13 Sep

Johnson & Johnson Seeks EU and US Label Expansion for Darzalex

WRITTEN BY Sarah Collins


Johnson & Johnson’s (JNJ) subsidiary Janssen Pharmaceuticals filed regulatory submissions for label expansion of its multiple myeloma drug Darzalex (daratumumab) in the United States and the European Union in early August. The company is seeking approval for a split dosing regimen for Darzalex that will provide an option of splitting the first infusion of Darzalex over two consecutive days, which is expected to improve the medication’s administration profile.

JNJ submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA (European Medicines Agency). If they are approved, JNJ stock could likely get a boost on positive market sentiment.

JNJ has witnessed a strong growth momentum in Darzalex sales over the past quarters and expects the expansion in indications to further accelerate sales going forward.

Johnson & Johnson Seeks EU and US Label Expansion for Darzalex

Multiple indications approved for Darzalex would target a wide market

Janssen Pharmaceuticals obtained the license to develop and commercialize Darzalex in 2012 when it entered into an agreement with Genmab A/S. Darzalex is approved for five indications for the treatment of multiple myeloma. In the United States, the drug first received approval in November 2015. It was approved in the European Union in May 2016. Darzalex registered sales of $1.24 billion in 2017.

Check out all the data we’ve added to our quote pages. Now you can get a valuation snapshot, earnings and revenue estimates, and historical data, as well as dividend information. Take a look!

Latest articles

On Thursday, Morgan Stanley released its Q3 results, its highest Q3 results in the last decade. Its stock reacted positively and opened at $44.39.

Boeing is set to release earnings on Wednesday, and CEO Dennis Muilenburg is preparing to testify before Congress. Not a good time for a massive scandal.

EIA inventory data showed a buildup of 104 Bcf (billion cubic feet) in natural gas inventories. The EIA reported the natural gas inventory on October 17.

Enphase Energy (ENPH) stock rose about 4% on October 17. ENPH has risen steadily this month after a sharp drop, and it has gained almost 430% YTD.

Netflix is down 6.1% today, and some traders are actively betting that Netflix stock will plunge in the coming weeks and months. Here's why.

Analyst Christopher Eberle reiterated a "buy" rating and a price target of $161 on Microsoft stock. He predicts that Azure could grow 61.6% in Q1.