BioPharm Updates: EGRX issued CRL; IPCI receives
Saturday, May 10, 2025 07:03:14 AM
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Posted On: 07/26/2017 9:44:43 PM
BioPharm Updates:
EGRX issued CRL; IPCI receives thumbs down from Advisory Committee; Dynavax DVAX FDA briefing documents released
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods. In its letter to Eagle, the FDA requested the company to conduct an additional clinical trial. Shares closed down 24% to $53.37.
Dynavax Technologies Corporation (NASDAQ
VAX) shares endured a volatile session, slipping over 20% in early trading before closing up 5% to $10.40 as investors digested key points noted in the FDA briefing documents released Wednesday for Friday’s Advisory Committee Meeting. The executive summary noted robust efficacy but with a lack of clarity in regard to safety:
In summary, Heplisav was shown to have a robust immune response in healthy adults 18- 70 years of age in Studies DV2-HBV-10 and-16. Heplisav met pre-specified noninferiority criteria to an active comparator vaccine, Engerix-B, in these two phase 3 clinical trials. Regarding safety, there appear to be imbalances in deaths and SAEs of MI in DV2-HBV-23, and imbalances in AESIs in DV2-HBV-16 and -23 (the studies that prospectively evaluated these events). Numbers and rates of events are low, and the lack of prospectively defined monitoring and evaluation of cardiac events limits the causal interpretation of these observations.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) - An FDA Advisory Committee voted 22-1 against recommending approval of Rexista, a generic abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. The assigned PDUFA date is September, 25, 2017.
Gilead Sciences, Inc. (Nasdaq: GILD) shares are trading up 2.1% to $75.76 in the after-hours session following the release of 2Q financials. Total 12-month revenue waw $7.1 billion compared with consensus of $6.3b and $7.8 billion for the same period in 2016.
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced that it has commenced an underwritten offering of $60m of shares of its common stock. Shares are trading down 4% in the after-hours session to $7.55 after closing up 14% during normal hours.
Other Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $1.88; +18%.
Immune Design Corp (NASDAQ:IMDZ): $11.65; +13%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.26; +13%.
Axsome Therapeutics Inc (NASDAQ:AXSM): $6.15; +8%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.18; +8%.
DECLINERS:
Neuralstem, Inc. (NASDAQ:CUR): $2.47; -12%.
Pernix Therapeutics Holdings Inc (NASDAQ
TX): $3.15; -9%.
AnaptysBio Inc (NASDAQ:ANAB): $25.77; -8%.
Dicerna Pharmaceuticals Inc (NASDAQRNA): $3.98; -8%.
Soligenix, Inc. NASDAQ:SNGX): $2.40; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: EGRX
Ryanodex
Exertional heat stroke (EHS)
CRL CRL issued July 26, 2017. Additional trial required.
TICKER: ESPR
Bempedoic Acid - 1002-039
Hypercholesterolemia
PHASE 2 Phase 2 initiation announced July 26, 2017 - data due 1Q 2018.
TICKER: IPCI
Rexista
Pain relief
PDUFA PDUFA date September 25, 2017. Advisory Committee Meeting July 26, 2017 voted 22-1 against recommending approval.
TICKER: GSK
Inhaled PI3Kδ inhibitor
Chronic obstructive pulmonary disease (COPD)
PHASE 2B Phase 2b data due 1H 2019.
TICKER: GSK
Closed Triple - CAPTAIN
Asthma
PHASE 3 Phase 3 data due 2H 2018.
TICKER: GSK
GSK 165
Osteoarthritis
PHASE 2 Phase 2 data due 2H 2017.
TICKER: GSK
anti-SAP mAb
Amyloidosis
PHASE 2B Phase 2b data likely due 4Q 2017.
TICKER: GSK
Daprodustat - ASCEND-D
Anemia
PHASE 3 Phase 3 trial commenced 4Q 2016. Data due 2H 2020.
TICKER: GSK
Danirixin
Chronic obstructive pulmonary disease (COPD)
PHASE 2B Phase 2b data likely due 1Q 2019.
TICKER: GSK
Dolutegravir + lamivudine (GEMINI 2)
HIV
PHASE 3 Phase 3 trial commenced August 2016. Data likely due 1Q 2018.
TICKER: GSK
Dolutegravir + lamivudine (GEMINI 1)
HIV
PHASE 3 Phase 3 trial commenced August 2016. Data likely due 1Q 2018.
TICKER: GSK
Tapinarof
Atopic dermatitis, psoriasis
PHASE 3 Phase 3 data due 1H 2019.
TICKER: OPHT
Fovista
Wet age-related macular degeneration (Wet-AMD)
PHASE 3 Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial due 3Q 2017 - company indicated that previous trial failures may be indicative of a low likelihood of success.
View in browser »
EGRX issued CRL; IPCI receives thumbs down from Advisory Committee; Dynavax DVAX FDA briefing documents released
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods. In its letter to Eagle, the FDA requested the company to conduct an additional clinical trial. Shares closed down 24% to $53.37.
Dynavax Technologies Corporation (NASDAQ
VAX) shares endured a volatile session, slipping over 20% in early trading before closing up 5% to $10.40 as investors digested key points noted in the FDA briefing documents released Wednesday for Friday’s Advisory Committee Meeting. The executive summary noted robust efficacy but with a lack of clarity in regard to safety: In summary, Heplisav was shown to have a robust immune response in healthy adults 18- 70 years of age in Studies DV2-HBV-10 and-16. Heplisav met pre-specified noninferiority criteria to an active comparator vaccine, Engerix-B, in these two phase 3 clinical trials. Regarding safety, there appear to be imbalances in deaths and SAEs of MI in DV2-HBV-23, and imbalances in AESIs in DV2-HBV-16 and -23 (the studies that prospectively evaluated these events). Numbers and rates of events are low, and the lack of prospectively defined monitoring and evaluation of cardiac events limits the causal interpretation of these observations.
IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) - An FDA Advisory Committee voted 22-1 against recommending approval of Rexista, a generic abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. The assigned PDUFA date is September, 25, 2017.
Gilead Sciences, Inc. (Nasdaq: GILD) shares are trading up 2.1% to $75.76 in the after-hours session following the release of 2Q financials. Total 12-month revenue waw $7.1 billion compared with consensus of $6.3b and $7.8 billion for the same period in 2016.
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) announced that it has commenced an underwritten offering of $60m of shares of its common stock. Shares are trading down 4% in the after-hours session to $7.55 after closing up 14% during normal hours.
Other Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $1.88; +18%.
Immune Design Corp (NASDAQ:IMDZ): $11.65; +13%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.26; +13%.
Axsome Therapeutics Inc (NASDAQ:AXSM): $6.15; +8%.
Moleculin Biotech Inc (NASDAQ:MBRX): $2.18; +8%.
DECLINERS:
Neuralstem, Inc. (NASDAQ:CUR): $2.47; -12%.
Pernix Therapeutics Holdings Inc (NASDAQ
TX): $3.15; -9%. AnaptysBio Inc (NASDAQ:ANAB): $25.77; -8%.
Dicerna Pharmaceuticals Inc (NASDAQ
RNA): $3.98; -8%. Soligenix, Inc. NASDAQ:SNGX): $2.40; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: EGRX
Ryanodex
Exertional heat stroke (EHS)
CRL CRL issued July 26, 2017. Additional trial required.
TICKER: ESPR
Bempedoic Acid - 1002-039
Hypercholesterolemia
PHASE 2 Phase 2 initiation announced July 26, 2017 - data due 1Q 2018.
TICKER: IPCI
Rexista
Pain relief
PDUFA PDUFA date September 25, 2017. Advisory Committee Meeting July 26, 2017 voted 22-1 against recommending approval.
TICKER: GSK
Inhaled PI3Kδ inhibitor
Chronic obstructive pulmonary disease (COPD)
PHASE 2B Phase 2b data due 1H 2019.
TICKER: GSK
Closed Triple - CAPTAIN
Asthma
PHASE 3 Phase 3 data due 2H 2018.
TICKER: GSK
GSK 165
Osteoarthritis
PHASE 2 Phase 2 data due 2H 2017.
TICKER: GSK
anti-SAP mAb
Amyloidosis
PHASE 2B Phase 2b data likely due 4Q 2017.
TICKER: GSK
Daprodustat - ASCEND-D
Anemia
PHASE 3 Phase 3 trial commenced 4Q 2016. Data due 2H 2020.
TICKER: GSK
Danirixin
Chronic obstructive pulmonary disease (COPD)
PHASE 2B Phase 2b data likely due 1Q 2019.
TICKER: GSK
Dolutegravir + lamivudine (GEMINI 2)
HIV
PHASE 3 Phase 3 trial commenced August 2016. Data likely due 1Q 2018.
TICKER: GSK
Dolutegravir + lamivudine (GEMINI 1)
HIV
PHASE 3 Phase 3 trial commenced August 2016. Data likely due 1Q 2018.
TICKER: GSK
Tapinarof
Atopic dermatitis, psoriasis
PHASE 3 Phase 3 data due 1H 2019.
TICKER: OPHT
Fovista
Wet age-related macular degeneration (Wet-AMD)
PHASE 3 Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial due 3Q 2017 - company indicated that previous trial failures may be indicative of a low likelihood of success.
View in browser »
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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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