Biopharma Business Growth and Strategy - Fresenius' Biopharma business is rapidly scaling, with revenue increasing from €04 billion in 2022 to an estimated >€08 billion in 2025[23, 24] - The company aims to approximately double its Biopharma revenue by 2030, targeting a ~20% EBIT margin[42, 43] - The global biosimilars market is projected to grow sixfold by 2035, reaching >€180 billion[19, 48] Manufacturing and Cost Leadership - Fresenius is investing >€300 million over the next 5 years to expand Biopharma manufacturing capacity and drive growth[122] - The company's vertical integration strategy, particularly through mAbxience, provides a competitive advantage, covering ~75% of manufacturing costs[64] - Fresenius aims to increase internal Drug Substance (DS) manufacturing to >60% of total capacity required by 2030[130] Portfolio and R&D - Fresenius has a competitive portfolio and pipeline covering €200 billion in originator sales[82, 89] - The company targets 2+ molecules per year entering development through in-house R&D and strategic in-licensing[82, 88] - Fresenius' US tocilizumab biosimilar, Tyenne, has achieved a market share of ~18% as of September 2025[163] Commercial Excellence - Fresenius is expanding its commercial presence in the US, with revenue growth of >60% expected from 2024 to 2025[161] - The company is implementing a targeted go-to-market strategy, molecule by molecule, to optimize market access and contracting[151, 165] - Fresenius has a strong European core with direct sales in >20 markets and deep payer access[157]

 IND submitted for ABP-102/CT-P72, a HER2 × CD3 T cell engager, with preclinical studies demonstrating enhanced HER2-high tumor selectivity and a favorable safety profile ABP-102/CT-P72 represents Abpro’s first IND submission for a phase 1 trial in a solid tumor indication, and is being co-developed by Abpro and Celltrion, Inc. BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abpro Holdings, Inc. (Nasdaq: ABP, “Abpro”), a biotechnology company developing novel breakthrough therapeutics for solid tumors, ...

Core Insights - Mivocabtagene autoleucel (miv-cel) has shown transformative results in treating stiff person syndrome (SPS), potentially becoming the first FDA-approved CAR T-cell therapy for autoimmune diseases [1][3][5] - The company plans to submit a Biologics License Application (BLA) for miv-cel in the first half of 2026 [1][5][8] Efficacy - Miv-cel demonstrated statistically significant improvements in all primary and secondary endpoints, reversing disability and eliminating the need for immunotherapies after a single dose [1][5][6] - The primary endpoint, the timed 25-foot walk (T25FW), showed a median improvement of 46% at Week 16 compared to baseline, with 81% of patients exceeding a 20% improvement [6][12] - Secondary endpoints also showed highly statistically significant benefits, with all p-values <0.0001, including improvements in the Modified Rankin Scale (mRS) and Hauser Ambulation Index (HAI) [6][12] Safety - Miv-cel was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed [1][14] - Grade 3/4 neutropenia was noted but was manageable, indicating a favorable safety profile [14] Clinical Trial Overview - The KYSA-8 trial is a single-arm registrational Phase 2 study involving 26 patients with SPS who had inadequate responses to non-approved treatments [4][11] - Patients received a single dose of miv-cel after lymphodepletion with cyclophosphamide and fludarabine, with follow-up for one year [12] Company Background - Kyverna Therapeutics is focused on developing cell therapies for autoimmune diseases, with miv-cel as its lead candidate [17] - The company has received Regenerative Medicine Advanced Therapy and Orphan Drug designations for miv-cel in the context of SPS [8][18]

STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01. A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate s ...

U.S. stock futures are up early Monday morning, following a mixed week that saw rotation out of expensive tech stocks in favor of value, despite the third consecutive interest rate cut on Wednesday. Investors on Monday will be eagerly awaiting the results of the Empire State Manufacturing Survey, alongside the speeches of Federal Reserve Governor Stephen Miran and New York Fed President John Williams, both scheduled early in the day, ahead of a slew of other economic data that is set to be released over the ...

Singapore investors often focus on local dividend plays like REITs and bank stocks, and with good reason. However, limiting your portfolio to a single market can constrain growth and expose you to localised risk. For those seeking global diversification and exposure to multi-national growth, here are three US dividend stocks that can add global resilience to your portfolio.AbbVie Inc. (NYSE: ABBV) – Diversified biopharmaceutical firm AbbVie is a global diversified biopharmaceutical company with a portfolio ...

Core Insights - Sanofi's regulatory submission for tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS) is expected to face delays, with further guidance from the FDA anticipated by the end of Q1 2026 [1][2] - The company has submitted an expanded access protocol for tolebrutinib, demonstrating its commitment to providing access to this investigational therapy for eligible patients [2] - Tolebrutinib is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target neuroinflammation, a key factor in disability progression in multiple sclerosis [5][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative treatments, particularly in neurology and immunoscience [7] - The company is committed to addressing significant unmet needs in multiple sclerosis and other neuro-inflammatory and neuro-degenerative conditions [6][7] - Sanofi's neurology pipeline includes several projects in phase 3 studies across various diseases, indicating a robust commitment to advancing treatment options [6]

Core Insights - Kyverna Therapeutics, Inc. is set to host a live webcast and conference call on December 15, 2025, to discuss topline results from the Phase 2 KYSA-8 clinical trial for KYV-101 in stiff person syndrome [1][2] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate KYV-101 advancing through late-stage clinical development [4] - KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy designed for potency and tolerability, aiming for deep B-cell depletion and immune system reset [3][4] - The company is also conducting registrational trials for myasthenia gravis and has ongoing Phase 1/2 trials for lupus nephritis, with plans to explore additional indications such as multiple sclerosis and rheumatoid arthritis [4]

Core Viewpoint - Arcutis Biotherapeutics is an attractive biotech stock due to its low-risk approval process, strong sales growth, and appealing valuation based on management's peak sales estimates [1] Company Overview - Arcutis' primary product, Zoryve, is a non-steroidal topical medication for inflammatory skin diseases, including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis, utilizing the active ingredient roflumilast, a PDE4 inhibitor [2] - The company has received approvals for various applications and is seeking further approval for Zoryve cream for children aged two to five years old, with additional trials ongoing for other indications [3] Financial Performance - In the third quarter, Arcutis reported net product revenue of $99.2 million, reflecting a 122% increase year-over-year and a 22% increase from the previous quarter [4] - Wall Street projects sales of $358 million for 2025 and $467 million for 2026 [4] Market Potential - CEO Frank Watanabe estimates peak sales for roflumilast/Zoryve could reach between $2.6 billion and $3.5 billion, with the current market cap at $3.6 billion, suggesting significant upside potential [6] - Analysts anticipate net income profit margins of 30% for Arcutis, indicating strong value if peak sales projections are met [6] Investment Appeal - The combination of a low-risk approval process and strong sales momentum positions Arcutis as an attractive option for growth-oriented investors [7]

Core Viewpoint - A lawsuit has been filed against MoonLake Immunotherapeutics and its senior executives for potential violations of federal securities laws, following disappointing results from clinical trials that raised questions about the company's drug's regulatory approval and commercial viability [1][2][5]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, captioned Peters v. MoonLake Immunotherapeutics, et al., No. 1:25-cv-08612 [2]. - Investors have until December 15, 2025, to request to be appointed to lead the case [2]. Group 2: Company Background - MoonLake is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases, specifically through its investigational therapeutic sonelokimab (SLK) [3]. - The company claimed that its "strong clinical data" from the Phase 2 MIRA trial indicated higher clinical responses and differentiation from competitors [4]. Group 3: Clinical Trial Results - The VELA Phase 3 trials for sonelokimab reported disappointing results, with VELA-2 failing to meet its primary endpoint, which raised concerns about the drug's chances for regulatory approval [6]. - Following the announcement of the trial results on September 28, 2025, MoonLake's stock price plummeted nearly 90%, from $61.99 per share to $6.24 per share [6].