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Amgen Inc. (NASDAQ:AMGN) Maintains Strong Outlook Despite Challenges
Financial Modeling Prep· 2026-02-04 19:06
Core Viewpoint - Amgen Inc. is experiencing strong performance and positive analyst outlook despite facing some challenges, with a maintained "Buy" rating and an increased price target from Cowen & Co. [1][5] Financial Performance - Amgen's fourth-quarter performance in 2025 exceeded expectations for both revenue and earnings per share, supporting a positive outlook from analysts [2][5] - The stock price is currently $338.59, reflecting a 1.80% decrease or $6.20 drop, with a market capitalization of approximately $182.32 billion [4] Growth Prospects - Key products like Repatha and Uplizna are expected to drive future growth, offsetting losses from Prolia and Xgeva [2][5] - Despite regulatory uncertainties and pipeline attrition, Amgen's long-term prospects remain strong, bolstered by positive data from Repatha and progress with MariTide [3][5] Market Activity - The stock has fluctuated between $338.59 and $349.50 today, with a yearly high of $353.25 and a low of $261.43 [4]
一个自免新星的非意外“死亡”
3 6 Ke· 2026-02-03 13:36
安进赌输了。 在炎症微环境中,APC表面OX40L表达上调,进一步放大抗原特异性T细胞反应及促炎细胞因子分泌。 在多种炎症性和自身免疫性疾病中,OX40L和OX40存在表达升高的现象,如特应性皮炎、哮喘、多发性硬化症、类风 湿性关节炎、炎症性肠病、克罗恩病和系统性红斑狼疮。鉴于其在T细胞激活中的上游调控地位,阻断该相互作用可 有效抑制T细胞相关病理性免疫应答,由此催生了OX40/OX40L靶向疗法的研发热潮。 而rocatinlimab则是该领域的领跑者之一,且早期结果惊艳。2022年12月,安进公布的rocatinlimab在特应性皮炎中的二 期数据显示,接受4种不同剂量rocatinlimab治疗的患者组的EASI评分与安慰剂组相比,均获得统计学显著改善。 600mg每两周(Q2W)组EASI降低57.4%,300mgQ2W组降低61.1%,安慰剂组降低15%(所有剂量组与安慰剂相比, P<0.001)。 2021年6月,安进以4亿美元首付款、高至8.5亿美元的潜在里程碑付款以及未来销售分成,从日本制药企业协和麒麟获 得OX40单抗rocatinlimab在日本外的全球权益。 引进之后,安进火力全开,推进 ...
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]
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) ...
AbCellera Biologics (NasdaqGS:ABCL) 2025 Conference Transcript
2025-11-13 14:02
AbCellera Biologics Conference Call Summary Company Overview - **Company**: AbCellera Biologics (NasdaqGS: ABCL) - **Date**: November 13, 2025 - **Key Focus**: Transition from a partnership-focused model to developing its own clinical assets [8][12][14] Core Points and Arguments Transition to Internal Development - AbCellera has shifted from primarily building capabilities through partnerships to developing its own clinical assets, completing this transition in 2025 with two wholly owned assets entering the clinic [12][14] - The company aims to retain more economic value from its assets, moving towards co-development models with partners [7][9][12] Partnership Strategy - AbCellera has worked on over 100 programs with partners, focusing on scientific merit, commercial opportunity, and differentiation when selecting partnership opportunities [18][19] - The company continues to engage with strategic partners like Lilly and AbbVie, leveraging its capabilities to enhance their programs [11][21] Clinical Pipeline - **ABCL635**: An antibody targeting the NK3R for treating hot flashes associated with menopause. The company believes it has a significant commercial opportunity due to the large unmet medical need [35][36] - The preferred administration method is a monthly injectable, which over 50% of surveyed women preferred over daily oral options [44] - The clinical development path is straightforward, with a proof of concept study expected to start in early 2026 [60][62] - **ABCL575**: An OX40 ligand antagonist, positioned to potentially outperform existing treatments by targeting upstream pathways [88][90] - **ABCL688**: Another candidate targeting GPCRs, expected to enter clinical trials mid-next year [102][107] Market Dynamics - The market for non-hormonal treatments for menopause is expanding, with competitors like Astellas and Bayer already establishing a presence. AbCellera aims to enter this market with a differentiated product [68][75][80] - The company estimates a $6 billion addressable market for non-hormonal treatments, with significant unmet needs among women contraindicated for hormone replacement therapy [74][76] Financial Position - AbCellera reported over $500 million in cash and equivalents, with total available liquidity around $700 million, providing sufficient resources for at least the next three years [108][109] Additional Important Insights - The company has received government funding to support clinical trials, which has facilitated the establishment of trial sites in Canada without delays [53][54] - The focus on difficult antibody discovery programs has positioned AbCellera as a leader in the field, with a strong reputation among partners [31][32] - The anticipated readouts for the first clinical assets are expected in 2026, which could significantly impact the company's valuation and market perception [14][12]
Kyowa Kirin Announces Late-Breaking Abstract Presentation at the European Academy of Dermatology and Venerology Congress
The Manila Times· 2025-09-11 12:08
Group 1: Rocatinlimab and Clinical Trials - Kyowa Kirin announced the presentation of Phase 3 ROCKET-SHUTTLE trial results for rocatinlimab at the EADV 2025 Annual Meeting, focusing on its efficacy and safety in treating moderate-to-severe atopic dermatitis [1][3] - The ROCKET program consists of eight global studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [4] Group 2: Atopic Dermatitis Overview - Moderate-to-severe atopic dermatitis is a chronic inflammatory skin disease characterized by severe itching and pain, with a significant unmet need for effective treatments [2][5] - Atopic dermatitis affects 15-20% of children and up to 10% of adults, with T-cell imbalance being a root cause of the disease [5] Group 3: Rocatinlimab Mechanism and Development - Rocatinlimab is an anti-OX40 monoclonal antibody that targets the OX40 receptor on activated T cells, potentially being the first T-cell rebalancing therapy for atopic dermatitis [6] - The drug is also being investigated for other conditions related to T-cell imbalance, including uncontrolled asthma and prurigo nodularis [7] Group 4: Collaboration and Commercialization - Kyowa Kirin and Amgen entered a collaboration agreement for the joint development and commercialization of rocatinlimab, with Amgen leading the global efforts except in Japan [8]
Why Is Sanofi Stock Falling Thursday?
Benzinga· 2025-09-04 18:36
Core Viewpoint - Sanofi SA's stock declined after the late-stage trial results for amlitelimab, a potential successor to Dupixent, did not meet investor expectations, raising concerns about the company's dermatology franchise sustainability post-patent expiration [1] Group 1: Trial Results - The global COAST 1 phase 3 study indicated that amlitelimab met all primary and key secondary endpoints, showing statistically significant skin clearance and disease severity improvement compared to placebo at Week 24 for patients aged 12 years and older with moderate-to-severe atopic dermatitis [2] - However, the efficacy of amlitelimab and Amgen's rocatinlimab in Phase 3 studies did not reach the benchmark set by Dupixent, which demonstrated a 36% improvement on EASI-75 over placebo [3] Group 2: Comparison with Competitors - Analyst observations noted that both rocatinlimab and amlitelimab offer a more favorable dosing schedule compared to Dupixent, with potential for monthly or quarterly dosing, respectively [4] - The results suggest that OX40/OX40L therapies, including amlitelimab, may provide slower and less robust responses than IL-13/4 drugs, likely confining their use to second-line treatments for patients who do not respond to IL-13/4 options [4] Group 3: Market Dynamics - Advanced therapies account for less than 20% of the atopic dermatitis market, with only three approved mechanisms (IL-13/4, IL-31, JAK), indicating a potential market opportunity for OX40 drugs, albeit smaller than for therapies that match or exceed IL-13/4 efficacy [5] - Ongoing discussions focus on the differences between amlitelimab and rocatinlimab, particularly regarding side effects like pyrexia and chills [5] Group 4: Side Effects and Dosing - Amgen's rocatinlimab is associated with immune-related side effects, including pyrexia (10%) and chills (6%), which may have limited dosing in Phase 3 trials to 300 mg, below the 600 mg tested in Phase 2, potentially affecting its efficacy [6] - In contrast, amlitelimab exhibited lower rates of pyrexia (1.1% vs. 0.7% placebo) and chills (0.4% vs. 0.0% placebo), while achieving comparable efficacy to rocatinlimab at higher dose levels [6] Group 5: Stock Performance - Following the trial results, Sanofi's stock price fell by 8.59% to $45.61 [7]
Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress
Prnewswire· 2025-07-29 12:00
Company Overview - Kyowa Kirin Co., Ltd. is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [7] - The company focuses on developing novel medicines and treatments for high unmet medical needs, including bone & mineral diseases, hematological diseases, and rare diseases [7] Product Development - Rocatinlimab is an investigational anti-OX40 human monoclonal antibody targeting moderate to severe atopic dermatitis, with the potential to be the first T-cell rebalancing therapy [5][6] - The Phase 3 ROCKET IGNITE trial results for rocatinlimab will be presented at the EADV 2025 Annual Meeting in Paris from September 17-20, 2025 [1][3] - The ROCKET program consists of eight studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [3] Market Context - Atopic dermatitis affects 15-20% of children and up to 10% of adults, characterized by chronic symptoms and unpredictable flare-ups [4] - The disease is driven by T-cell imbalance, which is a root cause of its inflammatory nature [2][4] Collaboration - Kyowa Kirin has a collaboration agreement with Amgen to jointly develop and commercialize rocatinlimab, with Amgen leading development globally except in Japan [8]
Prediction: These 2 Stocks Will Outperform the Market Through 2030
The Motley Fool· 2025-03-18 13:53
Group 1: Amgen - Amgen is positioned for growth with key products like Tezspire for asthma and Tepezza for thyroid eye disease, with ongoing clinical trials and international launches [3][4] - The company reported a 19% year-over-year revenue increase to $33.4 billion, with a solid 7% organic growth [4] - Amgen's pipeline includes promising candidates like MariTide for weight loss and rocatinlimab for eczema, indicating strong long-term performance potential [5] - The company offers a forward dividend yield of about 3%, significantly higher than the S&P 500 average of 1.3%, and has increased its payouts by 201% over the past decade [6] Group 2: Intuitive Surgical - Intuitive Surgical leads in robotic-assisted surgery with its da Vinci surgical system, recently launching the fifth generation of this device, which has seen strong demand [7][9] - The da Vinci 5 features improvements such as greater precision and efficiency, and a Force Feedback technology that enhances surgical accuracy [8] - The company experienced a 25% year-over-year revenue increase to $2.41 billion, with adjusted earnings per share rising from $1.60 to $2.21 [9] - Intuitive Surgical has treated 16 million patients with its systems, with a compound annual growth rate of 17% in procedure volume over the past five years, indicating sustained growth potential [10][11]
Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025
Prnewswire· 2025-02-26 13:00
Core Insights - Kyowa Kirin Co., Ltd. announced the presentation of Phase 3 ROCKET HORIZON trial results for rocatinlimab, targeting OX40 receptor in moderate-to-severe atopic dermatitis, at the AAD 2025 Annual Meeting [1][2] Group 1: Clinical Trial Details - ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial involving 726 adult patients, assessing the efficacy, safety, and tolerability of rocatinlimab administered subcutaneously every four weeks for 24 weeks [3] - Co-primary endpoints include achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 or 1 with a ≥ 2-point reduction from baseline at week 24, and a ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24 [3] - Key secondary endpoints focus on the impact of rocatinlimab on itch, safety, and tolerability [3] Group 2: Atopic Dermatitis Overview - Atopic dermatitis is a chronic inflammatory disease affecting 15-20% of children and up to 10% of adults, characterized by excessively dry, itchy skin and unpredictable flare-ups [4] - T-cell imbalance is identified as a root cause of atopic dermatitis, contributing to its clinical manifestations [4] Group 3: Rocatinlimab Overview - Rocatinlimab is an anti-OX40 receptor human monoclonal antibody under investigation for moderate-to-severe atopic dermatitis, as well as for moderate to severe uncontrolled asthma and prurigo nodularis [5] - The antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology [5] Group 4: Collaboration with Amgen - Kyowa Kirin and Amgen entered a collaboration agreement on June 1, 2021, for the joint development and commercialization of rocatinlimab, with Amgen leading the global development except in Japan [6] - If approved, both companies will co-promote rocatinlimab in the United States, with Kyowa Kirin having opt-in rights for co-promotion in select markets [6]