BPC updates June 30: ARRY Binimetinib NDA filing. AMPE fails to meet Phase 3 endpoints. CYNA Phase 3 data now due end of 3Q + updates for ARQL CYTK ITCI NDRM

Jul 01, 2016 No Comments by

Updates to the Company Pipeline Database for June 30, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts. Ticker Price Drug Indication Stage Summary AMPE 1.29 Ampion Osteoarthritis of the Knee Phase 3 STRIDE study mid April 2015 did not meet endpoint. Second Phase 3 trial also did not meet primary endpoint – June 2016 ARQL 1.90 […]

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BPC June 6 updates: DNAI OCUL plummet following data. ADMP issued CRL. MSTX delays Phase 3 Sickle cell disease data + updates for ADXS AEZS ARRY CARA GLYC IMMU ONTY

Jun 07, 2016 No Comments by

Updates to the Company Pipeline Database for June 6, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADMP 4.09 Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis. CRL CRL issued March 27 2015. NDA resubmitted. CRL issued again June 6, 2016. Intends to submit more data 2H 2016 ADXS […]

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BPC May 18 updates – ARIA and DNAI Phase 2 data due at ASCO + updates for AFMD ARRY IMGN ORMP

May 18, 2016 No Comments by

Updates to the Company Pipeline Database for May 18, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AFMD 3.10 AFM13 Hodgkin Lymphoma Phase 2 Phase 2a enrolment has slowed. Company to provide timeline update once enrolment trend is established ARIA 7.85 Brigatinib – ALTA trial Anaplastic lymphoma kinase positive (ALK+) […]

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Pipeline updates with upcoming data from ACHN ARRY EVOK RIGL PRTA NERV. FOLD FDA meeting mid year + updates for NERV LXRX NKTR FOMX

May 04, 2016 No Comments

Updates to the Company Pipeline Database for May 3, 2016, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACHN 8.25 Odalasvir (ACH-3102), simeprevir and ALS-335 Hepatitis C viral infection (HCV) Phase 2a Phase 2a top-line data due 3Q 2016 ACHN 8.25 Odalasvir (ACH-3102) and sofosbuvir Hepatitis C viral infection […]

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BNHLF receives expected CRL. SYN Phase 2 trial fail. ARRY Phase 3 data due 2016 + MDWD NBIX HSGX updates

Feb 03, 2016 No Comments

Updates to the Company Pipeline Database for February 2, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ARRY 3.05 Binimetinib (NEMO) Cancer – NRAS melanoma Phase 3 Endpoint met December 2015. NDA filing expected 1H 2016 ARRY 3.05 Selumetinib – SELECT-1 Cancer – differentiated thyroid cancer Phase 3 Phase […]

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IGXT receives CRL. FURX Phase 3 eluxadoline meets endpoints. AGEN offering + ARRY update

Feb 05, 2014 No Comments

IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that they received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for their VersaFilm Oral Film Product for the treatment of acute migraines. According to the company, the concerns raised in the CRL “primarily relate to […]

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Pipeline and news updates for INCY ARRY CLVS VICL BMRN SGYP ACOR GENT ENMD DSCO MACK ARIA

Nov 02, 2013 No Comments

Incyte Corporation(Nasdaq: INCY $40.40) provided a pipeline update noting that Phase 3 data of Jakafi (ruxolitinib) in patients with polycythemia vera (PV), are expected in early 2014, with a potential NDA filing in 1H 2014. Data from their Phase 3 trial measuring disease-related symptoms in patients with PV (RELIEF) are due in mid-2014. In addition, Phase 2 data from […]

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CSII receives PMA Approval. PFE to continue Remoxy development + updates for ZIOP AMRN CBST QCOR HALO ARRY

Oct 23, 2013 No Comments

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII $26.75) announced that it has received PMA approval from the FDA for their Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries. Pain Therapeutics, Inc. (Nasdaq:PTIE $3.77) and DURECT Corporation(Nasdaq: DRRX $1.56) reported Pfizer Inc. will continue the development program for REMOXY (oxycodone) Extended-Release Capsules CII, with new […]

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CHTP PDUFA delay. VNDA PDUFA date assigned. ANAC submits NDA + SNSS VRTX ARRY news

Jul 30, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the FDA has requested further information regarding the resubmitted New Drug Application (NDA) for NORTHERA (droxidopa). As a result the original PDUFA date will be extended from January 3, 2014, to a date to be confirmed later. The FDA noted deficiencies that relate to the formatting of certain submitted […]

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SRPT NDA due 1H 2014. ARRY positive data. CYTK ALS data now due early 2014 + INSV TSRO IMMY updates

Jul 24, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it met its primary and secondary endpoints in its Phase 2 trial of ARRY-502 in patients with mild to moderate persistent allergic asthma and will now seek a partner to further develop ARRY-502. Sarepta Therapeutics, Inc. (NASDAQ: SRPT) announced it will plans on submitting an NDA for eteplirsen in the first half of 2014 for […]

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ARRY Phase 2 asthma date due Tuesday. RMTI PRAN XOMA data due Sept/Oct + ISIS BCRX MACK IGXT updates

Jul 22, 2013 No Comments

Array BioPharma Inc. (Nasdaq:  ARRY) will report top-line results from its Phase 2 trial in mild to moderate persistent allergic asthma for ARRY-502, on Tuesday, July 23, 2013. Rockwell Medical (NASDAQ: RMTI) announced that it has completed dosing in its second Phase 3 trial SFP (Soluble Ferric Pyrophosphate), called CRUISE-2, for the treatment of iron deficiency in chronic […]

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