Analyst says TherapeuticsMD could jump if FDA meeting goes well
Cantor Fitzgerald analyst William Tanner reiterated his Overweight rating and $32 price target on TherapeuticsMD (TXMD) ahead of an expected meeting with the U.S. Food and Drug Administration, saying he believes shares could rally above $8 depending on the outcome.
‘BIG’ MEETING TODAY
Tanner expects TherapeuticsMD will meet with the FDA today, Friday, November 3, absent an announcement to the contrary, to discuss the next steps in the FDA’s review of the new drug application, or NDA, for TX-004 for vulvar vaginal atrophy.
Tanner expects TherapeuticsMD will most likely disclose the outcome of the FDA meeting and plans next week.
Until the announcement is made, Tanner believes the stock could be volatile. Tanner believes the outcome of the meeting could yield a stock price above $8.
Tanner sees three potential outcomes for the FDA meeting, with gathering long-term safety data post-approval being the highest probability outcome given that the FDA likely has “comfort” with the safety profile of vaginally delivered, low-dose estrogen, and that observing no increase above background levels for the 4mcg and 10mcg doses of TX-004 burnishes the safety profile.
Another, less likely but “messy” outcome, is that the FDA could argue that unmet medical need “does not exist” in VVA, but the analyst contended that he doubts the FDA would cite that as a reason to stall approval of TX-004 pending long-term safety data. If the FDA does require data collection prior to granting marketing approval, Tanner believes dispute resolution will be pursued.
The least likely outcome of the meeting, Tanner said, is the FDA deciding that long-term data are unnecessary, stating that “for no other reason than to reinforce safety observations, we believe the FDA would be inclined to want the data at some point.”
In a note to clients in September, Tanner noted TherapeuticsMD’s conference call with an author of the National Institutes of Health paper on vaginal estrogen and safety observations from the Women’s Health Initiative Observational Study.
The analyst said at the time that results of the analysis should provide the FDA “with additional comfort” regarding low-dose estrogen safety and support approval of TX-004 without the need for 12-month safety testing beforehand.
In Friday’s morning trading, shares of TherapeuticsMD are flat at $4.60 per share. The stock is down about 20% year-to-date.
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