Bayer Aktiengesellschaft: Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

Bayer Aktiengesellschaft / Key word(s): Study results

Bayer Aktiengesellschaft: Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

23-Nov-2025 / 16:47 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.


Leverkusen / Berlin, November 23, 2025 – Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.
 
The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients.
 
Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. 

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact: Mrs. Kristina Pollok, Bayer AG, Investor Relations, phone: +49-214-30-72704, e-mail: kristina.pollok@bayer.com

End of Inside Information


Information and Explanation of the Issuer to this announcement:

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team


23-Nov-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Bayer Aktiengesellschaft
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Phone: +49 (0)214 30-72704
E-mail: ir@bayer.com
Internet: www.bayer.com
ISIN: DE000BAY0017
WKN: BAY001
Indices: DAX, EURO STOXX 50, Stoxx 50
Listed: Regulated Market in Berlin, Dusseldorf, Frankfurt (Prime Standard), Hamburg, Hanover, Munich, Stuttgart; Regulated Unofficial Market in Tradegate Exchange
EQS News ID: 2234580

 
End of Announcement EQS News Service

2234580  23-Nov-2025 CET/CEST

Curatis Holding AG announces CHF 1.2 million private placement with strategic investor

Liestal, Switzerland, 21 November 2025: Curatis Holding AG (SIX: CURN) today announces that it has entered into a definitive agreement for a private placement of a convertible instrument of CHF 1.2 million with a strategic Swiss investor.

Under the terms of the agreement, the investor will subscribe for a convertible instrument convertible into shares of Curatis Holding AG. The shares are expected to be delivered from Curatis’ conditional capital. The instrument has been issued at prevailing market conditions. The transaction is expected to close within the next few days, subject to customary conditions.

First and foremost, the proceeds will allow to accelerate the development of the Company’s late stage clinical lead product candidate corticorelin.

FamiCord AG accelerates profitable growth in the third quarter of 2025 and further strengthens quality and visibility of revenues

FamiCord AG

/ Key word(s): 9 Month figures

FamiCord AG accelerates profitable growth in the third quarter of 2025 and further strengthens quality and visibility of revenues

21.11.2025 / 07:30 CET/CEST

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


FamiCord AG accelerates profitable growth in the third quarter of 2025 and further strengthens quality and visibility of revenues

  • Group revenues increase by around 2.5 percent to EUR 22.8 million in Q3 2025 and by roughly 10 percent to around EUR 66.4 million in the first nine months
  • EBITDA from continuing operations at EUR 3.8 million, on par with the previous year; 9M EBITDA reaches EUR 8.7 million with a margin of 13.1 percent
  • Share of recurring revenues grows noticeably faster than prepaid contracts, further increasing visibility and stability of the long-term revenue base

Leipzig, 21 November 2025 – FamiCord AG, Europe’s leading cell bank and the third largest worldwide, accelerated its profitable growth path in the third quarter of 2025 and further strengthened the quality of its revenues. Despite an environment still characterized by economic uncertainty, subdued consumer sentiment and comparatively low birth rates in many European countries, the Company again increased its revenues with an attractive margin profile and further improved its profitability. 

In the third quarter of 2025, Group revenues rose to EUR 22.8 million, corresponding to growth of around 2.5 percent compared with the previous year’s period (Q3 2024: EUR 22.2 million). For the first nine months of 2025, revenues increased by 10.1 percent to around EUR 66.4 million (9M 2024: EUR 60.3 million). Gross profit developed very positively both in the quarter and in the year to date, supported by a favorable product mix with higher-value packages and price adjustments implemented in recent periods. At the same time, the Company continued to keep its costs under control. 

The net amount of invoiced services (B2C) continued to develop positively, rising by around 4.0 percent to EUR 57.4 million in the first nine months of 2025 (9M 2024: EUR 55.2 million). Within this, annually recurring payments grew even more dynamically by around 6.9 percent to EUR 17.3 million (9M 2024: EUR 16.2 million). This underlines the growing weight of subscription-based revenues in the Group’s business model.

EBITDA from continuing operations in the third quarter remained at the previous year’s level at EUR 3.8 million (Q3 2024: EUR 3.8 million). At 16.5 percent, the EBITDA margin was slightly below the previous year’s level (Q3 2024: 17.3 percent). In the first nine months of 2025, EBITDA rose significantly to EUR 8.7 million (9M 2024: EUR 7.4 million), with the corresponding margin rising to over 13.1 percent (9M 2024: 12.2 percent). The significant improvement in profitability is primarily based on the sustained improvement in sales performance, the optimization of contract structures, and strict cost discipline in administration, marketing, and sales. Net income from continuing operations developed very positively both in the quarter and over the course of the year.

A key element in the business development remains the structure of the Company’s contracts. The trend already visible in the first half of 2025 continued in the third quarter: recurring revenues from subscription contracts grew significantly more strongly than prepaid contracts and prolongations. Unlike a year ago, when growth was driven by prepaid contracts, the share of subscriptions has now increased markedly.  The higher share of subscription models further increases the stability and visibility of the Company’s long-term revenue base. 

“Over the past quarters we have deliberately shifted our contract mix towards subscription models,” explains Jakub Baran, CEO of FamiCord AG. “The fact that recurring revenues are now growing significantly faster than prepaid contracts materially increases the visibility and stability of our long-term revenue base and makes our business model structurally more robust.”

The key figures for business development are as follows:

IFRS, in EUR ´000 Q3 Q3 9M 9M 9M
  2025 2024 2025 2024
Group revenue     22,789     22,232     66,365     60,261 10.1%
Gross profit       9,773       9,035     27,627     23,645 16.8%
EBITDA (cont. operations)       3,759       3,844       8,716       7,373 18.2%
EBITDA margin [%] 16.5% 17.3% 13.1% 12.2% +0.9PP
EBIT       1,695 1,686       2,451 869 182.2%
Net profit (cont. operations)       1,225 1,311       1,755 -131 1907.3%
Earnings per share [in EUR] 0.07          0.09 0.10 -0.01 796.9%
Operating cash flow  —       3,427       7,789 -56.0%
Cash & cash equivalents
(vs. 31.12.2024)
 —     11,296     16,823 -32.9%

This contract mix also has an impact on the cash flow profile. Reflecting the shift in contract mix towards subscription models, operating cash flow remained clearly positive at EUR 3.4 million for the first nine months of 2025 (9M 2024: EUR 7.8 million). As expected, this was below the very strong prior-year figure, which was still dominated by a high share of prepaid contracts and additionally benefited from an income tax refund already mentioned in previous releases. The lower operating cash flow in the current year must therefore be seen primarily as a consequence of the shift towards recurring revenues, which in turn improves the predictability and resilience of future cash inflows. 

The balance sheet of FamiCord remains solid. Total assets increased compared with year-end 2024, mainly due to the further expansion of the contract portfolio and the resulting higher contract liabilities. As a consequence, the equity ratio is below the prior-year level, which is a mechanical effect of the balance sheet extension and the increase in deferred revenues. At the same time, however, the equity ratio improved again compared with the end of the second quarter of 2025, even though the Company continued to grow its business. Liquidity remains comfortable at around EUR 11.3 million, providing adequate financial flexibility. The full consolidation of the subsidiaries in Slovakia and the Czech Republic – following the increase in ownership stakes in the end of the first half of the year – is progressing according to plan and further strengthens FamiCord’s position in Eastern Europe. 

In line with the strategic decisions taken in the first half of 2025, FamiCord continues to focus stronger on its core business of family stem cell banking. Activities relating to CAR-T cell therapies are no longer prioritized at Group level and, as already communicated, are excluded from Group EBITDA and reported separately as discontinued operations. This clear focus allows the Company to concentrate management attention and financial resources on areas that offer the best combination of growth potential and earnings quality. In its CDMO activities, FamiCord observed a tangible pick-up in demand, signing three new agreements in the third quarter with a total volume of around EUR 1 million, which are expected to contribute mainly to 2026 revenues.

On the basis of the performance in the first nine months of 2025, the Management Board looks to the remaining months of the year with confidence. The combination of solid revenue growth with attractive gross margins, a strong improvement in EBITDA, a positive operating cash flow despite the shift towards recurring revenues and a stable financial position provides a robust foundation. Against this backdrop, the Management Board confirms its outlook for the full year 2025, which continues to assume revenues of between EUR 85 million and EUR 95 million with EBITDA of between EUR 8.7 million and EUR 10.3 million.

The Management Board of FamiCord AG will be available to institutional investors, analysts and members of the press today at 10:00 a.m. CEST in a video conference to provide additional information on business development. To register for the video conference, please send an email to the Investor Relations department (ir@famicord.com).

Further information on FamiCord and its affiliated subsidiaries can be found at www.famicord.com.

Contact: 
FamiCord AG
Ingo Middelmenne
Head of Investor Relations
Phone: +49 (0174) 9091190
Email: ingo.middelmenne@famicord.com

Company profile

FamiCord (formerly Vita 34) was founded in Leipzig in 1997 and today is by far the leading cell bank in Europe and the third largest worldwide. As the first private umbilical cord blood bank in Europe and a pioneer in cell banking, the company has since offered the collection, logistics, processing and storage of stem cells from umbilical cord blood, umbilical cord tissue and other postnatal tissues as a full-service provider for cryopreservation. The donor’s own cells are either applicable directly as a medicine or constitute as a valuable starting material for medical cell therapy and are kept alive in the vapor of liquid nitrogen. Customers from about 50 countries have already provided for the health of their families with far over one million units of stored biological material at FamiCord. Furthermore, the Company is active in the area of Cell and Gene CDMO.

 


21.11.2025 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.
View original content: EQS News


Language: English
Company: FamiCord AG
Perlickstr. 5
04103 Leipzig
Germany
Phone: +49(0341)48792-40
Fax: +49(0341)48792-39
E-mail: ir@famicord.com
Internet: www.famicord.com
ISIN: DE000A0BL849
WKN: A0BL84
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2233846

 
End of News EQS News Service

2233846  21.11.2025 CET/CEST

Gerresheimer AG: Change in the Supervisory Board

Gerresheimer AG

/ Key word(s): Personnel

Gerresheimer AG: Change in the Supervisory Board

20.11.2025 / 13:18 CET/CEST

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


Gerresheimer AG: Change in the Supervisory Board

  • Klaus Röhrig succeeds Dr. Dorothea Wenzel
  • Composition of the Supervisory Board reflects the changed shareholder structure
     

Duesseldorf, November 20, 2025. Klaus Röhrig, co-founder and Co-Chief Investment Officer of the Active Ownership Group, has been appointed to the Supervisory Board of Gerresheimer AG until the next Annual General Meeting in June 2026. He succeeds Dr. Dorothea Wenzel, who made her position available  to reflect the changed shareholder structure of the company in the composition of the Supervisory Board. With his appointment, Klaus Röhrig also assumes the duties of Dr. Dorothea Wenzel on the Audit Committee of Gerresheimer AG.
 

“We sincerely thank Dr. Dorothea Wenzel for her dedicated work on the Supervisory Board and the Audit Comittee,” says Dr. Axel Herberg, Chairman of the Supervisory Board of Gerresheimer AG. “With her expertise and experience, she has made an significant contribution to the fulfillment of the committee’s duties.”
 

Annual General Meeting on June 3, 2026

Klaus Röhrig will stand for election to the Supervisory Board at the next Annual General Meeting on June 3, 2026. In total, four shareholder representatives will be up for election at the next Annual General Meeting of Gerresheimer AG’s co-determined Supervisory Board.
 

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, on-body devices, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 
 

Contact Gerresheimer

Media  
Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com       
Dersim Korkmaz
Corporate Communication
T +49 211 6181 296
dersim.korkmaz@gerresheimer.com   
 
Investor Relations
 
Guido Pickert
Vice President Investor Relations
T +49 211 6181 220
gerresheimer.ir@gerresheimer.com
 
 


20.11.2025 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.
View original content: EQS News


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: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2233454

 
End of News EQS News Service

2233454  20.11.2025 CET/CEST

MPH Health Care AG publishes figures for the third quarter of 2025: Equity (NAV) amounts to EUR 194.2 million, corresponding to EUR 45.36 per share. The equity ratio fell slightly to 92.8%

MPH Health Care AG

/ Key word(s): 9 Month figures/Quarterly / Interim Statement

MPH Health Care AG publishes figures for the third quarter of 2025: Equity (NAV) amounts to EUR 194.2 million, corresponding to EUR 45.36 per share. The equity ratio fell slightly to 92.8%

20.11.2025 / 08:30 CET/CEST

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


MPH Health Care AG publishes figures for the third quarter of 2025:

Equity (net asset value) amounts to EUR 194.2 million, corresponding to EUR 45.36 per share. The equity ratio fell slightly to 92.8% (31 December 2024: 95.5%).

Berlin, 20th November 2025 – MPH Health Care AG (ISIN: DE000A289V03) announces its preliminary IFRS consolidated results for the third quarter of 2025. According to this, equity decreased by 30% from EUR 277.9 million as of 31 December 2024 to EUR 194.2 million as of 30 September 2025. Net asset value (NAV) per share fell from EUR 64.90 (31 December 2024) to EUR 45.36 as of 30 September 2025.

The IFRS net result for the period decreased from EUR 54.5 million as of 30 September 2024 to EUR -78.5 million as of 30 September 2025. This result is due to the accounting valuations of the investments as at the reporting date, which do not affect cashflow. MPH AG is an investment company whose investments are reported as financial assets under the balance sheet item ‘Financial assets’ and are measured at fair value through profit or loss on the balance sheet date.

The equity ratio fell slightly from 95.5% to 92.8% and remains at a very high level.

The financial situation has improved compared to the previous year. From 1 January to 30 September 2025, operating cashflow amounted to EUR 2,156 thousand (previous year: EUR 2,073 thousand) and net cashflow amounted to EUR 2,421 thousand (previous year: EUR -5,131 thousand).

The fair value losses are mainly due to the sharp decline in the share price of our listed investment CR Energy AG, which filed for (preliminary) insolvency proceedings with the competent local court in Potsdam in June 2025. The main proceedings were opened on 1 September 2025. The price of CR shares fell from EUR 4.78 on 31 December 2024 to EUR 0.37 on 30 September 2025.

The M1 Kliniken AG investment continued its growth trajectory in the first nine months of 2025, once again increasing both revenue and earnings. Consistently implemented efficiency measures and the targeted expansion of medical capacities remain key priorities and are making a significant contribution to further improving results. IFRS consolidated revenue from January to September 2025 amounted to EUR 274.3 million, compared with EUR 257.2 million in the same period of the previous year. This represents an increase of 6.7%. The consolidated EBIT margin increased to 8.9% in this period (same period of the previous year: 8.6%). Operating profit (EBIT) increased to EUR 24.5 million (previous year: EUR 22.1 million), representing a growth of +11%. Earnings before taxes (EBT) rose by around 10% to EUR 24.4 million as of 30 September 2025.

The Beauty segment remains the Group’s most important growth driver. The positive development already recorded in the first half of the year continued convincingly in the third quarter of 2025. In the first nine months of 2025, the segment continued to benefit from efficiency gains through optimised processes and higher utilisation of medical capacities. EBIT in the „Beauty“ segment increased disproportionately by around 30% to EUR 21.1 million.

The price of M1 Kliniken shares fell from EUR 16.60 on 31 December 2024 to EUR 14.30 on 30 September 2025.

M1 Kliniken AG remains on course for growth and aims to increase revenue in the high-margin beauty segment to EUR 200–300 million per year by 2029, with a sustainable EBIT margin of at least 20%. The group is thus consistently pursuing its goal of establishing M1 Med Beauty as the world’s leading brand for aesthetic medicine.

At this year’s Annual General Meeting of MPH Health Care AG on 17 July 2025, it was resolved to distribute a dividend of EUR 1.20 per dividend-bearing share, as in the previous year, and to carry forward the remaining amount of the 2024 net profit of EUR 72.5 million to new account.

About MPH Health Care AG:

MPH Health Care AG is an investment company with a strategic focus on the acquisition, development and sale of companies and company shares, particularly in growth segments of the healthcare market. This includes both insurance-financed and privately financed segments. However, MPH also aims to exploit potential opportunities in high-growth and high-yield sectors outside the healthcare market.

Contact:
Patrick Brenske, Management Board
Corporate Communications
E-Mail: ir@mph-ag.de


20.11.2025 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.
View original content: EQS News


Language: English
Company: MPH Health Care AG
Grünauer Straße 5
12557 Berlin
Germany
Phone: 030 / 863 21 45 60
Fax: 030 / 863 21 45 69
E-mail: info@mph-ag.de
Internet: www.mph-ag.de
ISIN: DE000A289V03
WKN: A289V0
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Basic Board), Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2232688

 
End of News EQS News Service

2232688  20.11.2025 CET/CEST

Ranibizumab Biosimilar Epruvy® launched in Germany

Formycon AG

/ Key word(s): Product Launch

Ranibizumab Biosimilar Epruvy® launched in Germany

20.11.2025 / 06:30 CET/CEST

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


Press Release // November 20, 2025
 

Ranibizumab Biosimilar Epruvy® launched in Germany
 

  • Sandoz commercializes Epruvy®1 in innovative pre-filled syringe (PFS) and vial presentation in Germany under license from Bioeq AG
  • The PFS delivery system represents a key advancement combining biosimilar development excellence with customer-friendly design and expertise in polymer engineering
  • Epruvy® expands therapeutic options and broadens patient access to ranibizumab biosimilars in Germany
     

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and Bioeq AG (“Bioeq”) jointly announce an agreement with Sandoz AG (“Sandoz”) for the commercialization of Epruvy® in Germany. The Lucentis®2 biosimilar Epruvy® (“ranibizumab”) is used to treat severe visual impairments such as neovascular (“wet”) age-related macular degeneration (“nAMD”) and other retinopathies. It is marketed by Sandoz in Germany under a license from Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Approved by the European Medicines Agency EMA in September 2024, Epruvy® is available in a vial presentation and, in addition, as a pre-filled syringe, providing patients and healthcare professionals in Germany with a convenient and efficient treatment option.

The innovative PFS technology has been specifically designed for intravitreal injections using a silicone-free device. The system addresses key safety aspects of this delicate ocular treatment, such as the elimination of silicone-oil related contamination, high dosing accuracy, combined with low injection pressure, which can minimize the risk of application errors.

The ready-to-use syringe reduces preparation time and supports efficient administration to patients with nAMD and other serious retinal diseases.

Nicola Mikulcik, CBO of Formycon, comments: “This first-of-its kind ophthalmic biosimilar presentation in Germany marks an important step in unlocking the full commercial potential of our Lucentis® biosimilars. With Sandoz as commercialization partner, we are ideally positioned to further expand market penetration and ensure that even more healthcare professionals and patients in Germany benefit from improved access to high-quality ophthalmic care. This new presentation streamlines clinical workflows and enhances safe usability, making it a compelling choice for ophthalmologists in daily practice. We are confident that this new product will accelerate adoption and strengthen our joint footprint in Europe’s most important healthcare markets.”

 ————

1 Epruvy® is a registered trademark of Sandoz AG.
2 Lucentis® is a registered trademark of Genentech Inc.

 

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Sandoz:
Sandoz is a global leader in generics and biosimilars. Our goal is to improve access to healthcare for patients by developing and marketing innovative, affordable solutions that address unmet medical needs. With our broad portfolio of high-quality medicines covering all major therapeutic areas, we achieved sales of USD 10.4 billion in 2024. Sandoz Germany is headquartered in Holzkirchen, in the greater Munich area.

In Germany, Sandoz markets its broad portfolio through the established brands HEXAL® and 1 A Pharma®. HEXAL® stands for modern drug supply for patients in Germany, from well-known OTC products such as ACC® akut, Lorano® akut, and Gingium® to innovative, biotechnologically manufactured drugs. In this way, we make an important contribution to the sustainable care of patients.

For over 25 years, 1 A Pharma® has been offering high-quality and affordable medicines under the principal “Simply understand.” The brand stands for consistent customer orientation, clear communication, and a focus on what really matters to physicians, pharmacists, and patients.

This and other media information can be found at www.sandoz.de

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

 


20.11.2025 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.
View original content: EQS News


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Indices: SDAX,
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2232852

 
End of News EQS News Service

2232852  20.11.2025 CET/CEST

SYNBIOTIC strengthens its presence at international events and monitors advances in cannabis research

SYNBIOTIC SE

/ Key word(s): Strategic Company Decision

SYNBIOTIC strengthens its presence at international events and monitors advances in cannabis research

18.11.2025 / 10:41 CET/CEST

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


SYNBIOTIC strengthens its presence at international events and monitors advances in cannabis research

The European medical cannabis and industrial hemp group SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) is entering the final stretch of the year with strategic initiatives: The Group has already participated in the international Talman House Roadshow in London and will be represented at the Equity Capital Forum in Frankfurt. At the same time, SYNBIOTIC points to current scientific findings on the so-called entourage effect and emphasizes the importance of natural full-spectrum approaches to CBD products.

SYNBIOTIC at the Talman House Event 2025 in London

As part of its ongoing capital market activities, SYNBIOTIC presented itself on 10 November 2025 as a sponsor and participant at the Talman House Event in London. The renowned industry meeting brings together leading players from the cannabis, healthcare and investment sectors to discuss the future of sustainable and innovative markets. SYNBIOTIC used the event to deepen its exchange with international investors and partner companies and to provide insights into the current development of the Group.
“Talman House is an excellent platform to bridge innovative European cannabis companies with international capital providers. For SYNBIOTIC, it is a valuable opportunity to strengthen our network and further expand the Group’s visibility,” said Daniel Kruse, Managing Director of SYNBIOTIC.
The event also served to continue close collaboration with the intercontinental network – including Hyde Advisory, Bob Hoban, Global Cannabis Network Collective and Golden Eagle Partners.

German Equity Capital Forum 2025

SYNBIOTIC will also be represented at the Equity Capital Forum 2025 from 24 to 26 November in Frankfurt. The aim is to demonstrate to institutional investors the positive development of a sector positioned in the areas of “Health Care,” “Food & Beverage,” and “Consumer Goods,” and to present the Group’s strategic developments.

Research confirms potential of the entourage effect – SYNBIOTIC focuses on full-spectrum approaches

Recent research findings once again highlight the significance of the so-called entourage effect in cannabis products. As reported by the “Pharmazeutische Zeitung” in its 23 October 2025 issue, the interplay of numerous cannabinoids and terpenes decisively influences the effect profile of cannabis. Researchers at the University of Bern show that full-spectrum extracts can have a different, in some cases enhanced, effect compared to isolated individual substances.
This confirms SYNBIOTIC’s strategy of utilizing its in-house capabilities for the development and production of full-spectrum cannabis extracts within the Group. These extracts offer enormous potential for future medical applications and new product forms – far beyond today’s use of cannabis flowers. This also applies to full-spectrum CBD products. Beyond the approval of CBD isolate products, SYNBIOTIC will continue to advocate for clear regulatory frameworks in the EFSA Novel Food process.
Joscha Krauß, Managing Director of MH medical hemp: “The entourage effect illustrates that nature provides complex mechanisms of action. It is precisely this interplay that defines high-quality CBD products and demonstrates why objective evaluation and research are so important.” MH medical hemp is a subsidiary of the SYNBIOTIC Group.

Publisher
SYNBIOTIC SE
Daniel Kruse
CEO
Münsterstraße 336
40470 Düsseldorf
Germany
www.synbiotic.com

Media
Rüdiger Tillmann
SYNBIOTIC Public Relations Manager
Email ruediger.tillmann@synbiotic.com
Mobile +49 170 9651451
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the medical cannabis and industrial hemp sector with a buy-and-build investment strategy focussed on Europe. The Group covers the entire value chain from cultivation to production and retail – from the field to shelf. The subsidiaries’ core businesses are research and development, production and the commercialisation of medical cannabis, industrial hemp and CBD products.
SYNBIOTIC is pursuing a clear pan-European strategy of further expanding its business areas in order to cover the relevant growth markets while minimising risks and increasing opportunities for investors through diversification.


18.11.2025 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.
View original content: EQS News


Language: English
Company: SYNBIOTIC SE
Münsterstr. 336
40470 Dusseldorf
Germany
E-mail: office@synbiotic.com
Internet: https://www.synbiotic.com/
ISIN: DE000A3E5A59
WKN: A3E5A5
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Tradegate Exchange
EQS News ID: 2231716

 
End of News EQS News Service

2231716  18.11.2025 CET/CEST

Gerresheimer: Science Based Targets Initiative confirms CO2e Reduction Targets

Gerresheimer AG

/ Key word(s): Sustainability

Gerresheimer: Science Based Targets Initiative confirms CO2e Reduction Targets

18.11.2025 / 10:02 CET/CEST

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


Gerresheimer: Science Based Targets Initiative confirms CO2e Reduction Targets

  • Targets align with the Paris Agreement to limit global warming to 1.5 °C
  • Reduction of Scope 1 and 2 emissions by 52% by 2030
  • Reduction of the intensity of selected Scope 3 emissions by 64% by 2034 

Duesseldorf, November 18, 2025. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has had its climate targets validated by the Science Based Targets initiative (SBTi). SBTi confirmed that Gerresheimer’s targets are scientifically based and aligned with the Paris Climate Agreement to limit global warming to 1.5 °C. By 2030, Gerresheimer aims to reduce its Scope 1 and Scope 2 emissions by 52% compared to the base year 2019. Already by the end of 2029, 65% of Gerresheimer’s suppliers in terms of expenditure on goods and services are also expected to set scientifically based climate targets. Finally, by 2034, Gerresheimer aims to reduce the intensity of emissions relative to operating profit in selected Scope 3 categories by 64% compared to the base year 2023. With the validation of its reduction targets by the SBTi, Gerresheimer underscores its commitment to measuring and managing climate protection and sustainability according to recognized standards and communicating its progress transparently.

“As a partner to the pharmaceutical and biotech industry, we support our customers on their path toward more sustainability,” says Uwe Röhrhoff, CEO of Gerresheimer AG. “The validation of our climate targets by SBTi is an important contribution to this.”

Reduction targets across the entire value chain

As part of its corporate strategy, Gerresheimer has set itself scientifically based emission targets and had them validated by SBTi. These targets cover emissions along the entire value chain (Scope 1 to 3).

Scope 1 includes all emissions caused directly by Gerresheimer through its own facilities and production processes. Scope 2 covers indirect emissions associated with energy supply, such as the purchase of electricity or heat. Scope 3 includes all other indirect emissions that occur outside the company, for example through suppliers, transport, and the use and disposal of sold products.

Ambitious targets in line with the Paris Climate Agreement

According to the newly defined targets validated by the SBTi, Gerresheimer aims to reduce Scope 1 and Scope 2 emissions by 52% by 2030 compared to the base year 2019.

Gerresheimer has also set itself the ambitious goal that by 2029, 65% of its suppliers, measured in terms of expenditure on purchased goods and services, will also set scientifically based CO2e targets. This enables Gerresheimer to make its suppliers’ climate responsibility transparent and at the same time provides it with an effective control instrument for climate management in its own supply chain.

The company also aims to reduce the intensity of emissions in relation to operating profit (EBITDA plus personnel expenses) in selected Scope 3 categories by 64% by 2034 compared to the base year 2023. Relevant for Gerresheimer here are the Scope 3 categories “fuel and energy-related activities,” “upstream and downstream transport and distribution,” and “end-of-life treatment of sold products.”

SBTi: Benchmark for science-based climate protection

The Science Based Targets Initiative was founded in 2015 by CDP, the United Nations Global Compact (UNGC), We Mean Business Coalition, the World Resources Institute (WRI), and the World Wide Fund for Nature (WWF). It provides companies with a clearly defined framework for developing scientifically based climate targets and reducing emissions in line with the goals of the Paris Agreement. It checks whether the targets set are in line with the latest climate research findings and contribute to limiting global warming to 1.5 °C. SBTi-approved targets are considered an international benchmark for credible and transparent climate protection in the industrial sector.

Transparent Sustainability Reporting

The validation by SBTi underscores Gerresheimer’s commitment to measuring and managing climate protection and sustainability in accordance with recognized standards, as well as communicating progress transparently.

The company reports annually on its goals, measures, and results in its Sustainability Report and also provides relevant information for international ratings such as CDP and EcoVadis. MSCI, Sustainalytics, and ISS also regularly assess Gerresheimer’s sustainability performance. An overview of Gerresheimer’s external sustainability ratings can be found here.

 

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, on-body devices, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 

 

Contact Gerresheimer

Media  
Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com           
Dersim Korkmaz
Corporate Communication
T +49 211 6181 296
dersim.korkmaz@gerresheimer.com
 
Investor Relations
 
Guido Pickert
Vice President Investor Relations
T +49 211 6181 220
gerresheimer.ir@gerresheimer.com
 
 


18.11.2025 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.
View original content: EQS News


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: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2231698

 
End of News EQS News Service

2231698  18.11.2025 CET/CEST

M1 Kliniken AG reports strong EBIT Growth of 11% and achieves Earnings per Share of EUR 0.86.

M1 Kliniken AG

/ Key word(s): 9 Month figures/Quarter Results

M1 Kliniken AG reports strong EBIT Growth of 11% and achieves Earnings per Share of EUR 0.86.

18.11.2025 / 08:30 CET/CEST

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


M1 Kliniken AG reports strong EBIT Growth of 11% and achieves Earnings per Share of EUR 0.86.

Berlin, 18. November 2025 – M1 Kliniken AG (ISIN: DE000A0STSQ8) successfully closed the last nine months of 2025, continuing its profitable growth trajectory. Consistent implementation of efficiency measures and the targeted expansion of medical capacities remain key priorities and have made a significant contribution to improved profits.

Key Financials at a Glance

  • Group revenue: +6.7% to EUR 274.3 million (YTD Q3 2024: EUR 257.2 million)
  • EBITDA: +9% to EUR 28.2 million (YTD Q3 2024: EUR 25.9 million)
  • EBIT: +11% to EUR 24.5 million (YTD Q3 2024: EUR 22.1 million)
  • EBIT margin: 8.9% (YTD Q3 2024: 8.6%)
  • EBT: +10% to EUR 24.4 million (YTD Q3 2024: EUR 22.2 million)
  • Earnings per share: EUR 0.86 (YTD Q3 2024: EUR 0.77)

Beauty-Segment: Profitability Significantly Increased Once Again

  • Revenue: +9.5% to EUR 77.8 million (YTD Q3 2024: EUR 71.0 million)
  • EBIT: +29.7% to EUR 21.1 million (YTD Q3 2024: EUR 16.3 million)
  • EBIT margin: 27.1% (YTD Q3 2024: 22.9%)

The Beauty segment remains the key growth driver of the Group. The positive development already seen in the first half of the year continued convincingly in the third quarter of 2025. In the first nine months of 2025, the segment continued to benefit from efficiency gains through optimized processes and higher utilization of medical capacities. A targeted pricing strategy aimed at attracting new customer groups supported the expansion of market share – without compromising margin quality. The positioning as the leading provider of high-quality aesthetic medicine at the best price is being consistently pursued.

Solid Revenue Growth in the Trading Segment

  • Revenue: +6% to EUR 196.5 million (YTD Q3 2024: EUR 186.2 million)
  • EBIT: -41.4% to EUR 3.4 million (YTD Q3 2024: EUR 5.8 million)

The Trading segment recorded a strong increase in revenue in the first nine months of 2025, while EBIT was below the previous year’s level.

M1 Kliniken AG has announced that its 85% subsidiary, HAEMATO AG, has signed an agreement to sell its wholly owned subsidiary HAEMATO Pharm GmbH to the PHOENIX group, one of Europe’s leading healthcare providers based in Mannheim. The transaction is subject to the usual antitrust approvals.

With this transaction, M1 Kliniken AG is consistently pursuing its strategic course of positioning itself as the world’s leading vertically integrated pure-play provider of medical aesthetics.

Outlook

M1 Kliniken AG will continue its profitable growth trajectory by expanding its network of national and international clinics. By 2029, this figure is expected to increase to between EUR 200 million and EUR 300 million – with a sustainable EBIT margin of at least 20%. The Group is consistently pursuing the goal of establishing M1 Med Beauty as the world’s leading brand for aesthetic medicine.

About M1 Kliniken AG

M1 Kliniken AG is the leading fully integrated provider of medical aesthetic services in Europe and Australia. With a clear strategic focus, high standardization, and consistent scalability, the Group currently operates 58 clinics in ten countries under the M1 Med Beauty brand. All treatments are performed exclusively by qualified physicians and adhere to uniform, high medical standards, while being offered at market-leading prices. Since late 2018, M1 has systematically driven its international expansion, which forms the basis for scalable future growth and the further development of its global market position. With the M1 Schlossklinik in Berlin, the Group operates one of Europe’s largest and most modern clinics for plastic and aesthetic surgery, featuring four operating theaters and 35 beds.

Contact:
M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
T: +49 (0)30 347 47 44 14
M: ir@m1-kliniken.de


18.11.2025 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.
View original content: EQS News


Language: English
Company: M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
Germany
Phone: +49 (0)30 347 47 44 14
Fax: +49 (0)30 347 47 44 17
E-mail: ir@m1-kliniken.de
Internet: https://www.m1-kliniken.de
ISIN: DE000A0STSQ8
WKN: A0STSQ
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Basic Board), Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2231348

 
End of News EQS News Service

2231348  18.11.2025 CET/CEST

Formycon achieves key development milestone with FYB208: Biosimilar candidate for Dupixent® (dupilumab) adds another growth driver to the biosimilar portfolio

Formycon AG

/ Key word(s): Miscellaneous

Formycon achieves key development milestone with FYB208: Biosimilar candidate for Dupixent® (dupilumab) adds another growth driver to the biosimilar portfolio

17.11.2025 / 06:30 CET/CEST

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


  

Press Release // November 17, 2025
 

Milestone achieved with FYB208: Biosimilar candidate for Dupixent® (dupilumab) as another growth driver in Formycon’s portfolio

  • Important preclinical milestone Technical Proof of Similarity (TPoS) demonstrates high analytical comparability of FYB208 to reference drug
  • Strong in vitro data support cost-effective development and streamlined clinical development program
  • Immunological biosimilar candidate FYB208/Dupilumab will address a rapidly growing market and is expected to provide patients with chronic inflammatory diseases such as COPD, asthma, and atopic dermatitis with greater access to highly effective therapy
     

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announced details of one of its previously undisclosed development projects: FYB208 is a biosimilar candidate for the immunological blockbuster drug Dupixent®1 (INN: dupilumab). With successful demonstration of the Technical Proof of Similarity (TPoS), FYB208 shows high analytical comparability to the reference drug.

Dupilumab is used to treat certain patients with chronic obstructive pulmonary disease (COPD), asthma, atopic dermatitis (neurodermatitis), and other chronic inflammatory diseases. The active ingredient inhibits the signaling pathways of interleukin-4 (IL-4) and IL-13, which are responsible for type 2 inflammatory reactions. Due to its wide range of therapeutic opportunities with approvals for additional indications, the active ingredient has been recording high growth rates for years. In 2024, global sales reached US$14.1 bn, an increase of 22% compared to the previous year.2 In 2025, growth continued at a similar rate: Dupixent® generated revenues of around US$8 bn in the first six months.3 Forecasts underscore the sustainably high potential of dupilumab: sales are expected to rise to more than US$ 20 bn4 by 2030.

Dr. Andreas Seidl, CSO of Formycon AG, commented: “With the achieved Technical Proof of Similarity, we successfully completed the preclinical development of our dupilumab biosimilar candidate. The convincing data on its comparability with the reference drug highlights our strong expertise in development of biosimilars, especially in chronic inflammatory diseases and marks another important milestone in our growth strategy. Based on this excellent data set, we are highly confident that we will be able to meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study). This allows us to advance development with an optimized timeline, in order to improve access to a much-needed treatment option for the many patients suffering from chronic inflammatory diseases. This is supported by the high productivity of the developed cell line, which enables competitive manufacturing.”

Full project and commercialization rights for FYB208 are held by Formycon. The company is currently developing the study design for the planned clinical pharmacokinetic (PK) study in close alignment with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Study planning is performed on the background that, following the publication of the Reflection Paper5 by EMA, the U.S. FDA has also recently published a draft guideline for the streamlined development of biosimilars6. The next development phase, including GMP manufacturing, has already been initiated following the successful achievement of the TPoS milestone.

—–

1 Dupixent® is a registered trademark of Sanofi Biotechnology.
2Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion | Regeneron Pharmaceuticals Inc.
3Regeneron Reports Second Quarter 2025 Financial and Operating Results | Regeneron Pharmaceuticals Inc.
4Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025
5Reflection paper on a tailored clinical approach in biosimilar development; EMA/CHMP/BMWP/60916/2025
6 FDA guidance for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated
  Recommendations for Assessing the Need for Comparative Efficacy Studies. https://www.fda.gov/media/189366/download

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations & Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110

Mail: Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

 


17.11.2025 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.
View original content: EQS News


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Indices: SDAX,
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2230186

 
End of News EQS News Service

2230186  17.11.2025 CET/CEST