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boost sales of naltrexone (Vivitrol), a once-struggling drug that has flourished as the opioid crisis has worsened in the U.S.
STOPS AND STARTS
—Merck (NYSE: MRK) paused enrollment in two Phase 3 studies that combine its cancer immunotherapy drug pembrolizumab (Keytruda) with other therapies in multiple myeloma patients. Merck said there were “reports of death” in the pembrolizumab groups. The news is fresh evidence of some of the safety perils involved in combining immunotherapy drugs with other treatments.
—Shares of San Diego, CA-based Regulus Therapeutics (NASDAQ: RGLS) fell 16 percent after the company disclosed it will stop developing two drugs, including its lead program for hepatitis C. Partner AstraZeneca also sent rights back to a third Regulus program.
—Biosimilar maker Coherus BioSciences (NASDAQ: CHRS) got a stop sign Monday from the FDA, which asked for more information and analysis as it reviews Coherus’s version of pegfilgrastim (Neulasta) for approval. Coherus shares immediately slumped 31 percent and remain down.
—Longtime Biogen (NASDAQ: BIIB) CFO Paul Clancy left the Cambridge company to join struggling Alexion Pharmaceuticals (NASDAQ: ALXN), which has completely overhauled its executive team. According to a note from Barclays analyst Geoff Meacham, Alexion might write off its $8.4 billion buyout of Synageva Biopharma. After Clancy’s move, Biogen shares fell 3 percent and Alexion shares climbed 9 percent.
—Seres Therapeutics (NASDAQ: MCRB) started a Phase 3 study of its microbiome treatment for recurrent C. difficile infection nearly a year after the drug failed a Phase 2 trial, triggering a $20 million milestone payment from partner Nestle Health Science.
SHARE MOVERS, BUYOUT RUMORS
—Shares of Cambridge-based Epizyme climbed nearly 11 percent after the company posted Phase 2 data on tazemetostat in a variety of blood cancers. CEO Robert Bazemore said in a statement the company will meet with the FDA later this year “to determine potential registration paths” for the drug.
—Chicago-based Avexis (NASDAQ: AVXS), developing what could be the first gene therapy for the rare disease spinal muscular atrophy, said it plans to begin a pivotal trial for patients with the most deadly form, Type 1, in the third quarter. Shares climbed 9 percent.
—Buyout rumors continued to swirl around Waltham, MA-based cancer drug maker Tesaro (NASDAQ: TSRO), with the latest news reports suggesting Sanofi and Gilead Sciences (NASDAQ: GILD) have expressed interest in the company.