Gerresheimer AG: BaFin announces expansion of audit of 2024 consolidated financial statements and initiation of audit of 2025 Half-Year Financial Report

Gerresheimer AG / Key word(s): Results / Full year/Results / Half year

Gerresheimer AG: BaFin announces expansion of audit of 2024 consolidated financial statements and initiation of audit of 2025 Half-Year Financial Report

25-Feb-2026 / 19:05 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Gerresheimer AG: BaFin announces expansion of audit of 2024 consolidated financial statements and initiation of audit of 2025 Half-Year Financial Report

Düsseldorf, February 25, 2026. The German Federal Financial Supervisory Authority (BaFin) has informed Gerresheimer AG (ISIN: DE000A0LD6E6, “Gerresheimer”) that it intends to

  • expand the audit of the published consolidated financial statements and the related Group management report for the 2023/2024 financial year of Gerresheimer AG, which was initiated on September 18, 2025, and
  • initiate an audit of the published condensed interim consolidated financial statements and the related interim group management report for the period from December 1, 2024, to May 31, 2025, of Gerresheimer AG.

Expansion of the audit of the 2024 consolidated financial statements
According to BaFin, the reason for expanding the audit of the consolidated financial statements and the associated Group management report for the 2024 financial year from December 1, 2023, to November 30, 2024, is “concrete evidence that

  1. the lease liabilities reported in the balance sheet with a carrying amount of €65.5 million and/or the undiscounted payment obligations corresponding to the lease liabilities disclosed in the notes may be incorrect;
     
  2. the disclosure of the useful lives of development costs capitalized as intangible assets with a carrying amount of €29.4 million may be incorrect;
     
  3. assets of the Advanced Technologies segment, which are reported in the balance sheet with a carrying amount of EUR 196.5 million, may have been impaired and that the impairment required in this case was not recognized.”

The assets of the Advanced Technologies segment relate to Sensile Medical AG, Olten, Switzerland. On February 10, 2026, Gerresheimer announced that non-cash impairments of approximately EUR 220 to 240 million were expected in the 2025 consolidated financial statements. These mainly relate to impairments of technology and development projects of Sensile Medical AG, Olten, Switzerland, and, among others, impairment losses to the assets of Gerresheimer Moulded Glass Chicago Inc., Chicago, USA.

 

Initiation of Audit of the 2025 Half-Year Financial Report
According to BaFin, the reason for the audit of the interim consolidated financial statements and the accompanying interim group management report for the period from December 1, 2024, to May 31, 2025 (Half-Year Financial Report) is “concrete indications that

  1. the assessment of certain risks in the interim group management report for the period from December 1, 2024, to May 31, 2025, in conjunction with the 2023/24 Group management report, was no longer accurate due to the financing of the acquisition of Bormioli Pharma;
  1. the recognition of impairment losses on assets was incorrectly omitted;
     
  2. revenues and cost of sales in connection with bill and hold agreements were incorrectly recognized.”

In its 2025 Half-Year Financial Report, the Company classified the risks from acquisitions, divestments, and cooperations, as well as the liquidity risk, as low, unchanged from the 2024 consolidated financial statements. BaFin sees indications that maintaining the risk classification was no longer appropriate.
With regards to the recognition of revenues and costs in connection with bill and hold agreements, BaFin also intends to examine in the 2025 Half-Year Financial Report whether these revenues should have been recognized in the first half of 2025 or only at a later date. Linked to this is the accounting of inventories as of the balance sheet date of May 31, 2025.

On December 22, 2025, the Company had already announced that it would comprehensively correct revenues from bill and hold agreements, not include revenues from new bill and hold agreements in the 2025 consolidated financial statements, and refrain from this practice in the future. In addition, the Company had announced that it would also correct the recognition of revenues from bill and hold agreements in the following interim financial information for the 2026 financial year by adjusting the previous year’s figures.

Gerresheimer expects BaFin to initiate the announced expansion of its audit of the 2024 consolidated financial statements and the audit of the interim financial statements for the first half of 2025.

The Company will continue to cooperate fully with BaFin in the context of the audits in order to clarify the facts transparently.

______________________

End of insider information

Contact Gerresheimer AG

Investor Relations

Guido Pickert
Vice President Investor Relations

T: +49 211 6181 220
gerresheimer.ir@gerresheimer.com

 

 
Media
Jutta Lorberg
Head of Corporate Communication
T: +49 211 6181 264
jutta.lorberg@gerresheimer.com

 

End of Inside Information


25-Feb-2026 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Gerresheimer AG
Peter-Müller-Str. 3
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: SDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2281718

 
End of Announcement EQS News Service

2281718  25-Feb-2026 CET/CEST

BIO-Europe Spring® 2026 Charts the Future of Life Sciences from Lisbon’s Shores

EBD Group

/ Key word(s): Conference

BIO-Europe Spring® 2026 Charts the Future of Life Sciences from Lisbon’s Shores

25.02.2026 / 13:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

BIO-Europe Spring® 2026 Charts the Future of Life Sciences from Lisbon’s Shores

MUNICH, GERMANY – February 25, 2026. The 20th annual BIO-Europe Spring is heading to Lisbon, Portugal, from March 23–25, 2026, with a digital experience to follow on March 31–April 1. For the first time, BIO-Europe Spring and LSX Europe will take place back-to-back as part of the Life Sciences Spring Innovation Week, creating a unique meeting point for the life science industry. With engagement already on the rise, Lisbon is poised to deliver expanded partnering, investment, and cross-border collaboration opportunities across the global life sciences ecosystem.

BIO-Europe Spring connects Europe’s top innovation centers with the global life sciences industry to cultivate thriving strategic partnerships. The 2026 edition in Lisbon will bring together over 3,700 international stakeholders – from academia, startups and scaling biotechs to top pharma executives and investors – for more than 20,000 high-impact partnering meetings.

Lisbon and Greater Lisbon, home to a rapidly growing life sciences cluster, feature internationally competitive pharmaceutical and biotech activity, world-class research institutions, major multinational hubs, and an emerging venture capital community – making the city an ideal host for this “must-attend” Life Sciences Spring Innovation Week.

For its 2026 edition, BIO-Europe Spring will feature an engaging program, curated by EBD Group (an Informa company), offering insightful content, high-impact partnering, and extensive networking opportunities.

BIO-Europe Spring 2026 Program Highlights Include:

  • Opening plenary – Where the Compass Points: Redrawing the Map of Biotech Partnering
    Dive into a dynamic discussion about biotech partnering strategies by experienced executives from BioNTech, CellmAbs, Novo Holdings, and Ottimo Bio.
  • The Art of Wayfinding with AI in Drug Discovery and Development
    Explore how AI is enhancing drug discovery and development and the complexities of integrating AI into the future of therapeutic innovations.
  • Forecasting the Waves: Biopharma Investment Landscape
    Join globally recognized venture capital and strategic investors from LifeArc, Syncona, Biovance Capital, Sofinnova Partners, and Forbion to gain insights into navigating today’s biopharma funding landscape.
  • High tide: China’s Innovation and Global Partnerships
    Understand the growing momentum of cross-border partnerships and the significant opportunities China brings to global biopharma companies to drive innovation.

Partnering and Registration

Partnering for BIO-Europe Spring is now open and in full swing. One-to-one meetings will be powered by partneringONE®, an industry-standard platform that enables delegates to search, request, schedule, and conduct meetings efficiently.

BIO-Europe Spring continues to provide a global platform for the biopharma community to connect. To enhance access and extend engagement beyond the in-person event, the conference will continue with two days of virtual partnering on March 31–April 1, allowing participants to connect regardless of time zone or travel constraints.

Registration information for BIO-Europe Spring is available online. Discounted rates are still available until March 20, 2026, with the next early bird deadline approaching on March 6, 2026.

Additional Links and Information

BIO-Europe Spring is organized by EBD Group, an Informa company.

For more information and live updates, please visit the conference website at: https://informaconnect.com/bioeurope-spring and follow BIO-Europe Spring 2026 on LinkedIn.

About Informa and EBD Group

EBD Group’s mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference portfolio in the industry. Each one of our landmark events, held in key life science markets around the world, is powered by our state-of-the-art partnering software, partneringONE, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings. Today, our events and those of our sister organization, LSX, (BIO-Europe, BIO-Europe Spring®, LSX Europe, Biotech Showcase™, LSX USA, Investival Showcase USA, ChinaBio® Partnering Forum, Asia Bio Partnering Forum, LSX Nordic, BioEquity Europe, Investival Showcase EU, and the European Lifestars Awards) annually attract more than 15,000 senior life science executives who engage in over 50,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry.

EBD is an Informa company. Informa is a leading international Live B2B Events, B2B Digital Services, and Academic Markets Group. Informa is a member of the FTSE 100 and works in over 30 countries.

For more information, please visit: https://informaconnect.com/partnering-investment-strategy/

Media Contacts: 
MC Services AG
+49 89 2102280
contact@mc-services.eu

Informa 
Paul Gilbertson 
paul.gilbertson@informa.com


25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


2281432  25.02.2026 CET/CEST

Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026

Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026




Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026

FLORHAM PARK, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the full year ended December 31, 2025, and provide a corporate update on March 4, 2026, at 8:30 a.m. Eastern Time.

Conference Call & Webcast Details:
Date: Wednesday, March 4, 2026
Time: 8:30 am Eastern Time
Toll Free: 1-800-717-1738
Conference ID:
Webcast:
08197
Click HERE

A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.

The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) and pediatric high grade gliomas; CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting solid tumors, such as triple negative breast, lung and colorectal cancers; CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors with significant unmet need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted iopofosine I 131 PRIME and orphan drug designations for the treatment of WM.

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: XLinkedIn, and Facebook.

Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer

Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer




Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer

Pharmaceutical veteran with extensive late-stage development and commercial experience to lead Rivus as it advances its pipeline of oral medicines that leverage energy expenditure for the treatment of MASH, obesity, and associated cardiometabolic diseases

CHARLOTTESVILLE, Va. and SOUTH SAN FRANCISCO, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to treating MASH, obesity, and associated cardiometabolic diseases, today announced the appointment of Jorge Bartolome as Chief Executive Officer and member of the Board. He succeeds Allen Cunningham, a co-founder who will move to the role of Chief Operating Officer.

Mr. Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record of building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Before joining Rivus, he served as Chief Executive Officer and Director of AreteiaTx and earlier served as President of Janssen Canada (Johnson & Johnson) and held increasingly senior positions over 20 years at GSK.

“Rivus is embarking on an important stage of its journey as the company advances two potentially transformative oral medicines targeting MASH, obesity, and associated cardiometabolic diseases,” said Ian F. Smith, Co-Chair of the Board of Rivus Pharmaceuticals. “Jorge’s extensive pharmaceutical background in late-stage drug development and commercialization makes him the ideal leader for Rivus to navigate the unprecedented opportunity to treat MASH, obesity, and its co-morbidities. It is an exciting time at Rivus, a company on the forefront of the next era for obesity treatments, focused on energy expenditure and preservation of muscle for sustained metabolic health.”

“I am honored to lead this talented team as we drive Rivus forward as a company with multiple oral therapies to address the growing unmet patient needs in MASH, obesity, and associated cardiometabolic diseases,” said Jorge Bartolome, Chief Executive Officer and Director, Rivus Pharmaceuticals. “Rivus has made remarkable progress developing a best-in-class oral mitochondrial uncoupler HU6 through three Phase 2 trials that achieved their primary endpoints and demonstrated a favorable safety and tolerability profile. 2026 will be a pivotal year for Rivus as we advance HU6 in the AMPLIFY Phase 2 trial in MASH and prepare for our first clinical trial for RV-8451, our differentiated oral, muscle-preserving GLP-1, in obesity.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c999693b-65d5-4e13-9622-8175bc2f813a

Rivus Pharmaceuticals' CEO

Jorge Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Previously, he served as Chief Executive Officer and Director of AreteiaTx, leading the company through positive Phase 3 trial data for a first-in-class oral therapy for asthma and COPD. Earlier, he served as President of Janssen Canada (Johnson & Johnson) after serving as Vice President, Cardiovascular business in the U.S. Mr. Bartolome began his career at GSK, serving in positions of increasing responsibility for over 20 years across North America, Asia, and Latin America, ultimately serving as Senior Vice President, Business Unit Leader in the U.S. for multiple therapeutic areas generating $8 billion in annual sales. He earned a B.A. in Economics from Duke University.

About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc. is a clinical-stage biotechnology company advancing new oral investigational medicines for MASH (metabolic dysfunction-associated steatohepatitis), obesity, and associated cardiometabolic diseases. Rivus is developing oral small molecule therapeutics that are designed to increase energy expenditure for sustained, fat-selective, muscle-preserving weight loss. These medicines leverage validated mechanisms, including mitochondrial uncoupling and GLP-1 agonism, to address the limitations of current treatments for these chronic diseases that need new chronic treatment options. Rivus’ lead candidate HU6 is a potential best-in-class oral mitochondrial uncoupler that has demonstrated positive results in three Phase 2 clinical trials. In addition, Rivus has a research and discovery platform and is developing a pipeline of preclinical therapies, including RV-8451, a differentiated oral muscle-preserving GLP-1, for obesity. Follow Rivus on LinkedIn and X and visit www.rivuspharma.com.

CONTACT: Company Contact: 
Amy Figueroa, CFA
Rivus Pharmaceuticals
afigueroa@rivuspharma.com

Media Contact:
Matt Wright
Real Chemistry
mwright@realchemistry.com

Prime Medicine to Participate in Upcoming Investor Conferences

Prime Medicine to Participate in Upcoming Investor Conferences




Prime Medicine to Participate in Upcoming Investor Conferences

CAMBRIDGE, Mass., Feb. 25, 2026 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that company management will participate in three upcoming conferences:

  • TD Cowen 46th Annual Health Care Conference: Fireside chat on Wednesday, March 4, 2026, at 1:10 p.m. ET in Boston, MA.
  • 2026 Jefferies Biotech on the Beach Summit: Company management will host 1×1 meetings on Tuesday, March 10, 2026, in Miami Beach, FL.
  • The Citizens Life Sciences Conference: Fireside chat on Wednesday, March 11, 2026, at 2:15 p.m. ET in Miami Beach, FL.

Live audio webcasts of the fireside chats will be available under “Events & Presentations” in the News & Events section of the Company’s website at www.primemedicine.com. Replays of each webcast will be available on the Prime Medicine website for 90 days following the event.

About Prime Medicine

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: liver, lung, and immunology and oncology. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

© 2026 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Investor and Media Contacts

Gregory Dearborn
Prime Medicine
857-209-0696
gdearborn@primemedicine.com 

Hannah Deresiewicz
Precision AQ
212-362-1200
hannah.deresiewicz@precisionaq.com

BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026

BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026




BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026

BURLINGTON, Mass. and JERUSALEM, Feb. 25, 2026 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation technologies, today announced that it will report its fourth quarter and full year 2025 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, March 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

Conference Call Dial-In & Webcast Information

Date: Wednesday, March 11, 2026
Time: 8:30 AM Eastern Time
United States: 1-877-300-8521
International: 1-412-317-6026
Israel: 1-80-921-2373
Conference ID: 10206784
Webcast: Link
   

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference

Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference




Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference

PRINCETON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief Executive Officer Prashant Kohli will participate and present in TD Cowen’s 46th Annual Health Care Conference, to be held March 2-4, 2026 in Boston, MA.

Mr. Kohli’s presentation is schedule for March 4, 2026 at 10:30 AM Eastern Time. To register for the webcast, click here. An archived replay will be available for 90 days following the event.

In addition, Mr. Kohli will participate in one-on-one and group investor meetings.

About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About GTx-104

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

About Grace Therapeutics

Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.

For more information, please visit: www.gracetx.com

For more information, please contact:

Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes

Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes




Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes

  • Partnership will leverage Vivtex’s proprietary technologies built to identify optimal oral formulations for peptide and protein therapeutics with improved bioavailability
  • Novo Nordisk will lead global development and commercialization, and Vivtex is eligible to receive up to 2.1 billion US dollars, as well as royalties on net sales of future products
  • Partnership expands Vivtex’s platform to metabolic diseases and supports Novo Nordisk’s mission to deliver scalable and innovative medicines to people with obesity and diabetes

Bagsværd, Denmark and Boston, MA, US, 25 February 2026 – Novo Nordisk and Vivtex Corporation today announced a partnership to develop next-generation oral biologic medicines for obesity, diabetes and associated comorbidities.

Under the agreement, Vivtex will license select oral drug-delivery technologies to Novo Nordisk, while Vivtex is eligible to receive upfront consideration, research funding and milestone payments totalling up to 2.1 billion US dollars, and tiered royalties on future product sales.

“Novo Nordisk has been at the forefront of innovation in protein and peptide engineering for several decades, and not least within oral formulation of peptides. We launched the first-ever oral biologic more than five years ago and have recently launched the world’s first oral biologic for obesity,” said Brian Vandahl, senior vice president, Therapeutics Discovery, at Novo Nordisk. “We continue to push the boundaries of science through both internal and external innovation to fulfil our mission of treating millions more people living with obesity and diabetes and their associated comorbidities.”

The collaboration aims to enable the oral delivery of biologic drug candidates that are traditionally limited to injectable administration due to poor absorption in the gastrointestinal tract. The partnership combines Novo Nordisk’s deep expertise in peptide and protein therapeutics with Vivtex’s proprietary gastrointestinal screening and formulation platform to identify next-generation oral therapeutics.

“Making biologics oral has been one of the most difficult challenges in drug delivery,” said Thomas von Erlach, Ph.D., CEO and co-founder of Vivtex. “Vivtex was founded to systematically solve this problem by integrating high-throughput experimentation with computational and AI-enabled analytics. Partnering with Novo Nordisk allows us to apply our platform across important metabolic disease areas, with the goal of enabling oral therapies that would otherwise require injection.”

Vivtex’s platform combines multiple proprietary gastrointestinal screening assays, drug-delivery technologies, and computational simulation and AI capabilities to optimize the oral delivery of biologic medicines. The platform is designed to achieve high oral bioavailability and consistent in-human performance.

Following research and formulation selection, Novo Nordisk will assume responsibility for global development, regulatory activities, manufacturing, and commercialization of any resulting products.

About Vivtex Corporation
Vivtex Corporation is a biotechnology company transforming the oral delivery of therapeutics. Founded by MIT scientists Drs. Thomas von Erlach, Giovanni Traverso, and Robert S. Langer, Vivtex has developed a robotics-driven platform that integrates its proprietary GI-ORIS™ high-throughput screening system — a “GI tract on a chip” — whole-gastrointestinal tissue robotic interface published in Nature Biomedical Engineering, with AI-enabled computational modeling to design and optimize orally delivered therapeutics, including biologics, for predictable human performance. The platform enables rapid screening of thousands of formulations per day and has demonstrated near-perfect correlation with human intestinal absorption, substantially outperforming conventional in vitro models. Vivtex partners with leading biotechnology and pharmaceutical companies to advance clinical programs and expand patient access to convenient, effective oral therapies.  Vivtex operates in Cambridge, Massachusetts, USA, and Schlieren, Switzerland. For more information, visit www.vivtex.com.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.

Contacts for further information

Novo Nordisk Media:  
Ambre James-Brown
+45 3079 9289
globalmedia@novonordisk.com

Liz Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
Novo Nordisk Investors:  
Jacob Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com

Sina Meyer
+45 3079 6656
azey@novonordisk.com

Max Ung
+45 3077 6414
mxun@novonordisk.com
Christoffer Sho Togo Tullin
+45 3079 1471
cftu@novonordisk.com

Alex Bruce
+45 3444 2613
axeu@novonordisk.com
Frederik Taylor Pitter (US)
+1 609 613 0568
fptr@novonordisk.com

Vivtex Media:  
Thomas von Erlach, CEO tvonerlach@vivtex.com Kimberly Ha
kimberly.ha@kkhadvisors.com

Attachment

ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026

ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026




ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026

Garching / Munich, February 25, 2026 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will provide further exploratory and post-hoc subgroup analysis data focusing on Pancreatic Neuroendocrine Tumors from its Phase 3 COMPETE trial in an oral presentation at the 23nd Annual European Neuroendocrine Tumor Society (ENETS) Conference, held from March 4 – March 6, 2026 in Kraków, Poland. The company will also host a conference booth (#6) and an interactive symposium on March 5, 2026, bringing together leading experts in radiopharmaceutical oncology to share their perspectives on key challenges and emerging clinical approaches for the treatment of neuroendocrine tumors (NETs).

Oral Presentation Details
Title: 177Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study
Presentation ID: D54
Session: Clinical science | Session 2B: Abstract session
Date and Time: Thursday, March 5, 11:50–11:57 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenter: Prof. Dr. Thomas Walter, Medical Oncologist, Lyon, France

Satellite Symposium Details
Title: Vote and Learn: Radiopharmaceutical Therapy in NETs
Date and Time: Thursday, March 5, 07:45–08:45 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenters: Dr. Francesca Spada, Medical Oncologist, Milano, Italy; Prof. Christophe Deroose, Nuclear Medicine Physician, Leuven, Belgium; Prof. Simron Singh, Medical Oncologist, Toronto, Canada

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NET tumors.

About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com

Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com

Attachment

Darwin AG Announces Preliminary Group Revenue for 2025 and Confirms Strategic Growth Trajectory

Darwin AG

/ Key word(s): Preliminary Results/Development of Sales

Darwin AG Announces Preliminary Group Revenue for 2025 and Confirms Strategic Growth Trajectory

25.02.2026 / 10:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Corporate News

 

Darwin AG Announces Preliminary Group Revenue for 2025 and Confirms Strategic Growth Trajectory

Munich, February 25, 2026 – Darwin AG (ISIN DE000A3C35W0) today announces its preliminary consolidated revenue for the 2025 financial year. Based on preliminary financial figures, the company generated consolidated revenue of approximately €55 million in the 2025 financial year (previous year: €25.3 million). This corresponds to revenue growth of approximately 117% compared to the previous year.

In addition, the company expects to report a positive consolidated net result.

We are very satisfied with the development of consolidated revenues in the 2025 financial year. The preliminary revenue figures underline the operational strength of our group,” comments CEO Dr. Daniel Wallerstorfer. “With the products of our wholly owned subsidiary Novogenia GmbH, we have gained international visibility for our comprehensive genetic analyses and the personalized nutritional supplements based on them. The strategic partnerships with 10X Health (USA) and M42 (Abu Dhabi) form the foundation for a new phase of scaling. For Darwin AG, we see significant potential for sustainable value creation through the implementation of these major projects and additional initiatives.

The full audited consolidated financial figures for 2025 will be published together with the 2025 Annual Report on May 12, 2026.

 

About Darwin AG

The “Darwin Group” (i.e. Darwin AG including its subsidiaries), headquartered in Munich (Germany), is a European healthcare company, particularly active in the field of human genetics and the development of personalized products based on genetic analysis. The genetic analyses conducted in the company’s own laboratory are used in the diagnosis, treatment, and prevention of diseases, as well as in the production of individually tailored nutritional supplements and cosmetics. Darwin also acts as a partner to physicians, therapists, pharmacists, nutritionists, and fitness trainers, helping to ensure treatment or support that is as optimal as possible for the patient’s or client’s needs by analyzing their respective genetic predispositions. In addition, Darwin holds investments in innovative companies in the biotech, healthcare, and life sciences sectors.

 

Contact:

Darwin AG
Brienner Str. 7
80333 München
Tel: +49 89 – 20 500 450
investor.relations@darwin-biotech.com
 
Media contact
MC Services AG
Katja Arnold, Pamela Keck
Phone: +49 89 – 210 228-0
darwin@mc-services.eu
 


25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


2281138  25.02.2026 CET/CEST