Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies




Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies

BESSINES-SUR-GARTEMPE, France–(BUSINESS WIRE)–Orano Med:

• ATEF (Advanced Thorium Extraction Facility) plant is now watertight, marking a major step toward the completion of civil engineering work.
• Construction is progressing according to schedule, with start-up planned for 2027.
• A site visit brought together institutional partners, local authorities, and economic stakeholders to celebrate this achievement.
• ATEF will be the world’s first industrial facility dedicated to the production of thorium-228, the precursor of lead-212 used in innovative targeted alpha therapies against cancer.

Orano Med, a subsidiary of the Orano group specializing in the development of targeted alpha therapies in oncology, announced today that the Advanced Thorium Extraction Facility (ATEF) in Bessines-sur-Gartempe, near Limoges, France, has now reached the dry-in phase, with sealing works completed. This marks a major milestone since the groundbreaking in November 2024.

To celebrate this milestone, a site visit was organized, bringing together numerous institutional and local partners who have supported the project since its inception. Among those present were Andréa Brouille, mayor of Bessines-sur-Gartempe and first vice-president of the Nouvelle-Aquitaine region, and Alain Auzemery, president of the ELAN community of municipalities and vice-president of the Haute-Vienne departmental council. Representatives from these authorities, the Nouvelle-Aquitaine Development and Innovation Agency (ADI NA), the Limoges and Haute-Vienne Chamber of Commerce and Industry, and the Limousin Union of Metallurgy Industries and Trades also took part in the visit.

Both Orano Med and Orano Projets¹ teams were present to share the progress of the work and discuss the next steps. “Construction is progressing according to schedule. We have the full commitment of our partners and all the companies and stakeholders involved to bring this exciting ATEF plant to fruition,” underscored Bruno Pagnard, ATEF project manager.

Eric Pluche, director of Orano’s Bessines-sur-Gartempe site, also emphasized the significance of the new ATEF facility, both for the development embarked upon by the Bessines-sur-Gartempe industrial site and, more broadly, for the local economy, which is gaining an innovative platform that will create skilled jobs. “With the hiring of 70 new employees, Orano is demonstrating its commitment to investing in the region over the long term and helping to boost its attractiveness,” he commented.

Orano Med is developing a new generation of targeted cancer therapies, known as Targeted Alpha Therapy (TAT), using the unique properties of lead-212. The development of these promising drugs has long been hampered by the difficulty of producing them on an industrial scale. With a floor area of nearly 7,000 m² and a production capacity ten times greater than that of the Maurice Tubiana laboratory, ATEF will be the world’s first industrial-scale facility dedicated to the production of thorium-228, a key precursor for the production of lead-212.

The coming months will be devoted to completion of civil engineering work, followed by the installation and qualification of the plant equipment. The facility is scheduled to begin operations in 2027. The total investment is estimated at €250 million, including €22 million of French government funding through the France 2030 scheme under the “Industrialization and Health Capacities 2030” call for projects.

“The ATEF plant is a key component in Orano Med’s fully integrated industrial platform. This platform will cover the entire value chain of targeted alpha therapies, from precursor production to lead-212–based therapies. It will enable the large-scale production of these treatments to meet the needs of patients worldwide,” said Fabrice Darvey, Director of Industrial Operations at Orano Med.

The combined production capacities of ATEF and the Maurice Tubiana laboratory will in the short term provide the necessary supplies for clinical trials and commercial launches of the first treatments developed by Orano Med. Within ten years, this industrial platform will be able to treat up to 25,000 patients per year.

About Orano Med

Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (²¹²Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in clinical development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using ²¹²Pb combined with various targeting agents through clinical and preclinical studies. Orano Med has ²¹²Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for ²¹²Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: http://www.oranomed.com

About Orano

As a recognized international leading operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

Orano, giving nuclear energy its full value.

Contacts

Halsin Partners

Mike Sinclair

msinclair@halsin.com

Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program




Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program

MATAWAN, N.J.–(BUSINESS WIRE)–Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company’s lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry”, can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.

Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:

“The FDA’s draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency’s call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulatory encouragement; it’s an affirmation of the value of platforms like Apitox.

The guidance opens the door to more efficient development timelines, including the possibility of a single, well-controlled chronic pain trial supported by confirmatory evidence, along with potential fast track or breakthrough designations. For Apitox, this could translate into accelerating our path to regulatory submission, and ultimately, faster relief to patients suffering from osteoarthritis pain.

The FDA’s leadership in advancing non-opioid pain therapies is an important step toward reshaping how we approach one of the world’s most urgent healthcare challenges. For Apimeds, this guidance reinforces our belief that innovative biologic treatments like Apitox can redefine the standard of care in osteoarthritis and beyond. We are committed to working closely with regulators to bring safer, more effective solutions for pain management to patients as quickly as possible.”

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and the information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds 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. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds’ results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds’ ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

Contacts

Media Contact:
Erik Emerson, CEO

erik@apimedsus.com

Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs




Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs

HENDERSON, Nev.–(BUSINESS WIRE)–#Biotech–Corstasis Therapeutics Inc. (www.corstasis.com), a late clinical-stage innovator of outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases, announced today the appointment of Amin M. Medjamia M.D. as Vice President of Medical Affairs.

Dr. Medjamia is an accomplished physician and medical affairs leader with more than 20 years of experience spanning biotechnology and medical devices. At Corstasis, he will oversee clinical strategy, scientific communications, and clinical algorithm development via medical engagement as the company advances its lead program Enbumyst™ (bumetanide nasal spray).

Prior to joining Corstasis, Dr. Medjamia held senior leadership roles at Abiomed, a Johnson & Johnson MedTech company, where he directed global evidence generation for the company’s portfolio of mechanical circulatory support devices. His leadership contributed to PMA approvals, global reimbursement milestones in France and Japan, and large-scale international randomized controlled trials.

“We are honored to welcome Dr. Medjamia to Corstasis at this critical time,” said Ben Esque, CEO of Corstasis. “His passion and expertise in cardiovascular medicine and evidence strategy will strengthen our ability to develop and deliver new pathways to improve patient outcomes and reduce cost of care.”

“I am excited to join Corstasis and help advance its mission of improving outpatient options for patients suffering from fluid overload,” said Dr. Medjamia.

About Corstasis Therapeutics

Corstasis Therapeutics is a late clinical-stage biopharmaceutical company whose mission is to develop and commercialize enhanced outpatient treatment options for patients with cardiorenal and hepatic diseases, with the intent of improving outcomes and reducing overall healthcare costs. Our lead product, *Enbumyst™ bumetanide nasal spray, has been developed for the short-term treatment of edema associated with congestive heart failure, liver and kidney disease, with an anticipated PDUFA action date of September 14, 2025.

*Enbumyst™ (Bumetanide Nasal spray) is an investigational therapy that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

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

Contacts

Corstasis Therapeutics Inc.

Ben Esque, CEO

Phone: 702-541-9222

Email: Info@corstasis.com

ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors




ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

• Submission based on three phase 2 trials where Daiichi Sankyo and AstraZeneca’s ENHERTU showed clinically meaningful responses across a broad range of tumors
• If approved, ENHERTU would become the first HER2 directed medicine and antibody drug conjugate to receive a tumor agnostic indication in the EU

TOKYO & MUNICH–(BUSINESS WIRE)–The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU^® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from three phase 2 trials including DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where ENHERTU demonstrated clinically meaningful responses across a broad range of tumors.

“ENHERTU has shown a clinically meaningful benefit across several studies in HER2 positive metastatic solid cancers and this validation by the EMA is an important first step toward bringing this medicine to these patients in the EU,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to working with the EMA to potentially secure a tumor agnostic indication for ENHERTU in the EU, similar to several other regions of the world where this approval has been received.”

About DESTINY-PanTumor02

DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology.

DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-Lung01

DESTINY-Lung01 is a global phase 2, open-label, two-cohort trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg and 5.4 mg/kg) in patients with HER2 mutant (cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (cohort 1 and 1a, n=90) unresectable or metastatic non-small cell lung cancer (NSCLC) who had progressed after one or more systemic therapies.

The primary endpoint is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.

DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-CRC02

DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of ENHERTU in patients with locally advanced, unresectable or metastatic HER2 positive (IHC 3+ or IHC 2+/ in situ hybridization (ISH)+) colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of ENHERTU. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm.

The primary endpoint is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology.

DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Expression in Solid Tumors

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.¹ In some cancers, the HER2 gene is amplified or the cells have activating mutations.² HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis.³

In the EU, HER2 directed therapies have been used to treat breast, gastric and lung cancers. Although HER2 is expressed in solid tumor types including biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, testing is not routinely performed in these additional tumor types and as a result, available literature is limited.² In these solid tumors, HER2 overexpression, classified as IHC 3+, has been observed at rates from 1% up to 31%.^4,5,6 Approximately 1% to 5% of patients with NSCLC have tumors with HER2 overexpression (IHC 3+).^4,7 In metastatic colorectal cancer, an estimated 2% to 4% of patients have tumors that are HER2 overexpressing (IHC 3+).^8,9 HER2 positive expression (IHC 3+) has been reported in approximately 4% to 28% of endometrial cancers and 1% to 5% of ovarian cancers.^{5,10,11,12,13}

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 40 countries/regions for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY^® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

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.daiichisankyo.com.

References

¹ Iqbal N, et al. Mol Biol Int. 2014;852748.

² Omar N, et al. Pathogenesis. 2015;2(3):1-9.

³ Pillai R, et al. Cancer. 2017;1;123(21): 4099-4105.

⁴ Yan M, et al. Cancer Metastasis Rev. 2015;34(1):157–164.

⁵ Buza N, et al. Modern Pathology. 2013;26(12):1605-12.

⁶ Gårdmark T, et al. BJU Int. 2005;95(7):982-6.

⁷ Zinner RG, et al. Lung Cancer. 2004;44(1):99-110.

⁸ Cecchi F, et al. J Clin Oncol. 2023;41(4).

⁹ Valtora E, et al. Mod Pathol. 2015;28(11):1481-91.

¹⁰ Semiz HS, et al. Turk Patologi Derg. 2023;39(1):55-63;

¹¹ Halle MK, et al. Br J Cancer. 2017;118(3):378-387

¹² Uzunparmak B, et al. Ann Oncol. 2023;34(11):1035-1046

¹³ Ersoy E, et al. Int J Gynecol Pathol. 2022;41(4):313-319

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

EU:
Simone Jendsch-Dowé

Daiichi Sankyo

simone.jendsch-dowe@daiichisankyo.com
+49 (89) 78080 (office)

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

EADV 2025: Galderma Reinforces Leadership in Dermatology With Latest Advances in Sensitive Skin and Itch




EADV 2025: Galderma Reinforces Leadership in Dermatology With Latest Advances in Sensitive Skin and Itch

• Galderma will present a wealth of data including new findings showing the impact of modern living on sensitive skin and insights from the largest global survey conducted on the condition
• Late-breaking data on Nemluvio’s^® (nemolizumab) mode of action in atopic dermatitis (AD) and long-term safety and efficacy data in prurigo nodularis (PN) and moderate-to-severe AD up to two years will also be presented, supporting its potential as a frontline treatment that addresses key disease symptoms^1-5
• The company will also host a symposium on itch, industry hubs on sensitive skin and acne, and multiple Meet the Expert sessions, demonstrating its ongoing commitment to healthcare professional education and clinical excellence

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the dermatology category leader, today announced it will unveil updates from its portfolio at the 34^th European Academy of Dermatology and Venereology (EADV) congress, taking place in Paris, September 17-20, 2025. Highlighting its commitment to addressing skin conditions across the dermatology spectrum, Galderma will present 12 abstracts, including data on sensitive skin, prurigo nodularis, and atopic dermatitis, and host a variety of events – from industry hubs on sensitive skin and acne, to a symposium on itch.

Unveiling the global landscape of sensitive skin

Galderma will present data from its robust research into sensitive skin, a growing global issue which now affects up to 70% of people worldwide – a 68% increase over the last 20 years.^6,7 Data from a first-of-its-kind real-world clinical study conducted in China by Galderma’s Global Sensitive Skin Faculty (GSSF) – a global network of dermatology experts dedicated to advancing sensitive skin research and education – will be presented, revealing the biological impact of modern living and associated environmental factors on individuals with sensitive skin.⁸ Full results from the study will be presented by GSSF members Prof. Adam Friedman, GSSF Co-Chair and Chair of Dermatology at The George Washington University, United States (U.S.); Dr. Aaron Farberg, Dermatologist and Mohs Surgeon, Baylor University Medical Center, U.S.; and Prof. Martina Kerscher, Head of Division of Cosmetic Sciences, University of Hamburg, Germany, at an industry hub, titled ‘Sensitive skin syndrome: A rising phenomenon linked to modern lifestyles and environmental changes’. The hub will take place on Friday, September 19 from 11:15 AM – 12:00 PM CET, Hub 2.12.

Findings from the largest global survey on the impact and prevalence of sensitive skin as reported by almost 17,000 participants will also be presented.⁷ This multi-continent investigation highlights the impact of sensitive skin and the need for targeted, region-specific interventions to optimize the care of individuals affected by the condition worldwide.⁷ Other data to be presented include the efficacy and tolerability of a gentle exfoliating hydroxy acid lotion in managing sensitive skin, as well as an evaluation of the key differences between sensitive skin and rosacea.

Galderma’s efforts to support people with sensitive skin spans from research and education to products, as evidenced by its flagship skincare brand, Cetaphil^®, which offers a range of solutions for people with sensitive skin.

Presenting data on Nemluvio’s mode of action and long-term benefit as a potential front-line therapy in prurigo nodularis and atopic dermatitis

Galderma will also be presenting seven abstracts on its first-in-class monoclonal antibody, Nemluvio, including late-breaking data from a skin and blood proteomic analysis of patients with moderate-to-severe atopic dermatitis.¹ These results will be presented on Friday September 19 at 3:15 – 3:30 PM CET in the Paris Nord room. Interim analysis data in prurigo nodularis showing continued improvements in itch intensity and skin lesions up to 100 weeks will also be shared on Wednesday September 17, 6:10 – 6:17 PM CET, Room E01 – E03.² Additional data will be presented on Nemluvio’s long-term safety and efficacy in moderate-to-severe atopic dermatitis, including in adolescents up to 56 weeks, and adolescents and adults up to 104 weeks also showing continued improvements in itch intensity and skin lesions.^3,9 These data reinforce Nemluvio’s safety and efficacy profile, following its approval in the United States, Europe and several other countries around the world for the treatment of prurigo nodularis and moderate-to-severe atopic dermatitis.^2-5

Galderma will also host a symposium titled ‘Ditching the itch: Exploring the latest advances in atopic dermatitis and prurigo nodularis, targeting freedom from itch and long-term skin lesion control’ on Friday, September 19 from 1:00 – 2:00 PM CET, Room S03. Experts will discuss advancing treatment strategies in atopic dermatitis and prurigo nodularis, and the importance of understanding itch as the most urgent symptom to target as it severely affects patients’ quality of life in these diseases.^10,11

Showcasing dermatology leadership through expert engagements

Expert dermatologists will discuss approaches and advancements in the treatment of acne during an industry hub titled, ‘A holistic approach to acne and acne sequelae: Combining retinoids, CTMP™ and cosmetic corrective procedures’ on Thursday September 18 from 2:15 – 3:00 PM CET, Hub 2.07.

Galderma will also host a series of Meet the Expert sessions on atopic dermatitis at its booth (#EO1), including dedicated sessions titled ‘What would you do? A case-based discussion on atopic dermatitis treatment strategies’ on Thursday September 18; 12:00 – 12:30 PM CET and ‘Rethinking atopic dermatitis relief: Science-driven skincare solutions across the flare cycle’ on Thursday September 18 from 11:45 AM – 12:00 PM CET and Friday, September 19 from 2:00 – 2:15 PM CET.

More details on Galderma’s scientific presentations at EADV can be found here.

About Nemluvio

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^12,13 Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the U.S. Food and Drug Administration and European Commission.^4,5 Additional reviews and submissions are ongoing.

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. Liu D, et al. Nemolizumab suppressed multiaxial inflammatory pathways and improved barrier protein signatures in skin and blood proteomic analysis of patients with moderate-to-severe AD. Late-breaking oral presented at the European Academy of Dermatology and Venereology (EADV) Congress; September 17-20, 2025; Paris, France
2. Metz M, et al. Clinically meaningful and sustained itch and skin responses in the OLYMPIA open-label extension nemolizumab study in patients with prurigo nodularis: An interim analysis up to 100 weeks. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
3. Nemluvio AD data. Silverberg J, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
4. Nemluvio^® U.S. Prescribing Information. Available online. Accessed September 2025
5. Nemluvio^® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed September 2025
6. Richters R, et al. What Is Sensitive Skin? A Systematic Literature Review of Objective Measurements. Skin Pharmacol Physiol. 2015;28(2),75-83. doi:10.1159/000363149
7. Vidal S, et al. Defining the Prevalence, Clinical Characteristics, and Demographic Influences on Patients with Sensitive Skin Syndrome: Insights from the Largest Global Survey of Sensitive Skin. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
8. Friedman A. Sensitive skin syndrome: A rising phenomenon linked to modern lifestyles and environmental changes. Presented during an industry hub at the EADV Congress; September 17-20, 2025; Paris, France
9. Reich A, et al. Long-term efficacy and safety of nemolizumab in adolescents with moderate-to-severe atopic dermatitis: Post hoc analyses from ARCADIA LTE 1-year cut-off. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
10. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722
11. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006
12. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed September 2025
13. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed September 2025

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

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

Richard Harbinson

Corporate Communications Director

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

Céline Buguet

Franchises and R&D Communications Director

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

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

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

Jessica Cohen

Investor Relations and Strategy Director

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

Tubulis Strengthens Leadership Team with Appointment of Halley Gilbert as Chief Legal and Operating Officer




Tubulis Strengthens Leadership Team with Appointment of Halley Gilbert as Chief Legal and Operating Officer

MUNICH–(BUSINESS WIRE)–Tubulis today announced the appointment of Halley Gilbert, JD, as Chief Legal Officer and Chief Operating Officer (CLO/COO). Bringing over 20 years of transaction and operations experience in the biopharmaceutical industry, Ms. Gilbert will further expand Tubulis’ leadership capabilities at a pivotal stage of clinical and corporate development. In this newly created role, she will leverage her combined expertise as an attorney and seasoned biotech executive to shape Tubulis’ strategy and support the continued growth of the company’s U.S. presence. Ms. Gilbert will be responsible for legal and administrative functions and play a key role in executing strategic transactions for the company.

“Halley’s extensive legal and operational experience and deep commitment to supporting rapidly growing biotech companies make her an ideal addition to our team as we further expand our clinical and business operations,” said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. “Her industry know-how and strategic leadership will be instrumental as we advance our lead ADC candidates through clinical development and continue to expand our pipeline with new modalities.”

“ADCs are transforming the oncology landscape, and Tubulis is leading the way with its differentiated approach to ADC design,” said Halley Gilbert, JD, CLO and COO of Tubulis. “Their innovative platforms and exciting research ethos allow them to unlock the full therapeutic potential of this powerful drug class. I am thrilled to be joining such a motivated team and look forward to helping shape the path toward commercialization and delivering a meaningful clinical impact to patients.”

Ms. Gilbert brings extensive legal and operational experience within the life sciences industry, having served as CLO and COO at both public and private biotech companies. Most recently, she served as Chief Legal Officer of Cargo Therapeutics and played a key leadership role in the company’s initial public offering and subsequent sale. Prior to Cargo, Ms. Gilbert was the first employee of Invyvid, Inc. (formerly Adagio), where she enabled the company’s rapid growth from launch to IPO, and accelerated its transition from early R&D to late-stage clinical development. In addition, for the past five years, Ms. Gilbert has been a member of the Board of Directors at Vaxcyte, Inc., Arcutis Biotherapeutics, and CytomyX Therapeutics, Inc.

About Tubulis

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

Contacts

For Tubulis
Dominik Schumacher, CEO & Co-founder

Phone: +49 (0) 175 800 5594

Email: contact@tubulis.com

Media Requests for Tubulis
Trophic Communications

Stephanie May, PhD

Phone: +49 (0) 171 185 56 82

Email: tubulis@trophic.eu

Abselion Launches AAVX and AAV9 Total Capsid Quantification Kits




Abselion Launches AAVX and AAV9 Total Capsid Quantification Kits

• Ready-to-use solution for Amperia benchtop platform supports rapid, reliable quantification across a range of serotypes
• Kits incorporate Thermo Fisher Scientific’s CaptureSelect affinity reagents for enhanced specificity and consistency

CAMBRIDGE, United Kingdom–(BUSINESS WIRE)–#AAV–Abselion, a pioneering life sciences technology company focused on simplifying biomolecule quantification, has expanded its product offering, with the launch of the AAVX Total Capsid Quantification Kit and the AAV9 Total Capsid Quantification Kit. Both kits are designed for use with its Amperia™ benchtop quantification platform and include Thermo Fisher Scientific’s CaptureSelect™ affinity reagents. Combining these trusted reagents with Abselion’s consistent assay format reduces the need for in-house optimisation. These kits offer researchers working in adeno-associated virus (AAV) development and characterisation a more streamlined and accessible workflow to generate reproducible titre measurements across a broad range of serotypes and process conditions.

Abselion’s Amperia benchtop platform is a simple-to-use solution for rapid and accurate automated quantification of a range of biomolecules, without optics, fluidics, or specialist training. Each kit is supplied in a ready-to-use format, including sensor strips, assay plates, matched detection reagents, and assay buffers for the binding and detection steps. The expanded kit range enhances the utility of Amperia for scientists working across gene therapy development and process workflows, offering a practical, dependable approach to total capsid quantification from purified or complex samples.

Abselion has entered into a licensing agreement with Thermo Fisher Scientific to incorporate CaptureSelect affinity reagents into its AAV quantification kits. CaptureSelect technology is based on recombinant single-domain antibodies designed for high target specificity, low cross-reactivity, and consistent batch performance to ensure robust titre quantification. With the integration of these reagents, the new kits advance Abselion’s AAV assay format, bringing improved performance and broader serotype applicability.

Both kits use a sandwich-style immunoassay format, in which biotin- and HRP-conjugated CaptureSelect antibodies are sequentially applied to bind AAV capsids. The resulting signal is detected electrochemically using Amperia sensor strips, enabling accurate quantitative detection across a range of AAV sample types and concentrations.

The AAVX Total Capsid Quantification Kit includes CaptureSelect Anti-AAVX Biotin and HRP Conjugates, enabling broad serotype coverage including AAV1–8 and AAVrh10. The AAV9 Total Capsid Quantification Kit incorporates CaptureSelect Anti-AAV9 Biotin and HRP Conjugates for focused quantification of AAV9 particles.

Dr Ruizhi Wang, CEO and Founder, Abselion, said: “Reliable quantification of total AAV capsid concentration is key to maintaining consistency and supporting informed decision-making. The integration of Thermo Fisher Scientific’s CaptureSelect reagents strengthens the performance of Abselion’s AAV kits and reflects our focus on making high-quality titre measurement simpler and more accessible. With these additions, Amperia offers researchers a ready-to-use solution that combines trusted reagent technologies with a streamlined assay format, enabling reliable quantification across a wider range of serotypes and development workflows.”

Dr Kelly Flook, Sr. Manager, Product Management, Pharma Analytics, Thermo Fisher Scientific, said: “CaptureSelect affinity reagents are designed to deliver high specificity and lot-to-lot consistency, making them well suited for applications such as AAV capsid quantification. We’re pleased that Abselion has incorporated these reagents under licence to support their assay kits for the Amperia platform.”

For further information about Abselion’s AAVX and AAV9 Total Capsid Quantification Kits, please visit: https://www.abselion.com/assay-kits/ or download the application note “Empowering AAV Quantification for Gene Therapy Research”. The Abselion team will also be attending Festival of Biologics (30 Sep–02 Oct in Basel, Switzerland). Meet the team at booth 240 to learn more.

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +44 7789 053885

Email: michelle.ricketts@codoncommunications.com

‘RevoAb™’, A New Service for Antibody Developability Engineering




‘RevoAb™’, A New Service for Antibody Developability Engineering

SENDAI, Japan–(BUSINESS WIRE)–RevolKa Ltd. (RevolKa), a venture-backed biotech company providing a cutting-edge AI-driven protein engineering technology platform, called aiProtein^® is pleased to announce the launch of a new contract research service, ‘RevoAb™’. This service engineers antibodies to improve physicochemical properties while protecting antigen binding affinity.

About RevoAb™

Since December 2023, RevolKa has offered contract research services for antibody engineering using aiProtein^®, its AI-driven protein engineering technology, through FUJIFILM Wako Pure Chemical Corporation in Japan.

RevoAb™ is a new online service for antibody developability engineering based on “RevolKa’s Refined Naturalness Design concept,” This refines antibody framework sequences to be close to those in naturally occurring antibodies. The pilot version was released in Japan in July 2025. Based on customer feedback, we are now launching an upgraded RevoAb™ world-wide.

With RevoAb™, users can instantly access multiple antibody sequences with potential improvement in properties, such as expression levels, stability, solubility, etc., at low prices.

For more details, please visit.:

https://revoab.revolka.com/en/

Story behind RevoAb™ Development.

Antibodies are proteins that provide immune protection by recognizing and binding to substances (antigens) from infecting bacteria and viruses. They are widely used in industries, such as therapeutics and diagnostics. However, antibodies are often fragile for industrial applications, and enhancing their properties typically requires significant time and resources.

RevolKa has successfully engineered many proteins using aiProtein^® in collaboration with customers. For antibodies, we identified that part of aiProtein^® could become a valuable tool for scientists struggling with suboptimal physicochemical properties. It is engineering of framework sequences of antibody by using RevolKa’s Refined Naturalness Design concept. We developed RevoAb™ to provide research scientists with “Winning Antibody Sequences” instantly online.

Fees

Registration

Please review and agree to the terms of use and privacy policy before filling out the form on the landing page.

Contacts

Inquiries Regarding RevoAb™
For any question, please contact us at support-revotune@revolka.co.jp

A.forall expands US generics portfolio




A.forall expands US generics portfolio

Four FDA-approved products strengthen portfolio and reaffirm commitment to global reach

ANDERLECHT, Belgium–(BUSINESS WIRE)–#FocusToGrow–A.forall is pleased to announce the acquisition of four FDA-approved injectable generics and two late-stage pipeline assets from Provepharm’s US portfolio. With this acquisition, A.forall considerably extends its marketed portfolio in the US, marking a significant expansion of its US footprint and a key milestone in the company’s sharpened focus on high-quality generics worldwide.

Strengthening Essential Healthcare

The acquired portfolio includes four well-established hospital products that address critical therapeutic needs:

• Dihydroergotamine Mesylate (neurology – for the treatment of migraine and cluster headaches)
• Piperacillin/Tazobactam (infectious disease – broad-spectrum antibiotic for hospital-acquired infections)
• Tranexamic Acid (hematology – to control bleeding in surgical and trauma settings)
• Phenylephrine Hydrochloride (anesthesiology – to manage hypotension during surgery)

These medicines are widely integrated in US hospital protocols and marketed via established pharmaceutical distributors and group purchasing organizations, ensuring strong clinical familiarity among healthcare professionals. The newly acquired products will be commercialized through A.forall’s US subsidiary, Milla Pharmaceuticals Inc.

The two late-stage pipeline products target complementary therapeutic areas and are expected to launch in the coming years.

Steen Vangsgaard, CEO of A.forall, comments: “This acquisition fits perfectly with our renewed strategy to develop, commercialize and add value to medicines, increasing their availability where they matter most. These products expand our US relevance and give us immediate access to a robust portfolio that meets essential therapeutic needs. It’s a strategic investment that delivers scale, diversification and valuable cross-selling opportunities.”

Strategic US Focus

For A.forall, the US is a strategic priority. With a dedicated team on the ground, strong partnerships and a robust pipeline, the company continues to invest in one of the world’s most competitive and complex healthcare environments.

Since 2017, six products of A.forall were registered successfully in the US market, demonstrating consistent growth and commitment to American healthcare providers.

“By integrating this portfolio with our existing capabilities, we focus to reach further into markets where high-quality generic medicines make the greatest difference,” Vangsgaard adds. “This acquisition strengthens our brand recognition and significantly expands our commercial presence in the world’s largest pharmaceutical market.”

This acquisition follows the recent decision to divest A.forall’s Retail & Hospital division and focus entirely on generics: a strategy that gives the company a sharper scope, stronger momentum and a clear direction for growth.

About A.forall

A.forall is a Belgian pharmaceutical group with headquarters in Anderlecht and offices in Ireland and the United States. At current, the company employs over 144 people and distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. A.forall is also a global player in the generics market, now with 35+ molecules on the European and U.S. market and a fully stocked pipeline of mainly injectable generics and value-added products covering various therapeutic areas.

Driven by one mission #MakingAffordableMedicinesAvailableToAll, A.forall focuses 100% on the development, licensing and commercialization of generic medicines worldwide.

A.forall is part of The Riverside Company’s portfolio, a global investment firm focused on the smaller end of the middle market that has invested in more than 220 healthcare companies since 1988.

For more information, visit: www.aforallpharma.com.

Contacts

We’re happy to provide additional context or answer any questions you may have.

For media inquiries or more information, please contact:

A.forall Group NV

Communication Department
communications@aforallpharma.com
+32 2 526 64 14

New Arizona’s Bioscience Roadmap Details How the State Becomes a Nationally Recognized Bioscience Hub




New Arizona’s Bioscience Roadmap Details How the State Becomes a Nationally Recognized Bioscience Hub

• The Flinn Foundation has commissioned a new Arizona’s Bioscience Roadmap to guide discovery, innovation, and economic growth through 2030
• The strategic plan was first launched more than two decades ago and includes goals for accelerating commercialization, empowering startups, and developing and retaining workers
• Developed by SRI International of Menlo Park, Calif., the plan will be launched at stakeholder events statewide and online the week of Sept. 8, 2025

PHOENIX–(BUSINESS WIRE)–#AZBioRoadmap–A new blueprint for Arizona’s emerging bioscience ecosystem lays out a plan for the state to capitalize on more than two decades of momentum and become a nationally recognized leader in the space.

The next iteration of Arizona’s Bioscience Roadmap, which will be unveiled the week of Monday, Sept. 8, builds on Arizona’s skilled talent base, world-class research, and entrepreneurial spirit to improve the economy as well as Arizonans’ health and quality of life.

The report analyzes Arizona’s strengths and challenges, acknowledging the uncertainty around federal funding for bioscience research and how that may impact the state going forward.

More than 140,000 people are employed in bioscience companies and hospitals in Arizona. On average, their salaries are 30% higher than private-sector salaries statewide. Crossover opportunities with semiconductor manufacturing and other tech-heavy industries provide a key opportunity for growth in the next five years, the Roadmap concludes.

Medical device manufacturing, neuroscience, oncology, and precision medicine are among the areas of particular excellence and promise in Arizona.

“With the right vision, strategies, determination, and courage — and with its rapidly growing resources, existing and potential strengths, and remarkable collaborative spirit — Arizona has a chance to make transformational contributions to bioscientific research and clinical care, with a profound impact on people here in Arizona and around the world,” said Dr. Eric Reiman, chair of the Flinn Foundation board of directors.

“The Flinn Foundation is excited to help in that endeavor.”

The Bioscience Roadmap is the longest-running statewide bioscience strategic plan in the nation. It was launched by the Flinn Foundation in 2002. Since then, the Foundation has tracked and publicly reported performance metrics from the six subsectors that make up the Arizona biosciences:

• Agricultural feedstock and industrial biosciences
• Bioscience-related distribution
• Medical devices and equipment
• Pharmaceuticals
• Research, testing, and medical laboratories
• Hospitals

The most recent report from April 2025 showed Arizona’s growth rate continues to outpace the nation in several categories, including bioscience jobs, National Institutes of Health funding, and university research and development, and included several record highs for the state.

The new Roadmap, developed by SRI International in collaboration with Arizona leaders and commissioned by the Flinn Foundation, establishes five goals:

1. Amplify the collaborative gene: Arizona’s collaborative culture is something to be celebrated and leveraged. Unlike more entrenched regions, Arizona organizations and participants see how facilitating one another’s individual success helps the entire ecosystem. Collaboration can also accelerate innovation across technology sectors.

2. Accelerate research into impact: Arizona will increase the scale, speed, and success of commercialization of discoveries that address critical needs. Getting new treatments and products to patients quickly is vital, especially where they enable transformative improvements in quality of life.

3. Elevate Arizona’s startup ecosystem: The state will nurture and empower entrepreneurs and startups, providing resources and support to launch, scale, and retain bio ventures. An increasingly vibrant startup community will attract investors and global-scale bioscience firms.

4. Strengthen talent and career pathways: Arizona will attract, develop, and retain top professionals and skilled workers. A large, skilled and sustained talent pool is necessary to help home-grown startups thrive and attract out-of-state companies to Arizona.

5. Tell Arizona’s bioscience story: Arizona will be recognized nationally for its contributions to health outcomes and economic growth and a competitive policy environment.

The plan emerged from more than a year of research, interviews, and focus groups throughout the state.

“The Roadmap was shaped by the people of Arizona and belongs to the people of Arizona,” said Tammy McLeod, Ph.D., Flinn Foundation president and CEO.

“This plan is more than just a well-researched document; it serves as a living guide and inspiration for our leading researchers, entrepreneurs, policymakers, and educators as well as the students who can see a future for themselves in the biosciences here in Arizona.”

Christiana McFarland is the director of SRI’s Center for Innovation Strategy and Policy, which produced the report.

“Executing this Roadmap will require focus and collaboration among key partners. Doing so will strengthen Arizona’s economy, improve health outcomes, and cement the state’s place as a vital contributor to bioscience in the United States and beyond,” McFarland said.

Read the full Arizona’s Bioscience Roadmap report and executive summary: https://www.flinn.org/bioscience/arizonas-bioscience-roadmap/about-the-roadmap/

About the Flinn Foundation

The Flinn Foundation is a privately endowed, philanthropic grantmaking organization established in 1965 by Dr. Robert S. and Irene P. Flinn to improve the quality of life in Arizona to benefit future generations. Based in Phoenix, the Foundation supports the advancement of the biosciences in Arizona as well as the merit-based Flinn Scholarship, arts and culture, and the Arizona Center for Civic Leadership.

Contacts

Stacy Sullivan, Vice President, Communications, Flinn Foundation, 602-320-1762, ssullivan@flinn.org

Brian Powell, Communications Manager, Flinn Foundation, 602-744-6806, bpowell@flinn.org