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Sciences (NASDAQ: GILD) rival CAR-T treatment Yescarta, NICE said there is no evidence the treatment is better than rescue chemotherapy. NICE did previously, however, clear Kymriah for use in children.
—The FDA cleared Mersana Therapeutics to resume an early-stage study of an experimental cancer drug two months after Mersana disclosed that a trial volunteer died. Mersana will monitor patients more closely and try less frequent dosing. Shares fell more than 20 percent.
—Wiconsin biotech Stemina Biomarker Discovery discussed with Xconomy’s Jeff Buchanan its ongoing autism study and a potential test to detect the disorder early in at-risk kids.
—The FDA found no new safety issues in a post-marketing review of antipsychotic drug pimavanserin (Nuplazid) from Acadia Pharmaceuticals (NASDAQ: ACAD), boosting shares more than 24 percent in late-day trading Thursday. The review began after reports of deaths and serious side effects in patients taking the drug.
—The Committee for Medicinal Products for Human Use, which helps guide drug approval decisions in Europe, rejected eteplirsen (Exondys 51), the Duchenne muscular dystrophy drug from Sarepta Therapeutics (NASDAQ: SRPT), for the second time. Sarepta still plans to explore a path forward in Europe and will seek more advice from regulators there next year.
DEALS & DOLLARS
—Indigo Ag raised a $250 million Series E round to support more R&D on microbials and expand its grain-selling software platform.
—Five months after emerging with $300 million in funding, South San Francisco, CA-based Allogene late last week revealed plans for an IPO to finance clinical testing of cancer cell therapies made from donor T cells rather than a patient’s own T cells.
—Amicus Therapeutics (NASDAQ: FOLD) became the latest biotech to place a bet on gene therapy, paying $100 million to buy Celenex and its 10 experimental gene therapies for lysosomal storage diseases. Celenex is a spinout of Nationwide Children’s Hospital in Columbus, OH, a top gene-therapy testing center.
—Galera Therapeutics of Malvern, PA, raised a $150 million Series C round to advance a drug meant to prevent one of the dangerous side effects of radiation therapy for cancer.
—San Francisco-based uBiome, which helps people understand how their microbiomes affect health, is moving into therapeutics. The company raised $83 million in Series C financing, which it will use to develop drugs that could treat cancer, autoimmune disease, and obesity.
—Takeda Pharmaceutical paid Molecular Templates (NASDAQ: MTEM), of Austin, TX, $30 million to co-develop cancer drugs that target the CD38 protein, which is widely expressed on multiple myeloma cells. Molecular Templates shares surged 52 percent.
Ben Fidler and Frank Vinluan contributed to this report.