Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss

Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss




Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss

  • Wegovy® HD demonstrated a mean weight loss of 20.7%1, and around one-third of patients achieved 25% or greater weight loss in the STEP UP trial
  • First US FDA approval of a GLP-1 treatment under the Commissioner’s National Priority Voucher pilot programme, for products addressing critical US national health priorities
  • Wegovy® HD complements Wegovy® 2.4 mg, which is already approved in the US for weight management and cardiovascular risk reduction
  • Novo Nordisk expects to launch Wegovy® HD in the US in April 2026

Bagsværd, Denmark, 19 March 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy® HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction long-term. The FDA awarded a Commissioner’s National Priority Voucher for Wegovy® HD, accelerating its review and underscoring its potential to address critical patient needs and national health priorities in the US.

The accelerated approval is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7%1 mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP type 2 diabetes (T2D) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.

“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO of Novo Nordisk. “Earlier this year, we launched the Wegovy® pill, and with the accelerated approval of Wegovy® HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”

Novo Nordisk expects to launch Wegovy® HD in a single-dose pen in the US in April 2026.

Wegovy® 7.2 mg is already approved for adults with obesity in the EU and the UK. Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.

About the STEP UP trials
The STEP UP and STEP UP T2D phase 3 trials investigated the efficacy and safety of injectable semaglutide 7.2 mg in people with obesity with or without type 2 diabetes.

The 72-week STEP UP trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included approximately 1,400 adults with obesity. The 72-week STEP UP T2D trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to placebo in approximately 500 adults with obesity and type 2 diabetes.

Mean weight loss at 72 weeks with semaglutide 7.2 mg in STEP UP trials
  STEP UP STEP UP T2D
Efficacy estimand* 20.7% 14.1%
Treatment-regimen estimand** 18.7% 13.2%
Categorical weight loss 31.2% of patients achieved ≥25% weight loss 21.3% of patients achieved ≥20% weight loss

* Treatment effect if all people adhered to treatment, ** Treatment effect regardless of treatment adherence

About Wegovy®
Wegovy® is approved as once-daily Wegovy® pill (semaglutide tablet 25 mg) and once-weekly Wegovy® injections (semaglutide 1.7 mg, 2.4 mg and 7.2 mg) by the FDA.

Wegovy® is approved as a once-weekly injection by the EMA and by other regulatory authorities worldwide. The Wegovy® pill is currently pending marketing approval from the EMA and other regulatory authorities.

Wegovy® is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy® injection is indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older. It is approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

Publication of inside information pursuant to Market Abuse Regulation, Article 17.

Contacts for further information

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

Liz Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
Novo Nordisk Investors:  
Michael Novod
+45 3075 6050
nvno@novonordisk.com

Jacob Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com

Sina Meyer
+45 3079 6656
azey@novonordisk.com

Max Ung
+45 3077 6414
mxun@novonordisk.com

Christoffer Sho Togo Tullin
+45 3079 1471
cftu@novonordisk.com

Alex Bruce
+45 3444 2613
axeu@novonordisk.com

Frederik Taylor Pitter
+1 609 613 0568
fptr@novonordisk.com

 

Company announcement No 19 / 2026


1 Based on the efficacy estimand: treatment effect if all people adhered to treatment

Attachment

Marinomed Biotech AG has decided to conduct a cash capital increase to cover short-term capital requirements of approximately EUR 2 million

Marinomed Biotech AG / Key word(s): Capital Increase

Marinomed Biotech AG has decided to conduct a cash capital increase to cover short-term capital requirements of approximately EUR 2 million

19-March-2026 / 16:14 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.


Ad hoc announcement

Marinomed Biotech AG has decided to conduct a cash capital increase to cover short-term capital requirements of approximately EUR 2 million

 

Korneuburg, Austria, March 19, 2026

The Executive Board of Marinomed Biotech AG (“Company”) resolved today, with the approval of the Supervisory Board, to carry out a capital increase against cash contributions—while preserving the subscription rights of existing shareholders—by partially utilizing the authorized capital provided for in Section 5(6) of the Articles of Association, in order to meet short-term capital requirements, and to increase the share capital from the current EUR 1,839,940 by up to EUR 459,985 through the issuance of up to 459,985 new no-par value bearer shares (“New Shares”) with a notional proportionate amount of the share capital of EUR 1.00 per share to up to EUR 2,299,925 (the “Capital Increase”). Existing shareholders of the Company (“Existing Shareholders”) will be granted subscription rights (“Subscription Rights”) on a 4:1 basis, i.e., for every four existing shares, one New Share may be subscribed for at a subscription price of EUR 14.00 per New Share (“Subscription Price”). The goal of the transaction is to generate gross proceeds of at least EUR 2 million.

Because the Company has not yet received sufficient payments from the transfer of the Carragelose business to Unither Pharmaceuticals (“Unither”), the Company has a short-term capital requirement to cover its anticipated liquidity needs of approximately EUR 2 million until mid of the fiscal year 2026. The net proceeds from the capital increase are therefore to be used to fulfill the restructuring plan and close the financing gap.

The Company will make use of the prospectus exemptions provided for in Article 1(4)(db) and Article 1(5)(ba) of Regulation (EU) 2017/1129 (“Prospectus Regulation”), as amended, in connection with the offering of the New Shares and the admission of the New Shares to trading on the Vienna Stock Exchange. The document required for this purpose pursuant to Annex IX of the Prospectus Regulation will be filed in electronic form with the Financial Market Authority (FMA), as the competent authority of the home Member State, prior to the commencement of the public offering and will be made available to the public at the same time as it is filed with the FMA via the website www.marinomed.com.

The record date for the entitlement of existing shareholders to subscribe for New Shares is March 25, 2026, at 11:59 p.m. CEST (“Record Date”). The subscription period is scheduled to begin on March 26, 2026 9:00 a.m. Central European Time and is expected to end on April 9, 2026 5:40 p.m. Central European Time, although the subscription period may be extended at any time. The subscription rights will not be tradable on the Vienna Stock Exchange. Any New Shares not subscribed for through the exercise of subscription rights in connection with the subscription offer (“Rump Shares”) will be offered following the subscription offer as part of a prospectus-exempt private placement (“Rump Placement”) to eligible institutional investors and selected non-institutional investors within the European Economic Area at the Subscription Price. A binding commitment has been received from an institutional investor who, as of today, does not yet hold any shares in the Company, to subscribe for and acquire New Shares in the total amount of EUR 1 million at the Subscription Price as part of the Rump Placement.

This announcement is made in accordance with Article 17 of the Market Abuse Regulation (EU) No. 596/2014.

Disclaimer:

The New Shares and Subscription Rights have not been and will not be registered under any foreign securities laws—in particular under the U.S. Securities Act of 1933, as amended (“Securities Act”) – with foreign securities authorities and may not be offered or sold, in particular in the United States of America (“U.S.”), without registration or an exemption from the registration requirements under the Securities Act. This announcement is not intended for distribution in the U.S. or within the U.S. and may not be distributed or forwarded to publications with general circulation in the U.S. Foreign shareholders may be subject to restrictions on the exercise of their subscription rights. Foreign shareholders are therefore urged to inform themselves of the restrictions applicable to them regarding the exercise of subscription rights. This announcement is neither an offer to sell nor a solicitation of an offer to subscribe for or purchase securities in countries where such an offer or solicitation is legally prohibited.

+++ End of ad-hoc announcement +++

 

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline. The Company develops innovative patent-protected products based on the Marinosolv® platform. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

 

For further inquiries contact:

Marinomed Biotech AG
PR: Luca Horinek
IR.: Tobias Meister
T: +43 2262 90300 158
E-Mail: pr@marinomed.com
E-Mail: ir@marinomed.com
 

 

Disclaimer 

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only. 

End of Inside Information


19-March-2026 CET/CEST News transmitted by EQS Group


Language: English
Company: Marinomed Biotech AG
Hovengasse 25
2100 Korneuburg
Austria
Phone: +43 2262 90300
E-mail: office@marinomed.com
Internet: www.marinomed.com
ISIN: ATMARINOMED6
WKN: A2N9MM
Listed: Regulated Unofficial Market in Dusseldorf, Frankfurt, Munich, Stuttgart, Tradegate BSX; Vienna Stock Exchange (Official Market)
EQS News ID: 2294718

 
End of Announcement EQS News Service

2294718  19-March-2026 CET/CEST

MEDICLIN invites you to the 2026 virtual press conference on the financial statements for the year 2025

MEDICLIN AG

/ Key word(s): Conference/Miscellaneous

MEDICLIN invites you to the 2026 virtual press conference on the financial statements for the year 2025

19.03.2026 / 15:15 CET/CEST

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


PRESS RELEASE

Press conference
MEDICLIN invites you to the 2026 virtual press conference on the financial statements for the year 2025
               
Offenburg, 19 March 2026 – MEDICLIN Aktiengesellschaft (Ticker: MED; WKN 659 510) invites you to its 2026 virtual press conference on the financial statements fort the year 2025. The event will take place on
Friday, 27 March 2026 at 11.00 am (CET).

The Management Board of MEDICLIN will report on the 2025 financial year, current developments at MEDICLIN and the outlook for 2026 in a webcast.

Following the presentation by the Management Board, you will have the opportunity to ask questions. The presentation will be held in German.

To participate in the press conference, please register at the following link (German only):

MEDICLIN virtual press conference on the financial statements for the year 2023

You will then receive the link to the webcast and the dial-in details for the telephone conference. Please note that whilst the webcast provides an audio feed via your internet browser, you will need to dial in by telephone to actively participate and ask questions.

Please dial in 10 minutes before the start of the event.

The replay of the webcast (without the Q&A session) will be available on the MEDICLIN website soon after the press conference.

We look forward to your participation.

CONTACT
Head of Investor Relations and Sustainability
Ender Gülcan | T. +49 781488326 | ender.guelcan@mediclin.de
MEDICLIN AG | Okenstraße 27 | 77625 Offenburg

MEDICLIN Aktiengesellschaft is one of Germany’s leading healthcare providers, with a clear focus on medical rehabilitation. MEDICLIN operates 31 clinics, six long-term care facilities, and ten medical care centers across Germany. MEDICLIN employs approximately 9,900 people. Through a strong network, MEDICLIN offers integrated care ranging from the initial doctor’s visit through surgery and subsequent rehabilitation to outpatient follow-up care. Medical and therapeutic staff, as well as nursing staff, work together in close coordination. MEDICLIN tailors the care and support provided to people in need of care to their individual needs and personal requirements. MEDICLIN is a company of the ASKLEPIOS Group.www.mediclin.de
 


19.03.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

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


Language: English
Company: MEDICLIN AG
Okenstraße 27
77652 Offenburg
Germany
Phone: +49 (0)781 488-326
Fax: +49 (0)781 488-184
E-mail: ender.guelcan@mediclin.de
Internet: www.mediclin.de
ISIN: DE0006595101
WKN: 659510
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2294652

 
End of News EQS News Service

2294652  19.03.2026 CET/CEST

Secarna Pharmaceuticals establishes Advisory Board with financial markets expert Jens Holstein and shareholder representative Richard Mark Engelhard

Secarna Pharmaceuticals GmbH & Co. KG

/ Key word(s): Miscellaneous

Secarna Pharmaceuticals establishes Advisory Board with financial markets expert Jens Holstein and shareholder representative Richard Mark Engelhard

19.03.2026 / 13:00 CET/CEST

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


Secarna Pharmaceuticals establishes Advisory Board with financial markets expert Jens Holstein and shareholder representative Richard Mark Engelhard

  • Advisory Board to provide strategic guidance as well as financial and industry expertise to support Secarna’s management team and shareholders in shaping and executing on its long-term growth trajectory

Martinsried (Munich), Germany, March 19, 2026 – Secarna Pharmaceuticals GmbH & Co. KG, a company redefining the discovery and development of best-in-class oligonucleotide therapeutics today announced the establishment of an Advisory Board to support the Company’s growth trajectory. Financial markets expert Jens Holstein and shareholder representative Richard Mark Engelhard have been appointed members of the Board.

The Advisory Board aims to provide strategic guidance as well as financial and industry expertise to support sustainable business growth as Secarna strives to fulfill on its mission to transform untreatable medical conditions into treatable ones by leveraging its AI-empowered OligoCreator® platform to identify and characterize oligonucleotide therapeutics and bringing its lead compound SECN-15 to clinical proof of concept (POC).

“We are delighted to welcome such experienced industry leaders to our Advisory Board at this pivotal stage of Secarna’s development,” said Konstantin Petropoulos, PhD, CEO of Secarna Pharmaceuticals. “We look forward to building on their industry perspectives and combined experience to help drive our long-term growth objectives.”

Jens Holstein, former CFO of BioNTech SE, commented: “I’m excited to join Secarna’s Advisory Board and support the Company as it continues its journey as a leading developer of oligonucleotide therapeutics. I look forward to contributing my financial and corporate strategy expertise in the life sciences, biotech and pharma environment to help guide sustainable growth and long-term value creation.”

Richard Mark Engelhard, representing shareholder Engelhard Arzneimittel GmbH & Co KG, stated: “Secarna’s recent development demonstrates the strength of its AI-empowered platform as well as it’s growing proprietary pipeline with SECN-15 as novel, potential best-in-class oligonucleotide in the field of oncology. I am pleased to join the Advisory Board and further support the management team as the Company continues to scale and execute on a compelling long-term growth and value-creation trajectory. Having supported Secarna for many years as a shareholder, I’m excited to now contribute in this expanded role.”

Richard Mark Engelhard is General Manager of Engelhard Arzneimittel GmbH & Co. KG, one of the leading brand-name manufacturers in the OTC medicines segment.

Jens Holstein has over 30 years of leadership experience in the life sciences and biopharmaceutical sector. In 2021 he joined BioNTech SE as CFO and retired from this position mid of 2025. BioNTech is well-known for its pioneering work in immunotherapies and for its mRNA vaccines, including its COVID-19 vaccine Comirnaty®. At BioNTech, he led the financial strategy that supported the company’s growth into a global, fully integrated immunotherapy leader. Prior to this position, he served for almost 10 years as CFO of MorphoSys AG. He was instrumental in transforming the company into a fully integrated biopharmaceutical player. MorphoSys has been listed in Germany (MDAX) and the US (NASDAQ). He also held executive roles within the Fresenius SE Group, including Regional CFO for EMEA and Regional CFO of Fresenius Kabi Asia Pacific Ltd. He also served as Managing Director at Fresenius ProServe GmbH and CFO of its subsidiary Wittgensteiner Kliniken AG. He is currently a non-executive member of the Board of Directors of the US-listed diagnostic company Veracyte Inc. and serves as Chairman of the audit committee. He holds a degree in Business Administration (Dipl. Kfm) from the University of Münster.

About Secarna Pharmaceuticals

Secarna Pharmaceuticals is a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotide therapeutics, offering hope to patients facing conditions that are beyond the reach of current approaches and modalities. With the Company’s proprietary AI-empowered OligoCreator® platform, which includes multiple delivery technologies, Secarna identifies and characterizes oligonucleotide therapeutics with unparalleled speed and excellent safety and efficacy. By delivering these novel therapeutics to the cells, organs, or tissues where they are needed, targeted oligonucleotide therapies have the potential to revolutionize treatments for a wide range of difficult-to-treat disorders. Secarna’s unique OligoCreator® platform is leveraged to transform untreatable conditions into treatable ones, profoundly changing the future of medicine. www.secarna.com

 

Contact

Secarna Pharmaceuticals GmbH & Co. KG
Konstantin Petropoulos, PhD, MBA

CEO
Phone: +49 (0)89 215 46 375
info@secarna.com

For media inquiries

MC Services AG
Anne Hennecke/Vera Lang

Phone: +49 (0)211 52 92 52 16

Email: secarna@mc-services.eu

 

 


19.03.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

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


2293244  19.03.2026 CET/CEST

Notice to convene Evaxion’s Annual General Meeting

Notice to convene Evaxion’s Annual General Meeting




Notice to convene Evaxion’s Annual General Meeting

COPENHAGEN, Denmark, March 19, 2026 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, announces that its Annual General Meeting is convened to be held on April 16, 2026, at 14.00 CET.

The meeting will be held at the company’s offices, Dr Neergaards Vej 5F, 2970 Hørsholm, Denmark.

The agenda and proposals can be found on Evaxion’s website, along with other materials:
www.evaxion.ai/investors/events-presentations/annual-general-meeting-2026/

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

About Evaxion
Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases.

With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development

We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options.

For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website

Forward-looking statement 
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law. 

Curia Expands Glasgow Manufacturing Capacity and Enhances Cell Line Development Platform

Curia Expands Glasgow Manufacturing Capacity and Enhances Cell Line Development Platform




Curia Expands Glasgow Manufacturing Capacity and Enhances Cell Line Development Platform

ALBANY, N.Y., March 19, 2026 (GLOBE NEWSWIRE) — Curia, a leading contract research, development and manufacturing organization (CDMO), today announced progress on the expansion at its Glasgow, UK sterile drug product facility as well as enhancements to its proprietary platform for cell line development.

The Glasgow, UK, site is well known throughout the industry for its more than 25 years of experience with formulation, lyophilization development and sterile fill-finish capabilities, including ADCs and other highly potent products. The current expansion is expected to be completed by early 2027. The investment will add an Annex 1 compliant isolator-based vial filling line and lyophilizer. Once complete, Glasgow will be able to fill batches up to 20,000 vials and will be well‑positioned to support future small‑scale commercial fills.

“This expansion in Glasgow comes as Curia is nearing completion of our significant expansion in our commercial drug product facility in Albuquerque, NM,” said Ron Aungst, VP, Drug Product Business Unit Operations. “Curia has already secured crucial equipment with long lead times to help the Glasgow expansion project stay on track, and we do not anticipate any disruption to current operations during the expansion.”

Curia’s clinical drug substance development capabilities have also been enhanced with improvements to the company’s cell line development (CLD) platform. The CLD offering at Curia’s Hopkinton, MA facility has been enhanced to incorporate IP-free semi-targeted integration technology that results in 6-fold higher titers compared to random integration technology. Curia’s stable platform, CHO-GSN®, was derived from the same parental cell line as its transient platform, TunaCHO®, allowing partners to efficiently scale-up from discovery to GMP.

“Our biologics division has always had end-to-end capabilities, and we are excited to offer a cell line that makes it more cost-efficient and faster to advance partners through early-stage clinical manufacturing,” said Jamie Grabowski, President, Research & Development. “With biotech-friendly licensing terms, reengineered cell line will be a critical component of successfully guiding partners on their path to commercialization.”

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20+ global sites and 3,100 employees partnering with biopharmaceutical customers to bring life-changing therapies to market. Our offerings in small molecule, generic APIs and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill-finish capabilities. Our scientific and process experts, along with our regulatory compliant facilities, provide a best-in-class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
corporatecommunications@CuriaGlobal.com

Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026

Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026




Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026

Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation 

Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors

Pelareorep’s ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers

SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) — Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming.

“These new translational findings strengthen our understanding of pelareorep as a systemic immune‑priming agent that reshapes the tumor microenvironment,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly 95% of pancreatic cancers and 45% of colorectal cancers. As we advance registrational programs in gastrointestinal cancers, we believe pelareorep will enhance immunotherapy activity and potentially help patients who did not respond initially.”

Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year.1

Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure (“TLS”) formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology.

Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting.

Together, the data support pelareorep as a novel immune‑priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno‑oncology modalities.

Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial

New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”).

An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months).

As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a 62% objective response rate in first-line mPDAC patients, more than double the response rates historically observed with chemotherapy alone.

Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures

AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T‑cell activation, and sustained anti‑tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy.

These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

  1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
  2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
  3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
  4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
  5. Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

Reference

  1. Leiphrakpam PD, Chowdhury S, Zhang M, et al. Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes. J Gastrointest Cancer. 2025 Feb 24;56(1):71.

About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the timing of the AACR Annual Meeting 2026; expectations as to the content and potential opportunities associated with the findings from the various studies expected to be presented via abstracts in the future; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers as well as breast cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca

Sol-Gel Files Annual Report on Form 20-F for the Year Ended December 31, 2025

Sol-Gel Files Annual Report on Form 20-F for the Year Ended December 31, 2025




Sol-Gel Files Annual Report on Form 20-F for the Year Ended December 31, 2025

NESS ZIONA, Israel, March 19, 2026 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), announced today that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2025 with the U.S. Securities and Exchange Commission (the “SEC”). The annual report on Form 20-F, which contains Sol-Gel’s audited annual financial statements for 2025, can be accessed on the SEC’s website at http://www.sec.gov, as well as via the Company’s investor relations website at https://ir.sol-gel.com/financials/sec-filings. The Company will deliver a hard copy of its 2025 annual report on Form 20-F, including its complete audited financial statements, free of charge to its shareholders, upon request to Eyal Ben-Or, Chief Financial Officer, at Eyal.Ben-Or@sol-gel.com.

Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety profile relative to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®.

To learn more about Sol-Gel, visit www.sol-gel.com

Sol-Gel Investor Relations:
Eyal Ben-Or
Chief Financial Officer
ir@sol-gel.com

Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder

Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder




Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder

Vancouver, Canada, March 19, 2026 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the successful continuation of treatment of participants in the third cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).

This positive progress follows the Company’s recent announcement on March 11, 2026, regarding the advancement of participant enrollment for the third cohort at Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center. Patients at the prestigious U.S. institutions – Yale University and Johns Hopkins University – continue to progress successfully through their treatment protocol, demonstrating continued safety and tolerability with no serious adverse events reported to date.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The successful ongoing treatment at these leading U.S. medical centers reflects strong momentum and confidence in CMND-100 as a potential breakthrough therapy for AUD.

“Building on the encouraging recruitment momentum and positive topline results from prior cohorts, we are pleased with the successful continuation of treatment in our U.S. clinical sites,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the timing and progress of its clinical trials. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

Fauna Bio Announces Target Designation Milestone in Obesity Discovery Collaboration

Fauna Bio Announces Target Designation Milestone in Obesity Discovery Collaboration




Fauna Bio Announces Target Designation Milestone in Obesity Discovery Collaboration

Achievement marks advancement of novel obesity target identified through Convergence™ AI platform


EMERYVILLE, Calif.–(BUSINESS WIRE)–Fauna Bio, a biotechnology company pioneering the use of extreme mammal biology and comparative genomics to discover novel therapeutic targets, today announced the designation of a target under its strategic obesity discovery collaboration with Eli Lilly and Company (Lilly), initiated in December, 2023.

The designated target, identified using Fauna Bio’s proprietary Convergence™ AI platform, represents a potential first-in-class approach to treating obesity by leveraging insights from hibernating mammals that naturally regulate body weight and metabolism. This milestone triggers a payment to Fauna Bio under the terms of the collaboration agreement,.

“This target designation validates the power of our Convergence™ platform to identify truly novel biology in metabolic disease,” said Ashley Zehnder, Ph.D., Chief Executive Officer and co-founder of Fauna Bio. “By studying how hibernating mammals achieve remarkable feats of metabolic regulation—including dramatic, healthy weight cycling—we are uncovering therapeutic targets that have eluded traditional discovery approaches.”

The Convergence™ AI platform analyzes genomic data from over 450 mammal species, including more than 60 hibernators, integrating this comparative biology with human patient data to identify disease-relevant targets. The platform’s proprietary Graph Neural Network enables rapid evaluation and prioritization of novel targets across multiple therapeutic modalities.

“We are pleased to advance this collaboration into its next phase,” continued Zehnder. “This achievement reflects the deep scientific expertise of both teams and reinforces the value of our unique approach to drug discovery.”

About Fauna Bio

Fauna Bio is a biotechnology company improving human health by leveraging animal genomics and extreme mammal biology. The company’s proprietary Convergence™ platform integrates comparative genomic analyses across hundreds of mammal species with human disease data to identify novel therapeutic targets and develop transformative medicines. By studying animals that naturally resist disease—including hibernators that exhibit remarkable metabolic resilience—Fauna Bio translates these discoveries into innovative therapies for patients in need. The company is based in Emeryville, California. For more information, visit www.faunabio.com.

Contacts

Direct media inquiries to:

(510) 545-3945

media@faunabio.com