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18 months to address, but a new timeline emerged after discussions with the regulator.
—Ionis Pharmaceuticals (NASDAQ: IONS) subsidiary Akcea Therapeutics (NASDAQ: AKCA) filed for FDA approval of volanesorsen, a drug developed by Ionis for the metabolic disease familial chylomicronemia syndrome.
SETBACKS AND CUTBACKS
—San Diego-based Otonomy (NASDAQ: OTIC) scrapped development of an experimental drug for the hearing disorder Meniere’s disease after the treatment badly failed a Phase 3 trial. Otonomy shares plunged more than 82 percent.
—The FDA refused to review an experimental Parkinson’s disease drug from Acorda Therapeutics (NASDAQ: ACOR), citing manufacturing concerns and other questions. Shares fell more than 20 percent.
—InVivo Therapeutics (NASDAQ: NVIV) laid off 39 percent of staff in a shake-up that also cut the job of chief scientific officer Thomas Ulich.
DEALS AND OTHER DOLLARS
—Summit, NJ-based Celgene (NASDAQ: CELG) is expanding its relationship with Forma Therapeutics by exercising a $195 million option to pursue drugs in more therapeutic areas. Celgene still holds another option to buy Watertown, MA-based Forma outright.
—Jazz Pharmaceuticals (NASDAQ: JAZZ) is paying ImmunoGen (NASDAQ: IMGN) $75 million up front to partner on three of the Waltham, MA, biotech’s experimental drugs for blood cancers.
—SetPoint Medical raised $30 million in Series D funding. The Valencia, CA, company will use the cash for Phase 2 tests of its implantable electrical-signal device to treat rheumatoid arthritis.
—Last Friday, Gene therapy developer RegenxBio (NASDAQ: RENX) said it would acquire Dimension Therapeutics (NASDAQ: DMTX) in a stock deal valued at $86 million. Cambridge-based Dimension was created by RegenxBio four years ago and its experimental treatments are all based on RegenxBio’s drug platform.
—Redwood City, CA-based Armo Biosciences added new investor Qiming Venture Partners in a $67 million Series C-1 financing that will help Armo test its experimental immunotherapy in several cancers.
—This week we unveiled the finalists for the Patient Partnership award, which includes a group of creative initiatives companies and academics are using to team with patient groups to better understand diseases.
Image of T cells attacking cancer via the National Cancer Institute.