SAN DIEGO - Halozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced that the U.S. Food and Drug Administration (FDA) has updated the Prescription Drug User Fee Act (PDUFA) goal date for reviewing the Biologics License Application (BLA) of a subcutaneous formulation of Opdivo® (nivolumab), which is co-formulated with Halozyme's proprietary ENHANZE® technology. The new goal date is set for December 29, 2024.
The BLA submission is supported by data from the CheckMate-67T trial, the first Phase 3 study to evaluate the subcutaneous form of nivolumab with ENHANZE®. This study aimed to demonstrate noninferior pharmacokinetics, efficacy, and consistent safety compared to its intravenous formulation in adult patients with solid tumors. If approved, this would mark the first subcutaneously administered PD-1 inhibitor available for use.
Halozyme's ENHANZE® technology utilizes a recombinant human hyaluronidase enzyme, rHuPH20, to potentially improve the delivery and absorption of injected drugs. The company has established partnerships with multiple pharmaceutical firms, including Bristol Myers (NYSE:BMY) Squibb, to incorporate ENHANZE® into various treatments.
The company, headquartered in San Diego, CA, has made strides in advancing drug delivery solutions aimed at enhancing patient experiences and outcomes. Halozyme has already impacted over 800,000 patient lives with its technology across numerous global markets and continues to develop drug-device combination products.
The announcement is based on a press release statement and includes forward-looking statements about the potential approval and benefits of the ENHANZE® co-formulated treatment. These statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
The FDA's decision on the BLA will be a significant milestone for Halozyme and its partners, potentially offering a new delivery method for cancer treatments and reducing the treatment burden for patients.
InvestingPro Insights
As Halozyme Therapeutics , Inc. (NASDAQ: HALO) awaits the FDA's decision on the BLA for their innovative ENHANZE® co-formulated treatment, the company's financial health and market performance offer additional insights.
Halozyme's management has demonstrated confidence in the company's prospects through aggressive share buybacks, aligning with the positive sentiment surrounding its technology and partnerships. Moreover, the company is trading at a low P/E ratio of 18.26 relative to its near-term earnings growth, indicating potential value for investors considering its recent financial achievements.
InvestingPro data underscores Halozyme's robust financial position, with a significant revenue growth of 22.41% over the last twelve months as of Q1 2024. This growth is complemented by an impressive operating income margin of 44.24%, reflecting the company's efficiency in translating sales into profit. Moreover, the company's stock has experienced a strong return over the last three months, with a 17.23% price total return, suggesting a favorable market reception to its operational performance and future prospects.
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