BioPharm Updates: Vertex Pharmaceuticals Incorpor
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Posted On: 07/19/2017 7:44:11 AM
BioPharm Updates:
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 $7.18.
Gilead Sciences, Inc.(NASDAQ: GILD) announced that the FDA has approved Vosevi (sofosbuvir /velpatasvir /voxilaprevir) tablets for the re-treatment of chronic hepatitis C virus (HCV) infection.
Capricor Therapeutics Inc (NASDAQ:CAPR) soared to close up 99% to $1.36. The company announced that the FDA has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's candidate for the treatment of Duchenne muscular dystrophy. 12-month results from its Phase 1/2 HOPE Trial are due in 4Q 2017.
Novavax, Inc. (NASDAQ:NVAX) shares closed up 27% to $1.45. The company announced Monday it will host a conference call on July 24, 2017 where it will announce top-line data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults (60 years of age and older).
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC) shares tumbled 61% to $0.48. The company announced an equity offering of $5m including three types of warrants with the Preferred Stock converting into common stock at a price of the lesser of $1.22 of 87.5% of the lowest volume weighted average price of its common stock over 10 days.
Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $2.05; +21%.
CymaBay Therapeutics Inc (NASDAQ:CBAY): $6.94; +16%.
Uniqure NV (NASDAQ:QURE): $7.17; +10%.
Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $5.12; +9%.
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV): $1.47; +9%.
DECLINERS:
Soligenix, Inc. (NASDAQ:SNGX): $2.49; -12%.
Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): $6.78; -9%.
Spring Bank Pharmaceuticals Inc (NASDAQ:SBPH): $14.32; -9%.
Aradigm Corporation (NASDAQ:ARDM): $1.31; -8%.
AzurRx BioPharma Inc (NASDAQ:AZRX): $3.27; -8%.
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 $7.18.
Gilead Sciences, Inc.(NASDAQ: GILD) announced that the FDA has approved Vosevi (sofosbuvir /velpatasvir /voxilaprevir) tablets for the re-treatment of chronic hepatitis C virus (HCV) infection.
Capricor Therapeutics Inc (NASDAQ:CAPR) soared to close up 99% to $1.36. The company announced that the FDA has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's candidate for the treatment of Duchenne muscular dystrophy. 12-month results from its Phase 1/2 HOPE Trial are due in 4Q 2017.
Novavax, Inc. (NASDAQ:NVAX) shares closed up 27% to $1.45. The company announced Monday it will host a conference call on July 24, 2017 where it will announce top-line data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults (60 years of age and older).
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC) shares tumbled 61% to $0.48. The company announced an equity offering of $5m including three types of warrants with the Preferred Stock converting into common stock at a price of the lesser of $1.22 of 87.5% of the lowest volume weighted average price of its common stock over 10 days.
Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $2.05; +21%.
CymaBay Therapeutics Inc (NASDAQ:CBAY): $6.94; +16%.
Uniqure NV (NASDAQ:QURE): $7.17; +10%.
Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $5.12; +9%.
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV): $1.47; +9%.
DECLINERS:
Soligenix, Inc. (NASDAQ:SNGX): $2.49; -12%.
Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): $6.78; -9%.
Spring Bank Pharmaceuticals Inc (NASDAQ:SBPH): $14.32; -9%.
Aradigm Corporation (NASDAQ:ARDM): $1.31; -8%.
AzurRx BioPharma Inc (NASDAQ:AZRX): $3.27; -8%.
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