Latest news with #DarzalexFaspro
Yahoo
5 days ago
- Business
- Yahoo
Janssen's Darzalex new indication gains EC approval for SMM
The European Commission (EC) has approved the Johnson & Johnson company Janssen-Cilag International's new indication for Darzalex Faspro (daratumumab) subcutaneous (SC) formulation to treat adults with smouldering multiple myeloma (SMM) at high-risk of developing MM. Daratumumab is co-formulated with Halozyme's drug delivery technology, Enhanze. The EC approval is based on outcomes from the Phase III AQUILA study, which assessed the safety and efficacy of fixed-duration daratumumab SC administration against active monitoring in patients with high-risk SMM. The primary endpoint of the study is progression-free survival, while secondary endpoints encompass overall response rate, time to progression and overall survival. Patients included in the study had been diagnosed with SMM within the previous five years. Those with prior exposure to either approved or investigational treatments for SMM or multiple myeloma were excluded from participation. Halozyme president and CEO Dr Helen Torley stated: "This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease." Halozyme's Enhanze drug delivery technology, featuring the enzyme rHuPH20, enables rapid SC delivery of drugs and fluids, enhancing patient experience and reducing treatment burden. It has been licensed to companies including Takeda, Roche, Pfizer, AbbVie and Acumen Pharmaceuticals. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter stated: 'Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma. 'We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival.' "Janssen's Darzalex new indication gains EC approval for SMM" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
21-05-2025
- Business
- Business Insider
Johnson & Johnson: FDA panel votes 6-2 in favor of Darzalex Faspro
Johnson & Johnson the U.S. FDA Oncologic Drugs Advisory Committee voted (6-2) in favor of the benefit-risk profile of single-agent Darzalex Faspro for the treatment of adult patients with high-risk smoldering multiple myeloma. An application for the approval of Darzalex Faspro for adult patients with HR-SMM was submitted to the FDA in November 2024. Confident Investing Starts Here:
Yahoo
14-05-2025
- Business
- Yahoo
Halozyme, J&J slide as analyst cuts rating on CMS draft guidance
Shares of Halozyme Therapeutics (HALO) and Jonhson & Johnson (JNJ) are under pressure on Tuesday after Leerink downgraded the stocks to Underperform and Market Perform, respectively. This comes after the Centers for Medicare and Medicaid Services issued draft guidance for 2028 Inflation Reduction Act drug price controls, which the firm says creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter DOWNGRADES ON CMS ACTION: On Tuesday, Leerink analyst David Risinger downgraded Halozyme to Underperform from Market Perform with a price target of $47, down from $63, and Leerink downgraded Johnson & Johnson to Market Perform from Outperform with a price target of $153, down from $169. The firm, however, is not making any changes to its revenue projections this time as it awaits final guidance from CMS in the second half of 2025. Leerink explains that the catalyst for its downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. The 'surprise' is CMS draft guidance language suggests that combination products, which do not enhance efficacy, may be negotiated 13 years after the original active ingredient was approved, rather than 13 years after combination approval. The firm notes that Halozyme could face U.S. revenue pressure from Opdivo SC in 2028, Darzalex Faspro in 2029 and Ocrevus SC in 2031. In addition, CMS action may reduce new business opportunities to license ENHANZE. A caveat is that the Street already anticipates the company's Faspro royalty to decline from 5% to 2.5% in 2029 and go to zero in 2032. Its new investment thesis on Halozyme is that Leerink expects shares to underperform because it will be difficult for investors to assign value to the company's major growth drivers since they could start to roll over in 3-5 years. Regarding Johnson & Johnson, the firm notes Darzalex Faspro may be price controlled in 2029 rather than 2034 as it had been assuming. In the case of Darzalex, it was approved in November 2015, and Darzalex Faspro was approved in 2020. Leerink has been modeling that Darzalex Faspro will generate $10.7B in U.S. sales in 2028, or 16% of J&J Worldwide Pharma sales of $66.4B and 10% of total company sales of $96.8B. The firm believes that U.S. Darzalex's profit contribution could be approximately $8.6B in 2028, or 22% of its total company operating profit estimate of $39.1B. If it is price controlled in 2029, the drug's U.S. profit contribution could take a meaningful hit, it points out. Leerink's new investment thesis is that J&J's 5-year growth prospects are at risk of downward revisions if Darzalex Faspro is price controlled in 2029, and we are not anticipating an upward re-rating of the stock in the near-medium term. The firm also highlights that in its 2028 draft guidance, CMS included a new paragraph suggesting a possible reconsideration of its approach to fixedcombination drug negotiations. It believes this development raises concerns for multiple Halozyme's products and J&J's Darzalex Faspro. PRICE ACTION: In Tuesday morning trading, shares of Johnson & Johnson dropped almost 3% to $149.87, while Halozyme's stock has plunged about 27% and is now trading at $49.02. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on HALO: Disclaimer & DisclosureReport an Issue Coinbase, Caterpillar upgraded: Wall Street's top analyst calls Halozyme downgraded to Underperform from Market Perform at Leerink Cautious Optimism for Halozyme Amid Uncertainties: Hold Rating Maintained Halozyme Therapeutics Reports Strong Earnings and Growth Halozyme's Strong Financial Performance and Strategic Developments Justify Buy Rating with $75 Price Target Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
