RARITAN, N.J. - 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) in the treatment of high-risk smoldering multiple myeloma, a precursor to active multiple myeloma. If approved, DARZALEX FASPRO® would be the first therapy sanctioned for use in this patient population before the onset of the full-blown disease.
The applications rely on data from the Phase 3 AQUILA study, which evaluated DARZALEX FASPRO® as a monotherapy in adults with high-risk smoldering multiple myeloma. This condition is characterized by the presence of abnormal cells in the bone marrow without the symptoms typical of active multiple myeloma. Currently, standard care involves observation until the disease progresses, but recent evidence suggests that early intervention could benefit patients at high risk of developing active multiple myeloma.
According to Dr. Yusri Elsayed of Johnson & Johnson, DARZALEX has already altered the standard of care in multiple myeloma, and the company hopes that with FDA and EMA approval, it could transform the treatment landscape for patients with high-risk smoldering multiple myeloma. The first results from the AQUILA study are set to be presented at the American Society of Hematology (ASH) Annual Meeting in December.
DARZALEX FASPRO® is currently approved for multiple indications in the treatment of multiple myeloma, both as a monotherapy and in combination with other drugs. It is the only subcutaneous CD38-directed antibody treatment approved for multiple myeloma patients. The partnership between Janssen Biotech, Inc. and Genmab (NASDAQ:GMAB) A/S has granted Janssen the exclusive license to develop, manufacture, and commercialize daratumumab.
The press release notes that the company's forward-looking statements, including those regarding DARZALEX FASPRO®'s potential benefits and treatment impact, are subject to risks and uncertainties that could cause actual results to differ materially from expectations. The information is based on a press release statement.
In other recent news, Johnson & Johnson reported a strong third quarter with operational sales growth of 6.3%, totaling $22.5 billion. The company also raised its full-year guidance for the third consecutive quarter. Notably, the Innovative Medicine segment showed strength with sales exceeding $14 billion for two consecutive quarters.
In terms of analyst upgrades, both RBC Capital Markets and Stifel Financial (NYSE:SF) adjusted their price targets for Johnson & Johnson following these robust results. RBC Capital Markets increased its price target from $178.00 to $181.00, while Stifel raised its target to $170 from the previous $160.
Recent developments for the company also include the successful Phase 3 GRAVITI study of TREMFYA® (guselkumab) for treating Crohn's disease. The study found that patients treated with TREMFYA® achieved clinical and endoscopic remission more frequently than those receiving a placebo. Pending FDA approval, TREMFYA® could become the first IL-23 treatment for Crohn's disease.
However, Johnson & Johnson has also faced legal challenges. The company has been ordered to pay $15 million in a talc cancer case, a decision they plan to appeal. These are among the recent developments for Johnson & Johnson.
InvestingPro Insights
Johnson & Johnson's recent application for a new indication of DARZALEX FASPRO® aligns with the company's strong position in the pharmaceutical industry. According to InvestingPro data, J&J boasts a substantial market capitalization of $377.35 billion, underlining its significant presence in the healthcare sector.
InvestingPro Tips highlight J&J's financial stability and consistent performance. The company has raised its dividend for 54 consecutive years, demonstrating a commitment to shareholder returns that complements its innovative drug development efforts. This track record is particularly relevant as J&J seeks to expand its product offerings and potentially capture a new market segment with DARZALEX FASPRO®.
Furthermore, J&J's revenue growth of 4.77% over the last twelve months and a robust gross profit margin of 69.39% suggest that the company has the financial resources to support ongoing research and development initiatives, such as the AQUILA study for DARZALEX FASPRO®.
It's worth noting that J&J operates with a moderate level of debt and its cash flows can sufficiently cover interest payments. This financial prudence could provide the flexibility needed to navigate the regulatory approval process and potential market launch of new indications for DARZALEX FASPRO®.
Investors considering J&J's prospects might be interested to know that InvestingPro offers 10 additional tips for this stock, providing a more comprehensive analysis of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.