Biopharm Watch: Neothetics NEOT plunges 70
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Posted On: 06/26/2017 9:04:15 PM
Biopharm Watch:
Neothetics NEOT plunges 70% while Matinas MTNB slides 27% on disappointing trial data
Neothetics, Inc. (NASDAQ:NEOT) shares plunged to closed down 70% to $0.71 following its announcement that its Phase 2 trial of LIPO-202-CL-31, for the reduction of submental subcutaneous fat, did not demonstrate improvement on any efficacy measurements or separation from placebo.
Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB) shares slid to close down 27% to $2.00 following the release of top-line data from its Phase 2 trial of MAT2203 in women with moderate to severe vulvovaginal candidiasis (VVC). While the company noted that the trial met the primary endpoint in demonstrating MAT2203 is safe and well tolerated, efficacy was below that of fluconazole, the guideline recommended therapy for the treatment of VVC. The lack of conviction with the data was reflected when it noted:
"…we were pleased to see what we believe could indicate clinical response which may provide support for the systemic delivery of MAT2203 to the site of infection…"
Seattle Genetics, Inc. (NASDAQ: SGEN) announced that its ECHELON-1 trial of ADCETRIS for the treatment of previously untreated Hodgkin lymphoma met its primary endpoint of a statistically significant improvement in progression-free survival (PFS). The Phase 3 trial exhibited a significant improvement in modified PFS versus the control arm (hazard ratio=0.770; p-value=0.035). The PFS rate for patients in the ADCETRIS arm was 82.1% compared to 77.2% in the control arm. While the trial did meet the primary endpoint, shares were swiftly sold off, closing down 8% to $56.60 with investors disappointed with the marginal improvement of PFS.
Neos Therapeutics, Inc. (Nasdaq:NEOS) announced that it has commenced an underwritten public offering of $30 million in shares of its common stock. Shares are trading down 4.8% in the after-hours session to $7.00.
bluebird bio, Inc. (Nasdaq: BLUE) also announced that it has commenced an underwritten public offering of $350 million of its common stock.
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that the FDA has set a PDUFA date of February 14, 2018 for the supplemental new drug application (sNDA) for the Makena subcutaneous auto-injector. The FDA acknowledged that it had previously communicated a 6-month review for the sNDA, but it has now determined that the filing is subject to a standard 10-month review.
Kadmon Holdings Inc (NYSE:KDMN) shares closed up 10% to $3.72. The company noted that it will present interim data from its ongoing Phase 2 clinical trial of KD025, in previously treated patients with chronic graft-versus-host disease (cGVHD), at its R&D Day on July 11, 2017.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $1.95; +56%.
Moleculin Biotech Inc (NASDAQ:MBRX): $1.52; +38%.
ContraFect Corp (NASDAQ:CFRX): $1.45; +21%.
Sorrento Therapeutics Inc (NASDAQ:SRNE): $2.10; +14%.
ImmunoGen, Inc. (NASDAQ:IMGN): $6.82; +13%.
DECLINERS:
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.55; -11%.
Vital Therapies Inc (NASDAQ:VTL): $2.95; -9%.
Acceleron Pharma Inc (NASDAQ:XLRN): $31.01; -9%.
Agios Pharmaceuticals Inc (NASDAQ:AGIO): $54.70; -8%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.07; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALNY
Givosiran
Acute hepatic porphyrias
PHASE 1 Phase 1 additional data released June 26, 2017 with a Phase 3 trial to be initiated in late 2017.
TICKER: AMAG
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
PDUFA sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
TICKER: KDMN
KD025
Chronic graft-versus-host disease (cGVHD)
PHASE 2 Phase 2 initiated September 2016. Interim data to be presented July 11, 2017.
TICKER: MTNB
MAT2203
Vulvovaginal candidiasis (VVC)
PHASE 2 Phase 2 top-line data released June 26, 2017. Not successful in demonstrating meaningful clinical response.
TICKER: NEOT
LIPO-202
Reduction of localized fat deposits under the chin (submental fat)
PHASE 2 Phase 3 endpoints not met December 2015. Phase 2 trial initiated December 23, 2016 with data released June 26, 2017 - no efficacy shown.
TICKER: SGEN
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
PHASE 3 Phase 3 data released June 26, 2017 - primary endpoint met.
Neothetics NEOT plunges 70% while Matinas MTNB slides 27% on disappointing trial data
Neothetics, Inc. (NASDAQ:NEOT) shares plunged to closed down 70% to $0.71 following its announcement that its Phase 2 trial of LIPO-202-CL-31, for the reduction of submental subcutaneous fat, did not demonstrate improvement on any efficacy measurements or separation from placebo.
Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB) shares slid to close down 27% to $2.00 following the release of top-line data from its Phase 2 trial of MAT2203 in women with moderate to severe vulvovaginal candidiasis (VVC). While the company noted that the trial met the primary endpoint in demonstrating MAT2203 is safe and well tolerated, efficacy was below that of fluconazole, the guideline recommended therapy for the treatment of VVC. The lack of conviction with the data was reflected when it noted:
"…we were pleased to see what we believe could indicate clinical response which may provide support for the systemic delivery of MAT2203 to the site of infection…"
Seattle Genetics, Inc. (NASDAQ: SGEN) announced that its ECHELON-1 trial of ADCETRIS for the treatment of previously untreated Hodgkin lymphoma met its primary endpoint of a statistically significant improvement in progression-free survival (PFS). The Phase 3 trial exhibited a significant improvement in modified PFS versus the control arm (hazard ratio=0.770; p-value=0.035). The PFS rate for patients in the ADCETRIS arm was 82.1% compared to 77.2% in the control arm. While the trial did meet the primary endpoint, shares were swiftly sold off, closing down 8% to $56.60 with investors disappointed with the marginal improvement of PFS.
Neos Therapeutics, Inc. (Nasdaq:NEOS) announced that it has commenced an underwritten public offering of $30 million in shares of its common stock. Shares are trading down 4.8% in the after-hours session to $7.00.
bluebird bio, Inc. (Nasdaq: BLUE) also announced that it has commenced an underwritten public offering of $350 million of its common stock.
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that the FDA has set a PDUFA date of February 14, 2018 for the supplemental new drug application (sNDA) for the Makena subcutaneous auto-injector. The FDA acknowledged that it had previously communicated a 6-month review for the sNDA, but it has now determined that the filing is subject to a standard 10-month review.
Kadmon Holdings Inc (NYSE:KDMN) shares closed up 10% to $3.72. The company noted that it will present interim data from its ongoing Phase 2 clinical trial of KD025, in previously treated patients with chronic graft-versus-host disease (cGVHD), at its R&D Day on July 11, 2017.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $1.95; +56%.
Moleculin Biotech Inc (NASDAQ:MBRX): $1.52; +38%.
ContraFect Corp (NASDAQ:CFRX): $1.45; +21%.
Sorrento Therapeutics Inc (NASDAQ:SRNE): $2.10; +14%.
ImmunoGen, Inc. (NASDAQ:IMGN): $6.82; +13%.
DECLINERS:
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $2.55; -11%.
Vital Therapies Inc (NASDAQ:VTL): $2.95; -9%.
Acceleron Pharma Inc (NASDAQ:XLRN): $31.01; -9%.
Agios Pharmaceuticals Inc (NASDAQ:AGIO): $54.70; -8%.
Apricus Biosciences Inc (NASDAQ:APRI): $1.07; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ALNY
Givosiran
Acute hepatic porphyrias
PHASE 1 Phase 1 additional data released June 26, 2017 with a Phase 3 trial to be initiated in late 2017.
TICKER: AMAG
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
PDUFA sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
TICKER: KDMN
KD025
Chronic graft-versus-host disease (cGVHD)
PHASE 2 Phase 2 initiated September 2016. Interim data to be presented July 11, 2017.
TICKER: MTNB
MAT2203
Vulvovaginal candidiasis (VVC)
PHASE 2 Phase 2 top-line data released June 26, 2017. Not successful in demonstrating meaningful clinical response.
TICKER: NEOT
LIPO-202
Reduction of localized fat deposits under the chin (submental fat)
PHASE 2 Phase 3 endpoints not met December 2015. Phase 2 trial initiated December 23, 2016 with data released June 26, 2017 - no efficacy shown.
TICKER: SGEN
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
PHASE 3 Phase 3 data released June 26, 2017 - primary endpoint met.
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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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