CHMA issued CRL. TRVN Phase 2b data to be presented May 21. RGLS primary endpoint data due later this quarter.

Apr 15, 2016 No Comments

Updates to the Company Pipeline Database for April 15, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CHMA 3.30 Mycapssa Acromegaly CRL CRL April 15 2016 RGLS 7.23 RG-101 with multiple approved DAAs HCV Phase 2 Additional Phase 2 interim data released April 2016. Primary endpoint data due late […]

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ASND maintains guidance with Phase 3 trial planned for mid 2016

Apr 14, 2016 No Comments

Updates to the Company Pipeline Database for April 14, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ASND 18.39 TransCon Growth hormone deficiency in children Phase 3 Phase 3 planned for mid 2016 Tweet

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PTIE DRRX PDUFA date set for September 25. Advisory Committee recommends CLVS complete Phase 3 trial before FDA Approval decision + updates for RPRX FWP

Apr 12, 2016 No Comments

Updates to the Company Pipeline Database for April 12, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CLVS 14.24 Rociletinib Cancer – mutant EGFR T790M-positive lung cancer PDUFA Oncologic Drugs Advisory Committee (ODAC) met April 12, 2016,recommended the FDA wait to see results from the Phase 3 TIGER-3 trial […]

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ARIA initiates Phase 3 Brigatinib trial. VKTX and BOTA updates. CRTV added to database.

Apr 11, 2016 No Comments

Updates to the Company Pipeline Database for April 11, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ARIA 6.34 Brigatinib ALK+ non-small cell lung cancer (NSCLC) – front line Phase 3 Phase 3 trial initiated April 2016. Enrolment to be completed 2018 BOTA 1.59 BTA585 Respiratory syncytial virus (RSV) […]

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ICPT secures unanimous backing from Advisory Committee. IONS CARDIO-TTR placed on clinical hold. DRRX update.

Apr 07, 2016 No Comments

Updates to the Company Pipeline Database for April 6, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary DRRX 1.33 POSIMIR -PERSIST 3 Post-operative pain relief Phase 3 CRL Feb 12 2014. Phase 3 commenced November 2015 in response to CRL. Enrolment originally expected to take one year but the […]

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BIND tumbles following Phase 2 data + APRI KMDA updates

Apr 06, 2016 No Comments

Updates to the Company Pipeline Database for April 6, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: APRI 4.14 Vitaros Erectile dysfunction NDA filing NDA to be resubmitted 3Q 2016 BIND 1.82 BIND-014 iNSITE 1 Cancer – Non-small cell lung cancer (NSCLC) with squamous histology Phase 2 Partner required to continue with program BIND 1.82 […]

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AKAO Phase 3 data release moved forward to 1Q 2017. IRWD discontinues IW-9179 trial + updates for ADXS BLCM NVLS ORMP

Apr 05, 2016 No Comments

Updates to the Company Pipeline Database for April 5, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADXS 9.28 ADXS-PSA and Keytruda Castrate-resistant prostate cancer Phase 1/2 Completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in April 2016 AKAO 2.72 Plazomicin – EPIC trial Complicated […]

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PGNX PDUFA delayed until July 19. CYTR Phase 3 data due 2Q + updates for QURE VCEL ZFGN CAPR NAVB NTEC

Apr 05, 2016 No Comments

Updates to the Company Pipeline Database for April 4, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CAPR 2.74 CAP-1002 HOPE-Duchenne Duchenne Muscular Dystrophy (DMD) Phase 1/2 Phase 1/2 data due 1Q 2017 CYTR 3.02 Aldoxorubicin with doxorubicin Cancer – soft tissue sarcomas refractory Phase 3 Phase 3 initiated […]

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ARRY discontinues Phase 3 MILO trial. RIGL Phase 3 data due mid 2016 + CANF update

Apr 02, 2016 No Comments

Updates to the Company Pipeline Database for April 1, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ARRY 3.00 Binimetinib – MILO Recurrent low-grade serous ovarian cancer (LGSOC) Phase 3 Phase 3 trial discontinued April 2016 CANF 2.77 CF101 Rheumatoid arthritis Phase 3 Phase 3 to be initiated 2Q […]

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