Fed Governor Adriana Kugler to resign
SAN DIEGO - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company valued at $7.86 billion with an impressive 76.51% gross profit margin, announced today that Bristol Myers Squibb has received a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the subcutaneous formulation of its cancer drug Opdivo, developed with Halozyme’s ENHANZE technology. According to InvestingPro data, the company maintains a perfect Piotroski Score of 9, indicating exceptional financial strength.
The CHMP’s recommendation to approve the new Opdivo formulation pertains to its use in adult solid tumors, either as a standalone treatment, in maintenance therapy following nivolumab plus Yervoy combination therapy, or when used with chemotherapy or cabozantinib. The European Commission, which holds the authority to approve medications within the EU, is expected to make a decision on extending the marketing authorization for this formulation by June 2, 2025. This development comes as Halozyme demonstrates strong market performance, with a 56.93% return over the past year and trading near its 52-week high of $66.
Dr. Helen Torley, president and CEO of Halozyme, expressed satisfaction with the CHMP’s recommendation, highlighting the potential benefits for cancer patients, including faster and more flexible treatment options, which may also help reduce the strain on healthcare resources.
The positive opinion from CHMP is backed by encouraging results from the Phase 3 CheckMate -67T trial. Further details on the study and its outcomes can be found in a press release issued by Bristol Myers Squibb on March 28, 2025.
Previously, on December 27, 2024, the U.S. Food and Drug Administration approved the nivolumab and hyaluronidase-nvhy combination, marketed as Opdivo Qvantig.
Halozyme specializes in developing solutions to enhance patient experiences and outcomes for both new and existing therapies. Their ENHANZE drug delivery technology is designed to improve the administration of injected drugs, aiming to provide rapid subcutaneous delivery and reduce treatment burdens.
This news is based on a press release statement. The final decision by the European Commission will determine the availability of this new cancer treatment option in the EU. InvestingPro analysis suggests Halozyme is currently undervalued, with additional metrics and insights available in the comprehensive Pro Research Report, one of 1,400+ detailed company analyses available to subscribers.
In other recent news, Halozyme Therapeutics reported its fiscal year 2024 financial results, with total revenues reaching $1,015 million, slightly surpassing consensus estimates. The company’s royalty revenues were a significant contributor, amounting to $571.0 million, which aligns with predictions from H.C. Wainwright. Halozyme’s net earnings for the year were $444 million, translating to $3.43 per diluted share. Analysts at H.C. Wainwright have updated their full-year 2025 earnings per share estimate to $4.63 and raised their price target for Halozyme to $72, maintaining a Buy rating. JMP Securities also increased their price target to $78, reaffirming a Market Outperform rating, following Halozyme’s robust fourth-quarter results. The ongoing patent dispute with Merck over Halozyme’s hyaluronidase enzyme platform remains a significant development. Merck has challenged several of Halozyme’s patents as it aims to introduce a subcutaneous version of its cancer drug KEYTRUDA. Meanwhile, the retirement of Halozyme’s Chief Technical Officer, Michael J. LaBarre, marks a notable leadership transition for the company.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.