Author Archive

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

Jan 07, 2014 No Comments

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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CBST PDUFA under priority review. THLD Ph3 TH-302 timeline update. PPHM initiates Ph3 trial

Dec 30, 2013 No Comments

Cubist Pharmaceuticals, Inc. (NASDAQ:CBST $68.27) announced that the FDA  has accepted their New Drug Application (NDA) for tedizolid phosphate, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date, under priority review, is June 20, 2014. Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM 1.41) announced that enrollment has commenced in their Phase 3 SUNRISE […]

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SGYP Phase 2b plecanatide data now due early 2Q 2014 + FURX shelf

Dec 24, 2013 No Comments

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP $4.84) announced it has closed patient enrollment in its plecanatide Phase 2b trial in irritable bowel syndrome with constipation (IBS-C). Data are due at the beginning of 2Q 2014, which is a slight delay from last month’s guidance of a 1Q data release date. Furiex Pharmaceuticals Inc (NASDAQ:FURX) filed a mixed shelf, […]

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POZN PDUFA date extension. TSRO disappoints with data + TTNP SNTS RVX updates

Dec 24, 2013 No Comments

A Merry Xmas to all readers and followers of BioPharmCatalyst. Happy holidays and all the best for the final few days of 2013! POZEN Inc. (NASDAQ:POZN $9.43) announced that the FDA has assigned a new PDUFA date concerning its New Drug Application (NDA) for PA8140/PA32540 tablets, of April 25, 2014. This will allow the FDA to review […]

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UTHR FDA Approval. BCRX files NDA. AUXL files sBLA. AMRN SPA decision due by Jan 15, PDUFA delayed + ARIA update

Dec 20, 2013 No Comments

United Therapeutics Corporation (NASDAQ: UTHR $87.84) announced today that the FDA has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH). BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX $6.92) announced that it has submitted a New Drug Application (NDA) for intravenous peramivir, for the treatment of acute uncomplicated influenza in adults. Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL $20.59)  announced […]

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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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ALIM PSDV to refile NDA 1Q 2014. THRX FDA Approval for COPD. INSV NDA due 2H 2014 + updates for XLRN BIOD CVM OPXA

Dec 18, 2013 No Comments

Alimera Sciences, Inc. (NASDAQ: ALIM $2.55) (Alimera) and pSivida Corp. (NASDAQ: PSDV $2.97) announced that Alimera Sciences will respond to the Complete Response Letter (CRL) in 1Q 2014, for ILUVIEN for the treatment of Diabetic Macular Edema (DME). They have entered into labeling discussions with the FDA and intend to address maunfacturing concerns raised and to provide recent safety data from patients […]

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CHMP agendas now online. ONTX fails Ph3 pancreatic trial. NAVB files sNDA + updates for SCMP VICL PBYI

Dec 17, 2013 No Comments

The European Medicines Agency (EMA) announced that they are publishing, for the first time, the agendas of the Committee for Medicinal Products for Human Use (CHMP) meetings. The minutes of each of these meetings held in December will be published once they have been adopted by the relevant Committee at its meeting in January. It will then […]

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ACRX PDUFA date set. ENDP to acquire PATH. TRGT fails Ph2b trial + updates for SPPI NBS CBST ALNY

Dec 17, 2013 No Comments

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX $9.67) announced that the FDA has set a PDUFA action date of July 27, 2014, for Zalviso. Targacept, Inc. (NASDAQ: TRGT $5.95) announced top-line results from a Phase 2b clinical trial of TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia. The trial did not meet the primary endpoint. Endo […]

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AVEO unlikely to meet endpoint. AUXL initiates Phase 2b frozen shoulder trial

Dec 14, 2013 No Comments

AVEO Oncology (NASDAQ: AVEO $1.71) announced that data from a planned interim analysis of the Phase 2 BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer (CRC) indicate that the study is unlikely to meet the primary endpoint. Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL $20.26) announced that the first patient was dosed in its Phase 2b study […]

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XOMA IGXT offering details. IMUC fails GBM trial + AZN BMY positive Adcom vote

Dec 13, 2013 No Comments

XOMA Corporation (Nasdaq:XOMA) announced its intention to issue shares in an underwritten public offering. ImmunoCellular Therapeutics, Ltd. (NYSE MKT:IMUC $1.10) announced that it failed to meet the primary endpoint in their Phase 2 trial of ICT-107, in patients with newly diagnosed glioblastoma multiforme (GBM). IntelGenx Technologies Corp. (OTCQX:IGXT $0.48) announced that it will issue $3.5 million of […]

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