Upcoming data for CUR KBIO NKTR. AVNR approval delay likely. DVAX reverse split + AEZS RMTI GNCA HRTX IMMU TLOG OPK DSCO ANAC IMMU HPTX SPPI RPTP CMRX VSAR

Nov 08, 2014 No Comments by

Neuralstem, Inc. (NYSE MKT: CUR) announced that the Phase 2 data lock of NSI-566 spinal cord-derived stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS) is scheduled to conclude in late January 2015 at which time the company anticipates providing its Phase 2 ALS results. The company also noted that a Phase 2 trial of NSI-189 for […]

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MDCO and NVS Adcom dates set. AEZS raising more cash. Approvals for BMY AZN GSK + updates for MSTX ALKS

Jan 09, 2014 No Comments by

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.46) announced that it has commenced another underwritten public offering of common shares and warrants, their third offering in just over five months. GW Pharmaceuticals plc (Nasdaq: GWPH $38.06) announced the pricing of its follow-on offering of American Depositary Shares, or ADSs, on the NASDAQ Global Market. GW will issue 2,441,110 ADSs […]

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AEZS PDUFA date set. NBIX meets endpoint. PSTI Ph 1/2 PLX-PAD next week + RCPT GNBT GEVA

Jan 07, 2014 No Comments by

Aeterna Zentaris Inc. (NASDAQ: AEZS)  announced that the FDA has assigned a PDUFA date of November 5, 2014 for Macimorelin Acetate in patients with Adult Growth Hormone Deficiency (AGHD). Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced that they met the primary endpoint in their Phase 2b Kinect 2 trial of NBI-98854 in patients with tardive dyskinesia. They intend to submit […]

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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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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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Updates for AEZS AZN BMRN BMY ITMN MRK NBIX QCOR RNN THRX TSRO VRTX

Jul 25, 2013 No Comments

AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) announced that the FDA has a assigned a PDUFA date of Jan. 11, 2014 for the resubmission of dapagliflozin for the treatment of adults with type 2 diabetes. Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced a pipeline update noting that topline data from the Phase 2b Kinect of NBI-98854 against placebo, in tardive dyskinesia […]

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AEZS ATM agreement. AMAG – Rienso recall. ACRX NDA due 3Q + IRWD NPSP BIIB GILD

May 21, 2013 No Comments

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced the pricing of an underwritten public offering of 10,500,000 shares at a price of $13.00 per share for gross proceeds of $136.5 million. Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) announced that it has entered into an “At Market” Issuance (“ATM”) Sales Agreement, with MLV & Co. LLC (“MLV”), where it may, from […]

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Pipeline updates for ACHN BCRX BLRX CLVS RIGL INSM TRGT CBST INFI AEZS SCMP SGEN FURX EXEL FLML TSRX KERX ZIOP ISIS

May 08, 2013 No Comments

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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FDA Panel recommends approval of Probuphine. ENTA IPO. ALIM NDA refiling due this month + updates for ANAC AEZS KYTH

Mar 22, 2013 No Comments

 Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members voted for approval (10 positive votes, 4 negative votes and 1 abstention) of Probuphine for the maintenance treatment of adult patients with opioid dependence. The PDUFA date is April 30, 2013. – Alimera Sciences, Inc. […]

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Pipeline and news updates for BIIB TSRX SPPI ACAD ACRX FOLD PPHM BLRX XOMA GEVA ZIOP KERX ANX MSTX CYTR AEZS MDCO

Mar 13, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the FDA for recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. On March 4, 2013 Biogen Idec announced the FDA accepted for review the company’s BLA for its factor IX candidate, rFIXFc, for use in patients with hemophilia B. Trius Therapeutics, Inc. (Nasdaq:TSRX) […]

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NAVB PDUFA date set + pipeline updates for SGYP INSM AEZS CLVS NKTR ICPT

Nov 14, 2012 No Comments

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced today that the FDA has set a PDUFA goal date of April 30, 2013 for the Class 2 resubmission of its New Drug Application (NDA) for Lymphoseek Injection. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor. Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) announced that it expects to release top-line data from […]

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