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- Pozen presents positive Phase III data at stroke conference.
- GSK files MAA with EMA for trametinib as monotherapy and in combo with dabrafenib for metastatic melanoma.
- Addex Therapeutics to refocus pipeline, structure Geneva operations.
- Germany’s Federal Joint Committee says Vertex’s Kalydeco provides significant benefit.
- Acceleron’s eight Phase II trials.
- Lilly discontinues tabalumab for rheumatoid arthritis.
- €196 M pan-European drug discovery platform launched.
- Elan, Biogen Idec ink $3.25 B deal for MS drug Tysabri.
- Celsion Phase III HEAT study fails.
- FDA to hold a public hearing on ALS on Feb 25.
- Genzyme/ISIS’ Kinamro to be priced at $176,000/year.
- Pharmaxis’ Bronchitol gets negative vote from FDA advisory committee.
- VC Edmond de Rothschild to raise $500 M over four years.
- Antibody company KaloBios preparing for IPO.
- Stemline jumps 18% on its first day of trading.
Main remarks from Cytokinetics Inc. (Nasdaq: CYTK) last PRs and quarterly results are:
- Data from the phase II trial of ‘357 in myasthenia gravis are delayed until 1H of 2012.
- Amgen (Nasdaq: AMGN) is continuing the development of Omecamtiv mercabil (OM) in its phase IIb safety and efficacy trial, now dubbed ATOMIC-AHF. Remember that top-line data won’t be released until 1H 2013.
- Cytokinetics is collecting data from a Part A study of its phase II PK, PD, multiple dose, safety and tolerability trial of ‘357 in patients with ALS who are not getting riluzole. Data will be presented at the 22nd International Symposium on ALS and Motor Neurone Diseases Meeting in Sydney, Australia on November 30 – December 2. It initiated a Part B in patients who are also receiving riluzole on Nov 1 with results expected in 1H of 2012
The main short term catalyst for Incyte Pharmaceuticals (Nasdaq: INCY) is a PDUFA date of Dec 3 for its JAK1/JAK2 inhibitor ruxolinitib -ruxo for short. This drug met its primary and secondary endpoints in two pivotal Phase III trials named COMFORT I and COMFORT II. In both trials patients treated in the ruxo arm experienced significant spleen reduction as well as clinically meaningful improvements of symptoms and quality of life. These trials were conducted under a Special Protocol Assessment with the FDA.