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Agios to Present at the 2025 RBC Capital Markets Global Healthcare Conference on May 21, 2025

On May 9, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the 2025 RBC Capital Markets Global Healthcare Conference on Wednesday, May 21, 2025, at 8:00 am ET (Press release, Agios Pharmaceuticals, MAY 9, 2025, View Source [SID1234652816]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Jabez Biosciences, Inc. Announced Phase 1 Clinical Trial of JBZ-001 at AACR 2025

On May 8, 2025 Jabez Biosciences, Inc., a pioneering biotechnology company focused on innovative cancer therapies, reported the progress of its Phase 1 clinical trial for JBZ-001 (HOSU-53), a novel dihydroorotate dehydrogenase (DHODH) inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held April 25-30, 2025, in Chicago, IL (Press release, Jabez Biosciences, MAY 9, 2025, View Source [SID1234652823]). The trial, conducted in collaboration with The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), targets adults with advanced solid tumors and non-Hodgkin lymphoma.

Asrar Alahmadi, MBBS, lead Principal Investigator of the Phase 1 trial and assistant professor in the College of Medicine at The Ohio State University, presented the clinical trial abstract entitled: An open-label phase 1 study to investigate JBZ-001 in adults with advanced solid tumors and non-Hodgkin lymphoma (Jabez Biosciences’ Clinical Trial NCT06801002 in Progress at OSUCCC—James) at the AACR (Free AACR Whitepaper) Annual Meeting at McCormick Place Convention Center, Chicago. The abstract was also published online in the Proceedings of the AACR (Free AACR Whitepaper) on April 25, 2025.

JBZ-001, an orally bioavailable small-molecule DHODH inhibitor, was designed to disrupt de novo pyrimidine nucleotide biosynthesis, a critical pathway for cancer cell proliferation. By targeting DHODH, the rate-limiting enzyme in this pathway, JBZ-001 demonstrated potential to induce cytotoxic effects in tumor cells, offering a promising new approach to cancer treatment. The development of JBZ-001 marks a significant milestone in Jabez Biosciences’ "bench-to-bedside" academic collaboration, with the compound receiving FDA approval for a commercial Investigational New Drug (IND) application in 2024.

The Phase 1 study, underway at OSUCCC – James, aims to assess the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma. The trial’s open-label design allows for real-time evaluation of the drug’s effects, paving the way for future clinical development.

Jabez Biosciences expressed gratitude to its research partners for their collaboration in bringing JBZ-001 to this stage. The company remains focused on advancing its pipeline of targeted cancer therapies to address unmet medical needs.

For more information about Jabez Biosciences, Inc. and its clinical programs, please visit www.jabezbio.com. For details on the clinical trial, refer to ClinicalTrials.gov (NCT06801002).

HAYA Therapeutics Raises $65 Million in Series A Funding to Deliver Precision RNA-Guided Medicines for Chronic and Age-Related Diseases

On May 8, 2025 HAYA Therapeutics, SA, a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics that reprogram disease-driving cell states for rare, common, chronic and age-related diseases, reported that the company has raised $65 million in Series A funding (Press release, Haya Therapeutics, MAY 8, 2025, View Source [SID1234652791]). The financing will accelerate the clinical development of HAYA’s lead long non-coding RNA (lncRNA) targeting candidate HTX-001 in heart failure and the continued expansion of its RNA-guided regulatory genome pipeline development engine. This investment emphasizes investor confidence in HAYA’s groundbreaking science and positions the company to deliver on its mission of bringing disease-modifying, precision medicines faster and more efficiently to patients. The round was led by Sofinnova Partners and Earlybird Venture Capital, with participation from Eli Lilly and Company (Lilly), ATHOS, +ND Capital, Alexandria Venture Investments and LifeLink Ventures, with additional support from existing investors Apollo Health Ventures, Longview Ventures (an affiliate of Broadview Ventures), 4see ventures, BERNINA Bioinvest and Schroders Capital.

"This is a defining moment for HAYA as we are advancing our lead program into the clinic. This funding validates our organization, pioneering approach and vision for improving the way chronic and complex diseases are treated by creating a new generation of therapies that reprogram disease-driving cell states into healthy ones," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "We’re excited that Sofinnova Partners, Earlybird and our syndicate of investors share our vision for the potentially industry changing nature of our platform as we move beyond traditional approaches by leveraging novel therapeutic targets emerging from the regulatory genome."

The company will use the funds to initiate clinical trials for HTX-001, HAYA’s first-in-class lncRNA-targeting therapy for heart failure, initially focused on non-obstructive hypertrophic cardiomyopathy (nHCM). In parallel, the company will strengthen its platform capabilities and expand its pipeline of disease-modifying therapies across multiple therapeutic areas—including pulmonary fibrosis, obesity and age-related common and chronic diseases.

"HAYA’s platform unlocks the dark genome’s therapeutic potential by targeting disease-driving cell states via long non-coding RNAs. This novel approach opens a new frontier in precision medicine, moving beyond traditional target classes to address disease at its epigenetic and cellular roots. Leading this round alongside Earlybird reflects our deep conviction in the HAYA team and their mission to develop safer, more effective therapies across a broad range of indications, including their lead program in nHCM, as they advance it toward the clinic to address a major unmet need," noted Henrijette Richter, Managing Partner at Sofinnova Partners.

The core of HAYA’s proprietary platform maps and decodes the biology of the regulatory genome, also referred to as the "genome’s dark matter" or "Dark Genome," which constitutes 98% of the human genome. While the regulatory genome does not code for proteins it is now recognized as the master control layer of gene expression and cell identity. HAYA has developed the most comprehensive atlas of the regulatory genome by combining integrated multimodal functional genomics with a stack of proprietary computational and machine learning methodologies, enabling the precise identification and modulation of pathogenic cell states across diverse diseases. HAYA’s regulatory genome platform enables the development of RNA-guided therapeutics with unprecedented precision, speed and scalability. This next-generation approach is designed to go beyond symptom management and directly reprogram the cellular drivers of disease.

To support its strategic growth, HAYA recently assembled an industry-leading C-level suite to drive scalable growth, business and clinical development and expand strategic collaborations with pharmaceutical and technology partners. The company recently announced a partnership with Lilly, one of the largest collaborations to date in the regulatory genome space, focused on RNA-based drug targets for obesity and metabolic disorders.

Takeda Announces FY2024 Full Year Results and FY2025 Outlook Reflecting Growth & Launch Products Momentum, Strong Cash Flow Generation and Late-Stage Pipeline Progress

On May 8, 2025 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for fiscal year 2024 (period ended March 31, 2025) with continued strong momentum in Growth & Launch Products offsetting loss of exclusivity impact to drive revenue and Core Operating Profit growth, supported by robust cost management (Press release, Takeda, MAY 8, 2025, View Source [SID1234652790]).

Takeda has built a high-value late-stage pipeline with potentially life-transforming new treatment options for patients. Following a positive Phase 3 readout for rusfertide in Oncology in March 2025, the company anticipates a further two Phase 3 readouts in core therapeutic areas this fiscal year.

FY2025 Management Guidance at CER reflects residual carry-over of VYVANSE generic impact, continued efficiency savings and investment in R&D and launch preparation for Takeda’s late-stage pipeline.

Takeda chief executive officer, Christophe Weber, commented:
"Takeda delivered excellent results in FY2024. Our return to Core Operating Profit margin growth underscores the strength of our Growth & Launch Products portfolio and the ability of our multi-year efficiency program to deliver meaningful cost savings.

"FY2025 will be a pivotal year as we invest in launch readiness for the late-stage pipeline, which will contribute to our broadly flat Core Operating Profit outlook for FY2025 but will be key to achieving Takeda’s long-term growth potential."

Takeda chief financial officer, Milano Furuta, commented:
"Takeda’s success in delivering revenue and Core Operating Profit growth in FY2024 and our outlook for broadly flat revenue and profit in FY2025, demonstrates our ability to manage through one of the largest generic impacts on our business in Takeda’s history while progressing a highly promising late-stage pipeline. Our performance and outlook speak to the strength of our Growth & Launch Products, our innovative pipeline and the resilience of our organization as a whole.

"Takeda is now at an inflection point, with multiple anticipated Phase 3 data readouts this fiscal year, and I’m excited about our growth trajectory."

FINANCIAL HIGHLIGHTS for FY2024 Ended March 31, 2025

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

Revenue

4,581.6

4,263.8

+7.5%

Operating Profit

342.6

214.1

+60.0%

Net Profit

107.9

144.1

-25.1%

EPS (Yen)

-25.8%

Operating Cash Flow

1,057.2

716.3

+47.6%

Adjusted Free Cash Flow (Non-IFRS)

769.0

283.4

+171.3%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

4,579.8

4,263.8

+7.4%

+2.8%

Operating Profit

1,162.6

1,054.9

+10.2%

+4.9%

Margin

25.4%

24.7%

+0.6pp

―

Net Profit

775.6

756.8

+2.5%

-3.4%

EPS (Yen)

491

484

+1.5%

-4.3%

FY2025 Outlook

(Billion yen, except percentages and per share amounts)

Item

FY2025 FORECAST

FY2025

MANAGEMENT

GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,530.0

—

Core Revenue (Non-IFRS)

4,530.0

Broadly flat

Operating Profit

475.0

—

Core Operating Profit (Non-IFRS)

1,140.0

Broadly flat

Net Profit

228.0

—

EPS (Yen)

145

—

Core EPS (Yen) (Non-IFRS)

485

Broadly flat

Adjusted Free Cash Flow (Non-IFRS)

750.0-850.0

—

Annual Dividend per Share (Yen)

200

—

Additional Information About Takeda’s FY2024 Results
For more details about Takeda’s FY2024 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q4 investor presentation (available at View Source)

Vergent Bioscience to Present Data on Abenacianine for Injection (VGT-309) at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 8, 2025 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that an abstract on abenacianine for injection (VGT-309) will be featured at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago (Press release, Vergent Bioscience, MAY 8, 2025, View Source [SID1234652789]). The poster will highlight data from the Phase 2B, multicenter VISUALIZE study (NCT06145048) evaluating the safety and efficacy of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung. Abenacianine is an investigational tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with minimally invasive and robotic-assisted surgical procedures.

Following are details about the poster presentation at ASCO (Free ASCO Whitepaper) 2025:

Title:

"Phase 2 Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Abenacianine for Injection (VGT-309), a Tumor-Targeted, Intraoperative Molecular Imaging Agent, for Patients Undergoing Surgery for Cancer in the Lung"

Authors:

Luis J Herrera; Gavin M Wright, MBBS, FRACS, Ph.D.; Jae Y Kim, M.D.; Janani S Reisenauer, M.D.; David C Rice, M.D.; Sunil Singhal, M.D.

Presenter:

Sunil Singhal, M.D., director of the Center for Precision Surgery at the Abramson Cancer Center, vice chair of translational research in the Department of Surgery, chief of thoracic surgery and William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine

Abstract ID:

3069

Poster Board #:

384

Date and Time:

June 2, 2025, at 1:30-4:30 p.m. CT

About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE study (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection (VGT-309)
Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous infusion several hours to several days before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’s imaging component is the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence.