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.

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.

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference




ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

-Two poster presentations showcase best- and first-in-class potential of ALX2004, a novel, antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors

-Robust body of preclinical data supports ALX2004 differentiation in EGFR-ADC class and continued evaluation in first-in-human trial

Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

“Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR-NCI-EORTC Conference.”

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference




ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

-Two poster presentations showcase best- and first-in-class potential of ALX2004, a novel, antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors

-Robust body of preclinical data supports ALX2004 differentiation in EGFR-ADC class and continued evaluation in first-in-human trial

Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

“Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR-NCI-EORTC Conference.”

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery




eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

Princeton, NJ, Oct. 23, 2025 (GLOBE NEWSWIRE) — eteraflex connects and CliniExperts have announced a strategic partnership that unites their complementary expertise in clinical research, regulatory strategy, and technology integration under a single, scalable service platform.

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

eteraflex connects & cliniexperts group

The alliance combines eteraflex connects leadership in scientific program management, data analytics, and client engagement with CliniExperts’ being one of the premier regulatory service provider, clinical trial management excellence, and medical affairs capabilities. Together, they will deliver comprehensive end-to-end solutions for pharmaceutical, biotechnology, and medical device innovators — from regulatory strategy, Clinical Development support, through regulatory submission and post-approval support.

Operating from offices in Princeton, NJ (Headquarters) and Canton, MA, with Global Capability Centers in Hyderabad, Chennai, New Delhi, and Bengaluru, the unified organization now employs over 300 plus professionals and consultants. This expanded infrastructure provides clients with a globally synchronized framework that ensures scientific rigor, regulatory precision, and operational efficiency across markets.

This partnership represents a defining evolution for both organizations and the life sciences ecosystem we serve,” said Santhosh RK, Managing Partner, eteraflex connects. “By integrating CliniExperts’ regulatory and clinical operations excellence with our technology-driven service model, we are building a platform that delivers measurable acceleration, compliance confidence, and data integrity for every client program.”

Dr. Ashwini Kumar, CEO, CliniExperts Group, added, “Our combined strengths enable our clients to access complete clinical development and regulatory pathways through one unified partner. Supported by our unmatched Clinical Operation Skills, Globally compliant EDC platform and analytics, we deliver transparent, efficient, and outcome-focused solutions from first patient to final submission and from IND to securing Marketing Authorization.”

The strategic partnership brings together proven capabilities across:

  • Clinical Operations – Full-service trial management for Drugs, Biologics, and Medical Devices across all phases.
  • Regulatory Strategy and Submissions – Comprehensive global submissions, licensing, and post-market support.
  • Biostatistics and Data Management – Integrated data handling with validated systems and analytics frameworks.
  • Functional Service Provider (FSP) Delivery – Scalable and optimized workforce management enabled through HeliX, ensuring predictable performance and cost control.
  • Technology-Enhanced Delivery – Unified digital ecosystem using globally compliant EDC platforms for real-time data management, quality assurance, and analytical oversight.

The alliance will be guided by a Joint Strategic Board responsible for governance, innovation strategy, and operational harmonization across global regions. The Board will ensure continued alignment with international compliance standards and the highest levels of ethical and scientific integrity.

By uniting technology leadership, regulatory experience, and execution excellence, eteraflex connects and CliniExperts are creating a single global operations that delivers consistent, compliant, and accelerated outcomes for clients seeking to bring new therapies, devices, and innovations to market.

About eteraflex connects LLC
eteraflex connects is a U.S.-based life sciences consulting providing integrated program management, biostatistics, CSA and regulatory services to biotechnology and medical device innovators. With over 18 years of operational heritage and technology-driven capabilities, eteraflex connects operates from Princeton, NJ (HQ), Canton, MA, and Global Capability Centers in Hyderabad and Chennai, India.

About CliniExperts
CliniExperts Group of companies is a leading regulatory and clinical research organization established in 2009, providing end-to-end services across Drugs, Biologics, Medical Devices, and Consumer Health. With ISO 9001 and ISO 27001 certifications and a track record of over 65 successful studies, and more than 10,000 product approvals across various regions from different regulatory bodies , CliniExperts operates from Delhi , Bengaluru in India and delivering regulatory and clinical solutions with global compliance excellence.

Media Contact
Communications Office
eteraflex connects LLC
Email: media@eteraflexconnects.com
Phone: +1 (609) 506-1555
Website: www.eteraflexconnects.com

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery




eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

Princeton, NJ, Oct. 23, 2025 (GLOBE NEWSWIRE) — eteraflex connects and CliniExperts have announced a strategic partnership that unites their complementary expertise in clinical research, regulatory strategy, and technology integration under a single, scalable service platform.

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

eteraflex connects & cliniexperts group

The alliance combines eteraflex connects leadership in scientific program management, data analytics, and client engagement with CliniExperts’ being one of the premier regulatory service provider, clinical trial management excellence, and medical affairs capabilities. Together, they will deliver comprehensive end-to-end solutions for pharmaceutical, biotechnology, and medical device innovators — from regulatory strategy, Clinical Development support, through regulatory submission and post-approval support.

Operating from offices in Princeton, NJ (Headquarters) and Canton, MA, with Global Capability Centers in Hyderabad, Chennai, New Delhi, and Bengaluru, the unified organization now employs over 300 plus professionals and consultants. This expanded infrastructure provides clients with a globally synchronized framework that ensures scientific rigor, regulatory precision, and operational efficiency across markets.

This partnership represents a defining evolution for both organizations and the life sciences ecosystem we serve,” said Santhosh RK, Managing Partner, eteraflex connects. “By integrating CliniExperts’ regulatory and clinical operations excellence with our technology-driven service model, we are building a platform that delivers measurable acceleration, compliance confidence, and data integrity for every client program.”

Dr. Ashwini Kumar, CEO, CliniExperts Group, added, “Our combined strengths enable our clients to access complete clinical development and regulatory pathways through one unified partner. Supported by our unmatched Clinical Operation Skills, Globally compliant EDC platform and analytics, we deliver transparent, efficient, and outcome-focused solutions from first patient to final submission and from IND to securing Marketing Authorization.”

The strategic partnership brings together proven capabilities across:

  • Clinical Operations – Full-service trial management for Drugs, Biologics, and Medical Devices across all phases.
  • Regulatory Strategy and Submissions – Comprehensive global submissions, licensing, and post-market support.
  • Biostatistics and Data Management – Integrated data handling with validated systems and analytics frameworks.
  • Functional Service Provider (FSP) Delivery – Scalable and optimized workforce management enabled through HeliX, ensuring predictable performance and cost control.
  • Technology-Enhanced Delivery – Unified digital ecosystem using globally compliant EDC platforms for real-time data management, quality assurance, and analytical oversight.

The alliance will be guided by a Joint Strategic Board responsible for governance, innovation strategy, and operational harmonization across global regions. The Board will ensure continued alignment with international compliance standards and the highest levels of ethical and scientific integrity.

By uniting technology leadership, regulatory experience, and execution excellence, eteraflex connects and CliniExperts are creating a single global operations that delivers consistent, compliant, and accelerated outcomes for clients seeking to bring new therapies, devices, and innovations to market.

About eteraflex connects LLC
eteraflex connects is a U.S.-based life sciences consulting providing integrated program management, biostatistics, CSA and regulatory services to biotechnology and medical device innovators. With over 18 years of operational heritage and technology-driven capabilities, eteraflex connects operates from Princeton, NJ (HQ), Canton, MA, and Global Capability Centers in Hyderabad and Chennai, India.

About CliniExperts
CliniExperts Group of companies is a leading regulatory and clinical research organization established in 2009, providing end-to-end services across Drugs, Biologics, Medical Devices, and Consumer Health. With ISO 9001 and ISO 27001 certifications and a track record of over 65 successful studies, and more than 10,000 product approvals across various regions from different regulatory bodies , CliniExperts operates from Delhi , Bengaluru in India and delivering regulatory and clinical solutions with global compliance excellence.

Media Contact
Communications Office
eteraflex connects LLC
Email: media@eteraflexconnects.com
Phone: +1 (609) 506-1555
Website: www.eteraflexconnects.com