DUBLIN, April 25, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+ ...

Core Insights - Jazz Pharmaceuticals is presenting significant clinical trial data at the ASCO Annual Meeting, highlighting the potential of Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for first-line maintenance therapy in extensive-stage small cell lung cancer (ES-SCLC) [1][2] - The company is also showcasing long-term outcomes for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal cancer, indicating its potential to change treatment paradigms [1][2] - Efficacy and safety data for dordaviprone (ONC201) in recurrent H3 K27M-mutant diffuse glioma patients are also being presented, addressing a significant unmet medical need [1][2] Group 1: Zepzelca® (lurbinectedin) - The Phase 3 IMforte trial data shows statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) for Zepzelca in combination with atezolizumab for ES-SCLC patients [2][4] - The FDA has received a supplemental New Drug Application based on this trial data, marking a milestone for Zepzelca's approval process [2][4] - An investor webcast is scheduled for June 10 to review Zepzelca data, featuring commentary from experts [3] Group 2: Ziihera® (zanidatamab-hrii) - Updated long-term outcomes and median overall survival findings from the Phase 2 trial of Ziihera in combination with chemotherapy for HER2-positive metastatic gastroesophageal adenocarcinoma will be presented [2][4] - Ziihera is positioned as a differentiated HER2-targeted therapy, with further Phase 3 findings expected later this year [2][4] Group 3: Dordaviprone (ONC201) - New efficacy and safety findings for dordaviprone in adult and pediatric patients with recurrent H3 K27M-mutant diffuse glioma are being highlighted [2][4] - The drug addresses a significant unmet need, as there are currently no FDA-approved therapies for this patient population [2][4] Group 4: Company Overview - Jazz Pharmaceuticals is committed to advancing targeted treatment options that address pressing patient needs, with a focus on oncology and neuroscience [55] - The company has a diverse portfolio of marketed medicines and is dedicated to developing potentially life-changing therapies for serious diseases [55]

Group 1 - Jazz Pharmaceuticals plc will report its 2025 first quarter financial results on May 6, 2025, after the U.S. financial markets close [1] - A live audio webcast will be hosted by company management at 4:30 p.m. ET / 9:30 p.m. IST to discuss the financial results and provide a business update [1] - Interested parties can access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website [2] Group 2 - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases with limited therapeutic options [4] - The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders, epilepsy, and a growing portfolio of cancer treatments [4] - Jazz Pharmaceuticals is headquartered in Dublin, Ireland, with research and development laboratories and manufacturing facilities in multiple countries [4]

Core Insights - Jazz Pharmaceuticals has successfully acquired Chimerix, Inc. for approximately $935 million in cash, enhancing its oncology pipeline and commitment to addressing rare diseases with significant unmet needs [1][2][3] Acquisition Details - The acquisition was completed through a tender offer for Chimerix's outstanding shares at $8.55 per share, which expired on April 17, 2025 [3] - Following the acquisition, Chimerix became a wholly owned subsidiary of Jazz Pharmaceuticals [3] Product Development - The acquisition includes dordaviprone, a novel first-in-class small molecule treatment for H3 K27M-mutant diffuse glioma, which is currently under Priority Review by the FDA with a PDUFA action date set for August 18, 2025 [2][4] - If approved, dordaviprone may be the first FDA-approved therapy for this specific type of glioma and could offer a promising near-term commercial opportunity [2][4] Clinical Trials - Dordaviprone is being evaluated in the ongoing Phase 3 ACTION trial for newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially expanding its use into first-line settings [2][4] Company Overview - Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases, with a diverse portfolio that includes therapies for sleep disorders, epilepsy, and cancer treatments [5]

Core Viewpoint - Jazz Pharmaceuticals and Harmony Biosciences are significant players in the neuroscience sector, particularly in sleep disorders, with Jazz having a more diversified portfolio and stronger financial performance compared to Harmony [1][2][22]. Group 1: Company Overview - Jazz Pharmaceuticals markets several neuroscience drugs, including the oral sleep disorder drug Xywav and the CBD drug Epidiolex, while Harmony Biosciences has one marketed drug, Wakix, for narcolepsy [1][10]. - Jazz derives over two-thirds of its total revenues from its neuroscience franchise, while Harmony generates all its revenue from Wakix sales [3][11]. Group 2: Financial Performance - Jazz's total revenues for 2024 rose 6% year over year to $4.1 billion, with $2.9 billion from neuroscience and $1.1 billion from oncology drugs [9]. - Harmony's 2024 sales increased 23% year over year to $715 million, with expectations for 2025 sales between $820 million and $860 million, indicating an 18% year-over-year growth [11]. Group 3: Product Pipeline and Development - Jazz's Xywav sales rose 16% year over year to $1.5 billion in 2024, and Epidiolex sales increased 15% year over year to $972 million [4][5]. - Harmony is developing next-generation formulations of Wakix and has acquired Zynerba Pharmaceuticals to explore the cannabis space [12][13]. Group 4: Market Position and Valuation - Jazz has a diversified product lineup, including five oncology drugs, which accounted for 29% of its 2024 product revenues [6]. - Harmony's shares trade at a higher price/earnings (P/E) ratio of 8.63 compared to Jazz's 5.07, indicating that Harmony is more expensive [19]. Group 5: Investment Outlook - Jazz is viewed as a better investment option due to its diversified portfolio, rising EPS estimates, and robust cash reserves, while Harmony's reliance on a single product presents a concentration risk [22][23]. - Jazz holds a Zacks Rank 2 (Buy), while Harmony has a Zacks Rank 3 (Hold), reinforcing Jazz's favorable investment standing [24].

Core Viewpoint - Investors are evaluating the value opportunities presented by Jazz Pharmaceuticals (JAZZ) and argenex SE (ARGX), with JAZZ currently appearing to offer superior value based on various valuation metrics [1][7]. Valuation Metrics - JAZZ has a forward P/E ratio of 4.35, significantly lower than ARGX's forward P/E of 46.77, indicating that JAZZ may be undervalued [5]. - The PEG ratio for JAZZ is 0.60, while ARGX has a PEG ratio of 1.44, suggesting that JAZZ has a more favorable growth outlook relative to its valuation [5]. - JAZZ's P/B ratio stands at 1.50, compared to ARGX's P/B of 6.49, further supporting the notion that JAZZ is undervalued relative to its book value [6]. Earnings Outlook - Both JAZZ and ARGX hold a Zacks Rank of 2 (Buy), indicating positive earnings estimate revisions for both companies, which reflects an improving earnings outlook [3].

Company Overview - Jazz Pharmaceuticals (JAZZ) shares increased by 7.1% to close at $110.12, following a significant volume of trading, contrasting with a 24.9% loss over the past four weeks [1] - The rise in share price was influenced by President Trump's announcement of a 90-day pause on tariffs against non-retaliating countries [1] Earnings Expectations - Jazz is projected to report quarterly earnings of $4.65 per share, reflecting a year-over-year increase of 73.5% [2] - Expected revenues for the upcoming quarter are $978.58 million, which is an 8.5% increase compared to the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for Jazz has been revised 3.2% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [3] - The stock currently holds a Zacks Rank of 2 (Buy), suggesting favorable market sentiment [3] Industry Context - Jazz operates within the Zacks Medical - Biomedical and Genetics industry, where Novavax (NVAX) also competes [3] - Novavax's consensus EPS estimate has increased by 7.6% over the past month to -$0.43, representing a 59.1% change from the previous year [4] - Novavax currently holds a Zacks Rank of 3 (Hold), indicating a more cautious outlook compared to Jazz [4]

Core Insights - Investors are evaluating Jazz Pharmaceuticals (JAZZ) and argenex SE (ARGX) for potential undervalued stock opportunities in the Medical - Biomedical and Genetics sector [1] Valuation Metrics - JAZZ has a Zacks Rank of 2 (Buy), indicating a stronger earnings outlook compared to ARGX, which has a Zacks Rank of 3 (Hold) [3] - JAZZ's forward P/E ratio is significantly lower at 5.27, while ARGX's forward P/E ratio stands at 47.10 [5] - The PEG ratio for JAZZ is 0.72, suggesting better value relative to its expected earnings growth, compared to ARGX's PEG ratio of 1.45 [5] - JAZZ's P/B ratio is 1.82, indicating a more favorable market value to book value comparison than ARGX's P/B ratio of 6.51 [6] - These metrics contribute to JAZZ receiving a Value grade of A, while ARGX has a Value grade of D [6] Earnings Outlook - JAZZ is noted for its improving earnings outlook, which enhances its attractiveness in the Zacks Rank model [7]

DUBLIN, March 26, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company will participate in the 24th Annual Needham Healthcare Conference. Company management will participate in a fireside chat on Wednesday, April 9, 2025, at 9:45 a.m. PT / 12:45 p.m. ET / 5:45 p.m. IST.An audio webcast of the fireside chat will be available via the Investors section of the Jazz Pharmaceuticals website at https://investor.jazzpharma.com/investors/events-presentations. A replay of the ...

Taking full advantage of the stock market and investing with confidence are common goals for new and old investors, and Zacks Premium offers many different ways to do both.The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.Zacks Premium includes access to the Zacks Style Scores as well. What are the Zacks Style Sco ...