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Genmab shares rise on cancer drug's FDA licence application
June 8, 2015 / 12:48 PM / 3 years ago

Genmab shares rise on cancer drug's FDA licence application

COPENHAGEN, June 8 (Reuters) - Shares in Genmab rose almost 3 percent on Monday after partner Johnson and Johnson’s announcement late on Friday that the companies have applied to U.S. authorities for a licence to market their blood cancer drug daratumumab.

The multiple myeloma treatment received breakthrough designation from the U.S. Food and Drug Administration (FDA) in 2013, which SydBank analyst Soren Lontoft said could reduce the licence approval process to four months from the more usual six months.

Breakthrough status is granted by the FDA when a drug shows significant improvement over available treatment of life-threatening illnesses.

Friday’s statement said that the biologics licence application (BLA) would be supported mainly by Phase II study data, which is allowed for treatments given breakthrough status, and additional research can be submitted during the process.

Analysts at Jyske Bank said on Monday that Phase II results presented to the American Society of Clinical Oncology’s annual meeting on May 30 boosted their confidence in daratumumab’s potential.

“We believe the presented Phase II results on daratumumab in multiple myeloma for patients who have run out of options were very encouraging,” the bank wrote in a research note.

Genmab granted Janssen Biotech, a subsidiary of Johnson & Johnson, an exclusive worldwide licence to develop and sell daratumumab.

Monday was the first day of trading on the Copenhagen stock exchange since Friday’s announcement. Genmab shares were up 2.8 percent at 1236 GMT, outperforming a 0.9 percent fall for the Danish benchmark index. (Reporting By Alexander Tange; Editing by David Goodman)

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