BioPharm Updates:
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) announced that the FDA has indicated that it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). The PDUFA date is set for April 17, 2018. Shares surged on the news, closing up 33% to $3.37.
Endocyte, Inc. (NASDAQ:ECYT) shares surged to close up 157% to $3.63 following its announcement of a worldwide license of PSMA-617 from ABX GmbH that will allow it to initiate a Phase 3 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) in 1H 2018.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that it did not meet the primary endpoint in its Phase 2/3 trial evaluating trigriluzole compared to placebo for the treatment of patients with spinocerebellar ataxia (SCA). Shares closed down 5% to $35.56.
Seres Therapeutics, Inc., (NASDAQ:MCRB) announced what it referred to as "positive top-line results" from its Phase 1b trial of SER-287 for the treatment of mild-to-moderate Ulcerative Colitis (UC). However, although there were no safety issues noted, the data showed that the clinical response rate in the placebo group was 60%, equal to patients who took vancomycin and SER 287 daily but much higher than patients who were treated with SER-287 weekly (43%) and vancomycin and SER 287 weekly (29%). Shares closed down 23% to $12.30.
Zogenix, Inc. (Nasdaq:ZGNX) announced that it intends to offer and sell 4.3m shares of its common stock in an underwritten public offering.
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV) announced that the FDA has set a PDUFA date of May 31, 2018 for KIT-302, for the treatment of osteoarthritis pain and hypertension simultaneously. Shares closed down 11% to $1.91.
Dynavax Technologies Corporation (NASDAQ
VAX) shares closed up 8% to $23.25 following a Reuters report that it is reviewing strategic options for its hepatitis B vaccine Heplisav-B. The company has an upcoming PDUFA date of November 10.
Arbutus Biopharma Corporation (Nasdaq:ABUS) announced that it has signed a share purchase agreement with Roivant Sciences for the sale of convertible preferred shares for gross proceeds of $116.4m.
Vical Incorporated (Nasdaq:VICL) announced after-hours that its Phase 2 trial of VL‑2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of the trial. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. Vical plans to initiate a single Phase 2 trial for the treatment of invasive aspergillosis (IA) in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the fourth quarter of 2017. Shares are currently up 36% to $3.36.
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:
Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $2.64; +25%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $5.50; +20%.
Mersana Therapeutics Inc (NASDAQ:MRSN): $19.84; +15%.
Ardelyx Inc (NASDAQ:ARDX): $6.40; +14%.
Galectin Therapeutics Inc (NASDAQ:GALT): $2.44; +14%.
DECLINERS:
Acer Therapeutics Inc (NASDAQ:ACER): $16.04; -14%.
Spring Bank Pharmaceuticals Inc (NASDAQ:SBPH): $15.30; -9%.
bluebird bio Inc (NASDAQ:BLUE): $125.45; -9%.
Rockwell Medical Inc (NASDAQ:RMTI): $7.85; -8%.
Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $1.22; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: BHVN
BHV-4157 Trigriluzole
Spinocerebellar Ataxia
PHASE 2/3 Phase 2b/3 negative top-line data released October 2, 2017.
TICKER: ECYT
Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
PHASE 3 Phase 3 trial to be initiated 1H 2018.
TICKER: JNJ
INVOKANA CANVAS
Type 2 diabetes
SNDA FILING Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality. sNDA filing announced October 2, 2017.
TICKER: KTOV
KIT-302
Osteoarthritis and Hypertension
PDUFA PDUFA date May 31, 2018.
TICKER: MCRB
SER-287
Mild-to-Moderate Ulcerative Colitis
PHASE 1B Phase 1b data released October 2, 2017 - did not perform better than placebo.
TICKER: RDHL
RHB-104 MAP US
Crohn’s disease
PHASE 3 Phase 3 data due mid-2018.
TICKER: RIGL
Fostamatinib
Immune Thrombocytopenic Purpura (ITP)
PDUFA Phase 3 data from the first trial released August 30 2016. Primary endpoint met. Data from second trial did not meet the primary endpoint. PDUFA date April 17, 2018. Noted October 2, 2017 that no Advisory Committee meeting is planned.
TICKER: SGMO
ST-400
beta-thalassemia
PHASE 1/2 Phase 1/2 trial to commence 1H 2018.
TICKER: SPHS
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
PHASE 2 Phase 2b initial biopsy data due late 1Q 2018.
TICKER: VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer
PHASE 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis released October 2, 2017 noted trial to continue as planned. Top-line data due 1Q 2018.
TICKER: VICL
VL-2397
Invasive aspergillosis
PHASE 2 Phase 2 trial to be initiated 4Q 2017. Eligible for Limited Use Indication Approval assuming positive data.
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) announced that the FDA has indicated that it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). The PDUFA date is set for April 17, 2018. Shares surged on the news, closing up 33% to $3.37.
Endocyte, Inc. (NASDAQ:ECYT) shares surged to close up 157% to $3.63 following its announcement of a worldwide license of PSMA-617 from ABX GmbH that will allow it to initiate a Phase 3 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) in 1H 2018.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that it did not meet the primary endpoint in its Phase 2/3 trial evaluating trigriluzole compared to placebo for the treatment of patients with spinocerebellar ataxia (SCA). Shares closed down 5% to $35.56.
Seres Therapeutics, Inc., (NASDAQ:MCRB) announced what it referred to as "positive top-line results" from its Phase 1b trial of SER-287 for the treatment of mild-to-moderate Ulcerative Colitis (UC). However, although there were no safety issues noted, the data showed that the clinical response rate in the placebo group was 60%, equal to patients who took vancomycin and SER 287 daily but much higher than patients who were treated with SER-287 weekly (43%) and vancomycin and SER 287 weekly (29%). Shares closed down 23% to $12.30.
Zogenix, Inc. (Nasdaq:ZGNX) announced that it intends to offer and sell 4.3m shares of its common stock in an underwritten public offering.
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV) announced that the FDA has set a PDUFA date of May 31, 2018 for KIT-302, for the treatment of osteoarthritis pain and hypertension simultaneously. Shares closed down 11% to $1.91.
Dynavax Technologies Corporation (NASDAQ
VAX) shares closed up 8% to $23.25 following a Reuters report that it is reviewing strategic options for its hepatitis B vaccine Heplisav-B. The company has an upcoming PDUFA date of November 10. Arbutus Biopharma Corporation (Nasdaq:ABUS) announced that it has signed a share purchase agreement with Roivant Sciences for the sale of convertible preferred shares for gross proceeds of $116.4m.
Vical Incorporated (Nasdaq:VICL) announced after-hours that its Phase 2 trial of VL‑2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of the trial. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. Vical plans to initiate a single Phase 2 trial for the treatment of invasive aspergillosis (IA) in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the fourth quarter of 2017. Shares are currently up 36% to $3.36.
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:
Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $2.64; +25%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $5.50; +20%.
Mersana Therapeutics Inc (NASDAQ:MRSN): $19.84; +15%.
Ardelyx Inc (NASDAQ:ARDX): $6.40; +14%.
Galectin Therapeutics Inc (NASDAQ:GALT): $2.44; +14%.
DECLINERS:
Acer Therapeutics Inc (NASDAQ:ACER): $16.04; -14%.
Spring Bank Pharmaceuticals Inc (NASDAQ:SBPH): $15.30; -9%.
bluebird bio Inc (NASDAQ:BLUE): $125.45; -9%.
Rockwell Medical Inc (NASDAQ:RMTI): $7.85; -8%.
Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $1.22; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: BHVN
BHV-4157 Trigriluzole
Spinocerebellar Ataxia
PHASE 2/3 Phase 2b/3 negative top-line data released October 2, 2017.
TICKER: ECYT
Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
PHASE 3 Phase 3 trial to be initiated 1H 2018.
TICKER: JNJ
INVOKANA CANVAS
Type 2 diabetes
SNDA FILING Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality. sNDA filing announced October 2, 2017.
TICKER: KTOV
KIT-302
Osteoarthritis and Hypertension
PDUFA PDUFA date May 31, 2018.
TICKER: MCRB
SER-287
Mild-to-Moderate Ulcerative Colitis
PHASE 1B Phase 1b data released October 2, 2017 - did not perform better than placebo.
TICKER: RDHL
RHB-104 MAP US
Crohn’s disease
PHASE 3 Phase 3 data due mid-2018.
TICKER: RIGL
Fostamatinib
Immune Thrombocytopenic Purpura (ITP)
PDUFA Phase 3 data from the first trial released August 30 2016. Primary endpoint met. Data from second trial did not meet the primary endpoint. PDUFA date April 17, 2018. Noted October 2, 2017 that no Advisory Committee meeting is planned.
TICKER: SGMO
ST-400
beta-thalassemia
PHASE 1/2 Phase 1/2 trial to commence 1H 2018.
TICKER: SPHS
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
PHASE 2 Phase 2b initial biopsy data due late 1Q 2018.
TICKER: VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer
PHASE 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis released October 2, 2017 noted trial to continue as planned. Top-line data due 1Q 2018.
TICKER: VICL
VL-2397
Invasive aspergillosis
PHASE 2 Phase 2 trial to be initiated 4Q 2017. Eligible for Limited Use Indication Approval assuming positive data.
2
'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
