BioPharm Updates: Amicus Therapeutics (NASDAQ:FOL
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Posted On: 07/11/2017 11:43:52 PM
BioPharm Updates:
Amicus Therapeutics (NASDAQ:FOLD) shares surged to close up 26% to $12.92 following its announcement that the FDA no longer requires the company to initiate a Phase 3 trial prior to submitting its New Drug Application (NDA) for migalastat in patients with Fabry disease. In light of the positive news, the company plans to file the NDA in 4Q 2017. The FDA had previously requested Amicus to complete an additional Phase 3 trial, with data from the proposed trial not available until 2019 so today’s news is a significant positive for the company.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced today that it received a Complete Response Letter (CRL) from the FDA for its NDA of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The CRL noted manufacturing deficiencies identified during a pre-NDA approval inspection of its manufacturing facility. The company previously received a CRL in July 2016 also due to manufacturing deficiencies.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares closed the normal session up 41% to $26.00 following its release Monday after-hours that its Phase 2 trial of ralinepag for the treatment of pulmonary arterial hypertension (PAH) met the primary endpoint. Shares have pulled back 2.1% in Tuesday’s after-hours session following its announcement that that it intends to issue $150m of shares of its common stock in an underwritten public offering.
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) shares slumped to close down 34% to $1.29 following its announcement it will issue 2,431,746 American Depositary Shares (ADS) at a purchase price of $1.45 per ADS in a registered direct offering. Warrants with an exercise price of $1.50 per ADS were also attached to the offering.
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) also announced that it intends to issue 12.5m shares of its common stock in an underwritten public offering. Shares are currently down 9% to $11.10 after hours.
Neothetics, Inc. (NASDAQ:NEOT) shares closed down 12% to $0.465. The company announced Monday that it intends to reduce its workforce and initiate other measures to preserve its capital and cash. The company also noted that it will be exploring a range of strategic alternatives focusing on seeking an acquisition, business combination or partnership.
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:
Opexa Therapeutics Inc (NASDAQ:OPXA): $1.01; +29%.
Ampliphi Biosciences Corp (NYSEMKT:APHB): $1.07; +16%.
Verastem Inc (NASDAQ:VSTM): $4.01; +16%.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI): $2.80; +14%.
Novocure Ltd (NASDAQ:NVCR): $20.00; +10%.
DECLINERS:
pSivida Corp. (NASDAQ
SDV): $1.38; -17%.
Kadmon Holdings Inc (NYSE:KDMN): $3.38; -9%.
Tocagen Inc (NASDAQ:TOCA): $10.90; -7%.
ImmunoGen, Inc. (NASDAQ:IMGN): $6.82; -7%.
Fibrocell Science Inc (NASDAQ:FCSC): $3.46; -7%.
Amicus Therapeutics (NASDAQ:FOLD) shares surged to close up 26% to $12.92 following its announcement that the FDA no longer requires the company to initiate a Phase 3 trial prior to submitting its New Drug Application (NDA) for migalastat in patients with Fabry disease. In light of the positive news, the company plans to file the NDA in 4Q 2017. The FDA had previously requested Amicus to complete an additional Phase 3 trial, with data from the proposed trial not available until 2019 so today’s news is a significant positive for the company.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced today that it received a Complete Response Letter (CRL) from the FDA for its NDA of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The CRL noted manufacturing deficiencies identified during a pre-NDA approval inspection of its manufacturing facility. The company previously received a CRL in July 2016 also due to manufacturing deficiencies.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares closed the normal session up 41% to $26.00 following its release Monday after-hours that its Phase 2 trial of ralinepag for the treatment of pulmonary arterial hypertension (PAH) met the primary endpoint. Shares have pulled back 2.1% in Tuesday’s after-hours session following its announcement that that it intends to issue $150m of shares of its common stock in an underwritten public offering.
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) shares slumped to close down 34% to $1.29 following its announcement it will issue 2,431,746 American Depositary Shares (ADS) at a purchase price of $1.45 per ADS in a registered direct offering. Warrants with an exercise price of $1.50 per ADS were also attached to the offering.
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) also announced that it intends to issue 12.5m shares of its common stock in an underwritten public offering. Shares are currently down 9% to $11.10 after hours.
Neothetics, Inc. (NASDAQ:NEOT) shares closed down 12% to $0.465. The company announced Monday that it intends to reduce its workforce and initiate other measures to preserve its capital and cash. The company also noted that it will be exploring a range of strategic alternatives focusing on seeking an acquisition, business combination or partnership.
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:
Opexa Therapeutics Inc (NASDAQ:OPXA): $1.01; +29%.
Ampliphi Biosciences Corp (NYSEMKT:APHB): $1.07; +16%.
Verastem Inc (NASDAQ:VSTM): $4.01; +16%.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI): $2.80; +14%.
Novocure Ltd (NASDAQ:NVCR): $20.00; +10%.
DECLINERS:
pSivida Corp. (NASDAQ
SDV): $1.38; -17%. Kadmon Holdings Inc (NYSE:KDMN): $3.38; -9%.
Tocagen Inc (NASDAQ:TOCA): $10.90; -7%.
ImmunoGen, Inc. (NASDAQ:IMGN): $6.82; -7%.
Fibrocell Science Inc (NASDAQ:FCSC): $3.46; -7%.
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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