Aankondiging • Jan 14

Ventyx Biosciences Highlights 2025 Pipeline Strategy and Provides Clinical Updates on Its Nlrp3 Inhibitor Portfolio

Ventyx Biosciences, Inc. highlighted its 2025 pipeline strategy and provided clinical updates on its NLRP3 inhibitor portfolio, including VTX2735 and VTX3232. Pipeline Updates and Anticipated Milestones: NLRP3 Inhibitor Portfolio: Ventyx is advancing a portfolio of potential best-in-class oral NLRP3 inhibitors for systemic inflammatory conditions and neurodegenerative diseases, including VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a CNS-penetrant NLRP3 inhibitor. VTX2735 in Recurrent Pericarditis: A single dose, open-label Phase 2 trial of VTX2735 in participants with recurrent pericarditis is expected to initiate in January. The trial will enroll approximately 30 participants for a 6-week primary treatment period, followed by a 7-week extension period. Key endpoints include safety, change in the NRS pain score, and change in high sensitivity C-reactive protein (hsCRP). Topline results are expected in the second half of 2025. Recurrent pericarditis is considered to be an autoinflammatory condition caused by over-activity of the innate-immune system. In particular, the disease pathophysiology is associated with aberrant activation of the NLRP3 inflammasome and IL-1, the initial cytokine of the innate immune system. Recently, concentrations of NLRP3 have been shown to be elevated in pericardial samples from patients with recurrent pericarditis compared to healthy controls. Patients refractory to non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are commonly treated with injectable IL-1 therapies, though substantial unmet medical need remains. They believe that, by treating and preventing disease recurrence, VTX2735 has the potential to offer a safe, effective, and convenient oral therapy for patients suffering from recurrent pericarditis.VTX3232 in Cardiometabolic Diseases: Dosing has initiated in a randomized, placebo-controlled Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors. The trial is expected to enroll approximately 160 subjects randomized to one of four groups for a 12-week primary treatment period: monotherapy placebo, monotherapy VTX3232, combination semaglutide + placebo, or combination semaglutide + VTX3232. Key endpoints include safety and change in hsCRP. The trial also includes a panel of exploratory endpoints, including biomarkers of inflammation and cardiometabolic disease, as well as imaging to assess body composition and liver fat. Topline results are expected in the second half of 2025. Activation of the NLRP3 inflammasome, and resulting chronic inflammation, has been linked to a range of cardiometabolic diseases including atherosclerosis, insulin resistance, and obesity. The Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors is designed as a signal-finding trial to identify the effects of NLRP3 inhibition on a broad panel of inflammatory and metabolic biomarkers, including IL-6 and hsCRP. Data from the Phase 2 trial are expected to inform future development of the Company’s NLRP3 inhibitors in cardiometabolic diseases.VTX3232 in Parkinson’s Disease: Enrollment is progressing in the ongoing Phase 2 biomarker and imaging trial of VTX3232 in participants with early Parkinson’s disease. This trial is expected to enroll approximately 10 participants for a 28-day open-label treatment period. Key endpoints include safety, pharmacokinetics, and biomarkers in cerebrospinal fluid (CSF) and plasma. The trial also includes exploratory TSPO PET imaging as a marker of microglial activation. Topline results are expected in the first half of 2025. In a disease as complex as human Parkinson’s disease, the regulatory networks in microglia and other neural cell types linking the pathological consequence of NLRP3-mediated neuroinflammation to the progression of Parkinson’s disease are still unclear. However, overexpression of IL-1b and IL-18 has been observed in CSF samples from Parkinson’s disease patients, suggesting NLRP3 inhibition in the CNS may offer a disease-modifying therapeutic approach. The Phase 2 trial of VTX3232 in early Parkinson’s disease is designed to generate data in support of this therapeutic hypothesis by demonstrating the ability to modulate key inflammatory and disease-related biomarkers in the CSF, downstream of NLRP3 activation. Beyond Parkinson’s disease, NLRP3 inhibition in the CNS may have therapeutic utility in a range of neurodegenerative diseases with high unmet medical need, including Alzheimer’s disease, multiple sclerosis, and amyotrophic lateral sclerosis, among others. Inflammatory Bowel Disease (IBD) Portfolio: Tamuzimod (VTX002, S1P1R Modulator, ulcerative colitis): Phase 2 long-term extension (LTE) data presented in October 2024 at the United European Gastroenterology Week meeting continue to reinforce the potential best-in-class profile of tamuzimod in ulcerative colitis (UC). While tamuzimod achieved high rates of clinical and endoscopic remission, a therapeutic ceiling may have been reached with monotherapies. Combination treatment is an emerging therapeutic concept in IBD, and its efficacy and safety profile could position tamuzimod as the backbone of future combination regimens with another oral or biologic agent. The Company continues to explore partnership opportunities for tamuzimod in ulcerative colitis. VTX958 (TYK2 Inhibitor, Crohn’s disease): As previously announced, in a Phase 2 trial, VTX958 did not meet the primary endpoint of change from baseline in the Crohn’s Disease Activity Index (symptomatic outcome) due to an abnormally high placebo response. VTX958 did demonstrate robust, dose-dependent, nominally statistically significant endoscopic response at Week 12 as measured by Simple Endoscopic Score-Crohn’s Disease (SES-CD; an objective endpoint) and showed a greater magnitude of decrease compared to placebo in two key biomarkers of inflammation, CRP and fecal calprotectin. Recognizing the opportunity for a safe and effective oral TYK2 inhibitor as early-line therapy in Crohn’s disease, they are continuing the analysis of the Phase 2 data including data from the 52-week treat-through LTE phase. Full analysis of the Phase 2 data is expected to inform a future development strategy for VTX958 in Crohn's disease, including potential partnership opportunities.

Aankondiging • Mar 11

Ventyx Biosciences, Inc. Reports Clinical Data for Its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Ventyx Biosciences, Inc. will provide clinical and pipeline updates during its virtual investor event. Pipeline Updates: VTX3232 (CNS-penetrant NLRP3 Inhibitor): The company completed a Phase 1 single- and multiple-ascending dose trial of VTX3232 in adult healthy volunteers to assess the safety, pharmacokinetics and pharmacodynamics of VTX3232. Separate cohorts were included in this trial in which serial cerebrospinal fluid (CSF) sampling was conducted to assess drug exposure and target engagement in the CSF. VTX3232 was well-tolerated with no dose-limiting toxicities identified. All treatment-emergent adverse events were graded mild or moderate. VTX3232 exhibited a dose-dependent and dose-linear pharmacokinetic profile. Repeat doses of 3 mg QD maintained steady-state IL-1ß IC50 coverage in both plasma and CSF over 24 hours. Repeat doses of 40 mg QD exceeded steady-state IL-1ß IC90 coverage in both plasma and CSF over 24 hours. Robust, dose-dependent pharmacodynamic effects were observed in a whole blood ex vivo IL-1ß stimulation assay. Additionally, reductions in inflammatory biomarkers were observed in plasma and CSF samples. It believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases. The company expect to initiate a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease during the second half of 2024. The company also expect to initiate a Phase 2a trial of VTX3232 in subjects with obesity and certain additional risk factors for cardiovascular disease during the second half of 2024; VTX2735 (Peripheral NLRP3 Inhibitor): The company completed a Phase 2 trial of VTX2735 in patients with cryopyrin-associated periodic syndromes, or CAPS, a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. This trial enrolled 7 patients with familial cold autoinflammatory syndrome (FCAS), the most common subset of CAPS. Treatment with VTX2735 demonstrated clinically meaningful improvements in disease activity, including an 85% mean reduction in the Key Symptom Score during Treatment Period 1. Reductions in inflammatory biomarkers were also observed, consistent with improvements in disease activity. VTX2735 was well-tolerated and all drug-related adverse events were graded mild. The company believe these data establish compelling clinical proof of concept for its peripheral NLRP3 inhibitor VTX2735. The company plan to evaluate VTX2735 in cardiovascular diseases with an initial focus on the secondary prevention of major adverse cardiovascular events (MACE) and recurrent pericarditis; VTX002 (S1P1R Modulator): In October 2023, the company announced positive results from the Phase 2 trial of VTX002 in patients with moderately to severely active ulcerative colitis (UC). The company believe these results establish VTX002 as a potential best-in-disease oral agent in UC based on its differentiated efficacy profile, including a high rate of complete endoscopic remission, and its potential best-in-class safety profile. At the company virtual investor event, the company will present data from the ongoing Phase 2 open-label extension. the company believe these data continue to support the potentially differentiated profile of VTX002 in ulcerative colitis, with robust rates of clinical remission and endoscopic remission observed among participants completing 52 weeks of treatment with VTX002. At least half of the patients in the 60 mg treat-through group achieved clinical remission or endoscopic remission at Week 52. Activities are underway to prepare for a Phase 3 trial. The company intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of VTX002 in ulcerative colitis; VTX958 (TYK2 Inhibitor): The company is evaluating VTX958 in a Phase 2 trial in patients with moderately to severely active Crohn’s disease. The company recently implemented a protocol amendment for the ongoing Phase 2 trial to streamline trial design and accelerate the detection of an efficacy signal. As a result of the protocol amendment, target enrollment in the trial was revised from approximately 132 patients to approximately 93 patients. The trial’s sole primary endpoint is now the change from baseline in the mean Crohn’s disease activity index (CDAI) score at Week 12. It anticipate completing randomization of the trial during the first quarter of 2024 and expect to report topline results from the Phase 2 Crohn’s disease trial during the middle of 2024.

Pharmaceuticals Groei van de industrie	5.95%
Inkomstengroei	n/a
Rendement op eigen vermogen	-55.71%
Nettomarge	n/a
Laatste winstupdate	30 Sep 2025

Datum	Inkomsten	G+A Uitgaven	R&D-uitgaven
30 Sep 25	-107	29	88
30 Jun 25	-119	30	101
31 Mar 25	-124	31	106
31 Dec 24	-135	31	117
30 Sep 24	-153	32	134
30 Jun 24	-171	32	153
31 Mar 24	-193	33	174
31 Dec 23	-193	32	176
30 Sep 23	-181	32	164
30 Jun 23	-158	30	140
31 Mar 23	-125	27	106
31 Dec 22	-108	25	88
30 Sep 22	-91	21	71
30 Jun 22	-73	17	56
31 Mar 22	-69	13	51
31 Dec 21	-85	9	58
30 Sep 21	-84	5	46
30 Jun 21	-79	3	37
31 Mar 21	-65	1	29
31 Dec 20	-28	1	6

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/03/05 02:12
Aandelenkoers aan het einde van de dag	2026/03/03 00:00
Inkomsten	2025/09/30
Jaarlijkse inkomsten	2024/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Hiroshi Shibutani	Goldman Sachs
Michael Yee	Jefferies LLC
Andrew Tsai	Jefferies LLC

This company has been acquired

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Recente prestatie-updates uit het verleden

Ventyx Biosciences, Inc. to Report Q1, 2024 Results on May 09, 2024

Ventyx Biosciences, Inc. to Report Q2, 2023 Results on Aug 10, 2023

Ventyx Biosciences, Inc. to Report Q1, 2023 Results on May 11, 2023

Recent updates

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Price target increased by 9.4% to US$15.75

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Chief Financial Officer notifies of intention to sell stock

Chief Scientific Officer notifies of intention to sell stock

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