Relief Therapeutics Convenes Extraordinary General Meeting

Relief Therapeutics Holding SA / Key word(s): AGMEGM

Relief Therapeutics Convenes Extraordinary General Meeting

24-Oct-2025 / 06:59 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


Relief Therapeutics Convenes Extraordinary General Meeting

GENEVA (Oct. 24, 2025) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTFRLFTY) (Relief Therapeutics or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has convened an extraordinary general meeting (EGM) to seek shareholder approval for the proposed business combination between Relief and NeuroX Group SA (NeuroX), as previously announced on October 8, 2025. The EGM will be held on November 14, 2025, at 5:30 p.m. CEST in Geneva, Switzerland.

AGENDA
Shareholders will be asked to approve several proposals, all contingent upon the completion of the proposed business combination.

These include an ordinary capital increase through the issuance of 140 million new ordinary shares, to be paid in by contribution in kind of NeuroX shares.

Shareholders will also vote on the election of new members to the board of directors, with four nominees — Walid Hanna, Olaf Blanke, Michael Stuenkel and Martin Reiss — proposed to join Relief’s board and succeed current directors who will step down. Gregory Van Beek, current vice-chairman, will continue to serve on the board to ensure continuity and oversee the integration of the two companies. In addition, shareholders will elect members of the nomination and compensation committee.

Further proposals include approval to rename the combined company MindMaze Therapeutics Holding SA, and to increase the capital band and conditional capital to levels commensurate with the post-transaction share capital.

The formal notice of convocation of the EGM, including information regarding attendance in person or by proxy, registration requirements, and ancillary documents, will be mailed to registered shareholders. The EGM comprehensive agenda and an investor presentation with additional information on the proposed combined company are available for download on Relief’s website.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief’s clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

ABOUT NEUROX
NeuroX is a Swiss-based, commercial-stage company that in 2025 acquired strategic assets of MindMaze Group SA and MindMaze SA (MindMaze), including intellectual property and the MindMaze® brand.

MindMaze has developed first-of-its-kind neurotherapeutics that provide disease-modifying motor and cognitive treatments for neurological diseases and brain disorders. These neurotherapeutics are delivered through proprietary software and hardware, underpinned by an advanced brain technology platform that integrates wearables and sensors, and provides digital assessments as well as telehealth services. The unique suite of MindMaze solutions is delivered globally across the continuum-of-care, both in-clinic and in patients’ home, to successfully address some of neurology’s major unmet needs. NeuroX has already partnered with leading pharmaceutical companies that use its proprietary technology across multiple clinical trials.

Over the last decade, MindMaze has raised and invested more than USD 350 million to establish clinical evidence, demonstrate significant medico-economic outcomes, and market MindMaze’s disease-modifying therapeutic platform across neurological diseases, including stroke, Parkinson’s disease, and at-risk aging. In the United States, MindMaze has received a unique reimbursement code (CAT-3) to support the delivery of its home-based neurotherapeutic training. Its R&D pipeline focuses on adjacent neurological diseases, such as spinal cord injury, multiple sclerosis, traumatic brain injury, and Alzheimer’s disease/dementia.

Moved by the mission to accelerate the brain’s ability to recover, the MindMaze platform innovates by combining software-delivered behavioral treatments, drugs, devices, data, and AI to establish a new paradigm of precision medicine in neurology and neural repair.

CONTACT
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements, which may be identified by words such as “believe,” “assume,” “expect,” “intend,” “may,” “could,” “will,” or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. There can be no assurance that the proposed business combination will be completed on the terms described herein or at all. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Additional features:

File: Ad hoc release


End of Inside Information


Language: English
Company: Relief Therapeutics Holding SA
Avenue de Secheron 15
1202 Geneva
Switzerland
Phone: +41 22 545 11 16
E-mail: contact@relieftherapeutics.com
Internet: https://relieftherapeutics.com
ISIN: CH1251125998
Valor: 125112599
Listed: SIX Swiss Exchange
EQS News ID: 2217994

 
End of Announcement EQS News Service

2217994  24-Oct-2025 CET/CEST

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




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

Pentixapharm Strengthens Pipeline Prioritization and Improves Cost Structure

Pentixapharm Holding AG

/ Key word(s): Strategic Company Decision

Pentixapharm Strengthens Pipeline Prioritization and Improves Cost Structure

23.10.2025 / 22:12 CET/CEST

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


Pentixapharm Strengthens Pipeline Prioritization and Improves Cost Structure

 

  • Company focuses resources on its most advanced clinical development programs while reducing early-stage research activities
  • Organizational adjustments include a workforce reduction of approximately 50 %, expected to lower operating costs and extend cash runway into Q1 2027
  • Measures mark targeted continuation of the clinical development strategy outlined in May 2025

 

Berlin, Germany, October 23, 2025 – The Managing Board and Supervisory Board of Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today jointly resolved to significantly reduce early-stage research and development activities and concentrate resources on the company’s most advanced clinical programs.

This prioritization allows Pentixapharm to invest more effectively in its most value-generating development programs, including the Phase 3-ready CXCR4 flagship program for the improved diagnosis of treatment-resistant hypertension. This decision represents a continuation of the clinical development strategy introduced in May 2025, which prioritizes high-value CXCR4-targeted programs.

The sharpened focus includes an adjustment of the organizational structure, accompanied by a targeted workforce reduction of approximately 50 % at Pentixapharm AG. Implementation is anticipated to be completed in the first quarter of 2026. The adjustments are expected to lower annual operating costs and extend the company’s cash runway through the first quarter of 2027.

“Our Phase 3-ready PentixaFor CXCR4 program for the diagnosis of treatment-resistant hypertension has made significant progress in recent months and remains a central value driver, showcasing Pentixapharm’s clinical development expertise,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm AG. “Optimizing our operational costs is an important step to enhance the company’s efficiency and lay a solid foundation for achieving the next clinical milestones. While the adjustment of our organizational structure was a carefully considered decision, it is essential to safeguard the company’s long-term value and support sustainable growth. We will implement the measures responsibly and support to our employees throughout the transition period.”

 

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com


23.10.2025 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: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2218058

 
End of News EQS News Service

2218058  23.10.2025 CET/CEST

Pentixapharm Holding AG: Pentixapharm Focuses Development on Advanced Clinical Programs and Strengthens Financial Position by Discontinuing Preclinical Activities

Pentixapharm Holding AG / Key word(s): Strategic Company Decision

Pentixapharm Holding AG: Pentixapharm Focuses Development on Advanced Clinical Programs and Strengthens Financial Position by Discontinuing Preclinical Activities

23-Oct-2025 / 20:59 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 Disclosure of Inside Information Pursuant to Article 17 Regulation (EU)
No. 596/2014

 

Pentixapharm Focuses Development on Advanced Clinical Programs and Strengthens Financial Position by Discontinuing Preclinical Activities

 

Berlin, Germany, October 23, 2025 – The Managing Board and Supervisory Board of Pentixapharm Holding AG (Frankfurt Prime Standard: PTP, ISIN: DE000A40AEG0), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today jointly resolved to significantly reduce early-stage research and development activities and concentrate resources on the company’s most advanced clinical programs.

This prioritization allows Pentixapharm to invest more effectively in its most value-generating development programs, including its Phase 3-ready CXCR4 flagship program aimed at improving the diagnosis of treatment-resistant hypertension. This decision represents a continuation of the clinical development strategy introduced in May 2025, which prioritizes high-value CXCR4-targeted programs.

The sharpened focus includes an adjustment of the organizational structure, accompanied by a targeted workforce reduction of approximately 50 % at Pentixapharm AG. Implementation is anticipated to be completed in the first half of 2026. The adjustments are expected to lower annual operating costs and extend the company’s cash runway through the first quarter of 2027.

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

End of Inside Information


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


Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2218032

 
End of Announcement EQS News Service

2218032  23-Oct-2025 CET/CEST

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




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




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




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).

Participant Call Link: Click Here
Webcast: Click Here
   

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.

Pheton Holdings Ltd Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

Pheton Holdings Ltd Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency




Pheton Holdings Ltd Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

Beijing, China, Oct. 23, 2025 (GLOBE NEWSWIRE) — Pheton Holdings Ltd (NASDAQ: PTHL) (the “Company”), a healthcare solution provider specializing in treatment planning systems for brachytherapy and other related products and services, today announced, on October 20, 2025, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that based on the closing bid price of the Class A ordinary shares of the Company for the last 30 consecutive business days, the Company no longer meets the continued listing requirement of Nasdaq under Nasdaq Listing Rules 5550(a)(2), to maintain a minimum bid price of $1 per share.

The notification has no immediate effect on the listing or trading of the Company’s Class A ordinary shares on Nasdaq. Nasdaq has provided the Company with an 180 calendar days compliance period, or until April 20, 2026, in which to regain compliance with Nasdaq continued listing requirement. In the event that the Company does not regain compliance in the compliance period, the Company may be eligible for an additional 180 calendar days, should the Company meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and is able to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that the Company’s securities will be subject to delisting.

The Company is currently evaluating options to regain compliance and intends to timely regain compliance with Nasdaq’s continued listing requirement. Although the Company will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other Nasdaq continued listing requirement.

About Pheton Holdings Ltd

Founded in 1998, Pheton Holdings Ltd, through its wholly owned operating subsidiary, Beijing Feitian Zhaoye Technology Co., Ltd., focuses on healthcare solutions for brachytherapy, a targeted radiation therapy used in cancer treatment. Its lead product, Beijing Feitian’s Treatment Planning System, helps ensure safe and effective brachytherapy using radioactive sources inside the patient to kill cancer cells and shrink tumors. Pheton Holdings is committed to leveraging its products and services to establish a potential new standard of care across multiple malignant tumor applications. For more information, please visit: http://www.ftzy.com.cn/ir.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. The Company may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s future business development; financial condition and results of operations; product and service demand and acceptance; reputation and brand; the impact of competition and pricing; changes in technology; government regulations; fluctuations in general economic and business conditions in U.S., Hong Kong and China and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For investor and media inquiries, please contact:

Pheton Holdings Ltd
Investor Relations
Email: ir@ftzy.com.cn

Jackson Lin
Lambert Global
Tel: +1 (646) 717-4593
Email: jlin@lambert.com

Sight Sciences to Report Third Quarter 2025 Financial Results on November 6, 2025

Sight Sciences to Report Third Quarter 2025 Financial Results on November 6, 2025




Sight Sciences to Report Third Quarter 2025 Financial Results on November 6, 2025

MENLO PARK, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences or the Company), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, today announced it will report financial results for the third quarter ended September 30, 2025, after the market close on Thursday, November 6, 2025. The Company’s management will discuss the results during a conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at www.sightsciences.com, on the Investors page in the News & Events section. The webcast will be available for replay for at least 90 days after the event.

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System and OMNI® Edge Surgical System are implant-free, minimally invasive glaucoma surgery technologies (i) indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma. The OMNI Surgical System is CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is the world’s leading cause of irreversible blindness. The SION® Surgical System is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease (MGD), enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease. Visit www.sightsciences.com for more information.

Sight Sciences, the Sight Sciences logo, TearCare, and SmartLids are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories.

© 2025 Sight Sciences. All rights reserved.

Media contact:
pr@sightsciences.com

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
investor.relations@sightsciences.com

Zymeworks Presents Initial Clinical Data from the Phase 1 trial of ZW191, an Antibody-Drug Conjugate Targeting Folate Receptor-⍺ at AACR-NCI-EORTC Conference

Zymeworks Presents Initial Clinical Data from the Phase 1 trial of ZW191, an Antibody-Drug Conjugate Targeting Folate Receptor-⍺ at AACR-NCI-EORTC Conference




Zymeworks Presents Initial Clinical Data from the Phase 1 trial of ZW191, an Antibody-Drug Conjugate Targeting Folate Receptor-⍺ at AACR-NCI-EORTC Conference

  • Preliminary efficacy data, combined with a tolerable safety profile, reinforce the potential of ZW191 in patients with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancer
  • 64% overall response rate in gynecological cancers at doses 6.4mg/kg
  • Responses observed at all doses evaluated at 3.2mg/kg and above demonstrating wide therapeutic index of Zymeworks’ novel antibody-drug conjugate platform
  • Dose optimization of ZW191 in ovarian cancer to initiate in 4Q-2025
  • Investor and analyst call to be held today at 3:30 pm Eastern Time (ET)

VANCOUVER, British Columbia, Oct. 23, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced preliminary results from a Phase 1 study evaluating ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-alpha (FR⍺), at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025, in Boston, MA.

“These first clinical data from our Phase 1 study of ZW191 provide early validation of our innovative approach to designing novel ADCs, through combining a unique antibody design with our proprietary payload, ZD06519,” said Sabeen Mekan, MD, Senior Vice President of Clinical Development of Zymeworks. “We are encouraged by the early signs of anti-tumor activity and favorable safety profile in a heavily pretreated population, which supports best-in-class potential and strengthens our confidence in this approach. With dose optimization planned to begin in the fourth quarter of this year and additional candidates such as ZW251 advancing in development, we remain focused on delivering meaningful new treatment options for patients with challenging cancers.”

Key Findings

As of September 10, 2025, the study enrolled 41 patients from doses 1.6 to 11.2 mg/kg (which was ongoing as of this date) in a heavily pretreated patient population of platinum resistant ovarian cancer, metastatic endometrial cancer, and metastatic non-small cell lung cancer who were enrolled regardless of FR⍺ expression levels. The majority of patients (85%) remain on study treatment.

  • ZW191 exhibited promising preliminary anti-tumor activity:
    • For all response-evaluable participants (n=27) across dose levels, objective response rate (ORR) was 44%; across doses of 6.4 mg/kg to 9.6 mg/kg, ORR was 53%.
    • For response-evaluable gynecological cancer participants (n=24) across dose levels, ORR was 50%; across doses of 6.4 mg/kg to 9.6 mg/kg, ORR was 64%.
    • Responses were observed beginning at the 3.2 mg/kg dose and in tumors with low/negative levels of FRα expression.
  • ZW191 demonstrated a manageable safety profile, with low rates of dose modifications, dose delays, and Grade ≥3 treatment-related adverse events (AE).
      • No serious treatment-related AEs, discontinuations due to AEs, or deaths were reported.
      • The most common ≥ Grade 3 treatment-related AEs were anemia (10%), neutropenia (5%) and thrombocytopenia (5%).
    • These data represent a broad therapeutic window for ZW191 and provide the rationale for further investigation in advanced solid tumors.

Since this data-cut, 11.2 mg/kg has been determined as the maximum tolerated dose and based on safety, efficacy, and pharmacokinetic data, two dose levels – 6.4 mg/kg and 9.6 mg/kg – have been selected for dose optimization, with approximately 30 patients planned in each cohort. This next stage of development is designed to further evaluate ZW191’s clinical activity and safety to inform a registrational strategy.

“It is rewarding to see the scientific promise behind ZW191, including its novel antibody and payload technology, begin to translate into meaningful observations in the clinic,” said Patricia LoRusso, DO, PhD (hc), FAACR and lead author. “These early efficacy and safety findings represent an important step in exploring new treatment strategies for patients with advanced, aggressive cancers and I look forward to observing ZW191’s continued progress.”

Presentation Details

  • Title: Preliminary Results From a Phase 1 First-in-Human Multicenter Open-Label Study Of ZW191, a Folate Receptor α–Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
  • Session: Poster Session A
  • Date/Time: Thursday, October 23, 2025 at 12:30-4:00 pm ET

Investor & Analyst Call
A live webcast will be held today at 3:30 pm ET with lead author Patricia LoRusso, DO, PhD (hc), FAACR and Zymeworks senior management to discuss the data presented. Dial-in details and webcast replay available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations.

About ZW191
ZW191 is an ADC engineered to target a protein called folate receptor-⍺ (FR⍺), found in ~75% of high-grade serous ovarian carcinomas1 and ~70% of lung adenocarcinomas2. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

About Zymeworks Inc.
Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from the NMPA in China, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. It is the first and only dual HER2-targeted bispecific antibody approved for this indication in the U.S., Europe, and China. Zanidatamab is also being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. A Phase 1 study for ZW191 is actively recruiting and ZW251 is expected to enter clinical trials in 2025. In addition to Zymeworks’ pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ data presentations and key findings; the timing and status of ongoing and future studies and the release of data; the potential therapeutic effects of and commercial potential of Zymeworks’ product candidates; Zymeworks’ preclinical pipeline; plans for product candidates’ next stages of development; the ability to advance product candidates into later stages of development and the timing of such advancement; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “anticipate”, “potential”, “will”, “on track”, “continue”, “progress” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:
Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com

1 Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
2 O’Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.