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Johnson & Johnson : Janssen Seeks FDA Approval of New Darzalex Subcutaneous Formulation

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07/12/2019 | 12:24pm EDT

By Stephen Nakrosis

The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) said Friday it submitted an application with the U.S. Food and Drug Administration seeking approval of its new subcutaneous formulation of Darzalex, or daratumumab, for certain patients with multiple myeloma.

Janssen said the Biologics License Application was supported by data from its Phase 3 Columba study, which included 522 patients, and data from the Phase 2 Pleiades study, which included 240 patients.

"The Darzalex subcutaneous formulation showed non-inferiority to the existing IV formulation, both as a monotherapy and in combination with common background therapies, while administered with a considerably shorter infusion time. We look forward to working closely with the FDA in their review of the data supporting this regulatory application," said Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

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Financials (USD)
Sales 2019 82 226 M
EBIT 2019 25 622 M
Net income 2019 19 665 M
Debt 2019 7 881 M
Yield 2019 2,94%
P/E ratio 2019 17,7x
P/E ratio 2020 16,6x
EV / Sales2019 4,19x
EV / Sales2020 3,93x
Capitalization 337 B
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Average target price 149,16  $
Last Close Price 127,70  $
Spread / Highest target 35,5%
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Joseph J. Wolk Chief Financial Officer & Executive Vice President
Paulus Stoffels Chief Scientific Officer
Charles O. Prince Independent Director
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