TherapeuticsMD (NASDAQ:TXMD) announced this morning that the FDA approved TX-004 for treating symptoms of vulvar and vaginal atrophy (VVA). Once designated as Yuvexxy, the drug will be marketed in the U.S. as Imvexxy. The drug will be launched at the 4mcg and 10mcg doses and the label will carry the estrogen class black box warning.
In reaction, Oppenheimer analyst Jay Olson boosted his price target for TXMD from $10.00 to $12.00, while reiterating an Outperform rating on the stock. The new price target implies a potential upside of 98% from where the stock is currently trading.
Olson commented, “TXMD announced FDA approval of Imvexxy (estradiol vaginal inserts) with a label supporting what we view as the best-in-class profile based on safety, efficacy and convenience […] Based on widely accepted guidelines, patients should begin treatment at the lowest available dose, meaning that Imvexxy should now become the treatment of choice for dyspareunia. We are optimistic about the potential for Imvexxy and raise our probability of success to 100% (from 85%) with peak sales of ~$350M in 2030E.
“Imvexxy offers the lowest estrogen dose available of any FDA-approved treatment for dyspareunia. Estrogen exposure levels for Premarin (75X), Estrace (25X) and Vagifem (2.5X) are significantly higher than Imvexxy. Systemic estrogen levels for Imvexxy are similar to placebo, and the 4 mcg dose is numerically lower than placebo,” the analyst added.
As usual, we recommend taking analyst notes with a grain of salt. They are often successful in moving the stock price, but you always need to take things into perspective.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jay Olson has a yearly average return of -2.2% and a 43% success rate. Olson has a -3.8% average return when recommending TXMD, and is ranked #4230 out of 4811 analysts.
TipRanks shows a large amount of bulls liking the odds on this biotech firm. Out of 9 analysts polled in the last 12 months, 8 are bullish on TherapeuticsMD stock, while only 1 is playing it safe on the sidelines. The 12-month average price target stands at $14.13, marking a 133% upside from today’s closing price.