TRGT fails Phase 2b. Positive news for SLXP PGNX EXEL. Phase 3 data due soon for ADHD ZSPH + AERI SGYP VTUS ANTH GNCA updates

Jul 15, 2014 No Comments by

Targacept, Inc. (NASDAQ: TRGT) announced that it did not meet the primary endpoint in their Phase 2b monotherapy trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals(NASDAQ:PGNX) announced that the FDA has informed Salix that RELISTOR Subcutaneous Injection, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic […]

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INSM data due today. CYCC topline Sapacitabine data due 2015. EXEL data due later this year + BIND EVOK ECYT news

Mar 26, 2014 No Comments by

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) said it expects to complete enrolment in their Phase 3 SEAMLESS trial of Sapacitabine in patients with acute myeloid leukemia (AML). Topline data are due in 2015. Insmed Incorporated (NASDAQ: INSM) will announce results from its U.S. phase 2 clinical trial of ARIKAYCE, to treat nontuberculous mycobacteria (NTM) lung infections on Wednesday, March 26, 2014 at approximately 7:00 a.m. […]

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BDSI ENDP Phase 3 endpoint met. PGNX ATOS TXNP DSCI to raise cash. EXEL XNPT price offerings. APPA NASDAQ uplist + CYTR

Jan 24, 2014 No Comments by

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) filed a $150m shelf and also noted that it has entered into a sales agreement where up to $50m of common stock may be issued and sold under a sales agreement with Cantor Fitzgerald & Co. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced that it intends to offer shares of its common stock in an […]

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AMAG issued CRL. EXEL EBS offerings + NKTR KERX offering details

Jan 23, 2014 No Comments

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced that the FDA issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. Emergent BioSolutions Inc. (NYSE: EBS) announced that it intends to offer $200 million aggregate principal amount of Convertible Senior Notes due 2021. Exelixis, Inc.(Nasdaq: EXEL) announced that it plans to […]

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EXEL positive CHMP opinion. JAZZ to acquire GENT. BMY PFE PDUFA date set + clinical updates for ATHX OPK NBY

Dec 20, 2013 No Comments

Exelixis, Inc.(NASDAQ:EXEL $5.80) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion of the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). Athersys, Inc. (Nasdaq:ATHX $2.12)  announced that Pfizer Inc. has completed […]

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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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MNKD PDUFA date set. EXAS Adcom meeting due 1Q 2014 + updates for EXEL SNSS SPPI MELA ITMN RCPT CTIC ESPR PRAN CLVS

Oct 31, 2013 No Comments

Exact Sciences (NASDAQ: EXAS $11.00) noted in their earnings conference call that they expect an advisory committee meeting for Cologuard will occur in 1Q 2014. MannKind Corporation (Nasdaq: MNKD $4.92) announced that the FDA has set a PDUFA date of April 15, 2014 for the resubmission of their New Drug Application (NDA) for AFREZZA. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS $5.00) announced the initiation of […]

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NKTR misses Phase 2 endpoint. DRTX files NDA + updates for SNSS SRPT INFI EXEL ACOR AMAG NYMX

Sep 26, 2013 No Comments

Nektar Therapeutics (Nasdaq: NKTR $10.44) announced that it failed to meet the primary endpoint in its Phase 2 trial of NKTR-181 for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis of the knee. The company noted that the placebo did not show the expected increase in pain scores as expected. Durata Therapeutics, Inc. (Nasdaq:DRTX […]

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Positive Adcom vote for THRX. CCXI disappoints. DRTX NDA filing due this month + updates for EXEL CUR OMER IRWD

Sep 11, 2013 No Comments

GlaxoSmithKline plc (LSE: GSK $50.52) and Theravance, Inc. (NASDAQ: THRX $37.79) announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease […]

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ENDP receives CRL, expects to resubmit 3Q. BMRN Vimizim PDUFA set + IDIX EXEL initiate Phase 2 and 3 trials

May 31, 2013 No Comments

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced that the FDA has assigned a PDUFA date of February 28, 2014 for the Biologics License Application (BLA) for Vimizim (BMN-110, elosulfase alfa), for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. While a priority review was granted,  the FDA […]

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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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