- Entera Bio ( NASDAQ: ENTX ) is up ~9% in Wednesday morning trading after saying that the US FDA has agreed to a Type D meeting protocol review to finalize the phase 3 trial design of a candidate for post-menopausal osteoporosis.
- The study, proposed to last 24 months, would evaluate EB613, an oral, once daily mini tablet of teriparatide. That active ingredient is currently marketed as an injectable by Eli Lilly ( LLY ) under the name Forteo.
- EB613 met primary and secondary endpoints in a placebo controlled, dose ranging phase 2 study.
- Entera Bio ( ENTX ) said that responses to FDA are due by March 30 and it anticipates beginning the phase 3 trial in the second half of the year.
- Seeking Alpha's Quant Ratings views Entera Bio ( ENTX ) as a hold.
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Entera Bio up 9% after FDA agrees to review design for phase 3 osteoporosis candidate