TherapeuticsMD (TXMD) was expected to announce Monday the FDA rejection of its estrogen therapy for postmenopausal women. And that's what happened, except the FDA's reason for slamming the door on TherapeuticsMD places the future of its product, known as TX-004HR, in jeopardy.
The FDA wants 12-month endometrial safety data on TX-004HR. TherapeuticsMD conducted a single study that lasted just 12 weeks. The company does not have any long-term safety data on TX-004HR to settle the FDA's concerns.
TherapeuticsMD disagrees with the FDA's rejection and will ask for a meeting with the agency within 30 days to clarify exactly what's needed. But if the FDA sticks with its request, TherapeuticMD will be forced to conduct an entirely new clinical trial of TX-004HR that lasts at least 12 months. That could delay a resubmission and FDA approval by two years.
The company lacks the cash to conduct a long-term safety study of TX-004HR without cutting expenses elsewhere or raising more money.
Time is the last thing TherapeuticsMD can waste because TX-004HR is a me-too female hormone product entering a mature treatment market where Big Pharma competitors are already coming under selling pressure from a generic entry.
On a conference call Monday morning, TherapeuticsMD CEO Robert Finizio cried foul over the FDA's decision to reject TX-004HR based on long-term safety concerns. He insisted FDA never asked for long-term safety data in prior communications with the company. But he also couldn't explain why FDA wanted new, longer safety data. His message to investors was basically: Trust me, we'll figure this out. Everything will be fine.
Unfortunately, that's the same promise Finizio offered before FDA rejected his company's lead product.
TherapeuticsMD shares fell 16% to $3.90 in early Monday trading.
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