Bioparm News and information:
The biotech sector has sprung to life over the last few days, with the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ:IBB) reaching new 52-week highs Wednesday to close at $316.10, levels not seen since early January 2016. Positive newsflow has hit the trading screens over the last week, most notably by Clovis Oncology, Inc. (NASDAQ: CLVS) which has seen its shares surge 57% since Monday when it announced positive data from its Phase 3 ARIEL3 trial of rucaparib. Combined with talk that President Trump's executive order on drug pricing will be less severe than previously feared, has seen significantly more money and confidence flow into the sector. The New York Times noted the draft of the policy, "is light on specifics but clear on philosophy: Easing regulatory hurdles for the drug industry is the best way to get prices down." The report article went on to note that "the proposals identify some issues that have stoked public outrage — such as the high out-of-pocket costs for medicines — but it largely leaves the drug industry unscathed."
Ra Pharmaceuticals, Inc. (NASDAQ:RARX) announced that it will host a conference call on Tuesday, June 27, 2017 to discuss initial data from its Phase 2 trial of RA101495 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Early safety, tolerability, preliminary efficacy and pharmacodynamic data on the first two treatment naïve patients enrolled will be presented.
Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH) announced that it intends to offer shares of its common stock in an underwritten public offering.
Cara Therapeutics, Inc. (Nasdaq:CARA) shares closed up 10% to $19.50. The company announced interim conditional power analysis has been completed in its Phase 3 trial of I.V. CR845. The company noted that the trial will continue following guidance from the Independent Data Monitoring Committee (IDMC), with trial completion expected 4Q 2017. However, no data was disclosed by the company.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC) announced that it will suspend further patient randomization of its Phase 3 trial ICT-107 trial due to insufficient financial resources.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.04; +22%.
Immune Design Corp (NASDAQ:IMDZ): $9.55; +19%.
Esperion Therapeutics Inc (NASDAQ:ESPR): $41.02; +19%.
Concordia International Corp (NASDAQ:CXRX): $1.38; +18%.
Vital Therapies Inc (NASDAQ:VTL): $3.45; +13%.
DECLINERS:
Neos Therapeutics Inc (NASDAQ:NEOS): $7.30; -9%.
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN): $4.23; -6%.
Nantkwest Inc (NASDAQ:NK): $7.00; -6%.
Jounce Therapeutics Inc (NASDAQ:JNCE): $15.74; -4%.
Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): $6.50; -3%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: CARA
IV CR845
Acute pain
PHASE 3 Phase 3 initiated September 2015. Placed on clinical hold February 2016. Clinical hold released April 2016 with enrollment resuming June 2016. Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
TICKER: IMUC
ICT-107 dendritic cell vaccine
Glioblastoma antigens and cancer stem cells
PHASE 3 Phase 2b failed to meet primary endpoint. Phase 3 initiated dosing June 2016 - noted June 21, 2017 that further enrollment to be suspended.
TICKER: RARX
RA101495
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 initiation of dosing announced April 26, 2017. Initial data due June 27, 2017.
TICKER: RXII
RXI-109-1501
Retinal scarring
PHASE 1/2 Phase 2 completion of enrollment announced June 21, 2017.
The biotech sector has sprung to life over the last few days, with the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ:IBB) reaching new 52-week highs Wednesday to close at $316.10, levels not seen since early January 2016. Positive newsflow has hit the trading screens over the last week, most notably by Clovis Oncology, Inc. (NASDAQ: CLVS) which has seen its shares surge 57% since Monday when it announced positive data from its Phase 3 ARIEL3 trial of rucaparib. Combined with talk that President Trump's executive order on drug pricing will be less severe than previously feared, has seen significantly more money and confidence flow into the sector. The New York Times noted the draft of the policy, "is light on specifics but clear on philosophy: Easing regulatory hurdles for the drug industry is the best way to get prices down." The report article went on to note that "the proposals identify some issues that have stoked public outrage — such as the high out-of-pocket costs for medicines — but it largely leaves the drug industry unscathed."
Ra Pharmaceuticals, Inc. (NASDAQ:RARX) announced that it will host a conference call on Tuesday, June 27, 2017 to discuss initial data from its Phase 2 trial of RA101495 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Early safety, tolerability, preliminary efficacy and pharmacodynamic data on the first two treatment naïve patients enrolled will be presented.
Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH) announced that it intends to offer shares of its common stock in an underwritten public offering.
Cara Therapeutics, Inc. (Nasdaq:CARA) shares closed up 10% to $19.50. The company announced interim conditional power analysis has been completed in its Phase 3 trial of I.V. CR845. The company noted that the trial will continue following guidance from the Independent Data Monitoring Committee (IDMC), with trial completion expected 4Q 2017. However, no data was disclosed by the company.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC) announced that it will suspend further patient randomization of its Phase 3 trial ICT-107 trial due to insufficient financial resources.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Moleculin Biotech Inc (NASDAQ:MBRX): $1.04; +22%.
Immune Design Corp (NASDAQ:IMDZ): $9.55; +19%.
Esperion Therapeutics Inc (NASDAQ:ESPR): $41.02; +19%.
Concordia International Corp (NASDAQ:CXRX): $1.38; +18%.
Vital Therapies Inc (NASDAQ:VTL): $3.45; +13%.
DECLINERS:
Neos Therapeutics Inc (NASDAQ:NEOS): $7.30; -9%.
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN): $4.23; -6%.
Nantkwest Inc (NASDAQ:NK): $7.00; -6%.
Jounce Therapeutics Inc (NASDAQ:JNCE): $15.74; -4%.
Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): $6.50; -3%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: CARA
IV CR845
Acute pain
PHASE 3 Phase 3 initiated September 2015. Placed on clinical hold February 2016. Clinical hold released April 2016 with enrollment resuming June 2016. Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
TICKER: IMUC
ICT-107 dendritic cell vaccine
Glioblastoma antigens and cancer stem cells
PHASE 3 Phase 2b failed to meet primary endpoint. Phase 3 initiated dosing June 2016 - noted June 21, 2017 that further enrollment to be suspended.
TICKER: RARX
RA101495
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 initiation of dosing announced April 26, 2017. Initial data due June 27, 2017.
TICKER: RXII
RXI-109-1501
Retinal scarring
PHASE 1/2 Phase 2 completion of enrollment announced June 21, 2017.
1
'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
