SAN DIEGO - Halozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced today that the U.S. Food and Drug Administration (FDA) has approved OCREVUS ZUNOVO™, a new formulation for the treatment of multiple sclerosis (MS) developed in collaboration with Roche. This approval introduces a subcutaneous (SC) injection option for patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), which can be administered twice a year.
OCREVUS ZUNOVO™ utilizes Halozyme's ENHANZE® drug delivery technology and is designed to be a more convenient alternative to the existing intravenous (IV) formulations. The FDA's decision is supported by findings from the Phase III OCARINA II trial, which demonstrated that the subcutaneous administration of OCREVUS maintains non-inferior levels of the drug in the blood compared to the IV formulation. The safety and efficacy profiles were found to be comparable between the two methods of administration.
The trial also reported that 97% of the participants experienced suppression of relapse activity and MRI lesions through 48 weeks, with over 92% of patients expressing satisfaction with the SC administration. The most common adverse events were injection reactions, which were generally mild or moderate and did not lead to discontinuation of treatment.
Halozyme's ENHANZE® technology is aimed at enhancing the delivery and dispersion of injected drugs, potentially reducing treatment burden for patients. The technology has been employed in multiple commercialized products and is licensed to several pharmaceutical and biotech companies.
The approval of OCREVUS ZUNOVO™ is expected to offer more flexibility in the treatment of MS, particularly benefiting centers without IV infrastructure or those facing IV constraints. This development may also provide patients with a more manageable treatment schedule and a reduced time spent receiving medication.
This news is based on a press release statement from Halozyme Therapeutics , Inc. and has not been independently verified. OCREVUS ZUNOVO™ is a trademark of Genentech, a member of the Roche Group.
In other recent news, Halozyme Therapeutics reported robust growth in the second quarter of 2024, with total revenue reaching $231 million, marking a significant step towards projected annual growth. The company's royalty revenue grew by 12% due to the success of key products like DARZALEX FASPRO and Phesgo, both utilizing Halozyme's ENHANZE technology. TD Cowen increased Halozyme's stock price target from $59.00 to $65.00, reiterating a Buy rating following the company's strong Q2 earnings. Concurrently, H.C. Wainwright maintained a Buy rating on Halozyme, highlighting the U.S. approval of Tecentriq Hybreza, a drug utilizing Halozyme's technology, and forecasting its peak sales to reach approximately $5.6 billion by 2032. These are among the recent developments contributing to Halozyme's positive financial trajectory. The company's CEO, Helen Torley, underscored the growth of key products and ongoing partnership pursuits across various therapeutic areas. Lastly, Halozyme's patent coverage for ENHANZE in Europe has been extended until March 2029, further protecting its key products in the market.
InvestingPro Insights
In light of the recent FDA approval of OCREVUS ZUNOVO™, Halozyme Therapeutics, Inc. (NASDAQ: HALO) is poised to potentially benefit from the expanded use of its ENHANZE® drug delivery technology. The market has responded positively to the company's advancements, as reflected in the recent performance metrics. With a market capitalization of $7.94 billion, Halozyme showcases a robust financial standing. An InvestingPro Tip highlights that the company has a perfect Piotroski Score of 9, indicating top-notch financial health. Moreover, Halozyme's management has been actively engaging in share buybacks, a sign of confidence in the company's future prospects.
InvestingPro Data reveals a Price/Earnings (P/E) ratio of 23.91, suggesting that the stock is trading at a price relatively proportional to its earnings. This is further supported by a low Price/Earnings to Growth (PEG) ratio of 0.44 in the last twelve months as of Q2 2024, indicating potential undervaluation based on near-term earnings growth expectations. Additionally, the company's stock has experienced a significant uptick, with a 6-month price total return of 46.41% and a year-to-date return of 63.8%, underscoring strong recent performance.
While analysts have revised their earnings downwards for the upcoming period, the company's solid fundamentals, as evidenced by a high return on assets of 17.85% and a gross profit margin of 70.93%, may cushion the impact of such revisions. It's important for investors to consider the full range of financial metrics and expert analyses available on InvestingPro, which offers an additional 10 InvestingPro Tips for a more comprehensive assessment of Halozyme's investment potential.
The prospects for Halozyme, including its strategic collaborations and technological advancements, coupled with its financial health, make it a noteworthy consideration for investors. As the company continues to navigate the pharmaceutical landscape with its latest FDA approval, keeping an eye on its financial metrics and market performance through platforms like InvestingPro could prove valuable.
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