EMA

CHMP reverses course on neratinib, handing Puma an unexpected win on European marketing vote — shares soar

Alan Auerbach

Puma Biotechnology $PBYI CEO Alan Auerbach just beat some heavy odds weighing against neratinib.

After appealing a negative opinion adopted by the Committee for Medicinal Products for Human Use, the EMA group has reversed course and is now recommending an approval. The committee members had initially sided against a green light, citing concerns over the serious diarrhea linked with the drug as well as the relevance of the late-stage data they saw in extended adjuvant early-stage HER2-positive breast cancer.

The about-face dramatically changes Puma’s prospects in Europe, becoming an odds-on favorite for formal approval. And their shares shot up 24% on the news in early trading Tuesday.

This isn’t the first time Puma has prevailed against critics. A legion of short sellers went after the biotech at every turn in its lead up to an FDA review. But the biotech handily won the all-important US approval after agency experts largely gave the biotech a pass on safety issues, preferring to give physicians and patients another drug to consider.

The drug is sold in the US as Nerlynx.


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Director/Sr Director, Oncology/Immuno-Oncology
Aro Biotherapeutics Company Denver, CO
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Aro BioTx Philadelphia, PA
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Molecular Templates Austin, TX
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Molecular Templates Austin, TX

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