September 15, 2017 / 8:10 AM / 10 months ago

Santhera shares plummet after negative CHMP opinion

ZURICH (Reuters) - Swiss drugmaker Santhera’s shares plunged nearly 60 percent in early trading on Friday, after a European panel recommended against approving one of its drugs to be used in patients with Duchenne muscular dystrophy (DMD).

The shares fell 58.5 percent, wiping more than 250 million Swiss francs ($259.66 million) off the company’s market value. It was the biggest drop in Santhera’s history.

Liestal-based Santhera’s shares have been buoyed by optimism its drug Raxone would win regulatory approval for use against DMD, a severe genetic disease where muscles grow weaker over time.

The negative opinion of the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, is a severe blow, though Santhera vowed to appeal.

“We are surprised and disappointed,” Chief Executive Thomas Meier said.

“These patients in the respiratory decline stage currently have no treatment options, and because we are confident that they could benefit from treatment with Raxone, we plan to appeal this opinion and seek re-examination.”

Before Friday, Santhera’s shares had risen nearly 40 percent over the previous 12 months, in part due to optimism that Raxone’s approval in the UK for a special early access program could lead to broader European approval.

($1 = 0.9628 Swiss francs)

Reporting by John Miller; editing by Jason Neely

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