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Kyowa Kirin 将重新掌控罗卡替尼单抗的研发及商业化项目,展现其致力于满足特应性皮炎医疗需求巨大缺口的坚定决心
Globenewswire· 2026-01-31 15:28
Kyowa Kirin 坚定致力于将罗卡替尼单抗开发为具有显著市场潜力、能够改变患者生活的差异化创新药物。罗卡替尼单抗作为一种试验性 T 细胞再平衡疗法,其创新之处在于直接作用于致病性 T 细胞上表达的 OX40 受体,有望为中重度特应性皮炎 (msAD) 患者提供长期疾病控制。公司计划于 2026 年上半年递交监管申请。 东京、新泽西普林斯顿, Jan. 31, 2026 (GLOBE NEWSWIRE) -- 总部位于日本的全球专业制药公司 Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) 今日宣布终止与 Amgen 公司目前有关罗卡替尼单抗的研发及商业化合作。 Kyowa Kirin 将重新掌控全球罗卡替尼单抗项目,包括监管申报及未来商业化进程。 此项商业决策源于 Amgen 对其战略投资组合进行优先排序和优化的考量。 双方正推动该项目的平稳有序交接,重点确保当前临床试验受试者的连续性和权益不受影响。 与 Kyowa Kirin 合作开发多款试验性疗法已超过 41 年的 Amgen,将继续负责罗卡替尼单抗的生产。 Kyowa Kirin 总裁兼首席运营官 Abd ...
Kyowa Kirin Regains Global Rights To Atopic Dermatitis Drug After Amgen Collaboration Ends
Benzinga· 2026-01-30 18:09
Core Insights - Kyowa Kirin Co., Ltd. and Amgen Inc. have terminated their collaboration on the development and commercialization of rocatinlimab, with Kyowa Kirin regaining control over the global program [1][2] Group 1: Collaboration Details - The collaboration was initiated in June 2021, focusing on KHK4083, a Phase 3-ready anti-OX40 monoclonal antibody for atopic dermatitis and other autoimmune diseases [2] - Amgen made an upfront payment of $400 million and Kyowa Kirin was eligible for milestone payments up to $850 million [3] Group 2: Clinical Trial Insights - Preliminary topline results from the ASCEND study, evaluating rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis, were released in September 2025 [3] - The incidence of gastrointestinal ulceration events with rocatinlimab is reported to be less than 1 per 100 patient-years across the Phase 3 ROCKET program [4] Group 3: Analyst Commentary - The decision to terminate the agreement was unexpected, occurring after a broad Phase 3 program and just before a planned regulatory submission [5] - Recent updates in the OX40 development landscape have diminished enthusiasm for the target, with Phase 3 efficacy falling short of Phase II benchmarks [5] - Concerns regarding rocatinlimab's toxicity profile, including high rates of pyrexia and chills, may pose commercial challenges [6] Group 4: Investor Sentiment - The discontinuation of rocatinlimab is not expected to impact the investment thesis for Amgen, given low investor expectations for therapies targeting the OX40 pathway [7] - Amgen's CEO shared findings from part 2 of the Phase 2 study of MariTide, an investigational obesity treatment, at a J.P. Morgan Healthcare Conference [7] - Amgen acquired Dark Blue Therapeutics for up to $840 million, focusing on precision oncology medicines [7] Group 5: Stock Performance - As of the publication date, Amgen's stock was down 0.81% at $340.17 [8]
Regeneron Falls, But Hints That It Could Be Ready To Flex Its Dealmaking Muscles
Investors· 2026-01-30 21:06
Core Viewpoint - Regeneron Pharmaceuticals is showing potential for business development deals following a strong fourth-quarter report, as indicated by RBC Capital Markets analyst Brian Abrahams [1] Group 1: Financial Performance - Regeneron stock experienced volatility after the market opened, reflecting investor reactions to its fourth-quarter performance [1] - The company's press release was noted to be "more direct" regarding business development opportunities compared to previous communications [1] Group 2: Market Position and Analyst Insights - Analyst Brian Abrahams suggested that Regeneron could actively seek deals in the upcoming year, indicating a strategic shift in its approach to business development [1] - The stock's relative strength rating has risen to 82, showcasing improved market performance [1]
Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis
Globenewswire· 2026-01-30 13:00
Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential.Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD).Regulatory submission is planned in the first half of 2026. TOKYO and PRINCETON, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) ...
Sanofi Edges Higher As Immunology Powerhouse, Dupixent, Wallops Forecasts
Investors· 2026-01-29 17:08
Group 1 - Sanofi reported adjusted earnings of 91 cents per share on $13.5 billion in fourth-quarter sales, exceeding analysts' expectations of 84 cents per share and $13.57 billion in sales [1][1][1] - The company's earnings per share increased from 68 cents in the same period last year, while sales rose from $11.89 billion [1][1][1] Group 2 - Sanofi's stock experienced a slight increase following the earnings report, indicating a positive market reaction to the results [1][1][1]
Amgen (AMGN) is a Top-Ranked Value Stock: Should You Buy?
ZACKS· 2026-01-29 15:41
Company Overview - Amgen is one of the largest biotech companies globally, focusing on oncology/hematology, cardiovascular disease, inflammation, bone health, and rare diseases markets [11] - The company has developed significant drugs such as Epogen and Neupogen, and launched next-generation products like Aranesp and Neulasta [11] - Amgen's acquisition of Immunex Corporation provided access to the blockbuster drug Enbrel, although older drugs are facing declining sales due to competition [11] Financial Performance - Amgen has a Zacks Rank of 3 (Hold) and a VGM Score of B, indicating a solid position in the market [12] - The company has a Value Style Score of B, supported by a forward P/E ratio of 15.68, which is attractive for value investors [12] - For fiscal 2025, three analysts have revised their earnings estimates upwards, with the Zacks Consensus Estimate increasing to $21.28 per share [12] - Amgen has an average earnings surprise of +12.7%, suggesting a positive trend in earnings performance [12] Investment Considerations - With a strong Zacks Rank and favorable Value and VGM Style Scores, Amgen is recommended for investors' consideration [13]
Countdown to Amgen (AMGN) Q4 Earnings: Wall Street Forecasts for Key Metrics
ZACKS· 2026-01-29 15:16
Core Viewpoint - Amgen (AMGN) is expected to report quarterly earnings of $4.74 per share, a decline of 10.7% year-over-year, with revenues projected at $9.46 billion, reflecting a 4.2% increase compared to the previous year [1]. Earnings Estimates - The consensus EPS estimate has been revised upward by 0.1% over the past 30 days, indicating analysts have adjusted their projections positively [2]. - Revisions to earnings estimates are crucial indicators for predicting investor actions regarding the stock, with empirical research showing a strong correlation between these revisions and short-term stock price performance [3]. Revenue and Product Sales Projections - Analysts predict 'Revenue- Other revenues' will reach $402.12 million, an increase of 8.7% from the prior-year quarter [5]. - 'Revenue- Product sales' is expected to be $9.04 billion, reflecting a 3.7% increase year-over-year [5]. - 'Product Sales- Vectibix- Total' is projected at $279.69 million, indicating a 13.7% increase from the previous year [5]. Specific Product Sales Estimates - 'Product Sales- Enbrel- Total' is estimated at $649.46 million, showing a significant decline of 36% year-over-year [6]. - 'Product Sales- Neulasta- U.S.' is projected at $56.02 million, down 22.2% from the year-ago quarter [6]. - 'Product Sales- Neulasta- ROW' is expected to reach $19.40 million, reflecting a 25.4% decline [6]. - 'Product Sales- BLINCYTO- ROW' is estimated at $152.62 million, an increase of 12.2% year-over-year [7]. - 'Product Sales- Repatha- U.S.' is projected at $442.32 million, indicating a substantial increase of 40.4% from the previous year [7]. - 'Product Sales- Repatha- ROW' is expected to be $360.19 million, reflecting a 23.8% increase [8]. - 'Product Sales- BLINCYTO- U.S.' is projected at $287.58 million, indicating a 17.4% increase [8]. - 'Product Sales- KYPROLIS- U.S.' is expected to reach $228.82 million, showing a slight decline of 3% year-over-year [8]. - 'Product Sales- KYPROLIS- ROW' is projected at $130.37 million, reflecting a 4.1% decline [9]. Stock Performance - Amgen shares have increased by 4.6% over the past month, outperforming the Zacks S&P 500 composite, which has risen by 0.8% [9].
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Quarterly Earnings Preview
Financial Modeling Prep· 2026-01-29 12:00
Core Viewpoint - Regeneron Pharmaceuticals is a leading biotechnology company focused on developing innovative medicines for serious diseases, competing with major players like Amgen and Biogen [1] Financial Performance - Regeneron is set to release its quarterly earnings on January 30, 2026, with an estimated EPS of $10.56 and revenue of approximately $3.78 billion, while the Zacks Consensus Estimate projects revenues at $3.82 billion [2] - Historically, Regeneron has exceeded earnings estimates in three of the last four quarters, with an average surprise of 21.81% [2] Product Focus - The upcoming earnings report will emphasize profits from the asthma drug Dupixent and sales of Eylea HD, with Eylea's legacy sales declining due to competition, but Eylea HD expected to boost overall franchise revenues [3] - Strong demand for Dupixent across multiple indications is anticipated to drive solid profit growth, offsetting the decline in Eylea sales [3] Stock Performance - Regeneron's stock has increased over 16% since the last analysis, reinforcing a Buy rating, although it is still trading below its all-time high of approximately $1,200 reached in August 2024 [4] - The earnings report could potentially drive the stock price higher if results exceed expectations, while a miss might lead to a decline in stock value [4] Valuation Metrics - Regeneron has a price-to-earnings (P/E) ratio of approximately 17, indicating investors are willing to pay $17 for every $1 of earnings [5] - The company's price-to-sales ratio stands at about 5.44, and the enterprise value to sales ratio is roughly 5.46, indicating consistent valuation metrics [5] - Regeneron demonstrates a solid financial position with a low debt-to-equity ratio of 0.087 and a strong current ratio of 4.06 [5][6]
Amgen Set to Report Q4 Earnings: What Investors Should Know
ZACKS· 2026-01-28 17:27
Core Insights - Amgen (AMGN) is set to report its fourth-quarter and full-year 2025 results on February 3, with earnings expected to be $4.74 per share and sales at $9.46 billion, reflecting a 12.8% earnings surprise in the last reported quarter [1][10]. Group 1: Sales Performance - Product sales are anticipated to be driven by strong volume growth from drugs like Evenity, Repatha, and Blincyto, although prices are expected to decline due to increased rebates [2]. - The Zacks Consensus Estimate for sales of Evenity, Repatha, and Blincyto is $559 million, $798 million, and $434 million, respectively [3]. - Newer drugs such as Imdelltra, Tavneos, and Tezspire are expected to contribute to top-line growth, alongside sales from rare disease drugs like Uplizna, estimated at $183 million [4]. Group 2: Patent Expirations and Competitive Pressures - Patents for key drugs Prolia and Xgeva expired in February 2025 in the U.S., leading to expected sales erosion due to the launch of biosimilars, with estimates of $980 million for Prolia and $444 million for Xgeva [5]. - Competitive pressures have negatively impacted volume growth for Kyprolis, with an estimated sales figure of $365 million, while Enbrel sales are likely to decline due to price reductions [6]. Group 3: Biosimilars and R&D Costs - Amgen's biosimilars, including Wezlana and Pavblu, are expected to contribute to sales growth, although Wezlana is not expected to generate U.S. sales in the fourth quarter [7]. - Lower revenues from oncology biosimilars and legacy products are anticipated, alongside higher R&D costs that may negatively impact operating margins [8][9]. Group 4: Earnings Expectations - Amgen's Earnings ESP is -0.40%, indicating a lower likelihood of an earnings beat, with the most accurate estimate at $4.72 per share compared to the consensus of $4.74 [13][14].
15 Best S&P 500 Dividend Stocks to Buy in 2026
Insider Monkey· 2026-01-26 01:16
Core Insights - The article discusses the 15 best S&P 500 dividend stocks to consider for investment in 2026, emphasizing the stability that dividend stocks can provide during market downturns [1] Dividend and Buyback Strategy - Dan Lefkovitz from Morningstar Indexes suggests that combining dividend-paying stocks with companies that actively buy back shares can yield better returns compared to a high-dividend-only strategy [2] - An index that includes both dividends and buybacks has outperformed a high-dividend-only index over the past three years, although it still lags behind the overall US market [2] Cash Return to Shareholders - The article highlights the difference in how companies return cash to shareholders, noting that dividends are a long-term commitment while buybacks are more flexible and often increase when management perceives the stock as undervalued [3] - Large technology companies have been leading in buyback activities, while dividend payments are primarily concentrated in sectors like financials, utilities, energy, and consumer staples [3] International Dividend Yields - Income-focused investors are encouraged to look beyond the US, as domestic dividend yields have decreased to approximately 1.1%, while some European regions offer yields above 3% [4] - Caution is advised against chasing high yields, as unusually high payouts may indicate underlying business stress and potential future dividend cuts [4] Methodology for Stock Selection - The selection process for the 15 best dividend stocks involved screening S&P 500 companies with a market cap of at least $10 billion, focusing on those with stable dividends and yields around 2% as of January 21 [6] - The final list was based on popularity among hedge funds, utilizing data from Insider Monkey's Q3 2025 database [6][7] Company-Specific Insights - **Verizon Communications Inc. (NYSE:VZ)**: - Holds a dividend yield of 7.06% as of January 21, with 60 hedge fund holders [8] - Bernstein has cut its price target for Verizon to $44, citing increased competition in the telecom industry [8] - Verizon's $20 billion acquisition of Frontier Communications was approved, with commitments to expand fiber internet and wireless coverage in California [9] - **Amgen Inc. (NASDAQ:AMGN)**: - Has a dividend yield of 3.05% as of January 21, with 62 hedge fund holders [11] - Bernstein downgraded Amgen to Market Perform, indicating 2026 may be a waiting year for its product MariTide [11] - Amgen announced the acquisition of Dark Blue Therapeutics for up to $840 million, enhancing its oncology pipeline [12][13]