Vistin Pharma ASA: Invitation to Q3 2025 conference call




Vistin Pharma ASA: Invitation to Q3 2025 conference call

Oslo, Norway, 24 October 2025

Vistin Pharma ASA (VISTN) will release its third quarter and YTD 2025 results on Friday 31st of October 2025. Vistin Pharma will host a conference call for all shareholders and interested parties on the same day at 08:30 CET. There will be a Q&A session following the management discussion.

The conference call will be held in English.

The third quarter conference call will be available via web and audio through the following access points:

Webcast: https://edge.media-server.com/mmc/p/zojifvb6

Telephone conference (online registration):
https://register-conf.media-server.com/register/BI4b6411bcd117427f8df81e59f7b2fd65

*****

For further information, please contact:

Alexander Karlsen
CFO
+47 97053621
alexander.karlsen@vistin.com

About Vistin Pharma | www.vistin.com

Vistin Pharma is a Norwegian pharmaceutical company producing Metformin Hydrochloride (API). The Metformin is also available as Direct Compressible lubricated granules. As a solely dedicated European Metformin producer, Vistin Pharma is a well-positioned supplier to leading pharmaceutical companies. Vistin Pharma is headquartered in Oslo, Norway, and has highly qualified employees and a dedicated manufacturing facility in Kragerø.

Vistin Pharma ASA: Invitation to Q3 2025 conference call




Vistin Pharma ASA: Invitation to Q3 2025 conference call

Oslo, Norway, 24 October 2025

Vistin Pharma ASA (VISTN) will release its third quarter and YTD 2025 results on Friday 31st of October 2025. Vistin Pharma will host a conference call for all shareholders and interested parties on the same day at 08:30 CET. There will be a Q&A session following the management discussion.

The conference call will be held in English.

The third quarter conference call will be available via web and audio through the following access points:

Webcast: https://edge.media-server.com/mmc/p/zojifvb6

Telephone conference (online registration):
https://register-conf.media-server.com/register/BI4b6411bcd117427f8df81e59f7b2fd65

*****

For further information, please contact:

Alexander Karlsen
CFO
+47 97053621
alexander.karlsen@vistin.com

About Vistin Pharma | www.vistin.com

Vistin Pharma is a Norwegian pharmaceutical company producing Metformin Hydrochloride (API). The Metformin is also available as Direct Compressible lubricated granules. As a solely dedicated European Metformin producer, Vistin Pharma is a well-positioned supplier to leading pharmaceutical companies. Vistin Pharma is headquartered in Oslo, Norway, and has highly qualified employees and a dedicated manufacturing facility in Kragerø.

Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President




Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President

AMSTERDAM, Oct. 24, 2025 (GLOBE NEWSWIRE) — Polpharma Group, one of the largest pharmaceutical groups operating across Central and Eastern Europe and Central Asia, announces a planned leadership transition.

Effective January 1, 2026, Markus Sieger will step down as CEO of the Group , after a decade of dedicated service. He will continue to support the strategic development of the Group as a member of the Supervisory Board, in line with the succession plan agreed upon at the start of his tenure.

Under Markus Sieger’s leadership, Polpharma Group has achieved significant growth – both financially and in its mission to build a purpose-driven organization: “We help people live healthy lives in a healthy world.” The company has become a trusted partner to healthcare systems across Europe and Central Asia, delivering high-quality, affordable medicines to millions of patients.

Jerzy Starak, owner of Polpharma Group, expressed his appreciation: “On behalf of the entire Polpharma community, I extend my heartfelt thanks to Markus for his outstanding commitment and vision over the past ten years. His leadership was instrumental in navigating the company through a dynamic and challenging landscape, strengthening our values, and setting a strategic course for the future. I am pleased that Markus will continue to be part of our team as a member of the Supervisory Board.”

At the same time, Polpharma Group is pleased to announce the appointment of Sebastian Szymanek as its new CEO, effective January 1, 2026. Sebastian currently serves as the President of the Management Board of Zakłady Farmaceutyczne Polpharma S.A. in Poland.

With nearly 30 years of experience in the pharmaceutical industry, Sebastian brings a deep understanding of both generic and innovative sectors. He joined Polpharma in 2007 and has held several key leadership roles within the commercial division. In 2014, he became the General Manager for Poland, and from 2017 to March 2021, he served as President of the Management Board of Polpharma Biuro Handlowe. Since September 2021, he has led Zakłady Farmaceutyczne Polpharma S.A. as President of the Management Board.

Throughout his 18-year tenure at Polpharma, Sebastian has played a pivotal role in transforming the company into a dynamic market leader. His contributions span strategic project execution, cross-functional team leadership, and strengthening the company’s market position both domestically and internationally.

Nick Haggar, Chairman of the Supervisory Board of Polpharma Group, commented:
“I am confident that Sebastian is the right person to lead Polpharma Group into its next chapter. His deep knowledge of the organization, proven leadership capabilities, operational focus, and unwavering commitment to our mission make him the ideal choice to guide the Group’s continued growth and innovation.”

About the Polpharma Group

The Polpharma Group is a leading regional manufacturer of pharmaceuticals. It is active in the markets of Central and Eastern Europe, the Caucasus, and Central Asia. For over 90 years, it has enjoyed the trust of patients, healthcare professionals, and business partners, offering modern medicines, active substances, and innovative solutions to patients and business partners around the world. Every year, Polpharma Group factories produce 400 million packages of medicines, which are sold directly or through a network of partners in over 40 countries around the world. The Polpharma Group comprises : Zakłady Farmaceutyczne Polpharma S.A. in Poland, Zakłady Farmaceutyczne Santo in Kazakhstan, and companies Farmaprojects in Spain, 089Farm in Germany, and Swiss Pharma International in Switzerland. The Group employs 5,600 people.

For media inquiries, please contact:

Beata Zduńczyk-Golędzinowska
Head of Corporate Communications
rzecznik@polpharma.com

Source: Polpharma Group

Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President




Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President

AMSTERDAM, Oct. 24, 2025 (GLOBE NEWSWIRE) — Polpharma Group, one of the largest pharmaceutical groups operating across Central and Eastern Europe and Central Asia, announces a planned leadership transition.

Effective January 1, 2026, Markus Sieger will step down as CEO of the Group , after a decade of dedicated service. He will continue to support the strategic development of the Group as a member of the Supervisory Board, in line with the succession plan agreed upon at the start of his tenure.

Under Markus Sieger’s leadership, Polpharma Group has achieved significant growth – both financially and in its mission to build a purpose-driven organization: “We help people live healthy lives in a healthy world.” The company has become a trusted partner to healthcare systems across Europe and Central Asia, delivering high-quality, affordable medicines to millions of patients.

Jerzy Starak, owner of Polpharma Group, expressed his appreciation: “On behalf of the entire Polpharma community, I extend my heartfelt thanks to Markus for his outstanding commitment and vision over the past ten years. His leadership was instrumental in navigating the company through a dynamic and challenging landscape, strengthening our values, and setting a strategic course for the future. I am pleased that Markus will continue to be part of our team as a member of the Supervisory Board.”

At the same time, Polpharma Group is pleased to announce the appointment of Sebastian Szymanek as its new CEO, effective January 1, 2026. Sebastian currently serves as the President of the Management Board of Zakłady Farmaceutyczne Polpharma S.A. in Poland.

With nearly 30 years of experience in the pharmaceutical industry, Sebastian brings a deep understanding of both generic and innovative sectors. He joined Polpharma in 2007 and has held several key leadership roles within the commercial division. In 2014, he became the General Manager for Poland, and from 2017 to March 2021, he served as President of the Management Board of Polpharma Biuro Handlowe. Since September 2021, he has led Zakłady Farmaceutyczne Polpharma S.A. as President of the Management Board.

Throughout his 18-year tenure at Polpharma, Sebastian has played a pivotal role in transforming the company into a dynamic market leader. His contributions span strategic project execution, cross-functional team leadership, and strengthening the company’s market position both domestically and internationally.

Nick Haggar, Chairman of the Supervisory Board of Polpharma Group, commented:
“I am confident that Sebastian is the right person to lead Polpharma Group into its next chapter. His deep knowledge of the organization, proven leadership capabilities, operational focus, and unwavering commitment to our mission make him the ideal choice to guide the Group’s continued growth and innovation.”

About the Polpharma Group

The Polpharma Group is a leading regional manufacturer of pharmaceuticals. It is active in the markets of Central and Eastern Europe, the Caucasus, and Central Asia. For over 90 years, it has enjoyed the trust of patients, healthcare professionals, and business partners, offering modern medicines, active substances, and innovative solutions to patients and business partners around the world. Every year, Polpharma Group factories produce 400 million packages of medicines, which are sold directly or through a network of partners in over 40 countries around the world. The Polpharma Group comprises : Zakłady Farmaceutyczne Polpharma S.A. in Poland, Zakłady Farmaceutyczne Santo in Kazakhstan, and companies Farmaprojects in Spain, 089Farm in Germany, and Swiss Pharma International in Switzerland. The Group employs 5,600 people.

For media inquiries, please contact:

Beata Zduńczyk-Golędzinowska
Head of Corporate Communications
rzecznik@polpharma.com

Source: Polpharma Group

Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases




Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases

First patient enrolled in randomized, placebo-controlled study

Bensheim, 24. October 2025 – Neurodegenerative diseases represent one of the biggest challenges of our time. In Germany alone, there are currently around 1.8 million people living with dementia, a figure that is set to rise to 2.7 million by 2050. Increased life expectancy, combined with the growing number of patients, is having an increasingly significant impact on those affected, their families, and national healthcare systems.

Despite advances in research, there is still a lack of treatment options that are effectively capable of providing symptomatic relief and sustainably improving patients’ quality of life.

Within this context, there is a need to develop additional therapeutic options based on robust clinical evidence. Cannabis-based medicines (CbM), particularly in the form of full-spectrum extract, represents a potential area of research due to its potential to modulate the neurophysiological systems involved in degenerative processes.

Toward this objective, the NEUROBIS study is being launched in Italy, a phase II, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy in terms of quality of life and safety of CbMs in neurodegenerative diseases.

This 36-month-long clinical trial has been authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022) and involves 180 patients suffering from amyotrophic lateral sclerosis (ALS), Parkinson’s disease, or Alzheimer’s disease. The first patient has already been enrolled, marking a milestone in clinical research on the use of CBMs as a supportive treatment.

The clinical trial is led by Professor Letizia Mazzini, an internationally renowned neurologist and researcher with over 30 years of experience in the study of neurodegenerative diseases, director of the ALS Center in Novara, and one of Italy’s leading experts on motor neuron diseases.

“We are proud to launch this pioneering clinical trial in Italy,” states Professor Mazzini. “Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis as an additional option for patients suffering from neurodegenerative diseases. Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”

Bernhard Babel, CEO of Avextra, highlights the strategic value of this research initiative: “The launch of the NEUROBIS study represents a major step forward in our clinical research program. Thanks to our standardized full-spectrum extract, developed based on the highest quality and consistency standards, we’re working towards improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”

About Avextra

Building trust through research and patient-focused innovation: German biotech company Avextra is committed to advancing cannabis-based prescription medicines. Avextra is investing specifically in research, with six pioneering studies currently being conducted in Germany to pave the way for the regulatory approval we are aiming for. Our goal: to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.

Learn more at www.avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/

Avextra Media Enquiries:
For media enquiries or to set up an interview please contact:
E-Mail: press@avextra.com
Phone: +49 30 408174037 

Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases




Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases

First patient enrolled in randomized, placebo-controlled study

Bensheim, 24. October 2025 – Neurodegenerative diseases represent one of the biggest challenges of our time. In Germany alone, there are currently around 1.8 million people living with dementia, a figure that is set to rise to 2.7 million by 2050. Increased life expectancy, combined with the growing number of patients, is having an increasingly significant impact on those affected, their families, and national healthcare systems.

Despite advances in research, there is still a lack of treatment options that are effectively capable of providing symptomatic relief and sustainably improving patients’ quality of life.

Within this context, there is a need to develop additional therapeutic options based on robust clinical evidence. Cannabis-based medicines (CbM), particularly in the form of full-spectrum extract, represents a potential area of research due to its potential to modulate the neurophysiological systems involved in degenerative processes.

Toward this objective, the NEUROBIS study is being launched in Italy, a phase II, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy in terms of quality of life and safety of CbMs in neurodegenerative diseases.

This 36-month-long clinical trial has been authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022) and involves 180 patients suffering from amyotrophic lateral sclerosis (ALS), Parkinson’s disease, or Alzheimer’s disease. The first patient has already been enrolled, marking a milestone in clinical research on the use of CBMs as a supportive treatment.

The clinical trial is led by Professor Letizia Mazzini, an internationally renowned neurologist and researcher with over 30 years of experience in the study of neurodegenerative diseases, director of the ALS Center in Novara, and one of Italy’s leading experts on motor neuron diseases.

“We are proud to launch this pioneering clinical trial in Italy,” states Professor Mazzini. “Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis as an additional option for patients suffering from neurodegenerative diseases. Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”

Bernhard Babel, CEO of Avextra, highlights the strategic value of this research initiative: “The launch of the NEUROBIS study represents a major step forward in our clinical research program. Thanks to our standardized full-spectrum extract, developed based on the highest quality and consistency standards, we’re working towards improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”

About Avextra

Building trust through research and patient-focused innovation: German biotech company Avextra is committed to advancing cannabis-based prescription medicines. Avextra is investing specifically in research, with six pioneering studies currently being conducted in Germany to pave the way for the regulatory approval we are aiming for. Our goal: to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.

Learn more at www.avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/

Avextra Media Enquiries:
For media enquiries or to set up an interview please contact:
E-Mail: press@avextra.com
Phone: +49 30 408174037 

Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025




Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025

TORONTO and HOUSTON, Oct. 23, 2025 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer and autoimmune diseases, announced today that updated MDNA11 clinical data will be presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025 taking place December 10-12, 2025, in London, United Kingdom.

Updated clinical data from the Phase 1/2 ABILITY-1 Study evaluating MDNA11, an emerging best-in-class IL-2 therapy, as a monotherapy and in combination with pembrolizumab, will be presented by Dr. André Mansinho, a principal investigator of the study.

Details for the presentations are as follows:

Title: ABILITY-1, a phase 1/2 of MDNA11, a next-generation IL-2 agonist, alone or with pembrolizumab in advanced solid tumors: interim analysis
Presenter: Dr. André Mansinho, MD MSc, Assistant Professor, Faculty of Medicine, University of Lisbon
Date: December 10, 2025

Following the conclusion of the ESMO Immuno-Oncology 2025 Congress, a copy of the presentation will be available on the “Events and Presentations” page of Medicenna’s website.

About Medicenna Therapeutics

Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively.

For more information, please visit www.medicenna.com, and follow us on X and LinkedIn.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts, such as statements on the therapeutic potential and safety profile of MDNA11. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.

This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.

Investor/Media Contact:

Shushu Feng
Investor Relations, Medicenna Therapeutics
(416) 964-5442
ir@medicenna.com

Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting




Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting

Presentation by ADHD expert Dr. Ann Childress to highlight Phase 3 findings supporting the potential for true, entire active-day symptom control

KANSAS CITY, Kan., Oct. 23, 2025 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that data from its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) has been selected for podium presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago. This recognition highlights growing scientific interest in CTx-1301, a once-daily, extended-release formulation designed to simplify treatment for millions living with ADHD.

The Phase 3 data will be presented by Ann Childress, M.D., a leading ADHD specialist and past President of the American Professional Society of ADHD and Related Disorders (APSARD). Her presentation, “Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD,” is scheduled for Friday, October 24, 2025.

“We look forward to presenting the results of this pivotal trial at AACAP, a premier scientific forum for child and adolescent psychiatry,” said Dr. Childress. “The data provide valuable insights into CTx-1301’s ability to deliver symptom relief with the convenience of once-daily dosing.”

“Selection for an AACAP podium presentation is a meaningful acknowledgment of the scientific rigor behind our Phase 3 program,” said Raul Silva, M.D., Chief Science Officer of Cingulate. “CTx-1301 was designed to help address well-documented limitations in current stimulant therapies — such as delayed onset, inconsistent duration, and the need for multiple daily doses — with the goal of improving function for individuals living with ADHD.”

The session will be livestreamed and available on demand at aacap.confex.com. Results from the study will be discussed in detail during the presentation and summarized in a follow-up company announcement following the conference.

About Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurodevelopmental disorder affecting an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults. The condition is characterized by inattention, hyperactivity, and impulsivity that impair academic, professional, and social functioning. Stimulant medications remain the gold-standard therapy; however, most currently available extended-release formulations require multiple doses per day and often fail to provide consistent coverage across the entire active day.

About CTx-1301
CTx-1301 (dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway.

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve patient outcomes in conditions characterized by burdensome daily dosing and suboptimal therapeutic coverage. Cingulate’s lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in Kansas City, Kansas. For more information, visit Cingulate.com.

About Dr. Ann Childress
Ann C. Childress, M.D., a board-certified physician in Psychiatry and Child and Adolescent Psychiatry, has been a practicing psychiatrist for more than 35 years. Dr. Childress has held numerous prominent positions, including chief of mental health at various psychiatric hospitals as well as professorships within prestigious universities. Dr. Childress is past President of the American Professional Society of ADHD and Related Disorders, Education Director for the Nevada Psychiatric Association, a Distinguished Life Fellow of the American Psychiatric Association and a member of the American Academy of Child and Adolescent Psychiatry.

Dr. Childress is the founder and principal investigator of Clinical Research of Southern Nevada and is the founder and president of the Center for Psychiatry and Behavioral Medicine, both entities located in Las Vegas, Nevada. She has conducted more than 200 clinical studies, working on most of the major psychiatric drugs that have been approved for ADHD over the last few decades by various major pharmaceutical companies, including Pfizer, Janssen, Shire, and Novartis.

Dr. Childress has been working with Cingulate since 2018, serving as a key opinion and thought leader, helping design multiple clinical protocols, and currently serving as the lead investigator on Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents.

Forward-Looking Statements
This press release 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. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities, the potential approval and commercialization of CTx-1301 and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor & Media Contact
Thomas Dalton, Vice President, Corporate Communications
Cingulate Inc.
Email: tdalton@cingulate.com | Phone: (913) 942-2301

AVAVA Earns New FDA Clearance for the Treatment of Wrinkles




AVAVA Earns New FDA Clearance for the Treatment of Wrinkles

The High-Energy Non-Ablative Platform Redefining What’s Possible in Skin Revitalization

WALTHAM, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) — AVAVA, the powerful non-ablative energy platform powered by Focal Point Technology™, today announced FDA clearance for the treatment of wrinkles, marking another milestone in its mission to reshape the future of aesthetics.

This latest clearance, coming just months after FDA approval for acne scars, is for fine lines and wrinkles in the Fitzpatrick I-VI. It reinforces AVAVA’s leadership in next generation energy-based devices that deliver visible, natural-looking results across all skin tones, with minimal disruption and little to no downtime.

“As an early adopter of AVAVA^®, I’ve seen firsthand how its precision-based energy delivery is changing the way we approach wrinkle treatment,” said Paul Jarrod Frank, M.D., Cosmetic Dermatologist in New York City. “The technology provides measurable improvement across all skin types while maintaining comfort and consistency, hallmarks of how we practice at PFRANKMD.”

Clinically Proven. Patient-Loved.
In a multi-site study of 33 subjects for facial treatment submitted to the FDA, AVAVA^® demonstrated statistically significant wrinkle improvement (p < 0.001), with most participants showing visible wrinkle reduction with an average 1.7-point improvement on the dermatologist-graded Wrinkle and Elastosis Scale.

In a separate single site, in-clinic survey intended to capture real world patient experience, AVAVA polled 125 patients across 284 treatments. All reported exceptional satisfaction with their treatment experience.*

• 100% said they would have another treatment and recommend AVAVA^®
• 97% described their experience as enjoyable
• 85% returned to normal activities immediately

“AVAVA^® represents a true leap forward in precision-based wrinkle treatment,” said Marie V. Hayag, M.D., FAAD, Board-Certified Dermatologist. “Its ability to target multiple skin depths with unparalleled accuracy allows me to deliver meaningful, natural-looking results across all skin tones.”

The Difference: Redefining Precision and Performance
At the core of AVAVA^® is Focal Point Technology™, a breakthrough technology that directs energy into precise, predictable depths within the skin. Known as the “Martini Effect™”, this conical beam design focuses energy deep in the skin to renew collagen and elastin, without the excess disruption seen in older laser systems.

“The ability to achieve measurable texture and tightening improvement across all skin types with minimal downtime truly sets it apart. The patient satisfaction is remarkable,” said Jody Comstock, M.D., Board-Certified Dermatologist.

Paired with ComfortCool™ integrated cooling and the AVAVASync™ digital ecosystem, AVAVA^® bridges science, artistry, and intelligence, transforming both the provider experience and the business of aesthetics.

Results Patients Love. Technology Investors Trust.
By combining measurable clinical outcomes with exceptional satisfaction, AVAVA is poised for continued expansion in the $8-billion-and-growing U.S. aesthetic device market. Providers cite its ability to deliver consistent results with unmatched control, driving patient loyalty and practice growth.

“Our vision has always been to go beyond what’s expected,” said Irina Erenburg, Ph.D., President & CEO. “AVAVA stands for precision, control, and confidence, empowering providers and patients alike to achieve results that feel natural, not manufactured.”

About AVAVA
AVAVA is redefining what’s possible in energy-based aesthetics. Combining Focal Point Technology™, ComfortCool™ integrated cooling, and the AVAVASync™ digital ecosystem, AVAVA^® delivers precision skin revitalization for all tones and all generations. Formed out of Blossom Innovations and led by the inventors of Fraxel^®, AVAVA continues to pioneer the next era of aesthetic technology through fearless vision and boundless energy.

Media Contact:
Stacy Mackler
Public Relations, AVAVA
smackler@avavaskin.com

*Data from AVAVA Clinic on file at AVAVA, Inc

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/9b989d67-8304-49e3-b07b-9d431e13b490

https://www.globenewswire.com/NewsRoom/AttachmentNg/71196b9e-22fb-419c-ab28-6d09bfc57377

https://www.globenewswire.com/NewsRoom/AttachmentNg/9474bdef-53a3-4b23-8cdb-355093e2c2ce

https://www.globenewswire.com/NewsRoom/AttachmentNg/79add6b3-8fe0-4cfd-bd81-0d7da4ad891e

Eton Pharmaceuticals to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025




Eton Pharmaceuticals to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025

DEER PARK, Ill., Oct. 23, 2025 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report third quarter 2025 financial results on Thursday, November 6, 2025. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET (3:30 p.m. CT).

In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com.

The live webcast can also be accessed on the Investors section of Eton’s website at https://ir.etonpharma.com/. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI™, INCRELEX^®, ALKINDI SPRINKLE^®, GALZIN^®, PKU GOLIKE^®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia^®, ET-700, ET-800 and ZENEO^® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

Investor Relations:

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: Eton Pharmaceuticals, Inc.