Actionable news
All posts from Actionable news
Actionable news in GILD: Gilead Sciences, Inc.,

Vertex VRTX soars on cystic fibrosis combo data; AEZS PDUFA set for December 30; ImmunoCellular IMUC tumbles on offering

Price and Volume Movers

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) shares have surged in the after-hours session, currently trading up 25% to $165.70, equivalent to an increase in its market cap of over $8b. The company announced positive data from its Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min). The efficacy of the drug combinations was measured by improvement in the percentage predicted forced expiratory volume in one second (ppFEV1). Data from the Phase 1 and 2 trials exhibited impressive improvements in ppFEV1 of between 9.6 and 12.0 percentage points.

Otonomy, Inc. (Nasdaq:OTIC) announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) has been accepted for filing by the FDA and assigned a PDUFA date of March 2, 2018.

Aeterna Zentaris Inc. (NASDAQ: AEZS) also announced that its New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017. Shares are currently trading up 45% to $1.48 on the news.

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced that it intends to offer and sell $75m of shares of its common stock in an underwritten public offering. Shares are down after-hours 8% to...