RARITAN, NJ – Johnson & Johnson (NYSE:JNJ) has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) submitted. The applications target the treatment of high-risk smoldering multiple myeloma, a precursor to active multiple myeloma. If approved, DARZALEX FASPRO® would be the first approved therapy for this patient group before the onset of full-blown disease.
The applications are based on data from the phase 3 AQUILA study, which examined DARZALEX FASPRO® as monotherapy in adults with high-risk smoldering multiple myeloma. This disease is characterized by the presence of abnormal cells in the bone marrow without the typical symptoms of active multiple myeloma. To date, standard care has been observation until the disease progresses. However, recent evidence suggests that early intervention could benefit patients at high risk of developing active multiple myeloma.
Dr. Yusri Elsayed from Johnson & Johnson emphasizes that DARZALEX has already changed the standard of care for multiple myeloma. The company now hopes to further improve the treatment landscape for patients with high-risk smoldering multiple myeloma with FDA and EMA approval. The initial results of the AQUILA study are scheduled to be presented at the annual meeting of the American Society of Hematology (ASH) in December.
DARZALEX FASPRO® is currently approved for multiple indications in the treatment of multiple myeloma, both as monotherapy and in combination with other medications. It is the only approved subcutaneous CD38-targeting antibody treatment for patients with multiple myeloma. The partnership between Janssen Biotech, Inc. and Genmab A/S has granted Janssen the exclusive license to develop, manufacture and commercialize daratumumab.
The press release cautions that the Company’s forward-looking statements, including those regarding the potential benefits and treatment effects of DARZALEX FASPRO®, are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
In other recent news, Johnson & Johnson reported a strong third quarter with operating revenue growth of 6.3% to a total of $22.5 billion. The company also raised its full-year guidance for the third consecutive time. Of particular note is the Innovative Medicine division, which reported sales of over $14 billion for two consecutive quarters.
In terms of analyst upgrades, both RBC Capital Markets and Stifel Financial adjusted their price targets on Johnson & Johnson following these robust results. RBC Capital Markets raised its price target to $181.00 from $178.00, while Stifel raised its target to $170 from $160.
The company’s most recent developments include the successful Phase 3 GRAVITI trial of TREMFYA® (guselkumab) for the treatment of Crohn’s disease. The study found that patients treated with TREMFYA® achieved clinical and endoscopic remission more often than those who received placebo. Pending FDA approval, TREMFYA® could become the first IL-23 treatment for Crohn’s disease.
However, Johnson & Johnson also faced legal challenges. The company was ordered to pay $15 million in a talc cancer case, a ruling they plan to appeal.
InvestingPro Insights
Johnson & Johnson’s recent application for a new indication of DARZALEX FASPRO® underscores the company’s strong position in the pharmaceutical industry. According to InvestingPro data, J&J has a sizeable market capitalization of $377.35 billion, highlighting its significant presence in the healthcare sector.
InvestingPro tips highlight J&J’s financial stability and consistent performance. The company has increased its dividend for 54 consecutive years, demonstrating a strong commitment to shareholder returns. This track record is particularly relevant as J&J expands its product offerings and potentially enters a new market segment with DARZALEX FASPRO®.
J&J’s trailing twelve month revenue growth of 4.77% and a robust gross margin of 69.39% indicate that the company has the financial resources to support ongoing research and development initiatives such as the AQUILA trial for DARZALEX FASPRO® support.
It’s worth noting that J&J operates with moderate leverage and its cash flows are sufficient to cover interest payments. This financial prudence could provide the flexibility needed to navigate the approval process and potential launch of new indications for DARZALEX FASPRO®.
Investors considering J&J’s prospects may be interested to learn that InvestingPro offers 10 additional picks for this stock that provide a more comprehensive analysis of the company’s financial health and market position.
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