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Jazz Pharmaceuticals (JAZZ) Gets Price Target Boost Following Positive Xywav Phase 4 Data
Yahoo Finance· 2025-10-02 05:53
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ranks among the stocks with low beta that can beat market volatility. On September 23, Morgan Stanley reaffirmed its Overweight rating on Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and raised its price target from $163 to $167. The adjustment came after Jazz Pharmaceuticals plc (NASDAQ:JAZZ) revealed findings from the Xywav Phase 4 DUET open-label research at World Sleep Singapore through many poster presentations. The study’s findings indicate that oxybates, the family ...
Piper Sandler Reaffirms Jazz Pharmaceuticals (JAZZ) Price Target Ahead of Trial Data
Yahoo Finance· 2025-09-27 04:59
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ranks among the most undervalued NASDAQ stocks to buy now. Piper Sandler reaffirmed its Overweight rating and $147 price target for Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on September 15 in expectation of data from the upcoming clinical trial. Jazz is gearing up to report progression-free survival data from its HERIZON-GEA-01 study in the fourth quarter of 2025. The trial assesses zanidatamab as the first-line therapy for advanced/metastatic gastroesophageal adenocarc ...
Jazz Pharmaceuticals plc (JAZZ) Advances Rare Cancer Portfolio with First CNS Glioma Therapy Approval
Yahoo Finance· 2025-09-23 23:11
Core Insights - Jazz Pharmaceuticals plc is recognized as one of the top pharmaceutical stocks to buy, focusing on innovative therapies for conditions with limited treatment options [2] - The company has received FDA accelerated approval for Modeyso, the first therapy for a rare CNS cancer, with a 22% overall response rate in clinical trials [3] - Jazz is expanding its portfolio in rare oncology, with ongoing developments for Zepzelca and zanidatamab, indicating a strong pipeline for future growth [4][5] Company Overview - Jazz Pharmaceuticals specializes in sleep medicine, epilepsy, and oncology, with key products including Xywav, Xyrem, Epidiolex, and Zepzelca [2] - Strategic acquisitions, such as GW Pharmaceuticals and Chimerix, have enhanced its drug pipeline with promising investigational therapies [2] Recent Developments - The FDA approval of Modeyso marks a significant milestone for Jazz, as it addresses an ultra-rare cancer with no prior treatment options [3] - The company is planning a supplemental New Drug Application for Zepzelca based on positive Phase III results, further solidifying its position in the oncology market [4] Future Outlook - Jazz Pharmaceuticals is expected to experience near-term growth driven by the commercial launch of Modeyso and ongoing pivotal trial results [5]
10 Best Pharma Stocks to Buy According to Billionaires
Insider Monkey· 2025-09-21 13:29
Core Insights - President Trump has demanded major pharmaceutical companies to lower drug prices to "most favored nation" levels by September 29, prompting a response from the industry [1][2] - The administration has not specified the actions it may take if companies do not comply, but has indicated a willingness to use all available measures to protect American families from high drug prices [2] - A total of 17 large pharmaceutical companies received letters from the government, instructing them to sell drugs directly to consumers, bypassing pharmacy benefit managers [3] Company Highlights - **Jazz Pharmaceuticals plc (NASDAQ:JAZZ)**: - Ranked 10th among the best pharmaceutical stocks, with 10 billionaire holdings [8] - Recently received FDA accelerated approval for Modeyso, the first therapy for a rare CNS cancer, showing a 22% overall response rate in trials [9] - Focused on rare oncology indications and has ongoing trials for other promising drugs [10][11] - **Elanco Animal Health Incorporated (NYSE:ELAN)**: - Also ranked 9th with 10 billionaire holdings, recognized for its leadership in veterinary pharmaceuticals [12] - Joined the S&P MidCap 400 Index in September 2025, reflecting increased investor confidence [13] - Reported double-digit organic growth in Q2 2025 and has a strong innovation pipeline with six potential blockbuster products expected by year-end [14][15]
Amneal's generic targeting Jazz Pharma’s Xyrem cleared (AMRX)
Seeking Alpha· 2025-09-11 15:56
Core Viewpoint - Amneal Pharmaceuticals received FDA approval for its generic version of Jazz Pharmaceuticals' sleep disorder therapy Xyrem, allowing market entry for the product [2] Company Summary - Amneal Pharmaceuticals' Abbreviated New Drug Application (ANDA) has been approved by the FDA, enabling the launch of its generic product [2]
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
Globenewswire· 2025-09-11 12:00
Core Insights - Amneal Pharmaceuticals has received FDA approval for its sodium oxybate oral solution 500 mg/mL, expanding its Affordable Medicines portfolio and providing a more affordable alternative for narcolepsy treatment [1][3]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. [4]. - The company operates in various segments, including Affordable Medicines, Specialty, and AvKARE, focusing on complex product categories and therapeutic areas [4]. Product Details - Sodium oxybate is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy [2]. - The approval of sodium oxybate oral solution addresses a critical therapy area for approximately 150,000 individuals in the U.S. living with narcolepsy [3]. Market Impact - The introduction of sodium oxybate by Amneal is significant as it provides patients, providers, and payers with a more affordable option in a market historically dominated by a single manufacturer [3].
JAZZ Stock Down on Wider-Than-Expected Q2 Loss, '25 Sales View Cut
ZACKS· 2025-08-06 14:26
Core Insights - Jazz Pharmaceuticals reported a second-quarter 2025 adjusted loss of $8.25 per share, which was wider than the Zacks Consensus Estimate of a loss of $6.12, primarily due to a one-time charge from the acquisition of Chimerix that impacted earnings by $14.75 per share [1][10] Financial Performance - Total revenues increased by 2% year over year to $1.05 billion, aligning with the Zacks Consensus Estimate [2] - Net product sales rose 2% year over year to $986 million, missing the Zacks Consensus Estimate of $999 million and the model estimate of $1 billion [3] - Royalty revenues from high-sodium oxybate authorized generic remained flat year over year at $54 million, exceeding the Zacks Consensus Estimate of $49 million and the model estimate of $43 million [3] - Other royalties and contract revenues increased by 9% year over year to $6 million [4] Neuroscience Segment - Sales of neuroscience products grew by 3% year over year to $707 million [5] - Combined net product sales for the oxybate business (Xyrem + Xywav) rose about 5% to $451 million, surpassing the Zacks Consensus Estimate of $440 million [5] - Xywav sales reached $415 million, up 13%, attributed to strong uptake in narcolepsy and idiopathic hypersomnia indications [6] - Sales of the epilepsy drug Epidiolex/Epidyolex increased by 2% to nearly $252 million, but fell short of the Zacks Consensus Estimate of $271 million [7] Oncology Segment - Oncology product sales decreased by 1% to $274 million [8] - Rylaze/Enrylaze sales were $101 million, down 7% year over year, missing both the Zacks Consensus Estimate and model estimates [9] - Zepzelca sales were $75 million, down 8% year over year, due to increased competition and treatment protocol updates [11] Operating Costs - Adjusted selling, general and administrative expenses rose by 2% year over year to $310 million [13] - Adjusted research and development expenses decreased by 18% to $167 million [13] Guidance and Market Reaction - The company lowered its 2025 revenue guidance to $4.15-$4.30 billion, reflecting a $100 million cut at the upper end [10][14] - Adjusted earnings per share outlook was raised to $4.80-$5.60, up from the previous range of $4.00-$5.60 [10][18] - Shares of Jazz fell more than 7% in after-market trading following the earnings guidance and wider-than-expected loss [15]
ALKS Down Despite Positive Top-Line Data From Narcolepsy Study
ZACKS· 2025-07-22 14:41
Core Insights - Alkermes (ALKS) announced positive top-line data from the phase II Vibrance-1 study for its oral orexin 2 receptor agonist, alixorexton, aimed at treating narcolepsy type 1 (NT1) [1][8] - The study demonstrated statistically significant improvements in wakefulness and excessive daytime sleepiness compared to placebo [2][3] - The 6 mg dose of alixorexton was the only one to achieve statistical significance in reducing weekly cataplexy rates, which may have negatively impacted investor sentiment [4] Study Results - Alixorexton treatment across all doses showed a dose-dependent improvement in wakefulness on the Maintenance of Wakefulness Test (MWT), the primary endpoint of the study [2] - Statistically significant improvements in excessive daytime sleepiness were observed at week six on the Epworth Sleepiness Scale, a key secondary endpoint [3] - The 6 mg dose was the only one to achieve statistical significance in improving weekly cataplexy rates, another key secondary endpoint [4] Safety and Tolerability - Treatment with alixorexton was generally safe and well-tolerated across all doses [5] Future Development Plans - Alkermes plans to initiate a global phase III trial for alixorexton in patients with NT1, building on the success of the Vibrance-1 study [9][10] - Alixorexton is also being studied for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with ongoing phase II studies [11][12] Competitive Landscape - Upon potential approval, alixorexton may face competition from Axsome's Sunosi (solriamfetol), which is already marketed for narcolepsy treatment [13] - Other drugs from Jazz Pharmaceuticals, such as Xyrem and Xywav, also hold significant market share in the sleep disorder segment [14]
Jazz Pharmaceuticals (JAZZ) 2025 Conference Transcript
2025-05-14 18:00
Summary of Jazz Pharmaceuticals (JAZZ) 2025 Conference Call Company Overview - **Company**: Jazz Pharmaceuticals (JAZZ) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Points Financial Performance - **1Q Revenue**: Approximately $898 million, consistent with 1Q 2024 [3] - **Growth Drivers**: Strong performance in neuroscience products, particularly XiWave and Epidiolex [4] - **Oncology Performance**: Oncology revenue declined by 11% year-on-year, attributed to a calendar anomaly with only 12 shipping weeks in the quarter [5][6] Product Performance - **XiWave**: Experienced seasonality affecting patient insurance reauthorization, resulting in a net addition of 450 patients, with 325 in idiopathic hypersomnia and 125 in narcolepsy [4] - **Epidiolex**: Achieved double-digit growth, impacted by higher-than-usual inventory drawdown in 1Q [5] - **Oncology Products**: - Rylase faced competitive dynamics affecting sales [7] - Zepzelca's performance was impacted by competition and longer patient progression times due to new data from Imfinzi [7] - Upcoming ASCO presentation for Phase III IMFORT trial data for Zepzelca [7][8] Acquisitions and Pipeline - **Chimerix Acquisition**: Completed in April, bringing dordavaprone for H3K27M mutant diffuse glioma, a severe brain cancer with poor prognosis [11][12] - **Zanidatumab**: Positive CHMP recommendation for approval in Europe for second-line BTC, with data to be presented at ASCO [12][13] - **Phase II GEA Study**: Updated data to be presented at ASCO, with confidence in upcoming Phase III study results [13][14] Regulatory and Market Dynamics - **Tariffs**: Company positioned to mitigate potential impacts from tariffs on imported pharmaceuticals, with no expected impact on 2025 financials [14][15] - **FDA Interactions**: No disruptions noted in FDA review processes for upcoming PDUFA dates for Subselka and dordavaprone [21] Competitive Landscape - **Generics Impact**: Anticipation of true generics for Xyrem starting in 2026, with potential revenue impacts for Jazz [22][24] - **Xywav Positioning**: Positioned as the only low sodium oxybate, with expectations of maintaining market share despite generics [26][27] Future Outlook - **Revenue Guidance**: Confirmed top-line revenue guidance with modest adjustments, expecting mid-single-digit growth for the full year [17][18] - **Pipeline Investments**: Strong financial position allows for continued investment in marketed products and pipeline development [16] Additional Insights - **Orexin Therapies**: Seen as complementary to oxybate therapy rather than competitive, with current data not supporting claims of improved nighttime sleep quality [59][60] - **Chimerix Trial Adjustments**: Ongoing evaluation of the ACTION trial protocol to enhance chances of success [62][63] Conclusion - Jazz Pharmaceuticals is navigating a complex landscape with strong performance in neuroscience, challenges in oncology, and strategic acquisitions. The company is well-positioned to manage upcoming competitive pressures and regulatory challenges while maintaining a focus on growth and innovation in its product pipeline.
JAZZ Misses Q1 Earnings & Sales Estimates, Cuts '25 EPS Outlook
ZACKS· 2025-05-07 16:55
Core Viewpoint - Jazz Pharmaceuticals reported disappointing first-quarter 2025 earnings, significantly missing consensus estimates due to increased operating expenses and a decline in revenues, leading to a drop in share price [1][2][4]. Financial Performance - Adjusted earnings for Q1 2025 were $1.68 per share, missing the Zacks Consensus Estimate of $4.51, representing a 36% year-over-year decline [1]. - Total revenues decreased by 0.5% year over year to $897.8 million, also falling short of the Zacks Consensus Estimate of $981 million [2]. - Net product sales remained flat at $839.4 million, missing both the Zacks Consensus Estimate and internal estimates [4]. Segment Performance - Neuroscience segment sales increased by 4% to $605.2 million, with combined oxybate sales (Xyrem + Xywav) rising about 1% to $382 million, but still missing estimates [6][7]. - Sales of Xyrem plummeted 42% year over year to $37.2 million due to patient transitions to Xywav and the introduction of authorized generics [6]. - Xywav sales reached $344.8 million, up 9% year over year, driven by strong uptake in narcolepsy and idiopathic hypersomnia indications [7]. - Oncology segment sales fell by 11% to $229.4 million, with specific drugs like Rylaze and Zepzelca experiencing significant declines due to competitive pressures and protocol updates [9][10][11]. Operating Costs - Adjusted selling, general and administrative expenses surged by 52% year over year to $472.3 million, primarily due to antitrust litigation settlements [13]. - Adjusted research and development expenses decreased by 22% to $220.9 million, attributed to lower clinical program costs [13]. Guidance and Outlook - Jazz Pharmaceuticals maintained its total sales guidance for 2025, projecting revenues between $4.15 billion and $4.40 billion, indicating a 5% year-over-year growth at the midpoint [15]. - Adjusted SG&A expenses are now expected to be between $1.47 billion and $1.53 billion, while adjusted R&D expenses are forecasted to be between $760 million and $810 million [16]. - The company revised its adjusted earnings guidance down to a range of $4.00 to $5.60 per share, significantly lower than previous estimates [16].