Author Archive

EDIT: Error made re ACRX PDUFA date. GEVA data due 2H 2014. BDSI pipeline update + OREX IDIX EXEL news

Dec 03, 2013 No Comments

Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA $60.42) announced that they met the enrollment target of 50 patients in ARISE (Acid Lipase Replacement Investigating Safety and Efficacy), a global Phase 3 trial with sebelipase alfa in children and adults with lysosomal acid lipase deficiency (LAL Deficiency). Top-line results are due in 2H 2014. AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX $9.96) announced that the Zalviso […]

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DRTX PDUFA date set. QRXPY files NDA + updates for PGNX VTUS CYCC OREX RPRX HTBX

Nov 26, 2013 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that they have resubmitted their MOXDUO New Drug Application (NDA) for the treatment of acute pain. If accepted, the PDUFA date will most likely be in late May, 2014. The company previously mentioned that they expect to be asked to attend an Advisory Committee meeting. Durata Therapeutics, Inc. (Nasdaq:DRTX) […]

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Offering news for AEZS APPA CSII NWBO +CYTR FOLD news

Nov 21, 2013 No Comments

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.05) priced their public offering of 13.1 million units, with each unit consisting of one common share and one whole warrant to purchase one common share, at a purchase price of US$1.15 per unit. Net proceeds are expected to be approximately $13.7 million. CytRx Corporation (NASDAQ: CYTR $2.15) announced initiation of […]

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VNDA gets thumbs up at Adcom. TTNP FDA meeting next week + updates for CNAT PTN CPRX CMRX SYN ACAD PTCT ATHX KYTH NBY RNN

Nov 14, 2013 No Comments

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA $13.04) – The Peripheral and Central Nervous System Drugs Advisory Committee gave a positive vote with respect to Vanda’s NDA for tasimelteon, for the treatment of Non-24-Hour Disorder in the totally blind. The committee voted 10-0 in favour regarding the efficacy of tasimelteon. The PDUFA date is January 31, 2014. Titan Pharmaceuticals, Inc. (TTNP.OB $0.795) said […]

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PCYC FDA Approval. Offering priced for CHTP SNTA + updates for DSCI SGYP NKTR

Nov 13, 2013 No Comments

Pharmacyclics, Inc. (NASDAQ: PCYC $123.82) announced that the FDA has approved IMBRUVICA (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Synta Pharmaceuticals Corp. (NASDAQ: SNTA $3.78) announced that it has priced an underwritten public offering of 14,000,000 shares at a price to the […]

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FDA says no to early NDA filing for SRPT + CHTP offering+ updates for APPA GTXI OREX SNSS SNTA SPPI ARIA PBYI CLSN KBIO ARIA PBYI OXGN BDSI SGYP ONTX MGNX

Nov 13, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it plans to offer shares of its common stock in an underwritten public offering. A.P. Pharma, Inc. (OTCBB: APPA.OB) said that their resubmission of the NDA for Sustol (formerly known as APF530) is targeted for 1Q 2014 GTx, Inc. (Nasdaq: GTXI) said that they expect to complete enrollment of their Phase […]

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VPHM acquired by SHPG. BMY Adcom December + updates for ALNY GALE

Nov 12, 2013 No Comments

Bristol-Myers Squibb Co (NYSE:BMY $52.58) The Endocrinologic and Metabolic Drugs Advisory Committee will meet on December 12, 2013 to discuss the efficacy and safety of new drug application (NDA) dapagliflozin. Dapagliflozin is a sodiumglucose cotransporter 2 inhibitor developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Shire plc (LSE: SHP, NASDAQ: SHPG $135.33) and ViroPharma Incorporated […]

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CNDO Phase 2 trial halted. MACK data release delay. ARQL data due 1Q 2014 + pipeline updates for AVEO APPY INSV NKTR APPY CCXI BCRX OXXI ANAC AMBI TSRO INFI + SLXP SNTS TTPH news

Nov 08, 2013 No Comments

Coronado Biosciences, Inc. (NASDAQ: CNDO $1.63) announced that the Independent Data Monitoring Committee (IDMC) recommended that their Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn’s disease be stopped due to lack of efficacy. AVEO Oncology (NASDAQ: AVEO $2.07) provided an update noting that data are anticipated in 2014 from the Phase 2 trial […]

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NBY Phase 2b fail. CRIS CUDC-427 placed on partial hold. Upcoming data releases for IMUC FURX + updates for XLRN OCRX INCY ABIO ALXA ESPR DCTH ACAD ALNY

Nov 06, 2013 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY $0.90) announced that the auriclosene Phase 2b clinical study of impetigo did not meet its primary clinical endpoint. Curis, Inc. (Nasdaq:CRIS $2.86) announced that the FDA has placed their Phase 1 study of CUDC-427 on partial clinical hold following the report of death of a patient who progressed to […]

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AEZS file NDA. IMGN fail Phase 2 trial. ECYT decision due Dec-Jan. ADHD data due Dec. KERX positive data + updates for STEM SGEN PTLA ISIS INSM ZGNX ITMN

Nov 06, 2013 No Comments

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.39) announced that it has submitted a NDA for AEZS-130 for adult growth hormone deficiency (“AGHD”). ImmunoGen, Inc. (Nasdaq: IMGN $13.41) announced that it will discontinue their Phase 2 trail of IMGN901 for SCLC, following the recommendation from the Data Monitoring Committee (DMC) due to a higher rate of infection and […]

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Offering news for ITMN ZGNX TTPH. ZLCS data due 4Q. RPRX to request lift of Proellex clinical hold + MSTX BLRX updates

Nov 04, 2013 No Comments

InterMune, Inc. (NASDAQ: ITMN $14.95) announced that it plans to offer 6,500,000 shares of its common stock in an underwritten public offering. Zogenix, Inc. (Nasdaq:ZGNX $2.54) announced today that it intends to offer $60 million of shares of its common stock in an underwritten public offering. Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH $12.28) also announced it has commenced an underwritten public offering […]

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