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."

zu dem Meeting am 19.06.

Ventrus: FDA Schedules Type B Pre-NDA Meeting On June 19 For Dolizem
By RTT News,  April 04, 2014, 08:09:00 AM EDT

(RTTNews.com) - Ventrus Biosciences Inc. ( VTUS ) announced Friday that the U.S. Food and Drug Administration or FDA has scheduled a Type B pre-NDA meeting on Thursday, June 19, 2014 at which the company will seek guidance on its planned new drug application or NDA for Dolizem (diltiazem hydrochloride cream) in anal fissures.

Ventrus said it would expect to file an NDA in the second half of 2014 with an anticipated PDUFA date in the second half of 2015 if there is a positive outcome of this pre-NDA meeting.