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On Thursday, H.C. Wainwright maintained a Buy rating and a $72.00 price target on Halozyme Therapeutics (NASDAQ:HALO) shares, which currently trade at $54.43. According to InvestingPro analysis, the company appears undervalued, with a "GREAT" financial health rating and perfect Piotroski Score of 9. The firm’s analyst, Mitchell Kapoor, expressed continued confidence in the company following a significant regulatory approval in Europe. The European Commission (EC) has granted approval for the subcutaneous (SC) version of Bristol-Myers Squibb (NYSE:BMY)’s PD-1 inhibitor, Opdivo, which utilizes Halozyme’s ENHANZE technology.
The EC’s approval covers multiple adult solid tumors for the following uses: as monotherapy, as monotherapy maintenance after completing intravenous nivolumab in combination with Yervoy, or in combination with chemotherapy or Exelixis (NASDAQ:EXEL)’s Cabometyx. This authorization is effective across all 27 member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. This decision comes on the heels of the U.S. approval for Opdivo Qvantig in December.
The SC formulation of Opdivo, known as Opdivo SC, offers a significant reduction in administration time, taking approximately three to five minutes compared to 30 minutes for the intravenous version. This development is not only a convenience but also a time-saving advancement for both patients and healthcare providers.
Kapoor noted that the introduction of SC Opdivo is a critical development for Bristol-Myers Squibb in its competition with Merck (NSE:PROR) & Co.’s Keytruda. According to Kapoor, Merck is now slightly trailing in the race to develop a subcutaneous PD-1 inhibitor. The analyst’s reiteration of the Buy rating and the 12-month price target reflects a positive outlook on Halozyme’s prospects following this approval.
In other recent news, Halozyme Therapeutics has been at the center of several developments impacting its business outlook. The European Commission has granted approval for a new subcutaneous formulation of Opdivo, developed in collaboration with Halozyme’s ENHANZE technology, allowing its use for various adult solid tumors across the EU and additional regions. Meanwhile, JMP Securities has maintained a positive outlook on Halozyme, keeping a Market Outperform rating and a $78.00 price target, despite concerns over new Medicare draft guidance that could affect drug pricing. Conversely, Morgan Stanley (NYSE:MS) has downgraded Halozyme from Overweight to Equalweight, lowering the price target to $62.00, citing potential challenges from the same Medicare draft guidance. Evercore ISI has reiterated its Outperform rating on Halozyme, emphasizing the clinical benefits of its ENHANZE technology, even as CMS draft guidance introduces new criteria for combination products. Leerink Partners has downgraded Halozyme to Underperform, reducing its price target to $47.00, due to revised financial models and concerns about future pricing negotiations under the 2028 Inflation Reduction Act. These recent developments highlight the dynamic regulatory and market environment facing Halozyme Therapeutics.
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