Author Archive

PATH receives FDA Approval. TSRX offering. AVEO prices offering

Jan 17, 2013 No Comments

NuPathe Inc. (NASDAQ: PATH) today announced that FDA approved Zecuity for the acute treatment of migraine with or without aura in adults. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN). The company now plans to focus on securing commercial partners and preparing for the launch of Zecuity expected in 4Q 2013. A conference […]

Read more

HPTX PDUFA delay. QRXPY to refile NDA this quarter + updates for BIIB ELN EXEL AVEO

Jan 16, 2013 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) said that the FDA has advised the company not to expect a final action by the PDUFA date of January 23, 2013. The FDA explained it is continuing to work on label and post-marketing requirements. This follows a previous three month extension. Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that they have submitted applications […]

Read more

ALNY and PCRX offering details. APPY initiates pivotal blood-based appendicitis trial

Jan 15, 2013 No Comments

Venaxis, Inc. (Nasdaq: APPY) today announced that it has begun enrolling patients into its pivotal study of its blood-based appendicitis test, APPY1.  It anticipates completing the study in 3Q 2013 and filing with the FDA for regulatory clearance in 4Q 2013. Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) today announced the pricing of an underwritten registered public offering of 8,000,000 shares […]

Read more

SNTS FDA Approval for UCERIS. ITMN and ALNY raise cash

Jan 14, 2013 No Comments

Santarus, Inc. (NASDAQ: SNTS) announced today that the FDA has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company received approval two days before the set PDUFA date. InterMune, Inc. (Nasdaq: ITMN) today announced that it plans to offer $85.0 million aggregate principal amount of convertible senior […]

Read more

ARQL fails Phase 2 CRC trial. AEGR prices offering. GNBT reverse split vote

Jan 12, 2013 No Comments

ArQule, Inc. (Nasdaq: ARQL) announced that it did not meet the primary endpoint of Progression-Free Survival in its Phase 2 signal trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC). Median PFS was 8.3 months compared with 7.3 months in the control arm.  The Objective […]

Read more

EXAS pivotal data due March. SNSS pivotal trial update. AEGR offering

Jan 10, 2013 No Comments

Exact Sciences Corp. (Nasdaq: EXAS) noted that it continues to expect topline results from its DeeP-C pivotal trial for colorectal cancer screening, in March 2013. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced an update of its VALOR Phase 3 trial of vosaroxin plus cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). Target enrollment of 675 patients […]

Read more

IDIX expects clinical hold response this quarter + CTIC INO THRX VPHM updates

Jan 09, 2013 No Comments

Idenix Pharmaceuticals Inc (NASDAQ: IDIX) noted today that it expects a  response from the FDA regarding the clinical hold of IDX184, during 1Q 2013. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) today announced that it has initiated a Phase 3 trial, known as PERSIST-1 or PAC325, for pacritinib, for the treatment of patients with myelofibrosis. GlaxoSmithKline plc (LSE: GSK) […]

Read more

TTNP expects March Adcom meeting + updates for MDCO IPXL SVNT THRX

Jan 08, 2013 No Comments

Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that it expects an Advisory Committee meeting for Probuphine to be convened during the second half of March 2013. The PDUFA date is April 30, 2013. Impax Pharmaceuticals (NASDAQ: IPXL)  announced that it expects to release Phase 2b data of  IPX159 in patients with Restless Legs, during 1Q 2013. The Medicines Company […]

Read more

DCTH expects May Adcom meeting. EDIT – BLRX + Pipeline updates for ALNY CLVS INFI OREX FOLD ICPT

Jan 07, 2013 No Comments

BioLineRx (NASDAQ: BLRX) announced today that the results of the interim analysis of its Phase 2/3 CLARITY trial of BL-1020, for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. EDIT: DMC will provide estimate of the total number of patients required in the study in order to achieve statistical significance in the Phase 2/3 data […]

Read more


Jan 03, 2013 No Comments

Synageva BioPharma Corp. (NASDAQ:GEVA) announced that offered 2,150,000 shares at $47.53 per share, for proceeds of $80 million in a public offering. Titan Pharmaceuticals, Inc. (OTCBB:TTNP)  announced that the New Drug Application (NDA) for Probuphine, for the maintenance treatment of opioid dependence in adult patients, has been granted Priority Review. The PDUFA date is April 30, 2013. InterMune, Inc. (NASDAQ: ITMN) […]

Read more

Holiday News from AEGR AUXL SGYP OMER and a Happy New Year!

Jan 01, 2013 2 Comments

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), announced that the FDA has set a PDUFA date of September 6, 2013, for its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), for the potential treatment of Peyronie’s disease (PD). Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) announced that the FDA approved JUXTAPID (lomitapide) capsules,to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol […]

Read more