Clearmind Medicine Announces Receipt of Nasdaq Minimum Bid Price Notification




Clearmind Medicine Announces Receipt of Nasdaq Minimum Bid Price Notification

Vancouver, Canada, Dec. 05, 2025 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, announced today that on December 4, 2025, the Company received a written notice from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the Company’s closing bid price for its common shares was below $1.00 per share for the last 30 consecutive business days.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until June 2, 2026, to regain compliance with the minimum bid price requirement. During the compliance period, the Company’s common shares will continue to be listed and traded on the Nasdaq Stock Market under the symbol “CMND”.. To regain compliance, the closing bid price of the Company’s common shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period.

If the Company is not in compliance by June 2, 2026, the Company may be afforded a second 180-calendar day compliance period. To qualify for this additional time, the Company will be required to 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 minimum bid price requirement and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company does not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common shares will be subject to delisting.

The Company intends to monitor the closing bid price of its common shares between now June 2, 2026, and will consider available options to resolve the Company’s noncompliance with the minimum bid price requirement as may be necessary. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.

About Clearmind Medicine Inc.

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

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

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

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

Investor Relations
invest@clearmindmedicine.com

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

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

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses regaining compliance with Nasdaq’s continued listing requirements, and timing and effect thereof. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

Children’s National Hospital welcomes First Lady Melania Trump for holiday visit




Children’s National Hospital welcomes First Lady Melania Trump for holiday visit

Continuing a beloved tradition dating back to 1945, the First Lady visited Children’s National to read to patients, meet families and bring holiday warmth to those spending the season in the hospital.

Washington, DC, Dec. 05, 2025 (GLOBE NEWSWIRE) — First Lady Melania Trump visited Children’s National Hospital today to celebrate the holiday season with patients, families and staff, renewing a tradition that dates back to 1945 when First Lady Bess Truman first visited families who could not spend their holidays at home. 

During her visit, Mrs. Trump read a holiday story, “How Does Santa Go Down the Chimney?” by Mac Barnett, to assembled children and families, greeted patients at the bedside, posed for photos with families, and spent time with nurses, doctors and support staff. Her presence brought warmth and joy to children and parents during what can be a difficult time. 

Introducing the First Lady was a former patient named Caoilinn, who first met the First Lady in 2017 at the opening of the Bunny Mellon Healing Garden. Now a confident Virginia Military Institute student, pursuing the dream she formed during her earliest days of cancer treatment here, she serves as an incredible reminder of the power of Children’s National – not just saving lives but saving lifetimes. 

Mrs. Trump was escorted by two incredible patients, Faith and Riley, and their bubbly personalities and positive energy brought further festive spirit to this special event.

“We are grateful to the First Lady for sharing her time, compassion and holiday spirit with our patients and families,” said Michelle Riley-Brown, MHA, FACHE, president & CEO of Children’s National. “From incredible former patients like Caoilinn to children like Riley and Faith, I am reminded every day of the incredible strength and courage of the young lives we care for. Her visit brings moments of joy, comfort and hope to families who are spending this holiday away from home.” 

The First Lady’s holiday visit remains one of the most cherished traditions at Children’s National, offering meaningful connection and encouragement to patients, families and staff during the holiday season.

Link to photos here.

Children’s National media contact: Media@childrensnational.org | (202) 476-4500

###

About Children’s National Hospital
Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger. Today, it is one of the top 10 children’s hospitals in the nation and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated four times in a row as a Magnet^® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. In 1987, Children’s National founded Safe Kids Worldwide, a non-profit dedicated to reducing unintentional injuries among children through comprehensive national and global education, research and advocacy. As a non-profit, Children’s National relies on generous donors to help ensure that every child receives the care they need.

For more information, follow us on Facebook, Instagram and LinkedIn.

CONTACT: Media
Children's National Hospital
2024764500
Media@childrensnational.org

Kymera Therapeutics to Announce KT-621 BroADen Phase 1b Atopic Dermatitis Trial Results on December 8, 2025




Kymera Therapeutics to Announce KT-621 BroADen Phase 1b Atopic Dermatitis Trial Results on December 8, 2025

Company to host video conference call and webcast at 8:00 a.m. ET on Monday, December 8, 2025

WATERTOWN, Mass., Dec. 05, 2025 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, will announce results from the BroADen Phase 1b clinical trial evaluating KT-621, its oral STAT6 degrader, in patients with moderate to severe atopic dermatitis (AD) on Monday, December 8, 2025. A press release detailing the results will be issued at 7:00 a.m. ET, followed by a video conference call and webcast at 8:00 a.m. ET.

To join the video call or view the livestreamed webcast, please register via this link, or visit “News and Events” in the Investors section of the Company’s website at www.kymeratx.com. A replay of the webcast and copy of the presentation will be available following the event. 

About KT-621
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation. In the Phase 1 clinical study in healthy volunteers, KT-621 demonstrated complete STAT6 degradation in blood and skin following low daily oral doses, reductions of multiple disease relevant Type 2 biomarkers, and a safety profile undifferentiated from placebo. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, bullous pemphigoid (BP), chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.

The Company’s KT-621 BROADEN2 Phase 2b trial in moderate to severe AD patients is ongoing, and patient dosing has commenced. Data is expected to be reported by mid-2027. The BREADTH Phase 2b trial in asthma is planned to start in the first quarter of 2026. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Type 2 dermatology, gastroenterology and respiratory indications.

About Kymera Therapeutics 
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn. 

Investor and Media Contact: 
Justine Koenigsberg
Vice President, Investor Relations
investors@kymeratx.com
media@kymeratx.com
857-285-5300 

GeneLife Expands GeneAI Forecast With New Cancer Risk Prediction Models




GeneLife Expands GeneAI Forecast With New Cancer Risk Prediction Models

AI-Driven Risk Prediction for Breast, Prostate and Pancreatic Cancers

TOKYO, Dec. 05, 2025 (GLOBE NEWSWIRE) — A.D.A.M. Innovations Co. (Japanese Name: Genesis Healthcare Co.) (“A.D.A.M. Innovations” or the “Company”), Japan’s leading AI-driven genomics company, today announced the release of three new first-of-their-kind cancer prediction models for its GeneLife GeneAI Forecast platform: breast cancer (women), prostate cancer (men), and pancreatic cancer (unisex), developed using the largest Japanese population genetic database built by the company over 22 years of operation, improving relevance compared with western-derived tools.

With these three additional cancer models, GeneAI Forecast, supported by Japan’s largest commercial genomic population database, now offers a total of 11 unique predictive models for diseases with rising mortality. The release of these models advances GeneLife GeneAI Forecast’s mission to deliver personalized, prevention-focused health insights for the Japanese and broader East Asian population.

Expanding AI-Powered Prevention

GeneAI Forecast uses A.D.A.M. Innovations’ extensive genomic database, built from 2.9 million completed tests, and combines genetic data with lifestyle factors such as BMI, smoking, alcohol consumption, and several other biomarkers.

This dynamic system provides users a personalized baseline risk and illustrates how lifestyle modifications can impact their long-term health. High-risk individuals can use these insights to optimize their lifestyle choices, reduce disease onset risk, or support early detection.

The three new models join existing predictive forecasts for stroke, myocardial infarction, type 2 diabetes, hypertension, chronic kidney disease, lung cancer, stomach cancer, and colorectal cancer.

GeneLife consumers can access the full line of Gene AI Forecast features through the Genesis CONNECT and WGS CONNECT subscription plans.

Designed for Japanese and East Asian Populations

“These new cancer models reflect our commitment to bringing AI-driven, personalized prevention into everyday life,” said Michel Mommejat, President of A.D.A.M. Innovations. “We aim to help individuals understand their risks and support a more proactive approach to early prevention and intervention, leading to long-term health and longevity.”

For additional information, please visit:
www.genelife.jp
www.adam-innovations.com

About A.D.A.M. Innovations Co.

Founded in 2004 in Tokyo, A.D.A.M. Innovations (formerly Genesis Healthcare Co.) is a pioneer in genomics, AI, and precision health solutions. The company develops cutting-edge technologies spanning consumer genetics, clinical diagnostics, and AI-driven R&D data platforms. To date, A.D.A.M. Innovations has conducted more than 2.8 million genetic tests and maintains the largest R&D genomic database of the Japanese population.

About GeneLife
GeneLife is the consumer genomic brand of A.D.A.M. Innovations. GeneLife, brings genetic testing directly to individuals through at-home kits and e-commerce channels. With a 74% market share (source: Fuji Kimera), GeneLife stands as the market leader, delivering personalized health and wellness insights to empower better living and longevity.

GeneLife, GeneAI Forecast are registered trademarks of A.D.A.M. Innovations Co.

Corporate contact:
Email: press@adam-innnovations.com

Media Relations:
Crocker Coulson
Email: Crocker.Coulson@aumadvisors.com
+1 (646) 652-7185

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/05d63b3d-36ed-44da-b976-b579fed900e4

Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease




Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease

• Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapies
• CREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each dose
• Findings highlight CREXONT as a key therapy in a category with limited innovation
• ELEVATE-PD study is ongoing with longer-term data expected in 2026

BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson’s Study Group (PSG) Annual Meeting.

The first 55 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT^® (carbidopa and levodopa) extended-release capsules, including significant increases in daily “Good On” time, reductions in “Off” time, improved motor symptom control, and consistent gains in “Good On” time per dose—regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD with a COMT inhibitor, or RYTARY^® (carbidopa and levodopa) extended-release capsules.¹

CREXONT is Amneal’s next-generation extended-release CD/LD formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available today.^2-4*

“These early results confirm what clinicians are already seeing every day—patients on CREXONT feel better, stay ‘On’ longer, and experience more predictable control of their symptoms,” said Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL. “For Parkinson’s patients and the clinicians who care for them, this represents a real-world step forward in how we can manage the disease day-to-day.”

“The ELEVATE-PD study interim results showcase CREXONT’s differentiated clinical performance and substantial real-world benefit,” said Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal Pharmaceuticals. “These interim results reinforce what patients and providers are already experiencing: CREXONT is measurably improving daily function and elevating care for people living with Parkinson’s. In a field with limited innovation for decades, CREXONT is perhaps the most significant therapy advancement in decades.”

Key Interim Findings (First 55 Patients, Six-Week Analysis)
Among patients switching to CREXONT (mean age 66.4 ± 8.95 years)¹:

Increase in Daily “Good On” Time

• +3.13 hours when switching from IR CD-LD (n=36)
• +2.31 hours from IR CD-LD+COMT inhibitor (n=6)
• +1.80 hours from Rytary^® (n=11)

Reduction in Daily “Off” time:

• –2.83 hours (IR CD/LD)
• –2.36 hours (IR CD/LD + COMT)
• –2.57 hours (Rytary)

Increase in “Good On” Time per Dose:

• +1.86, +0.77, and +0.79 hours, respectively

MDS-UPDRS Improvements (Total Score):

• –14.2, –4.1, and –13.9 points, respectively

Safety: In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. CREXONT should not be taken with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. The most common (≥3%) were nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%).

Amneal will present longer-term outcomes and patient-reported results in 2026 as part of the ongoing, rolling ELEVATE-PD program, further strengthening the evidence for CREXONT’s impact on motor symptom control and functional independence.

Poster #92 was presented today at the PSG Annual Meeting in San Diego.

About CREXONT^®

CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action and extended-release pellets containing a mucoadhesive polymer technology with a levodopa core for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. Learn more about CREXONT at crexont.com.

About ELEVATE-PD

ELEVATE-PD is an open-label, Phase 4, multi-center clinical study designed to evaluate the real-world efficacy and safety of switching to CREXONT in adults with moderately severe Parkinson’s disease experiencing motor complications such as OFF periods and dyskinesia despite being on a stable dose of oral levodopa-based regimen. The trial plans to enroll approximately 220 participants and will follow them for 13–14 months, consisting of 10 clinical visits.

INDICATION

CREXONT^® (carbidopa and levodopa) extended-release capsules for oral use is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.

IMPORTANT SAFETY INFORMATION

• Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
• Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
• CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.
• The most common side effects that may occur with CREXONT are nausea and anxiety.
• Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
• You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
• Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
• Do not take CREXONT with alcohol.

Tell your healthcare provider if you:

• Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.
• Experience hallucinations or abnormal thoughts and behaviors.
• Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.
• Have thoughts of suicide or have attempted suicide.
• Have abnormal involuntary movements that appear or get worse during treatment.
• Have ever had a peptic ulcer or glaucoma.
• Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.
• Are breastfeeding during therapy.
• Have side effects; your doctor can adjust your dose.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information. For more information talk to your healthcare provider.

About Parkinson’s Disease

Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S.^3,4 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.⁵ While PD is not considered a fatal disease, it is associated with significant morbidity and disability.⁶ The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.^3,7

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

References:

1. Phase 4 ELEVATE-PD study (NCT06765668).
2. CREXONT package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2024.
3. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069.
4. Modi NB, et al. Clin Neuropharmacol. 2019;42(1):4-8.
5. Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
6. Marras et al. NPJ Parkinson’s Dis. 2018;4:21.
7. NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019.
8. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
9. John Hopkins Medicine. Young-Onset Parkinson’s disease.

* Based on the time that LD plasma levers were maintained above 50% of C_max³

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

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




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

PRINCETON, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 14 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto^® (mitomycin) for pyelocalyceal solution and ZUSDURI™ (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.

Up to 32,500 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).

About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel^® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product is approved to treat low-grade upper tract urothelial cancer, and UroGen’s second product is the first and only FDA-approved medication for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both medicines are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, New Jersey with operations in Israel. To learn more, visit www.urogen.com or follow us on X (Twitter), @UroGenPharma.

Jelmyto^®, RTGel^®, ZUSDURI™ and UroGen^® are registered trademarks of UroGen Pharma Ltd.

INVESTOR CONTACT:
Vincent Perrone
vincent.perrone@urogen.com
(609) 460-3588

MEDIA CONTACT:
Cindy Romano
Cindy.romano@urogen.com
(609) 460-3583

Mural Oncology Announces Effectiveness of Scheme of Arrangement and Completion of Acquisition




Mural Oncology Announces Effectiveness of Scheme of Arrangement and Completion of Acquisition

WALTHAM, Mass. and DUBLIN, Dec. 05, 2025 (GLOBE NEWSWIRE) — Mural Oncology plc, (Nasdaq: MURA) (“Mural”) announces that the scheme of arrangement between Mural and its shareholders under Chapter 1 of Part 9 of the Companies Act 2014 (the “Scheme”) pursuant to which XRA 5 Corp. (“Sub”), a wholly-owned subsidiary of XOMA Royalty Corporation (Nasdaq: XOMA) (“XOMA Royalty”) will acquire the entire issued and to be issued share capital of Mural, became effective today, 5 December 2025 (the “Effective Date”).

Distribution of cheques and crediting of DTC participant accounts for the cash consideration paid by Sub to Scheme Shareholders under the terms of the Scheme is expected to commence as soon as practicable following the Effective Date, with DTC participant accounts expected to be credited and the distribution of cheques expected to be complete as soon as practicable. In accordance with the requirements of the Irish Takeover Rules, all consideration paid by Sub to Scheme Shareholders under the terms of the Scheme will be distributed by no later than 19 December 2025.

Cancellation of the admission of Mural Shares to trading on the Nasdaq Global Market occurred with effect from 8.00 pm (U.S. Eastern Time) on 4 December 2025.

Except as otherwise defined herein, capitalised terms used but not defined in this announcement have the same meanings as given to them in the definitive proxy statement of Mural dated 23 September 2025 relating to the Acquisition, which also constitutes a scheme circular under Irish law.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION

FOR IMMEDIATE RELEASE

Enquiries

Mural Oncology plc
ir@muraloncology.com

Lucid Capital Markets, LLC (Financial Adviser to Mural)
570 Lexington Ave, 40th Floor
New York, NY 10022

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this announcement regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Mural, XOMA Royalty or Sub. Forward-looking statements are intended to be identified by words such as “anticipate”, “target”, “expect”, “estimate”, “intend”, “plan”, “believe”, “will”, “may”, “would”, “could” or “should” or other words of similar meaning or the negative thereof. Forward-looking statements include but are not limited to statements regarding the expected timing of the payment of the consideration paid by Sub to Scheme Shareholders and the expected timing of the cancellation of the admission of Mural Shares to trading on the Nasdaq Global Market.

These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from those expressed or implied by such forward-looking statements. Risks and uncertainties that may cause actual results to differ from expectations include: risks and uncertainties pertaining to Mural’s business, including those described in Mural’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the “SEC”) and definitive proxy statement filed with the SEC on 23 September 2025, as well as Mural’s subsequent filings with the SEC; and other potential risks and uncertainties related to XOMA Royalty, including those described in more detail in XOMA Royalty’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and its other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All subsequent oral or written forward-looking statements attributable to Mural, XOMA Royalty or Sub or any persons acting on their behalf are expressly qualified in their entirety by the cautionary statement above. None of Mural, XOMA Royalty or Sub undertake any obligation to update or revise the forward-looking statements contained in this announcement, whether as a result of new information, future events or otherwise, except to the extent legally required.

Statements Required by the Irish Takeover Rules 

The directors of Mural accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors of Mural (who have taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

Lucid, which is authorized and regulated by the SEC and the Financial Industry Regulatory Authority (“FINRA”) in the United States, is acting as financial adviser exclusively for Mural and for no one else in connection with the subject matter of this Announcement and will not regard any other person as its client in relation to the matters in this Announcement and will not be responsible to anyone other than Mural for providing the protections afforded to clients of Lucid or its affiliates, nor for providing advice in relation to any matter referred to in this Announcement. Neither Lucid nor any of its subsidiaries, affiliates or branches owes or accepts any duty, liability or responsibility whatsoever (whether direct, indirect, consequential, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Lucid in relation to the matters in this Announcement, any statement or other matter or arrangement referred to herein or otherwise.

Davy Corporate Finance, which is authorized and regulated in Ireland by the Central Bank of Ireland, is acting exclusively for XOMA Royalty and no one else in connection with the matters referred to in this Announcement and will not be responsible to anyone other than XOMA Royalty for providing the protections afforded to clients of Davy Corporate Finance or for providing advice in connection with the matters referred to in this Announcement.

Wilmer Cutler Pickering Hale and Dorr LLP and Arthur Cox LLP are acting as legal advisers on U.S. and Irish law matters respectively to Mural, and Gibson, Dunn & Crutcher LLP and Mason Hayes & Curran LLP are acting as legal advisers on U.S. and Irish law matters respectively to XOMA Royalty and Sub.

General

The release, publication or distribution of this announcement in or into certain jurisdictions may be restricted by the laws of those jurisdictions. Accordingly, copies of this announcement and all other documents relating to the Acquisition are not being, and must not be, released, published, mailed or otherwise forwarded, distributed or sent in, into or from any such restricted jurisdictions. Persons receiving such documents (including, without limitation, nominees, trustees and custodians) should observe these restrictions. Failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, each of Mural, XOMA Royalty and Sub disclaims any responsibility or liability for the violations of any such restrictions by any person.

Publication on a Website

In accordance with Rule 26.1 of the Irish Takeover Rules, a copy of this announcement will be available on Mural’s website at https://ir.muraloncology.com/ by no later than 12:00 noon (U.S. Eastern Time) on the business day following publication of this announcement. Neither the content of the website referred to in this announcement nor the content of any other websites accessible from hyperlinks on such website is incorporated into, or forms part of, this announcement.

Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting




Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting

— Results from the Phase 1/2 Trial are a Foundation for the Ongoing Pivotal Study of Soficabtagene Geleucel for R/R T-Cell ALL/ LBL in Pediatric and Adult Patients

ST. LOUIS, Mo., Dec. 05, 2025 (GLOBE NEWSWIRE) — Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced an upcoming scientific presentation of the company’s Phase 1/2 study of WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”). Researchers will present Phase 1/2 correlative data and long-term follow-up update for its investigational cell therapy this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 6-9 in Orlando.

Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL).

In the Phase 1/2 Study, Sofi-cel exhibited over one-hundred-fold expansion following infusion and persisted in circulation for up to three months. The serum cytokine profile was consistent with the mechanism of action. In the Long-Term Follow-Up study, there were no reported late adverse-events of special interest or drug-related serious adverse effects. Three patients who received a successful allogeneic stem cell transplant in the Phase 1/2 study remain alive approximately two years after Sofi-cel infusion, highlighting the promise of this investigational therapy in a challenging patient population.

“The robust cellular pharmacokinetics and long-term survival observed in heavily pretreated patients with R/R T-ALL/LBL in the Phase 1/2 study give confidence in the therapeutic potential of Soficabtagene Geleucel,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “The T-RRex investigators bring extensive experience in this challenging disease and are committed to delivering meaningful clinical benefit for patients with limited treatment options.”

The pivotal Phase 2 T-RRex study (NCT06514794) is a single-arm trial evaluating the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL. The study is currently enrolling patients aged ≥ 1 year with R/R T-ALL/LBL and will include an exploratory cohort assessing patients with minimal residual disease (MRD)-positive status.

Wugen Presentation at ASH

4163 WU-CART-007, a CD7-directed allogeneic CAR-T cell therapy for R/R T-cell acute lymphoblastic leukemia/lymphoma: Phase 1/2 correlative data and long-term follow-up update

Presenter: Alexander S. Hamil, Ph.D., Wugen Inc., St. Louis
Presentation type: Poster
Time/location: Sunday, Dec. 7, 6:00-8:00 p.m. ET; OCCC – West Halls B3-B4
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II

About Soficabtagene Geleucel (Sofi-cel)
Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD). Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT04984356 and on the pivotal trial on clinicaltrials.gov, identifier NCT06514794.

Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

About Wugen
Wugen, Inc., headquartered in St. Louis, Missouri, is a clinical-stage biotechnology company focused on developing next-generation, allogeneic CAR-T cell therapies for cancer. Wugen’s proprietary gene-editing platform is designed to overcome key limitations of first-generation cell therapies, enabling scalable, off-the-shelf treatments with biologics-like cost of goods margins. The lead program, Soficabtagene Geleucel, targets CD7 and has demonstrated best-in-class efficacy in T-ALL/T-LBL, with the potential to be the first approved allogeneic CAR-T therapy for T-cell malignancies.

Investor Contact:
Mark Lewis
Wugen
Mlewis@wugen.com
314-501-1968

ORIC® Pharmaceuticals Presents Enozertinib Data in NSCLC Patients with HER2 Exon 20 Mutations at the ESMO Asia Congress 2025




ORIC® Pharmaceuticals Presents Enozertinib Data in NSCLC Patients with HER2 Exon 20 Mutations at the ESMO Asia Congress 2025

Systemic activity of 35% ORR in 2L+ patients, including in patients with active brain metastases

Manageable safety profile with low discontinuation rate

Enrollment completed; no further development planned in this patient population

Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) — ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, announced data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025. Data in previously treated NSCLC patients with HER2 exon 20 mutations were presented at a poster session, and the poster can be found in the publication section of ORIC’s website here.

Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies include chemotherapy and HER2 targeted therapies. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), disease control rate (DCR), and safety.

Previously Treated NSCLC Patients with HER2 Exon 20 Mutations
As of the August 29, 2025 cutoff date, 49 patients were dosed — 26 patients received 80 mg QD oral enozertinib and 23 patients received 120 mg QD. Patients were treated with up to 4 prior therapies, with 80% of patients having received prior chemotherapy and 35% having received a prior HER2 targeted therapy. Brain metastases were present in 47% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs), and no significant off-target toxicities. Most frequent TRAEs included paronychia, diarrhea, and dermatitis acneiform. Only 2 patients discontinued treatment due to TRAEs. Higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort.

Preliminary Activity Analysis
Tumor responses were observed in both the 80 mg and 120 mg cohorts, including in patients with baseline brain metastases. Patients in the 80 mg cohort experienced deeper tumor regressions potentially due to the lower rate of dose reductions.

• 35% ORR (26% confirmed ORR) and 100% DCR in the 80 mg cohort
• As of the data cutoff (at a median follow-up of 50 weeks), 32% of patients remained on treatment in both the 80 mg and 120 mg cohorts

Next Steps 
Based on data generated in patients with EGFR exon 20 and EGFR atypical mutations, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L NSCLC patients with EGFR exon 20 and EGFR P-loop and alpha C-helix compressing (PACC) mutations, with the next update expected in mid-2026, ahead of initiation of potential Phase 3 trial(s). Enrollment in HER2 exon 20 has been completed with no further development planned in this patient population.

Conference Call and Webcast Details
In conjunction with the ESMO Asia Congress, ORIC will host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain-penetrant inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the clinical development of enozertinib; clinical outcomes from studies of enozertinib, which may materially change as patient enrollment continues or more patient data become available; the potential advantages of enozertinib; and plans underlying ORIC’s clinical trials and development. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on November 13, 2025, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Contact:

Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com

Ipsen provides update on legacy of Henri Beaufour




Ipsen provides update on legacy of Henri Beaufour

PARIS, FRANCE, 5 December 2025, Ipsen (Euronext: IPN; ADR: IPSEY) has been informed that the shares of Beech Tree will be transferred to the Alasol Foundation, in accordance with the wishes of Mr. Henri Beaufour, Ipsen’s Board Member and a representative of the founding family who passed away on November 28, 2025. This transfer is expected to take place in early 2026 after having obtained the required regulatory approvals*.

Beech Tree is the holding company owning directly and indirectly the stake in Ipsen shares of Mr. Beaufour. Alasol Foundation is a public interest foundation created by Mr. Beaufour to promote education, school and vocational training for disadvantaged children and young adults.

This transfer of shares has no effect on the existing shareholders’ agreement between Beech Tree and Highrock.

About Ipsen 
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.  

Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. 

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. 

Ipsen Contacts 

Investors 
Henry Wheeler                henry.wheeler@ipsen.com          +33 764471149 
Khalid Deojee                  khalid.deojee@ipsen.com          +33 666019526 

Media 
Sally Bain                        sally.bain@ipsen.com                +1 8573200517 
Anne Liontas                    anne.liontas.ext@ipsen.com      +33 767347296 

*According to a press release from Beech Tree.

Disclaimers and/or forward-looking statements 
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. 

Attachment

• Ipsen Media Update_Henri Beaufour_05122025