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Bio Roundup: Surprise News, a Gene Therapy Mess & a CAR-T Step

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its blood-based cancer diagnostic can detect tumors with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR), defects that make them more vulnerable to immunotherapies like pembrolizumab (Keytruda).

—Australian biotech Opthea reported that its wet age-related macular degeneration drug OPT-302, when combined with ranibizumab (Lucentis), was better than Lucentis alone in a Phase 2 study.

—The Merck (NYSE: MRK) and AstraZeneca (NYSE: AZN) drug olaparib (Lynparza) succeeded in a Phase 3 trial in a subset of patients with metastatic castration resistant prostate cancer—a first for a relatively new class of drugs known as PARP inhibitors.

—-Rhythm Pharmaceuticals (NASDAQ: RYTM) reported that setmelanotide, an experimental drug for rare genetic obesity disorders, aced two Phase 3 studies. The Boston company plans to file for FDA approval in two diseases, pre-opiomelancortin deficiency and Lepin receptor deficiency.


—The FDA extended its review of experimental Intra-Cellular Therapies (NASDAQ: ITCI) schizophrenia drug lumateperone by three months, giving it more time to review safety data from animal tests.

—The agency rejected a dry eye disease medication from Kala Pharmaceuticals (NASDAQ: KALA), pending data from an additional trial. Kala has another Phase 3 study underway with results expected next year.

—An FDA advisory panel voted 16 to 2 to recommend approval of Gilead Sciences (NASDAQ: GILD) drug Discovy for HIV prevention in men and transgender women.

—European regulators approved the Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NYSE: SNY) drug dupilumab (Dupixent) for adolescents with moderate to severe eczema. Dupixent also succeeded in a Phase 3 trial in six to 11 year old eczema patients.

—Running out of cash to advance an experimental liver patch product to human testing, San Diego-based Organovo (NASDAQ: ONVO) announced a corporate restructuring that could lead to a sale of the business or a merger with another company.

—Last month, Mallinckrodt (NYSE: MNK) announced it would spin off its generics subsidiary, which markets opioids. This week, the drug maker suspended those plans, citing market conditions that include “increasing uncertainties created by the opioid litigation.”


—Boston biotech Luca Biologics launched with a pipeline of preclinical microbiome treatments for women’s health.

—Neoleukin (NASDAQ: NLTX), a University of Washington spinout making protein drugs, went public via a reverse merger with Aquinox Pharmaceuticals of Vancouver, BC.

—A new report from CB Insights showed that healthcare startups around the world raised a record $26.9 billion through 2,258 deals in the first half of 2019.

—Bridge Bio (NASDAQ: BBIO) offered to buy out the shares of Eidos Therapeutics (NASDAQ: EIDX) it doesn’t already own in a stock deal that values Eidos shares at $38.31 apiece.

—Nonalcoholic steatohepatitis drug developer 3-V Biosciences of San Mateo, CA, changed its name to Sagimet Biosciences and announced the second tranche of its Series E funding, which now totals $25 million.

—Exo Imaging raised a $35 million Series B to develop smaller, more affordable ultrasound diagnostic tools.


—Former Gilead executive John Hutchison was named CEO of Assembly Biosciences (NASDAQ: ASMB)… Ribon Therapeutics hired Sudha Parasuraman as chief medical officer… Teva Pharmaceutical (NYSE: TEVA) chief financial officer Mike McClellan is stepping down… Rafael Amado left Adaptimmune for the chief medical officer job at Allogene Therapeutics (NASDAQ: ALLO)… Genentech’s Priti Hegde was appointed chief scientific officer of Foundation Medicine… former Achaogen executive Janet Dorling joined CymaBay Therapeutics (NASDAQ: CBAY) as chief commercial officer… Editas Medicine (NASDAQ: EDIT) named interim CEO Cynthia Collins its full-time president and CEO.

Frank Vinluan contributed to this report.

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