Intelligent Manufacturing in China Sets a New Benchmark for Design: GUTX Probiotic Dual-Compartment Fresh Probiotics Wins the 2025 French Design Awards

Intelligent Manufacturing in China Sets a New Benchmark for Design: GUTX Probiotic Dual-Compartment Fresh Probiotics Wins the 2025 French Design Awards




Intelligent Manufacturing in China Sets a New Benchmark for Design: GUTX Probiotic Dual-Compartment Fresh Probiotics Wins the 2025 French Design Awards

HANGZHOU, China–(BUSINESS WIRE)–Recently, the winners of the prestigious French Design Awards, often referred to as the “pinnacle” of the design world, have been announced.

In this award selection, GUTX, a professional probiotic brand produced by Siliankang® under Hangzhou Grand Biologic Pharmaceutical INC won the 2025 French Design Awards for its world-first “Dual-Compartment Fresh Probiotic” packaging design. This not only signifies that GUTX’s packaging innovation has gained authoritative recognition from the global design community, but also makes it the first brand in China to win this award in the field of probiotic packaging, leaving a significant mark on the industrial design of China’s health industry.

Dual-compartment packaging breaks through industry pain points, achieving a dual pursuit of aesthetics and functionality

GUTX’s award-winning “Dual-Compartment Fresh Probiotic” product packaging is designed to address the pain point of unclear probiotic activity in traditional products. Its innovative “powder-liquid separation dual-compartment structure” completely revolutionizes the traditional single-form packaging of probiotic powders. It places the highly active probiotic powder and the exclusive activation liquid in separate sealed compartments and no need to brew when using it. Simply press the button to instantly mix the powder and liquid, and the probiotics will be quickly activated, truly achieving “ready to drink and enjoy freshness immediately”.

Looking to the future: From Chinese design to the global stage

GUTX Dual-Compartment Fresh Probiotic won an award for its outstanding packaging design, which is not only an honor for the brand but also a milestone for the industry. This signifies a shift in China’s health industry from simply “product output” to “output of design standards and technological standards.”

The brand plans to showcase the award-winning design at Milan Design Week this April. Participating in this grand event will allow GUTX to showcase the functional value and aesthetic appeal of its dual-compartment packaging on the world stage, and will undoubtedly be a significant opportunity for GUTX and even Chinese probiotics to expand overseas. This will help brands break through geographical boundaries, promote innovative probiotic products intelligent manufacturing in China to overseas markets, and allow global consumers to witness the dual strength of Chinese design and technology.

Contacts

Hangzhou Grand Biologic Pharmaceutical INC

Contact Person: Fan Jiaxu

fanjiaxu@hzydsw.cn
https://www.hzydsw.cn/

GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.

GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.




GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.

HAMBURG, Germany & MUNICH–(BUSINESS WIRE)–GAIA, the pioneer in evidence-based digital therapeutics and Daiichi Sankyo Europe, today announced an exclusive strategic partnership to commercialize lipodia upon regulatory approval1.




This digital therapeutic is designed to support adults living with hypercholesterolemia. The comprehensive collaboration brings together GAIA’s long-standing expertise in developing clinically validated non-pharmacological interventions with Daiichi Sankyo’s highly scientific experience in cardiovascular risk management and health. Together, the partners – both members of the German Association of Research-Based Pharmaceutical Companies (vfa) – aim to address a persistent gap in chronic care: leveraging digital technologies to make a difference in patients’ lives by supporting sustainable, long-term behaviour change.

Expanding Cardiovascular Care Beyond Medicines

Under the agreement, Daiichi Sankyo Europe secures exclusive rights for lipodia, marking a strategic expansion of its cardiovascular portfolio into digital therapeutics. The partnership initially covers Germany as the largest European healthcare market and incorporates expansion mechanisms for all major markets on the continent. It reflects a growing recognition that holistic heart health requires integrated solutions that combine pharmacological treatment with evidence-based behavioural support. Cardiovascular diseases (CVD) remain Europe’s leading cause of death and are responsible for more than 10,000 deaths every day. Yet, 80% of heart disease and stroke are preventable. The major risk factors for CVD include high blood pressure, high cholesterol, diabetes, smoking, obesity and physical inactivity, with poor diet, excessive alcohol consumption, and stress further contributing to its prevalence.2 Grounded in the latest, evidence-based behavioural health science and combining it with top-of-class psychological and psychotherapeutic methods, lipodia adapts dynamically to individual patient needs through interactive dialogues. Comprehensive additional functionalities further support the integration of healthy routines into everyday life, helping patients translate intention into sustained action. Lipodia is a next-generation, fully-automated digital therapeutic, accessible on almost any connected device, enabling flexible, location-independent use.

Dr. Mario Weiss, CEO GAIA: “Digital therapeutics unlock a new dimension of cardiovascular care by addressing the behavioural and psychological factors that medication alone cannot solve. With lipodia, we are translating more than two decades of scientific, technological, and therapeutic expertise into a scalable solution for one of the most widespread chronic conditions. Through our partnership with Daiichi Sankyo Europe, we are in the best position to integrate this evidence-based digital therapy into routine care in the near future, achieving the reach, scientific credibility, and impact that patients and physicians expect.”

Oliver Appelhans, Head of EU Specialty Business Unit, Daiichi Sankyo Europe:

“At Daiichi Sankyo, we care for every heartbeat. Our goal is to protect people from cardiovascular disease and help those who suffer from it, so they can enjoy every precious moment that life has to offer. Digital therapeutics represent an important next step in delivering holistic heart health. By partnering with GAIA, we are combining pharmaceutical excellence with evidence-based digital therapeutic innovation to support patients beyond our medicines. This collaboration reflects our patient-centric approach to develop new solutions that improve long-term outcomes.”

Pathway to Reimbursed Access

To ensure broad patient access, GAIA plans to submit lipodia for reimbursement as soon as the data from the pivotal phase 3 RCT are available. Upon approval, the digital therapeutic would be reimbursed by statutory health insurance through the DiGA pathway3 and prescribed by physicians as part of routine cardiovascular care in the third largest healthcare market in the world — significantly lowering access barriers for patients.

With cardiovascular disease remaining one of the leading causes of morbidity in Germany and beyond, the partnership positions lipodia as a scalable, evidence-based complement to established treatment pathways and reinforces Germany’s role as a leading market for regulated digital therapeutics.

About GAIA

GAIA is the global leader in the development of evidence-based, fully-automated digital therapeutics that have benefited patients, physicians, and insurers for over two decades. Its product portfolio includes not only digital health applications (DiGA) but also numerous innovative therapeutics for mental health conditions, as well as other therapeutic areas such as immunology, rheumatology, MS, and back pain.

For over 25 years, GAIA has combined scientific, technological, and therapeutic expertise under one roof. Its goal is to support as many people as possible in restoring and maintaining their mental and physical health, thus improving their quality of life and well-being. The expert team at GAIA has confirmed the efficacy of its products in over 30 RCTs and meta-analyses. GAIA is the 48th member of the Association of Research-Based Pharmaceutical Companies (vfa). For more information, please visit www.gaia-group.com/en.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.eu.

1Patients are in phase-3 of the RCT

2World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/. Last accessed October 2025

3DiGA (Digitale Gesundheitsanwendungen) can be prescribed to persons covered by the German statutory health insurance and are reimbursed by the health insurance, if the DiGA has successfully completed the assessment of the German Federal Institute for Drugs and Medicinal Devices (BfArM) leading to a listing in a directory of reimbursable digital health applications. See https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/Interesting-facts/_node.html, last accessed on 19Feb2026

Contacts

Press contact GAIA
Ulrike Voß

GAIA AG

Hans-Henny-Jahnn-Weg 53

22085 Hamburg

E-Mail: presse@gaia-group.com
Telefon: +49 40 3510520

www.gaia-group.com

Press contact Daiichi Sankyo:
Erika Verni

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München

E-mail: erika.verni@daiichisankyo.com
Telefon: +49 15154478431

Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency

Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency




Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency

Ad hoc announcement pursuant to Art. 53 LR


ZUG, Switzerland–(BUSINESS WIRE)–Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the full year 2025.

  • Record net sales of 5,207 million USD, surpassing 5 billion USD in a year for the first time and representing 17.7% year-on-year growth on a constant currency1 basis, primarily driven by volume.
  • Broad-based net sales growth, growing double-digits in both International markets and the U.S.
  • Outperforming the market in each product category, with strong net sales growth in Injectable Aesthetics (11.5%), Dermatological Skincare (9.3%) and Therapeutic Dermatology (50.2%), all year-on-year at constant currency.
  • Strong launch momentum across future growth drivers, including Nemluvio® (nemolizumab) delivering 452 million USD in net sales; Relfydess™ (RelabotulinumtoxinA) outperforming expectations in 17 International markets; Sculptra® gaining significant market share in its first year in China; and continued new product launches across Galderma’s full portfolio of flagship brands.
  • Significant progress and strategic investments across a robust innovation pipeline, highlighted by key submissions and approvals from the broadest pipeline in the industry in Injectable Aesthetics, the introduction of scientifically-differentiated products in Dermatological Skincare, and the initiation of clinical trials for new nemolizumab indications in Therapeutic Dermatology.
  • Extended scientific leadership in dermatology, with a strong presence at key congresses and industry events as well as market leadership in education.
  • Core EBITDA grew to 1,211 million USD, up 18.9% year-on-year at constant currency, ahead of net sales growth. Reported Core EBITDA margin was 23.3%, representing a year-on-year margin expansion of 24 basis points at constant currency, which exceeded initial expectations in a year of major launches and reinvestments in growth.
  • Core EPS3 grew to 3.69 USD, up 76.7% year-on-year, driven by strong Core EBITDA growth, reduced financing and tax expenses, as well as share repurchases.
  • Strengthened balance sheet and cash flow generation, with net leverage4 reduced to 1.5x at the end of December 2025, alongside lowered interest payments and improvements in net working capital.
  • 2026 full-year guidance with attractive top- and bottom-line growth, expecting net sales growth of 17-20% at constant currency and a Core EBITDA margin of approximately 26% at constant currency.
  • Sustained confidence in the mid-term outlook, specifying 2023-2027 guidance within or above the previously communicated ranges and raising the peak sales guidance for Nemluvio from above 2 billion USD to above 4 billion USD for prurigo nodularis and atopic dermatitis globally.

“2025 was an outstanding year for Galderma and a defining step in our journey towards becoming the undisputed dermatology powerhouse. We delivered record financial results with broad-based net sales growth across all product categories and geographies, driven by clear strategic focus, disciplined execution, science-driven innovation and the successful scaling of our proven Integrated Dermatology Strategy. With a strengthened financial profile, global scale and the world’s broadest dermatology portfolio, we enter our next phase of growth with clarity, confidence and ambition.”

FLEMMING ØRNSKOV, M.D., MPH

CHIEF EXECUTIVE OFFICER

GALDERMA

Commercial performance

For the full year 2025, Galderma delivered record net sales of 5,207 million USD, exceeding 5 billion USD for the first year. Year-on-year net sales growth for the year was 17.7% at constant currency. Growth overall was predominantly volume-driven, with a favorable product mix more than offsetting pricing effects from the competitive environment. In the fourth quarter, net sales grew 25.2% year-on-year at constant currency, reflecting an acceleration in each product category.

Net sales growth for the year was widespread across geographies and product categories. Both geographies’ net sales grew double-digits while all product categories outpaced their respective markets.

International sustained its strong net sales growth momentum in highly attractive, largely underpenetrated markets. Injectable Aesthetics delivered double-digit net sales growth and outperformed the market in both Neuromodulators and Fillers & Biostimulators. Both Restylane and Sculptra delivered net sales growth with market share gains in most key countries despite continued softness in the Filler market. Dermatological Skincare also delivered double-digit net sales growth, with outstanding growth particularly in India and China. Therapeutic Dermatology net sales growth was driven by Nemluvio, with strong launch trajectories also in its first European markets.

The U.S. delivered net sales growth in each product category. Net sales growth was especially strong for Neuromodulators as well as for Therapeutic Dermatology, driven by Nemluvio. Injectable Aesthetics outgrew a soft market and gained share in both Neuromodulators and Fillers & Biostimulators. Neuromodulators and Biostimulators net sales grew double-digit while Fillers continued to be impacted by market softness. Dermatological Skincare net sales growth was mainly driven by Alastin, growing double-digits, while Cetaphil had a strong fourth quarter from the ramp-up of recent launches and year-end activations. Therapeutic Dermatology had outstanding net sales growth driven by Nemluvio’s strong trajectory in prurigo nodularis and atopic dermatitis, more than offsetting the anticipated decline in mature products.

Overall, Galderma capitalized on its five key opportunity areas for 2025, including 1) significant launches, including the strong uptake of Nemluvio and Relfydess in first markets and of Sculptra in China, 2) market share gains, 3) a strengthened financial profile, 4) a shift to long-term growth, and 5) dynamic commercial investments to continue to drive growth.

Injectable Aesthetics

Injectable Aesthetics net sales for the full year were 2,572 million USD, up 11.5% year-on-year at constant currency. Galderma remained on a strong growth trajectory, consistently outpacing the market, driven by focused execution, new product launches and further geographic penetration.

Neuromodulators net sales were 1,471 million USD, up 14.3% year-on-year at constant currency. Both geographies delivered double-digit growth and continued to gain market share. Dysport® continued to outperform globally, with strong growth in top markets. Relfydess had a strong year of launches, gaining significant share as a next generation neuromodulator recognized for its superior profile, while setting a high comparable base for 2026. Demonstrating focused execution of its Neuromodulator portfolio strategy, with net sales increasing for both Relfydess and Dysport in markets where Relfydess was launched.

Fillers & Biostimulators net sales were 1,101 million USD, up 8.0% year-on-year at constant currency. Both geographies continued to gain market share, driven especially by Sculptra and the uptake of new launches, including Sculptra in China and Restylane® SHAYPE™ in Brazil. Fillers globally continued to be impacted by market softness with important pricing pressures, as a result of lower consumer demand and aggressive promotional activity from competitors in the mid-face. Biostimulators maintained its double-digit net sales growth momentum in both geographies, as Sculptra continued to strengthen its position as the leading brand with proven regenerative capabilities. Sculptra growth was particularly high in key International markets and especially in China thanks to a strong launch trajectory.

Galderma also made progress in preparing the next frontier of growth in Injectable Aesthetics, maintaining its commercial and regulatory momentum.

In Neuromodulators, Relfydess is quickly ramping up and is now approved in 23 International markets. On February 2, 2026, Galderma announced that the U.S. Food & Drug Administration (FDA) accepted the resubmission of Relfydess’ Biologics License Application (BLA) for the temporary improvement of moderate‑to‑severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults.

In Fillers, the U.S. FDA approved Restylane Lyft™ with Lidocaine in November 2025 for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion. In Biostimulators, Galderma continues to demonstrate leadership in regenerative aesthetics. Beyond the important launch of Sculptra in China, a new chapter opened for the brand in December 2025, with the European Union (EU) Medical Device Regulation (MDR) certification expanding its approved clinical applications beyond the face to include the gluteal area, posterior thighs, décolletage, and upper arms.

Galderma is also shaping the aesthetics journey for patients undergoing medication-driven weight loss, based on its proven Restylane and Sculptra portfolio. With its dedicated scientific agenda for market-leading education and training activities with healthcare professionals, Galderma also saw strong conversion of new patients to its portfolio in the U.S. from its SCULPT & LIFT™ direct-to-consumer campaign.

Dermatological Skincare

Dermatological Skincare net sales for the full year were 1,449 million USD, up 9.3% year-on-year at constant currency. Both Cetaphil and Alastin continued on their strong growth trajectories, outpacing their respective segments globally.

Growth was very strong in International markets, with Cetaphil gaining share and delivering exceptional performance in Asia. Notably, China and India continued to deliver outstanding net sales growth, with particularly strong performance from year-end activations. Alastin continued to ramp-up in International markets. In the U.S., growth was driven by Alastin, which continued to deliver double-digit growth and to be the fastest growing top physician-dispensed skincare brand. Cetaphil in the U.S., in a year of constrained consumer spending, had a strong fourth quarter from the ramp-up of recent launches and year-end activations.

Galderma’s digital-first strategy remained a powerful growth engine for Cetaphil, with e-commerce its fastest growing channel. Growth was particularly strong in the fourth quarter for Cetaphil in China, with strong year-end activations. This included another record performance during the Double 11 shopping festival, outperforming the skincare market online, a major Zootopia 2 campaign, and celebrity endorsements. Globally, Cetaphil also had over 100 million impressions from key global activations, including CetaSphere – one of the world’s largest skincare advocacy networks – and Derm on Tour – an immersive, science-driven pop-up experience offering free dermatology consultations in select cities. Alastin grew across channels, with a focus on physician-first engagement.

Galderma also launched differentiated innovation in Dermatological Skincare to drive further growth, starting in the U.S. with the opportunity to expand in International markets. Among key Cetaphil launches were the Skin Activator Hydrating & Firming line for aging, fragile skin and the Nourishing Oil to Foam Cleanser for sensitive skin, both creating entirely new categories based on strong science delivering breakthrough benefits. Alastin® also further strengthened its portfolio with the launch of Restorative Skin Complex featuring Next Generation TriHex Technology (TriHex+TM). This formula includes two groundbreaking additions, proven to help visibly restore facial radiance and plumping by supporting the skin’s own regenerative abilities. In International markets, Galderma continued to roll-out key innovation, such as Cetaphil’s Bright Healthy Radiance or Gentle Exfoliating lines.

Therapeutic Dermatology

Therapeutic Dermatology net sales were 1,185 million USD, up 50.2% year-on-year at constant currency. Net sales growth was very strong, driven by an outstanding launch trajectory of Nemluvio in prurigo nodularis and atopic dermatitis. This more than offset the anticipated decline in the mature Therapeutic Dermatology portfolio in the U.S., along with modest growth from the mature portfolio in International markets.

For the year, Nemluvio contributed 452 million USD in net sales. The vast majority of Nemluvio sales were recorded in the U.S., split roughly equally between prurigo nodularis and atopic dermatitis, with the share of the latter increasing quickly. The launch trajectory has been very strong in the U.S., and even stronger in Nemluvio’s first International launch markets despite representing a small share of sales.

Nemluvio’s significant market share gains in the U.S. are underpinned by a differentiated profile, salesforce expansion, market-leading education, and enhanced market access. In the U.S., Nemluvio paid new patient starts (NBRx), from the end of December 2025 to the end of January 2026, was trending at about 35% market share in prurigo nodularis and about 8% in atopic dermatitis. The majority of patients starting treatment continue to be new to biologics. Following broad first-line biologic access for Nemluvio across commercial plans in 2025, Galderma secured its first major Medicare access win beginning January 2026. An important gross-to-net impact is expected in the first quarter of the year, driven both by access expansion and typical seasonal copay resets in the period.

Beyond launching Nemluvio in five International markets in 2025, Galderma continued to make regulatory progress, with approvals now secured in Canada and South Korea, and additional submissions underway.

Scientific leadership and excellence in medical education

In 2025, Galderma reaffirmed its leadership in dermatology, supported by an innovative, science‑based portfolio, continued progress on its scientific agenda, and a strong presence at scientific congresses and key industry events.

Among the highlights, Galderma presented long‑term Nemluvio data in prurigo nodularis and atopic dermatitis, reinforcing its consistent safety profile and durable clinical efficacy across both indications up to two years, at the European Academy of Dermatology and Venereology (EADV) 2025, the Revolutionizing Atopic Dermatitis (RAD) Conference, and the XIV International Congress of Dermatology (ICD). In addition, Galderma announced the initiation of two new clinical trials evaluating nemolizumab in Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO), with the first patient enrolled in the CPUO trial in December 2025.

As well as presenting new Relfydess data throughout the year, Galderma unveiled final nine-month data from a phase IV first-of-its-kind trial showing lasting efficacy and patient satisfaction with Restylane Lyft or Contour® in combination with Sculptra when addressing facial aesthetic changes following medication-driven weight loss. This work supported the development of international consensus‑based guidelines.

Galderma also had a strong presence at additional major medical congresses, including the IMCAS World Congress 2025, the Aesthetic & Anti-Aging Medicine World Congress (AMWC) Monaco, AMWC Dubai, and the American Society for Dermatologic Surgery (ASDS) 2025 Annual Meeting.

During the year, over 290,000 healthcare professionals were reached through education, training and medical awareness activities,5 including the Galderma Aesthetic Injector Network (GAIN) – which celebrated its 10th anniversary in 2025 – the Global Sensitive Skincare Faculty (GSSF), and the Skin Knowledge and Innovation Network (SKIN).

Financial scorecard

For the full year 2025, Galderma delivered 1,211 million USD in Core EBITDA, up 18.9% year-on-year at constant currency. The reported Core EBITDA margin was 23.3%, representing a margin expansion of 24 basis points at constant currency compared to 2024. Core EBITDA grew ahead of net sales, in a year of major launches with reinvestments into growth, thanks to ongoing operating leverage as well as a reduced adverse P&L impact from nemolizumab as a result of greater sales. Improvements in operating expenses also offset the impact of pricing effects and unfavorable product mix on gross margin.

Galderma delivered even greater growth in Core net income for the full year. Core net income was 871 million USD, up 75.4% year-on-year, driven by strong Core EBITDA growth as well as reduced financing and tax expenses. The latter include a one-time, non-cash benefit on the effective tax rate, from recognizing deferred tax assets on past tax losses in Switzerland.

Galderma demonstrated very strong cash generation for the year, due to significant Core EBITDA growth, favorable net working capital movements, and lower interest payments. Net working capital positions improved significantly behind effective net working capital management, structural improvements driven by shifts in market and product mix and phasing benefits.

Core CapEx benefitted from improved phasing of project spend as well as continued focus on spend efficiencies and site operating performance. Core CapEx as a percentage of sales continues to come down due to the high net sales growth. Investments significantly increased capacity at all of Galderma’s manufacturing sites, including the build-out of the biologics production site for Relfydess in Uppsala, Sweden. Beyond CapEx, Galderma also committed to spend more than 650 million USD on U.S. manufacturing through 2030, via contract manufacturing partners. Additional technology transfers to the U.S. focused on key growth drivers have also been initiated.

Core EPS was 3.69 USD per share, up 76.7% year-on-year, benefitting from the share repurchases executed in the year. Galderma repurchased shares for 363 million USD in the accelerated bookbuild offerings of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (“ADIA”) and Auba Investment Pte. Ltd. (“Auba”) which took place throughout the year. Funded from existing liquidity on hand, they are to be held in treasury to support Galderma’s employee participation plans, business development activities and/or treasury management.

Continuing on a rapid deleveraging trajectory, net leverage came down to 1.5x at the end of December 2025. For the full year, Galderma’s ambitious deleveraging and refinancing was underpinned by further partial repayment of its Term Loan of 1.5 billion USD. This was based on an early debt repayment of 240 million USD and debt refinancing of 1,260 million USD, which included several CHF and EUR bond issuances.

Building on its strengthened financial profile headlined by investment grade ratings from S&P (BBB, positive) and Fitch (BBB, stable), Galderma swiftly replaced in February 2026 its Revolving Credit Facility originally implemented at the time of the IPO in 2024, with significantly improved terms and a size increase from 0.7 to 1 billion USD.

Galderma continued to demonstrate its commitment to superior shareholder returns, including through share repurchases and dividend payment. Following another record year, Galderma’s Board will propose, for approval at the upcoming Annual General Meeting, a dividend payment out of reserves from capital contributions of 0.35 CHF (gross) per share.6

Galderma continued to diversify and strengthen its long‑term shareholder base. This included an additional 10% equity investment from L’Oréal, bringing their total shareholding in Galderma to 20%, with the transaction closed in February 2026.

ESG remains an integral pillar of Galderma’s strategy. In 2025, Galderma focused on strengthening the three constitutive elements of its ESG Strategy. This included streamlining its ESG Framework through an inaugural double materiality assessment, strengthening its ESG Governance to support auditable non-financial reporting, and delivering against a clear ESG Ambition. Galderma’s ESG Strategy has gained external recognition through improvements in key ESG ratings. For instance, in 2025, Galderma received an AA rating (on a scale of AAA-CCC) in the MSCI ESG Ratings assessment, up from BBB in 2024.

Outlook

Galderma expects 2026 to be another year of opportunities, with very strong top-line growth and significant Core EBITDA margin expansion. Galderma expects net sales growth of 17-20% at constant currency and a Core EBITDA margin of approximately 26% at constant currency for the full year.

Galderma’s proven integrated dermatology strategy is underpinning net sales growth, expected to be ahead of the market in each product category. It also continues to drive operating leverage, while allocating appropriate level of investments into growth in a competitive environment. Confident in the ability to deliver, the guidance also reflects existing uncertainties. Galderma’s dynamic approach to commercial investments provides resilience and flexibility to capture opportunities, leveraging a broad portfolio and geographic reach.

In terms of foreign exchange impacts, while guidance is at constant currency, based on spot rates as of the end of February 2026, USD depreciation is expected to have a positive impact on reported net sales and a negative impact on reported Core EBITDA margin, which is due to headquarter costs denominated mainly in CHF. A table with Galderma’s exposure to key foreign exchange currency pairs is available in the Appendix. As for tariffs, exposure remains manageable, with the guidance assuming a 15% U.S. tariff on the import value of Restylane and Sculptra.

Following a stronger than originally anticipated first year on the market in the U.S. and in European markets in prurigo nodularis and atopic dermatitis, Galderma is raising its peak sales guidance for Nemluvio from above 2 billion USD to above 4 billion USD for both indications globally. This reflects its strong launch trajectory with higher demand than expected based on positive real-world experience in addition to an already differentiated clinical profile.

In light of its greater expectation for Nemluvio and confidence in its broad-based growth trajectory, Galderma is specifying its 2023-2027 mid-term guidance to be within or above the previously stated ranges as per the table available in the Appendix, along with additional modelling metrics for 2026. Guidance for the mid-term is based on the same tariff assumption as for 20267, and subject to the same expected impact from foreign exchange.

Webcast details

Galderma will host its financial results call today at 14:00 CET to discuss the full year 2025 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at https://investors.galderma.com/events-presentations.

2025 Annual Report

Galderma issued its 2025 Annual Report today, and it is available at https://investors.galderma.com/financial-reports.

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.

Contacts

For further information:

Media

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

Investors

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

Read full story here

Allosteric Bioscience, Inc. Targets Optimizing Aging and Longevity: Quantum Computing, Advanced AI, Genomics

Allosteric Bioscience, Inc. Targets Optimizing Aging and Longevity: Quantum Computing, Advanced AI, Genomics




Allosteric Bioscience, Inc. Targets Optimizing Aging and Longevity: Quantum Computing, Advanced AI, Genomics

NEW YORK–(BUSINESS WIRE)–Allosteric Bioscience, Inc. is utilizing Genetics, Genomics, Systems Biology, Quantum Computing, Advanced Proprietary AI and Proprietary Molecular Technologies for understanding and controlling the Molecular Mechanism of Aging and Longevity with the goal of optimizing the aging process and extending longevity.


Aging factors that are being targeted are Lamin A which is critical for proper cellular function, Tryptophan Metabolism involved in most aging related diseases, improved DNA repair, optimizing mitochondrial metabolism, prevention and treatment of sarcopenia (muscle wasting due to aging or weight loss drugs) and control of factors comprising a Master Aging Complex identified by Dr. Arthur P. Bollon, who is President and Co-Founder of Allosteric Bioscience, Inc.

Dr. Bollon indicates that “Creation of modulators for key controlling factors involved in the aging molecular mechanism could reduce aging related diseases and significantly extend longevity. We welcome inquires about our technologies and opportunities for collaboration and partnering”.

Contacts

Dr. Arthur P. Bollon, President and Co-Founder of Allosteric Bioscience, Inc., arthurb@flash.net, abollon@allostericbioscience.com, 469-585-7613.

Bruce Meyers, Executive Chairman and Co-Founder of Allosteric Bioscience, Inc., bmeyers@allostericbioscience.com, 469-391-7957.

www.allostericbioscience.com

Allosteric Bioscience, Inc. Targets Extending Longevity

Allosteric Bioscience, Inc. Targets Extending Longevity




Allosteric Bioscience, Inc. Targets Extending Longevity

NEW YORK–(BUSINESS WIRE)–Allosteric Bioscience, Inc. is delineating the Molecular Mechanism of Aging and Longevity with the goal of optimizing the aging process and extending longevity. It is utilizing Genomics, Biology, Genetics, Quantum Computing, Advanced Proprietary AI and Proprietary Molecular Technologies.


Select targets include Sarcopenia (muscle loss) prevention and treatment, Lamin A epigenetics, Tryptophan Metabolism, improved DNA repair, optimizing mitochondrial metabolism and control of factors comprising a Master Aging Complex identified by Dr. Arthur P. Bollon, who is President and Co-Founder of Allosteric Bioscience, Inc.

Dr. Bollon indicates that “Delineation of the Aging and Longevity Molecular Mechanism permits making modulators for key factors that will enhance the aging process, reduce aging related diseases and significantly extend longevity. We welcome inquires about our technologies and opportunities for collaboration and partnering”.

Contacts

Dr. Arthur P. Bollon, President and Co-Founder of Allosteric Bioscience, Inc., arthurb@flash.net, abollon@allostericbioscience.com, 469-585-7613.

Bruce Meyers, Executive Chairman and Co-Founder of Allosteric Bioscience, Inc., bmeyers@allostericbioscience.com, 469-391-7957.

www.allostericbioscience.com

Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients

Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients




Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients

TORONTO–(BUSINESS WIRE)–#ARDS–Vasomune Therapeutics, Inc., (“Vasomune”), a clinical-stage biopharmaceutical company, today announced U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application to develop Pegevongitide (AV-001) for use in the acute resuscitation of severely burned patients. Pegevongitide, an injectable Tie2 agonist that blocks vascular leak, is currently being researched for the prevention and treatment of acute respiratory distress syndrome (ARDS) (NCT05123755).


“Vascular leak reflects a loss of endothelial barrier integrity, thereby allowing fluid and proteins to escape the intravascular space into surrounding tissues. This disrupts oxygen delivery, organ perfusion, and destabilizes hemodynamics. By activating the pivotal target Tie2, Pegevongitide targets a root mechanism of endothelial instability and leakage,” said Harold Kim, Ph.D., Vice-President of Research at Vasomune.

“In severely burned patients, vascular leak allows large volumes of fluid, proteins, and inflammatory mediators to shift from the bloodstream into injured and uninjured tissues,” said Dr. John C Kubasiak, Chief of Burn Surgery at Loyola University Medical Center in Chicago. “As a burn surgeon, I witness the impact of vascular leak driving profound edema, shock, impaired oxygen delivery, and multi-organ dysfunction.”

This new IND clearance allows Vasomune to initiate a clinical program evaluating Pegevongitide safety and efficacy in the resuscitation of severely burned patients. Pegevongitide offers a promising new approach by targeting the Tie2/Angiopoietin-1 signaling pathway to stabilize blood vessels, prevent vascular leakage and reduce vascular inflammation. Published preclinical data using Pegevongitide supports that this mechanism can reduce vascular leak and improve hemodynamic function.

Dr. Ei Yamada, President & CEO of AnGes, said that “We are encouraged by the FDA decision to allow the expansion of our AV-001 development program. Our commitment to developing AV-001 will allow us to take a step forward in the treatment of serious pathologies driven by vascular leak.”

About Vasomune Therapeutics, Inc.

Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to boost the body’s ability to defend against vascular leak. Founded in 2014, Vasomune has focused on vascular normalization strategies, and has progressed the lead candidate Pegevongitide (AV-001) from bench to bedside. Vascular dysfunction and vascular leak are associated with the pathology of several disease states, including bacterial and viral pneumonia and acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Vasomune’s corporate headquarters and laboratories are in Toronto, Canada with US offices in Raleigh, NC. For more information about the company please visit http://www.vasomune.com.

About AnGes, Inc.

AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. The company’s flagship development product and genetic drug, HGF gene therapy products, received Breakthrough Therapy designation from the FDA in 2024. AnGes is currently working on the development of a Tie2 tyrosine kinase receptor agonist (AV-001) for viral and bacterial-associated pneumonia and an NF-κB decoy oligonucleotide for chronic discogenic lumbar back pain. Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit https://www.anges.co.jp/en/.

Contacts

Shahid Ahmad, Vice-President Operations and Planning

Vasomune Media Relations

sahmad@vasomune.com

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)




Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

An investigational medicine that addresses the genetic root cause of BAG3 DCM, AFTX-201 is being evaluated in the UPBEAT© clinical trial

AFTX-201 is designed using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids

WALTHAM, Mass.–(BUSINESS WIRE)–Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for AFTX-201, a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM).


AFTX-201 is designed to deliver a fully human, full-length BAG3 transgene using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than those associated with gene therapies using conventional capsids such as AAV9 or AAVrh74. The safety and efficacy of AFTX-201 as a treatment for people living with BAG3 DCM is being investigated in the UPBEAT© clinical trial. AFTX-201 is given as a simple one-time intravenous administration. Preclinical studies in an animal disease model demonstrated that AFTX-201 increased BAG3 protein levels in the heart and completely restored cardiac function.

“We are grateful to the FDA for granting the Fast Track designation to AFTX-201 as a treatment for BAG3 DCM and to the patient and physician communities for their support of our UPBEAT clinical trial,” said Hideo Makimura, M.D., Ph.D., Chief Medical Officer at Affinia. “This Fast Track designation, together with the FDA’s recent approval of our IND application for AFTX-201 and the European Medicines Agency’s designation of AFTX-201 as an Orphan Drug, strengthens our conviction that AFTX-201 has the potential to significantly improve the lives of those affected by BAG3 DCM.”

“DCM is the leading cause of heart failure in young people and the most frequent indication for heart transplantation despite current treatments,” said Greg Ruf, Founder and Executive Director of the DCM Foundation. “People whose DCM is caused by a genetic mutation such as BAG3 may benefit from a gene therapy approach.”

Fast Track designation is designed to help drugs reach patients faster based on the drug’s potential to fill an unmet medical need and treat serious conditions. Programs receiving FTD benefit from early and frequent interactions with the FDA during the clinical development process and review of the marketing application on a rolling basis before the sponsor submits the complete application. If relevant criteria are met, the FDA may also consider an accelerated approval and priority review of the marketing application. These benefits could decrease the development time of the drug to approval.

About the UPBEAT© clinical trial

The UPBEAT clinical trial (NCT07426419 on clinicaltrials.gov) is a multicenter, single-arm, open-label Phase 1/2 clinical trial designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of AFTX-201 in adults with genetically confirmed BAG3-associated dilated cardiomyopathy. The trial includes a dose-exploration phase followed by a dose-expansion phase. All participants will receive a single intravenous infusion of AFTX-201 at a dose that has been deemed safe and efficacious based on preclinical studies. The primary objective of the trial is to evaluate safety and tolerability through 52 weeks following administration. Secondary and exploratory objectives include pharmacodynamic and preliminary efficacy assessments, which will be evaluated as changes from baseline. Study design, dose selection, and monitoring plans are informed by input from patients, clinicians, and regulators and by completed nonclinical proof-of-concept, biodistribution, and safety studies, which demonstrated complete correction of heart ejection fraction to normal (wild-type) level and adequate safety margin for the doses being explored in the clinical trial. Protocol-defined stopping rules, centralized safety data review, and oversight by an independent Data Safety Monitoring Board are implemented to ensure the safety of participants. Interested participants are encouraged to reach out to Affinia via clinicaltrials@affiniatx.com and to their medical care provider.

About Affinia Therapeutics

Affinia Therapeutics is a clinical-stage biotech company pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics’ pipeline of first-in-class or best-in-class product candidates, initially in cardiovascular diseases, leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit https://www.affiniatx.com.

Contacts

Media contact:
Kathy Vincent

kathy@kathyvincent.com
310-403-8951

Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America

Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America




Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America

  • Shield Across America mobile screening tour launches during Colorectal Cancer Awareness Month to address nation’s dangerously low screening rates by bringing Shield blood test directly to Americans
  • Route will focus on rural communities across the country with the lowest screening rates and highest CRC incidence and mortality
  • Shield is proven to increase screening rates with a 93% adherence

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of Shield Across America, a historic coast-to-coast mobile screening tour bringing Shield, the first and only FDA-approved blood test as a primary colorectal cancer (CRC) screening option and recommended in national guidelines, directly to over 100 communities across the country from Las Vegas to Hartford, Atlanta and more.




From national sporting events to rural senior centers and beyond, the tour will educate patients on the importance of CRC screening and provide patients of screening-eligible age the opportunity to screen with Shield via the mobile screening lab. The Shield Across America tour will focus on rural areas that face the biggest barriers to colorectal cancer screening and the highest incidence and mortality rates.

The tour launch coincides with National CRC Awareness Month, underscoring Guardant Health’s commitment to close America’s colorectal cancer screening gap and help more Americans get screened.

CRC remains the second leading cause of cancer-related deaths in the U.S., and recently the leading cancer death for those under 50. Despite being highly treatable when caught early, more than 54 million eligible Americans – 1 in 3 – do not complete their CRC screening because they find current options unpleasant or inconvenient. Shield Across America aims to eliminate the barriers that have kept many Americans from getting screened by expanding access to Shield through mobile screening lab stops nationwide.

“Shield Across America seeks to address a fundamental challenge in colorectal cancer screening in our country: access,” said AmirAli Talasaz, Guardant Health co-CEO. “By bringing screening directly to where Americans live, work and enjoy with a focus on our rural communities who face some of the biggest barriers to screening, we aim to encourage more people to get their lifesaving screening and close our nation’s screening gap.”

Shield is proven to increase screening rates in the real world, with 93% of patients completing the test in the first 100,000 Shield tests ordered – a significant improvement in screening adherence rates over other types of tests.1 Recently, the National Comprehensive Cancer Network included the Shield blood test in its updated CRC screening guidelines, paving the way for improved patient access and additional major clinical guideline inclusions.

Built on Guardant’s proprietary technology pioneered more than a decade ago, Shield is covered by Medicare, the Veterans Affairs Community Care Network and TRICARE, for active-duty service members, and is commercially available across the U.S.

Shield is available by prescription only and can be completed during a routine doctor’s visit. To find a screening event near you or find more details on the Shield test to discuss with your local provider, visit ShieldAcrossAmerica.com.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

 

1 Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.

Contacts

Investor Contact:
Zarak Khurshid

investors@guardanthealth.com

Media Contact:
Meaghan Smith

press@guardanthealth.com

Poplar Therapeutics Closes $45 million Series A Extension to Advance Development of Lead Program, PHB-050, A New Class of Anti-IgE Therapy for Multiple Atopic Conditions

Poplar Therapeutics Closes $45 million Series A Extension to Advance Development of Lead Program, PHB-050, A New Class of Anti-IgE Therapy for Multiple Atopic Conditions




Poplar Therapeutics Closes $45 million Series A Extension to Advance Development of Lead Program, PHB-050, A New Class of Anti-IgE Therapy for Multiple Atopic Conditions

Extension financing adds new investors, Janus Henderson Investors and RA Capital, with strong renewed participation from existing investors

Proceeds will support further clinical development of lead program PHB-050 in food allergy and other atopic conditions

Phase 1 clinical trial for PHB-050 remains on track

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Poplar Therapeutics, Inc., a clinical-stage immunology company developing a new class of anti-IgE therapy to treat food allergy and other atopic conditions, today announced the closing of its Series A extension round, bringing its total Series A financing to $95 million. The round was led by Janus Henderson Investors, with RA Capital also participating as a new investor. The financing was further supported by existing investors, including SR One, Vida Ventures and affiliates of ArrowMark Partners. The additional capital from this financing will support the continued advancement of its lead asset, PHB-050, through clinical development.


“Poplar Therapeutics is advancing a differentiated approach that has the potential to redefine how IgE-mediated diseases are treated,” said Daniel Lyons, PhD, CFA, Portfolio Manager, Research Analyst, Janus Henderson Investors. “We believe the upcoming Phase 1 data will be an important milestone in validating this novel mechanism and we look forward to supporting the company as it works to bring this therapy to patients in need.”

PHB-050 is currently in a Phase 1 clinical trial for food allergy. The ongoing trial is expected to generate key data on safety, pharmacokinetics and the potential to rapidly reduce circulating IgE levels toward zero, which could inform the next stage of clinical development.

“This extension reflects the strong conviction of our new and existing investors in Poplar’s differentiated science and clinical strategy and will allow us to continue the development of our potential best-in-class anti-IgE therapy through Phase 2 clinical trials,” said Chip Baird, chief executive officer of Poplar Therapeutics. “We are thrilled to have Janus and RA Capital join our exceptional investor partners in our shared goal of transforming the treatment of atopic disease. We believe that PHB-050 has the potential to help millions of patients in need of effective treatment options.”

Despite the availability of omalizumab (Xolair®), a first-generation anti-IgE therapy, millions of patients with atopic diseases such as food allergy, allergic asthma and atopic dermatitis lack effective treatment options, representing a significant unmet medical need. Patients with elevated IgE levels are ineligible for or do not adequately respond to currently available treatments.

About PHB-050

More than seven million patients with atopic conditions have high IgE levels, with approximately three million considered ineligible for or resistant to current standard therapies. In food allergy, approximately 50% of patients are classified as having high IgE levels.

PHB-050 is a novel, next-generation anti-IgE antibody designed to treat multiple atopic diseases, including food allergy, asthma and atopic dermatitis with potential application for select orphan immunology and inflammatory diseases. Its unique triple-action mechanism is designed to not only block IgE from binding to mast cells that trigger allergic reactions, but also to rapidly reduce circulating IgE and inhibit its production.

About Poplar Therapeutics

Poplar Therapeutics, Inc. is a clinical-stage immunology company developing a new class of anti-IgE therapy to challenge convention in treating allergic disorders, which was incorporated in 2024. Its lead program, PHB-050, is a next-generation anti-IgE antibody with a unique triple-action design currently being studied in atopic diseases. Poplar is pursuing the bold idea that IgE can be rapidly driven toward zero, with the goal of helping people with IgE-mediated conditions move from fear toward freedom.

Contacts

Media Contact:

Terri Clevenger

tclevenger@waterhousebrands.com

 

Sanaregen™ Vision Therapeutics Receives FDA Clearance for Clinical Trial to Treat Retinal Degeneration

Sanaregen™ Vision Therapeutics Receives FDA Clearance for Clinical Trial to Treat Retinal Degeneration




Sanaregen™ Vision Therapeutics Receives FDA Clearance for Clinical Trial to Treat Retinal Degeneration

NASHVILLE, Tenn.–(BUSINESS WIRE)–#ClinicalTrials–Sanaregen Vision Therapeutics, a clinical-stage regenerative medicine company, today announced clearance by the U.S. Food and Drug Administration to conduct a Phase I/II clinical trial for SVT-001, its investigational cell therapy.


The trial will assess safety and effectiveness of SVT-001 to improve retinal function and restore vision in individuals with Familial Drusen, an inherited form of macular degeneration. There are currently no approved disease-modifying treatments for the condition.

“This is a pivotal moment not only for our company, but for the families that have endured generations of early-onset blindness,” said Anthony Oliva, Ph.D., Chief Scientific Officer and co-founder. “We believe SVT-001 provides true hope to prevent the almost inevitable vision loss caused by this devastating condition that has largely been overlooked.”

Doug Oliver, President and co-founder, reflects on forwarding SVT-001 into clinical trials. “This represents nearly a decade of advocacy, scientific groundwork, regulatory cooperation and mission focus.” Oliver, a global award-winning patient advocate who has Familial Drusen, is known for his personal experience of vision recovery following cell-based therapy, which fueled his work with lawmakers to craft the 21st Century Cures Act. “I believe this cell therapy will ultimately be proven safe, easily administered, and highly effective at preventing and reversing vision loss. It’s a very exciting time for our company and patients alike.”

Rare Disease with Broader Market Implications

Familial Drusen is an aggressive retinal degeneration disorder characterized by early-age accumulation of waxy pathological deposits beneath the retina, called drusen. Many affected patients begin experiencing progressive central blindness around 40 years of age. While distinct from the much more prevalent disorder, dry age-related macular degeneration (AMD), the pathological similarities, including drusen accumulation and geographic atrophy, positions SVT-001 as a promising therapeutic candidate for AMD.

About Sanaregen Vision Therapeutics, Inc.

Sanaregen Vision Therapeutics is a U.S.-based biopharma company committed to developing affordable, accessible, and innovative cell-based therapies for degenerative retinal diseases.

Forward-Looking Statements

This release contains forward-looking statements subject to risks and uncertainties. Actual results may differ materially. We undertake no obligation to update this information, which speaks only as of this date, except as required by law.

Contacts

Media Contact:
Kristen Hayner

KH Strategic Communications

kristen@kristenhayner.com

Investment Inquiries:
invest@sanaregenvision.com
sanaregenvision.com/invest

Patient Inquiries:
sighttrial@sanaregenvision.com
+1 615.369.3576