TherapeuticsMD Inc (NASDAQ:TXMD) shares were rocketing almost 32% yesterday and continue to jump just under 2% in pre-market trading today after the drug maker reported third quarter financials and provided thrilled investors with an encouraging update on its regulatory and clinical progress. The TXMD management team met with the FDA to talk about resubmitting an NDA for TX-004HR in dyspareunia.
The firm’s asset, designed to treat moderate-to-severe vaginal pain during sexual intercourse, had been tagged with a complete response letter (CRL) back in May for insufficient long-term safety data. Does the agency deem new data sufficient to resolve its concerns?
As of the “successful discussions with the FDA” held Friday, Oppenheimer analyst Jay Olson answers yes, cheering that the drug is now “back on track as best-case regulatory scenario emerges,” marching right along in the Street’s bullish parade.
In reaction, spotlighting “a favorable setup for TXMD,” the analyst reiterates an Outperform rating on TXMD stock with a $10 price target, which implies a nearly 71% increase from current levels. (To watch Olson’s track record, click here)
Olson underscores, “We are encouraged by the positive outcome of the FDA meeting and believe this result is a best-case scenario. Assuming FDA approval, management expects estrogen-class labeling for TX-004HR with a number of important differentiating features, including rapid onset of efficacy; minimal discharge from the soft gel formulation, with no applicator, which allows patients to be ambulatory immediately after dosing; the lowest available dose with no systemic exposure; and packaging which should provide clear patient education to optimize convenience, compliance and persistency.”
When assessing the work TXMD has accomplished “already,” the analyst anticipates a probably resubmission by the close of the month, not expecting any further data to be added to the resubmission. Looking ahead, the analyst calls for a Class 1 designation with a 60-day review which could bring about a prospective green light in January to kick off the new year. Angling for a fourth quarter of 2018 FDA approval for the dyspareunia candidate, Olson predicts a launch by the first quarter of 2019 for TherapeuticsMD.
Ultimately, Olson concludes on a bullish note of confidence for the drug maker’s momentum ahead: “We see this filing as relatively de-risked, considering that TXMD had a pre-NDA meeting with the FDA in August and has had several months now to complete any remaining work needed. We appreciate the constructive TX-004HR dialogue with the FDA—may bode well for TX-001HR.”
The word on the Street goes to the bulls on this biotech player, considering TipRanks analytics exhibit TXMD as a Strong Buy. Based on 7 analysts polled by TipRanks in the last 3 months, 6 rate a Buy on TherapeuticsMD stock while 1 maintains a Hold. The 12-month average price target stands at $15.57, marking a 171% upside from where the stock is currently trading.