Regeneron Revives NGF Inhibitor With Phase II/III Data; Safety Issue Remains

Regeneron Pharmaceuticals Inc. reported statistically significant pain relief for osteoarthritis sufferers enrolled in the company's Phase II/III clinical trial for fasinumab, but the data didn't relieve concerns about neuro-musculoskeletal side effects for medicines that inhibit nerve growth factor (NGF).

Tarrytown, New York-based Regeneron's stock initially increased, fell, then rose again on May 2 after it said pain scores were essentially cut in half for patients treated with the NGF-targeting monoclonal antibody, but the rate of neuro-musculoskeletal adverse events was nearly three times as high as in the placebo group – 17% versus 6%. Severe joint risks shut down clinical trials for NGF inhibitors in the past, including fasinumab, so the higher rate of those side effects wasn't unexpected, but analysts noted that longer term confirmatory trials are needed to confirm that safety risks don't outweigh efficacy.

Regeneron's share price increased by about $3 when the stock market opened, but fell almost $7 below the company's $376.71...

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.