New Published Data Confirms Nemluvio® (Nemolizumab) Can Rapidly Relieve Itch and Improve Sleep in as Early as Two Days in Both Atopic Dermatitis and Prurigo Nodularis




New Published Data Confirms Nemluvio® (Nemolizumab) Can Rapidly Relieve Itch and Improve Sleep in as Early as Two Days in Both Atopic Dermatitis and Prurigo Nodularis

• Post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs, published in the Journal of the European Academy of Dermatology and Venereology, highlight nemolizumab’s fast onset of action and improvement of itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis and prurigo nodularis¹
• Significant improvements in itch were observed as early as 48 hours after initial treatment and steadily increased through to Day 14¹
• Nemolizumab is the first approved monoclonal antibody that specifically targets and inhibits the signalling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in atopic dermatitis and prurigo nodularis^2-4
• Nemolizumab is approved by multiple regulatory authorities around the world for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis, including in the U.S. and EU^5,6

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, today released new clinical data confirming nemolizumab’s rapid onset of action on itch and sleep, with significant improvements observed as early as 48 hours after treatment in some patients with atopic dermatitis and prurigo nodularis.¹ The findings from post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs were published in the Journal of the European Academy of Dermatology and Venereology.

Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31.^2,5,6 IL-31 is a neuroimmune cytokine that drives itch and other symptoms in both atopic dermatitis and prurigo nodularis.^3,4 These new findings reinforce the critical role of IL-31 pathway inhibition in achieving rapid itch response.

Atopic dermatitis and prurigo nodularis are debilitating skin conditions that significantly affect quality of life, with symptoms such as persistent itch, skin lesions and poor sleep quality.^7-13 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis seeking freedom from itch, and 88% of those with prurigo nodularis rating it as their worst symptom.^13,14

Rapid relief of itch and sleep disturbance observed within 48 hours

The relevant analyses focused on data from the ARCADIA 1 and 2 trials in atopic dermatitis and the OLYMPIA 1 and 2 trials in prurigo nodularis. During those trials, patients reported itch intensity and sleep disturbance daily. Daily assessments of patients with atopic dermatitis and prurigo nodularis using a ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) and Sleep Disturbance Numerical Rating Scale (SD-NRS) showed that in some patients:

• Nemolizumab reduced itch within two days (atopic dermatitis: 10.7% nemolizumab-treated compared to 2.9% placebo, 95% CI of the difference: 5.6-10.1; P<0.0001; prurigo nodularis: 17.2% nemolizumab-treated compared to 3.7% placebo; 95% CI of the difference: 6.8-16.7; p<0.0001)¹
• Nemolizumab improved sleep disturbance within two days (atopic dermatitis: 9.9% nemolizumab-treated compared to 4.6% placebo, 95% CI of the difference: 2.8-7.7; p=0.0001; prurigo nodularis: 13.4% nemolizumab-treated compared to 4.3% placebo; 95% CI – of the difference: 4.0-13.0; p=0.0013)¹
• By Day 14, a quarter of patients with atopic dermatitis and more than a third of patients with prurigo nodularis achieved significant and clinically meaningful responses in both itch and sleep outcomes¹

Taken individually, each study (ARCADIA 1 and 2 for atopic dermatitis and OLYMPIA 1 and 2 for prurigo nodularis) also demonstrated a significant PP-NRS response at Day 2.¹

These new data reinforce nemolizumab’s efficacy and its potential to deliver rapid relief from itch – the most burdensome symptom for many patients with atopic dermatitis and prurigo nodularis.^13,14

Media can find more information and resources on atopic dermatitis and prurigo nodularis in this toolkit.

About Nemluvio^® (nemolizumab)

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^15,16

Nemluvio was approved by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis, and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.⁵ To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.

About the ARCADIA clinical trial program¹⁷

The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.

These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors).

The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.

About atopic dermatitis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^7,8,18 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.^8,19 It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.^20,21

About the OLYMPIA clinical trial program^22,23

The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study.

These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.

About prurigo nodularis

Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.^10,24,25 It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.^26,27 The majority of patients report that the persistent itch negatively impacts their quality of life.¹¹ Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.^28,29

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Ständer S, et al. Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis Phase 3 studies. JEADV. 2025 Early View. doi: 10.1111/jdv.70250
2. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1): 173-182. doi: 10.1016/j.jaci.2019.08.013
3. Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2
4. Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390
5. Nemluvio^® U.S. Prescribing Information. Available online. Accessed December 2025
6. Nemluvio^® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed December 2025
7. Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: 10.3390/ijms21082867
8. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286- 1
9. Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(8 suppl):S115-S123. PMID:28978208
10. Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042
11. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi: 10.2340/00015555-3471
12. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722
13. Rodriguez D, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol. 2023;159(11):1205-1212. doi: 10.1001/jamadermatol.2023.3251
14. Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932
15. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed December 2025
16. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed December 2025
17. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0
18. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911
19. Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257
20. Luger, T, et al. Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey. Dermatol Ther (Heidelb). 2022;12:949–969. https://doi.org/10.1007/s13555-022-00700-6
21. Oisín S, et al. 545 – Prevalence of moderate and severe atopic dermatitis in Ireland: a cross-sectional, real-world study of a secondary care population. BJD. 2024;190(S2):ii43–ii44. https://doi.org/10.1093/bjd/ljad498.045
22. Ständer S, et al. Efficacy and Safety of Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;161(2):147-156. doi: 10.1001/jamadermatol.2024.4796
23. Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333
24. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183
25. Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570
26. Ryczek A, et al. Prevalence of Prurigo Nodularis in Poland. Acta Derm Venereol. 2020;100:adv00155. doi: 10.2340/00015555-3518
27. Ständer, S, et al. Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis. Acta Dermato-Venereologica. 2020;100(18):1–6. https://doi.org/10.2340/00015555-3655
28. Joel MZ, et al. Risk of itch-induced sleep deprivation and subsequent mental health comorbidities in patients with prurigo nodularis: A population-level analysis using the Health Improvement Network. E-poster presented at EADV 2023. Abstract available online
29. Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi:10.1056/NEJMe1916733

Contacts

For further information:

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christian.marcoux@galderma.com
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Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma




Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

• Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype
• Approval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placebo
• SWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimab
• An estimated 2 million Americans live with severe asthma and 50% continue to experience frequent exacerbations and hospitalizations requiring novel solutions

PHILADELPHIA–(BUSINESS WIRE)–GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care. Treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualized asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year).¹

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalization and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalization and/or ED visits over 52 weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09). Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.¹

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: “Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year. Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”

Depemokimab is a novel therapy that has been developed with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing.¹ These distinct properties could potentially improve patient outcomes while reducing health system burden.

An estimated 2 million Americans live with severe asthma and half continue to experience frequent exacerbations that may lead to hospitalizations, emergency department visits and corresponding increased health system costs.^2,3,4 While biologics have demonstrated benefit in controlling severe asthma, only 20% of eligible patients in the US currently receive one, increasing their risk of exacerbations and worsening disease.⁵ Longer dosing intervals have been associated with an increased likelihood that patients would consider a biologic and 73% of physicians believe it would be beneficial.^6,7

Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, Yale University said: “Current biologic treatments for asthma are often underutilized and frequent injections can be inconvenient for many patients and lead to inconsistent use. There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections for severe asthma patients that reduces the frequency of doses and may improve overall health care utilization. Exdensur could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”

Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform said: “The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. An innovative treatment option like Exdensur that offers the long-acting protection from exacerbations that severe asthma patients with an eosinophilic phenotype deserve, with the benefit of fewer doses, is truly welcome.”

Depemokimab recently received a positive CHMP opinion in Europe, with an approval decision expected in Q1 2026. Regulatory submissions are also under review across the globe, including in China and Japan.

About severe asthma

Severe asthma is defined as asthma that requires treatment with medium- to high-dose inhaled corticosteroids plus a second therapy (i.e., systemic corticosteroid or biologic) to prevent it from becoming uncontrolled, or which remains uncontrolled despite therapy.⁸ Type 2 inflammation is the underlying cause of pathology in more than 80% of patients with severe asthma, in which patients exhibit elevated levels of eosinophils (a type of white blood cell).⁹

About Exdensur (depemokimab-ulaa)

Exdensur is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It has been developed with an extended half-life to enable twice-yearly dosing.¹

The US Prescribing Information is available here.

EXDENSUR is indicated for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus.

Important Safety Information for EXDENSUR

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a severe hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

Acute Asthma Symptoms or Deteriorating Disease

EXDENSUR should not be used to treat acute asthma symptoms or acute exacerbations.

Risk Associated with Abrupt Reduction of Corticosteroid Dosage

Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of EXDENSUR therapy. Reductions in corticosteroid dose, if appropriate, should be gradual and under the supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

Patients with pre-existing helminth infections should be treated for their infection prior to initiation of EXDENSUR therapy. If patients become infected while receiving EXDENSUR and do not respond to anti-helminth treatment, discontinue EXDENSUR until the infection resolves.

ADVERSE REACTIONS

In patients receiving EXDENSUR, the most common adverse reactions (≥4%) were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. Injection site reactions also occurred.

USE IN SPECIFIC POPULATIONS

The data in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.

The potential clinical impact of depemokimab-ulaa transmission to the fetus is unknown as the effect of YTE modification on placental transfer is uncertain and may lead to prolonged exposure in an infant. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1-888-825-5249.

About the SWIFT phase III trials

Results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.¹

The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care (SOC) treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.¹

About the depemokimab development program

The phase III program consists of SWIFT-1 and SWIFT-2 in severe asthma, with an open label extension study (AGILE), and the ANCHOR-1 and ANCHOR-2 trials in chronic rhinosinusitis with nasal polyps (CRSwNP).^1,10,11 Depemokimab is currently being evaluated in phase III trials for the treatment of other diseases with underlying type 2 inflammation, including OCEAN for EGPA and DESTINY for HES.^12,13 GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of depemokimab as an add-on therapy in patients with uncontrolled moderate to severe COPD with type 2 inflammation.¹⁴

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD, along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q3 Results for 2025.

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References

1. Jackson, David J., et al. “Twice-yearly Depemokimab in severe asthma with an eosinophilic phenotype.” New England Journal of Medicine, vol. 391, no. 24, 19 Dec. 2024, pp. 2337–2349, https://doi.org/10.1056/nejmoa2406673.
2. Wang, Eileen, et al. “Characterization of severe asthma worldwide.” CHEST, vol. 157, no. 4, Apr. 2020, pp. 790–804, https://doi.org/10.1016/j.chest.2019.10.053.
3. Menzies-Gow, Andrew, et al. “A renewed charter: Key principles to improve patient care in severe asthma.” Advances in Therapy, vol. 39, no. 12, 17 Oct. 2022, pp. 5307–5326, https://doi.org/10.1007/s12325-022-02340-w.
4. “Cost of Asthma on Society.” Cost of Asthma on Society, Asthma & Allergy Foundation of America, 31 Jan. 2025, https://www.aafa.org/advocacy/key-issues/access-to-health-care/cost-of-asthma-on-society.
5. Park, Jihye, et al. “Unmet treatment needs in asthma patients with eosinophilic phenotype: A US claims-based study on asthma exacerbations and Healthcare Resource Utilization.” CHEST, vol. 166, no. 4, Oct. 2024, https://doi.org/10.1016/j.chest.2024.06.2816.
6. Tal-Singer, Ruth, et al. “Disease impact and perception of biologics in adults with type 2 inflammation respiratory disease: International survey results.” Patient Preference and Adherence, Volume 19, Apr. 2025, pp. 1159–1170, https://doi.org/10.2147/ppa.s517466.
7. Research Partnership Quant uptake Market Research, 200 HCPs Top two box on a seven-point scale where seven equaled “highly beneficial”.
8. Brussino, Luisa, et al. “Is it severe asthma or asthma with severe comorbidities?” Journal of Asthma and Allergy, Volume 10, Nov. 2017, pp. 303–305, https://doi.org/10.2147/jaa.s150462.
9. Heaney, Liam G., et al. “Eosinophilic and noneosinophilic asthma.” CHEST, vol. 160, no. 3, Sept. 2021, pp. 814–830, https://doi.org/10.1016/j.chest.2021.04.013.
10. “An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (AGILE).” ClinicalTrials.gov, GlaxoSmithKline, clinicaltrials.gov/study/NCT05243680. Accessed 8 Dec. 2025.
11. Gevaert P, Desrosiers M, Cornet M, Mullol J, De Corso E, Keles Turel N, Maspero J, Fujieda S, Zhang L, Sousa AR, Woods SJ, Davis AM, Schalkwijk S, Edwards D, Ranganathan P, Follows R, Marshall C, Han JK; ANCHOR-1 and ANCHOR-2 trial investigators. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials. Lancet. 2025 Mar 15;405(10482):911-926. doi: 10.1016/S0140-6736(25)00197-7.
12. “Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) (OCEAN).” ClinicalTrials.gov, GlaxoSmithKline, clinicaltrials.gov/study/NCT05263934. Accessed 8 Dec. 2025.
13. “Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY).” ClinicalTrials.gov, GlaxoSmithKline, clinicaltrials.gov/study/NCT05334368. Accessed 8 Dec. 2025.
14. “Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1).” ClinicalTrials.Gov, GlaxoSmithKline, clinicaltrials.gov/study/NCT06959095. Accessed 8 Dec. 2025.

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Immunome Announces Pricing of Public Offering of Common Stock




Immunome Announces Pricing of Public Offering of Common Stock

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (“Immunome”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced the pricing of an underwritten public offering of 18,625,000 shares of its common stock at a price to the public of $21.50 per share. All of the shares are to be sold by Immunome.

The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $400 million. In addition, Immunome has granted the underwriters a 30-day option to purchase up to an additional 2,793,750 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 18, 2025, subject to the satisfaction of customary closing conditions.

Leerink Partners, J.P. Morgan, TD Cowen, Goldman Sachs & Co. LLC and Guggenheim Securities are acting as joint bookrunning managers for the offering. Wedbush PacGrow and LifeSci Capital are acting as co-lead managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 13, 2024, and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at TDManualrequest@broadridge.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.

Forward-Looking Statements

Statements contained in this press release regarding Immunome’s expectations regarding the offering are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Immunome’s expectations of market conditions and the satisfaction of customary closing conditions related to the public offering, and the expected closing of the offering and the anticipated use of proceeds therefrom, and are based upon Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, Immunome’s expectations regarding market conditions, the satisfaction of customary closing conditions related to the offering, Immunome’s ability to complete the offering, and the risks and uncertainties inherent in Immunome’s business. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Immunome’s most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Immunome’s other filings with the SEC, including those contained or incorporated by reference in the preliminary prospectus supplement and accompanying prospectus related to the offering filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Immunome undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts

Investor Contact:
Max Rosett

Chief Financial Officer

mrosett@immunome.com

Media Contact:
Nicole Foderaro

Real Chemistry

media@immunome.com

Pfizer Reaffirms Full-Year 2025 EPS Guidance and Provides Full-Year 2026 Guidance




Pfizer Reaffirms Full-Year 2025 EPS Guidance and Provides Full-Year 2026 Guidance

• Continued Investment in Pipeline and Acquired Assets in 2026 to Fuel Long-Term Growth
• Reaffirms Full-Year 2025 Adjusted⁽¹⁾ Diluted EPS Guidance⁽²⁾ and Revises Full-Year 2025 Revenue Guidance⁽²⁾ to Approximately $62.0 Billion
• Full-Year 2026 Revenue Guidance⁽²⁾ Range of $59.5 to $62.5 Billion
• Full-Year 2026 Adjusted⁽¹⁾ Diluted EPS Guidance⁽²⁾ Range of $2.80 to $3.00

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today provided its full-year 2026 guidance⁽²⁾ while revising its November 4, 2025 full-year 2025 Revenue guidance⁽²⁾ and reaffirming all other components of full-year 2025 financial guidance⁽²⁾. The accompanying presentation can be found at www.pfizer.com/investors.

FULL-YEAR 2026 REVENUE GUIDANCE⁽²⁾

Pfizer anticipates full-year 2026 revenues to be in the range of $59.5 to $62.5 billion, while full-year 2025 revenue guidance⁽²⁾ is revised to approximately $62.0 billion from the range of $61.0 to $64.0 billion previously. Full-year 2026 revenue guidance⁽²⁾ includes the expectation of revenues from our COVID-19 products being approximately $1.5 billion lower than what is expected in 2025 plus an expected year-over-year negative revenue impact of approximately $1.5 billion due to certain products experiencing loss of exclusivity (LOE)⁽²⁾. Pfizer expects full-year 2026 operational⁽³⁾ revenue growth at the midpoint, excluding both COVID-19 and LOE products, to be approximately 4% year-over-year.

FULL-YEAR 2026 ADJUSTED⁽¹⁾ SI&A and ADJUSTED⁽¹⁾ R&D EXPENSES GUIDANCE⁽²⁾

Pfizer anticipates full-year 2026 Adjusted⁽¹⁾ SI&A expenses to be in the range of $12.5 to $13.5 billion, reflecting ongoing progress with our Cost Realignment Program. The company anticipates full-year 2026 Adjusted⁽¹⁾ R&D expenses to be in the range of $10.5 to $11.5 billion, reflecting continued focus on prioritization in key therapeutic areas and maximizing the development of PF-08634404 (a PD-1 x VEGF bispecific antibody in-licensed from 3SBio) as well as multiple clinical programs from Metsera. Consequently, total 2026 Adjusted⁽¹⁾ SI&A and R&D expenses are expected to be in the range of $23.0 to $25.0 billion.

FULL-YEAR 2026 ADJUSTED⁽¹⁾ DILUTED EPS GUIDANCE⁽²⁾

Pfizer anticipates full-year 2026 Adjusted⁽¹⁾ diluted EPS to be in a range of $2.80 to $3.00. 2026 Adjusted⁽¹⁾ diluted EPS guidance⁽²⁾ primarily reflects our expected revenues, anticipated stable gross and operating margins vs full-year 2025 guidance⁽²⁾, and an anticipated higher tax rate on Adjusted⁽¹⁾ income vs full-year 2025 guidance⁽²⁾.

A comparison of Pfizer’s 2025 Financial Guidance⁽²⁾ to its 2026 Financial Guidance⁽²⁾ is presented below.

Financial guidance for Adjusted⁽¹⁾ diluted EPS is calculated using approximately 5.71 billion weighted-average shares outstanding in 2025 and approximately 5.74 billion weighted-average shares outstanding in 2026, and assumes no share repurchases in 2025 or 2026.

CEO COMMENTARY

“2025 was a year of strong execution and strategic progress for Pfizer. We’ve strengthened our foundation, advanced our R&D pipeline and positioned our company for sustainable growth in the post-LOE period. As we move into 2026, we’re focused on serving patients with innovative medicines and vaccines while creating long-term value for our shareholders.”

PFIZER TO HOST CONFERENCE CALL

Pfizer will host a live conference call and webcast today, December 16, 2025, at 8:00 AM EST. To access the live conference call as well as view the Full-Year 2026 Financial Guidance presentation, visit our website at pfizer.com/investors.

You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is “71848”.

The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

DISCLOSURE NOTICE: The information contained in this press release is as of December 16, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release or the webcast as the result of new information or future events or developments.

This press release and the webcast contain or may contain forward-looking information about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy, goals and prospects; expectations for our product pipeline (including products from completed or anticipated acquisitions), in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, discontinuations, clinical trial results and other developing data, revenue contribution and projections, pricing and reimbursement, market dynamics, including demand, market size and utilization rates and growth, performance, timing and duration of exclusivity and potential benefits; the impact and potential impact of tariffs and pricing dynamics; strategic reviews; leverage and capital allocation objectives; an enterprise-wide cost realignment program (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our acquisition of Seagen, our acquisition of Metsera and our licensing agreement with 3SBio, and our ability to successfully capitalize on growth opportunities and prospects; our voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer’s plans to further invest in U.S. manufacturing; manufacturing and product supply; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and the expected seasonality of demand for certain of our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure you that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Pfizer’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:

Risks Related to Our Business, Industry and Operations, and Business Development:

• the outcome of research and development (R&D) activities, including the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates, including as a result of clinical trial data or regulatory feedback that could impact the future development of our product candidates, including our vaccine candidates such as our next generation pneumococcal conjugate vaccine candidate;
• our ability to successfully address comments received from regulatory authorities such as the U.S. Food and Drug Administration or the European Medicines Agency, or obtain approval for new products and indications from regulators on a timely basis or at all;
• regulatory decisions impacting labeling, approval or authorization, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain or maintain, and the scope of, recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates;
• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential;
• the success and impact of external business development activities, such as the November 2025 acquisition of Metsera, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, including the possibility that such transactions do not close; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business or operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities;
• competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
• the ability to successfully market both new and existing products, including biosimilars;
• difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
• the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
• risks and uncertainties related to Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, including, among others, the risk that as the market for COVID-19 products remains endemic and seasonal and/or COVID-19 infection rates do not follow prior patterns, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has in the past and may continue to lead to reduced revenues, excess inventory or other unanticipated charges; risks related to our ability to develop, receive regulatory approval for, and commercialize variant adapted vaccines, combinations and/or treatments; uncertainties related to recommendations and coverage for, and the public’s adherence to, vaccines, boosters, treatments or combinations, including uncertainties related to the potential impact of narrowing recommended patient populations; whether or when our EUAs or biologics licenses will expire, terminate or be revoked; risks related to our ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; and potential third-party royalties or other claims related to Comirnaty and Paxlovid;
• trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
• interest rate and foreign currency exchange rate fluctuations, including the impact of global trade tensions, as well as currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates;
• any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
• the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
• any significant issues related to the outsourcing of certain operational and staff functions to third parties;
• any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors;
• uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
• the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions, tariffs and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
• risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy regarding tariffs or other trade policy and/or the impact of any potential U.S. Governmental shutdowns, including impacts on governmental agencies due to a shutdown;
• the risk and impact of tariffs on our business, which is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, and potential retaliatory tariffs or other retaliatory actions imposed by other countries;
• the impact of disruptions related to climate change and natural disasters;
• any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
• the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on Oxbryta and other sickle cell disease assets;
• trade buying patterns;
• the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
• the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
• the ability to successfully achieve our climate-related goals and progress our environmental sustainability and other priorities;

Risks Related to Government Regulation and Legal Proceedings:

• the impact of any U.S. healthcare reform or legislation, including executive orders or other change in laws, regulations or policy, or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Drug Pricing Program or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022 (IRA) and the IRA Medicare Part D Redesign, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
• risks and uncertainties related to the impact of Pfizer’s voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer’s plans to further invest in U.S. manufacturing, including risks relating to entering into definitive agreements with the U.S. Government and the initiation of new tariffs not subject to Pfizer’s grace period;
• U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, including international reference pricing, including Most-Favored-Nation drug pricing, intellectual property, reimbursement or access to or recommendations for our medicines and vaccines, tax changes or other restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
• risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S., including the U.S. Food and Drug Administration’s recently adopted policy of disclosing Complete Response Letters for unapproved drug candidates and the attendant risk of disclosure of trade secrets or confidential commercial information;
• legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, data protection and cybersecurity, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets;
• leg

Contacts

Media: PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor: IR@Pfizer.com

Read full story here

Atom Therapeutics Launches Multi-Regional Phase 2 Trial of ABP-745 for Atherosclerotic Cardiovascular Disease (ASCVD)




Atom Therapeutics Launches Multi-Regional Phase 2 Trial of ABP-745 for Atherosclerotic Cardiovascular Disease (ASCVD)

HANGZHOU, China–(BUSINESS WIRE)–Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, today announced FDA approval of a Phase II clinical trial application of ABP-745, a novel anti-inflammatory agent for atherosclerosis. The company has launched a multi-regional Phase II trial globally.

Atherosclerosis is a common cardiovascular disease and a key driver of major adverse cardiovascular events (MACE). Each year, cardiovascular diseases caused by atherosclerosis lead to approximately 18 million deaths worldwide. Risk factors including hypertension, hyperlipidemia, hyperglycemia, and chronic inflammation cause damage to the vascular endothelium, prompting the deposition and oxidation of low-density lipoprotein (LDL) and cholesterol, and eliciting local inflammatory responses. This leads to the formation of foam cells and lipid-rich plaques, ultimately resulting in vascular narrowing, hardening, reduced elasticity, thinning, and even rupture. Rupture of unstable plaques triggers thrombosis, leading to acute vascular stenosis, which may cause severe outcomes including myocardial infarction, stroke, and death.

Current treatments for atherosclerosis primarily rely on lipid-lowering therapies, including statins, ezetimibe, and PCSK9 inhibitors; however, precise targeted intervention against inflammation pathways associated with plaque formation has not yet been achieved. Chronic inflammation is involved in every stage of atherosclerosis. The release of inflammatory mediators not only further aggravates endothelial injury, promotes lipid deposition, and increases plaque instability, but also elevates the risk of plaque rupture, making inflammation an independent risk factor for cardiovascular events.

Colchicine became the first anti-inflammatory drug approved by the FDA in 2023 for the treatment of cardiovascular disease. On top of standard lipid-lowering therapy, colchicine further reduced the risk of MACE by 31% through its anti-inflammatory mechanism. Recent clinical studies have shown that colchicine combining with standard treatment significantly reduces atherosclerotic plaque burden. Notably, 1% regression in plaque volume is associated with a 25% reduction in the odds of MACE. However, the use of colchicine in ASCVD is still limited due to its narrow therapeutic window, which restricts the dosage, and its potential for drug-drug interactions. For example, co-administration with certain statins can further increase the risk of rhabdomyolysis, thereby limiting its broader clinical application.

Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics, commented, “ABP-745’s entry into Phase II clinical trials for atherosclerosis represents a pivotal milestone, marking its expansion into diseases driven by chronic inflammation. This milestone enables Atom Therapeutics to establish a strategic foothold in the dual therapeutic areas of metabolism and cardiovascular diseases, thereby substantially strengthening the company’s core competitive edge in inflammatory diseases.”

ABP-745, administered orally, poses no risk of drug-drug interactions. Animal studies have shown that, compared with colchicine, its therapeutic safety window is significantly wider. ABP-745 inhibits activation of the NLRP3 inflammasome, suppresses the recruitment of inflammatory cells to plaque sites, and potently inhibits multiple key inflammatory cytokines, including IL-1β, IL-6, IL-18, TNF-α, and CRP, thereby covering the full inflammatory cascade of atherosclerosis from endothelial injury to plaque rupture. The study in mice showed that the administration of ABP-745 resulted in the reduction of aortic plaque area up to 56.1% compared with the model group. In another similar study, combination therapy of ABP-745 with statins reduced aortic plaque area by more than 75%. ABP-745 has demonstrated robust plaque-lowering effects.

ABP-745 has completed a favorable safety, tolerability and pharmacokinetic profile in its Phase I trial in the U.S. and China. A multi-regional Phase II trial for acute gout flares is currently advancing across the U.S., Australia, and China.

About Atom Therapeutics

Atom Therapeutics Co., Ltd (formerly Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) is a fast-growing innovative clinical stage biotechnology company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, lingdolinurad (ABP-671), is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, is in global Phase 2 clinical trials for acute gout. For more information, please visit: https://atomthera.us/

Contacts

Media Contact:
Daniel Eramian

Opus Biotech Communications

http://opusbiotech.com/
425-306-8716

Business Development Contact:
Roy J. Wu, MBA

Sr. Vice President, Business Development

Atom Therapeutics

Email: roy.wu@atombp.com

Tubulis to Present at the 44th Annual J.P. Morgan Healthcare Conference




Tubulis to Present at the 44th Annual J.P. Morgan Healthcare Conference

MUNICH–(BUSINESS WIRE)–Tubulis today announced that its CEO and Co-founder Dominik Schumacher will present a company overview and update at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco.

The presentation will take place on Monday, January 12, 2026, at 3:00 pm PT in the Mission Bay Room (32nd Floor) at The Westin St. Francis.

About Tubulis

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models and first clinical proof-of-concept in platinum-resistant ovarian cancer. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.

Contacts

For Tubulis
Dominik Schumacher, CEO & Co-founder

Phone: +49 (0) 175 800 5594

Email: contact@tubulis.com

Media Requests for Tubulis
Trophic Communications

Stephanie May, PhD

Phone: +49 (0) 171 185 56 82

Email: tubulis@trophic.eu

Latent Labs Announces Latent-X2: AI-Generated Antibodies With Drug-Like Developability and Low Ex Vivo Immunogenicity




Latent Labs Announces Latent-X2: AI-Generated Antibodies With Drug-Like Developability and Low Ex Vivo Immunogenicity

LONDON & SAN FRANCISCO–(BUSINESS WIRE)–Today, Latent Labs announces Latent-X2, a frontier AI model that can design drug-like biologics without iteration. Drug hunters can use Latent Lab’s AI platform, built on Latent-X2, to access difficult targets and accelerate development timelines by reducing wet lab work. The generated designs display drug-like properties including low ex vivo immunogenicity, significantly shortening the path from hit to clinical candidate. Alongside the release, Latent Labs welcomes Stefan Oschmann, former CEO of Merck KGaA, to its strategic advisory board. Latent Labs is opening access to the model for selected partners.

The Development Bottleneck. Current wet lab approaches are costly not merely in development effort but in clinical failure. Hits rarely possess properties needed for clinical success, and optimization to address liabilities frequently fails or produces zero-sum tradeoffs. Suboptimal starting points risk costly downstream failure in clinical programs, and addressing shortcomings requires long development timelines.

Latent Labs Platform. Through the Latent Labs Platform, partners and customers can generate antibodies and peptides for disease targets of their choice. It produces high-affinity binders across VHH, scFv, and macrocyclic peptide formats – approaching drug-like quality from the first generation. The platform provides a scientist-friendly workflow, accessible to customers via web browser or by integrating their own systems with the Latent Labs API.

Zero-Shot Antibody and Peptide Design. Latent-X2 generates antibodies that bind challenging targets from the first generation – achieving hits against half of 18 targets selected for diversity and difficulty, with picomolar to nanomolar affinities and each requiring only 4 to 24 designs. The model generalizes beyond antibodies: macrocyclic peptides bind K-Ras, long considered undruggable, matching or exceeding hits from trillion-scale mRNA display screens while testing 11 orders of magnitude fewer sequences.

Drug-Like by Default. Antibodies designed by Latent-X2 exhibit developability profiles matching or exceeding approved therapeutic controls in head-to-head comparison. This extends to proxies for immunogenicity: in the first such assessment of any AI-generated antibody, de novo VHH binders were evaluated across a ten-donor human panel in ex vivo T-cell activation and cytokine release assays, confirming both potent target engagement and low immunogenicity. While animal studies and clinical trials remain ahead, these results demonstrate that AI-generated molecules can now clear preclinical hurdles that previously required lengthy optimization.

“Semiconductors, satellites and aircraft once required repeated build-test cycles, consuming years and billions of dollars. Today they’re designed computationally before anything is fabricated. With Latent-X2, drug discovery can move towards that same step change – designing the right molecule from the start,” said Simon Kohl, CEO and founder of Latent Labs.

Strategic Advisory Board. Latent Labs announces the appointment of Stefan Oschmann, former CEO of Merck KGaA (until 2021), to its strategic advisory board. “The pharmaceutical industry has spent decades optimizing around the limitations of iterative lab work. Latent Labs is doing something different – building the capability to design molecules that work from first principles. That shift, if it holds, changes the entire logic of drug discovery,” said Oschmann.

Access. Latent-X2 will be available to selected partners. Interest for access can be expressed at partnerships@latentlabs.com.

Latent-X2 builds on the success of Latent-X1, released just five months ago. Latent-X1 has been adopted by industry and academic groups worldwide, who value its performance and no-code interface for real lab applications.

Ten months ago Latent Labs announced its $50M funding round, co-led by Radical Ventures and Sofinnova Partners, with participation by Anthropic’s CEO Dario Amodei, Eleven Labs’ CEO Mati Staniszewski, and Google’s Chief Scientist Jeff Dean. The team includes former AlphaFold 2 co-developers and ex-DeepMind team leads, with experience from Microsoft, Apple, Exscientia, Mammoth Bio, Altos Labs, and Zymergen.

Q&A

Commercial questions

What are the terms for commercial use?

• Latent-X2 is available on request and through commercial partnerships. For partnership inquiries, reach out to partnerships@latentlabs.com.

How can I get in touch for commercial partnerships?

• Contact partnerships@latentlabs.com.

Scientific questions

What is a typical application for Latent-X2?

• Typical applications include the design of antibodies (VHH, scFv) and macrocyclic peptides for drug development programs. The model is particularly suited for generating drug-like antibody molecules.

How is Latent-X2 different from Latent-X1?

• Latent-X1 focused on macrocyclic peptides and protein mini-binders with strong binding affinities. Latent-X2 advances to antibodies (VHH, scFv) with drug-like developability and demonstrated low ex vivo immunogenicity in initial studies. These profiles emerge without post-generation iteration.

How many designs are typically needed?

• Latent-X2 achieves strong lab results with 4 to 24 designs per target for antibodies, representing efficiency gains of many orders of magnitude compared to conventional screening methods.

What targets has Latent-X2 been validated against?

• We tested antibody designs against 18 soluble proteins, achieving picomolar to nanomolar hits against half the targets. Macrocyclic peptides were validated against 2 targets including K-Ras.

Do generated molecules require optimization?

• In our validation studies, developability profiles emerged directly from the model without iteration, on par or better than approved therapeutics. Nonetheless, we expect some designs to require further development and optimization.

Broader questions

How does Latent Labs ensure safe usage of the technology?

• Latent Labs actively participates in biosafety and biosecurity discussions with government and regulatory authorities regarding responsible development and preventing potential misuse of emerging technologies. Latent Labs continuously assesses its technologies and restricts access to its services in compliance with international sanctions lists from the EU and UK.

Contacts

contact@latentlabs.com

TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth




TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth

BORDEAUX, France–(BUSINESS WIRE)–#CellTherapyForAll–TreeFrog Therapeutics, a French biotech focused on bringing regenerative medicine to millions through their proprietary cell technology, C-Stem™ is delighted to announce the appointment of skilled biotech leader, Mark Rothera, as Chief Executive Officer and Board member. He succeeds Frédéric Desdouits, who is stepping down after five years in the role. In the new leadership configuration, co-founders Kévin Alessandri and Maxime Feyeux will transition from daily operations to focus on their roles on the Board.

Elsy Boglioli, Chair of the Board of TreeFrog Therapeutics, commented “On behalf of the Board, we are delighted to welcome Mark to TreeFrog. His 30+ years of biopharma leadership, including most recently, three biotech CEO roles in gene therapy and biologics, will be invaluable as we advance our Parkinson’s and liver programs, further strengthen our regenerative medicine platform and pursue strategic partnerships such as the one in place with Vertex for their Type 1 Diabetes pipeline. I would like to thank Frédéric for his leadership over the past 5 years which have been transformational for TreeFrog, moving from an early-stage research platform to a development engine with operations in France and in the US.”

Mark Rothera has built a strong reputation, driving the successful scale up of multiple biotech companies, including most recently, Viracta, Silence Therapeutics and Orchard Therapeutics. Renowned for building strong leadership teams that advance novel medicines through development to regulatory approval and commercialization, Mark has focused much of his career on specialty diseases and novel modalities including gene therapy and RNAi therapies. In his earlier career, he held commercial lead roles in PTC Therapeutics, Aegerion, Shire, and GSK. Mark serves on the Board of GenPharm and holds an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

“I am excited to join TreeFrog at this pivotal moment,” said Rothera. “I am proud to take the lead on delivering the vision of the co-founders – ‘Cell Therapy for All’. The company has developed technology that can unlock the potential of regenerative medicine to transform outcomes across a range of serious conditions. I am looking forward to working with the talented team at TreeFrog and our partners to advance breakthrough medicines to millions of patients.”

Ends

About TreeFrog Therapeutics

TreeFrog Therapeutics is a French-based regenerative medicine biotech set to unlock access to cell therapies for millions of patients. TreeFrog is unique in its approach to cell therapy development, bringing together biophysicists, cell biologists and bioproduction engineers to address the challenges of the industry – producing and differentiating cells of quality at unprecedented scale, cost-effectively. To succeed in their mission of Cell Therapy for all, TreeFrog operates a business model that includes its own therapeutic programs and partnerships with leading biotech and industry players. Since 2021, the company has raised $82 million to advance a pipeline of stem cell-based therapies in regenerative medicine.

For further information, visit www.treefrog.fr

Contacts

Media Contact
Rachel Mooney

Chief Communications Officer, TreeFrog Therapeutics

Tel: +33 674 06 34 61

Email: Rachel.mooney@treefrog.fr

LEO Pharma Appoints Marika Murto to Lead Global Product Strategy




LEO Pharma Appoints Marika Murto to Lead Global Product Strategy

• Marika Murto brings over 20 years of pharmaceutical expertise in product strategy, innovation, and business transformation
• Her appointment as SVP of Global Product Strategy will help unlock LEO Pharma’s portfolio potential, driving patient impact and supporting sustainable growth

BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma, a global leader in medical dermatology, announces the appointment of Marika Murto, PhD, as SVP of Global Product Strategy and member of the Global Leadership Team.

Marika joins LEO Pharma from Amgen, where she most recently served as Associate Vice President and U.S. Commercial Lead for Bone Health, driving strategic brand positioning and cross‑functional collaboration. Her career at Amgen included senior global and affiliate leadership roles, including General Manager for the Netherlands, Global Product Team Lead for Bone Health, and Country Director for Finland. She has also held senior commercial positions at Pfizer and Roche, gaining expertise across oncology, vaccines, specialty medicines, and portfolio strategy.

“I’m very excited to join LEO Pharma and lead Global Product Strategy at such an important point in the company’s journey. Effective product strategy is about uniting great science, market insight, and organizational excellence to create meaningful results for patients. I’m passionate about empowering diverse, results driven teams and embedding innovation in all that we do,” says Marika Murto.

With her deep global experience and ability to combine scientific understanding with strategic execution, Marika will play a key role in shaping the direction of LEO Pharma’s portfolio, ensuring it is positioned to deliver strong impact for patients and sustainable growth for the company.

“Marika’s strong international background, strategic mindset, and ability to connect vision with delivery make her an outstanding choice to lead Global Product Strategy. She has shown throughout her career that she can shape complex portfolios and succeed across diverse markets. I very much look forward to welcoming her to the LEO Pharma team,” says Christophe Bourdon, CEO.

“I’d like to sincerely thank Lisa Elliot for stepping in as interim head of Global Product Strategy during this important period. I’m truly pleased that she will continue to contribute her expertise, dedication, and deep knowledge of our company in her previous role within Global Asset & Payer Strategy,” says Christophe.

Marika Murto will join LEO Pharma as Senior Vice President of Global Product Strategy on February 1, 2026.

Contacts

Jeppe Ilkjær

Director, Strategic Communication and Projects

Corporate Affairs

Mobile +45 3050 2014

Mail JEILK@leo-pharma.com

RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)




RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)

• RoslinCT is performing technology transfer and will support commercial manufacture of Omisirge^® for an additional indication following successful clinical trials
• Omisirge^® now FDA-approved for an expanded patient population in hematology
• RoslinCT continues to support and advance multiple cell therapy projects at its Hopkinton, MA facility

BOSTON–(BUSINESS WIRE)–Ayrmid Ltd., the parent company of Gamida Cell Inc., a pioneering cell therapy company transforming cells into powerful therapeutics, and RoslinCT, a global leader in cell and gene therapy contract development and manufacturing, today announced the expansion of their strategic partnership to include the execution of a commercial supply agreement to support production of Omisirge^® (omidubicel-onlv).

Following positive clinical trial results, Omisirge^® has received FDA approval for a second indication, broadening its use in the treatment of hematology patients. Under the commercial supply agreement, RoslinCT will complete technology transfer and support commercial manufacturing of Omisirge^® for this additional indication at its state-of-the-art cGMP cell therapy manufacturing facility in Hopkinton, MA.

“We are excited to expand our collaboration with RoslinCT to add US manufacturing as Omisirge^® moves into its next phase with the recent FDA approval for patients suffering from severe aplastic anemia,” said Dr Joe Wiley, Chairman and Chief Executive Officer of Ayrmid Ltd. “This important strategic partnership enhances our dual sourcing approach and secures patient supply in the longer term.”

“The expansion of Omisirge^®’s commercial manufacturing at RoslinCT demonstrates the strength of our partnership and the capability of our facilities to support innovative therapies at scale,” said Peter Coleman, Chief Executive Officer of RoslinCT. “Alongside Omisirge^®, we continue to progress multiple cell therapy projects, reflecting our commitment to enabling transformative treatments for patients worldwide.”

About Omisirge^®

Omisirge^® is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from the youngest donor source, designed for ease of infusion. The product is FDA-approved and commercialized for patients with hematologic malignancies. With the new indication, Omisirge^® now provides treatment options for a broader patient population, enhancing its potential to improve outcomes.

About RoslinCT

RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies. Established in 2005 and built upon the ground-breaking technology cloning of Dolly the Sheep at the Roslin Institute in 1996, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones. These include being among one of the first in the world to produce clinical-grade human pluripotent stem cells. In collaboration with the partners, RoslinCT also developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation.

With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialisation and deliver life-saving Cell and Gene Therapies worldwide. RoslinCT is a GHO Capital portfolio company. Discover more about our services at www.roslinct.com.

About Ayrmid Ltd. and Gamida Cell

Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge (please see the current full Prescribing Information, including boxed warning, here) and APHEXDA^® (please see the current full Prescribing Information here). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.

Contacts

Gamida Investor and Media Contact:

e-mail: BD@Gamida-Cell.com

RoslinCT Media Contact:

Katerina Tsita

Katerina.Tsita@roslinct.com
+44 (0)7867 494071