Halister News

(Bloomberg) -- TherapeuticsMD indicated $5.01-$5.15 pre-market vs $4.80 prev. close after Oppenheimer analyst Jay Olson raised the stock to outperform from market perform and assigned PT $10 on the reasonable probability of positive news at TXMD’s FDA meeting on TX-004HR; an update is expected around July 14.

• Says the elimination of the 25 mcg dose is a positive as the remaining 4 and 10 mcg doses both provide essentially no systemic exposure to estrogen
• Encouraged by the recent North American Menopause Society (NAMS) position statement because it supports TX-004HR vs higher dose competitors
• Assigns 60% probability that TXMD resubmits the drug by July 31 with a potential FDA approval by Sept. 29 in the best case
• NOTE: June 19, TherapeuticsMD FDA Meeting Seen as ’Accommodating’: Jefferies
  • June 16, TherapeuticsMD Rises After FDA Meeting on TX-004HR; No Update aasf
  • May 8, TherapeuticsMD Fails to Win FDA Approval for TX-004HR

To contact the reporter on this story: Tatiana Darie in New York at tdarie1@bloomberg.net To contact the editors responsible for this story: Arie Shapira at ashapira3@bloomberg.net Brad Olesen