX = MC $155 M / Cash $124 M / FDA Decision for potential Blockbuster Drug on September 12 / Second Big Drug with Phase 3 Results also expected this Quarter ($700 M peak sales Potential ) = Potential 10 bagger here guys..RALLYYYYYYYYYYYYYY
Remaining Expected 2019 Milestones
The company's New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.
Results from the AMPLIFY clinical trial, the company's Phase 3 clinical trial evaluating tenapanor's efficacy in combination with phosphate binders, are currently expected to be announced in the third quarter of 2019.
Results from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, are currently expected to be announced in the fourth quarter of 2019.
5 Biggest New Drug Approvals Potentially on the Way in 2019....August 19, 2019
https://finance.yahoo.com/news/5-biggest-drug-approvals-potentially-100000979.html
5. Tenapanor
Small biotech Ardelyx should be only a few weeks away from some big news. The FDA is scheduled to announce an approval decision for tenapanor in treating irritable bowel syndrome with constipation (IBS-C) by Sept. 12, 2019.
EvaluatePharma expects that the drug could pull in nearly $700 million annually by 2024 if it's approved. Ardelyx hopes that the IBS-C is only the first of two approved indications for tenapanor. The company is also evaluating the drug in a phase 3 clinical study for treating hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.
Big impacts
FDA approvals for lumateperone and tenapanor would definitely have huge impacts for Intra-Cellular Therapies and Ardelyx. Neither company has an approved product on the market yet.
Remaining Expected 2019 Milestones
The company's New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.
Results from the AMPLIFY clinical trial, the company's Phase 3 clinical trial evaluating tenapanor's efficacy in combination with phosphate binders, are currently expected to be announced in the third quarter of 2019.
Results from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, are currently expected to be announced in the fourth quarter of 2019.
5 Biggest New Drug Approvals Potentially on the Way in 2019....August 19, 2019
https://finance.yahoo.com/news/5-biggest-drug-approvals-potentially-100000979.html
5. Tenapanor
Small biotech Ardelyx should be only a few weeks away from some big news. The FDA is scheduled to announce an approval decision for tenapanor in treating irritable bowel syndrome with constipation (IBS-C) by Sept. 12, 2019.
EvaluatePharma expects that the drug could pull in nearly $700 million annually by 2024 if it's approved. Ardelyx hopes that the IBS-C is only the first of two approved indications for tenapanor. The company is also evaluating the drug in a phase 3 clinical study for treating hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.
Big impacts
FDA approvals for lumateperone and tenapanor would definitely have huge impacts for Intra-Cellular Therapies and Ardelyx. Neither company has an approved product on the market yet.
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