Argenx receives EU approval for VYVGART subcutaneous injection

SAN DIEGO - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a $6.5 billion biotech company with exceptional financial health according to InvestingPro metrics, announced today that argenx has received European Commission (EC) approval for VYVGART 1000mg (efgartigimod alfa) with ENHANZE technology for subcutaneous injection in the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP).

The approved treatment, developed using Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), is indicated for CIDP patients who have previously received corticosteroids or immunoglobulins.

According to the company, VYVGART represents the first targeted IgG Fc-antibody fragment for CIDP and introduces the first novel mechanism of action for this condition in more than three decades.

The EC approval was based on results from the ADHERE clinical trial, which the company describes as the largest study of CIDP patients to date. The approval extends to all 27 European Union member states, plus Iceland, Norway, and Liechtenstein.

The subcutaneous formulation can be administered by patients, caregivers, or healthcare professionals and is available as a vial or prefilled syringe.

"This marks another milestone in our partnership with argenx and the expansion of access to Europe is another catalyst supporting our growth," said Dr. Helen Torley, president and chief executive officer of Halozyme, in a press release statement. The company’s strong execution is reflected in its impressive 25.7% revenue growth and industry-leading 76.2% gross profit margin over the last twelve months.

Halozyme’s ENHANZE drug delivery technology is designed to facilitate subcutaneous delivery of injected drugs, potentially improving patient experience through rapid delivery and reduced treatment burden. According to InvestingPro analysis, the company maintains a perfect Piotroski Score of 9, indicating strong operational efficiency, and appears undervalued based on its Fair Value assessment. Investors can access detailed financial analysis and 12 additional ProTips through the comprehensive Pro Research Report available on InvestingPro.

In other recent news, Halozyme Therapeutics has been in the spotlight due to several significant developments. The company recently announced that the European Commission approved a new subcutaneous formulation of Opdivo, developed in collaboration with Halozyme’s ENHANZE technology. This approval allows the medication to be used across the European Union and additional countries, offering quicker administration times for cancer treatments. On the financial front, analysts from TD Cowen have reiterated a Buy rating for Halozyme’s stock, suggesting that despite potential impacts from the Centers for Medicare & Medicaid Services, the shares remain undervalued. Similarly, H.C. Wainwright maintained a Buy rating, citing confidence in Halozyme following the European regulatory approval. Conversely, Morgan Stanley downgraded the stock to Equalweight, reducing the price target due to concerns over draft guidance that could impact industry incentives. JMP Securities, however, maintained a Market Outperform rating, emphasizing the clinical benefits of Halozyme’s ENHANZE technology despite the recent market volatility. These developments highlight both the challenges and opportunities facing Halozyme in the current regulatory and market landscape.

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