DVAX PDUFA delayed till December 15. OPK PDUFA set for October 22 + THERF CLDX CYTX OASM OCUL VRTX updates

Apr 28, 2016 No Comments

Updates to the Company Pipeline Database for April 27, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CLDX 4.08 Glembatumumab vedotin Cancer – Squamous cell lung cancer Phase 1/2 Phase 1/2 commenced April 2016 CYTX 0.35 ECCS-50 Scleroderma Phase 3 Pivotal trial initiated August 2015. Noted late April 2016 […]

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FDA requests further trials from CPRX. COLL FDA Approval + SMMT NVIV updates

Apr 26, 2016 No Comments

Updates to the Company Pipeline Database for April 26, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary COLL 18.43 Xtampza ER (oxycodone) Severe pain Approved Approved April 26 2016 CPRX 0.63 Firdapse Lambert-Easton Myasthenic Syndrome (LEMS) RTF – Refusal to file Refusal to file letter reported on Feb 17 […]

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Advisory Committee votes against SRPT eteplirsen. EXEL receives FDA Approval for RCC + BPMX TTHI updates

Apr 25, 2016 No Comments

Updates to the Company Pipeline Database for April 25, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BPMX 0.93 BPX-01 Acne Phase 2 Phase 2a enrolment completed April 2016. Trial expected to end by mid 2016 EXEL 4.66 CABOMETYX (cabozantinib) Cancer – metastatic renal cell cancer (RCC) Approved Approved […]

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RARE releases interim Phase 2 TIO data. FCSC azficel-T data due this quarter.

Apr 21, 2016 No Comments

Updates to the Company Pipeline Database for April 21, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary FCSC 3.10 azficel-T Chronic Dysphonia Phase 2 Phase 2 data due 2Q 2016 RARE 75.41 KRN23 Tumor-induced osteomalacia (TIO) Phase 2 Interim data released April 2016 Tweet

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Updates for BLUE BMRN CARA CYTR MNOV OMER

Apr 20, 2016 No Comments

Updates to the Company Pipeline Database for April 20, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BLUE 44.31 Lenti-D Childhood cerebral adrenoleukodystrophy (CCALD) Phase 2/3 Phase 2/3 trial initiated October 2013. Interim data released at AAN Conference April 20, 2016. BMRN 89.31 Vosoritide Achondroplasia Phase 2 Phase 2 […]

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SGYP PDUFA date set for January 29 2017. SCMP fails to meet endpoints in Phase 2 trial + GALE updates

Apr 20, 2016 No Comments

Updates to the Company Pipeline Database for April 19, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary GALE 1.47 GALE-301/302 Ovarian cancer Phase 2b Phase 2b to be initiated 2H 2016. GALE-301 Phase 2a primary analysis to be presented at ASCO 2016 SCMP 10.79 Cobiprostone Oral Mucositis Phase 2 […]

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HRTX says no substantive deficiencies with NDA filing + updates for FCSC IMMU OTIC RDHL STEM TTHI

Apr 18, 2016 No Comments

Updates to the Company Pipeline Database for April 18, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary FCSC 2.56 FCX-007 Recessive dystrophic epidermolysis bullosa Phase 1/2 Phase 1/2 to be initiated 2Q 2016 HRTX 21.49 APF530 – Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) PDUFA […]

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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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