ARDX ( $155 M) FDA Decision on Sept 12 & Phase 3 readout also this Quarter

Discussion in 'Stock picks and trading strategies' started by DollarChamp, Aug 19, 2019.

  1. DollarChamp

    DollarChamp Member

    FDA Decision for IBS-C Drug (irritable bowel syndrome with constipation) on September 12, 2019 and Phase 3 readout of the AMPLIFY clinical trial for the treatment of Hyperphosphatemia also in Q3 2019 . Tenapanor has over $500 million commercial opportunity in each of these indications. ARDX almost trading at cash level which shows how significantly underpriced this company is .


    Ardelyx (ARDX)

    Market-Cap : $155 million
    Cash: $124 Million
    Price: $2.47


    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.



    Ardelyx transported by success in IBS-C; tenapanor exchanges suffering for relief
    http://www.bioworld.com/content/ard...-ibs-c-tenapanor-exchanges-suffering-relief-0


    Ardelyx Announces Peer-Reviewed Publication of Positive Phase 3 Results of Tenapanor for the Treatment of Hyperphosphatemia in the Journal of the American Society of Nephrology
    https://www.prnewswire.com/news-rel...american-society-of-nephrology-300808726.html

    [​IMG]
     
  2. DollarChamp

    DollarChamp Member

    Could hit $4-5 before FDA decision in 3 Weeks ...
    [​IMG]
     
  3. DollarChamp

    DollarChamp Member

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