FDA Calendar Updates
IMGN (ImmunoGen, Inc.) $8.60;
Announced today that Genentech had submitted a BLA on July 6/7 for trastuzumab-DM1, or T-DM1, to treat patients with advanced HER2-positive breast cancer who had previously received multiple chemotherapies and HER2-targeted medicines. Roche have stated that sales of the drug could be close to just under $2b. Press release here.
NLTX (Nile Therapeutics, Inc) $0.31
Announced today that it had completed the dosing in its Phase 2 trial for acute decompensated heart failure, or ADHF. Data is due 4Q this year.Press release here.
Clinical Trial Database Updates
XNPT (XenoPort) $6.45
GSK (GlaxoSmithKline) $34.04
Reported today that it failed its Phase 2b trial for GSK1838262/XP13512 (gabapentin enacarbil) for migraines noting a higher than expected placebo response rate. This is the same product that received a CRL (Complete Response Letter) from the FDA earlier this year for Restless Legs Syndrome, citing safety concerns from preclinical studies. They intend to resubmit their NDA later this year. Press release here.
ONTY (Oncothyreon Inc). $3.27
Announced that it will issue up to $20m in common shares over a 2 year period to Small Cap Biotech Value Ltd. Press release here.
For more information on small cap biotech, FDA Calendar and a complete database of clinical trials see BioPharmCatalyst
Disclosure: No positions