Archive for February, 2011

SNTS receives RTF. SGEN submits brentuximab vedotin BLA

Feb 28, 2011 No Comments by

Santarus, Inc. (NASDAQ:SNTS) and biotech company Pharming Group NV (NYSE Euronext:PHARM) today announced the receipt of a refusal to file letter from the FDA for their RHUCIN BLA. The FDA indicated that the previously conducted studies evaluating RHUCIN for the treatment of acute attacks of Hereditary Angioedema (HAE) did not provide data for a sufficient […]

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25 Upcoming Catalysts

Feb 26, 2011 No Comments by

Some short and long term potential catalysts (share prices as at the close of trading Friday, February 25, 2011). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take SHORT or LONG positions in […]

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PLX receives CRL for Gaucher disease. INSM reverse split vote next Tuesday

Feb 25, 2011 No Comments by

AspenBio Pharma, Inc. (NASDAQ: APPY), yesterday announced that it had received a further 180 day extension by NASDAQ to push its bid price above $1 by August 22, 2011. Expect APPY to hold a vote for a reverse split next quarter allowing them to enforce the split prior to August 22, assuming they fail to […]

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PTN to raise cash + pipeline updates for EPCT LXRX BPAX GTXI

Feb 24, 2011 No Comments

EpiCept Corporation (Nasdaq: EPCT) said today that they expect to initiate a Phase 3 trial under SPA of Ceplene for the remission maintenance and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission. The SPA has not been submitted yet to the FDA but they hope to do so soon. The […]

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BioPharm News – Wed – AEZS SNSS DVAX ANTH

Feb 23, 2011 No Comments

Aeterna Zentaris Inc. (NASDAQ: AEZS) announced yesterday that they had entered into an At-the-Market Sales Agreement, dated February 22, 2011, with McNicoll, Lewis and Vlak LLC, under which the Company may, at its discretion, during the 24-month term of the agreement, sell up to a maximum of 12,500,000 of its common shares through ATM issuances […]

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FDA refuses to file DCTH NDA. CLDA acquired. FURX SNTS INFI DVAX news

Feb 22, 2011 No Comments

Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) was added to the Clinical Database following release of 4Q 2010 results today. They initiated a Phase 2 proof-of-concept study in January for PPD-10558 for the treatment of dyslipidemia in patients who experience statin associated myalgia. FURX also recently obtained FDA Fast Track Designation of MuDelta for the treatment of […]

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CHTP raises cash. EXEL positive Phase 2 data. ALNY NAVX news

Feb 18, 2011 No Comments

EXEL cabozantinib impressive – CHTP raises cash – ALNY NVAX: Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) priced its offering today of 8.75m shares at $4, resulting in net proceeds of $32.8m. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) gave a pipeline update yesterday after hours noting that they continue to enrol patients in their Phase 2b study of […]

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Pipeline updates for BDSI STEM XNPT ARIA ISPH

Feb 17, 2011 No Comments

XenoPort, Inc. (Nasdaq: XNPT) gave an update of their pipeline after hours yesterday and maintained previous guidance that they intend to report preliminary top-line results of their Phase 2b trial of arbaclofen placarbil (AP) in patients with gastroesophageal reflux disease (GERD) who experience symptoms in spite of treatment with a proton pump inhibitor (PPI). XNPT […]

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THLD receives SPA for soft tissue sarcoma. DSCO offering + HALO news

Feb 16, 2011 No Comments

Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) today announced that they had reached agreement with the FDA on a SPA (Special Protocol Assessment) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma. The 450 patient pivotal trial is expected to begin in the middle of 2011, and will enroll patients with metastatic or […]

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NPSP brings forward Phase 3 guidance. CTIC files shelf

Feb 16, 2011 No Comments

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) maintained previous guidance that they intend to file their NDA for GATTEX for short bowel syndrome in the second half of this year. However, they brought forward their timeline for their other Phase 3 candidate, NPSP558 for hypoparathyroidism. NPSP has met its randomization target for the Phase 3 trial and […]

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RPTP delays. ALKS Ph2 data, updates from SPPI LGND FOLD:

Feb 15, 2011 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP), today announced it has reopened enrollment of their Phase 3 clinical trial of their delayed-release oral formulation of cysteamine bitartrate in patients with nephropathic cystinosis. Data was expected to be released at the end March. However, due to a mathemactical error, six more patients need to be enrolled. Consequently, data is […]

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