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Genmab’s Darzalex Gets FDA Approval For Blood Disorder Treatment

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Genmab A/S announced on Jan. 15 that its drug, Darzalex Faspro has been approved by the US Food and Drug Administration (FDA) for the treatment of light-chain (AL) amyloidosis in adult patients.

Darzalex Faspro is a combination of daratumumab and hyaluronidase-fihj drugs. Amyloidosis is the build-up of amyloid in different organs of the body. Amyloid is an abnormal protein produced in the bone marrow. Light-chain (AL) amyloidosis is the most common form of amyloidosis.

The FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) means that it would be the only US approved therapy for AL amyloidosis. The approval was based on the study of Phase 3 ANDROMEDA (AMY3001) data of daratumumab and hyaluronidase-fihj in combination with dexamethasone.

Genmab’s (GMAB) shares closed at $44.40 on Jan. 15. The company granted Janssen Biotech a worldwide exclusive license to develop, manufacture, and commercialize Darzalex (daratumumab) in August 2012. The company expects to receive a milestone payment of $30 million, after the first sale of Darzalex Faspro commercially. According to the collaboration with Janssen Genmab will be entitled to receive tiered royalty payments that will be between 12% to 20% of the drug's net sales of the drug.

Darzalex (daratumumab) is the company’s key drug that is used for the treatment of multiple myeloma. Genmab expects that its collaboration with Janssen Biotech for the drug will result in recurring revenue growth in terms of royalty payments between DKK 4.1 billion to DKK 4.5 billion. The company’s guidance for FY20 suggests sales of Darzalex between $3.9 billion to $4.2 billion. (See GMAB stock analysis on TipRanks)

Following the FDA approval, H.C Wainwright analyst, Ram Selvaraju reiterated his Buy rating for the stock and increased the price target from $44 to $49.

Earlier this month, RBC Capital analyst Kennen MacKay kept a Buy rating on the stock and raised his price target from $40 to $46. Kennen said that he remained positive about the company’s prospects in 2021 due to its "blockbuster mill" research and development capabilities, profitability prospects, and its product pipeline.

Overall, analysts remain cautiously optimistic about the stock as the consensus is a Moderate Buy with 3 analysts recommending a Buy and one analyst suggesting a Hold. The average price target of $42.50 implies 4.3% downside potential to current levels. Shares have risen by 20.7% over the past three months.

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