Archive for April, 2012

SUPN IPO May 1. SLXP PDUFA date extended. Pipeline updates for ASTX RPRX and ARRY

Apr 30, 2012 No Comments by

Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN)  today announced the initial public offering of 10m shares at a price of $5.00 per share. The shares are expected to begin trading on The NASDAQ Global Market on Tuesday, May 1, 2012 under the trading symbol “SUPN.” Click HERE for a brief overview of the company. Salix Pharmaceuticals, Ltd (NASDAQ:SLXP) […]

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AEGR NDA accepted. VTUS data due late June/early July. FDA approves Stendra VVUS + ZLCS PRAN updates

Apr 30, 2012 No Comments by

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) today announced the FDA has accepted its New Drug Application (NDA) for lomitapide for patients with Homozygous Familial Hypercholesterolemia (HoFH). The company was granted a 10-month standard review which will result in a PDUFA date on or about January 5, 2012. Ventrus Biosciences, Inc. (Nasdaq:VTUS) announced that it has completed patient enrollment […]

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Supernus Pharmaceuticals, Inc (SUPN) – upcoming IPO profile

Apr 29, 2012 No Comments by

Initial Public Offering listing on Nasdaq Global Select Market under the symbol “SUPN” likely week of Apr 30-May 4, 2012. Pipeline: SEVERAL upcoming catalysts SPN-538 (extended release topiramate) for epilepsy. NDA filed with PDUFA date in July 2012. Topiramate is marketed by Johnson & Johnson under the brand name Topamax and is available in a generic form. Topiramate […]

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DVAX files BLA. RGEN Adcom meeting cancelled, CRL expected + ONXX ITMN CYTR CYTK THRX POZN news

Apr 27, 2012 No Comments

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that it has filed a U.S. Biologics License Application (BLA) to the FDA for HEPLISAV, for hepatitis B virus in adults 18 through 70 years of age. The company intends to file a European Marketing Authorization Application (MAA) for HEPLISAV in 3Q 2012. Repligen Corporation (NASDAQ:RGEN) announced the FDA notified the company that […]

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BioPharmCatalyst ASCO 2012 Calendar has been added!

Apr 26, 2012 No Comments

I am pleased to announce that the ASCO 2012 Calendar has been added to BioPharmCatalyst. You can find it next to the FDA Calendar tab. Abstract numbers, presentation types and times, drugs and indications are all available in the calendar.  Links to abstracts will be added as soon as they are uploaded onto the ASCO website on […]

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FURX issued CRL. PGNX PDUFA delay. INCY SPPI ANTH pipeline updates. TSPT offering + TRGT news

Apr 26, 2012 No Comments

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said today that its partner Takeda Pharmaceutical Company Limited received a complete response letter (CRL) from the FDA for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone. The FDA has requested additional data. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals (NASDAQ: PGNX)  announced that the FDA has extended the PDUFA date of their […]

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IRWD PDUFA extended. CYTR reverse split likely mid-May. NABI merger + KERX news

Apr 24, 2012 No Comments

Nabi Biopharmaceuticals (Nasdaq:NABI) announced plans to merge with Biota Holdings Limited (ASX:BTA), a Melbourne, Australia company to form a combined company to be named Biota Pharmaceuticals, Inc. CytRx Corporation (Nasdaq: CYTR) announced it has been informed by NASDAQ that its bid price needs to be above $1.00 for a minimum of 10 consecutive business days by the close of […]

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IDIX Phase 2b data due 2H 2012 + ALTH and INCY news from CHMP

Apr 20, 2012 No Comments

Allos Therapeutics, Inc. (NASDAQ: ALTH) announced today that the Committee For Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the marketing authorisation application (MAA) for FOLOTYN for patients with peripheral T-cell lymphoma (PTCL). Incyte Corporation(Nasdaq: INCY) announced that CHMP has recommended the approval of ruxolitinib for the treatment of disease-related splenomegaly or symptoms […]

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DEPO plans Serada NDA filing 2H 2012. IDRA pipeline update. PBMD listed on NASDAQ +MDGN news

Apr 17, 2012 No Comments

Depomed, Inc. (Nasdaq:DEPO) today announced that following a pre-NDA meeting with the FDA, it intends to file a new drug application (NDA) during 2H 2012 for Serada in patients with menopausal hot flashes. In its BREEZE 3, Phase 3 trial, it met three of the four primary endpoints. Australian healthcare company Prima BioMed Ltd (ASX: […]

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ECYT partnership with MRK. BIOD and INSM trial updates

Apr 16, 2012 No Comments

Endocyte Inc. (NASDAQ: ECYT) today announced that it has entered into an agreement with Merck, (NYSE: MRK) to develop and commercialize its candidate, vintafolide (EC145),  currently in a Phase 3 trial in patients with platinum-resistant ovarian cancer, and a Phase 2 trial for non-small cell lung cancer (NSCLC). Endocyte will receive a $120m upfront payment and is eligible for milestone […]

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Video – UPDATED: How to best make use of the FDA and PDUFA Calendars

Apr 15, 2012 No Comments
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