Crispr Therapeutics shares tumble after significant earnings miss
SAN DIEGO - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company with a market capitalization of $6.7 billion and an impressive InvestingPro Financial Health score of "GREAT," announced today that Bristol Myers Squibb has received approval from the European Commission (EC) for a new subcutaneous formulation of Opdivo (nivolumab), developed in collaboration with Halozyme’s ENHANZE technology. The approval allows the medication to be used for various adult solid tumors, either as a standalone treatment, maintenance post-combination therapy, or in combination with other drugs.
The EC’s decision enables the use of Opdivo across the 27 member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. This follows the U.S. Food and Drug Administration’s approval of the subcutaneous nivolumab and hyaluronidase-nvhy, marketed as Opdivo Qvantig™, on December 27, 2024.
Dr. Helen Torley, president and CEO of Halozyme, expressed that the approval marks a significant advancement for cancer patients, offering a quicker and potentially less burdensome method of administration—a 3-to-5-minute subcutaneous injection. She also mentioned that this is one of the 11 expected growth catalysts for Halozyme’s commercialized subcutaneous products this year. The company’s strong execution is reflected in its 25.7% revenue growth and perfect Piotroski Score of 9, according to InvestingPro data.
The approval is backed by positive results from the Phase 3 CheckMate -67T trial. Details regarding the study and its outcomes are available through a press release from Bristol Myers Squibb, issued on May 28, 2025.
Halozyme specializes in drug delivery technology, notably its ENHANZE platform, which employs a proprietary recombinant human hyaluronidase enzyme (rHuPH20) to facilitate the subcutaneous delivery of injectable drugs. The company’s technology aims to improve patient experience by reducing treatment duration and expanding treatment options.
The company, headquartered in San Diego, CA, has made a significant impact on patient care, with its technology reaching one million patient lives through ten commercialized products in over 100 global markets. Halozyme has partnered with several leading pharmaceutical firms to incorporate the ENHANZE technology into their drug formulations. Trading at a P/E ratio of 14.02 and showing strong cash flow generation, InvestingPro analysis indicates the stock is currently undervalued. Subscribers to InvestingPro can access the comprehensive Pro Research Report, which provides detailed analysis of Halozyme’s financial health, valuation metrics, and growth prospects.
The information in this article is based on a press release statement.
In other recent news, Halozyme Therapeutics has been at the center of attention due to new developments involving draft guidance from the Centers for Medicare & Medicaid Services (CMS). Despite reporting generally positive first-quarter results, the company faces potential challenges related to the 2028 Inflation Reduction Act (IRA) drug price controls. The CMS draft guidance suggests that combination products, like those using Halozyme’s ENHANZE technology, could be subject to earlier price negotiations, impacting their pricing protections. This has led to a series of analyst actions, with Morgan Stanley downgrading Halozyme from Overweight to Equalweight and lowering the price target to $62.00. Similarly, Leerink Partners downgraded the stock from Market Perform to Underperform, reducing the price target to $47.00. Evercore ISI, however, maintained its Outperform rating, reflecting a more optimistic view despite the regulatory uncertainties. JMP Securities also reaffirmed its positive outlook, keeping a $78.00 price target, emphasizing the clinical benefits of Halozyme’s technology. The ongoing discussions around the CMS guidance and its implications for drug pricing are critical for investors monitoring Halozyme’s future revenue and market strategy.
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