Shares of pico cap Ventrus Biosciences (VTUS +19.5%) jump on 3x higher volume. Today's action follows a breakout on May 29 when prices popped 23% on 14-fold surge in volume.
Traders appear to be taking positions before the company's pre-IND meeting with the FDA on June 19 where the parties will discuss guidance regarding an approval path for Dolizem (diltiazem hydrochloride cream) as a treatment for anal fissures. Based on a positive outcome of the meeting, Ventrus plans to file an NDA in 2H 2014 with an expected PDUFA date about a year later.
On February 12, shares cratered 61% on turnover of 18M shares after the firm reported that Dolizem failed to outperform placebo in a second Phase 3 trial. In the first Phase 3, the product did demonstrate a statistically significant improvement in pain versus placebo.
The company's previously-announced merger with Assembly Pharmaceuticals will close around July 10. The name of the combined firm will be Assembly Biosciences trading under the ticker "ASMB."