RWS Launches New CNS Rater Training Service to Strengthen Data Quality in Clinical Trials




RWS Launches New CNS Rater Training Service to Strengthen Data Quality in Clinical Trials

Service ensures that clinicians are properly qualified, consistently trained and monitored throughout the life of a trial

MAIDENHEAD, England–(BUSINESS WIRE)–RWS (RWS.L), a global AI solutions company, announces the launch of a new rater training, certification and retraining service designed specifically to improve data quality, consistency and reliability in central nervous system (CNS) clinical trials.

The new service helps pharmaceutical sponsors and clinical research organizations (CROs) reduce one of the biggest risks in CNS studies: variability in how clinical raters assess patients. Even small differences in rater judgment can significantly affect trial data, timelines and outcomes.

RWS’s CNS rater training service ensures that clinicians involved in patient assessments are properly qualified, consistently trained and monitored throughout the life of a trial. The service is designed for complex, global CNS programs, where long study durations, multiple assessment points and geographically dispersed teams increase the risk of inconsistent data.

“CNS trials are uniquely sensitive to rater variability,” said Dan Herron, Global Vice President, Digital Health, RWS. “This service is designed to help sponsors reduce noise in the data, maintain consistency over time, and protect the scientific integrity of their CNS studies – without adding operational complexity.”

As CNS trials become more global, decentralized and digitally enabled, challenges such as inconsistent onboarding, certification drift and uneven use of assessment tools have become harder to manage. These risks are often compounded by the use of electronic Clinical Outcome Assessment (eCOA) technologies across different regions and languages.

RWS addresses these challenges by combining specialist CNS scientific expertise with structured training design and secure, scalable digital delivery. The service supports the full rater lifecycle and aligns with protocol requirements, regulatory expectations and modern eCOA workflows.

Service features

The CNS rater training service includes:

• Rater qualification and eligibility review, based on CNS-specific experience and protocol-defined criteria.
• Customized, indication- and scale-specific training, developed by experts in CNS clinician-reported and rater-administered outcome measures.
• Digital certification and remediation workflows, with automated tracking and certificate issuance.
• Ongoing retraining and refreshers to reduce rater drift during long or multi-phase studies.
• Centralized tracking and reporting to support monitoring, inspections and audits.

Training can be delivered globally and in multiple languages – supported by RWS’s eLearning development, localization, multimedia and linguistic validation capabilities. The service is technology-agnostic and can be used alongside any eCOA platform, ensuring consistent rater training regardless of how endpoint data is collected.

The launch expands RWS’s portfolio of CNS-focused solutions for life sciences organizations, supporting the clinical content and data lifecycle – from outcome assessment strategy and licensing to training, localization and AI-enabled workflows.

About us

RWS is a global AI solutions company empowering the world’s most trusted enterprise AI.

Our proprietary Cultural Intelligence Layer, powered by 250,000 data specialists, cultural and language experts and deep domain professionals, backed by 45+ patents, makes enterprise AI culturally fluent, contextually accurate and secure, ensuring every interaction reflects a brand’s tone, context and customer values.

Through our Generate, Transform and Protect segments, we deliver intelligent content, enterprise knowledge, large-scale localization and IP protection for global growth. Trusted by 80+ of the world’s top 100 brands, RWS provides the confidence, governance and expertise organizations need to deploy AI safely, responsibly and at scale.

Headquartered in the UK, RWS is listed on AIM.

More information: rws.com.

Contacts

RWS

Denis Davies

Corporate Communications

ddavies@rws.com
+44 1628 410105

Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission




Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission

• The United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults
• RelabotulinumtoxinA is designed to optimize molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for frown lines and crow’s feet and has been approved in over 20 markets, including in the European Union^1-3

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD) today announced that the U.S. FDA has accepted the BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. Galderma has worked closely with the U.S. FDA to implement adjustments to its manufacturing process. Galderma is committed to using its expertise and heritage in the neuromodulator space to develop next-generation aesthetic solutions that address evolving needs.

The filing is based on data from the robust, large-scale READY (REelabotulinumtoxin Aesthetic Development StudY) clinical trial program, which is composed of four phase III trials, enrolling more than 1,900 participants.^1-4 Results demonstrated that RelabotulinumtoxinA delivered a fast onset of action as early as Day 1 and sustained results for six months for both frown lines and crow’s feet.^1,2

RelabotulinumtoxinA (Relfydess™) has been approved in over 20 markets for the treatment of frown lines and crow’s feet, including in the European Union, the United Kingdom, Asia, and Australia. Regulatory applications are continuing to be submitted and assessed by additional authorities globally.

Galderma offers a range of neuromodulator solutions aiming to address every single injector and patient need, and has the heritage, expertise and capability needed to continue bringing this advanced solution to patients and healthcare professionals globally. Today, Galderma is well positioned to be the leader in all aspects of Injectable Aesthetics, having the in-house capabilities to discover, research, develop, manufacture, and market best-in-class products.

About RelabotulinumtoxinA

Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator manufactured with PEARL™ Technology, which is designed to preserve molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for glabellar lines and lateral canthal lines, giving patients a natural, revitalized look in a refined and well-tolerated formulation.^1-5 RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^6,7 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA has received a marketing authorization in numerous markets and is an investigational drug product in the U.S. Authorization conditions may vary internationally.

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. Shridharani SM, et al. Efficacy and safety of RelabotulinumtoxinA, a new ready-to-use liquid formulation botulinum toxin: Results from the READY-1 double-blind, randomized, placebo-controlled phase 3 trial in glabellar lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131.
2. Ablon G, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, an investigational liquid botulinum toxin: clinical efficacy and safety results from the READY-2 phase 3 trial. Toxicon. 2024;237(1):107353. doi: 10.1026/j.toxicon.2024.107353.
3. Relfydess^®. EU Summary of Product Characteristics.
4. Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021
5. Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021
6. Sundberg AL and Stahl U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Presented at TOXINS; January 16-17, 2021; virtual meeting.
7. Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) – relabotulinumtoxinA. Presented at TOXINS; July 27-30, 2022; Louisiana, United States.

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

High-end Aesthetic Brand ‘Lorient’ Gains Global Prestige at IMCAS 2026




High-end Aesthetic Brand ‘Lorient’ Gains Global Prestige at IMCAS 2026

PARIS–(BUSINESS WIRE)–#AntiAging—Lorient, a premium aesthetic brand, announced that it has drawn global attention at the 27th IMCAS World Congress 2026 in Paris, attracting over 15,000 professionals and demonstrating its leadership in aesthetic innovation.

The highlight was a session led by Dr. Jani van Loghem, a globally revered key opinion leader known for establishing international aesthetic safety protocols. His involvement provided a prestigious validation of the technical excellence of Lorient. Alongside him, prominent Korean medical experts Dr. Won Lee and Dr. Do Young Rhee shared clinical insights that drew widespread praise from the international medical community.

Central to the academic discussions was Lorient’s “safety-first” philosophy for its premium HA filler range. By utilizing a sophisticated purification process that minimizes chemical cross-linking agents like BDDE, the brand proved its exceptional purity. This advanced manufacturing approach effectively reduces the risk of delayed inflammatory responses, a key concern for high-end practitioners. Dr. Jani van Loghem and Dr. Won Lee emphasized the filler’s low degree of modification, ensuring both a smooth injection experience and high biocompatibility. Additionally, its immediate reversibility with hyaluronidase provides an essential safety layer, further solidifying the trust of medical experts who prioritize patient welfare.

The spotlight also turned to ‘Lorient Element’, an innovative skin booster presented by Dr. Do Young Rhee. Engineered to overcome traditional limitations in pigment treatment, it features a potent blend of Tranexamic Acid, Ascorbic Acid, Niacinamide, and Glutathione at the maximum allowable concentrations. By utilizing a specialized hyaluronic acid delivery vehicle and low-molecular-weight particles under 500 Daltons, the formula ensures maximum penetration through the skin barrier. Clinical data showed that when combined with laser or microneedling treatments, Lorient Element improved pigmentation by over 60 percent in just four to five sessions.

Lorient stated that the successful session led by Dr. Jani van Loghem at IMCAS proves its advanced technology leads the global standard. Building on this success, Lorient is poised to accelerate strategic expansion into Europe, North America, and Southeast Asia, reinforcing its position as a visionary leader dedicated to setting the future of medical aesthetics.

Contacts

Lorient (Joonghun Pharmaceutical)

Jinwook Lee

+82-2-6929-0163

finest@mylorient.com

Tenacia Biopharmaceuticals and Golden Age Health Partner to Commercialize ZTALMY® for CDKL5 Deficiency Disorder in Mainland China




Tenacia Biopharmaceuticals and Golden Age Health Partner to Commercialize ZTALMY® for CDKL5 Deficiency Disorder in Mainland China

First-ever approved treatment for CDD in China now set for commercial launch through dedicated rare disease platform

SHANGHAI–(BUSINESS WIRE)–Tenacia Biopharmaceuticals (Shanghai) Co., Ltd. (“Tenacia“) and GOLDEN AGE HEALTH (SHANGHAI) CO., LTD., a subsidiary of Golden Age Health Pte. Ltd. (collectively, “GAH“) today announced a Commercialization Agreement granting GAH exclusive rights to commercialize ZTALMY^® (泽元安), the first and as of now only approved treatment for CDKL5 deficiency disorder (CDD) in Mainland China.

ZTALMY^® (ganaxolone oral suspension) was developed by Marinus and Tenacia obtains exclusive rights to develop and commercialize it in Greater China. In July 2024, the drug was approved by the National Medical Products Administration for treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.

Tenacia has partnered with GAH to leverage its comprehensive patient-focused commercialization platform—encompassing disease awareness, diagnosis support, market access, and patient affordability programs—to ensure this therapy reaches the families affected by this devastating rare epilepsy.

“Bringing the first approved therapy for CDKL5 deficiency disorder to patients in China represents exactly the type of mission-critical work Golden Age Health was built for,” said Chao (Brook) Wu, Chief Executive Officer of Golden Age Health (Shanghai). “We are honored to partner with Tenacia to ensure that children and families affected by CDD can access this breakthrough treatment as quickly as possible.”

Dr. Xiaoxiang Chen, Founder and CEO of Tenacia Biopharmaceuticals (Shanghai), said: “GAH’s proven expertise in rare disease commercialization and their commitment to patient access make them the ideal partner to bring ZTALMY^® to the patients who need it most in China. Together, we will work to maximize the impact of this important therapy.”

About CDKL5 Deficiency Disorder

CDKL5 deficiency disorder (CDD) is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene. Patients typically experience early-onset, treatment-resistant seizures, profound developmental delays, and motor impairments. CDD is included in China’s National Rare Disease Catalog, reflecting the urgent need for effective treatments for affected patients and their families.

About ZTALMY^® (ganaxolone oral suspension)

ZTALMY^® (ganaxolone oral suspension) is a neuroactive steroid GABA_A receptor positive allosteric modulator. The oral suspension formulation (110ml: 5.5g) is approved by China’s NMPA for the treatment of seizures associated with CDKL5 deficiency disorder in patients 2 years of age and older. It represents the first therapy specially approved for this indication in China.

About Golden Age Health

Golden Age Health is a specialty pharmaceutical company dedicated to redefining patient access to medicine across China, Asia-Pacific and MEA. Headquartered in Singapore, GAH pairs data-driven market-access expertise with deep medical-affairs and RWE capabilities to bring high-impact therapies to underserved populations.

About Tenacia Biopharmaceuticals

Founded in 2022 by Bain Capital, Tenacia is a commercial-stage biopharmaceutical company dedicated to developing innovative therapeutics for patients with underserved neurological disorders. Tenacia’s seasoned management team brings decades of drug development experience from both MNCs and biotechs. Their deep understanding of complex disease biology and insights into unmet patient needs enable Tenacia to create a highly efficient neuroscience R&D platform with a proven track record of advancing novel therapies. Empowered by its founder and strategic investor, Bain Capital – through significant initial investment, long-term commitment and extensive life science network – Tenacia is poised to become a leading neuroscience company in China and deliver substantial value to shareholders while upholding an unwavering commitment to the patients.

Forward-Looking Statements

This release contains forward-looking statements, including expectations regarding clinical development, regulatory matters and commercial launches. These statements involve risks and uncertainties that may cause actual outcomes to differ materially.

Contacts

Media & Investor Contacts
Golden Age Health
https://www.gahbioventures.com/
Media/IR: info@gahbioventures.com

Tenacia Biopharmaceuticals
官网：https://www.tenacia.com

AHF Receives Expedited Florida Hearing Opposing ADAP Reductions




AHF Receives Expedited Florida Hearing Opposing ADAP Reductions

Group sued Florida DOH over rules cutting lifesaving HIV/AIDS treatment for thousands

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Today, AIDS Healthcare Foundation (AHF) asked for and received an expedited hearing schedule in its legal efforts to block harmful changes to Florida’s AIDS Drug Assistance Plan (ADAP). It is estimated that 16,000 Floridians living with HIV/AIDS could lose access to life-saving medications and health insurance if these cuts go through. AHF and an ADAP recipient have brought an administrative suit to block these changes.

The cuts are scheduled to begin March 1. Under normal administrative procedures and timing rules, a decision on AHF’s case would not be reached until after March 1, making it too late to stop the cuts from being implemented. However, AHF asked for an expedited hearing schedule to get a decision before the cuts go into effect. The administrative law judge (ALJ), understanding the dire health impacts on these 16,000 should the cuts occur, agreed to move the case along more quickly.

The case will be heard on February 18, and the ALJ intends to issue a ruling on February 27. AHF is heartened that the ALJ understands the potential impacts these cuts represent and agreed to resolve this matter before the cuts would go into effect. If AHF is successful, these cuts will be prevented from occurring on March 1.

In its petition, filed Tuesday in Tallahassee, AHF asserted the Florida’s Department of Health illegally changed rules regarding income eligibility thresholds for its AIDS Drug Assistance Program (ADAP), without having gone through the mandatory rulemaking process. AHF’s petition was filed Tuesday with Florida’s Division of Administrative Hearings and prepared by Panza, Maurer & Maynard, P.A. of Tallahassee, Florida.

AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 2.8 million individuals across 50 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. In January 2025, AHF received the MLK, Jr. Social Justice Award, The King Center’s highest recognition for an organization leading work in the social justice arena. To learn more about AHF, visit us online at AIDShealth.org, find us on Facebook, and follow us on Instagram, Twitter, and TikTok.

Contacts

Media Contacts:
W. Imara Canady, National Director, Communications & Community Engagement, AHF

Cell: 770-940-6555/Email: imara.canady@ahf.org

Ged Kenslea, AHF Senior Communications Director

gedk@aidshealth.org
(323) 791-5526

The Cannabist Company Enters Into Forbearance Agreement With Senior Secured Noteholders




The Cannabist Company Enters Into Forbearance Agreement With Senior Secured Noteholders

CHELMSFORD, Mass.–(BUSINESS WIRE)–The Cannabist Company Holdings Inc. (Cboe CA: CBST) (OTCQB: CBSTF) (“The Cannabist Company” or “the Company”), one of the most experienced cultivators, manufacturers and retailers of cannabis products in the United States, today announced that it has entered into a forbearance agreement (the “Forbearance Agreement”), with an ad hoc group of noteholders (the “Forbearing Noteholders”) of the Company’s 9.25% Senior Secured Notes due December 31, 2028 (the “9.25% Senior Secured Notes”) and the 9.00% Senior Secured Convertible Notes due December 31, 2028 (the “9.00% Senior Secured Convertible Notes” and together with the 9.25% Senior Secured Notes, the “Notes”). The Forbearing Noteholders collectively hold more than 75% of the aggregate principal amount of Notes outstanding.

On December 31, 2025, the Company elected not to make the interest payments due on the Notes (the “December 31 Interest Payments”) under the amended and restated indenture, as supplemented, governing the Notes (the “Indenture”) to enhance its short-term financial flexibility and preserve liquidity as it continues to evaluate strategic alternatives following the recent announcement of the sale of its Virginia assets to an affiliate of Millstreet Credit Fund LP. The failure to make the December 31 Interest Payments on the due date did not constitute an event of default under the Indenture. However, the non-payment of the December 31 Interest Payments during the 30-day grace period under the Indenture constitutes an event of default.

During the grace period, the Company and the Forbearing Noteholders discussed potential strategies and options to address the Company’s liquidity needs, including potential additional asset sales or other strategic, financial or restructuring transactions or proceedings, which resulted in entering into the Forbearance Agreement.

Pursuant to the Forbearance Agreement, and subject to the terms and conditions set forth therein, the Forbearing Noteholders agreed to forbear from exercising any of their rights and remedies under the Indenture and applicable law until February 17, 2026 as a result of the Company’s failure to make the December 31 Interest Payments. The Company, its advisors and the advisors to the Forbearing Noteholders continue to discuss options to address the Company’s liquidity needs, however, there can be no assurances an agreement will be reached, or an extension of the Forbearance Agreement will be entered into prior to February 17, 2026.

About The Cannabist Company (f/k/a Columbia Care)

The Cannabist Company, formerly known as Columbia Care, is one of the most experienced cultivators, manufacturers and providers of cannabis products and related services, with licenses in 12 U.S. jurisdictions. The Company operates 77 facilities including 61 dispensaries and 16 cultivation and manufacturing facilities, including those under development. Columbia Care, now The Cannabist Company, is one of the original multi-state providers of cannabis in the U.S. and now delivers industry-leading products and services to both the medical and adult-use markets. In 2021, the Company launched Cannabist, its retail brand, creating a national dispensary network that leverages proprietary technology platforms. The Company offers products spanning flower, edibles, oils and tablets, and manufactures popular brands including dreamt, Seed & Strain, Triple Seven, Hedy, gLeaf, Classix, Press, and Amber. For more information, please visit www.cannabistcompany.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995 and corresponding Canadian securities laws. Such forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding use of proceeds, future events, plans, strategies, or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Generally, such forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “future”, “scheduled”, “estimates”, “forecasts”, “projects,” “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. Forward-looking statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking statements herein, as well as the risk factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2024, its quarterly report on Form 10-Q for the quarter ended September 30, 2025, and any subsequent quarterly reports on Form 10-Q, in each case, filed with the U.S. Securities and Exchange Commission at www.sec.gov and in Canada on SEDAR+, available at www.sedarplus.ca. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information or forward-looking statements that are contained or referenced herein, except as may be required in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to the Company or persons acting on its behalf is expressly qualified in its entirety by this notice regarding forward-looking information and statements.

Contacts

Investor & Media Contact
Lee Ann Evans

SVP, Capital Markets & Communications

investor@cannabistcompany.com

Bial Achieves Key Milestone in Phase 2b ACTIVATE Study of BIA 28-6156 in GBA1-Associated Parkinson’s Disease




Bial Achieves Key Milestone in Phase 2b ACTIVATE Study of BIA 28-6156 in GBA1-Associated Parkinson’s Disease

• 75% of patients have completed the Week 78 Last Study Visit
• Topline results expected in mid-2026

PORTO, Portugal–(BUSINESS WIRE)–#BIA28–Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, today announced that 75% of patients currently enrolled in its ongoing Phase 2b clinical study ACTIVATE (ClinicalTrials.gov identifier: NCT05819359) have completed the double-blind treatment period through week 78.

This operational milestone represents a significant step toward the completion of the ACTIVATE study, which is evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with Parkinson’s disease (PD) who have a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

The date of the Last Patient, Last Visit (LPLV) is anticipated in April 2026, with topline results on track to be released in mid-2026.

“We look forward to presenting data from our Phase 2b study. BIA 28-6156 is the leading asset in GBA-PD, and clinical outcomes are just around the corner,” said António Portela, CEO of Bial. “We are witnessing growing enthusiasm across the Parkinson’s community and are truly excited to be at the forefront of a potential and much-needed disease-modifying treatment for people living with GBA-PD.”

The study is reporting strong patient retention, despite its long duration and complexity. This reflects the commitment of participating patients, as well as the high quality and robustness of study conduct across sites. As part of its commitment to transparency and patient engagement, Bial has maintained regular communication with trial participants through newsletters distributed via clinical sites every three to four months or upon achievement of key milestones.

“We are deeply grateful to the patients and their families for their extraordinary commitment, and to the global clinical community whose efforts continue to drive progress for people living with GBA-PD,” added António Portela.

Recruitment for the ACTIVATE study was completed ahead of expectations, with 273 genetically confirmed GBA-PD patients enrolled over approximately 18 months across 85 clinical sites in 11 countries throughout Europe and North America. This rapid recruitment underscores the strong engagement of the global Parkinson’s disease community and highlights the substantial unmet medical need for disease-modifying therapies targeting GBA1-associated Parkinson’s disease.

PD is the second most common neurodegenerative disorder affecting more than 10 million people worldwide.⁽¹⁾ Between 5-15% of PD patients have mutations in the GBA1 gene, making it the largest genetic risk factor for PD.⁽²⁾

GBA-PD patients tend to have, on average, an earlier onset of symptoms compared to those with idiopathic PD,⁽³⁾ and have more severe clinical symptoms that progress significantly faster, leading to a worse overall prognosis,⁽²⁾ thus emphasising the importance of developing new treatments for this condition.

About BIA 28-6156

BIA 28-6156 is in development as a first-in-class, small molecule for once-daily oral administration, allosteric activator of beta-glucocerebrosidase (GCase), for the treatment of patients with GBA-PD. By increasing the activity of GCase, BIA 28-6156 may be the first drug to directly modify the underlying cause of the disease in this group of patients by re-establishing the sphingolipid recycling. ^(4,5)

About Bial

Bial is an innovation-driven pharmaceutical company dedicated to improving the health and lives of people worldwide. With a strong commitment to therapeutic innovation, Bial has established an ambitious R&D programme, consistently investing over 20% of its annual revenue in this area. The company focuses on two key areas with high unmet medical needs: neurosciences and rare diseases.

In Europe, Bial operates manufacturing facilities and an R&D centre at its headquarters in Portugal, and maintains subsidiaries in Spain, Germany, the United Kingdom, Italy, and Switzerland. In addition, Bial is present in the United States and selected emerging markets. As part of its international growth strategy, the company collaborates with established partners through strategic alliances and licensing agreements to expand access to its healthcare solutions.

Currently, Bial’s products are available in more than 50 countries, advancing its mission to pursue scientific excellence, mainly in neurosciences and rare diseases, delivering transformative medicines that empower patients’ lives.

For more information about BIA28-6156, please visit: https://www.bial.com/com/our-research/pipeline/bia-28-6156/

For more information about the trial design, please visit: www.clinicaltrials.gov (identifier: NCT05819359)

For more information about Bial, please visit: www.bial.com

References

1. APDA, www.apdaparkinson.org/what-is-parkinsons, accessed October 30 2024
2. Smith L, Schapira AHV. Cells. 2022 Apr 8;11(8):1261
3. Gan-Or et al., 2015; Grabowski, 2008
4. den Heijer JM et al. Br J Clin Pharmacol. 2021 Sep;87(9):3561-3573;
5. Guedes L. et al. Integrated safety analysis of BIA-28-6156 phase 1 clinical trials (a novel allosteric activator of beta-glucocerebrosidase). Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS), Copenhagen, Denmark. August 27–31, 2023

Contacts

Media Contacts:
Bial

Susana Vasconcelos

Director, Communication

T. +351229866100 | E. susana.vasconcelos@bial.com

Tubulis Adds Steve Kelsey as Independent Director to its Advisory Board




Tubulis Adds Steve Kelsey as Independent Director to its Advisory Board

• Appointment brings additional precision oncology expertise as company accelerates development of its ADC pipeline

MUNICH–(BUSINESS WIRE)–Tubulis today announced the appointment of Steve Kelsey, MD, as independent director to its Advisory Board. Dr. Kelsey, currently President, Research and Development at Revolution Medicines, brings more than two decades of global biotechnology experience spanning small molecules, antibodies and antibody drug conjugates (ADCs), with a strong track record of translating innovative science into approved and transformative oncology therapies. As independent director, he will provide strategic guidance as the company advances its ADC lead candidates, TUB-030 and TUB-040, through later-stage clinical development and continues to expand its pipeline.

“Steve is an outstanding drug developer with a mindset that perfectly aligns with our objective to change clinical paradigms and improve patient outcomes,” said Dr. Dominik Schumacher, Chief Executive Officer and Co-founder of Tubulis. “As we enter the next stage of clinical development with our lead therapeutic programs and continuously push the boundaries of ADCs using our strong research unit, Steve’s expertise in guiding precision oncology programs from pre-clinical through late-stage development will be instrumental in positioning our ADC portfolio across diverse tumor types and treatment lines.”

“The scientific rigor and body of data that the Tubulis team has generated to date stands out in our industry. The first clinical results underscore the potential inherent in the company’s pipeline and technology. My goal is to support this team of innovators in pushing the boundaries of what ADCs can deliver for patients,” added Dr. Steve Kelsey.

Dr. Kelsey is a highly regarded oncologist with a long-standing track record of translating novel mechanisms into clinically validated medicines. At Revolution Medicines, he is responsible for multiple targeted oncology programs as they advance into pivotal and late-stage clinical trials, with an emphasis on rigorous clinical design, biomarker-driven development and combination strategies in RAS-driven cancers. Prior to joining Revolution Medicines in 2017, he held senior R&D and clinical leadership roles at Onkaido Therapeutics (a Moderna oncology venture), Medivation, Geron and Genentech, contributing to the development of approved cancer therapies including Sutent® (sunitinib), Perjeta® (pertuzumab), Kadcyla® (Trastuzumab emtansine) and Erivedge® (vismodegib). Dr. Kelsey serves as an independent director at Delphia Therapeutics and Circle Pharma, and as a scientific advisor to Remix Therapeutics. He has authored over 100 peer reviewed publications spanning cell biology, drug discovery, drug development and patient care, and is a named inventor on several patents. He holds a Bachelor of Medicine and Bachelor of Surgery (MB ChB), as well as a Doctor of Medicine (MD) from the University of Birmingham, UK, and is a Fellow of the Royal College of Physicians and the Royal College of Pathologists.

About Tubulis

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models and first clinical proof-of-concept in platinum-resistant ovarian cancer. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.

Contacts

For Tubulis
Dominik Schumacher, CEO & Co-founder

Phone: +49 (0) 175 800 5594

Email: contact@tubulis.com

Media Requests for Tubulis
Trophic Communications

Stephanie May, PhD

Phone: +49 (0) 171 185 56 82

Email: tubulis@trophic.eu

Announcing the 2026 I.D.E.A.L. Bioscience Employers: Turning Action into Impact




Announcing the 2026 I.D.E.A.L. Bioscience Employers: Turning Action into Impact

OTTAWA, Ontario–(BUSINESS WIRE)–#biosciences–In an ever-evolving Canadian bio-economy, employers who embed inclusivity, diversity, equity, and accessibility (IDEA) into their workplace culture are seeing measurable results: more innovation, stronger productivity and a competitive edge in attracting and retaining top talent. BioTalent Canada’s 2026 I.D.E.A.L. Bioscience Employers™ have exemplified these IDEA principles into real-world business advantages.

The I.D.E.A.L. Bioscience Employer Recognition Program is more than a designation; it’s a signal to the industry that these employers offer exceptional workplaces where people and ideas thrive. Recognized employers stand out in a crowded talent market, demonstrating their commitment to practices that drive performance and growth.

“Canada’s bio-economy is built on brainpower and bold ideas. Employers who lead in IDEA are building workplaces where innovation happens, and people want to stay,” says Rob Henderson, President and CEO of BioTalent Canada. “This recognition helps employers showcase their strengths and connect with the talent that will shape the future of our sector.”

Now in its fourth year, the I.D.E.A.L. Bioscience Employer Recognition Program continues to attract a diverse range of Canadian SMEs and large organizations. After a rigorous evaluation process, the following organizations have been recognized as 2026 I.D.E.A.L. Bioscience Employers (listed alphabetically):

• AgriTech North
• Amino Labs North Inc
• Applied Pharmaceutical Innovation
• Aruna Revolution Health Inc
• Bioscience Association Manitoba (BAM)
• BioCanRx
• Enhanced Medical Nutrition (EMN)
• Feldan Therapeutics
• Gotcare
• Health Cities Inc.
• INTREPID Lab at CAMH
• Life Sciences Ontario (LSO)
• Neuraura Biotech Inc.
• Noa Therapeutics
• NorthernRNA
• Ontario Genomics
• Ontario Institute for Cancer Research (OICR)
• Providence Therapeutics
• Raft Brew Labs
• Scispot.io Inc
• Shift Health
• STEMCELL Technologies
• Tydra Labs

Employers are evaluated on their ability to:

• Align IDEA with organizational vision, values and strategies
• Demonstrate leadership accountability for IDEA outcomes
• Measure and assess IDEA efforts
• Prioritize IDEA learning and awareness
• Implement inclusive talent management practices
• Foster a culture of belonging
• Engage with external collaborators such as communities, clients and suppliers

“Recognition as an I.D.E.A.L. Bioscience Employer is a differentiator in today’s market,” adds Henderson. “It tells job seekers, partners, and investors that your organization is committed to excellence, not just in science, but in the way you support and develop your people. Diversity and inclusion are not a charitable endeavour – every study out there indicates it’s a smart way of building your company.”

Are you looking to build your organization’s IDEA strategy but not sure where to start? BioTalent Canada’s employer resources are available at biotalent.ca/resiliency.

Are you interested in showcasing your company’s achievements? Contact Soufiane at info@biotalent.ca to connect with one of our experts.

Rob Henderson is available for comment.

About BioTalent Canada:

BioTalent Canada supports the people behind life-changing science. Trusted as the go-to source for labour market intelligence, BioTalent Canada guides bio-economy contributors with evidence-based data and industry-driven standards. BioTalent Canada, as a workforce development council, is focused on igniting the industry’s brainpower, bridging the gap between job-ready talent and employers, and ensuring the long-term agility, resiliency, and sustainability of one of Canada’s most vital sectors.

BioTalent Canada has received varied distinctions following a thorough and independent analysis of the organization. By practicing the same industry standards it recommends to partners, the organization has been honored with the following titles:

• Great Place to Work® Employer from 2019-2025 and one of the Best Workplaces in Healthcare for 2023 by Great Place to Work Canada®
• The Best Leader in Diversity, Equity, and Inclusion at the 2024 Best Ottawa Business Awards
• 2024 Collaboration Catalyst by Magnet Network
• One of Canada’s Best Places to Work by HRD Canada for 2024
• 5-Star Diversity, Equity and Inclusion Employer by Canadian HR Reporter since 2023
• Employer of Choice by Canadian HR Reporter for 2025

For more information, please visit biotalent.ca.

About the I.D.E.A.L. Bioscience Employer™ Recognition Program

The I.D.E.A.L. Bioscience Employer™ Recognition Program (Inclusivity, Diversity, Equity, and Accessibility Leadership) recognizes organizations in Canada’s bio-economy that lead the way in fostering diverse and inclusive workplaces. Organizations are evaluated and benchmarked on IDEA best practices, with annual designations granted to those meeting or exceeding established standards. Organizations not attaining the designation receive guidance on how to improve.

Contacts

Media Inquiries:


Eli Duern

Project Manager, Marketing and Communications

BioTalent Canada

613-235-1402 ext. 225

eduern@biotalent.ca

Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With Obesity




Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With Obesity

– A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau –

– 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs. 13% in the placebo group –

– CT-388 demonstrated a safety and tolerability profile generally consistent with its drug class with no new or unexpected safety signals –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity. The study found that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was observed. For the treatment-regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001). At week 48 for the 24 mg dose, 95.7% of CT-388 treated participants achieved a weight loss of ≥5%, 87% achieved ≥10%, 47.8% achieved ≥20%, and 26.1% achieved ≥30%. 73% of participants who were pre-diabetic at baseline and treated with CT-388 at 24 mg achieved normal blood glucose levels at week 48 compared to 7.5% in the placebo group.

The treatment was well-tolerated, with the majority of gastrointestinal-related adverse events being mild-to-moderate, generally consistent with the incretin class of medicines. In addition, the treatment discontinuation rate due to adverse events was low (5.9% in CT-388 arms; 1.3% in placebo arm). The full results of the study will be presented at an upcoming medical congress.

“We are pleased to see such meaningful weight loss in people treated with CT-388,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development program as we advance to Phase III trials.”

With its growing cardiometabolic portfolio and strong diagnostic expertise of Roche, Genentech is advancing potentially transformative standards of care to improve the lives of people living with cardiometabolic diseases as well as reducing the significant burden on healthcare systems and society.

Obesity is recognized as the greatest single risk factor for chronic disease globally. By 2035, over four billion people (more than half of the global population) are projected to be living with excess weight or obesity, a trend affecting nearly every country. This rise is driven by a complex mix of genetics and biology as well as behavioral, environmental and socioeconomic factors, placing an increased strain on healthcare systems due to the associated burden of comorbidities and reduced quality of life.

Since integrating CT-388 into the pipeline, we have designated it within Genentech as a fast-track asset and significantly accelerated its clinical development with the goal to bring this potential therapy to patients as soon as possible. CT-388 is currently being investigated in an additional Phase II study (CT388-104) to evaluate the efficacy, safety and tolerability of CT-388 in participants who are living with obesity or are overweight and have type 2 diabetes. The Phase III clinical trial program of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter. In addition to offering robust efficacy as a standalone therapy, CT-388 also plays a key role in unlocking the promise of our obesity pipeline and is considered as a combination asset for petrelintide.

About the CT-388 (103) Phase II study [NCT06525935]

The multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding Phase II trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in 469 people with obesity. It includes adults with obesity (BMI≥30.0 kg/m2) or overweight (BMI ≥27.0 and <30.0 kg/m2) with at least one weight-related comorbidity without type 2 diabetes and evaluated five dosing cohorts with different up-titration schemes with 24 mg being the highest dose tested. The primary endpoint was percent change in body weight from baseline to week 48.

About CT-388

CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities. It aims to reduce appetite and regulate blood sugar by selectively targeting and activating both receptors which integrate nutrient-derived signals to control energy homeostasis. CT-388 was designed to have potent activation of both GLP-1 and GIP receptors, but with minimal to no ß-arrestin recruitment on either receptor. This biased signaling significantly minimizes receptor internalization and consequent desensitization, which is expected to lead to prolonged pharmacological activity.

About Genentech

Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit https://www.gene.com.

Contacts

Media Contact: Meghan Hindman (650) 467-6800

Advocacy Contact: Alana Laurin (650) 225-5171

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli +41 61 687 5284