BioPharm Update: Have I said that I hate DVAX,,,I swear they are always doing something the reduce shareholder value.
Kite informs no Adcom required; Esperion (ESPR) reports positive hypercholesterolemia data; Gale reverse merger
Kite Pharma Inc (NASDAQ:KITE) shares closed Tuesday's session up 6% to $120.13. The company announced that the FDA has advised an Advisory Committee Meeting will not be required for its regulatory filing for its CAR-T candidate, Axi-cel, for the treatment of Non-Hodgkin's Lymphoma (NHL). The PDUFA date under priority review is set for November 29, 2017.
Galena Biopharma, Inc.(NASDAQ:GALE) announced a reverse merger with SELLAS Life Sciences Group Ltd, a privately-held company. The combined company will be renamed SELLAS Life Science Group, Inc and is expected to close in 4Q 2017. Galena holders will own 32.5%, of the combined company. Shares of Galena closed down 27% to $0.41 following the news.
Esperion Therapeutics, Inc. (NASDAQ: ESPR) shares surged during the morning session before retracing gains to close up 15% to $52.13 following its announcement of positive top-line data from its Phase 2 trial (1002-038) of the bempedoic acid / ezetimibe combination plus atorvastatin, versus placebo, in patients with hypercholesterolemia. The trial met the primary endpoint with patients seeing their LDL cholesterol levels fall 64% from baseline levels compared to those on the placebo. The company announced after-hours a public offering of $150m.
Dynavax Technologies Corporation (NASDAQ: DVAX) also announced an offering of $125m of shares of its common stock.
FibroGen, Inc. (NASDAQ:FGEN) shares closed up 48% to $49.50 following news after-hours Tuesday that its Phase 2 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) met the primary efficacy endpoint.
Depomed Inc (NASDAQ
EPO) shares closed down 33% to $6.14 following an update to its earnings forecast. The company now expects 2017 revenue of $395m-$410m compared with prior guidance of $405m-$425m.
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:
Myokardia Inc (NASDAQ:MYOK): $36.20; +15%.
Imprimis Pharmaceuticals Inc (NASDAQ:IMMY): $2.23; +12%.
Cellectar Biosciences Inc (NASDAQ:CLRB): $1.76; +11%.
Coherus Biosciences Inc (NASDAQ:CHRS): $13.50; +9%.
CytomX Therapeutics Inc (NASDAQ:CTMX): $14.78; +8%.
DECLINERS:
Dermira Inc (NASDAQERM): $22.43; -13%.
Kura Oncology Inc (NASDAQ:KURA): $9.00; -13%.
Endo International (NASDAQ:ENDP): $8.18; -12%.
Novelion Therapeutics (NASDAQ:NVLN): $8.09; -12%.
Gemphire Therapeutics (NASDAQ:GEMP): $8.80; -11%.
Major pipeline updates below:
DRUG STAGE CATALYST
TICKER: AQXP
AQX-1125 LEADERSHIP
Bladder pain syndrome/interstitial cystitis (BPS/IC).
PHASE 3 Phase 2 trial did not meet endpoints - June 2015 but postive secondary endpoint data - August 2015. Phase 3 trial commenced September 2016. Data due 3Q 2018.
TICKER: ALDX
ADX-102
Noninfectious anterior uveitis
PHASE 3 Phase 3 trial initiation announced April 27, 2017 with data due 2H 2018.
TICKER: ALDX
ADX-102
Dry eye syndrome
PHASE 2A Phase 2a completion of dosing announced July 18, 2017. Data due September 2017.
TICKER: CNCE
CTP-543
Alopecia areata
PHASE 2A Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.
TICKER: ENTA
EDP-305
Primary biliary cholangitis (PBC)
PHASE 2 Phase 2 trial to commence 4Q 2017.
TICKER: ENTA
EDP-305
Non-alcoholic steatohepatitis (NASH) with cirrhosis
PHASE 2 Phase 2 trial to commence 4Q 2017.
TICKER: ESPR
Bempedoic Acid/ Ezetimibe/ Atorvastatin (1002-038)
Hypercholesterolemia
PHASE 2 Phase 2 data released August 8, 2017. Primary endpoint met.
TICKER: ESPR
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-046, 1002-047 and 1002-048
Hypercholesterolemia - statin intolerance
PHASE 3 Phase 3 initiation of efficacy trials announced January 8, 2017. Data due 2Q and 3Q 2018.
TICKER: ESPR
Bempedoic acid (ETC-1002-040) - Clear Harmony
Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins
PHASE 3 Phase 3 long-term safety and tolerability trial initiated January 2016. Completion of enrollment announced January 25, 2017. Top-line results due 2Q 2018.
TICKER: GWPH
Epidiolex
Lennox-Gastaut syndrome (LGS)
PHASE 3 First Phase 3 trial data released June 2016. Data from second Phase 3 trial also met endpoint - September 2016. NDA Filing due October 2017.
TICKER: MTNB
MAT2501
Non-tuberculous mycobacterium (NTM)
PHASE 2 Phase 2 trial to be initiated 2H 2018. Data from PK/tolerability trial due 2Q 2018.
TICKER: KPTI
Selinexor - SEAL
Dedifferentiated liposarcoma
PHASE 2/3 Phase 2/3 trial initiated January 2016. Top-line data for the Phase 2 portion due September or October 2017.
TICKER: KPTI
Selinexor - STORM
Quadruple Refractory Multiple Myeloma
PHASE 2B Phase 2b STORM Study Expansion data due April 2018.
TICKER: XNCR
XmAb5871
IgG4-Related Disease (IgG4-RD)
PHASE 2 Phase 2 top-line data due in 2017.
View in browser »
Kite informs no Adcom required; Esperion (ESPR) reports positive hypercholesterolemia data; Gale reverse merger
Kite Pharma Inc (NASDAQ:KITE) shares closed Tuesday's session up 6% to $120.13. The company announced that the FDA has advised an Advisory Committee Meeting will not be required for its regulatory filing for its CAR-T candidate, Axi-cel, for the treatment of Non-Hodgkin's Lymphoma (NHL). The PDUFA date under priority review is set for November 29, 2017.
Galena Biopharma, Inc.(NASDAQ:GALE) announced a reverse merger with SELLAS Life Sciences Group Ltd, a privately-held company. The combined company will be renamed SELLAS Life Science Group, Inc and is expected to close in 4Q 2017. Galena holders will own 32.5%, of the combined company. Shares of Galena closed down 27% to $0.41 following the news.
Esperion Therapeutics, Inc. (NASDAQ: ESPR) shares surged during the morning session before retracing gains to close up 15% to $52.13 following its announcement of positive top-line data from its Phase 2 trial (1002-038) of the bempedoic acid / ezetimibe combination plus atorvastatin, versus placebo, in patients with hypercholesterolemia. The trial met the primary endpoint with patients seeing their LDL cholesterol levels fall 64% from baseline levels compared to those on the placebo. The company announced after-hours a public offering of $150m.
Dynavax Technologies Corporation (NASDAQ: DVAX) also announced an offering of $125m of shares of its common stock.
FibroGen, Inc. (NASDAQ:FGEN) shares closed up 48% to $49.50 following news after-hours Tuesday that its Phase 2 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) met the primary efficacy endpoint.
Depomed Inc (NASDAQ
EPO) shares closed down 33% to $6.14 following an update to its earnings forecast. The company now expects 2017 revenue of $395m-$410m compared with prior guidance of $405m-$425m. 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:
Myokardia Inc (NASDAQ:MYOK): $36.20; +15%.
Imprimis Pharmaceuticals Inc (NASDAQ:IMMY): $2.23; +12%.
Cellectar Biosciences Inc (NASDAQ:CLRB): $1.76; +11%.
Coherus Biosciences Inc (NASDAQ:CHRS): $13.50; +9%.
CytomX Therapeutics Inc (NASDAQ:CTMX): $14.78; +8%.
DECLINERS:
Dermira Inc (NASDAQ
ERM): $22.43; -13%. Kura Oncology Inc (NASDAQ:KURA): $9.00; -13%.
Endo International (NASDAQ:ENDP): $8.18; -12%.
Novelion Therapeutics (NASDAQ:NVLN): $8.09; -12%.
Gemphire Therapeutics (NASDAQ:GEMP): $8.80; -11%.
Major pipeline updates below:
DRUG STAGE CATALYST
TICKER: AQXP
AQX-1125 LEADERSHIP
Bladder pain syndrome/interstitial cystitis (BPS/IC).
PHASE 3 Phase 2 trial did not meet endpoints - June 2015 but postive secondary endpoint data - August 2015. Phase 3 trial commenced September 2016. Data due 3Q 2018.
TICKER: ALDX
ADX-102
Noninfectious anterior uveitis
PHASE 3 Phase 3 trial initiation announced April 27, 2017 with data due 2H 2018.
TICKER: ALDX
ADX-102
Dry eye syndrome
PHASE 2A Phase 2a completion of dosing announced July 18, 2017. Data due September 2017.
TICKER: CNCE
CTP-543
Alopecia areata
PHASE 2A Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.
TICKER: ENTA
EDP-305
Primary biliary cholangitis (PBC)
PHASE 2 Phase 2 trial to commence 4Q 2017.
TICKER: ENTA
EDP-305
Non-alcoholic steatohepatitis (NASH) with cirrhosis
PHASE 2 Phase 2 trial to commence 4Q 2017.
TICKER: ESPR
Bempedoic Acid/ Ezetimibe/ Atorvastatin (1002-038)
Hypercholesterolemia
PHASE 2 Phase 2 data released August 8, 2017. Primary endpoint met.
TICKER: ESPR
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-046, 1002-047 and 1002-048
Hypercholesterolemia - statin intolerance
PHASE 3 Phase 3 initiation of efficacy trials announced January 8, 2017. Data due 2Q and 3Q 2018.
TICKER: ESPR
Bempedoic acid (ETC-1002-040) - Clear Harmony
Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins
PHASE 3 Phase 3 long-term safety and tolerability trial initiated January 2016. Completion of enrollment announced January 25, 2017. Top-line results due 2Q 2018.
TICKER: GWPH
Epidiolex
Lennox-Gastaut syndrome (LGS)
PHASE 3 First Phase 3 trial data released June 2016. Data from second Phase 3 trial also met endpoint - September 2016. NDA Filing due October 2017.
TICKER: MTNB
MAT2501
Non-tuberculous mycobacterium (NTM)
PHASE 2 Phase 2 trial to be initiated 2H 2018. Data from PK/tolerability trial due 2Q 2018.
TICKER: KPTI
Selinexor - SEAL
Dedifferentiated liposarcoma
PHASE 2/3 Phase 2/3 trial initiated January 2016. Top-line data for the Phase 2 portion due September or October 2017.
TICKER: KPTI
Selinexor - STORM
Quadruple Refractory Multiple Myeloma
PHASE 2B Phase 2b STORM Study Expansion data due April 2018.
TICKER: XNCR
XmAb5871
IgG4-Related Disease (IgG4-RD)
PHASE 2 Phase 2 top-line data due in 2017.
View in browser »
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
https://twitter.com/twitter/statuses/957208055766241280
https://twitter.com/twitter/statuses/957208055766241280
