Idorsia’s treatment for insomnia disorder wins the inaugural Prix Galien Bridges Award in the ‘Best Biotechnology & Pharmaceutical Product’ category




Idorsia’s treatment for insomnia disorder wins the inaugural Prix Galien Bridges Award in the ‘Best Biotechnology & Pharmaceutical Product’ category

• Idorsia’s dual orexin receptor antagonist, the first and only drug of its kind approved in Europe for the treatment of insomnia disorder, has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”
• Inaugural winners are honored for breakthrough innovations in life sciences

Allschwil, Switzerland – December 9, 2025
Idorsia Ltd (SIX: IDIA) announces that its novel treatment for insomnia disorder has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation.

Bettina Blosse, General Manager of Idorsia Nordics, commented:
“We are immensely proud to have been awarded the prestigious Prix Galien, particularly the first of its kind in the Nordics. The recognition from the jury is a wonderful endorsement of Idorsia’s commitment to innovation in healthcare and the value that the new treatment brings to improving patient care for insomnia disorder. My team is working to make this medicine accessible to all patients in the Nordic region.”

Martine Clozel, MD and Chief Scientific Officer added:
“Our research team began work on the science of orexin and orexin receptors immediately after they were first described in 1998. Our initial work led to the understanding that antagonism of the orexin system induced a very physiological sleep. With a treatment of insomnia disorder in mind, the team set the target to design a dual orexin receptor antagonist that, among a number of criteria, would achieve a rapid onset of effect and a duration of action sufficient to cover the totality of the night at optimally effective doses, avoiding morning carry-over effects. It took us more than 10 years, and we had to synthesize and characterize more than 25,000 compounds to arrive at the molecule which has now been recognized with the Prix Galien Bridges Award – for improving not only the nights of patients with insomnia disorder, but also most importantly their daytime functioning.”

The Prix Galien Awards were created in 1970 by Roland Mehl in honor of Galien, the father of medical science and modern pharmacology, to recognize outstanding innovation and scientific advancement. With chapters in 16 countries and Africa, Prix Galien is regarded worldwide as the equivalent of the Nobel Prize for the life science industry.
For more information about the Foundation, visit: https://www.galienfoundation.org/
For more information about Prix Galien Bridges, visit: https://www.galienfoundation.org/prix-galien-bridges.

Notes to the editor

About The Galien Foundation
The Galien Foundation fosters, recognizes, and rewards excellence in scientific innovation to improve the state of human health. Our vision is to be the catalyst for the development of the next generation of innovative treatments and technologies that will impact the state of medical practice and save lives. The late Professor Elie Wiesel, 1986 Peace Nobel Laureate, is The Honorary Founding President of The Galien Foundation

The Foundation oversees and directs activities in the US for the Prix Galien, an international awards program dedicated to progress through innovative medicines development, with chapters in 14 countries, Africa and an inaugural chapter established in India in 2024. The Prix Galien was created in 1970 by Roland Mehl in honor of Galen, the father of medical science and modern pharmacology.

About insomnia disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. This impact on sleep quantity or quality should be present for at least three nights per week, over the period of at least three months, and occurs despite an adequate opportunity to sleep.¹

Insomnia is a state of overactive wake signals and studies have shown that in patients with insomnia, brain regions associated with wakefulness remain more active during sleep.^2,3 Insomnia disorder is a common problem with an estimated prevalence in Switzerland of 9.2% of the working-age population.⁴

Insomnia as a disorder is distinctly different from a short period of poor sleep and it can affect both physical and mental health.^1,5 It is a persistent condition that has a negative impact on daytime performance.¹ Idorsia’s research has shown that poor sleep quality can affect many aspects of daily life, including the ability to concentrate, mood and energy levels.

The goal of treating insomnia is to improve sleep quality and quantity, as well as daytime performance, while avoiding side and after-effects the next morning. The currently recommended treatment for insomnia includes sleep hygiene, cognitive behavioral therapy and pharmacotherapy.⁴

About the orexin system
Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness.^6,7 There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B.^6,8 Orexin promotes wakefulness through its receptors OX1R and OX2R. ^6,8 Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness.⁹ Under normal circumstances, orexin levels rise throughout the day as wakefulness is promoted and then fall at night.¹⁰ Overactivity of the wake system is an important driver of insomnia.⁷

The Idorsia research team has been studying the science of orexin and orexin receptors since they were first described in 1998. The team’s initial work led to the conclusion that antagonism of the orexin system is key to maintaining natural sleep architecture in patients with insomnia. With this goal in mind, the team developed dual antagonists with the aim of a rapid onset of action and a duration of action sufficient to bridge the night but short enough to minimize any negative residual activity the next morning at optimally effective doses.

References

1. The Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM–5; American Psychiatric Association, 2013).
2. Buysse, D.J., et al. Drug Discov Today Dis Models. 2011;8(4):129-137.
3. Levenson, J.C., et al. Chest. 2015;147(4):1179-1192.
4. Hafner, Marco, et al., 2023. Santa Monica. CA: RAND Corporation.
5. Wardle-Pinkston S., et al. Sleep Med Rev. 2019;48.
6. Muehlan, C., et al. J Psychopharmacol. 2020;34(3):326-335.
7. Boof, M.L., et al. Eur J Clin Pharmacol. 2019;75(2):195-205.
8. Muehlan, C., et al. Expert Opin. Drug Metab. Toxicol. 2020;16(11):1063–1078.
9. Clifford, B.S., et al. Trends Neurosci. 2001;24(12).726-31.
10. Gotter, A.L., et al. BMC Neuroscience. 2013;14(1):14-19.

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Attachment

• Press Release PDF

Climate Policy Is Based on a Meaningless Number, according to the Journal of American Physicians and Surgeons




Climate Policy Is Based on a Meaningless Number, according to the Journal of American Physicians and Surgeons

TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) — Trillions of dollars are being spent for the ostensible purpose of keeping the earth’s global mean surface temperature (GMST) from rising more than 1.5 or 2.0 degrees Celsius above the “pre-industrial” baseline, but this is a meaningless number, writes Jonathan Cohler in the winter issue of the Journal of American Physicians and Surgeons.

Fundamental thermodynamics taught in first-year physics shows the fallacy of averaging temperatures. For example, the “average” of the temperature of a cup of boiling water and the temperature of your bath water makes no sense, Cohler explains. Nor does the “average” temperature of a spot on Mount Everest and a spot in the Sahara Desert.

The target number for GMST—the “most important number in the world,” some say—was formally adopted by 196 nations in the Paris Agreement of 2015. But the International Standards Organization has declined to define it, Cohler states. The Intergovernmental Panel on Climate Change (IPCC) gives a circular definition.

Rigorous mathematical proofs published in 2007 by Essex, McKitrick, and Andresen demonstrated that “there is no physically meaningful global temperature for the Earth in the context of the issue of global warming.” This paper has remained unchallenged for more than 18 years, Cohler notes.

True warming represents a net transfer of energy into a system, measured in joules or watt-seconds—not degrees Celsius, he explains.

Recent analysis by multiple frontier artificial intelligence (AI) systems, Cohler writes, has confirmed his conclusions. “When provided with the mathematical evidence, advanced AI platforms have characterized the situation as ‘the greatest mass delusion in scientific history’ and described IPCC methodologies as fundamentally fraudulent.”

“The exposure of this deception demands recognition that contemporary climate science is now primarily a political enterprise,” Cohler concludes. “When a field adopts physically meaningless metrics as its foundation, it has abandoned science for statistical theater designed to justify predetermined conclusions, not investigate physical reality.”

As George Orwell predicted, “The very concept of objective truth is fading out of the world. Lies will pass into history.”

The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.

Contact: Jane M. Orient, M.D., (520) 323-3110, janeorientmd@gmail.com

Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism




Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

• No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life
• Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study–all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2 study
• Initiation of EMBARQ-ColdU and SD marks second barzolvolimab Phase 3 program; Phase 3 in CSU ongoing

HAMPTON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) announced today the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. 

“Across studies in cold urticaria and symptomatic dermographism, barzolvolimab has demonstrated a unique and profound ability to offer rapid, sustained, complete disease response, providing hope for patients who are impacted by severe itching and hives that dramatically impact all aspects of their lives despite constant vigilance to avoid disease triggers,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “Advancing a promising agent that addresses the root driver of the disease—the mast cell—into a registrational study is a significant step forward for patients and physicians who desperately need better treatment options.”

EMBARQ-ColdU and SD is designed to establish the efficacy and safety of barzolvolimab in adult participants with ColdU and SD who remain symptomatic despite H1 antihistamine treatment. Participants who remain symptomatic after treatment with biologics are also eligible for the study. The randomized, double-blind, placebo-controlled, parallel group Phase 3 study will recruit participants from approximately 75 clinical trial sites across 7 countries. Approximately 240 participants will be enrolled to 2 separate cohorts (differentiated by subtype) to include approximately 120 participants with ColdU and 120 participants with SD. Participants in each cohort will be randomized in a 1:1 ratio to one of two treatment arms: cohort 1: barzolvolimab 150 mg every 4 weeks (Q4W) following a loading dose of 450 mg on Day 1 or cohort 2: matching placebo for 24 weeks. The primary endpoint of the study will evaluate the percent of patients with complete response (negative provocation test) at Week 12 as assessed by the TempTest® in ColdU and the FricTest® in SD. After completing the treatment period, participants will continue to be followed for 16 weeks.

“Barzolvolimab is now advancing across five indications demonstrating its significant potential to treat a broad array of mast cell driven diseases with Phase 3 studies ongoing in chronic spontaneous urticaria, cold urticaria and symptomatic dermographism and Phase 2 studies in prurigo nodularis and atopic dermatitis,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “We remain focused on executing these trials seamlessly and achieving our goal of making barzolvolimab available to meet the needs of patients.”

There are no advanced therapies approved to treat the more than 533K patients impacted by ColdU and SD across the United States and Europe. Patients are typically treated with up to four times the labeled dose of antihistamines, but more than 80% continue to report inadequate disease control. ColdU and SD are diseases of misery and despite best efforts, patients often find it impossible to avoid disease triggers and are impacted by severe itching and burning hives that dramatically impact all aspects of their lives. More than 60% of patients report moderate to severe impact on their mental/emotional well-being, daily activities, and social/intimate relationships, suffering from social stigma, including being asked if they are contagious, being stared at in public, and people refusing to shake hands or touch them.¹ Not surprisingly, patients with ColdU and SD also report high rates of anxiety and depression.²

Results from a placebo controlled Phase 2 study in ColdU and SD demonstrated that barzolvolimab met the primary endpoint of the study, a statistically significant difference between the percent of participants with a negative provocation test compared to placebo at Week 12 as assessed by the TempTest^® in ColdU and the FricTest^® in SD. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses with up to 75% of patients with ColdU and 67% of patients with SD obtaining a partial or complete response. Secondary endpoints in the study were also achieved at week 12 and strongly supported the primary endpoint results, including responder analyses, improvements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), changes in WI-NRSprovo (itch associated with provocation test) and Urticaria Control Test. These effects were sustained through the end of the treatment period (20 weeks) with up to 78% of patients with ColdU and 58% of patients with SD obtaining a partial or complete response. Barzolvolimab demonstrated a well-tolerated safety profile over the course of the study. Patients were followed for up to 24 weeks after treatment completion and patients with returning or continuing symptoms were given the option to enter an open label extension (OLE) during this follow up period. Consistent with the clinical endpoint results at Week 20, placebo-treated patients entered the OLE at a faster rate compared to barzolvolimab-treated patients. Data from the OLE are expected to be presented in Q1 2026.

For additional information on EMBARQ-ColdU and SD (NCT07266402), please visit www.clinicaltrials.gov.

¹Winders et al. Impact of chronic inducible urticaria (CIndU) on patients’ health-related quality of life: Results from Urticaria Voices study; presented at EAACI Congress 2025.
²EADV poster: Prevalence, clinical profile and burden of chronic inducible urticaria in EU5, US and Japan, Sep 2022.

TempTest^® and FricTest^® are registered trademarks of Moxie GmbH.

About Barzolvolimab
Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), two forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD), prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future.

About Chronic Inducible Urticaria (CIndU), Cold Urticaria (ColdU) and Symptomatic Dermographism (SD):
Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) are forms of Chronic Inducible Urticaria (CIndU), characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin. Approximately 0.5% of the total population suffers from chronic inducible urticarias. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for ColdU and SD other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.

Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com

Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism




Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

• No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life
• Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study–all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2 study
• Initiation of EMBARQ-ColdU and SD marks second barzolvolimab Phase 3 program; Phase 3 in CSU ongoing

HAMPTON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) announced today the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. 

“Across studies in cold urticaria and symptomatic dermographism, barzolvolimab has demonstrated a unique and profound ability to offer rapid, sustained, complete disease response, providing hope for patients who are impacted by severe itching and hives that dramatically impact all aspects of their lives despite constant vigilance to avoid disease triggers,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “Advancing a promising agent that addresses the root driver of the disease—the mast cell—into a registrational study is a significant step forward for patients and physicians who desperately need better treatment options.”

EMBARQ-ColdU and SD is designed to establish the efficacy and safety of barzolvolimab in adult participants with ColdU and SD who remain symptomatic despite H1 antihistamine treatment. Participants who remain symptomatic after treatment with biologics are also eligible for the study. The randomized, double-blind, placebo-controlled, parallel group Phase 3 study will recruit participants from approximately 75 clinical trial sites across 7 countries. Approximately 240 participants will be enrolled to 2 separate cohorts (differentiated by subtype) to include approximately 120 participants with ColdU and 120 participants with SD. Participants in each cohort will be randomized in a 1:1 ratio to one of two treatment arms: cohort 1: barzolvolimab 150 mg every 4 weeks (Q4W) following a loading dose of 450 mg on Day 1 or cohort 2: matching placebo for 24 weeks. The primary endpoint of the study will evaluate the percent of patients with complete response (negative provocation test) at Week 12 as assessed by the TempTest® in ColdU and the FricTest® in SD. After completing the treatment period, participants will continue to be followed for 16 weeks.

“Barzolvolimab is now advancing across five indications demonstrating its significant potential to treat a broad array of mast cell driven diseases with Phase 3 studies ongoing in chronic spontaneous urticaria, cold urticaria and symptomatic dermographism and Phase 2 studies in prurigo nodularis and atopic dermatitis,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “We remain focused on executing these trials seamlessly and achieving our goal of making barzolvolimab available to meet the needs of patients.”

There are no advanced therapies approved to treat the more than 533K patients impacted by ColdU and SD across the United States and Europe. Patients are typically treated with up to four times the labeled dose of antihistamines, but more than 80% continue to report inadequate disease control. ColdU and SD are diseases of misery and despite best efforts, patients often find it impossible to avoid disease triggers and are impacted by severe itching and burning hives that dramatically impact all aspects of their lives. More than 60% of patients report moderate to severe impact on their mental/emotional well-being, daily activities, and social/intimate relationships, suffering from social stigma, including being asked if they are contagious, being stared at in public, and people refusing to shake hands or touch them.¹ Not surprisingly, patients with ColdU and SD also report high rates of anxiety and depression.²

Results from a placebo controlled Phase 2 study in ColdU and SD demonstrated that barzolvolimab met the primary endpoint of the study, a statistically significant difference between the percent of participants with a negative provocation test compared to placebo at Week 12 as assessed by the TempTest^® in ColdU and the FricTest^® in SD. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses with up to 75% of patients with ColdU and 67% of patients with SD obtaining a partial or complete response. Secondary endpoints in the study were also achieved at week 12 and strongly supported the primary endpoint results, including responder analyses, improvements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), changes in WI-NRSprovo (itch associated with provocation test) and Urticaria Control Test. These effects were sustained through the end of the treatment period (20 weeks) with up to 78% of patients with ColdU and 58% of patients with SD obtaining a partial or complete response. Barzolvolimab demonstrated a well-tolerated safety profile over the course of the study. Patients were followed for up to 24 weeks after treatment completion and patients with returning or continuing symptoms were given the option to enter an open label extension (OLE) during this follow up period. Consistent with the clinical endpoint results at Week 20, placebo-treated patients entered the OLE at a faster rate compared to barzolvolimab-treated patients. Data from the OLE are expected to be presented in Q1 2026.

For additional information on EMBARQ-ColdU and SD (NCT07266402), please visit www.clinicaltrials.gov.

¹Winders et al. Impact of chronic inducible urticaria (CIndU) on patients’ health-related quality of life: Results from Urticaria Voices study; presented at EAACI Congress 2025.
²EADV poster: Prevalence, clinical profile and burden of chronic inducible urticaria in EU5, US and Japan, Sep 2022.

TempTest^® and FricTest^® are registered trademarks of Moxie GmbH.

About Barzolvolimab
Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), two forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD), prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future.

About Chronic Inducible Urticaria (CIndU), Cold Urticaria (ColdU) and Symptomatic Dermographism (SD):
Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) are forms of Chronic Inducible Urticaria (CIndU), characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin. Approximately 0.5% of the total population suffers from chronic inducible urticarias. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for ColdU and SD other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.

Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com

Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults




Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults

• Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population¹
• Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia¹
• Teva is committed to advancing this innovative treatment option and further build on its differentiated LAI franchise

PARSIPPANY, N.J. and TEL AVIV, Israel, Dec. 09, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-‘749) for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.¹ The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.

“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.”

Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not approved by any regulatory authority for any use at this time.

Olanzapine LAI utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-‘749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-‘749) treatment groups.¹ The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-‘749) based on additional parameters in adult patients with schizophrenia.¹ A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.² Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.^3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁴ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁴ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^2,3,4,5,6,7

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and obtain regulatory approval for olanzapine extended-release injectable suspension LAI (TEV-‘749) for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
3. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
4. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
5. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
6. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com 
Teva Investor Relations Inquires
TevaIR@tevapharm.com

Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults




Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults

• Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population¹
• Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia¹
• Teva is committed to advancing this innovative treatment option and further build on its differentiated LAI franchise

PARSIPPANY, N.J. and TEL AVIV, Israel, Dec. 09, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-‘749) for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.¹ The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.

“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.”

Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not approved by any regulatory authority for any use at this time.

Olanzapine LAI utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-‘749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-‘749) treatment groups.¹ The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-‘749) based on additional parameters in adult patients with schizophrenia.¹ A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.² Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.^3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁴ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁴ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^2,3,4,5,6,7

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and obtain regulatory approval for olanzapine extended-release injectable suspension LAI (TEV-‘749) for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
3. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
4. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
5. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
6. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com 
Teva Investor Relations Inquires
TevaIR@tevapharm.com

Century Therapeutics Appoints Accomplished Biotechnology Leaders Dr. Han Lee and Dr. Martin Murphy to Board of Directors




Century Therapeutics Appoints Accomplished Biotechnology Leaders Dr. Han Lee and Dr. Martin Murphy to Board of Directors

PHILADELPHIA, Dec. 09, 2025 (GLOBE NEWSWIRE) — Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced the appointments of Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., to its Board of Directors. As part of their appointments, Dr. Lee will serve as a member of the Audit and the Compensation Committees and Dr. Murphy will serve as a member of the Compensation and the Nominating and Corporate Governance Committees.

“We are pleased to welcome Dr. Lee and Dr. Murphy to our Board at an important time for Century as we execute with discipline and focus to bring our most differentiated iPSC-derived cell therapy programs, including CNTY-813 as a potentially curative, off-the-shelf investigational treatment for type 1 diabetes, closer to patients living with high-impact diseases,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “With Dr. Lee’s extensive capital formation and corporate development leadership experience and Dr. Murphy’s extensive experience in life science investment, company creation and strategic oversight of successfully evolving companies across the public and private sectors, we look forward to benefitting from their combined expertise and contributions as we move with urgency to bring our lead pipeline candidates into the clinic and deliver significant value for patients and stakeholders.”

Dr. Han Lee most recently served as President and Chief Financial Officer of ImmPACT Bio, Inc., a privately-owned clinical-stage biotechnology company, which was recently acquired by Lyell Immunopharma in 2024. Prior to ImmPACT, he served in the position of Chief Financial Officer at Neogene Therapeutics, Inc. and, before that, at Arcellx, Inc. Earlier in his career, Dr. Lee worked in corporate development and ventures at AstraZeneca plc. He holds a Ph.D. in genetics and an M.B.A., both from Yale University, and a B.A. in molecular cell biology, with a genetics emphasis, and a minor in chemistry from the University of California, Berkeley.

Dr. Martin Murphy currently holds various board chair and director positions at several organizations, including Synairgen plc, Cora Biosciences Limited and Legal & General UK Universities Ventures LP. Previously, he served as co-founder of Syncona Limited and Chief Executive Officer and investment committee chair of Syncona Investment Management Limited. Prior to Syncona, Dr. Murphy served in roles of increasing responsibility at MVM Life Science Partners LLP, 3i Group plc and McKinsey & Company. He holds a Ph.D. from the University of Cambridge and an M.A. in biochemistry from the University of Oxford.

About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements our timing and expectations regarding our preclinical and clinical development programs, including their planned development, therapeutic potential and market opportunity. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or CTA submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information:

Century Therapeutics
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com

JPA Health
Sarah McCabe
smccabe@jpa.com

Century Therapeutics Appoints Accomplished Biotechnology Leaders Dr. Han Lee and Dr. Martin Murphy to Board of Directors




Century Therapeutics Appoints Accomplished Biotechnology Leaders Dr. Han Lee and Dr. Martin Murphy to Board of Directors

PHILADELPHIA, Dec. 09, 2025 (GLOBE NEWSWIRE) — Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced the appointments of Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., to its Board of Directors. As part of their appointments, Dr. Lee will serve as a member of the Audit and the Compensation Committees and Dr. Murphy will serve as a member of the Compensation and the Nominating and Corporate Governance Committees.

“We are pleased to welcome Dr. Lee and Dr. Murphy to our Board at an important time for Century as we execute with discipline and focus to bring our most differentiated iPSC-derived cell therapy programs, including CNTY-813 as a potentially curative, off-the-shelf investigational treatment for type 1 diabetes, closer to patients living with high-impact diseases,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “With Dr. Lee’s extensive capital formation and corporate development leadership experience and Dr. Murphy’s extensive experience in life science investment, company creation and strategic oversight of successfully evolving companies across the public and private sectors, we look forward to benefitting from their combined expertise and contributions as we move with urgency to bring our lead pipeline candidates into the clinic and deliver significant value for patients and stakeholders.”

Dr. Han Lee most recently served as President and Chief Financial Officer of ImmPACT Bio, Inc., a privately-owned clinical-stage biotechnology company, which was recently acquired by Lyell Immunopharma in 2024. Prior to ImmPACT, he served in the position of Chief Financial Officer at Neogene Therapeutics, Inc. and, before that, at Arcellx, Inc. Earlier in his career, Dr. Lee worked in corporate development and ventures at AstraZeneca plc. He holds a Ph.D. in genetics and an M.B.A., both from Yale University, and a B.A. in molecular cell biology, with a genetics emphasis, and a minor in chemistry from the University of California, Berkeley.

Dr. Martin Murphy currently holds various board chair and director positions at several organizations, including Synairgen plc, Cora Biosciences Limited and Legal & General UK Universities Ventures LP. Previously, he served as co-founder of Syncona Limited and Chief Executive Officer and investment committee chair of Syncona Investment Management Limited. Prior to Syncona, Dr. Murphy served in roles of increasing responsibility at MVM Life Science Partners LLP, 3i Group plc and McKinsey & Company. He holds a Ph.D. from the University of Cambridge and an M.A. in biochemistry from the University of Oxford.

About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements our timing and expectations regarding our preclinical and clinical development programs, including their planned development, therapeutic potential and market opportunity. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or CTA submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information:

Century Therapeutics
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com

JPA Health
Sarah McCabe
smccabe@jpa.com

BioRegenx, Inc. (OTC: BRGX) Announces Major Corporate Progress, Auditor Transition, Technology Integration, and AI-Driven Strategic Vision




BioRegenx, Inc. (OTC: BRGX) Announces Major Corporate Progress, Auditor Transition, Technology Integration, and AI-Driven Strategic Vision

Company Finalizes GlycoCheck® License, Advances DocSun AI Acquisition and SDK Partnerships, and Engages Investment Bank for Planned 2026 Initiatives

CHATTANOOGA, Tenn., Dec. 09, 2025 (GLOBE NEWSWIRE) — BioRegenx, Inc. (“BioRegenx” or the “Company”) (OTC: BRGX), a health-technology company pioneering non-invasive diagnostic and predictive analytics solutions for microvascular and metabolic health, today announced a series of significant corporate, technological, and strategic milestones.

Highlights

• Engaged a new PCAOB-registered independent auditor following industry-wide SEC actions affecting prior firms.
• Finalized intellectual property license for the clinically validated GlycoCheck® vascular diagnostic platform.
• Fully integrated DocSun Biomedical Holdings, Inc., adding AI-driven non-contact vital-sign detection and SDK licensing capabilities.
• DocSun executed multiple Letters of Intent (LOIs) with recognized technology companies to explore SDK integrations within their platforms.
• Executed a letter of engagement with an investment bank to further pursue its planned corporate strategies in 2026.

Corporate Update and Auditor Engagement

In 2024, following the SEC’s enforcement actions that shuttered several audit firms —including BF Borges CPA PC, which affected approximately 500 public issuers—BioRegenx engaged a new PCAOB-registered independent auditing firm. This engagement, disclosed in the Company’s 2024 Form 10-K, underscores BioRegenx’s ongoing commitment to transparency, accountability, and accurate financial reporting.

BioRegenx continues to be advised by the New York-based law firm Sichenzia Ross Ference Carmel LLP. Partner Ross Carmel has supported the Company’s corporate uplisting strategy and introductions within its capital markets network. The Company values this relationship as part of its broader governance and advisory framework.

Since completing its merger with Findit, Inc. (FDIT), BioRegenx has remained current with all SEC reporting obligations and operates in accordance with applicable corporate-governance standards.

GlycoCheck®: Proven Foundation in Microvascular Health

Through its subsidiary Microvascular Health Solutions (MVHS), and in collaboration with KTF Technologies and Maastricht University, BioRegenx has finalized the license agreement for the GlycoCheck® system under exclusive worldwide distribution terms.

GlycoCheck® is a patented technology used in hospital and academic research worldwide. To date, 147 peer-reviewed studies have validated its ability to quantify the endothelial glycocalyx, a key determinant of microvascular integrity. The system is commercially deployed across universities, research institutions, and wellness clinics, generating recurring revenue with strong gross margins.

Each GlycoCheck® test produces high-resolution vascular data that contributes to BioRegenx’s developing analytics infrastructure, supporting evidence-based insights into vascular performance and potential clinical applications.

The global market for vascular diagnostics, clinical research, and wellness applications is estimated to exceed $20 billion annually. Published studies indicate that GlycoCheck® measurements correlate with conditions including cardiovascular disease, diabetes, hypertension, kidney disease, obesity, cognitive decline, and systemic inflammation.

BioRegenx views GlycoCheck® as a cornerstone technology for the future of non-invasive vascular assessment and data-driven health optimization.

DocSun AI: Advancing Non-Contact, Intelligent Health Analytics

The 2024 acquisition of DocSun Biomedical Holdings, Inc. introduced proprietary AI-driven, non-contact vital-sign detection into the Company’s portfolio. DocSun’s platform uses optical sensors and deep-learning algorithms to measure physiological parameters such as heart rate, oxygen saturation, and respiration without physical contact or wearable devices.

The DocSun SDK enables integration into third-party platforms, offering potential applications in telehealth, enterprise health, and wellness monitoring.

DocSun SDK LOIs with Recognized Technology Partners

DocSun has entered into several non-binding Letters of Intent (LOIs) with established technology companies to explore collaborative integration of its SDK within their technology stacks. These early-stage collaborations reflect growing industry interest in DocSun’s AI capabilities and the broader BioRegenx ecosystem’s potential to complement digital-health platforms.

Unified Vision: AI Meets Microvascular Diagnostics

BioRegenx is pursuing a strategy to align the GlycoCheck® diagnostic platform with DocSun’s AI analytics engine, creating a foundation for predictive vascular and metabolic-health insights.

By combining clinically validated microvascular data with AI-based analysis, BioRegenx aims to enable earlier and more precise identification of vascular changes and disease risk patterns. All research and development efforts are conducted under appropriate scientific and regulatory guidelines. The Company makes no assurances regarding regulatory approvals or commercialization outcomes but remains focused on advancing its technology responsibly.

CEO Comment

Bill Resides, CEO of BioRegenx, stated:

“The past year has been pivotal for BioRegenx. We engaged a new PCAOB auditor, finalized key IP agreements, and completed the integration of DocSun’s AI platform.

With DocSun’s SDK partnerships and the scientific foundation of GlycoCheck®, we are connecting biological measurement with intelligent analytics, moving toward a future where vascular health can be monitored non-invasively and continuously.

Our focus remains clear: to deliver technologies that provide early insight and help people live healthier, longer lives.”

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include those regarding potential technology integrations, collaborations, uplisting plans, and other future events. Such statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including regulatory, market, financing, and operational risks.

BioRegenx undertakes no obligation to update any forward-looking statements except as required by law.

About BioRegenx, Inc.

BioRegenx, Inc. (OTC: BRGX) is a health-technology company headquartered in Chattanooga, Tennessee, dedicated to advancing non-invasive diagnostics and AI-driven health analytics. Through its subsidiaries Microvascular Health Solutions (MVHS) and DocSun Biomedical Holdings, BioRegenx is developing an integrated ecosystem that unites vascular science and artificial intelligence to enable early, data-driven insight into human health.

Website: www.bioregenx.com
SEC Filings: www.sec.gov

Investor Relations Contact:
BioRegenx, Inc.
7407 Ziegler Road, Chattanooga, TN 37421
Phone: (866) 770-4067
Email: info@bioregenx.com

Tessera Therapeutics Announces Chief Financial Officer (CFO) Transition and Appointment of Kathy Bergsteinsson as CFO




Tessera Therapeutics Announces Chief Financial Officer (CFO) Transition and Appointment of Kathy Bergsteinsson as CFO

SOMERVILLE, Mass., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced a planned leadership transition in its executive team. After careful consideration, Howard Liang has made the personal decision to step down from his role as President and CFO at the end of the year to pursue the next chapter of his career. Howard will continue to serve as President through year end to ensure a thoughtful and seamless transition. 

“We are deeply grateful for Howard’s leadership, partnership, and the significant impact he has had in building Tessera over the past 5 years,” said Michael Severino, M.D., CEO. “Howard has been instrumental in shaping our strategy, advancing our platform, and strengthening Tessera’s foundation for long-term success. We thank him for his significant contributions and wish him every success in his next chapter.”

As part of this transition, Tessera is pleased to announce the appointment of Kathy Bergsteinsson as Chief Financial Officer. Kathy brings more than 25 years of experience across management, corporate finance, capital markets, M&A, and strategy. Prior to joining Tessera, Kathy served as CFO at Affini-T Therapeutics and spent 18 years at Morgan Stanley, where she was Managing Director and Head of Healthcare Equity Capital Markets. During her tenure, she helped raise over $100bn in equity financings across more than 70 IPOs and 150 follow-on offerings. She also worked in M&A, advising on approximately $110bn in strategic transactions. Kathy received her Bachelor of Science degree in industrial engineering from Stanford University and her Master of Business Administration from The Wharton School at the University of Pennsylvania.

“We are thrilled to welcome Kathy to Tessera,” said Michael Severino, M.D., CEO. “Her extensive strategic and financial expertise, combined with deep sector knowledge, will be invaluable as we enter this important next phase of growth for Tessera.” 

“I am excited to join Tessera at such a pivotal time for the company,” said Kathy Bergsteinsson. “The team has built a compelling Gene Writing and delivery platform with the potential to fundamentally reshape genetic medicine. I look forward to partnering with the leadership team to support Tessera’s strategic vision, advance its programs, and help position the company for long-term success.”

About Tessera Therapeutics

Tessera Therapeutics is pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, with the aim to unlock broad new therapeutic frontiers. Our Gene Writing platform is designed to write therapeutic messages into the genome by efficiently changing single or multiple DNA base pairs, precisely correcting insertions and deletions, or adding exon-length sequences and whole genes. Our proprietary lipid nanoparticle delivery platform is designed to enable the in vivo delivery of RNA to targeted cell types. We believe our Gene Writing and delivery platforms will enable transformative genetic medicines to not only cure diseases that arise from errors in a single gene, but also modify inherited risk factors for common diseases and create engineered cells to treat cancer and potentially autoimmune and other diseases. Tessera Therapeutics was founded in 2018 by Flagship Pioneering, a life sciences innovation enterprise that conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability.

For more information about Tessera, please visit www.tesseratherapeutics.com.

Contact

Jonathan Pappas
LifeSci Communications, LLC
jpappas@lifescicomms.com