PL BioScience Announces Conferences Attendance

PL BioScience GmbH

/ Key word(s): Conference

PL BioScience Announces Conferences Attendance

30.09.2025 / 09:15 CET/CEST

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


PL BioScience Announces Conferences Attendance

 

Aachen, Germany, September 30, 2025 – PL BioScience GmbH, a German life science company specializing in the production and development of Human Platelet Lysate (HPL) for cell expansion, today announced its participation in six life sciences conferences this fall.

Meet our management team and marketing colleagues at one of the upcoming conferences:

 

Festival of Biologics
September 30 – October 2 in Basel, Switzerland
Anna Kolkmann (Sales Manager) and Maria Noronha (Marketing Specialist) will be present
Booth: 501C
Scheduling meetings is possible through the Terrapinn Event App

 

BioJapan
October 8 – 10 in Yokohama, Japan
Jungsoo Park (VP Marketing & Sales) and Kana Miyakubi (Sales Account Manager) will be present
Booth: B-68 at the EU-Japan Centre for Industrial Cooperation Pavilion

 

Innovative Therapies Days 2025
October 9 – 10 in Besançon, France
Silver Sponsor of the conference
Cécilia Mesa (Sales Manager) will be present and exhibit a poster
Booth: 6
Scheduling meetings is possible through the B2Match platform

 

CPHI Frankfurt 2025
October 28 – 30 in Frankfurt, Germany
Hatim Hemeda (CEO & Co-Founder), Christian Wilkes (CFO & Co-Founder) and Jungsoo Park will be present
Booth: 4S115
Scheduling meetings and contacting are possible through the CPHI Event Planner App

 

BIO-EUROPE 2025
November 3 – 5 in Vienna, Austria
Hatim Hemeda and Christian Wilkes will be present
Scheduling meetings through the partneringONE system

 

Cell 2025
November 11 – 12 in London, United Kingdom
Network & Programme Sponsors
Silke Isenhardt (Field Application Scientist) and Maria Noronha (Marketing Specialist) will be present and exhibit a poster
Booth: 54
Contact will be possible through the event app from November

 

 

About PL BioScience:

PL BioScience GmbH, a life science company located in Aachen, Germany, specializes in the production and development of Human Platelet Lysate (HPL). The company has pioneered proprietary technology to produce fully artificial HPL, allowing for a fully lab-made, scalable supply of HPL. PL BioScience currently offers a comprehensive portfolio of donor-derived, natural HPL products tailored for a range of applications – the ELAREMTM platform. From academic and preclinical research to cell therapy and biopharmaceutical manufacturing, ELAREM™ ensures seamless translations of regenerative medicine breakthroughs – from the lab to patients in need. PL BioScience is the only company worldwide holding a patent for the gamma-irradiation of HPL, covering the manufacturing process for ELAREM™ Ultimate-FD PLUS.

For more information on PL BioScience and the ELAREM™ platform, visit: https://www.pl-bioscience.com/

 

Contact:
Dr. Hatim Hemeda, CEO
PL BioScience GmbH
+49(0)24195719-100
info@pl-bioscience.com

 

Media contact:
MC Services AG
Raimund Gabriel, Dr. Regina Lutz
+49 (0)89 210 228 0

 

U.S.: Catherine Featherston
+1-203-444-4393
E-Mail: plbioscience@mc-services.eu


30.09.2025 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.

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Language: English
Company: PL BioScience GmbH
Auf der Hüls 184-186
52068 Aachen
Germany
E-mail: info@pl-bioscience.com
Internet: www.pl-bioscience.com
EQS News ID: 2205624

 
End of News EQS News Service

2205624  30.09.2025 CET/CEST

ReproNovo Announces Clinical Trial Approval Notice for RPN-001 in China

ReproNovo SA

/ Key word(s): Miscellaneous

ReproNovo Announces Clinical Trial Approval Notice for RPN-001 in China

30.09.2025 / 07:00 CET/CEST

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


REPRONOVO ANNOUNCES CLINICAL TRIAL APPROVAL NOTICE FOR RPN-001 IN CHINA

  • The approval enables initiation of RPN-001 Phase 1 trial in China
     
  • Key regulatory milestone in the global development of RPN‑001
     

Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 – ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that China’s National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN‑001 as a potential treatment for male infertility associated with low serum testosterone.

“Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo,” said Joan-Carles Arce, MD, PhD, Chief Scientific & Medical Officer of ReproNovo. “With this approval, we will soon have active clinical programs in the U.S. and China, two of the world’s largest healthcare markets, which reinforces our commitment to global development in reproductive medicine.”

RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo’s global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway.

“We are committed to expanding access to innovative therapies where few treatment options currently exist,” said Jean Duvall, Chief Executive Officer of ReproNovo. “With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women’s health innovation.”
 

ABOUT REPRONOVO:
ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. Our team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market. Lead clinical compound, RPN-001 (leflutrozole), is being developed to treat male infertility. RPN-002 (nolasiban) is a first-in-disease and first-in-class molecular entity being developed to manage adenomyosis and increase the probability of embryo implantation in women undergoing assisted reproductive technology (ART) treatments. Both assets are Phase 2 ready. ReproNovo is financed by Jeito Capital, AXA IM Alts, founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn.
 

ABOUT RPN-001 (leflutrozole):
RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. The small molecule inhibits the enzyme aromatase, suppressing testosterone conversion to estradiol, thereby normalizing testosterone levels. Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. RPN-001 is currently being evaluated in a U.S. Phase 2 trial (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1). ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.
 

CONTACT INFORMATION:
ReproNovo
Rue de Langallerie 11
1003 Lausanne, Switzerland
info@repronovo.com
 

MEDIA CONTACT:
MC Services AG
Brittney Sojeva
repronovo@mc-services.eu
+49 211 529 252 14


30.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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2205250  30.09.2025 CET/CEST

Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

ABIVAX

/ Key word(s): Conference

Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

29.09.2025 / 22:05 CET/CEST

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


Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

  • Late Breaking Abstract titled EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) to be presented Sunday, October 5 at 5pm CEST

PARIS, France – September 29, 2025 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced the presentation of a second late breaking abstract for its lead drug candidate, obefazimod, for the treatment of moderately to severely active ulcerative colitis (UC) at The United European Gastroenterology Congress, taking place October 4-7, 2025, in Berlin, Germany.

“The acceptance of this additional late-breaking abstract underscores the significance of the ABTECT Phase 3 induction trial results which demonstrate the statistically significant and clinically meaningful clinical activity and impressive safety and tolerability profile of obefazimod in patients with moderately to severely active ulcerative colitis during the 8-week induction trials.  These findings are crucial steps towards potentially offering a novel, first-in-class oral treatment option for patients who urgently need new therapeutic approaches to achieve and maintain remission,” said Fabio Cataldi, MD, Chief Medical Officer of Abivax.

Obefazimod data to be presented:

Presentation Title Session Presenter Presentation/ Session
Number
Session Hall Date and Time (CEST)
 
EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) Late-breaking trials in IBD Bruce Sands, MD  LB /01 Room Helsinki Sunday, October 5, 2025
 
5:00 to 5:12pm CEST
EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES Hot off the press: IBD Treatment Silvio Danese, MD  LB / 06 Room Helsinki Monday, October 6, 2025
 
10:00am to 10:12am CEST

 
About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.

Contact:
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for the potential therapeutic benefit of obefazimod, and the Company’s participation at industry conferences. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.


29.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2205318  29.09.2025 CET/CEST

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

Heidelberg Pharma AG

/ Key word(s): Study results

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

25.09.2025 / 13:17 CET/CEST

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


PRESS RELEASE

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

  • HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities observed
  • Early evidence of clinical activity observed in Cohort 8, highlighted by a very good partial response observed in one patient

Ladenburg, Germany, 25 September 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the initiation of Cohort 9 in its ongoing Phase I/IIa dose escalation trial of HDP-101, the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma.

The Safety Review Committee (SRC) has confirmed that the 140 µg/kg dose level administered in Cohort 8 was safe and well tolerated. Based on these findings, the study is now progressing into Cohort 9 with an escalated dose of 175 µg/kg, administered in one dosing arm. Cohort 9 has already opened.

Eight patients were dosed in Cohort 8 and all patients completed the observation period, demonstrated a favorable safety and tolerability profile throughout. Encouraging signs of clinical activity have also emerged. Patients showed biological activity of HDP-101, and a very good partial response has already been observed in one patient. This adds to earlier positive outcomes, including one patient from Cohort 5 who is still on treatment and achieved complete remission, with no detectable tumor cells after ongoing HDP-101 monotherapy following multiple prior treatments. In addition, several patients across different cohorts have shown objective responses and promising anti-tumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “Our lead ATAC candidate HDP-101 continues to demonstrate a strong safety and tolerability profile across all treated patients. The results from Cohort 8 demonstrate encouraging signs of clinical activity of HDP-101, including a very good partial response in one patient. These early efficacy signals are promising as we advance HDP-101 through the ongoing dose escalation study.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HDP-101 in this patient population.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-Mail: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg
 
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228-40
E-Mail: katja.arnold@mc-services.eu
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Aoife Minihan
Tel: +44 20 3882 9621
Email: HeidelbergPharma@optimumcomms.com
 

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.


25.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2203868

 
End of News EQS News Service

2203868  25.09.2025 CET/CEST

Change in the Chairmanship of the Board of Directors

Media Release
Zofingen, September 26, 2025

Ad hoc announcement pursuant to Art. 53 Listing Rules

Dr. Andreas Casutt (1963) has been a member of the Board of Directors of Siegfried Holding AG (SIX: SFZN) since 2010 and its Chairman since 2014. The attorney and partner at the Zurich law firm Niederer Kraft Frey AG has decided not to stand for re-election at the Annual General Meeting on April 16, 2026. 

Andreas Casutt, Chairman of the Board of Directors: “Even after 16 years on Siegfried’s Board of Directors, this decision is not an easy one for me. But the timing for a change in the chairmanship is right. Siegfried is best positioned today to continue its successful journey of growth.”  

Martin Schmid, Vice Chairman of the Board of Directors: “Andreas has significantly shaped our company over the past years. Under his leadership, Siegfried developed into a successful, global CDMO. His personal contribution to Siegfried’s ongoing success is substantial.”

The Board of Directors will propose to the 2026 Annual General Meeting that Dr. Beat Walti (1968) be elected the new Chairman of the Board of Directors. Beat Walti was elected to the Board of Directors of Siegfried Holding in 2022. The attorney chairs the Board of Trustees of the Ernst Göhner Foundation, Siegfried’s largest shareholder, holds board mandates at the Danish company DSV A/S and, as Chairman, at the Zurich-based trading company Rahn AG. In addition, he has been a member of the Swiss National Council since 2014, where he serves on the Economic Affairs and Taxation Committee.

Andreas Casutt: “Beat has many years of experience on the governing bodies of companies and foundations in Switzerland as well as internationally. In recent years, he has made significant contributions to Siegfried’s development as a member of our Board of Directors. Together with the Board and the Executive Committee, he will actively drive forward the expansion of our company’s market position in the years ahead.”

Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial

Pentixapharm Holding AG

/ Key word(s): Study/Research Update

Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial (news with additional features)

26.09.2025 / 08:00 CET/CEST

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


 Achieves Key Milestone with CXCR4-based Radiotherapeutic

  • Favorable safety profile enables advancement of radiolabeled PentixaTher to fourth of five planned activity dose levels in investigator-initiated PENTILULA Phase 1/2 trial
  • Milestone marks important step for novel radiotherapeutic candidate in high unmet need indication with limited treatment options and poor prognosis

 Berlin, Germany, September 26, 2025 – Pentixapharm AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech, developing novel radiopharmaceuticals, today announced that its CXCR4-targeting radiolabeled candidate PentixaTher has advanced to the fourth dose level in the investigator-initiated PENTILULA Phase 1/2 study in acute myeloid leukemia (AML).

Based on favorable safety findings at the third dose level of 7.5 GBq, the investigator-initiated trial received approval from the independent Data Safety Monitoring Board (DSMB) to advance to the fourth of five planned dose levels at 10 GBq, underscoring PentixaTher’s tolerability to date. Importantly, this advancement not only reinforces the compound’s safety profile but also moves the study into a dose range with a higher likelihood for meaningful clinical efficacy. If favorable safety signals continue, the study is expected to escalate to a fifth and final dose level of 12.5 GBq.

AML is the most common acute leukemia in adults, with approximately 20,000 new cases annually in the U.S. and 17,000 new cases annually in Europe. Five-year survival rates range between approximately 32 and 37%, respectively.

“Advancing to higher dose levels marks a key step in validating the therapeutic potential and promise of PentixaTher,” said Dirk Pleimes, MD, CEO/CMO of Pentixapharm. “The encouraging results in this investor-led effort highlight the potential of CXCR4 as a powerful target for hematologic cancers and demonstrate the promise of radiopharmaceuticals to expand treatment options where medical need is greatest. The trial is expanding the clinical evidence base for CXCR4-targeted therapy to expand the boundaries of radiopharmaceuticals.”

Professor Françoise Kraeber-Bodéré, Nuclear Medicine Department, CHU Nantes, Principal Investigator, commented: “We are encouraged by the favorable safety profile observed to date, which has enabled us to move to higher activity dose levels. At dose level four, we are now entering a range considered of potentially higher effectiveness, and we look forward to evaluating the clinical impact in this high-need patient population.”

Professor Patrice Chevallier, Hematology Department, CHU Nantes added: “For patients with advanced AML, treatment options are limited, and prognosis in this often heavily pretreated population is poor. Reaching this dose level with an acceptable safety profile provides new hope that CXCR4-targeted radiopharmaceuticals could one day become a meaningful addition to the therapeutic landscape.”

  

About PentixaTher and the PENTILULA Phase 1/2 Study

Radiolabeled PentixaTher is a novel radiotherapeutic designed to selectively target the chemokine receptor CXCR4, a key player in the bone marrow microenvironment that is frequently overexpressed in aggressive hematological malignancies. The compound is labeled for the PENTILULA study with 177-lutetium, a clinically well-established isotope, enabling precise delivery of a targeted radiation payload. PentixaTher is currently being evaluated in the PENTILULA Phase 1/2 study (ClinicalTrials.gov ID: NCT06356922), initiated in November 2024. The multicenter, open-label, dose-escalation trial is led by an experienced investigator team at the University Hospital of Nantes and conducted at three additional clinical sites in France. It aims primarily to assess the safety and tolerability of PentixaTher, with secondary objectives including preliminary measures of clinical activity such as overall response rate, complete response rate, and overall survival. The study is supported by the French Ministry of Health.

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

 

About Nantes University Hospital

Nantes University Hospital (CHU de Nantes) is one of France’s leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting clinical trials and contributing to significant advancements in healthcare, in particular in nuclear medicine and hematology. [177Lu]Lu-PentixaTher is produced by ARRONAX, the hospital radiopharmacy unit (APUI), which is specially authorized for the preparation of the radiopharmaceutical investigational product.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com


Additional features:

File: 20250925 – Pentixapharm PR IIT Nantes EN FINAL


26.09.2025 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.
Archive at www.eqs-news.com


Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2203960

 
End of News EQS News Service

2203960  26.09.2025 CET/CEST

African Leaders Call for Bold, United Action to Tackle Global Health Crises and Sustain Malaria Progress

African Leaders Malaria Alliance (ALMA)

/ Key word(s): Miscellaneous

African Leaders Call for Bold, United Action to Tackle Global Health Crises and Sustain Malaria Progress

26.09.2025 / 13:15 CET/CEST

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


NEW YORK, United States of America, September 26, 2025/APO Group/ — African Heads of State and Government convened global leaders on Wednesday at a high-level event on the margins of the 80th United Nations General Assembly, sounding the alarm on escalating threats to global health security.

Convened under the theme “Uniting for Global Health Security”, the joint event brought together the Global Leaders Network for Women’s, Children’s and Adolescents’ Health, chaired by H.E. President Cyril Ramaphosa of South Africa, and the African Leaders Malaria Alliance (ALMA), chaired by President Advocate Duma Gideon Boko of Botswana. Discussions were moderated by the Rt Hon. Helen Clark, chair of the Partnership for Maternal, Newborn, and Child Health and former prime minister of New Zealand.

Amid growing concern over stagnating progress toward the Sustainable Development Goals for health, leaders called for urgent financial commitments, stronger partnerships, and bold, united action to protect the world’s most vulnerable, including women, children, and adolescents, from preventable diseases such as malaria.

“The fight against malaria is becoming increasingly complex,” said President Advocate Duma Gideon Boko. “Shrinking budgets, rising biological resistance, humanitarian crises, and the impact of climate change are all contributing towards creating a perfect storm of challenges,” he added.

Funding declines threaten progress

Recent years have seen a dramatic erosion of official development assistance (ODA) for health, with African leaders warning that life-saving programmes risk collapse in the absence of urgent and sustained financing. Between 2021 and 2025 alone, ODA for health in Africa declined by an estimated 70%, even as widening equity gaps, conflict, and displacement have expanded both needs and vulnerability.

H.E. President Cyril Ramaphosa highlighted the impact of these cuts, “essential programmes to eliminate malaria have been compromised. This leaves millions without care and erodes decades of progress that has been made so far.”

A successful Global Fund Replenishment is vital

Leaders reiterated support for the upcoming 8th replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which aims to raise US$18 billion at its November 2025 conference. The Global Fund, established in 2002, has been central to progress against the three diseases, saving more than 70 million lives. Leaders stressed that the upcoming replenishment is critical, not only to sustain momentum but also to prevent a reversal of hard-won gains amid rising threats.

The ALMA chair issued a rallying call on the upcoming replenishment, “I call on all countries and donors to invest boldly in the Global Fund replenishment. If we all come together, we will save 23 million lives from malaria, AIDS and TB, while strengthening our health systems.”

Strengthening national ownership, innovative resource mobilisation and local manufacturing

While underscoring the importance of global solidarity, the African leaders noted that African ownership and accountability must be at the centre of the response, with H.E. President William Ruto of the Republic of Kenya saying “the future of Africa health financing lies in our own hands. Encouragingly, across the continent, change is already underway.”

Through initiatives like national End Malaria Councils and Funds, countries are embracing innovative financing approaches to expand the pool of resources for malaria, with 11 African countries already having mobilised over US$166 million, illustrating the power of multi-sectoral collaboration. 

At the same time, African leaders recommended tried and tested innovations, calling for the World Bank’s International Development Association (IDA) to set up a 2nd Malaria Booster Programme. The first malaria booster program (phase I and phase II) between 2005 and 2015 saw millions invested in malaria control and millions of cases prevented and lives saved. This vital programme helped “reinforce local health systems, such as community health workers, and enhance data systems and surveillance” said H.E. Muhammed B.S Jallow, vice president of the Republic of The Gambia.

With the recent IDA21 replenishment, there’s an opportunity to deliver a similar programme to address the challenges we face today, with the ALMA chair, President Advocate Duma Gideon Boko saying, “as ALMA, we are calling on the World Bank International Development Association to establish a second Malaria Booster Programme.” he said.

A push for national ownership was made by Dr Sania Nishtar, CEO of GAVI, who said “we strongly believe countries and not global health institutions should be at the centre of global health.” Dr Nishtar highlighted GAVI’s African Vaccine Manufacturing Accelerator which she said “promotes African self-reliance in vaccine manufacturing.” The GAVI CEO also shared that the vaccine alliance is “implementing the fastest vaccine rollout in Gavi’s 25-year history” with the introduction of malaria vaccines across 23 African countries, with early evidence showing a 13% drop in all-cause child mortality in vaccinated areas.

The need for public-private partnerships to deliver sustainable financing

Leaders called for the establishment of a Public-Private Partnership Health Accelerator to respond to declining traditional funding, with President Advocate Duma Gideon Boko encouraging fellow leaders to “think bigger and cast our net wider to mobilise even more resources to respond to the critical health challenges.”

This partnership will deliver new investments and drive progress toward universal health coverage. The accelerator is expected to leverage partnerships with the private sector, philanthropic foundations, high networth individuals and the diaspora, whilst reinforcing domestic commitments.

“We need a private-public partnership health accelerator that will drive whole-of-society progress towards the SDGs through sustainable high-value investments,” shared the ALMA chair.

This call for public private partnerships was endorsed by fellow leaders, with the vice president of the Republic of the Gambia saying these partnerships “can help us deliver sustainable financing at this critical moment and lead our continent to prosperity.”

The Big Push against Malaria

Earlier this year, the Africa Centre for Disease Control and Prevention (Africa CDC) unveiled a bold strategy to transform health financing across the continent amidst the volatile and ever-evolving global financing landscape. This momentum was amplified in Abuja with the launch of the “Big Push” to End Malaria in early September, placing malaria elimination at the heart of Africa’s health and development agenda. Building on this, African leaders at the UN General Assembly called for a paradigm shift in investments to sustain the fight against malaria and broader health challenges across the continent.

The joint event signalled renewed determination to confront overlapping crises with urgency, innovation, and unity, with H.E Dr Jean Kaseya, Director General of the Africa-Centres for Disease Control and Prevention, urging leaders to continue to turn these crises into opportunities to “start to raise sustainable financing, to build our own data system owned by the continent, to start to manufacture our own vaccines, medicines, and to build strong surveillance system. Now Africa is leading the world.”

As African countries moves towards greater ownership of our health systems and development agenda, Professor Senait Fisseha, a champion of sexual and reproductive health rights encouraged leaders to “to ensure it reflect our values, what we believe and is right, and is needed for our people” so that “we can create a continent in which every woman, every girl, every child can live to her fullest potential.”

“Together, let us rise to this moment. Let us prove that resilient health systems are the cornerstone of dignity, security and prosperity,” said H.E. President William Ruto of the Republic of Kenya at the conclusion of his remarks, echoing ALMA chair, President Advocate Duma Gideon Boko who said “we can make malaria elimination a reality. We can deliver a healthy tomorrow for women, babies, children and adolescents. The time to start is now.”

Distributed by APO Group on behalf of African Leaders Malaria Alliance (ALMA).

Download image: https://apo-opa.co/4gLjJ2s

Image Caption: L-R : H.E. President Advocate Duma Gideon Boko of Botswana, Chair of the African Leaders Malaria Alliance; H.E. President Cyril Ramaphosa of South Africa and Chair of the Global Leaders Network; H.E. President William Ruto of Kenya ;and the Rt. Hon. Helen Clark at the UNGA80 side-event on Global Health Security at the United Nations

 


26.09.2025 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.
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2204474  26.09.2025 CET/CEST

DINAMIQS opens cGMP manufacturing facility for viral vectors

Media Release
Zofingen, September 29, 2025

DINAMIQS, a Siegfried company (SIX: SFZN), today inaugurated its state-of-the-art cGMP manufacturing facility for viral vectors — the first of its kind in Switzerland. The new facility enables end-to-end manufacturing of viral vector gene therapies, from molecule design to aseptic drug product filling. As part of this facility, new lab space has already been operational since Q3 2024. With this milestone, Siegfried strengthens its footprint in the rapidly growing cell and gene therapy market. To mark the inauguration, DINAMIQS also announced a strategic collaboration with SEAL Therapeutics to support the development and manufacturing of a gene therapy for a severe muscular dystrophy.

Marcel Imwinkelried, Chief Executive Officer Siegfried: “Since acquiring the startup in 2023, Siegfried’s ambition has been to bring DINAMIQS’ capabilities to commercial scale and establish it as a leading CDMO in the cell and gene therapy space. With the opening of the new manufacturing facility and growing customer demand, we are well on track to achieving this goal.”

Located in the Bio-Technopark in Zurich, DINAMIQS’ new 2,500m² cGMP facility brings R&D, clinical and commercial viral vector manufacturing under one roof, with production capacity up to 1,000L scale. Featuring a modular, segregated design and state-of-the-art closed, single-use technologies, it ensures strict containment, fast turnaround times, and full GMP compliance.

Martin Kessler, Chief Executive Officer DINAMIQS: “One of the biggest challenges that cell and gene therapy developers face today is scalability in process development and manufacturing. With the design of our facilities in Zurich, we enable our customers to get everything they need from one partner and one location. We offer lead optimization, R&D production and now also clinical and commercial supply – saving customers time and money when bringing their therapies to patients.”

In connection with the facility inauguration, DINAMIQS and SEAL Therapeutics announced the intention to enter a strategic collaboration. SEAL Therapeutics, a spin-off from the Biozentrum of the University of Basel, is developing an innovative gene therapy designed to address the functional defects that cause LAMA2 related muscular dystrophy, a severe childhood-onset disease characterized by progressive muscle loss and with no current treatment option. The research team led by Professor Dr. Markus Rüegg, Dr. Judith Reinhard and Dr. Thomas Meier will be supported by DINAMIQS experts to scale up production of their innovative gene therapy, enabling the transition from laboratory research toward potential patient treatment.

Markus Rüegg, Chief Executive Officer of SEAL Therapeutics: “To advance our viral vector-based gene therapy toward clinical application, we chose DINAMIQS for their specific expertise with the vector we require, their large-scale production capabilities, and their collaborative approach as a trusted Swiss-based partner.”

aap Implantate AG closes the first half of the year with sales of € 6.2 million; clinical trial nears positive conclusion

EQS-News: aap Implantate AG

/ Key word(s): Half Year Report/Half Year Results

aap Implantate AG closes the first half of the year with sales of € 6.2 million; clinical trial nears positive conclusion

16.09.2025 / 10:00 CET/CEST

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

aap Implantate AG (“aap” or “Company”) informs:

  • Human Clinical Trial of Silver Antibacterial Technology Successfully Nears Completion and Opens Next Step to Regulatory Approval;
  • Existing customer business EMEA grows normalized by 11%, total aap 3% after excluding one-time UN order;
  • US tariff impact successfully mitigated;
  • APAC region strong growth driver

The first half of 2025 was marked by geopolitical uncertainties, fragile supply chains and new US tariffs. Despite these challenges, the company succeeded in strengthening its operating base and consistently driving forward strategic initiatives.

The introduction of US import tariffs (“Liberation Day”) at the beginning of April represented a turning point. Operational adjustments in supply chains and targeted price adjustments in the USA have reduced the impact of tariffs to a minimum.

Regionally, we were able to further expand our position in important markets:

  • EMEA: The EMEA region, which accounts for over 50% of total sales, maintained a solid baseline. Adjusted for one-off effects from the previous year, the region even recorded strong growth of 11% in existing customer business. Germany (+8% despite hospital structural reform), South Africa (+36%) and the MEA markets as a whole performed particularly well.
  • LATAM: The region stabilized in Q2 but was unable to close the Q1 gap. Brazil stands out with +37% growth, driven by the successful launch of the first LOQTEQ® foot systems after certification. Mexico and Colombia, on the other hand, fell short of expectations – Mexico due to delayed customer contract processes, Colombia due to structural challenges due to financing bottlenecks in the healthcare sector.
  • APAC: Successful market development continues. With initial activities in the new markets of South Korea and Taiwan as well as strong growth in Thailand (+26%), the customer base was significantly expanded. The region achieved an impressive growth of 82% and promises further growth in the future.
  • USA: The strategic transformation was initially slower than expected, but the implemented strategies and intensified customer activities are now starting to take effect. In June, monthly sales of over USD 0.3 million were achieved – a clear signal that the reorganization and targeted customer relationships initiated in 2023 are bearing fruit.

 

Revenue Q2/HY 2025/2024

Revenue in EUR thousand Q2/2025 Q2/2024 Change
EMEA (= Europe, Middle East, Africa)
North America
LATAM (= Latin America)
APAC (= Asia-Pacific)
1.569
642
642
299
1.907
683
639
102
-18%
-6%
+1%
+>100%
Turnover 3.152 3.330 -5%

 

Revenue in EUR thousand H1/2025 H1/2024 Change
EMEA (= Europe, Middle East, Africa)
North America
LATAM (= Latin America)
APAC (= Asia-Pacific)
3.271
1.290
1.221
454
3.334
1.429
1.427
250
-2%
-10%
-14%
+82%
Turnover 6.236 6.440 -3%

With regard to the USA, the success story of the strategic realignment is somewhat clearer when viewed after adjusting for currency effects. The operating decline decreased continuously from -9% in the first half of the year to only -1% in the second quarter – clear evidence that the transformation initiated in 2023 is taking effect.

Revenue in USD (million) Q2/2025 Q2/2024 Change
North America 0,7 0,7 -1%

 

Revenue in USD (million) H1/2025 H1/2024 Change
North America 1,4 1,5 -9%

 

Due to the continuously growing customer base and simultaneous investments by existing customers in the aap portfolio, the company plans to increase orders on the revenue side for the second half of 2025 compared to the first 6 months.

Key financial figures for the first half of 2025 aap Group (unaudited)

In EUR million, rounded 01.01.-30.06.2025 01.01.-30.06.2024 Change
Turnover 6,2 6,4 -0,2
Gross margin* 5,2 5,2 -0,1
Other operating income 0,6 0,9 -0,3
Personnel costs -2,9 -3,2 0,3
Operating costs -3,2 -3,1 -0,1
EBITDA -0,3 -0,0 -0,2
Operating profit (EBIT) -1,0 -0,8 -0,2
Net Revenue -1,0 -0,9 -0,1
       
Margins in %      
Gross margin* 85% 87%  
EBITDA -5% -0%  
Operating profit (EBIT) -16% -12%  

*(Gross margin = sales +/- inventory changes – material expenses / sales revenues)

Key financial figures for the first half of 2025 aap by segment (unaudited)

  30.06.2025 30.06.2024
Figures in EUR thousand TraumaLOQTEQ® Silver Total TraumaLOQTEQ® Silver Total
Earnings before interest, taxes,
depreciation and amortization (EBITDA)
56 -348 -292 335 -382 -46

The measures taken at the end of 2023, ongoing optimizations and the organic increase in sales are showing financial success in the first half of the year. aap achieved an almost break-even result in consolidated earnings at EBITDA level, while the positive trend was confirmed in the trauma business at EBITDA level. The EBITDA difference compared to the previous year is primarily related to the deviation in sales and the reduced other operating income.

Cashflow (unaudited)

In EUR million, rounded 01.01.-30.06.2025 01.01.-30.06.2024 Change
Cash flow operating -0,2 -1,0 0,8
Cash Flow Investment -0,3 -0,0 -0,3
Cash Flow Financing -1,0 0,5 -1,5
       
  30.06.2025 31.12.2024  
Cash and cash equivalents 0,6 2,1 -1,5
Net position 0,4 0,4  

The significant improvement in operating cash flow was mainly due to a stable gross margin of over 85% (despite inflation-related increases in material prices), lower personnel costs compared to the previous year (mainly reduction in vacation provisions), and an improved margin and cost situation in the United States (higher margins with stable fixed costs).

 

Financing
In July 2025, the company was able to conclude a lease-sale back agreement with NordLeasing company to secure liquidity. The company thus received EUR 725 thousand. The leasing contract has a term of four years.

 

Operational activities

Bottlenecks at our notified body delayed the expected MDR approvals for plates and screws, which had a negative impact on sales planning and production. On the other hand, the MDR approvals for products of classes Im, Ir and IIa were successfully completed, which confirms the high quality of our submitted documents. These successes make us confident that the remaining registrations will follow soon.

Regarding the human clinical trial with antibacterial implants, we refer to the most recent press release of September 09, 2025. The Internet address contained in the press release regarding the guideline of the study has changed due to a name change of the funding agency. It has been updated in the following text.

The clinical trial is funded by the German Federal Ministry of Education and Research (“BMBF”). The grant granted to the company (funding codes 13GW0313A+B, 13GW0449A+B) is part of the BMBF’s field of action “Healthcare Economics in the Health Research Framework Program” (= funding body). According to the BMBF, funding is provided for projects on the topic of “Transferring medical technology solutions into patient care – proving clinical evidence without delay”. For further information, please refer to the corresponding guideline on the BMBF website: https://www.bmftr.bund.de/SharedDocs/Bekanntmachungen/DE/2024/07/2024-07-29-Bekanntmachung-L%c3%b6sungen.html.

Outlook for the second half of 2025

For the second half of 2025, in addition to the forecasts already formulated in the 2024 annual financial statements, the focus is on several important milestones: the stabilization of liquidity for ongoing investments, the completion of the human clinical trial, the preparation of the study report by the end of the year for our antibacterial implant technology and the completion of the MDR approval work. At the beginning of September, we had already very successfully passed the MDR recertification of the company and the US FDA inspection.

 

On the revenue side, the Management Board plans to increase sales for the second half of the year compared to the first six months and maintains its forecast for the year as a whole.

 

——————————————————————————————————————————————-

aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

 

 

About aap Implantate AG

 aap Implantate AG is a global medical technology company headquartered in Berlin, Germany. The company develops and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovative pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical and not yet adequately solved problems in traumatology.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 25 countries. In the USA, the company and its subsidiary aap Implants Inc. rely on a distribution agent and selective direct sales strategy. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

 

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

 

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

 

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 170; Email: r.digirolamo@aap.de

 


16.09.2025 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.
Archive at www.eqs-news.com


Newron presents H1 2025 results and provides business update

EQS-News: Newron Pharmaceuticals S.p.A.

/ Key word(s): Half Year Results

Newron presents H1 2025 results and provides business update

16.09.2025 / 07:00 CET/CEST

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

Newron presents H1 2025 results and provides business update 

Milan, Italy, September 16, 2025, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half-year ended June 30, 2025, and provided a business update for 2025 and beyond.

Highlights H1 2025:

Evenamide

Clinical trials:

  • In May, the Company announced regulatory approval for its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS). The program consists of two pivotal studies:
    • ENIGMA-TRS 1, an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients. Following a successful screening period, patient enrolment began post-period, in August 2025, with 12-week study results expected in Q4 2026
    • ENIGMA-TRS 2, approved by the US Food and Drug Administration, to be performed at centers in the US and selected additional countries. This 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients is expected to start by October 2025

Strategic licensing and partnerships:

  • In January, the Company announced a licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea
    • Under the terms of the agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming Phase III ENIGMA-TRS 1 study and will cover the costs related to this population
  • Following the execution (in December 2024) of the licensing agreement with EA Pharma, a subsidiary of Eisai, to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories, Newron in the reporting period received the upfront payment of EUR 44 million and invoiced the first milestone achievement
  • Newron continues to actively explore additional partnership opportunities for the global development and commercialization of evenamide in other territories

Industry engagement and scientific exchange:

  • In January, evenamide’s exceptional results in study 014/015 and study 008A were published in the peer reviewed International Journal of Neuropsychopharmacology
  • Post-period, in August 2025, new preclinical data from researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology. The research suggests that evenamide ameliorates schizophrenia-related dysfunction, targeting the key site of schizophrenia pathology in the hippocampus, and so could be an ideal therapeutic agent for the treatment of schizophrenia

Corporate

  • In April, Dr. Chris Martin was elected as the Chairman of Newron’s Board of Directors, succeeding Dr. Ulrich Köstlin who served as Chairman of the Company from 2013

Stefan Weber, CEO of Newron, commented: “Since the beginning of the year, Newron has continued to make exciting progress in the development of our novel drug candidate evenamide. Most notably, we announced the approval of our pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy in patients with treatment-resistant schizophrenia (TRS) and recently we began enrolling patients into the first study from the program, ENIGMA-TRS 1. We’re delighted to have achieved this crucial milestone on evenamide’s clinical development journey and continue to believe that this new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the treatments currently available.”

Evenamide – advancing schizophrenia treatment

In January, Newron announced its licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide as an add-on therapy for TRS and poorly responding patients with schizophrenia in South Korea. Under the terms of the agreement, Myung In Pharm, besides the usual financial terms for such agreement, will contribute 10% of the total patient population to be enrolled into Newron’s pivotal ENIGMA-TRS 1 clinical trial and cover the costs related to this population.

There has also been strong progress from EA Pharma, who Newron has entered into a license agreement with to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories. EA Pharma expects to initiate its clinical development program for evenamide in Japan. Also, the first milestone under the license agreement became due and was invoiced in the reporting period.

In May, Newron announced the regulatory approval of its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with TRS. More than one third of schizophrenia patients suffer from TRS and are not responding to the existing second-generation antipsychotics on the market. Consequently, these patients are in great need of the development and approval of new therapeutic treatments. If approved, evenamide would be the first medication added to existing antipsychotics that improves the symptoms of TRS.

The ENIGMA-TRS Phase III development program consists of two pivotal studies, ENIGMA-TRS 1 and ENIGMA-TRS 2:

  • ENIGMA-TRS 1 is an international, 52-week, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide as an add-on treatment to current antipsychotics, compared to placebo. Patients on second-generation antipsychotics (SGAs), including clozapine, will meet Treatment Response and Resistance Psychosis (TRRIP) international consensus criteria for TRS. The study will enroll at least 600 patients at study centers in Europe, Asia, Latin America and Canada.
  • The primary assessment of efficacy and safety of ENIGMA-TRS 1 will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue double-blind and placebo-controlled until the 52-week time point. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Newron expects to announce 12-week results from the study in Q4 2026.
  • ENIGMA-TRS 1 is actively screening across all target continents. Post-period, in August 2025, Newron announced that the first patients have been successfully enrolled following the completion of a 42-day screening period. Newron’s partner Myung In Pharm has also received the necessary approvals in South Korea to move towards enrolling patients in this region.
  • ENIGMA-TRS 2, the second study in Newron’s pivotal Phase III development program, has been approved by the US Food and Drug Administration (FDA), and will be performed at centers in the US and selected additional countries. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase III study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide as an add-on treatment to current antipsychotics, compared to placebo.
  • Patients will undergo the same screening as the ENIGMA-TRS 1 trial. The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. US investigational centers are expected to initiate the study by October 2025.

Shortly after the reporting period, in August 2025, new preclinical data from Dr. Anthony Grace and other researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology. The data suggests that evenamide ameliorates schizophrenia-related dysfunction, and for the first time demonstrates that evenamide targets the key site of schizophrenia pathology in the hippocampus. Using the neurodevelopmental MAM model of schizophrenia, researchers demonstrated that evenamide could offer a novel therapeutic strategy capable of addressing the positive, cognitive, and negative symptoms of schizophrenia, a key advantage over existing antipsychotic drugs which only target positive symptoms.  Importantly, time-course analysis indicates effects of a single dose of evenamide last long after elimination of drug, suggesting effect on neuronal plasticity. These findings help explain the robust and sustained symptom improvements observed in Newron’s Phase II and Phase III studies in patients with chronic schizophrenia, reinforcing evenamide’s potential as a transformative therapy for treatment-resistant and poorly responding patients, and offering a promising alternative to traditional dopamine D2-based antipsychotics.

Xadago®/safinamide – Parkinson’s disease

In partnership with Zambon and Meiji Seika, Newron continues to develop and market its product, Xadago®/safinamide.

Corporate

At the Annual General Meeting 2025, Dr. Chris Martin was elected as the new Chairman of the Board following his nomination by the Company. Chris Martin took over from Dr. Ulrich Köstlin, who served as Chairman of Newron’s Board since 2013. Dr. Martin is a recognized leader in the biopharma industry who has taken therapeutic technology from the lab bench through to regulatory approval and global market sales. He co-founded ADC Therapeutics in 2012 and served as its CEO from its inception until 2022, growing the company from a private biotech start-up to a New York Stock Exchange listed leader in the field of antibody-drug conjugates with products marketed worldwide. Chris Martin also co-founded and was the CEO of Spirogen, an innovator of antibody-drug conjugate payload technology, which was subsequently sold to AstraZeneca for a total of up to $440 million.

Outlook

Following the approval of the pivotal Phase III ENIGMA-TRS program for evenamide and the subsequent initiation of the ENIGMA-TRS 1 study, Newron’s key focus for the coming months is on progressing this study and initiating ENIGMA-TRS 2, initially in the US study centers.

In addition to its licensing agreements with Myung In Pharm and EA Pharma, Newron continues to be supported by one of world’s leading full-service investment banking and capital markets firms in a structured process to secure the most attractive, value creating transactions for the Company’s shareholders.

Furthermore, to comprehensively protect the future value of evenamide for shareholders and new investors, Newron is currently in the process of filing additional patent applications to further extend the Intellectual Property protection around evenamide as a novel treatment for schizophrenia. Additionally, the existing patent applications pertaining to evenamide continue to be granted within the European Union and the US.

Newron CEO Stefan Weber concluded: “We are very excited about our continued achievements, and we are one step closer to potentially bringing enormous benefits to schizophrenia patients who are insufficiently served by the treatments currently available. The financial position of our Company remains strong – Newron’s total available cash resources are expected to fund our planned development programs and operations well towards the end of the year 2026.”

Financial Summary (IFRS) H1 2025 and 2024:

In thousand EUR (except per share information)

  H1 2025 H1 2024
Licence income/Royalties/Other income 11,898 3,407
Research and development expenses (6,081) (6,453)
General and administrative expenses (4,423) (4,579)
Net loss (73) (9,557)
Loss per share (0.00) (0.51)
Cash generated/(used) in operating activities 33,353 (8,828)
  As of June 30, 2025 As of December 31, 2024
Cash and Other current financial assets 43,195 9,826
Total assets 61,394 63,908

Newron’s Half-Year Report 2025 is available for download on the Company’s website at: www.newron.com/investors/reports-and-presentation/year/2025

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system.

Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications.

Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea.

Newron has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika.

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

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com
 

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


16.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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