New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities

New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities




New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities

  • Sub-analysis of children with atopic dermatitis aged 2-17 in pivotal Phase 3 trials revealed early and clinically meaningful improvements in vIGA-AD and EASI-75 (skin clearance and severity), POEM (patient-reported outcomes) and PP-NRS (itch), regardless of comorbidity status, at week 8

JERSEY CITY, N.J.–(BUSINESS WIRE)–Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, on November 8, 2025. The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or without atopic comorbidities such as asthma, allergic rhinitis and food allergies.


“As many children with atopic dermatitis may also be living with potential comorbidities such as allergies and asthma that may add to their disease burden,1 it’s important to understand the effects of approved treatments on this population,” said Dr. Luz Fonacier, Professor of Medicine, Section Head of Allergy and Training Program Director, NYU Grossman Long Island School of Medicine. “These reassuring data show tapinarof cream provided early relief, including on bothersome symptoms such as itch, for children as young as 2 years of age with and without comorbidities.”

In the ADORING 1 and ADORING 2 pivotal trials, adults and children (≥2 years; N=813) with moderate to severe AD were randomized to VTAMA cream or vehicle once daily for 8 weeks. The results presented at ACAAI 2025 are from a sub-analysis of the 654 children in the trials aged 2-17, with and without comorbidities associated with AD. The data highlight improvements in clinically relevant patient-reported outcomes, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response, and Eczema Area and Severity Index (EASI) scores in children aged 2-17 years, regardless of comorbidities.

Notable findings include:

  • Early improvements in skin clearance were observed, with significant differences in vIGA-AD response rates as early as week 1 and maintained through week 8 in children with or without atopic comorbidities (with comorbidities: 42.3% with VTAMA cream vs. 11.8% with vehicle, p<0.0001; without comorbidities: 49.5% vs. 14.8%, respectively, p<0.0001).
  • Improvement in eczema severity, as measured by EASI scores, was observed as early as week 2 and sustained through week 8 (with comorbidities: 54.5% with VTAMA cream vs. 21.8% with vehicle, p<0.0001; without comorbidities: 63.1% vs. 20.4%, respectively, p<0.0001).
  • Improvements in patient-reported outcomes, including sleep, as measured by total mean Patient-Oriented Eczema Measure (POEM) and mean POEM sleep scores (based on a single question within the POEM and analyzed separately from the total POEM score), were noted as early as week 1 and maintained through week 8 (total POEM with comorbidities: 6.9 with VTAMA cream vs. 12.0 with vehicle, p<0.0001; total POEM without comorbidities: 6.7 vs. 11.9, respectively, p<0.0001; POEM sleep with comorbidities: 0.9 with VTAMA cream vs. 1.4 with vehicle, p=0.0003; POEM sleep without comorbidities: 0.6 vs. 1.4, respectively, p<0.0001).
  • Clinically meaningful improvements in itch (a ≥4-point Peak Pruritus- Numeric Rating Scale [PP-NRS] response) were observed at week 2, based on responder analysis, with continued improvement through week 8 (with comorbidities: 55.6% with VTAMA cream vs. 36.3% with vehicle, p=0.0043; without comorbidities: 63.3% vs. 29.2%, respectively, p<0.0001).

Consistent with the prescribing information, the most frequently reported treatment-emergent adverse events in the sub-analysis of children aged 2-17 in the ADORING 1 and ADORING 2 trials were folliculitis (7.8%), upper respiratory tract infection (4.6%) and headache (3.7%).

“We are proud to announce data from this new sub-analysis demonstrating early and consistent skin clearance with VTAMA cream, as well as other clinically meaningful improvements in key atopic dermatitis measures in children 2 years and older, regardless of comorbidity status,” said Rafael Chaves Cardona, MD, Head of U.S. Medical Affairs and Outcomes Research, Organon. “This study represents the largest pediatric data set to date for VTAMA, and when added to the wealth of data from the pivotal trials, as well as the ADORING 3 open-label, long-term extension trial, these findings support Organon’s commitment to offering treatment options with a favorable safety and efficacy profile for children 2 years and older.”

In December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA in May 2022, for the topical treatment of plaque psoriasis in adults.2

About the Phase 3 Program for VTAMA cream in Atopic Dermatitis

ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.2

INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

  • the topical treatment of plaque psoriasis in adults
  • the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

SELECTED SAFETY INFORMATION

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

Before prescribing VTAMA cream, please read the Prescribing Information.

For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com.

About Atopic Dermatitis (AD)

AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the U.S. alone and up to 10% of adults worldwide.3,4 AD occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the US.4,5, The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.3, Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.4 Around 90% of children with eczema also have another related condition such as allergies or asthma, according to international survey data.1

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok, and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations about the potential impact of VTAMA as a treatment option for AD. Forward-looking statements may be identified by words such as “potential,” “mission,” “expects,” “will,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

© 2025 Organon group of companies. All rights reserved. vIGA-AD is the trademark of Eli Lilly and Co. US-VTA-113019 11/25

1 Weidinger S, Simpson EL, Silverberg JI, et al. Burden of atopic dermatitis in paediatric patients: an international cross-sectional study. Br J Dermatol. 2024;190(6):846-857. doi:10.1093/bjd/ljad449

2 VTAMA (tapinarof) cream, 1%, Prescribing Information. Organon; Revised May 2025.

3 Atopic dermatitis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. November 2022. Accessed August 19, 2025. https://www.niams.nih.gov/health-topics/atopic-dermatitis
4 Eczema stats. National Eczema Association. Accessed June 5, 2025. https://nationaleczema.org/research/eczema-facts/
5 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed February 25, 2025. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf

Contacts

Media Contacts:

Felicia Bisaro

(646) 703-1807

Investor Contact:

Jennifer Halchak

(201) 275-2711

Biomunex to Present Preclinical Data of its MAIT Engager Platform in Immuno-Oncology at 2025 SITC Annual Meeting

Biomunex to Present Preclinical Data of its MAIT Engager Platform in Immuno-Oncology at 2025 SITC Annual Meeting




Biomunex to Present Preclinical Data of its MAIT Engager Platform in Immuno-Oncology at 2025 SITC Annual Meeting

  • Dr. Simon Plyte, Biomunex’s CSO, has been invited to present MAIT engagers preclinical data during an oral communication at 2025 SITC Annual meeting
  • With a very attractive safety and efficacy profile, MAIT engagers have a major potential to fuel an innovative portfolio of drug candidates in oncology
  • Biomunex’s ambition is to develop the next generation of immunotherapies in oncology: MAIT engagers, bispecific antibodies capable of identifying, mobilizing, and activating MAIT cells, a subpopulation of T cells, to kill cancer cells.

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biomunex Pharmaceuticals, a French biopharmaceutical company specializing in the development of next generation immunotherapies based on the discovery and development of bispecific and multispecific antibodies, today announces presentation of preclinical data from its MAIT engager platform at the Society for Immunotherapy of Cancer’s (“SITC”) 40th Annual Meeting being held in National Harbor, USA, from November 5th-9th, 2025.

MAIT engagers: a new class of bispecific antibodies for cancer treatment

Invited to present an oral communication on November 8th, Dr Simon Plyte, Biomunex CSO (Chief Scientific Officer), will make a presentation entitled: “The MAIT Engager platform : rapid generation of several MAIT T cell engagers with significantly improved safety profile and large therapeutic window (Abstract 1197).” He is also presenting a Poster regarding the topic on November 7th.

Biomunex is developing a large portfolio of MAIT engager drug candidates, a new therapeutic class in immuno-oncology, that is differentiated from classical TCEs (“T cell engagers”). MAIT engagers are bispecific antibodies that identify, mobilize and bridge MAIT cells (Mucosal-Associated Invariant T cells) to cancer cells resulting in MAIT activation and directed killing of tumors; MAIT engagers could become a breakthrough approach in the treatment of many cancers, particularly in solid tumors.

The presentation at SITC Annual meeting will focus on the MAIT engager differentiation from classical CD3+ TCEs and highlight the superior safety of MAIT engagers. MAIT engagers are expected to overcome some of the limitations of current CD3+ TCE therapies, including activation of regulatory T cells (Tregs) and cytokine release syndrome, serious side effects that are difficult to manage for cancer patients.

The Biomunex platform enables rapid generation of several MAIT engagers, that are not only as potent at classical CD3+ T cell engagers but also bring significantly improved safety profile and have the potential to provide a larger therapeutic window in specific tumor types. Moreover, MAIT engagers can effectively induce the “SPARK effect”, enabling long-term durable anti-cancer response.

Based on preclinical data, Biomunex expects the first MAIT engager to enter clinical trials soon. The MAIT engager platform paves the way for a series of innovative new immunotherapeutics targeting many cancers. “MAIT engagers are an attractive approach for the treatment of cancer with breakthrough potential for redefining the standard of care for solid tumors,” comments Dr. Simon Plyte, Biomunex’s CSO. “Presenting those preclinical data as an oral communication and a poster during the 40th SITC meeting is a unique opportunity in sharing the scientific and medical potential of this innovative approach with the scientific community”.

Biomunex accelerates development of its disruptive immunotherapies pipeline

Biomunex is becoming a major innovative player in oncology. Bi- and multi-specific antibodies and T cell engagers are attracting considerable interest from pharmaceutical companies, with the recent signing of many licensing and partnership agreements, including for Biomunex. “The last few months have marked the beginning of a new chapter in Biomunex’s development with the signing of a major agreement with Ipsen, following other licensing or partnership deals, demonstrating the team’s ability to develop drugs and technologies of interest for the pharmaceutical industry, such as the MAIT engagers presented at 2025 SITC Annual meeting, to treat cancer patients, but also to establish leading licensing agreements and partnerships with the industry,” comments Dr. Pierre-Emmanuel Gerard, Biomunex’s founder and President.

In addition to BMX-502 licensed to Ipsen, Biomunex is developing a portfolio of MAIT engager drug candidates and innovative new therapeutic approaches with high potential, based on its proprietary “Plug-and-Play” BiXAb® platform. This technology enables the generation of breakthrough immunotherapies faster than most other platforms in the field, with excellent drug-like properties and high industrial yield. Biomunex’s first BiXAb drug candidate is currently in Phase 1 clinical development in partnership, as a monotherapy or in combination, in patients with certain solid tumors or hematological malignancies.

***

Details about Biomunex’ presentations at 2025 SITC Annual Meeting

Abstract Title: “The MAIT Engager platform – rapid generation of several MAIT T cell engagers with significantly improved safety profile and large therapeutic window

Abstract Number: 1197 – Ranked amongst 150 best abstracts.

Poster presentation

Friday 7th Nov, 5:35–7 p.m. ET

Poster Reception | Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Oral presentation

Saturday 8th Nov, 1:08-1:16 p.m. ET

Concurrent Session 205a: Rapid Oral Abstract Session – Basic

Maryland Ballroom AB

About Biomunex Pharmaceuticals : www.biomunex.com

Biomunex Pharmaceuticals is a biopharmaceutical company based in Paris, France, and Cambridge, MA, USA, specializing in the discovery and development of innovative therapeutic approaches based on solid data and biological and clinical evidence to address unmet medical needs in oncology.

Biomunex has created and developed BiXAb®, a robust, next-generation, plug-and-play technology platform for bi- and multi-specific antibodies, using a proprietary in silico modeling approach, based on a very robust intellectual property and patent portfolio.

The BiXAb platform, which enables the generation of bispecific antibodies from any pair of monoclonal antibodies in a simple, rapid, and cost-effective manner, has been validated through licensing agreements and collaborations with the pharmaceutical and biotechnology industry, including Sanofi, Onward Therapeutics, and most recently Ipsen.

Biomunex is the first company in the world to develop a cancer immunotherapy approach that uses bispecific antibodies from its BiXAb platform to specifically target, engage, and redirect MAIT cells, a subpopulation of T cells naturally present throughout the body, particularly in mucosal and barrier tissues, to kill cancer cells for the treatment of solid tumors.

Contacts

Media:

Biomunex Pharmaceuticals
NewCap Agency – Nicolas Merigeau

nmerigeau@newcap.fr
+33 (0)1 44 71 94 98

Evinova China and Harbour BioMed Announce Strategic AI Collaboration to Accelerate AI-Enabled Drug Development

Evinova China and Harbour BioMed Announce Strategic AI Collaboration to Accelerate AI-Enabled Drug Development




Evinova China and Harbour BioMed Announce Strategic AI Collaboration to Accelerate AI-Enabled Drug Development

SHANGHAI–(BUSINESS WIRE)–Yesterday, during the 8th China International Import Expo (“CIIE”), Evinova, a global health-tech company accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, and Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, announced a strategic collaboration in artificial intelligence (AI).


Under the terms of the collaboration, Evinova China and Harbour BioMed will jointly apply AI and digital technologies to enhance the efficiency of innovative biologics development. Building on their own strengths, the two companies aim to build an open ecosystem for AI-driven drug R&D.

Nate Zhang, General Manager of Evinova China, stated, “Evinova leverages the digital transformation insights of top global pharmaceutical companies to design our AI-powered clinical development solutions and digital strategy consulting services, so that we can accelerate the delivery of better health outcomes. To realize our mission, Evinova China needs to partner with innovative companies like Harbour BioMed, which are rooted in China while harboring global ambitions. Together, through our world-class AI technology platforms and deep therapeutic expertise, we can help take China-originated breakthrough assets from the laboratory to the world.”

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, stated, “We are pleased to collaborate with Evinova to advance the application of AI in biotherapeutic development. Harbour BioMed has built a robust and differentiated product pipeline based on our industry-leading Harbour Mice® technology platform. Through this collaboration, we look forward to applying AI to improving clinical study efficiency and accelerating the delivery of innovative therapies to patients around the world.”

About Evinova

Evinova is a global health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a separate health-tech business within the AstraZeneca Group. Please visit evinova.com or follow the company on social media @Evinova.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed’s proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

Contacts

Media Contact:
Heather Bonsiero

Head of Communications and Marketing

Evinova

heather.bonsiero@evinova.com

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples




Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#CommittedToLife–Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States.




The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.

Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.

Product Name/Product Size

Unit of Use NDC Number

Unit of Sale NDC Number

Product Code

Batch Number

Expiration

Date

First Ship

Date

Last Ship

Date

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL fill in a 2 mL vial

63323-739-11

63323-739-12

730912

6133156

08/2026

01/02/2025

02/11/2025

6133194

08/2026

02/04/2025

04/11/2025

6133388

10/2026

05/23/2025

05/23/2025

Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:

  1. Short term treatment of active duodenal ulcer.
  2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
  3. Short term treatment of active benign gastric ulcer.
  4. Short term treatment of gastroesophageal reflux disease (GERD).
  5. Treatment of pathological hypersecretory conditions.

Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

Contacts

Media Contact

Matt Kuhn

847-220-3033

City of Hope Appoints Leading Lung Cancer Expert Dr. Christine M. Lovly to Head National Thoracic Oncology Program

City of Hope Appoints Leading Lung Cancer Expert Dr. Christine M. Lovly to Head National Thoracic Oncology Program




City of Hope Appoints Leading Lung Cancer Expert Dr. Christine M. Lovly to Head National Thoracic Oncology Program

  • Dr. Lovly brings nearly two decades of experience in clinical care, research and academic leadership to her new role.
  • Her work has advanced personalized therapies that improve outcomes and quality of life for people with lung cancer.

LOS ANGELES–(BUSINESS WIRE)–City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, today announced that internationally recognized physician-scientist Christine M. Lovly, M.D., Ph.D., F.A.S.C.O., will spearhead the development of its new national thoracic oncology program, furthering City of Hope’s mission to deliver exceptional multidisciplinary care and transformative research for patients with lung cancer. Dr. Lovly’s appointment is effective Jan. 1.




Dr. Lovly will be division chief of thoracic medical oncology, professor in the Department of Medical Oncology & Therapeutics Research at City of Hope National Medical Center and will hold the Dr. Norman and Melinda Payson Professorship in Medical Oncology.

She brings nearly two decades of experience in clinical care, translational research and academic leadership. She joins City of Hope at a critical time in the fight against lung cancer, as rates of the disease continue to rise — especially among women, younger people and nonsmokers.

Her pioneering work has shaped the modern landscape of lung cancer care, leading to more effective therapies tailored to the genetic makeup of individual tumors. Dr. Lovly is a leading authority on the molecular dynamics of targeted therapy response and resistance, especially in lung cancer subtypes characterized by EGFR and ALK alterations.

“Dr. Christine Lovly is a widely recognized expert whose groundbreaking research and unwavering commitment to patient-centered care make her an extraordinary addition to City of Hope. Her expertise in precision medicine and translational science will be instrumental in shaping our national thoracic oncology program and accelerating progress for patients with lung cancer across the country,” said Marcel van den Brink, M.D., Ph.D., president, City of Hope Los Angeles and City of Hope National Medical Center, and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D.

Dr. Lovly will be responsible for advancing multidisciplinary clinical care, building and mentoring a world-class faculty, expanding translational and clinical research, and fostering strategic partnerships to further solidify City of Hope as a national leader in lung cancer innovation and patient outcomes. Dr. Lovly’s arrival marks an exciting chapter for City of Hope. Her collaborative, innovative approach will further elevate City of Hope’s lung cancer program and strengthen its systemwide commitment to excellence.

Her research portfolio includes ongoing projects focused on biomarkers, drug development and residual disease. She integrates data science into her research, helping create predictive algorithms to uncover potent drug interactions with the potential to improve efficacy and lessen side effects. This body of work resulted in Dr. Lovly receiving the 2025 William J. Darby Award “for translational research that has changed the practice of medicine worldwide.”

Today the LUNGevity Foundation presented Dr. Lovly with the Face of Hope Award, which is given to individuals who recognize the needs of those living with lung cancer and is actively making a difference on their behalf. Past recipients include Richard Pazdur, M.D., director of the U.S. Food and Drug Administration’s Oncology Center of Excellence, and Robert Winn, M.D., president of the Association of American Cancer Institutes.

“I believe the future of lung cancer care lies in precision medicine and team-based collaboration, and City of Hope is the ideal place to bring that vision to life,” Dr. Lovly said. “I look forward to working alongside world-class clinicians and researchers to build a program that truly serves patients and their families.”

Dr. Lovly comes to City of Hope from Vanderbilt University Medical Center, where she was a tenured faculty member and held a joint appointment at the Veterans Affairs Medical Center. She is an elected member of the American Society for Clinical Investigation and serves on numerous editorial boards, including Cancer Discovery, Clinical Cancer Research and JCO Precision Oncology. Dr. Lovly holds leadership roles in multiple national and international organizations, including as a current member of the American Association for Cancer Research (AACR) Board of Directors.

Dr. Lovly contributes to the scientific leadership boards of LUNGevity Foundation, GO2 Foundation for Lung Cancer Research and Lung Cancer Research Foundation. Additionally, she plays a key role in shaping national standards of care through her service on the National Comprehensive Cancer Network (NCCN) guidelines panel for non-small cell lung cancer.

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked among the nation’s top cancer centers by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

Zen Logsdon

626-409-9367

zlogsdon@coh.org

FillPoint Health Forms Collaborative Partnership with Noble, an Aptar Pharma Company, to Enhance Patient Experience and Drive Treatment Adherence

FillPoint Health Forms Collaborative Partnership with Noble, an Aptar Pharma Company, to Enhance Patient Experience and Drive Treatment Adherence




FillPoint Health Forms Collaborative Partnership with Noble, an Aptar Pharma Company, to Enhance Patient Experience and Drive Treatment Adherence

DUBLIN, Ohio–(BUSINESS WIRE)–FillPoint Health, a Lyceum Health company and URAC/ACHC-accredited specialty pharmacy and MSO, announced today a strategic partnership with Noble, an Aptar Pharma company and global leader in drug delivery training and onboarding solutions. This collaboration aims to enhance the patient experience through provider engagement and pharmaceutical partnerships, ensuring proper device use, improved adherence, and better clinical outcomes.


Under this partnership, FillPoint Health and Noble will jointly develop and implement education and support programs that integrate Noble’s industry-leading training devices, patient onboarding tools, and education platforms into FillPoint’s provider-driven specialty pharmacy model. The collaboration will focus on bridging the gap between pharmaceutical manufacturers, healthcare providers, and patients, creating a consistent, high-touch experience from prescription to administration.

“Our partnership with Noble represents a critical step in advancing how specialty therapies are delivered and supported at the point of care,” said Michael Baldzicki, Chief Revenue Officer of FillPoint Health. “By combining Noble’s proven patient training expertise with FillPoint’s provider-centric pharmacy model, we can help patients start therapy with confidence, use their medications correctly, and stay adherent over time—ultimately improving outcomes and satisfaction.”

The collaboration aligns with FillPoint Health’s broader mission of empowering providers and patients through technology, education, and integrated care models. As part of Lyceum Health’s network, FillPoint Health partners with pharmaceutical manufacturers and specialty providers to deliver fair market value (FMV)-based services, risk-of-loss pharmacy models, and real-world data insights that enhance access, quality, and efficiency in specialty care.

“We’re excited to partner with FillPoint Health to further our shared vision of improving patient engagement and outcomes,” said Craig Baker, President, Noble – Aptar Pharma. “Together, we will leverage our complementary strengths to ensure patients are fully supported in their treatment journey, from training to adherence.”

The partnership will initially focus on key therapeutic areas—including cardiology, dermatology, neurology, and rare diseases—with plans to expand into additional specialty categories and manufacturer collaborations throughout 2026.

About FillPoint Health, A Lyceum Health Company

FillPoint Health is a URAC- and ACHC-accredited specialty pharmacy and MSO focused on enhancing specialty patient care through integrated provider, payer, and pharmaceutical partnerships. FillPoint operates as part of Lyceum Health, a group of companies that includes RxNexus, a digital patient-access platform, and NewPoint-Rx, a physician-dispense division enabling compliant, FMV-based, in-office dispensing. For more info, please visit fillpointhealth.com and lyceumhealth.com.

About Noble, An Aptar Pharma Company

Noble is an Aptar Pharma company and part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Noble is a global leader in the development of patient-centric onboarding and drug delivery training solutions designed to improve the patient experience and drive adherence. Noble partners with pharmaceutical and biotechnology companies worldwide to create innovative, user-friendly training and support programs that empower patients to start and stay on therapy. For more information, please visit gonoble.com and www.aptar.com.

Contacts

Media Contacts:
FillPoint Health, A Lyceum Health Company:

info@fillpointhealth.com
www.lyceumhealth.com

Noble, An Aptar Pharma Company:

Ciara Jackson

Aptar Pharma

ciara.jackson@aptar.com
+49 151 1951 6502

Schrödinger to Present at Jefferies London Healthcare Conference

Schrödinger to Present at Jefferies London Healthcare Conference




Schrödinger to Present at Jefferies London Healthcare Conference

NEW YORK–(BUSINESS WIRE)–Schrödinger, Inc. (Nasdaq: SDGR) today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference. The live presentation will take place on Wednesday, November 19, at 4:00 p.m. GMT (11:00 a.m. ET).


The live webcast can be accessed in the “Investors” section of Schrödinger’s website and will be archived for approximately 90 days following the event.

About Schrödinger

Schrödinger is transforming molecular discovery with its computational platform, which enables the discovery of novel, highly optimized molecules for drug development and materials design. Schrödinger’s software platform is built on more than 30 years of R&D investment and is licensed by biotechnology, pharmaceutical and industrial companies, and academic institutions around the world. Schrödinger also leverages the platform to advance a portfolio of collaborative and internal programs. Founded in 1990, Schrödinger has approximately 800 employees operating from 15 locations globally. To learn more, visit www.schrodinger.com, follow us on LinkedIn and Instagram, or visit our blog, Extrapolations.com.

Contacts

Matthew Luchini (Investors)

Schrödinger, Inc.

matthew.luchini@schrodinger.com
917-719-0636

Allie Nicodemo (Media)

Schrödinger, Inc.

allie.nicodemo@schrodinger.com
617-356-2325

MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034

MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034




MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034

LYON, France–(BUSINESS WIRE)–$MAAT #ASH–Regulatory News:


MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the presentation of updated preclinical data for MaaT034, its next generation drug candidate to be evaluated to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors at the 40th  Society for Immunotherapy Cancer Annual Meeting in National Harbor, MD held  from November 5 to 9, 2025.  The SITC Annual Meeting is one of the world’s leading scientific and medical conferences focused on cancer immunotherapy. The dataset demonstrates compelling anti-tumor efficacy results and immune activation in germ-free mouse models. New analyses of multi-omic data from these models amplify the results previously presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025.

MaaT034, the first-in-class co-cultured full ecosystem product, is designed to optimize intestinal microbiome functions and improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). MaaT034 is part of the Company’s MET-C platform, which leverages AI-driven co-culture technology to create donor-independent synthetic microbiome ecosystems at industrial scale, targeting specific disease indications.

To guide further development of MaaT034 in immuno-oncology, and in addition to its preclinical program, MaaT Pharma is also participating in two exploratory, investigator-sponsored clinical trials evaluating its donor-derived drug candidates (MaaT013 and MaaT033), respectively in metastatic melanoma and in non-small cell lung cancer (NSCLC).

Key findings from the presentation at SITC include:

  • Metagenomic analysis shows that MaaT034 successfully engrafts in the gut of germ-free mice and reproduces the microbial functions of native-based microbiome ecosystems.
  • MaaT034 improves dendritic cell (DC)-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
  • 70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment. In human FMT studies, the level of engraftment is significantly associated with positive clinical outcomes across multiple indications, as shown by a recent comprehensive meta-analysis1.
  • MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids, secondary bile acids, and tryptophan metabolites in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
  • MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila2 bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.

“With MaaT034, we are entering a new phase in our drug platform development, one that leverages our deep experience in the development of complex microbiome therapies and cutting-edge computational analysis to build a next-generation drug candidate capable of enhancing patient response to immunotherapy,” said Sheri Simmons, PhD, Acting Chief Scientific Officer, MaaT Pharma. “These findings strongly support advancing our donor-independent, synthetic microbiome therapy and we look forward to bringing MaaT034 into clinical development.”

Details of poster presentation:

  • Abstract number: 1150
  • Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, potentiates anti-PD1 mediated antitumoral activity in germ-free mice
  • Presentation Day: Saturday, Nov. 8, 2025
  • Primary Category: Microbiome and Other Environmental Factors

Upcoming investor and medical conferences participation

  • November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
  • November 25, 2025 – Investir Day event in Paris, France
  • December 6-9, 2025 – 67th American Society of Hematology (ASH) annual meeting in Orlando, Fl, USA

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1.  By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

1 Ianiro, G., Punčochář, M., Karcher, N. et al. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med 28, 1913–1923 (2022). https://doi.org/10.1038/s41591-022-01964-3
2 Akkermansia muciniphila is a commensal bacterium naturally present in large quantities in the gut microbiota of healthy people.

Contacts

MaaT Pharma – Investor Relations
Guilhaume DEBROAS, Ph.D.

Head of Investor Relations

+33 6 16 48 92 50

invest@maat-pharma.com

MaaT Pharma – Media Relations
Pauline RICHAUD

Senior PR & Corporate Communications Manager

+33 6 14 06 45 92

media@maat-pharma.com

Catalytic Agency – U.S. Media Relations
Heather Shea

Media relations for MaaT Pharma

+1 617-286-2013

heather.shea@catalyticagency.com

Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile

Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile




Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile

  • This approval is based on results showing the safety and effectiveness of Restylane Lyft in enhancing the chin profile, with high patient satisfaction and long-lasting results1,2
  • Restylane Lyft is the only hyaluronic acid (HA) injectable approved to treat the midface, facial folds and wrinkles, back of hands and the chin, with consistent results observed across diverse patient types1,2
  • Galderma’s Restylane portfolio, including Restylane Lyft, is supported by decades of clinical evidence and real patient experiences with over 77 million treatments delivered worldwide3,4

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Restylane Lyft with Lidocaine for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion.2 Restylane Lyft is a versatile HA injectable with over 20 years of worldwide safety data, which is also approved to treat the midface, facial folds and wrinkles (such as nasolabial folds) and back of hands.2,3,4


The Restylane portfolio offers a versatile range of HA injectables, from soft and flexible to firm gel formulations, empowering practitioners to deliver personalized aesthetic outcomes.5-8 Restylane Lyft, developed with NASHA® technology, has a firmer gel with minimal modification, closely resembling the skin’s natural HA.9,10 With its high G-prime (a measure of firmness), Restylane Lyft is specifically designed to provide structure and support, enabling it to enhance the chin for a balanced profile.2,5,11

 

“This approval reinforces our commitment to advancing our Injectable Aesthetics portfolio – the broadest on the market – to meet the diverse needs of patients. By expanding how innovations like Restylane Lyft can be used, we aim to empower aesthetic practitioners to achieve their patients’ unique aesthetic goals with enhanced flexibility and precision.”

 

BILL ANDRIOPOULOS, PHD

VICE PRESIDENT OF MEDICAL AFFAIRS

GALDERMA U.S.

 

 

The approval is based on results from a pivotal clinical trial, confirming the clinical performance and safety of Restylane Lyft for chin enhancement.1,2 The primary endpoint of the study was met, demonstrating its safety and effectiveness in improving chin projection three months after initial injection, with improvement sustained in the majority of patients through 12 months.1 Additional results showed:1

  • Global aesthetic improvement, as assessed by both patients and investigators, remained consistently high throughout the study. At Month 3, 99.1% of investigators and 94.5% of subjects reported visible improvement. These results were maintained at Month 12, with 95.4% of investigators and 89.0% of patients continuing to report positive outcomes
  • At the end of the study (Month 12), a high proportion of patients agreed or strongly agreed that Restylane Lyft delivered natural-looking chin projection, improved the appearance of the lower face, and provided a smooth transition from chin to jawline, with satisfaction rates up to 86.3%
  • Restylane Lyft was well tolerated, with no unexpected or serious adverse events related to the product reported during the study, reinforcing its favorable safety profile

 

“The chin plays a vital role in overall facial harmony. Restylane Lyft offers a safe and effective way to enhance this area, helping to bring balance and definition to the face. It’s already a trusted product in my clinic, supported by my own experience and over two decades of global safety data, so I’m pleased to now be able to also offer patients its benefits in the chin.”

 

ALIA S. BROWN, M.D. FAAD

ATLANTA BIOMEDICAL CLINICAL RESEARCH AND GEORGIA DERMATOLOGY PARTNERS

COSMETIC DERMATOLOGIST

 

 

Regulatory applications for Restylane Lyft for use on the chin will continue to be submitted and assessed by additional authorities globally. Galderma is working to bring this expanded indication to as many countries as possible.

IMPORTANT SAFETY INFORMATION

Restylane Lyft with Lidocaine is indicated for deep implantation into the facial tissue for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the mid-to-deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion.

Restylane Lyft with Lidocaine contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such material or for patients with severe allergies that have required in-hospital treatment. This product should not be used by people with bleeding disorders, with hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.

The most common side effects reported in the clinical study to support approval of augmentation of the chin region included bruising, nodules, exfoliation, hemorrhage, edema, papules and redness. Patients also reported pain, tenderness, swelling, itching, and lumps/bumps.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, superficial necrosis, and scarring at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.

Restylane Lyft with Lidocaine is only available through a licensed practitioner. Complete Instructions for Use are available here.

About the Restylane portfolio

Restylane hyaluronic acid (HA) injectables are designed differently to go beyond volumizing for natural-looking results.1,12-14 Our HA is exceptionally pure and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.9,10,15 Restylane’s unique technologies, NASHA HD, NASHA and OBT/XpresHAn are meaningfully designed to mimic the diverse range of facial structures and skin layers.12-14 With the highest G’ and highest flexibility, Restylane can provide structural support, natural expressions and a healthy glow.7,13,15-18 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural looking results.12,19,20

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. Galderma. Data on file. MA-60800. 43USCH2208 R Lyft Chin US Clinical Study Report.
  2. Restylane® Lyft. Instructions for Use. Available online. Galderma Laboratories, L.P., 2025.
  3. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
  4. Galderma. Data on file. MA-55607. Restylane® 27 years data publications analysis.
  5. Galderma Data on file. MA-56724. X-strain and G’ including Shaype.
  6. Nikolis A, Humphrey S, Rivers JK, et al. Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. J Drugs Dermatol. 2024;23(4):255–261.
  7. Öhrlund Å, Winlöf P, Bromée T, et al. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance. J Drugs Dermatol. 2024;23(1):1332–1336.
  8. Belmontesi M, De Angelis F, Di Gregorio C, et al. Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus. J Drugs Dermatol. 2018;17(1):83–88.
  9. Edsman K, Nord LI, Öhrlund Å, et al. Gel Properties of Hyaluronic Acid Dermal Fillers. Dermatol Surg. 2012;38:1170–1179.
  10. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
  11. Data on file. MA-34483. Study Report. Galderma Laboratories, L.P., 2021.
  12. Di Gregorio C, Avelar L, Lam S, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco.
  13. Nikolis A, Enright KM, Lazarova D, et al. The role of clinical examination in midface volume correction using hyaluronic acid fillers: should patients be stratified by skin thickness? Aesthet Surg J Open Forum. 2020; 2(1):1–12.
  14. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.
  15. Kablik J, Monheit GD, Yu LP, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312.
  16. Bromée T, Öhrlund Å, Winlöf P, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco.
  17. Narins RS, Brandt FS, Dayan SH, et al. Persistence of nasolabial fold correction with a HA dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg. 2011;37: 644-650.
  18. Talarico S, Meski AP, Buratini L. et al. High patient satisfaction of a HA filler producing enduring full-facial volume restoration: an 18-month open multicenter study. Dermatol Surg. 2015;41: 1361–1369.
  19. Solish N, Bertucci V, Percec I, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3): 738-746.
  20. Philipp‐Dormston WG, Schuster B, and Podda M. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7): 1600-1606.

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

Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates

Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates




Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates

MARSEILLE, France–(BUSINESS WIRE)–#immunotherapy–Regulatory News:


Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the Company will hold a conference call on Thursday, November 13, 2025, at 2 p.m. CET / 8 a.m. ET, to give an update on business progress during the third quarter of 2025.

Participants during the call will be:

  • Jonathan Dickinson, Chief Executive Officer
  • Sonia Quaratino, Executive Vice President, Chief Medical Officer
  • Yannis Morel, Executive Vice President, Chief Operating Officer
  • Stéphanie Cornen, Vice President, Investor Relation, Communication and Commercial Strategy
  • Frédéric Lombard, Senior Vice President, Chief Financial Officer

Details for the Virtual Event

The live webcast will be available at the following link: https://events.q4inc.com/attendee/424851735

Analysts may also join via telephone, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its antibody-engineering expertise, the company has developed innovative therapeutic approaches, including monoclonal antibodies (mAbs), Antibody Drug Conjugates (ADC) and multi-specific NK Cell Engagers through its proprietary ANKET® (Antibody-based NK cell Engager Therapeutics) platform.

Innate’s portfolio includes lacutamab, an anti-KIR3DL2 mAb developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, IPH4502, a differentiated Nectin‑4 ADC in development in solid tumors, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as renowned research institutions, working together to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code

   

FR0010331421

Ticker code

   

Euronext: IPH Nasdaq: IPHA

LEI

   

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma

Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.fr