Author Archive

APPY pivotal data due Thursday. ITMN offering.

Mar 13, 2014 No Comments

Venaxis, Inc. (Nasdaq: APPY) announced it will host a conference call to discuss top-line results from its pivotal study of the APPY1 Test on Thursday, March 13, 2014, at 8:30 a.m. ET.  InterMune, Inc. (NASDAQ: ITMN) announced that it plans to offer 7,500,000 shares of its common stock in an underwritten public offering.

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OXGN hits primary endpoint. SNTA data release extension +updates for SSH and OGXI

Mar 12, 2014 No Comments

OXiGENE, Inc. (Nasdaq:OXGN) announced that it met its primary endpoint of a statistically significant increase in progression-free survival in its Phase 2 clinical trial evaluating Avastin(bevacizumab) with or without ZYBRESTAT to treat patients with recurrent ovarian cancer. One of their secondary endpoints, objective response rate, was higher but not statistically significant. All patients will continue to be followed for […]

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ETRM Adcom rescheduled.

Mar 11, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that the FDA has rescheduled the Advisory Committee meeting of the Center for Devices and Radiologic Health’s (CDRH) for Tuesday, June 17, 2014 to review the Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity. The company noted that the delay is due to a scheduling conflict on behalf of the CDRH. […]

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Pipeline updates for NBY NWBO CMRX ACHN NLNK

Mar 08, 2014 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) provided an update noting that data from their Viral Conjunctivitis Phase 2 trial are due in mid-2014. Northwest Biotherapeutics (NASDAQ: NWBO) announced the Data Safety Monitoring Board (DSMB) review of the efficacy data of their Phase 3 GBM Trial is still pending. Regarding the safety review, the DSMB have reviewed the […]

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INSM data due late March. ENDP FDA Approval. FLML offering + updates for TTPH SNSS ADHD PTCT

Mar 07, 2014 No Comments

Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced the FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Flamel Technologies, S.A. (NASDAQ: FLML) announced that it is offering to sell American Depositary Shares (ADSs), […]

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Pipeline updates for OPK CLDX ANAC CNAT ACRX GEVA. Offering news for ACAD BLRX

Mar 04, 2014 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) announced that following an End-of-Phase 2 meeting with the FDA, a Phase 3 trial of AN2728 for the topical treatment of mild-to-moderate atopic dermatitis is scheduled to commence by the start of May 2014. Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced the initiation of a Phase 2 clinical trial of emricasan, in patients with nonalcoholic […]

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NKTR Phase 3 data due early 2015.Offerings for INO SNSS + XLRN update

Feb 27, 2014 No Comments

Nektar Therapeutics (Nasdaq: NKTR) provided a pipeline update noting that topline data from the Phase 3 pivotal trial of NKTR-102 in advanced breast cancer are due in early 2015. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase shares of its […]

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BCRX PDUFA date set. ITMN Phase 3 IPF trial meets endpoints. NBIX offering + ANIK approval.

Feb 26, 2014 No Comments

BioCryst Pharmaceuticals, Inc.(Nasdaq:BCRX) announced that the FDA has accepted for review the New Drug Application (NDA) for intravenous (i.v.) peramivir, with a PDUFA date of December 23, 2014. No Advisory Committee review is planned at this stage. Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced that it is offering to sell 7,000,000 shares of its common stock in an underwritten public […]

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ECYT – key data due March. AMPE offering. SLXP PDUFA delay. AUXL sNDA PDUFA set

Feb 25, 2014 No Comments

Salix Pharmaceuticals, Ltd.  (NASDAQ:SLXP) and Pharming Group NV (NYSE Euronext:PHARM) announced that the FDA has extended the PDUFA Date to July 16, 2014 for their Biologics License Application (BLA) for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Celsion Corporation (NASDAQ: CLSN) maintained previous guidance that their Phase 3 trial […]

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CHTP FDA decision delayed until Tuesday. BMRN FDA Approval. STEM offering

Feb 16, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $4.73) announced that as a result of severe weather conditions leading to an office closure, the FDA today notified the company that the goal date for their NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN $75.81) announced that the FDA […]

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ETRM Adcom date set. DRRX CRL. PCYC FDA Approval. MDCO negative Adcom opinion. DARA OXGN offerings. INCY STEM updates

Feb 13, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM $2.11) announced that the FDA Office of Device Evaluation has scheduled a meeting of the Center for Devices and Radiologic Health’s (CDRH) Advisory Committee on Thursday, May 29, 2014 to review the Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity.  The Medicines Company (NASDAQ: MDCO $30.00) announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal […]

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