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FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older

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FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older




FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older

  • The first and only approved achondroplasia therapy to provide continuous systemic exposure to CNP over the weekly dosing interval
  • Commercial availability expected during early part of Q2 2026
  • Rare Pediatric Disease Priority Review Voucher granted in connection with approval
  • Ascendis to host investor conference call Monday, March 2, at 8:00 am ET

COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for YUVIWEL® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Achondroplasia is a rare genetic condition causing skeletal dysplasia and, for many affected individuals, an increased risk of muscular, neurological, and cardiorespiratory complications. YUVIWEL is a prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed to provide continuous exposure of active CNP to receptors on tissues throughout the body to counteract the overactive FGFR3 signaling in achondroplasia.

“The approval of once-weekly YUVIWEL is a major step forward in the treatment of children with achondroplasia, giving physicians for the first time the option of prescribing a once-weekly medicine backed by compelling efficacy and excellent tolerability data from three randomized, double-blind, placebo-controlled clinical trials,” said Carlos A. Bacino, MD, FACMG, Professor of Molecular and Human Genetics, Baylor College of Medicine and Texas Children’s Hospital. “My goal is to help children and parents develop care plans tailored to their individual needs and objectives, and I look forward to adding YUVIWEL to my discussions with them.”

“Little People of America, the largest national advocacy and support organization for people with dwarfism, is committed to ensuring that the voices of people with dwarfism remain central in conversations about research and medical options such as YUVIWEL,” said the Board of Directors of Little People of America. “We champion dwarf and disability pride, advocate for inclusion and respect, and foster open dialogue across diverse perspectives. Our goal is to empower individuals and families to make healthcare decisions that reflect their own values and experiences, while pushing for research efforts and new treatment options such as this that could have the potential to support outcomes that truly matter to our community.”

The FDA based its approval of YUVIWEL on their review of the clinical package for TransCon CNP submitted with the Company’s New Drug Application, which included safety and efficacy data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data. The pivotal ApproaCH Trial data is available in JAMA Pediatrics.i

“We are confident in YUVIWEL’s potential to transform the treatment of achondroplasia and are deeply grateful to patients, clinicians, and advocates for their many contributions to this important milestone,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “We have listened to advocacy groups for people with dwarfism to ensure we address what the community actually cares about. This reflects our ongoing commitment to pursue outcomes that patient communities have told us are important to them, and gives the achondroplasia community a new way to look at the promise of pharmacological treatment options.”

Ascendis expects to make YUVIWEL available through prescribing physicians in the United States during the early part of the second quarter of 2026. Ascendis plans to offer a suite of patient services for YUVIWEL through its U.S. Ascendis Signature Access Program (A.S.A.P.), including support navigating the treatment journey and financial assistance programs for eligible patients.

With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV), which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. This program is designed to encourage development of new drugs and biologics for the prevention or treatment of rare pediatric diseases.

Conference Call and Webcast Information
Ascendis will host a call to review the FDA approval of YUVIWEL on Monday, March 2, 2026, at 8:00 am ET. Those who would like to participate may access the live webcast here or register in advance here. The link to the live webcast and slides will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.

The following information is intended for the U.S. audience only:
USE AND IMPORTANT SAFETY INFORMATION

What is YUVIWEL?
YUVIWEL is a prescription medicine used to increase linear growth in children 2 years and older with achondroplasia with open growth plates (epiphyses).

YUVIWEL is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of YUVIWEL?
YUVIWEL may cause serious side effects, including risk of low blood pressure. If your child experiences a decrease in blood pressure or symptoms of low blood pressure (dizziness, feeling tired, and/or nausea) while being treated with YUVIWEL, call your child’s healthcare provider.

The most common side effects of YUVIWEL include injection site reactions (redness, itching, skin discoloration, bleeding, swelling, bruising, pain, and blistering).

Before you give YUVIWEL to your child, tell the healthcare provider about all of your child’s medical conditions, including if they:

  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if YUVIWEL will harm the unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if YUVIWEL passes into breast milk

Tell the healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

These are not all of the possible side effects of YUVIWEL. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please see full Prescribing Information for YUVIWEL.

About Achondroplasia
Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, and is associated with an increased risk of muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia can vary from individual to individual and across different stages of life. Throughout infancy and childhood, observed complications include spinal abnormalities, enlarged brain ventricles, impaired muscle strength and reduced stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; some of which persist or worsen in adulthood. These medical complications can affect quality of life, physical well-being, influenced by a range of clinical, social, and individual factors. Some individuals with achondroplasia require multiple procedures and surgeries to address specific functional or anatomical concerns.

About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are 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. Examples of such statements include, but are not limited to, statements relating to (i) the expected timing for the commercial availability of YUVIWEL, (ii) the continued approval for the indication, (iii) the suite of patient services Ascendis plans to offer for YUVIWEL, (iv) YUVIWEL’s potential to transform the treatment of achondroplasia, (v) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients’ lives and (vi) Ascendis’ use of TransCon to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third‑party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on‑market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom‑to‑operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, TransCon, and YUVIWEL are trademarks owned by the Ascendis Pharma group. © February 2026 Ascendis Pharma A/S.

Investor Contacts:
Chad Fugere
Ascendis Pharma
ir@ascendispharma.com		 Media Contact:
Melinda Baker
Ascendis Pharma
media@ascendispharma.com
   
Patti Bank
ICR Healthcare
+1 (415) 513-1284
patti.bank@icrhealthcare.com		  
   

i Savarirayan R, McDonnell C, Bacino CA, et al. JAMA Pediatr 2026;180(1):18–25. Published online November 17, 2025. doi:10.1001/jamapediatrics.2025.4771

OpGen, Inc. (OTC: OPGN) Announces Name Change to CapForce Inc.

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OpGen, Inc. (OTC: OPGN) Announces Name Change to CapForce Inc.




OpGen, Inc. (OTC: OPGN) Announces Name Change to CapForce Inc.

CLARKSBURG, Md., Feb. 27, 2026 (GLOBE NEWSWIRE) — OpGen, Inc. (OTC: OPGN) today announced that it is changing its name to CapForce Inc., effective today. OpGen changed its name to CapForce Inc. in order to reflect the repositioning of the Company’s business to the digital investment banking and financial technology sectors. The name “CapForce” represents the “Force of Capital,” symbolizing the Company’s conviction as a next-generation category-defining fintech-powered investment bank that harnesses the intrinsic force of capital, through capital markets as the empowerment medium, to empower global mid-sized high growth companies to grow beyond the small-cap universe and punch above their weight to enter the mid-cap or even large-cap universe. In connection with the name change, the Company expects to change its ticker symbol to “CFOR.”

About CapForce Inc.

CapForce Inc. (Clarksburg, Md., U.S.A.), along with its subsidiaries CapForce International Holdings Ltd. and iCapX Sdn. Bhd., provides fintech-enabled digital investment banking services for global high-growth mid-sized private companies seeking public market listings and other capital markets advisory services, of listing market capitalization value in the range of $1 billion to $10 billion, with its key focus on small-cap and mid-cap listing stocks underserved by bulge bracket investment banks. In furtherance of such core strategy, CapForce Inc. is pursuing fintech-enabled and AI-powered asset and wealth management services for its core investment banking clients across the world with the development of a digital investment banking platform designed to facilitate cross-border securities activities, AI-powered robo-advisory services, and technology-driven capitalization table management solutions. The timing and implementation of these initiatives are subject to market conditions, regulatory approvals, and other relevant factors. CapForce Inc.’s controlling shareholder, AEI Capital Group, is an Asia-based alternative asset management group with groupwide AUM exceeding $7 billion, focused on global growth equity (private and public markets) as its core strategies, along with other satellite strategies in furtherance of its core strategies including private credit, hedge funds, funds-of-funds and real estate, having its footprints in Hong Kong, Kuala Lumpur, Singapore, London and Washington D.C.

For more information, please visit https://capforce.opgen.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are intended to qualify for the safe harbor from liability established thereunder. Such forward-looking statements are subject to risks and uncertainties that are often difficult to predict, are beyond the Company’s control, and which may cause results to differ materially from expectations, including risks regarding the implementation and execution of operational, legal, and administrative changes associated with the name change, the effectiveness of the Company’s rebranding efforts, potential confusion among customers, partners, or investors, and costs associated with the rebranding process. For further discussion of factors that could materially affect the outcome of the Company’s forward-looking statements and its future results and financial condition, see “Risk Factors” in Part I, Item 1A, of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CapForce Inc.:
Christian-Laurent Benoit Bonte
Chief Executive Officer
InvestorRelations@opgen.com

Femasys Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Femasys Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Femasys Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

ATLANTA, Feb. 27, 2026 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has granted to two new non-executive employees who began their employment with Femasys in February 2026 options to purchase 185,000 shares of Femasys common stock.

These inducement grants were granted at an exercise price per share of $0.50 and $0.57, equal to the closing price of Femasys common stock on the date of employment as reported by Nasdaq. This grant was approved by the Compensation Committee of Femasys’ Board of Directors and made as an inducement material to employment to individuals hired by Femasys. The stock options will vest as to 25% of the shares underlying the stock option on the first anniversary of the commencement of employment, with the remaining shares vesting 25% each year over the following three years, subject to continued employment with Femasys. Femasys provides this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rates of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction.1

FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.

Forward-Looking Statements 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts: 
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com

Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034

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Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034




Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034

  • IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in combination with IDEAYA’s PARG inhibitor IDE161.
  • IDEAYA has dosed the first patient in its Phase 1 trial of IDE034, initially evaluating safety, tolerability, and PK.
  • First dosing triggers a $5 million milestone payment to Biocytogen under the companies’ option and license agreement.

BEIJING, China–(BUSINESS WIRE)–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.


According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

“Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study.”

About Biocytogen

Biocytogen (SSE: 688796; HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen has established a dual-engine platform combining a fully human antibody library with an extensive target-humanized mouse model portfolio, enabling a systematic approach to accelerating global drug discovery and development.

Biocytogen has independently developed its proprietary RenMice® (RenMab®/ RenLite®/ RenNano®/RenTCR™/ RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, hu-VHH discovery, and TCR mimic antibody discovery, and has established a sub-brand, RenSuper™ Biologics, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen, Jiangsu, Shanghai), the USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@biocytogen.com.cn

Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034

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Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034




Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034

  • IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in combination with IDEAYA’s PARG inhibitor IDE161.
  • IDEAYA has dosed the first patient in its Phase 1 trial of IDE034, initially evaluating safety, tolerability, and PK.
  • First dosing triggers a $5 million milestone payment to Biocytogen under the companies’ option and license agreement.

BEIJING–(BUSINESS WIRE)–#Antibody–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.


According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

“Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study.”

About Biocytogen

Biocytogen (SSE: 688796; HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen has established a dual-engine platform combining a fully human antibody library with an extensive target-humanized mouse model portfolio, enabling a systematic approach to accelerating global drug discovery and development.

Biocytogen has independently developed its proprietary RenMice® (RenMab®/ RenLite®/ RenNano®/RenTCR™/ RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, hu-VHH discovery, and TCR mimic antibody discovery, and has established a sub-brand, RenSuper™ Biologics, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen, Jiangsu, Shanghai), the USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@biocytogen.com.cn

National Condom Month: Why Today’s Protection Is About Pleasure, Confidence and Connection, According to Sex & Relationship Expert, Dr. Deb Laino

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National Condom Month: Why Today’s Protection Is About Pleasure, Confidence and Connection, According to Sex & Relationship Expert, Dr. Deb Laino




National Condom Month: Why Today’s Protection Is About Pleasure, Confidence and Connection, According to Sex & Relationship Expert, Dr. Deb Laino

PHILADELPHIA–(BUSINESS WIRE)–In recognition of National Condom Month, sex and relationship therapist Dr. Deb Laino is encouraging young adults to prioritize safer sex practices – not just for protection, but for the emotional and relational benefits that come with feeling secure and aligned with your partner. As conversations around consent and sexual wellness continue to evolve, Dr. Laino emphasizes that condoms are not just about prevention – they help create a shared understanding of responsibility, reduce anxiety around unintended consequences, and allow couples to be more present with one another.

“Being responsible and using condoms should feel seamless, not awkward,” says Dr. Laino. “When you feel confident and comfortable, you can focus on the chemistry, the closeness, and the experience you’re creating together – which is what truly enhances pleasure and connection.”

When used correctly and consistently, condoms remain one of the most effective and accessible methods for helping prevent sexually transmitted infections (STIs) and unintended pregnancy. But beyond protection, they can also increase emotional safety, build mutual trust, and remove distractions or worry that can interfere with intimacy – ultimately allowing partners to feel more relaxed, confident, and connected in the moment.

Among one of the newest sexual health innovations is Trojan G.O.A.T.™ (Greatest of All Trojan) from Trojan Brand Condoms. Made with patent-pending UltraFlex™ Non-Latex material, G.O.A.T. is designed to be soft, flexible, strong, odorless, and colorless – helping partners experience a closer, more natural feel. The material is engineered to enhance body heat transfer and adapt to movement, supporting comfort and a sense of next-level intimacy without compromising reliability.

Trojan also offers a range of condoms to meet different preferences, including Trojan Pleasure Pack, which provides a mix of textures and sensations; Trojan BareSkin Raw, designed for an ultra-thin feel; and Trojan Magnum condoms, created for those who prefer a larger fit for added comfort and security.

Dr. Laino encourages individuals to approach safe sex proactively – having conversations with partners ahead of time, choosing products that feel comfortable, and viewing condom use as a shared responsibility.

For more information on Dr. Deb Laino, please visit the following website.

Contacts

Media Contact

Kaitlin Boyle, kaitlin.boyle@gcw.agency

Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2025

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Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2025




Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2025

OLDSMAR, Fla.–(BUSINESS WIRE)–Cryo-Cell International, Inc. (NYSE American LLC: CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for its fiscal year ended November 30, 2025.


Financial Results

Revenue

Consolidated revenues for fiscal 2025 were $31.6 million compared to $32.0 million for fiscal 2024. The revenues for fiscal 2025 consisted of $31.4 million in processing and storage fee revenue, $54,000 in product revenue and $130,000 in public banking revenue compared to $31.6 million in processing and storage fee revenue, $68,000 in product revenue and $367,000 in public banking revenue for fiscal 2024.

Net (Loss) Income

The Company reported a net loss of $2.4 million in fiscal 2025 or $0.30 per basic and diluted share, compared to net income of $402,000 in fiscal 2024 or $0.05 per basic and diluted share. Due to changes in sales trends and estimated recoverability of cost capitalized into inventory, an impairment charge of $4.4 million was recognized during the fourth quarter of November 30, 2025 to reduce the public inventory from cost to net realizable value.

About Cryo-Cell International, Inc.

Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. ‎More than 500,000 parents from 87 countries have entrusted Cryo-Cell International, Inc. with ‎their baby’s cord blood and cord tissue stem cells. In addition to its private bank, Cryo-Cell ‎International, Inc. has a public banking program in partnership with Duke University. Cryo-Cell’s ‎public bank has provided cord blood for more than 700 transplants and operates a cord ‎blood donation site at one of the country’s most prominent hospitals, Cedars–Sinai Hospital in ‎Los Angeles. Cryo-Cell’s facility is FDA registered, cGMP-/cGTP-‎compliant and licensed in all states requiring licensure. Besides being AABB accredited as a ‎cord blood facility, Cryo-Cell was also the first U.S. (for private use only) cord blood bank to ‎receive FACT accreditation for adhering to the most stringent cord blood quality standards ‎set by any internationally recognized, independent accrediting organization. Cryo-Cell has ‎the exclusive rights ‎to PrepaCyte-CB, the industry’s most advanced cord blood processing ‎technology.‎

Cryo-Cell’s mission is to provide premier cord blood and cord tissue cryopreservation services, to develop, manufacture and administer cellular therapies to significantly improve the lives of patients worldwide and to offer the highest quality and most cost effective biostorage solutions available.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, you can identify forward-looking statements by terminology such as “will,” “may,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “forecasts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Generally, the words “anticipate,” “believe,” “continue,” “expect,” “intend,” “estimate,” “project,” “plan” and similar expressions identify forward-looking statements. In particular, statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance contain forward-looking statements.

We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. These forward-looking statements involve risks and uncertainties and reflect only our current views, expectations and assumptions with respect to future events and our future performance. If risks or uncertainties materialize or assumptions prove incorrect, actual results or events could differ materially from those expressed or implied by such forward-looking statements. Risks that could cause actual results to differ from those expressed or implied by the forward-looking statements we make include, among others, the success of the Company’s global expansion initiatives and product diversification, including its addition of the ExtraVault services, the Company’s actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company’s future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company’s business, the success of the Company’s initiative to expand its core business units to include biopharmaceutical manufacturing and operating clinics, the complexities, uncertainties, required consents and timing related to the potential spinoff of Celle Corp., the uncertainty of profitability from its biopharmaceutical manufacturing and operating clinics, the Company’s ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations and the success and enforceability of the Company’s umbilical cord blood and cord tissue license agreements, together with the associated intellectual property and their ability to provide the Company with royalty fees, along with the Risk Factors set forth in the Company’s Form 10-Q filed on October 15, 2025.

This list of risks and uncertainties, however, is only a summary of some of the most important factors and is not intended to be exhaustive. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. These risks and uncertainties may cause our actual future results to be materially different than those expressed in our forward-looking statements. These forward-looking statements are made only as of the date hereof. Except as otherwise required by applicable law, we do not undertake and expressly disclaim any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments. All subsequent written and oral forward-looking statements attributable to us, or to persons acting on our behalf, are expressly qualified in their entirety by these cautionary statements.

Contacts

Irene Smith

813-749-2102

Ismith@cryo-cell.com

Prothena Announces up to $100 Million Share Repurchase Plan

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Prothena Announces up to $100 Million Share Repurchase Plan




Prothena Announces up to $100 Million Share Repurchase Plan

DUBLIN–(BUSINESS WIRE)–$PRTA #Prothena–Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that its Board of Directors has authorized a Share Repurchase Plan under which the Company may repurchase up to $100.0 million of the Company’s outstanding ordinary shares, par value $0.01 per share.


Prothena had cash, cash equivalents and restricted cash of $308.4 million and no debt as of December 31, 2025. Excluding any potential purchases under this Share Repurchase Plan, Prothena expects to end the year with approximately $255 million in cash, cash equivalents, and restricted cash. This financial guidance does not include the potential to earn up to $105 million of aggregate clinical milestone payments from strategic partners in 2026 related to the advancement of both coramitug for ATTR amyloidosis with cardiomyopathy by Novo Nordisk and PRX019 for neurodegenerative diseases by Bristol Myers Squibb.

Prothena may repurchase the shares from time to time in open market transactions, which may be structured to occur in accordance with the requirements of Rule 10b-18 of the Securities Exchange Act of 1934, as amended. Prothena may also enter into Rule 10b5-1 plans to facilitate repurchases. The timing, number of shares repurchased, and prices paid for the shares under this program will depend on general business and market conditions as well as corporate and regulatory limitations, prevailing share prices, and other considerations. The Share Repurchase Plan will expire on December 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of ordinary shares. No amount or any amount of outstanding ordinary shares may be acquired by the expiration of the Share Repurchase Plan, at Prothena’s sole discretion.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including Parkinson’s disease, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS) and a number of other neurodegenerative diseases. Prothena is developing and applying its proprietary CYTOPE® technology to target a broad spectrum of intracellular disease pathways in the brain and periphery. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, our plans and expectations regarding the Share Repurchase Plan, capital allocation, and other objectives and expectations; our anticipated cash burn and projected year end cash, cash equivalents, and restricted cash; and the receipt of clinical milestone payments in 2026. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to uncertainties related to the completion of operational and financial closing procedures, audit adjustments and other developments that may arise that would require adjustments to the preliminary financial results included in this press release, as well as those described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2026, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

Contacts

Mark Johnson, CFA, Vice President, Investor Relations

650-837-8550

IR@prothena.com
Media@prothena.com

Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome

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Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome




Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome

SAN DIEGO, Feb. 27, 2026 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).

The decision by Aardvark to voluntarily pause the HERO (NCT06828861) and open-label extension (NCT07197034) trials was based on reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study. Aardvark is conducting a comprehensive review of the data to inform next steps. Out of an abundance of caution, the company has voluntarily paused ongoing enrollment and dosing in the HERO trial during this evaluation.

“The safety of every patient in our clinical studies is our highest priority, so we will thoroughly evaluate the signals seen at higher than therapeutic doses of ARD-101 in a healthy volunteer study,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We are committed to advancing the ARD-101 clinical program and we are evaluating optimal therapeutic dosing levels to support its progress. We will continue to collaborate closely with the FDA and scientific and clinical experts, and we greatly appreciate our partnership with the PWS community as we determine next steps for this program.”

Based on the ongoing activities in the ARD-101 program, Aardvark no longer anticipates announcing topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of this year.

About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed on the luminal side of the intestine. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones, including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome (PWS). 

About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting interim, preliminary or topline results, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-101, including the review of the data from the healthy volunteer study, the expected timeline for announcing topline data from the Phase 3 HERO trial, potential next steps for ARD-101, and Aardvark’s expected timing for providing further guidance. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that Aardvark filed with the Securities and Exchange Commission on November 13, 2025. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

Investor Contact:
Courtney Mogerley 
Argot Partners 
(212) 600-1902 
Aardvark@Argotpartners.com

Media Contact:
Andrea Cohen
Sam Brown LLC
(917) 209-7163
Andreacohen@Sambrown.com

Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome

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Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome




Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome

SAN DIEGO, Feb. 27, 2026 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).

The decision by Aardvark to voluntarily pause the HERO (NCT06828861) and open-label extension (NCT07197034) trials was based on reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study. Aardvark is conducting a comprehensive review of the data to inform next steps. Out of an abundance of caution, the company has voluntarily paused ongoing enrollment and dosing in the HERO trial during this evaluation.

“The safety of every patient in our clinical studies is our highest priority, so we will thoroughly evaluate the signals seen at higher than therapeutic doses of ARD-101 in a healthy volunteer study,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We are committed to advancing the ARD-101 clinical program and we are evaluating optimal therapeutic dosing levels to support its progress. We will continue to collaborate closely with the FDA and scientific and clinical experts, and we greatly appreciate our partnership with the PWS community as we determine next steps for this program.”

Based on the ongoing activities in the ARD-101 program, Aardvark no longer anticipates announcing topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of this year.

About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed on the luminal side of the intestine. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones, including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome (PWS). 

About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting interim, preliminary or topline results, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-101, including the review of the data from the healthy volunteer study, the expected timeline for announcing topline data from the Phase 3 HERO trial, potential next steps for ARD-101, and Aardvark’s expected timing for providing further guidance. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that Aardvark filed with the Securities and Exchange Commission on November 13, 2025. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

Investor Contact:
Courtney Mogerley 
Argot Partners 
(212) 600-1902 
Aardvark@Argotpartners.com

Media Contact:
Andrea Cohen
Sam Brown LLC
(917) 209-7163
Andreacohen@Sambrown.com