BioPharm Updates: Xenon Pharmaceuticals Inc. (N
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Posted On: 06/28/2017 5:39:40 AM
BioPharm Updates:
Xenon Pharmaceuticals Inc. (Nasdaq:XENE) shares slumped to close down 21% to $3.00 following its announcement that the Phase 2 trial of TV-45070 in patients with post-herpetic neuralgia (PHN) did not meet both the primary endpoint and secondary endpoints.
Alder BioPharmaceuticals, Inc., (NASDAQ:ALDR) announced that its Phase 3 PROMISE 1 trial of eptinezumab, for migraine prevention, met the primary and key secondary endpoints. The data revealed that patients taking eptinezumab experienced 4.3 monthly migraine days for the higher dose and 3.9 days for the lower dose compared to an average 3.2 days for placebo. Shares slid 28% to close down at $13.48 with concerns that the data showed it would struggle with other competitors in the market.
Agile Therapeutics, Inc. (NASDAQ:AGRX) announced it has resubmitted its New Drug Application (NDA) to the FDA for its Twirla contraceptive patch (AG200-15). Agile resubmitted the NDA in response to a February 2013 Complete Response Letter (CRL) from the FDA, which recommended that Agile conduct a new clinical trial. However, data from the trial released in January earlier this year did not impress investors, with shares losing half of their value.
ADMA Biologics, Inc. (NASDAQ:ADMA) noted that it intends to resubmit its Biologics License Application (BLA) for RI-002 for primary immune deficiency diseases in mid-2018. The company received a CRL in July 2016, with third party manufacturing concerns cited for the decision. Shares closed Tuesday up 13% to $4.06.
Merck (NYSE:MRK) announced that its REVEAL outcomes trial of anacetrapib met its primary endpoint, significantly reducing major coronary events (coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen.
Minerva Neurosciences, Inc. (NASDAQ:NERV) announced after hours that it will issue 5m shares of its common stock in an underwritten public offering.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.98; +30%.
Sophiris Bio Inc (NASDAQ:SPHS): $2.39; +13%.
Fibrocell Science Inc (NASDAQ:FCSC): $3.93; +14%.
Strongbridge Biopharma (NASDAQ:SBBP): $6.55; +10%.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.75; +8%.
DECLINERS:
Ra Pharmaceuticals Inc (NASDAQ:RARX): $17.69; -20%.
Neuralstem, Inc. (NASDAQ:CUR): $5.70; -10%.
Curis, Inc. (NASDAQ:CRIS): $2.00; -10%.
Matinas BioPharma Holdings Inc (NYSEMKT:MTNB): $1.81; -10%.
Omeros Corporation (NASDAQ:OMER): $22.47; -9%.
Cascadian Therapeutics Inc (NASDAQ:CASC): $3.60; -9%.
Xenon Pharmaceuticals Inc. (Nasdaq:XENE) shares slumped to close down 21% to $3.00 following its announcement that the Phase 2 trial of TV-45070 in patients with post-herpetic neuralgia (PHN) did not meet both the primary endpoint and secondary endpoints.
Alder BioPharmaceuticals, Inc., (NASDAQ:ALDR) announced that its Phase 3 PROMISE 1 trial of eptinezumab, for migraine prevention, met the primary and key secondary endpoints. The data revealed that patients taking eptinezumab experienced 4.3 monthly migraine days for the higher dose and 3.9 days for the lower dose compared to an average 3.2 days for placebo. Shares slid 28% to close down at $13.48 with concerns that the data showed it would struggle with other competitors in the market.
Agile Therapeutics, Inc. (NASDAQ:AGRX) announced it has resubmitted its New Drug Application (NDA) to the FDA for its Twirla contraceptive patch (AG200-15). Agile resubmitted the NDA in response to a February 2013 Complete Response Letter (CRL) from the FDA, which recommended that Agile conduct a new clinical trial. However, data from the trial released in January earlier this year did not impress investors, with shares losing half of their value.
ADMA Biologics, Inc. (NASDAQ:ADMA) noted that it intends to resubmit its Biologics License Application (BLA) for RI-002 for primary immune deficiency diseases in mid-2018. The company received a CRL in July 2016, with third party manufacturing concerns cited for the decision. Shares closed Tuesday up 13% to $4.06.
Merck (NYSE:MRK) announced that its REVEAL outcomes trial of anacetrapib met its primary endpoint, significantly reducing major coronary events (coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen.
Minerva Neurosciences, Inc. (NASDAQ:NERV) announced after hours that it will issue 5m shares of its common stock in an underwritten public offering.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.98; +30%.
Sophiris Bio Inc (NASDAQ:SPHS): $2.39; +13%.
Fibrocell Science Inc (NASDAQ:FCSC): $3.93; +14%.
Strongbridge Biopharma (NASDAQ:SBBP): $6.55; +10%.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.75; +8%.
DECLINERS:
Ra Pharmaceuticals Inc (NASDAQ:RARX): $17.69; -20%.
Neuralstem, Inc. (NASDAQ:CUR): $5.70; -10%.
Curis, Inc. (NASDAQ:CRIS): $2.00; -10%.
Matinas BioPharma Holdings Inc (NYSEMKT:MTNB): $1.81; -10%.
Omeros Corporation (NASDAQ:OMER): $22.47; -9%.
Cascadian Therapeutics Inc (NASDAQ:CASC): $3.60; -9%.
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