FDA Calendar

Wednesday, June 10, 2015

Random Catalysts : $GALE, $EXEL $IMGN

Today's focus is on ONCOLOGY, will add more over the next few days.

$GALE -

Phase 3 NeuVax Phase 3 PRESENT breast cancer immunotherapy clinical trial 

Expected Catalyst: Interim analysis in Q4 2015 or Q1 2016

http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=911858

'NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent cancer recurrence after standard of care treatment in the adjuvant setting in breast and gastric cancers. '

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$GALE -

Phase 2 GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial Data at the European Hematology Association 20th Congress

Expected Catalyst: June @ EHS conference

http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=914567

"GALE-401 is a reformulated, controlled release version of anagrelide. In Phase 1 studies in healthy volunteers, GALE-401 was shown to significantly reduce the Cmax while maintaining plasma exposure to reduce platelet counts. Thus, GALE-401 may reduce treatment-related adverse events while maintaining effective therapeutic levels to decrease platelet production.''

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$EXEL

PDUFA: cobimetinib, to be used in combination with vemurafenib for patients with advanced melanoma harboring a BRAF V600 mutation

Expected Catalyst - August 11th, 2015

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$IMGN

Phase 3 GATSBY Kadcyla using IMGN's  ADC technology - HER2 + Gastric with partner Roche

Expected Catalyst 2H 2015

http://files.shareholder.com/downloads/ABEA-5VU3S1/267484631x0x808585/F5C7CB12-072F-45F4-BB4F-44899C84386A/IMGN_Corporate_presentation_as_of_6-2-15_for_website.pdf

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