- Theratechnologies Inc THTX has completed discussions with the FDA and European Medicines Agency regarding its proposed trial design and protocol for its Phase 3 trial for tesamorelin in nonalcoholic steatohepatitis (NASH).
- The trial will include a futility analysis after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy.
- A supplemental marketing application is expected to be filed after approximately 1,100 patients, including about 75 to 100 HIV patients, have completed 18 months of treatment and have received a second liver biopsy.
- Following potential approval, an additional 1,800 patients are expected to be enrolled to continue measuring clinical outcomes over five years.
- The Company says that the final Phase 3 trial design will result in higher costs than previously estimated.
- As a result, the Company has initiated a search for a potential partner to help launch the program. An advisory firm has been retained.
- Partner identification and negotiations will alter the initiation of the Phase 3 trial that was previously expected to begin in Q3 of 2021.
- The Company reported Q2 sales of $17.8 million, +4% Y/Y propelled by higher Egrifta sales of $10.3 million, +12%.
- Trogarzo sales declined 6% to $7.4 million on lower unit sales as patients refrained from visiting their physicians. Competitive pressures and higher rebates also impacted the sales.
- It posted a net loss of $(0.07) for the quarter compared to $(0.08) a year ago.
- The Company had $56.7 million in cash, sufficient to fund the Company's operations for at least the next twelve months.
- Price Action: THTX shares closed at $3.68 on Wednesday.
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THTXTheratechnologies Inc
$2.57-1.91%
Edge Rankings
Momentum
98.09
Growth
-
Quality
-
Value
26.96
Price Trend
Short
Medium
Long
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