IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance




IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

BEIJING–(BUSINESS WIRE)–#Biocytogen–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers.

IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen, said: “The IND clearance for IDE034 is an important milestone in the development of this first-in-class TOP1 ADC licensed project, representing a significant advancement for IDEAYA in expanding its clinical pipeline with bispecific, precision-targeted strategies. It also validates our RenLite^® platform and proprietary linker-payload technologies that enable the discovery and optimization of bispecific ADCs. We look forward to seeing IDE034 demonstrate clinical potential across multiple B7H3/PTK7 co-expressing solid tumors, offering new therapeutic options for patients.”

Preclinical studies have shown that IDE034 monotherapy induces deep and durable tumor regressions in multiple B7H3/PTK7-positive tumor models, demonstrating strong anti-tumor activity. In addition, IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response and intends to present additional preclinical data supporting the combination rationale at a major medical conference in H1 2026. B7H3 and PTK7 are co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46%, and 27%, respectively, indicating the broad clinical potential of IDE034.

Looking ahead, Biocytogen will continue to provide high-quality source antibodies through RenBiologics to support the clinical translation of licensed projects and actively explore additional early-stage assets for external licensing opportunities.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

Aptar Named One of America’s Most Responsible Companies by Newsweek for the Seventh Consecutive Year




Aptar Named One of America’s Most Responsible Companies by Newsweek for the Seventh Consecutive Year

Ranked among the Top 100 Companies

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery and consumer product dosing, dispensing and protection technologies, today announced that it has been named one of America’s Most Responsible Companies 2026 by Newsweek for the seventh consecutive year. Aptar is ranked number 56 out of 600 U.S. companies.

“Being recognized by Newsweek for the seventh consecutive year underscores our strong commitment to sustainability as a responsible corporate citizen. Our leadership in sustainable solutions positions us at the forefront of industry transformation, enabling global brands to meet evolving customer and consumer expectations. We continue to invest in renewable energy, certify sites as landfill free, and develop innovative products that are more recyclable, reusable, refillable and incorporate sustainable materials. This is progress that strengthens our competitive advantage and creates long-term value for all stakeholders,” said Stephan B. Tanda, Aptar President and CEO.

In addition to the recognition by Newsweek, Aptar was recently recognized by Forbes as a World’s Top Companies for Women, one of the World’s Most Sustainable Companies by TIME and was also named to the CDP A-list for the fourth consecutive year.

Aptar actively strives to create new opportunities through product innovation while respecting the planet. As an active member of the Ellen MacArthur Foundation and the World Business Council for Sustainable Development (WBSCD), the company is working alongside other leaders to further actions towards a more circular economy. Aptar publishes an annual Sustainability Report and GRI Index to record and highlight its sustainability efforts.

Newsweek, in partnership with Statista, evaluated the top 2,000 largest public companies with U.S. headquarters by revenue, based on publicly available data encompassing the three pillars of ESG (Environment, Social and Governance) and a company perception study of 26,000 individuals. Both the survey and analysis evaluated over 30 key performance indicators (KPIs), including emissions, energy use, board diversity, as well as disclosure and transparency. The ranking represents the 600 U.S. companies with the highest overall CSR scores, across 14 industries.

The full list of America’s Most Responsible Companies 2026 by Newsweek can be found here.

About Aptar

Aptar is a global leader in drug delivery and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

Contacts

Investor Relations Contact:
Mary Skafidas

Mary.skafidas@aptar.com
+1 347-351-6407

Media Contact:
Katie Reardon

Katie.Reardon@aptar.com
+1 815-479-5671

AdvoCare Launches Highly Anticipated Creatine+ — A Premium Sports Performance Supplement for Athletes and Active Lifestyles




AdvoCare Launches Highly Anticipated Creatine+ — A Premium Sports Performance Supplement for Athletes and Active Lifestyles

RICHARDSON, Texas–(BUSINESS WIRE)–#AdvoCareRehydrate–AdvoCare International, LLC, a leading health and wellness company, is thrilled to introduce Creatine+, a powerful new addition to its performance nutrition lineup. Formulated for athletes and active individuals, Creatine+ is designed to support muscle strength, recovery, endurance, and hydration—making it an essential tool for anyone serious about training.

Each serving delivers 5 grams of unflavored creatine monohydrate, aligning with clinically researched doses shown to enhance high-intensity exercise performance, increase lean muscle mass, and accelerate post-workout recovery. The unflavored formula mixes easily into your favorite beverages or stacks seamlessly with AdvoCare staples like Spark^® and Rehydrate.

“Creatine is widely regarded as one of the most scientifically validated dietary supplements in the world,” said Christina Helwig, CEO of AdvoCare. “We’re proud to offer Creatine+ as a clean, effective option that integrates effortlessly into our customers’ existing wellness routines. It’s a natural fit for anyone looking to push their limits and recover stronger.”

Creatine+ is available now at AdvoCare.com. Each 30-serving canister is priced at $39.95, offering a convenient and affordable way to elevate your performance.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

AdvoCare International, LLC:

AdvoCare International, LLC is making pursuing wellness easy and accessible. As an established health and wellness consumer packaged goods company, AdvoCare serves health-aware consumers through products that offer whole body support focusing on energy, hydration, immunity and gut health. Since 1993, AdvoCare has offered trusted health and wellness products like Spark^® to millions of customers and athletes across the world.

Contacts

Media Contact:

Ginger Greenberg

ggreenberg@sunwestpr.com

OmniAb to Hold OmniUltra Virtual Investor Event on December 15




OmniAb to Hold OmniUltra Virtual Investor Event on December 15

EMERYVILLE, Calif.–(BUSINESS WIRE)–$OABI #OABI—OmniAb, Inc. (NASDAQ: OABI) today announced it will hold a virtual investor event to showcase the launch of OmniUltra^™ on Monday, December 15, 2025, beginning at 5:00 p.m. Eastern time.

The event is expected to last approximately one hour and will include a review of OmniAb’s newest technology offering, OmniUltra, the industry’s only transgenic chicken engineered to express ultralong CDRH3 domains on a human antibody framework. Management will provide an overview of this innovative and pioneering technology platform, its market use and applications, as well as its strategic importance to the business.

Conference Call and Webcast Information

About OmniAb^®

OmniAb licenses cutting edge discovery research technology to pharmaceutical and biotech companies and academic institutions to enable the discovery of next-generation therapeutics. Our technology platform creates and screens diverse antibody repertoires and is designed to quickly identify optimal antibodies and other target-binding proteins for our partners’ drug development efforts. At the heart of the OmniAb platform is something we call Biological Intelligence™, which powers the immune systems of our proprietary, engineered transgenic animals to create optimized antibody candidates for human therapeutics. We believe the OmniAb animals comprise the most diverse host systems available in the industry. Our suite of technologies and methods, including computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms, is used to identify fully-human antibodies with exceptional performance and developability characteristics. We provide our partners both integrated end-to-end capabilities and highly customizable offerings, which address critical industry challenges and provide optimized discovery solutions. Our business model aligns scientific and economic interests of our partners through structured agreements that generally include upfront/access fees, service revenue, milestones and royalties on commercial sales.

For more information, please visit www.omniab.com.

Contacts

OmniAb, Inc.

investors@OmniAb.com
X @OmniAbTech

Alliance Advisors IR

Yvonne Briggs

ybriggs@allianceadvisors.com
(310) 691-7100

Oligonucleotide Synthesis Market Industry Trends and Global Forecasts Report 2025-2035: Market Strengthens With 110+ Providers, North America Leads, Clinical Pipeline Exceeds 300 Trials – ResearchAndMarkets.com




Oligonucleotide Synthesis Market Industry Trends and Global Forecasts Report 2025-2035: Market Strengthens With 110+ Providers, North America Leads, Clinical Pipeline Exceeds 300 Trials – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Oligonucleotide Synthesis Market Industry Trends and Global Forecasts to 2035: By Application Area, Type of Product Synthesized, Type of Oligonucleotide Synthesized, Scale of Operation, Therapeutic Area, End-Users, Company Size and Key Geographical Regions” report has been added to ResearchAndMarkets.com’s offering.

The global oligonucleotide synthesis market is estimated to grow from USD 4.8 billion in 2025, to USD 13.5 billion by 2035, at a CAGR of 9.9% during the forecast period, till 2035.

Oligonucleotide Synthesis Market: Growth and Trends

Oligonucleotides are one of the fastest growing segments in the pharmaceutical industry. These molecules are extensively utilized in biopharmaceutical and biotechnology fields for various applications, including research, genetic testing, forensic analysis, and other analytical methods. Currently, researchers are investigating the potential of oligonucleotides as a pharmacological approach for the treatment of a myriad of disease indications. In addition, it is worth noting that close to 300 clinical trials have been registered across different geographical regions to evaluate various oligonucleotides for therapeutic purposes.

As the oligonucleotide manufacturing industry advances, numerous automatic oligo synthesizers are being incorporated into large scale production for developing and producing oligonucleotide therapeutics. These synthesizers can execute steps, such as molecule synthesis, removal of protecting groups, purification, desalting and lyophilization, with increased efficiency. However, the challenges associated with oligonucleotide production, including extended timelines, lack of purification techniques, lack of expertise, and regulatory and compliance-related issues among the developers, have driven drug developers to outsource key operations.

At present, over 110 oligonucleotide synthesis providers offer custom oligonucleotide synthesis, oligonucleotide modification and oligonucleotide purification services, which are intended for research, diagnostic and therapeutic applications. The growing oligonucleotide-based drugs pipeline, encouraging clinical trial results and extensive research activity in the domain, is likely to present lucrative market growth opportunities for custom / contract service providers, during the forecast period.

Oligonucleotide Synthesis Market: Key Segments

Currently, the Oligonucleotide Finished Dosage Form holds the Largest Share of the Oligonucleotide Synthesis Market

Based on the type of product synthesized, the market is segmented into active pharmaceutical ingredients and finished dosage forms. It is worth highlighting that the majority of the current oligonucleotide synthesis market is captured by oligonucleotide finished dosage form and this trend is likely to remain same in the coming decade.

Antisense Oligonucleotide is Likely to Dominate the Oligonucleotide Synthesis Market During the Forecast Period

Based on the type of oligonucleotide synthesized, the market is segmented into antisense, DNA, siRNA and other oligonucleotides. It is worth highlighting that siRNA and antisense oligonucleotides-based therapies are likely to grow at a relatively higher CAGR, during the forecast period. This can be attributed to the rising number of approved siRNA and antisense oligonucleotides-based therapies for various rare diseases, genetic disorders and other disorders.

By Scale of Operation, Commercial Scale is Likely to Capture the Larger Share of the Oligonucleotide Synthesis Market During the Forecast Period

Based on scales of operation, the market is segmented into clinical and commercial scale. It is worth highlighting that the commercial scale manufacturing will be the primary driver of the overall market in the coming decade.

Currently, Pharmaceutical and Biopharmaceutical Companies hold the Largest Share within the Oligonucleotide Synthesis Market

Based on end user, the market is segmented into pharmaceutical and biopharmaceutical companies, academic and research institutes, and hospitals. It is worth highlighting that the revenues generated from manufacturing of oligonucleotides by pharmaceutical and biopharmaceutical companies is expected to grow substantially in the coming decade as compared to other end-users.

By Company Size, Mid-Sized Companies are Likely to Grow at a Relatively Higher Pace During the Forecast Period

Based on company size, the market is segmented into small, mid-sized, and large and very large companies. It is worth highlighting that the majority of the current oligonucleotide synthesis market is captured by large and very large players.

Rare Diseases Segment Accounts for the Largest Share for the Oligonucleotide Synthesis Market

Based on therapeutic areas, the market is segmented into cardiovascular disorders, genetic disorders, liver disorders, rare diseases and other disorders. While rare diseases account for a relatively higher market share, it is worth highlighting that cardiovascular disorders segment is expected to witness substantial market growth in the coming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Oligonucleotide Synthesis Market Insights: The report delves into the current state of the oligonucleotide synthesis market and identifies potential growth opportunities within the industry.

• Presently, over 110 synthesis providers claim to have the necessary capabilities to offer oligonucleotide synthesis services; the majority of these firms are based in North America.
• Stakeholders in this domain synthesize various types of oligonucleotides, across different scales of operations; close to 90% of the players offer purification services.
• In pursuit of building a competitive edge in this field, stakeholders are actively upgrading their existing capabilities and adding new competencies in order to enhance their respective portfolios.
• Close to 300 clinical trials (with over 75,000 enrolled patients) have been registered to investigate oligonucleotide based-therapeutic products, across different geographies.
• Since 2017, several deals have been inked between various stakeholders engaged in this domain; acquisitions emerged as the most common type of partnership model.
• To keep pace with the growing demand for oligonucleotides, companies have made elaborate investments to expand their existing capacities and capabilities; this trend is most pronounced in the US and China.
• Several big pharma players have undertaken various initiatives, including partnerships, expansions and funding initiatives; 48% of such initiatives were focused on the development and manufacturing of RNAi oligonucleotides.
• The global, installed oligonucleotide synthesis capacity is spread across various geographies; interestingly, more than 75% of the total capacity is installed at the facilities owned by large and very large players.
• Given the growing complexity of APIs, the demand for oligonucleotides has upsurged; by 2035, it is anticipated to reach around 2,200 kilograms, across clinical and commercial scales.
• Considering the wide array of applications of oligonucleotides and the continuous research efforts of stakeholders in this domain, the adoption of these modalities is poised to witness steady growth in the foreseeable future.
• Driven by the increasing number of chronic indications (requiring novel personalized therapies) and ongoing research on oligonucleotide-based therapeutics, this market is anticipated to grow at a CAGR of 9.9%, till 2035.
• Over 40% of the market is expected to be captured by revenues generated from manufacturing drugs for rare diseases; further, oligonucleotide synthesis market in China is likely to grow at a faster pace.

Reasons to Buy this Report

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

Players in the Oligonucleotide Synthesis Market, Profiled in the Report Include:

• Agilent Technologies
• Ajinomoto Bio-Pharma Services
• CordenPharma
• Creative Biolabs
• Ella Biotech
• Eurofins Genomics
• Future synthesis
• Integrated DNA Technologies
• Kaneka Eurogentec
• LGC Biosearch Technologies
• Microsynth
• Nitto Avecia
• Merck
• Ribo Biotechnology
• STA Pharmaceutical
• Sumitomo Chemical
• Thermo Fisher Scientific
• TriLink Biotechnologies

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

• Founder and Managing Director, BianoGMP
• Co-Founder and Managing Director, Hanugen Therapeutics
• Chief Scientific Officer and Managing Director, IBA Life Sciences
• Chief Scientific Officer, Axolabs
• Business Officer, SBS Genetech
• Chem Lab Manager, Aptagen
• Global Corporate Sales and Business Development, Invitek Diagnostics

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 10% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older

For more information about this report visit https://www.researchandmarkets.com/r/7vifmq

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

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press@researchandmarkets.com
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GXP-Storage Appoints Former Eli Lilly Global Clinical Research Executive Chris Otto to Board of Directors




GXP-Storage Appoints Former Eli Lilly Global Clinical Research Executive Chris Otto to Board of Directors

Veteran brings over three decades of global clinical research experience to strengthen innovation and international expansion

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–GXP-Storage^®, a life sciences leader in compliant, visible and scalable material management, announced today the appointment of Chris Otto as an Independent Board Member, effective November 12, 2025. With over three decades of global clinical research and development experience, Otto brings deep operational expertise from his career at Eli Lilly and Company, where he most recently served as Global Leader and Associate Vice President of Clinical Laboratory Sciences, including accountability for clinical imaging and connected devices.

Otto’s appointment advances GXP-Storage’s mission to simplify material management across the full clinical lifecycle. As decentralized and hybrid trials become the norm, the company’s purpose-built facilities and GXP-Guardian^® digital platform provide sponsors with complete visibility, validated environments and audit-ready confidence across global research networks.

“Clinical trials are more complex than ever before, and our customers need partners that understand the regulatory and operational demands of global studies,” said Jeff Johnson, Founder and CEO of GXP-Storage. “Chris brings deep experience managing international clinical operations at scale. His insight will be invaluable as we expand our global capabilities and help sponsors reduce operational burden while maintaining full compliance.”

Otto held leadership positions across Clinical Data Sciences, Clinical Pharmacology, and R&D IT during his tenure at Eli Lilly and Company. He also spent five years in Japan, where he established Lilly Japan’s Clinical Laboratory Sciences organization and led multiple R&D initiatives and functions. His experience spans clinical development strategy, operational excellence and international research coordination across therapeutic areas.

“What attracted me to GXP-Storage is their understanding that you can’t optimize materials in transit without equally optimizing them at rest,” said Otto. “Their integrated approach creates the visibility and control that sponsors need to protect irreplaceable samples while maintaining inspection readiness, an issue I saw time and again in global studies.”

GXP-Storage’s expanding footprint—including its acquisition of Qualogy Ltd in the UK’s Golden Triangle—and dual ISO 9001:2015 and ISO 20387:2018 certifications, establishes one of the most comprehensive quality frameworks in regulated material management.

About GXP-Storage

GXP-Storage is the trusted partner for regulated material management in life sciences. Combining purpose-built facilities with the validated GXP-Guardian^® digital platform, the company delivers total custody, real-time visibility and audit-proven compliance across every temperature—from controlled ambient to cryogenic. Trusted by global pharma, biotech, CDMO and healthcare organizations, GXP-Storage transforms storage from a compliance risk into a strategic advantage. Learn more at www.gxp-storage.com.

Contacts

For GXP-Storage

Mandy Wilkins

Propel Marketing Group

mandyw@propelmg.com

insitro Appoints R&D Veteran Stephen Hitchcock and AI Visionary Vijay Pande as Scientific Advisors




insitro Appoints R&D Veteran Stephen Hitchcock and AI Visionary Vijay Pande as Scientific Advisors

Former Takeda CSO and a16z Bio + Health Founder to Guide Clinical Translation and Scaling of insitro’s ChemML™ Platform

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–insitro, the AI therapeutics company built on causal biology, today announced the appointment of two scientific advisors: Stephen Hitchcock, Ph.D., a preeminent drug development leader and former Chief Scientific Officer of Takeda, and Vijay Pande, Ph.D., co-founder of VZVC and, previously, founder and General Partner of Andreessen Horowitz’s Bio + Health fund.

Hitchcock and Pande will advise on the continued development and scaling of insitro’s AI-driven ChemML™ platform as it is deployed across insitro’s pipeline and partner programs. Their guidance will focus on translating compelling targets into the medicinal chemistry and preclinical development strategies required to advance therapeutics into clinical trials – connecting computational prediction with the realities of drug development at scale.

“Drug discovery often falters at the gap between biological promise and clinical reality,” said Daphne Koller, Ph.D., founder and CEO of insitro. “ChemML is designed to bridge that divide. By integrating computational prediction with high-throughput medicinal chemistry, we can rapidly create novel molecules that also solve for the complex pharmacological properties that determine a molecule’s success in patients – not just in the lab.”

“Steve brings deep experience navigating the complexities of drug development, while Vijay has been a pioneer in the use of machine learning for biology and chemistry,” Koller added. “Their combined perspective – spanning traditional R&D rigor and computational strategy – is critical as we advance our internal pipeline in metabolic disease and neuroscience, and work with strategic partners such as Bristol Myers Squibb and Eli Lilly.”

• Stephen Hitchcock, Ph.D., is a pharmaceutical R&D executive leader with more than 30 years of experience in biotech and large pharma (Takeda, Eli Lilly, and Amgen). As the former Chief Scientific Officer and Head of Global Research at Takeda, he directed the global research teams responsible for delivering clinical candidates against historically intractable targets across multiple therapeutic areas. He is currently a Venture Partner at 5AM Ventures and the CEO of Implexsys Bioscience.

  “The ChemML platform distinguishes itself by moving beyond binding affinity to solve for the multiparametric pharmacological profile that drives safety and efficacy,” Hitchcock said. “This simultaneous optimization, particularly when applied to novel targets in challenging indications such as ALS – identified through insitro’s collaboration with Bristol Myers Squibb – represents a fundamentally different approach to drug discovery. I believe this technology will enable scientists to drug targets that would otherwise remain intractable, particularly in areas like CNS disorders where pharmacological complexity has historically limited progress.”
  

• Vijay Pande, Ph.D., served as a Stanford University faculty member for 16 years – notably as the Henry Dreyfus Professor of Chemistry, Structural Biology, and Computer Science – where he pioneered the use of computational methods in biology and chemistry. He founded Folding@home, a distributed computing project that helped establish large-scale computation as a practical tool for biological research. Pande subsequently served as a General Partner at Andreessen Horowitz, where he founded the firm’s Bio + Health fund. He co-founded VZVC earlier this year to invest in companies leveraging technology to solve humanity’s biggest problems, including healthcare and care access.

  “AI is transforming every dimension of our lives, yet its most profound potential lies in rewriting the trajectory of human health,” Pande said. “I am delighted to work with Steve and the insitro team as they advance this shift from descriptive science to predictive engineering. insitro has built the first true ‘closed loop’ system where high-quality data generation and model training reinforce one another. This structural advantage allows insitro to solve for clinical relevance at the very start of design, bridging the gap between computational promise and patient impact.”

The appointments follow several recent validation milestones for insitro’s integrated platform. The company expanded its collaboration with Bristol Myers Squibb in October to apply ChemML to a novel ALS target discovered in the partnership’s first phase – a deal with a potential value exceeding $2 billion. In September, insitro announced a partnership with Eli Lilly to build first-in-kind predictive ADMET models using data from 40 years of Lilly chemistry residing in Lilly’s TuneLab and validating ChemML as a core engine for the industry’s most difficult optimization challenges.

“For decades, drug discovery has been trapped in a cycle of elegant biochemistry yielding clinical disappointment,” said Philip Tagari, Chief Scientific Officer of insitro. “R&D teams optimize for binding affinity because it’s measurable, then confront the unmeasured complexity – brain penetration, metabolic stability, selectivity – only after molecules fail in vivo. ChemML inverts this entirely by treating pharmacology as a design constraint from the first iteration, solving simultaneously for the complete profile that determines therapeutic success. As we scale this approach across ALS, metabolic disease, and other intractable indications, Steve and Vijay bring the strategic perspective needed to bridge computational prediction with clinical reality, ensuring we build medicines that work in people, not just in silico.”

About insitro

insitro is the AI therapeutics company built on causal biology. By generating the largest integrated multi-modal corpus of human and cellular data and disentangling it through the lens of AI, we have created a platform that reveals how disease begins, progresses, and can be resolved. Our approach enables us to precisely identify genetic drivers, select the right targets, and use AI to design medicines that treat disease at its root. Focused on metabolic disease and neuroscience, our models create a self-learning loop that accelerates discovery and moves us closer to systematically eradicating grievous illness. insitro is backed by world-class investors and has brought in ~$800M in capital, including ~$150M from non-dilutive pharma partnerships including BMS, Lilly, and Gilead. Learn more at insitro.com.

Contacts

Media Contact
Eric McKeeby

eric@insitro.com

Taiho Oncology Europe announces the launch of Lytgobi®▼ (futibatinib) in the United Kingdom for eligible adult patients with a previously treated subtype of locally advanced or metastatic cholangiocarcinoma1




Taiho Oncology Europe announces the launch of Lytgobi®▼ (futibatinib) in the United Kingdom for eligible adult patients with a previously treated subtype of locally advanced or metastatic cholangiocarcinoma1

Lytgobi (futibatinib) marks the first medicine launched by Taiho Oncology Europe in the UK²

BAAR, Switzerland–(BUSINESS WIRE)–For United Kingdom (UK) Trade and Medical Media Only

Taiho Oncology Europe GmbH announced today the UK launch of Lytgobi^® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor.^1,3 This development follows the conditional marketing authorisation (4 September 2024) and subsequent National Institute for Health and Care Excellence (NICE) recommendation (11 September 2024) for futibatinib monotherapy as an option for the treatment of eligible adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.^1,4

CCA is an aggressive cancer of the bile ducts that carry bile inside the liver and from the liver and gallbladder to the small intestine. In England, approximately 3,110 people were diagnosed with CCA in 2023,^5,6 and the disease is growing in incidence worldwide.⁷ CCA is usually diagnosed at an advanced stage, with a very poor prognosis with less than one in five patients surviving five years, and there is an unmet need for additional treatment options such as futibatinib.^7,8

“Patients with CCA are mostly identified at a late stage of disease and consequently have a poor prognosis. The launch of futibatinib in the UK and positive NICE recommendation for treating locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic treatment in adults represents a much needed additional treatment option for eligible patients with this aggressive cancer,” said Professor John Bridgewater, Clinical Researcher and Medical Oncologist at University College London Cancer Institute and University College London Hospitals NHS Foundation Trust.

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.¹ The medicine is taken orally, once daily, on a continuous basis (treatment should be continued until disease progression or unacceptable toxicity).¹

The conditional marketing authorisation^*, where UK approval is granted for medicines that fulfil an unmet medical need while regulatory data review is ongoing,⁹ is based on findings from the pivotal Phase 2 FOENIX-CCA2^‡ global open-label, single-arm trial evaluating 103 patients with unresectable, locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement.^1,10 The trial showed that futibatinib provided a clinically meaningful benefit, meeting its primary endpoint of objective response (partial or complete response as assessed by independent central review) with a rate of 42% (95% CI, 32–52), and a median duration of response of 9.7 months (95% CI, 7.6–17.0).^10,11 Among the secondary endpoints, the 12-month overall survival rate was 72% (95% CI, 62–80).¹⁰

The most common (≥20%) adverse reactions were hyperphosphatemia (89.7%), nail disorders (44.1%), constipation (37.2%), alopecia (35.2%), diarrhoea (33.8%), dry mouth (31.0%), fatigue (31.0%), nausea (28.3%), dry skin (27.6%), increased AST (26.9%), abdominal pain (24.8%), stomatitis (24.8%), vomiting (23.4%), palmar-plantar erythrodysaesthesia syndrome (22.8%), arthralgia (21.4%), and decreased appetite (20.0%).¹

The results of the FOENIX-CCA2 trial were published in The New England Journal of Medicine in 2023.¹⁰ Within Europe, eligible patients were enrolled in this trial from France, Germany, Italy, the Netherlands, Spain and the United Kingdom.¹⁰

“The launch of futibatinib in the UK is the culmination of extensive and productive collaboration among researchers, healthcare professionals, and patients, all united in their commitment to advance care in cholangiocarcinoma and to improve the lives of eligible patients,” said Dr. Peter Foertig, General Manager of Taiho Oncology Europe. “This marks the first medicine Taiho Oncology has introduced in the UK on our own, signifying our intention to establish a strong presence and reinforcing our ongoing commitment to bringing innovative oral therapies to patients with cancer.”

Futibatinib was developed by Taiho Oncology Europe’s parent company, Taiho Pharmaceutical Co., Ltd., Tokyo. The larger Taiho family of companies continues to investigate its potential in other tumours.¹²

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

^* A conditional marketing authorisation is granted for medicines that fulfil an unmet medical need to treat serious diseases, and the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. As part of this authorisation there will be ongoing review of data to ensure the benefit-risk balance remains positive.⁹

^‡ The FOENIX-CCA2 trial is a Phase 1 / 2 Study of TAS-120 in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: FGFR Oral SElective Novel Inhibitor X [across] tumors.

About Lytgobi (futibatinib) 

Futibatinib is an oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. Futibatinib irreversibly binds to the adenosine triphosphate-binding pocket of FGFR1–4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumour-cell proliferation and increased tumour-cell death in tumours with FGFR1–4 genetic aberrations.^1,3

About Taiho Oncology Europe 

The mission of Taiho Oncology Europe is to improve the lives of patients with cancer, their families, and their caregivers. The company specialises in orally administered anti-cancer agents and has a growing pipeline of selectively targeted anti-cancer agents. Taiho Oncology Europe GmbH (Baar, Switzerland) is the European subsidiary of Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan). For more information, visit www.taihooncology.eu.

Lytgobi is a registered trademark of Taiho Pharmaceutical Co., Ltd.

References:

1. Lytgobi^® (futibatinib): Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/100700/smpc#gref Last accessed: November 2025.
2. Taiho Oncology Europe. Futibatinib in Italy for the treatment of cholangiocarcinoma. Published 12 February 2025. Available at Taiho Oncology Europe Announces Availability of Lytgobi® (futibatinib) in Italy for the Treatment of Cholangiocarcinoma Last accessed: November 2025.
3. Sootome H, Fujita H, Ito K, et al. Futibatinib is a novel irreversible FGFR 1–4 inhibitor that shows selective anti-tumor activity against FGFR-deregulated tumors. Cancer Res. 2020;80:4986-4997. Available at: https://aacrjournals.org/cancerres/article/80/22/4986/645861/Futibatinib-Is-a-Novel-Irreversible-FGFR-1-4 Last accessed: November 2025.
4. NICE. Futibatinib for previously treated advanced cholangiocarcinoma with FGFR2 fusion or rearrangement. Published: 11 September 2024. Available at https://www.nice.org.uk/guidance/ta1005 Last accessed: November 2025.
5. Tataru D, Khan SA, Hill R, et al. Cholangiocarcinoma across England: temporal changes in incidence, survival and routes to diagnosis by region and level of socioeconomic deprivation. JHEP Reports. 2023;6(3):100983. Available at: https://www.jhep-reports.eu/article/S2589-5559(23)00314-2/fulltext Last accessed: November 2025.
6. Office for National Statistics. Population estimates for the UK, England, Wales, Scotland and Northern Ireland: mid-2023. Available at: Population estimates for the UK, England, Wales, Scotland and Northern Ireland – Office for National Statistics Last accessed: November 2025.
7. Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557-588. Available at: https://www.nature.com/articles/s41575-020-0310-z#:~:text=CCA%20is%20a%20rare%20cancer,in%20the%20past%20few%20decades Last accessed: November 2025.
8. Valle JW, Bai LY, Orlova R, et al. Ramucirumab (RAM) or merestinib (MER) or placebo (PL) plus gemcitabine (GEM) and cisplatin (CIS) as first-line treatment for advanced or metastatic biliary tract cancer (BTC): a randomized, double-blind, phase II study. J Clinical Oncol. 2020;38(4):Abstract 477. Available at: https://ascopubs.org/doi/10.1200/JCO.2020.38.4_suppl.477 Last accessed: November 2025.
9. GOV.UK. Conditional marketing authorisations, exceptional circumstances MAs, scientific advice. Available at: https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice Last accessed: November 2025.
10. Goyal L, Meric-Bernstam F, Hollebecque A, et al. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2206834 Last accessed: November 2025.
11. National Library of Medicine. A study of TAS-120 in patients with advanced solid tumors. Available at: https://clinicaltrials.gov/study/NCT02052778 Last accessed: November 2025
12. National Library of Medicine. Futibatinib search results. Available at: https://clinicaltrials.gov/search?term=Futibatinib%20 Last accessed: November 2025

LYT-PM-UK-0011

Contacts

Taiho Oncology Europe Media Contact:
Leigh Labrie

+1 609.664.9878

llabrie@taihooncology.com

www.taihooncology.com

Beth Gaffey

+44 7884 318 976

bethan.gaffey@precisionaq.com

Merck Showcases Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at CTAD 2025




Merck Showcases Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at CTAD 2025

Merck granted Fast Track Designation by the U.S. FDA for MK-2214 for the treatment of Alzheimer’s disease

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and address an unmet medical need.

Key data being presented:

• MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau: First presentation of data from three Phase 1 studies evaluating MK-2214. Two studies assessed the safety, tolerability and pharmacokinetics of a single ascending dose of MK-2214 in healthy volunteers, while a third assessed the safety, tolerability and pharmacokinetics of a multiple ascending dose regimen in individuals with mild cognitive impairment and mild-to-moderate Alzheimer’s disease. The results from these studies helped inform an ongoing Phase 2 trial of MK-2214 evaluating safety and efficacy, including its effect on certain changes in the brains of people with early Alzheimer’s disease (NCT07033494).
• MK-1167, an investigational oral positive allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor: First presentation of data from a Phase 1 first-in-human study evaluating MK-1167. The trial assessed the effect of single doses of MK-1167 on glutamate metabolism in the prefrontal cortex of healthy adult male volunteers, as measured by 13C-magnetic resonance spectroscopy. The results from this study helped inform dose selection for an ongoing Phase 2 trial of MK-1167 evaluating safety and efficacy, including its effect on memory and mental activity, in people with mild-to-moderate Alzheimer’s disease dementia taking stable donepezil treatment (NCT06721156).

“Alzheimer’s disease remains one of the greatest neurological challenges of our time and yet new insights are providing important new paths to evaluate potential new therapeutic approaches,” said Dr. Mike Egan, vice president, neuroscience, global clinical development, Merck Research Laboratories. “We are pleased to share data showing progress in our pipeline of candidates targeting Alzheimer’s disease at CTAD 2025.”

Details on Merck abstracts at CTAD 2025:

MK-2214 is being developed through an agreement with Teijin Pharma.

About Alzheimer’s disease

Alzheimer’s disease is a progressive brain disorder and the most common cause of dementia, in which people lose memory, thinking skills and the ability to live independently. Alzheimer’s disease affects approximately seven million people in the U.S., with this number estimated to grow to 14 million by 2060. Recent progress in the area of human genetics in addition to advanced technology and screening tools is helping us better understand pathology in the brain and fueling innovative research in Alzheimer’s.

Merck in Neuroscience

At Merck, we are committed to discovering and developing novel therapeutics for a variety of diseases involving the nervous system, which remain among today’s most significant medical challenges. Our research is focused on investigating the complexities of central and peripheral nervous system disorders to treat, slow progression or prevent disease.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Katie Fey

(929) 738-2078

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Ronovo Surgical Announces Appointment of Non-Executive Directors to Accelerate Global Growth




Ronovo Surgical Announces Appointment of Non-Executive Directors to Accelerate Global Growth

SHANGHAI–(BUSINESS WIRE)–#MIS–Ronovo Surgical, a global innovator in next-generation surgical robotics, announces today the appointment of Dr. Eduardo Parra-Davila and Jeroen M.M. van Heesewijk as Non-Executive Directors to its Board of Directors.

Dr. Parra-Davila is one of the world’s leading general surgeons with over 25 years of experience and over 5,000 cases of robotic surgery. He currently serves as Chief of General Surgery and Director of Minimally Invasive Colorectal Surgery and Hernia/Abdominal Wall Reconstruction at Good Samaritan Medical Center in West Palm Beach (Florida). As a founding member of the Society of Robotic Surgery (SRS) and the Clinical Robotic Surgery Association (CRSA), Dr. Parra-Davila has trained thousands of surgeons globally in minimally invasive and robotic surgery. He is also a contributing member of American College of Surgeons (ACS), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), American Hernia Society (AHS) and American Society of Colon and Rectal Surgeons (ASCRS).

Mr. van Heesewijk is a seasoned executive with over 30 years of management experience in the medical devices industry, including professional leadership roles for 7 years in Europe and 15 years in China. He most recently served as SVP of Asia Pacific and Global Distribution at Intuitive. Previously, he served in numerous senior executive roles within Philips, including VP of Strategic Business Development at Philips Medical Systems Asia Pacific, President of Philips Medical Systems Greater China, as well as GM of Philips Balkan, Philips Romania Srl. and Philips Bulgaria Ltd. With an academic background in international law and international relations, Mr. van Heesewijk holds a profound understanding of corporate governance structures.

Dr. John Ma, Founder, Chairman, and CEO of Ronovo Surgical, commented:

“We are delighted to welcome Dr. Parra-Davila and Mr. van Heesewijk to our Board. Their extensive experience and insights will be invaluable to Ronovo as we execute our long-term strategy. These appointments reflect our commitment to strengthening corporate governance, accelerating international growth, and creating long-term value for stakeholders.”

About Ronovo Surgical and Carina™ Platform

Founded in 2019, Ronovo Surgical is a digital and robotic surgery company built by a world-class team of medtech veterans and robotic surgeons. Dedicated to addressing unmet clinical needs, Ronovo envisions a future where robot-assisted surgery (RAS) is the practical choice for minimally invasive patient care across all surgical specialties. Ronovo is committed to customer-centric innovation and optimizing cost-effectiveness of robotic surgery solutions while simplifying the learning curve and broadening RAS utilization across surgical specialties. In just four years, Ronovo accelerated from conceptual design to commercialization of its Carina™ Platform for robot-assisted laparoscopic surgery. Its proprietary design is protected by more than 200 patent applications globally.

Carina™ received regulatory approval from China’s National Medical Products Administration (NMPA) in March 2025, becoming the first modular robotic surgery system in the country to obtain simultaneous approvals covering the four major specialties of General Surgery, Gynecology, Urology and Thoracic Surgery. With its configurable modular architecture, Carina™ offers flexibility, adaptability and affordability to address adoption challenges posed by legacy robotic surgery systems. In parallel, Ronovo has initiated global expansion, with regulatory submissions underway in Europe and South America. The platform has already received enthusiastic support from international key opinion leaders, validating its differentiated value proposition and ability to meet significant unmet needs across healthcare systems.

For more information, please visit: http://www.ronovosurgical.com/.

Contacts

ZiHan Lin

VP of International Operations

zlin@ronovo.com