Here is a listing of BioPharm stock catalysts. It'
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Posted On: 09/27/2017 12:50:33 PM
Here is a listing of BioPharm stock catalysts. It's a good listing to show what is coming up on the radar:
Axovant AXON tumbles on Phase 3 trial failure; PTCT - FDA Panel briefing documents released for upcoming Adcom
Axovant Sciences (NASDAQ: AXON) shares tumbled following the announcement that its Phase 3 MINDSET clinical trial of intepirdine in patients with mild to moderate Alzheimer's disease (AD) did not meet its co-primary efficacy endpoints. Shares closed down 74% to $6.33.
Genocea Biosciences, Inc. (NASDAQ:GNCA) shares plunged to close down 77% to $1.25 following its announcement Monday after-hours that it will cease development for GEN-003 for the treatment of genital herpes. The company had previously announced that a Phase 3 trial was due to commence in 4Q 2017.
PTC Therapeutics, Inc. (NASDAQ
TCT) shares slid following the release of briefing documents for its meeting with an FDA Panel this Thursday which will discuss its NDA of Ataluren for the treatment of Duchenne muscular dystrophy (DMD). The documents were hardly glowing as noted by the following comment:
The application contains a large number of exploratory analyses that lack interpretability and are often entirely based on unblinded data. The presentation of the data in the application is often unclear as to which analyses were used by the applicant. Ultimately, no positive results from any prospectively planned analyses that are persuasive have been provided with this application. In the one instance where an exploratory analysis (the unblinded post hoc analysis of Study 007) was prospectively tested (in Study 020), the results were clearly negative.
The company previously received a Received a Refusal to File letter for their NDA Filing in February, 2016, followed by and appeal in October, 2016 which was rejected. A decision was made by the company to resubmit its NDA under protest and the application was issued a new PDUFA date of October 24, 2017. Given the background information, the negative comments made in the briefing documents should not have surprised investors, yet shares still closed down 14% to $16.81.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced that it has commenced an underwritten public offering of $150m of shares of its common stock.
Ascendis Pharma A/S (Nasdaq:ASND) also announced that it has commenced an underwritten public offering of $125mof American Depositary Shares.
Major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Bioblast Pharma Ltd (NASDAQ:ORPN): $2.22; +25%.
Myovant Sciences Ltd (NYSE:MYOV): $14.88; +20%.
Versartis Inc (NASDAQ:VSAR): $2.80; +14%.
Galectin Therapeutics Inc (NASDAQ:GALT): $2.30; +13%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.66; +10%.
DECLINERS:
ProQR Therapeutics NV (NASDAQRQR): $5.20 -19%,
Kadmon Holdings Inc (NYSE:KDMN): $3.24; -15%.
Repligen Corporation (NASDAQ:RGEN): $36.98; -14%.
TherapeuticsMD Inc (NYSEMKT:TXMD): $5.29; -13%.
Evoke Pharma Inc (NASDAQ:EVOK): $3.20; -11%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ADRO
ADU-S100
Solid tumors or lymphomas
PHASE 1B Phase 1b initiation of dosing announced September 26, 2017.
TICKER: ALNY
ALN-CC5 (cemdisiran)
Atypical hemolytic-uremic syndrome (aHUS)
PHASE 1/2 Phase 2 trial initiation announced September 26, 2017 with initial data due 2018.
TICKER: ARGS
ARGX-113
Pemphigus vulgaris (PV)
PHASE 2 Phase 2 initiation announced September 26, 2017 with interim data due 2H 2018.
TICKER: AXON
Intepirdine - MINDSET
Alzheimer's disease
PHASE 3 Phase 3 data released September 26, 2017 - primary endpoints not met.
TICKER: BLRX
BL-8040 in combination with atezolizumab - BATTLE
Acute myeloid leukemia (AML)
PHASE 1/2 Phase 1/2 initiation announced September 26, 2017.
TICKER: FCSC
FCX-007
Recessive dystrophic epidermolysis bullosa
PHASE 1/2 Phase 1/2 initial data from three patients released September 26, 2017.
TICKER: SVRA
AeroVanc - AVAIL
MRSA in cystic fibrosis
PHASE 3 Phase 3 initiation announced September 26, 2017.
TICKER: VTGN
AV-101
Adjunctive Treatment Major Depressive Disorder
PHASE 2 Phase 2 trial to commence January 2018 with completion due 2H 2018.
TICKER: VTGN
AV-101
Monotherapy Treatment Major Depressive Disorder
PHASE 2 Phase 2 top-line data due 1H 2018.
Axovant AXON tumbles on Phase 3 trial failure; PTCT - FDA Panel briefing documents released for upcoming Adcom
Axovant Sciences (NASDAQ: AXON) shares tumbled following the announcement that its Phase 3 MINDSET clinical trial of intepirdine in patients with mild to moderate Alzheimer's disease (AD) did not meet its co-primary efficacy endpoints. Shares closed down 74% to $6.33.
Genocea Biosciences, Inc. (NASDAQ:GNCA) shares plunged to close down 77% to $1.25 following its announcement Monday after-hours that it will cease development for GEN-003 for the treatment of genital herpes. The company had previously announced that a Phase 3 trial was due to commence in 4Q 2017.
PTC Therapeutics, Inc. (NASDAQ
TCT) shares slid following the release of briefing documents for its meeting with an FDA Panel this Thursday which will discuss its NDA of Ataluren for the treatment of Duchenne muscular dystrophy (DMD). The documents were hardly glowing as noted by the following comment: The application contains a large number of exploratory analyses that lack interpretability and are often entirely based on unblinded data. The presentation of the data in the application is often unclear as to which analyses were used by the applicant. Ultimately, no positive results from any prospectively planned analyses that are persuasive have been provided with this application. In the one instance where an exploratory analysis (the unblinded post hoc analysis of Study 007) was prospectively tested (in Study 020), the results were clearly negative.
The company previously received a Received a Refusal to File letter for their NDA Filing in February, 2016, followed by and appeal in October, 2016 which was rejected. A decision was made by the company to resubmit its NDA under protest and the application was issued a new PDUFA date of October 24, 2017. Given the background information, the negative comments made in the briefing documents should not have surprised investors, yet shares still closed down 14% to $16.81.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced that it has commenced an underwritten public offering of $150m of shares of its common stock.
Ascendis Pharma A/S (Nasdaq:ASND) also announced that it has commenced an underwritten public offering of $125mof American Depositary Shares.
Major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Bioblast Pharma Ltd (NASDAQ:ORPN): $2.22; +25%.
Myovant Sciences Ltd (NYSE:MYOV): $14.88; +20%.
Versartis Inc (NASDAQ:VSAR): $2.80; +14%.
Galectin Therapeutics Inc (NASDAQ:GALT): $2.30; +13%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.66; +10%.
DECLINERS:
ProQR Therapeutics NV (NASDAQ
RQR): $5.20 -19%, Kadmon Holdings Inc (NYSE:KDMN): $3.24; -15%.
Repligen Corporation (NASDAQ:RGEN): $36.98; -14%.
TherapeuticsMD Inc (NYSEMKT:TXMD): $5.29; -13%.
Evoke Pharma Inc (NASDAQ:EVOK): $3.20; -11%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ADRO
ADU-S100
Solid tumors or lymphomas
PHASE 1B Phase 1b initiation of dosing announced September 26, 2017.
TICKER: ALNY
ALN-CC5 (cemdisiran)
Atypical hemolytic-uremic syndrome (aHUS)
PHASE 1/2 Phase 2 trial initiation announced September 26, 2017 with initial data due 2018.
TICKER: ARGS
ARGX-113
Pemphigus vulgaris (PV)
PHASE 2 Phase 2 initiation announced September 26, 2017 with interim data due 2H 2018.
TICKER: AXON
Intepirdine - MINDSET
Alzheimer's disease
PHASE 3 Phase 3 data released September 26, 2017 - primary endpoints not met.
TICKER: BLRX
BL-8040 in combination with atezolizumab - BATTLE
Acute myeloid leukemia (AML)
PHASE 1/2 Phase 1/2 initiation announced September 26, 2017.
TICKER: FCSC
FCX-007
Recessive dystrophic epidermolysis bullosa
PHASE 1/2 Phase 1/2 initial data from three patients released September 26, 2017.
TICKER: SVRA
AeroVanc - AVAIL
MRSA in cystic fibrosis
PHASE 3 Phase 3 initiation announced September 26, 2017.
TICKER: VTGN
AV-101
Adjunctive Treatment Major Depressive Disorder
PHASE 2 Phase 2 trial to commence January 2018 with completion due 2H 2018.
TICKER: VTGN
AV-101
Monotherapy Treatment Major Depressive Disorder
PHASE 2 Phase 2 top-line data due 1H 2018.
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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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