$ARDX - Biopharma I just entered at $1.72 this morning. Tried to get in at $1.70, never got filled, kept raising my bid. Boom. Motley Fool noticed the recent approval from the FDA. Got another baby step and then this drug should (operative word for non-Bio-pharma traders and investors) be approved for use in 2023 and we’re off to the races.
Last on this list of biotech stocks to buy is Ardelyx (NASDAQ:ARDX), a company famous for its popular drug Ibsrela. That said, there may be more to talk about when it comes to Ardelyx. That’s because the company is in the process of bringing a new experimental drug to market.
This drug is likely to be named Xphozah, helping patients with chronic kidney disease. This medicine can be a game changer, as it helps regulate blood phosphorus levels for kidney patients on dialysis. Notably, the U.S. Food & Drug Administration (FDA) appears to be in Ardelyx’s corner when it comes to the drug. They voted 10 to 2 in favor of Xphozah being used in combination with other similar drugs. So, it’s likely we’ll see FDA clearance take hold some time in 2023.
This drug’s immense potential is noteworthy. However, with a market capitalization of less than $350 million, there’s clearly plenty of risk being priced into this stock. Nothing is certain in the world of gaining approvals from the FDA.
$TSLQ, I’m currently down about 4.00% after adding some at $54.25 to my nibble. New averaged down price is $56.06. From my notes last night I said I would hope for a drop to the trendline and then a pop back up. And that’s where we are at this moment:
Letting those “free” or “zero cost” shares of $ARDX ride without a stop/loss for now while I watch the Biopharma website for news on other approvals around the planet.
Nice little trade from a few weeks ago where I kept the gains in the underlying. Those “FREE” shares (to me the trader who kept them for just a few days) are now up +30.09% in about a month’s time.
I almost sold 100% of these shares. But that little news blurb I saw right about the time I was about to sell told me to just let the gains ride. This biotech is suddenly cash rich, in bed with a major Biopharma firm which could end up buying them out. Lot of different phase trial stuff in the pipeline too:
$ARDX I"ll draw a new trendline on the daily chart soon. Let the month end, see where we are. Good looking chart here:
WALTHAM, Mass., Dec. 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, provided an update regarding the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH (tenapanor).
Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx)
Earlier today, Peter Stein, M.D., Director of the Office of New Drugs, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA), requested a meeting with Ardelyx to discuss the status of his review of the appeal. After a productive conversation, Dr. Stein communicated that the FDA is finalizing the response and may require up to a few more weeks to do so. Ardelyx will communicate the response to the appeal once it has been received from the FDA.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.
Weekly chart shows a young baby bull running out of the barn. Strong 17 x 43 EMA bullish crossover a few weeks ago. Strong breakout on this weekly chart this week and volume is beginning to pick up with traders noticing the 52-Week High today on the daily chart:
Tip: use that 50 EMA on the daily chart x .97 to set a stop/loss and keep tightening by the day - or week - or month - depending on your time frame.
This is what an early stage bull run can look like. But it could all come crashing down too, with a bad result from any of these different biopharma trials this company is overseeing at this moment. Crapshoot. But, the odds are looking better by the week:
I’m adding a few more shares to my “Zero Cost” stash of $ARDX.
Just hit a new 52-Week High and the breakout on the weekly chart is a beautiful long candlestick breaking through a down trendline and also breaking above an important horizontal resistance set recently:
