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Day: June 1, 2025

Nxera Pharma Achieves Development Milestone in Collaboration with Eli Lilly Targeting Metabolic Diseases

Tokyo, Japan and Cambridge, UK, 2 June 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that it has achieved a development milestone under its multi-target collaboration and license agreement with Eli Lilly and Company (“Lilly”) targeting diabetes and metabolic diseases, resulting in a payment to Nxera. The payment amount is undisclosed under the agreement with Lilly. However, Nxera makes this announcement in accordance with the timely disclosure requirements as the achievement of the milestone represents significant progress in research and development for Nxera. Nxera expects to receive the milestone payment in the third quarter of the fiscal year ending December 2025. Nxera and Lilly entered the multi-target collaboration in 2022 to leverage Nxera’s GPCR-focused structure-based drug design capabilities...

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Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML

– New Drug Application based on positive results from the Phase 2 KOMET-001 trial – – FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025 – – Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. The application has been granted Priority Review and assigned a Prescription Drug User...

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Cenovus Energy provides operations update on impact of Alberta wildfires

CALGARY, Alberta, June 01, 2025 (GLOBE NEWSWIRE) — Cenovus Energy Inc. (TSX: CVE) (NYSE: CVE) is providing an update on its Oil Sands operations following ongoing wildfire activity in northern Alberta. Cenovus is focused on the safety of its people and the integrity of its assets, and all staff are safe. Based on the inspections the company has completed to date, it is not aware of any damage to its infrastructure and would anticipate a full restart of Christina Lake operations in the near term. As a precaution, currently only essential personnel are at the Christina Lake oil sands asset, where the company began safely and methodically shutting in production on May 29. Operations will resume as soon as it’s safe to do so. Approximately 238,000 barrels per day of production have been impacted, and the company will provide an update...

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Transgene and NEC Present Durable Disease-Free Survival and Sustained T Cell Responses at 24 Months with Individualized Cancer Vaccine TG4050

All patients in the treatment arm remain disease-free after a minimum of 2-year follow-up in the randomized Phase I trial in resected HPV-negative locally advanced head and neck cancer – Demonstrating clinical proof of principle for TG4050 Single agent TG4050 induced long-lasting neoantigen-specific CD8+ T cell responses Treatment was well-tolerated with no unexpected safety signals Data presented during rapid oral session at ASCO 2025 Conference call scheduled on Friday June 6, 2025 at 3:00 p.m. CET (in English). See details below Strasbourg, France & Tokyo, Japan, June 1st, 2025, 7:15 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, have presented new...

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Bicara Therapeutics Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025

Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median OS of 21.3 months and 2-year OS of 46% in HPV-negative HNSCC Conference call and webcast today at 3:00 p.m. CT / 4:00 p.m. ET BOSTON, June 01, 2025 (GLOBE NEWSWIRE) — Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today presented updated data from the company’s Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Ficerafusp alfa is a first-in-class...

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Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO

Data Highlights Transformative Promise of CAR T in Solid Tumors Phase 1 Trial with ALLO-316 Demonstrated Potential to Provide Meaningful Clinical Benefit in Patients with CD70 TPS ≥ 50% Advanced or Metastatic RCCA Single Dose of ALLO-316 Achieved a 31% Confirmed Response Rate Four of Five Confirmed Responders Remain in Response Including One Ongoing Remission Over 12 MonthsRobust Expansion, Persistence, and Tumor Infiltration of ALLO-316 Seen with Standard Lymphodepletion, Showcasing Dagger® Technology as a Next-Generation Allogeneic Platform Phase 1 Safety Profile was Manageable; Proactive Diagnostic and Management Strategies Proved Effective in Mitigating IEC-HS While Preserving EfficacySOUTH SAN FRANCISCO, Calif., June 01, 2025 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology...

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Replimune Presents New Analyses from the IGNYTE Study of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

– RP1 plus nivolumab generated robust responses in both injected and non-injected lesions – – Deep/visceral injections, including into the liver and lung, resulted in numerically higher rates of response compared to superficial injections only and were generally well tolerated – WOBURN, Mass., June 01, 2025 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented two posters highlighting data updates for RP1 (vusolimogene oderparepvec) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago. “The new analyses we presented from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD-1 failed melanoma confirms our belief in the systemic...

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Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis

33% reduction in relative risk of invasive disease observed in pre-menopausal early breast cancer (EBC) patients receiving Kisqali in 1-year post-treatment analysis1Tolerability remained consistent, with fewer treatment discontinuations due to adverse events among pre-menopausal patients1Rising breast cancer diagnosis rates and more aggressive disease in younger women underscore importance of early detection and care with effective and tolerable treatments that help prevent cancer recurrence2Separate real-world analysis presented at ASCO demonstrates differences in treatment outcomes that underscore critical need to improve care for Black patients with EBC3Basel, June 1, 2025 – Novartis is announcing data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali® (ribociclib) plus...

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Seer’s Proteograph Platform Enables Unprecedented 20,000-Sample Proteomics Study with Korea University to Develop AI-Driven Diagnostics for Cancers in Young Adults

First-of-its-kind study will use Seer’s next-generation workflow to identify early-onset cancer biomarkers and power deep, unbiased mass spectrometry-based proteomics Seer’s new Proteograph ONE Assay to accelerate analysis and reduce costs, making large-scale studies feasible  REDWOOD CITY, Calif., June 01, 2025 (GLOBE NEWSWIRE) — Seer, Inc. (Nasdaq: SEER), the pioneer and trusted partner for deep, unbiased proteomic insights, and Korea University, a leading research institution committed to innovation and global impact, today announced the launch of a population-level study aimed at identifying novel blood-based biomarkers that could lead to cancer diagnostics for young adults in their 20s and 30s. Relying on Seer’s newly launched Proteograph® ONE Assay and SP200 Automation Instrument along with the Thermo Scientific™ Orbitrap™...

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NIO Inc. Provides May 2025 Delivery Update

23,231 vehicles were delivered in May 2025, increasing by 13.1% year-over-year 89,225 vehicles were delivered year-to-date in 2025, increasing by 34.7% year-over-year Cumulative deliveries reached 760,789 as of May 31, 2025SHANGHAI, June 01, 2025 (GLOBE NEWSWIRE) — NIO Inc. (NYSE: NIO; HKEX: 9866; SGX: NIO) (“NIO” or the “Company”), a pioneer and a leading company in the global smart electric vehicle market, today announced its May 2025 delivery results. The Company delivered 23,231 vehicles in May 2025, representing an increase of 13.1% year-over-year. The deliveries consisted of 13,270 vehicles from the Company’s premium smart electric vehicle brand NIO, 6,281 vehicles from the Company’s family-oriented smart electric vehicle brand ONVO, and 3,680 vehicles from the Company’s small smart high-end electric car brand FIREFLY....

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