Protocols

Active Biotech shares crater after Teva’s MS drug laquinimod flops (again); FDA approves Foundation Medicine’s genomic tumor diagnostic test

→ We already knew from a Phase III readout last spring that Teva’s big multiple sclerosis drug hope laquinimod didn’t work in treating relapsing remitting MS. This morning we find out that it’s no better in the primary progressive form of the disease. Teva’s partner Active Biotech reported that the Phase II in PPMS — dubbed ARPEGGIO — flunked the primary on brain atrophy as well as a secondary on time to confirmed disability progression. Active’s shares $ACTI cratered on the news, dropping more than 40%. Teva has spent years in pursuit of a laquiniqmod approval, despite mounting evidence that it couldn’t compete. Recently the struggling outfit launched a restructuring that led to the departure of R&D chief Michael Hayden.

→  5AM Ventures and New Enterprise Associates led a $7.5 million seed round for Akouos, a startup gene therapy company focused on inner ear therapies. “Our mission is to make healthy hearing available to all,” said Manny Simons, founder and CEO of Akouos. “Our cornerstone partnership with Massachusetts Eye and Ear, the world’s largest hearing research center, and with Lonza, a global leader in viral gene and cell therapy manufacturing, sets a strong foundation for the important work to be done in this emergent field.”

→ Alnylam CEO John Maraganore is getting ready to start marketing the biotech’s first RNAi drug, and he believes that the company will have so many new drugs following the path to the market that Alnylam won’t need regular steep increases in prices to keep revenue growing. As a result, he says he will limit annual price hikes to the inflation rate, which is currently much, much lower than what the rest of the industry does.

Foundation Medicine $FMI has scored a key FDA OK for its comprehensive companion diagnostic test for solid tumors, along with a preliminary determination that the diagnostic will be covered by the Centers for Medicare and Medicaid Services. Designed to help health care professionals make cancer treatment decisions, FoundationOne CDx is a profiling test that assesses genomic alterations in 324 genes known to drive cancer growth. The test also reports genomic biomarkers that can inform the use of immunotherapies. The company estimates that 1 in 3 patients across 5 common advanced cancers would match with an FDA-approved therapy. “Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” said CEO Troy Cox in a statement.



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