BioPharm Update: AEZS Continues to rise. Ironwood
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Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it met the primary endpoint in its Phase 2b trial evaluating IW-3718 in adult patients with uncontrolled gastroesophageal reflux disease (GERD). The trial measured IW-3718 plus a proton pump inhibitor (PPI) against patients treated with a PPI alone. The data showed that patients treated with IW-3718 plus a PPI showed a mean decrease of 58% from baseline in heartburn severity compared to 46% in patients treated with a PPI alone (p = 0.04). While the data were statistically significant (p=0.04), the 12 point percentage difference was less than investor expectations, which saw shares sold off 8% to $17.00. Ironwood plans to advance IW-3718 into Phase 3 development in 2H 2018.
Shares of Aeterna Zentaris Inc. (NASDAQ: AEZS) continued their upward surge following Tuesday’s announcement that the FDA has set a PDUFA date of December 30, 2017 for its New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD). Shares of Aeterna Zentaris closed up 20% to $2.80 and are currently trading up a further 21% to $3.40 in the after-hours session following news that the company will be undergoing a “strategic review” of operations, commencing with the appointment Michael Ward as new CEO. The stock closed Tuesday’s session at a mere $1.02.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares closed up 20% to $40.93 following Wednesday’s earnings release which showed revenue from its Duchenne Muscular Dystrophy drug, Exondys 51, increase to $35m in 2Q 2017, with guidance for 2017 of between $125m and $130m, both above market expectations.
Amgen (NASDAQ:AMGN) announced that the FDA has accepted its Biologics License Application (BLA) for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. The PDUFA date is May 17, 2018. Aimovig will be jointly marketed with Novartis (NYSE:NVS).
Nivalis Therapeutics, Inc. (Nivalis) (Nasdaq: NVLS) will commence trading under the ticker ALPN from July 25, 2017 following its reverse merger with Alpine Immune Sciences, Inc. The merger will also result in a reverse split (1:4) of the stock.
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:
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV): $1.80; +16%.
Soligenix, Inc. (NASDAQ:SNGX): $2.87; +16%.
Orexigen Therapeutics, Inc. (NASDAQ:OREX): $2.60; +12%.
Diffusion Pharmaceuticals Inc (NASDAQFFN): $2.14: +11%.
Leap Therapeutics Inc (NASDAQ:LPTX): $7.66; +9%.
DECLINERS:
Inovio Pharmaceuticals Inc (NASDAQ:INO): $6.01; -11%.
Adamis Pharmaceuticals Corp (NASDAQ:ADMP): $4.65; -9%.
XBiotech Inc (NASDAQ:XBIT): $4.77; -8%.
Matinas BioPharma Holdings Inc (NYSEMKT:MTNB): $1.34; -8%.
Applied Genetic Technologies Corp (NASDAQ:AGTC): $4.60; -7%.
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