Cybin Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures

Cybin Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures




Cybin Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures

– Funding agreement contemplates a conversion formula with a potential 30% premium upon conversion and positions the Company for growth, and accelerated advancement of its clinical pipeline programs, CYB003 and CYB004 –

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American: CYBN) (Cboe Canada: CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce the Company has entered into a securities purchase agreement (the “Securities Purchase Agreement”) with High Trail Special Situations LLC (“High Trail”), pursuant to which the Company agreed to sell and issue to High Trail up to US$500,000,000 in aggregate principal amount of unsecured convertible debentures (the “Convertible Debentures”). The sale and issue of US$50,000,000 principal amount of Convertible Debentures was completed on June 30, 2025 (the “Private Placement”). The sale and issue of US$450,000,000 of the principal amount of Convertible Debentures will be determined at a future date, upon mutual agreement of the parties.


“This financing represents a major inflection point for Cybin and supports our position as a leader within our sector,” said Doug Drysdale, Chief Executive Officer of Cybin. “High Trail Capital is an experienced investor, and its confidence and appreciation of our breakthrough clinical data and intellectual property portfolio recognize the potential of the Company. This financing comes at an opportune time for Cybin, as we advance our lead programs, CYB003 and CYB004, in Phase 3 and Phase 2, respectively. CYB003 demonstrated over 70% remission rates and continued durability over 12 months for patients with uncontrolled depression. We await the conclusion of our CYB004 Phase 2 proof-of-concept study, in patients with generalized anxiety disorder,” said Drysdale.

Joseph Gunnar & Co., LLC acted as the sole placement agent in connection with this transaction.

Pipeline Acceleration Drives Multiple Value Creation Catalysts

The funding will accelerate Cybin’s clinical-stage programs across multiple high-value indications:

CYB003 Program Achievements:

  • Breakthrough Clinical Results: Unprecedented 71% remission rate in major depressive disorder at 12 months after two 16 mg doses in Phase 2 study
  • Durability advantage: 12-month sustained efficacy demonstrating long-term therapeutic benefit
  • FDA Recognition: Breakthrough Therapy Designation received, expediting regulatory pathway
  • Multinational Phase 3 PARADIGM program underway

CYB004 Program Momentum:

  • Dual Indication Strategy: Expanding addressable market opportunity
  • Phase 2 GAD study expected to complete around mid-year 20251

Commercialization Infrastructure:

  • Manufacturing Scale-Up: Finalizing production capabilities for market launch
  • IP Portfolio Expansion: Strengthening competitive moat with more than 90 patents issued and over 230 applications pending
  • Strategic Partnerships: Developing market access and pre-commercialization alliances

Value Catalysts Drive Sustained Momentum

Near-Term Catalysts:

  • CYB004 Phase 2 GAD study expected to complete around mid-20251
  • Initiation of second CYB003 pivotal study, EMBRACE, around mid-20251
  • EXTEND study initiation imminent1

Medium-Term Catalysts (2025-2026):

  • Phase 3 top line readout for CYB003 2H 20261
  • Regulatory submission preparations
  • Commercial manufacturing readiness
  • International market expansion planning

Transaction Terms

The Convertible Debentures have a two-year term from the closing date (the “Term”). The Company shall pay guaranteed interest equal to 5.5% of the principal per annum for the Term. Such interest was pre-paid on closing. Upon the occurrence of an event of default, interest shall increase to a rate of 18% per annum on the outstanding principal balance. Pursuant to the terms of the Securities Purchase Agreement, the Company and High Trail may, upon mutual consent, enter into subsequent securities purchase agreements for the purchase and sale of up to an additional US$450,000,000 principal amount of Convertible Debentures, in tranches, in amounts on such dates as may be mutually agreed and each subsequent tranche shall include prepaid interest at a rate of 9.5%.

Subject to the terms of the Securities Purchase Agreement and the Convertible Debentures, High Trail will be entitled to convert the principal amount of, and accrued and unpaid interest, if any, on each Convertible Debenture, in whole or in part, from time to time, into common shares in the capital of the Company (the “Common Shares”) at a conversion price per Common Share equal to the lower of (a) 130% of the volume weighted average price (“VWAP”) of the Common Shares on the day prior to the initial issuance of the Convertible Debentures, or (b) the VWAP of the Common Shares during the five trading days immediately prior to the date of conversion.

The Company, in its sole discretion, may prepay any outstanding amount under the Convertible Debentures, in whole or in part, in cash by providing High Trail with advance written notice prior to such prepayment. The prepayment shall include, (i) if paid during the first year after closing, a 5% prepayment premium on the amount of the prepayment or (ii) if paid thereafter, a 3% prepayment premium on the amount of the prepayment.

The terms of the Convertible Debentures restrict the conversion of Convertible Debentures by High Trail if such a conversion or exercise would cause High Trail, together with any affiliate thereof, to beneficially own in excess of 4.99% of the number of Common Shares outstanding immediately after giving effect to such conversion.

The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.

The Convertible Debentures were offered on a private placement basis pursuant to prospectus exemptions in Canada and pursuant to exemptions and exclusions from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws. The Company has agreed to use commercially reasonable efforts to: (a) file a prospectus supplement to the Company’s base shelf prospectus dated August 17, 2023, as amended on December 22, 2023, April 8, 2024 and January 6, 2025, with applicable Canadian securities regulators to qualify the secondary market sales of the Common Shares in the United States; and (b) either (i) prepare and file the Canadian prospectus supplement with the United States Securities and Exchange Commission, or (ii) file a prospectus supplement pursuant to General Instruction II.L of Form F-10 with the United States Securities and Exchange Commission to the Company’s registration statement on Form F-10 (File No. 333-284173), which was declared effective by the SEC on January 14, 2025, or on such other form as may be available to the Company, in either case qualifying the resale of the Common Shares underlying the Convertible Debentures.

No securities regulatory authority has either approved or disapproved of the contents of this news release. This news release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been registered under the U.S. Securities Act, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws

About Cybin

Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.

Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Notes:

  1. There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See “Cautionary Notes and Forward-Looking Statements”.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release constitute forward-looking information and forward-looking statements within the meaning of applicable securities laws (together, “forward-looking statements”). Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the use of Private Placement proceeds; the conversion of the Convertible Debentures into Common Shares; the sale and issue of US$450,000,000 principal amount of Convertible Debentures at a future date; CYB004 Phase 2 GAD study expected to complete around mid-2025; Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025; the Company’s Medium-Term Catalysts for 2025-2026; Phase 3 PARADIGM program enrollment acceleration; the Company’s ability to achieve commercial success; and the Company’s ability to address the need for new and innovative treatment options for people who suffer from mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company’s operations; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and nine month periods ended December 31, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company’s profile on www.sedarplus.ca and with the SEC on EDGAR at www.sec.gov/edgar. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Cboe Canada nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Contacts

Investor & Media Contact:

Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com

Iksuda Therapeutics Receives FDA IND Clearance for IKS014

Iksuda Therapeutics Receives FDA IND Clearance for IKS014




Iksuda Therapeutics Receives FDA IND Clearance for IKS014

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore

Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across multiple tumour types

NEWCASTLE, England–(BUSINESS WIRE)–Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours, enabling the expansion of ongoing clinical trials.

IKS014 is currently being investigated in an open-label phase 1 dose-escalation study (https://clinicaltrials.gov/study/NCT05872295) designed to evaluate the safety and tolerability of increasing dose levels of IKS014 and establish a recommended phase 2 dose. Preliminary data from this study has demonstrated promising clinical activity across multiple tumour types, including breast, ovarian, gallbladder, and oesophageal cancers, and including patients who have relapsed after prior treatment with Enhertu. Gaining access to U.S. centres for the dose expansion stage of this phase 1 trial will enable efficient confirmation of the role of IKS014 in this important patient sub-set.

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:

“The FDA clearance of our IND application for IKS014 represents a significant milestone in our mission to address the critical unmet needs of patients with HER2-positive cancers, particularly those who have exhausted current standard-of-care options. Early clinical data has been extremely encouraging, and we are excited to expand our program to reach more patients.

“The early efficacy signals that have been observed, particularly in patients that have relapsed after receiving prior treatments of Kadcyla and Enhertu, suggest IKS014 could potentially offer a new treatment option for patients who currently have limited alternatives. We look forward to working with our clinical partners to further evaluate the potential of IKS014.”

The first stage of this phase 1 trial, to determine the recommended phase 2 dose for dose expansion, is nearing completion. The expansion phase will assess several patient cohorts including those with HER2-positive breast cancer who are refractory to or cannot tolerate Enhertu, patients with HER2-low breast cancer and patients with HER2-positive positive gastric cancer. The IND clearance will allow Iksuda to access patients across sites in the United States, alongside sites in Australia, New Zealand, and Singapore. The phase 1 trial is expected to complete in 2H 2026.

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index vs other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (https://iksuda.com/2022/01/iksuda-deepens-clinical-pipeline/).

About Iksuda Therapeutics: www.iksuda.com

Iksuda Therapeutics is a clinical stage, UK-based biotechnology company focussed on the development of class leading antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda’s pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink® platform. The Company’s design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer.

Contacts

For further information please contact:
Iksuda Therapeutics
Dave Simpson, Chief Executive Officer

Tel: +44 (0) 191 6031680

Email info@iksuda.com

FTI Consulting (Financial Media and IR)
Simon Conway / Rob Winder / Amy Byrne

Tel: +44 (0) 020 3727 1000

Iksuda@fticonsulting.com

RevolKa Ltd. Joins Research and Development Program for Innovative Biologics Funded by the Japanese Agency for Medical Research and Development (AMED)

RevolKa Ltd. Joins Research and Development Program for Innovative Biologics Funded by the Japanese Agency for Medical Research and Development (AMED)




RevolKa Ltd. Joins Research and Development Program for Innovative Biologics Funded by the Japanese Agency for Medical Research and Development (AMED)

RevolKa Fueling Up AI Protein Engineering Platform-based Therapeutic Program

SENDAI, Japan–(BUSINESS WIRE)–RevolKa Ltd. (RevolKa), a venture-backed biotech company providing a cutting-edge AI-driven protein engineering technology platform, called aiProtein® has announced its participation in a research and development program funded by a government grant of 54 million JPY (approximately US$372K for the first year) from the Japanese Agency for Medical Research and Development (AMED). This project, set to continue over 4 years, is led by Prof. Mitsuo Umetsu of Tohoku University, who also serves as RevolKa’s Chief Scientific Officer. This opportunity will further accelerate RevolKa’s rare disease drug discovery and development efforts, previously announced on July 30th, 2024. (https://www.revolka.com/news/english/collab-en/a65).

RevolKa’s core technology, aiProtein®: a robust directed protein evolution platform integrated with AI (artificial intelligence) creates exceptionally high performance proteins, going beyond natural evolution and offering advantages for therapeutic strategies. aiProtein® has generated many successful outcomes with many partner companies.


About aiProtein® Technology

RevolKa’s proprietary technology, aiProtein® is an AI-assisted directed evolution platform for proteins. Naturally occurring proteins are linear polymers composed of amino acids and their derivatives, folding into a tertiary structure through internal complex atomic interactions to exhibit biological functions. Proteins have evolved their biological functional complexity over hundreds of millions of years. However, the relationship between protein sequence, structure, and function remains poorly understood to enable rational design of protein sequences for specific function. RevolKa’s AI engine is trained with sequence-function relationship data, enabling statistical prediction of optimized protein sequences with desired functions. Furthermore, aiProtein® can evolve multiple properties simultaneously. This technology is a powerful and cost-effective solution for creating novel and highly functional proteins suitable for pharmaceutical and industrial applications.

About RevolKa Ltd.

RevolKa is a venture-backed biotechnology company founded in April 2021 by academic and industry experts in biotechnology and artificial intelligence. Our mission is to contribute to human well-being by creating novel proteins for therapeutics and industrial applications using our proprietary technology, aiProtein®. The name “RevolKa” is derived from the Latin word for evolution, “evolutio” and the Ainu (an indigenous Japanese people) word for raise, “reska”. RevolKa’s headquarters and laboratories are located in Sendai, Japan. The company’s investors include D3 LLC, Tohoku University Venture Partners Co., Ltd., DEEPCORE Inc., and SBI Investment Co., Ltd. For more information, visit https://www.revolka.com/en/.

Contacts

RevolKa Ltd.

Ayumi Iwase

Email: info@revolka.co.jp

Syngenta to Become Global Leader in Biologicals; Expanding Nature Inspired Solutions for Farmers

Syngenta to Become Global Leader in Biologicals; Expanding Nature Inspired Solutions for Farmers




Syngenta to Become Global Leader in Biologicals; Expanding Nature Inspired Solutions for Farmers

  • Industry-leading innovation pipeline contains several new products with blockbuster potential
  • Market value of agricultural biologicals products expected to exceed USD 20 billion by 2030

BASEL, Switzerland–(BUSINESS WIRE)–Syngenta is accelerating the rollout of its nature-inspired, science-based biological solutions, responding to rising demand for sustainable, high-performance tools that help farmers boost productivity efficiently and responsibly. It also contributes toward Syngenta’s fulfilment of commitments outlined in its Sustainability Priorities.


Jonathan Brown, Global Head Biologicals & Seedcare, comments: “With our recent partnerships and acquisitions and extended manufacturing capacities, Syngenta is positioning itself as the leader in biologicals. Our scientific expertise is at the forefront of our research and development efforts to provide farmers with the next generation of biologicals, helping them transition towards more sustainable farming practices, such as regenerative agriculture.”

In December 2024, the company acquired Intrinsyx Bio, a California-based start-up specializing in the development of nutrient-use efficiency products. Most recently, in early 2025, Syngenta concluded the integration of Novartis’ Strains and Natural Products Collection, the repository of natural compounds and genetic strains for agricultural use. These additions will accelerate the development of biologicals, bringing new tools to the market as a sustainable complement to conventional crop protection solutions.

Also in 2025, Syngenta opened a 22,000 m² biologicals facility in Orangeburg, South Carolina, in the United States, which is purpose-built to produce 16,000 tons of biostimulants annually. This new manufacturing facility complements Syngenta’s existing global network of biologicals’ manufacturing facilities in Brazil, Italy, India and Norway.

These strategic milestones effectively enhance both Syngenta’s R&D, operating out of the centers of excellence in Stein, Switzerland; Jealott’s Hill, UK; Atessa, Italy; and production capacity for biologicals, facilitating Syngenta’s roll out of its biologicals pipeline, with multiple candidates demonstrating strong commercial potential with projected annual sales above USD 100 million.

Syngenta Biologicals posted strong Q1 2025 results, with standout performance in North America and China. The global biologicals market is growing at around 10% CAGR and is projected to reach nearly USD 20 billion by 2030, according to AgbioInvestor and Syngenta’s estimate, underlining the pivotal role of biologicals in the future of sustainable farming.

Derived predominantly from naturally occurring substances, biologicals offer significant potential for sustainable agriculture. The market can be categorized into three main categories:

  • Biocontrols – Naturally derived products for managing pests, diseases, and weeds.
  • Biostimulants – Products enhancing natural plant processes to improve abiotic stress tolerance and crop quality.
  • Nutrient Use Efficiency (NUE) products – Any substance or microorganism to improve macro- and micronutrient availability and uptake to promote growth and enhance yield.

About Syngenta

Syngenta is a global leader in agricultural innovation with a presence in more than 90 countries. Syngenta is focused on developing technologies and farming practices that empower farmers, so they can make the transformation required to feed the world’s population while preserving our planet. Its bold scientific discoveries deliver better benefits for farmers and society on a bigger scale than ever before. Guided by its Sustainability Priorities, Syngenta is developing new technologies and solutions that support farmers to grow healthier plants in healthier soil with a higher yield. Syngenta Crop Protection is headquartered in Basel, Switzerland; Syngenta Seeds is headquartered in the United States. Read our stories and follow us on LinkedIn, Instagram & X.

Data protection is important to us. You are receiving this publication on the legal basis of Article 6 para 1 lit. f GDPR (“legitimate interest”). However, if you do not wish to receive further information about Syngenta, just send us a brief informal message and we will no longer process your details for this purpose. You can also find further details in our privacy statement.

Cautionary Statement Regarding Forward-Looking Statements

This document may contain forward-looking statements, which can be identified by terminology such as ‘expect’, ‘would’, ‘will’, ‘potential’, ‘plans’, ‘prospects’, ‘estimated’, ‘aiming’, ‘on track’ and similar expressions. Such statements may be subject to risks and uncertainties that could cause the actual results to differ materially from these statements. For Syngenta, such risks and uncertainties include risks relating to legal proceedings, regulatory approvals, new product development, increasing competition, customer credit risk, general economic and market conditions, compliance and remediation, intellectual property rights, implementation of organizational changes, impairment of intangible assets, consumer perceptions of genetically modified crops and organisms or crop protection chemicals, climatic variations, fluctuations in exchange rates and/or commodity prices, single source supply arrangements, political uncertainty, natural disasters, and breaches of data security or other disruptions of information technology. Syngenta assumes no obligation to update forward-looking statements to reflect actual results, changed assumptions, or other factors.

©2025 Syngenta. Rosentalstrasse 67, 4058 Basel, Switzerland.

Contacts

Media Contacts
Syngenta Media Relations

media@syngentagroup.com

Web Resources
Pictures

Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025

Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025




Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025

ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia’s website.


About Aurinia

Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.

Contacts

ir@auriniapharma.com

Torrent Pharma to Acquire Controlling Stake in J. B. Chemicals & Pharmaceuticals from KKR

Torrent Pharma to Acquire Controlling Stake in J. B. Chemicals & Pharmaceuticals from KKR




Torrent Pharma to Acquire Controlling Stake in J. B. Chemicals & Pharmaceuticals from KKR

Acquisition to be followed by merger; strengthens Torrent’s IPM market presence

MUMBAI, India–(BUSINESS WIRE)–Torrent Pharmaceuticals Limited (“Torrent”) and global investment firm KKR today announced that Torrent has entered into definitive agreements to acquire controlling stake in J. B. Chemicals and Pharmaceuticals (“JB Pharma”) from KKR at an Equity Valuation of INR 25,689 crores (on fully diluted basis), followed by a merger of the two entities. The transaction marks a significant step in Torrent’s ambition to create a future-ready, diversified healthcare platform combining a deep chronic segment heritage with emerging international CDMO capabilities.


The transaction will be executed in 2 phases:

  1. Acquisition of 46.39% equity stake (on a fully diluted basis) through a Share Purchase Agreement (“SPA”) at a consideration of INR 11,917 crores (INR 1,600 per share) followed by a mandatory open offer to acquire up to 26% of JB Pharma shares from public shareholders at an open offer price of INR 1,639.18 per share. In addition to the above, Torrent has also expressed its intent to acquire up to 2.80% of equity shares from certain employees of JB Pharma at the same price per share as KKR.
  2. Merger between Torrent and JB Pharma through a scheme of arrangement. As per the approval given by the Board of Directors of both companies, upon merger of JB Pharma with Torrent, every shareholder holding 100 shares in JB Pharma shall receive 51 shares of Torrent.

Samir Mehta, Executive Chairman, Torrent, commented: “We are pleased to have on board the JB Pharma heritage and build on the platform for the future. Torrent’s deep India presence and JB Pharma’s fast growing India business, combined with the CDMO and international footprint offers immense potential to scale both revenue and profitability. This strategic alignment furthers our goal of strengthening our presence in the Indian pharma market, and build a larger diversified global presence. Moreover, the CDMO platform provides a new long-term avenue of growth for Torrent.”

Gaurav Trehan, Co-Head of Asia Pacific and Head of Asia Pacific Private Equity, KKR, and CEO of KKR India, said: “JB Pharma’s transformation under our stewardship is a testament to KKR’s ability to scale high-quality companies. We are proud to have collaborated with JB Pharma’s management team, led by Nikhil Chopra, to bring the breadth of KKR’s global experience and operational expertise to support the company’s organic and inorganic growth, and help JB Pharma become one of India’s fastest growing branded pharmaceutical companies. We believe the company is well-positioned for continued growth ahead and wish the team every success in its next chapter with Torrent.”

Nikhil Chopra, Chief Executive Officer and Whole Time Director of JB Pharma, remarked: “Over the past five years, JB Pharma has emerged as one of India’s fastest growing pharmaceutical players, owing to KKR’s strategic guidance, stewardship of our independent directors and a focused strategic and executional excellence by the management team. We have built a strong foundation to deliver market-leading growth, as well as consistent improvement in profitability in the medium and long term. As we now enter a new chapter alongside Torrent Pharmaceuticals, we are confident that the combined strengths of our organizations will unlock greater opportunities to enhance healthcare access across our markets.”

Strategic Rationale for Acquisition

  • Acquisition provides access to a fast-growing India franchise, with leading brands in the chronic segment, and entry into untapped therapeutic areas like ophthalmology
  • Strengthens market share in the IPM for Torrent
  • Operational synergies across multiple business functions
  • Platform diversification: entry into the CDMO segment with long-term potential
  • Consolidation in key international markets and greater ability to scale up

Transaction Structure & Approvals

  • Torrent will acquire 46.39% stake (on a fully diluted basis) through an SPA and additional potential acquisition of up to 2.80%, aggregating to 49.19% which will trigger a mandatory open offer of 26.0% as per Regulation 3 and 4 of SEBI (SAST) Regulations followed by a merger through a Scheme.
  • Both the SPA and Scheme are subject to standard requisite statutory and regulatory approvals, including from Securities and Exchange Board of India (SEBI), Stock Exchanges, the Competition Commission of India (CCI), National Company Law Tribunal (NCLT), and other approvals, as applicable.

Advisors

Moelis & Company and NovaOne acted as financial advisors for Torrent. Khaitan & Co. acted as legal counsel to Torrent. Ernst and Young Merchant Banking Services LLP (for Torrent) and BDO Valuation Advisory LLP (for JB Pharma) acted as independent registered valuers. Kotak Investment Banking and Rothschild & Co acted as financial advisors to KKR. Shardul Amarchand Mangaldas & Co acted as legal counsel to KKR and JB Pharma. Goldman Sachs (India) Securities Pvt. Ltd. acted as the financial advisor to JB Pharma. AZB & Partners acted as legal counsel to the Board of Directors of JB Pharma. Fairness opinion on the share exchange ratio recommended by the valuer was provided by Axis Capital Limited to the Board of Torrent and by ICICI Securities Limited to the Board of JB Pharma.

About Torrent

Torrent Pharma is a leading player in the Indian pharmaceutical sector, concentrating on the chronic and sub-chronic therapeutic segments. The Company has established itself as a leader in developing niche pharmaceutical solutions through its patient-centric innovation. It also has a strong global presence across Brazil, Germany, and the United States.

About JB Pharma

J.B. Pharma (BSE: 506943 | NSE: JBCHEPHARM | ISIN: INE572A01028), is one of the fastest growing pharmaceutical companies in India and a leading player in the hypertension segment. Besides its strong India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. In India, the company has six brands among the top 300 IPM brands in the country. The company exports its finished formulations to over 40 countries including the USA, and is also a leading CDMO player in the segment of medicated lozenges. It has eight state of the art manufacturing facilities in India including a dedicated manufacturing facility for lozenges. The manufacturing facilities are certified by leading regulators across the world.

About KKR

KKR is a leading global investment firm that offers alternative asset management as well as capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com. For additional information about Global Atlantic Financial Group, please visit Global Atlantic Financial Group’s website at www.globalatlantic.com.

Contacts

Media Contacts

For KKR:

Wei Jun Ong

+65 6922 5813

WeiJun.Ong@kkr.com

For Torrent Pharma:

Jayesh Desai

+91 9824501396

Eurofins Scientific: Director/PDMR Shareholding

Eurofins Scientific: Director/PDMR Shareholding




Eurofins Scientific: Director/PDMR Shareholding

LUXEMBOURG–(BUSINESS WIRE)–Eurofins Scientific SE (EUFI.PA) (Paris:ERF) has received various notifications of dealing from Persons Discharging Managerial Responsibilities (“PDMR”). The notification of Dealing Form for each PDMR can be found below.


This notification is made in accordance with the European Market Abuse Regulation.

NOTIFICATION AND PUBLIC DISCLOSURE OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES AND PERSONS CLOSELY ASSOCIATED WITH THEM

 

1.

Details of the person discharging managerial responsibilities/person closely associated

a)

Name

Analytical Bioventures S.C.A (RCS B89265)

23, Va Fleuri, L-1526 Luxembourg

2.

Reason for the notification

a)

Position / status

Analytical Bioventures S.C.A. is a company controlled by Eurofins Scientific S.E., CEO Dr. Gilles Martin

b)

Initial notification / amendment

Initial

3.

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a)

Name

Eurofins Scientific S.E.

 

b)

LEI

529900JEHFM47DYY3S57

 

4.

Details of the transaction(s) section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a)

Description of the financial instrument, type of instrument

Share

 

Identification code

ISIN: FR0014000MR3

b)

Nature of the transaction

Acquisition of shares

 

 

c)

Price(s) and volume(s)

Price(s)

Volume(s)

EUR 59.7304

2000

d)

Aggregated information

 

— Aggregated volume

2000

— Price

EUR 119,460.80

e)

Date of the transaction

2025-06-19

f)

Place of the transaction

XPAR

NOTIFICATION AND PUBLIC DISCLOSURE OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES AND PERSONS CLOSELY ASSOCIATED WITH THEM

 

1.

Details of the person discharging managerial responsibilities/person closely associated

a)

Name

Analytical Bioventures S.C.A (RCS B89265)

23, Va Fleuri, L-1526 Luxembourg

2.

Reason for the notification

a)

Position / status

Analytical Bioventures S.C.A. is a company controlled by Eurofins Scientific S.E., CEO Dr. Gilles Martin

b)

Initial notification / amendment

Initial

3.

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a)

Name

Eurofins Scientific S.E.

 

b)

LEI

529900JEHFM47DYY3S57

 

4.

Details of the transaction(s) section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a)

Description of the financial instrument, type of instrument

Share

 

Identification code

ISIN: FR0014000MR3

b)

Nature of the transaction

Acquisition of shares

 

 

c)

Price(s) and volume(s)

Price(s)

Volume(s)

EUR 59.4081

2000

d)

Aggregated information

 

— Aggregated volume

2000

— Price

EUR 118,816.20

e)

Date of the transaction

2025-06-20

f)

Place of the transaction

XPAR

NOTIFICATION AND PUBLIC DISCLOSURE OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES AND PERSONS CLOSELY ASSOCIATED WITH THEM

 

1.

Details of the person discharging managerial responsibilities/person closely associated

a)

Name

Analytical Bioventures S.C.A (RCS B89265)

23, Va Fleuri, L-1526 Luxembourg

2.

Reason for the notification

a)

Position / status

Analytical Bioventures S.C.A. is a company controlled by Eurofins Scientific S.E., CEO Dr. Gilles Martin

b)

Initial notification / amendment

Initial

3.

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a)

Name

Eurofins Scientific S.E.

 

b)

LEI

529900JEHFM47DYY3S57

 

4.

Details of the transaction(s) section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a)

Description of the financial instrument, type of instrument

Share

 

Identification code

ISIN: FR0014000MR3

b)

Nature of the transaction

Acquisition of shares

 

 

c)

Price(s) and volume(s)

Price(s)

Volume(s)

EUR 59.3430

2000

d)

Aggregated information

 

— Aggregated volume

2000

— Price

EUR 118,686.00

e)

Date of the transaction

2025-06-23

f)

Place of the transaction

XPAR

NOTIFICATION AND PUBLIC DISCLOSURE OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES AND PERSONS CLOSELY ASSOCIATED WITH THEM

 

1.

Details of the person discharging managerial responsibilities/person closely associated

a)

Name

Analytical Bioventures S.C.A (RCS B89265)

23, Va Fleuri, L-1526 Luxembourg

2.

Reason for the notification

a)

Position / status

Analytical Bioventures S.C.A. is a company controlled by Eurofins Scientific S.E., CEO Dr. Gilles Martin

b)

Initial notification / amendment

Initial

3.

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a)

Name

Eurofins Scientific S.E.

 

b)

LEI

529900JEHFM47DYY3S57

 

4.

Details of the transaction(s) section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a)

Description of the financial instrument, type of instrument

Share

 

Identification code

ISIN: FR0014000MR3

b)

Nature of the transaction

Acquisition of shares

 

 

c)

Price(s) and volume(s)

Price(s)

Volume(s)

EUR 59.8980

1432

d)

Aggregated information

 

— Aggregated volume

1432

— Price

EUR 85,773.94

e)

Date of the transaction

2025-06-24

f)

Place of the transaction

XPAR

About Eurofins – the global leader in bio-analysis

Eurofins is Testing for Life. With ca. 63,000 staff across a network of more than 950 laboratories in over 1,000 companies in 60 countries, Eurofins offers a portfolio of over 200,000 analytical methods.

Eurofins Scientific S.E. shares are listed on Euronext Paris Stock Exchange.

Contacts

For more information, please visit www.eurofins.com or contact:
Investor Relations

Eurofins Scientific SE

Phone: +32 2 766 1620

E-mail: ir@sc.eurofinseu.com

BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA®

BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA®




BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA®

BASEL, Switzerland–(BUSINESS WIRE)–$ONC #BeOneBeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications. The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland.


“The CHMP’s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,” said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. “We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.”

The BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. The recommended dose of BRUKINSA remains – 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake and take two tablets daily. The new tablet formulation maintains BRUKINSA’s dosing flexibility by providing patients and prescribers with the option of once- or twice-daily dosing and is designed to simplify management of dose reductions as per label recommendation. Additionally, the BRUKINSA tablets are smaller than the capsules and have a film coat, which makes them easier to swallow.

BeOne Medicines will begin to convert BRUKINSA from capsules to tablets in regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing our impact on the environment. This adjustment will decrease the bottle size by ~70% while also enabling the shipment of this medication with reduced temperature controls, which we expect to reduce energy needs, greenhouse gas emissions, and global transport costs.

Today’s announcement follows the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of BRUKINSA for all five approved indications earlier this month. In the U.S., BRUKINSA is the leader in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy, and for the first time, has become the overall BTK inhibitor market share leader.1

Important Safety Information

The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.

This information is intended for a global audience. Product indications vary by region.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future potential approval of the tablet formulation of BRUKINSA by the European Commission and the timing of such approval; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom.

____________________

1 As of May 7, 2025, based on reported sales from Q1 2025 earnings. BeiGene Announces First Quarter 2025 Financial Results and Business Updates – NASDAQ (US) Website.

 

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Kim Bencker

+1 610-256-8932

media@beonemed.com

Takeda Announces New Assignments of Directors

Takeda Announces New Assignments of Directors




Takeda Announces New Assignments of Directors

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TOKYO:4502/NYSE:TAK) has announced new assignments of directors, determined at the Board of Directors meeting, following the 149th Annual Meeting of Shareholders, held in Osaka today.


Takeda’s Board of Directors has 11 members serving as external directors out of a total of 14 members, helping to ensure transparency and objectivity. An external director will continue to chair the Board of Directors. The Audit and Supervisory Committee, the Nomination Committee and the Compensation Committee will be composed solely of external directors including their chairs.

Takeda highly values strong, independent governance and its Board of Directors helps to ensure that all decisions and actions are in the best interests of global stakeholders and aligned with the company’s values. This robust corporate governance model has been, and will continue to be, critical to Takeda’s success.

Details of the new assignments are as follows:

1. New Assignment of Directors Who Are Not Audit and Supervisory Committee Members (Effective June 25, 2025)

Name

Category

Role

Christophe Weber

Internal

Existing

Representative Director, President & Chief Executive Officer

Milano Furuta

Internal

Existing

Director, Chief Financial Officer

Andrew Plump

Internal

Existing

Director, President, Research & Development

Masami Iijima

External

Existing

External Director, Chair of the Board Meeting

Ian Clark

External

Existing

External Director

Steven Gillis

External

Existing

External Director

Emiko Higashi

External

Existing

External Director

John Maraganore

External

Existing

External Director

Michel Orsinger

External

Existing

External Director

Miki Tsusaka

External

Existing

External Director

2. Directors Who Are Audit and Supervisory Committee Members

Name

Category

Role

Koji Hatsukawa

External

External Director, Head of Audit and Supervisory Committee

Jean-Luc Butel

External

External Director, Audit and Supervisory Committee Member

Yoshiaki Fujimori

External

External Director, Audit and Supervisory Committee Member

Kimberly A. Reed

External

External Director, Audit and Supervisory Committee Member

Directors who are Audit and Supervisory Committee Members are within their 2-year tenure and were not subject to reelection this year.

3. New Assignment of Nomination Committee and Compensation Committee Members (Effective June 25, 2025)

Nomination committee:

Masami Iijima (Chairperson), Steven Gillis, Emiko Higashi, Michel Orsinger, Jean-Luc Butel and Yoshiaki Fujimori

(Observer: Christophe Weber)

Compensation committee:

Emiko Higashi (Chairperson), John Maraganore, Michel Orsinger, Miki Tsusaka and Kimberly A. Reed

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Contacts

Media Contacts:

Japanese Media

Aya Shishido

aya.shishido@takeda.com
+81 (0) 70-2819-9041

U.S. and International Media
Brendan Jennings

brendan.jennings@takeda.com
+81 (0) 80-2705-8259

Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin

Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin




Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin

  • Systemic Sclerosis (SSc) is a life-threatening autoimmune disease that causes severe inflammation and fibrosis, while Chronic Pruritus of Unknown Origin (CPUO) is characterized by a persistent, chronic itch with an unknown cause1-3
  • Nemolizumab is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31. It is approved for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world4-6
  • IL-31 is a neuroimmune cytokine that is involved in inflammation and fibrosis – both hallmarks of SSc – and drives itch, a key symptom of CPUO1,3,4
  • Enrollment for Galderma’s phase II studies of nemolizumab is planned to begin in H2 2025

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the initiation of two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients living with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO) – two chronic conditions with high unmet need.1-3,7


Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a role in driving itch – the main symptom of CPUO – and inflammation and fibrosis, which are hallmarks of SSc.1,3,4

 

“Investigating nemolizumab in two new trials in Systemic Sclerosis and Chronic Pruritus of Unknown Origin, both of which are associated with poor patient outcomes and low quality of life, underscores our commitment to addressing skin conditions with high unmet needs. These trials may help us better understand these complex diseases and offer hope for patients seeking relief from these severe and potentially life-threatening conditions.”

BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.

GLOBAL HEAD OF R&D

GALDERMA

 

Systemic Sclerosis (SSc)

SSc is a rare, potentially fatal autoimmune disease that causes inflammation and fibrosis (hardening) of the skin and internal organs.1 It most commonly affects women between the ages of 30 and 50 years old, often leading to a lower quality of life and a much higher risk of death compared to healthy people of the same age.2,8 Currently, there are no approved therapies that address the disease as a whole, highlighting the urgent need for effective treatments.1,2,8

Galderma’s phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of nemolizumab in adults with SSc. Patient enrollment is planned to begin in H2 2025, with completion anticipated in 2028. This trial represents a significant step towards addressing the remaining unmet treatment needs in SSc and demonstrates Galderma’s commitment to driving progress for patients living with this disease.

The study was designed in collaboration with a Steering Committee of world-leading rheumatology and dermatology experts, including lead trial investigator, Professor Oliver Distler, M.D., Zürich, Switzerland; Professor Dinesh Khanna, M.D., Director of the Scleroderma Program, University of Michigan, United States (U.S.); Professor Robert Spiera, M.D., Director of the Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery, New York, U.S.; and Professor Johann Gudjonsson, M.D., PhD, Dermatologist, University Hospital Michigan, U.S.

The trial is expected to be conducted in several countries in North America, Europe and South America. More information about the study will be made available soon on the clinicaltrials.gov website.

 

“Systemic Sclerosis can have a profound impact on both the quality and length of a person’s life. It causes the skin to harden, damages blood vessels, leads to joint pain, and can result in serious fibrosis in multiple internal organs, sometimes with life-threatening consequences. With no currently approved treatments that are indicated to treat the several symptoms this autoimmune disease presents, I look forward to investigating the role that nemolizumab could potentially play in this condition.”

PROFESSOR OLIVER DISTLER, M.D.
LEAD INVESTIGATOR: SYSTEMIC SCLEROSIS PHASE II STUDY

ZÜRICH, SWITZERLAND

 

Chronic Pruritus of Unknown Origin (CPUO)

CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause and mostly affects the elderly.3 The chronic and persistent itch is often described as being as debilitating as chronic pain, leading to reduced quality of life and affecting sleep patterns and mood.3,7 There are currently no approved treatments for this condition.3

Galderma’s new phase II CPUO trial reinforces the company’s commitment to exploring options for patients with chronic skin conditions that significantly impact quality of life. This randomized, double-blind, placebo-controlled proof-of-concept study will explore the pharmacokinetics and pharmacodynamics of nemolizumab in adults. Enrollment is expected to start in H2 2025 in the U.S., with completion anticipated in 2026. The study was designed in collaboration with a Steering Committee of world-leading dermatology experts, including the lead investigator Dr. Shawn Kwatra, M.D., PhD., Joseph W. Burnett Endowed Professor, Chairman of Dermatology, University of Maryland School of Medicine, U.S., and Dr. Sarina Elmariah, MD, PhD, MPH, Associate Professor and Dermatology Director at the Center for Itch and Neurosensory Disorders at the University of California in San Francisco, U.S.

The study is being conducted in the U.S. and more information about the study will be made available soon on the clinicaltrials.gov website.

 

“It is challenging to treat Chronic Pruritus of Unknown Origin as physicians have limited therapeutic options specifically targeting the underlying cause of itch. With the extensive data showing that IL-31 is a key driver of itch, I’m excited to explore whether nemolizumab’s inhibition of IL-31 signaling might effectively reduce the intractable itch experienced by patients with Chronic Pruritus of Unknown Origin.”

DOCTOR SHAWN KWATRA, M.D., PHD

LEAD INVESTIGATOR, CHRONIC PRURITUS OF UNKNOWN ORIGIN PHASE II STUDY

JOSEPH W. BURNETT ENDOWED PROFESSOR

CHAIRMAN OF DERMATOLOGY, UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, U.S.

 

About nemolizumab

Nemolizumab was approved in August 2024 by the U.S. Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.5 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.5 To date, nemolizumab is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.9,10

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1.

Jimenez SA, Mendoza FA, Piera-Velasquez S. A review of recent studies on the pathogenesis of Systemic Sclerosis: focus on fibrosis pathways. Front Immunol. 2025;16: 1551911. doi: 10.3389/fimmu.2025.1551911

2.

Truchetet ME, et al. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol. 2021;64(3): 262–283. doi: 10.1007/s12016-021-08889-8

3.

Teresa J, et al. Therapeutics in chronic pruritus of unknown origin. Itch. 2023;8(1): pe64. doi: 10.1097/itx.0000000000000064

4.

Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1): 173-182. doi: 10.1016/j.jaci.2019.08.013

5.

Nemluvio® U.S. Prescribing Information. Available online. Accessed June 2025

6.

Nemluvio® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed June 2025

7.

Andrade E, et al. Interventions for chronic pruritus of unknown origin. CDSR. 2020;1(1): CD013128. doi: 10.1002/14651858.CD013128.pub2

8.

Scleroderma & Systemic Sclerosis. National Health Service. Available online. Accessed June 2025

9.

Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed June 2025

10.

Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed June 2025

 

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com
+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43