Ventyx Biosciences

Instil Bio's PD-L1xVEGF Bispecific Antibody Shows Promise in NSCLC, Driving 48% Stock Surge

5 hours ago

• Instil Bio's stock jumped 48.4% following positive updates on IMM2510/AXN-2510, a novel PD-L1xVEGF bispecific antibody showing 23% objective response rate in relapsed/refractory non-small cell lung cancer. • The Phase 2 trial of IMM2510/AXN-2510 in first-line NSCLC in China is progressing well, with enrollment expected to complete by Q3 2025 and initial results anticipated later this year. • Instil Bio plans to expand clinical development with a U.S. Phase 1b/2 trial in solid tumors by 2025, potentially accelerating the global development pathway for this promising immunotherapy.

Ventyx's VTX958 Shows Promising Endoscopic Response in Phase 2 Crohn's Disease Trial Despite Missing Primary Endpoint

3 months ago

• Phase 2 trial of VTX958, an oral TYK2 inhibitor, demonstrated significant endoscopic improvement in Crohn's disease patients, with up to 32.4% achieving endoscopic response at Week 12. • While the trial missed its primary CDAI endpoint due to high placebo response, VTX958 showed robust dose-dependent improvements in objective measures including endoscopic scores and inflammatory biomarkers. • The drug maintained a favorable safety profile, supporting its potential as a novel oral therapy option for Crohn's disease patients, with ongoing analysis of 52-week extension data to inform future development.

Ventyx Reports Promising 52-Week Data for Tamuzimod in Ulcerative Colitis Treatment

4 months ago

• Ventyx Biosciences presented extended Phase 2 trial results for tamuzimod (VTX002) at UEG Week 2024, demonstrating sustained efficacy in ulcerative colitis treatment over 52 weeks. • The S1P1R modulator showed potential best-in-class safety profile among oral ulcerative colitis therapies, with high rates of clinical and endoscopic remission observed. • Researchers suggest tamuzimod could serve as a foundation for future combination therapies in ulcerative colitis treatment, marking a significant advancement in oral immunology therapeutics.

Ventyx Biosciences Advances NLRP3 Inhibitor Portfolio with Phase 2 Trials

4 months ago

• Ventyx Biosciences initiated a Phase 2 trial of VTX3232 for obesity and cardiometabolic risk factors, with topline data expected in the second half of 2025. • A Phase 2 trial of VTX2735 for recurrent pericarditis is expected to begin in January, with topline results anticipated in the second half of 2025. • Topline data from an ongoing Phase 2 biomarker trial of VTX3232 in early Parkinson’s disease are expected in the first half of 2025.

VYNE Therapeutics Advances VYN201 and VYN202 in Vitiligo and Psoriasis Trials

5 months ago

• VYNE Therapeutics completes enrollment for Phase 2b trial of VYN201 gel (repibresib) in nonsegmental vitiligo, with top-line data expected mid-2025. • A Phase 1b trial of oral VYN202 for moderate-to-severe plaque psoriasis has begun, with results anticipated by the end of 2025. • Both VYN201 and VYN202 are BET inhibitors designed to address immune-mediated conditions with high unmet needs.

BioAge Labs Halts Azelaprag Trial Due to Safety Concerns, Faces Investor Scrutiny

6 months ago

• BioAge Labs discontinued its Phase 2 STRIDES trial of azelaprag for obesity treatment after observing elevated liver enzymes in participants. • The trial's halt led to a significant drop in BioAge's stock price, prompting investor concern and a formal investigation by Hagens Berman. • BioAge is now facing a class-action lawsuit alleging misleading statements about azelaprag's safety profile prior to the company's IPO. • Despite the setback, BioAge plans to advance other programs, including NLRP3 inhibitors for central nervous system targets, and is working on new drugs targeting azelaprag’s original target.

NLRP3 Inhibitors Show Promise Across Autoimmune, Neurodegenerative, and Metabolic Diseases

6 months ago

• The NLRP3 protein inhibitors pipeline is robust, with over 20 companies developing more than 25 inhibitors targeting various inflammatory conditions. • NLRP3 inhibitors are being explored for treating neurodegenerative diseases like Alzheimer’s and Parkinson’s, as well as metabolic conditions such as NASH. • Clinical trials are underway, with companies like Novo Nordisk and NodThera reporting positive data on their NLRP3 inhibitor candidates. • Collaborations, such as the one between Halia Therapeutics and Biolexis Therapeutics, are advancing the development of brain-penetrant NLRP3 inhibitors for neuroinflammation.

Ventyx Biosciences and Tonix Pharmaceuticals Report Pipeline Updates and Financial Results

6 months ago

• Ventyx Biosciences advances VTX3232 into Phase 2 trials for early Parkinson's and obesity, expecting topline results in H1 and H2 2025, respectively. • Tonix Pharmaceuticals submitted an NDA for TNX-102 SL for fibromyalgia, with a potential FDA decision expected in December 2024. • Tonix Pharmaceuticals secured a DoD contract worth up to $34 million for antiviral drug development and reported Q3 2024 product revenue of $2.8 million. • Ventyx Biosciences reported a cash balance of $274.8 million, expected to fund operations into at least H2 2026, while Tonix Pharmaceuticals reported $28.2 million in cash.

Sanofi's Q3 Sales Surge 15.7% Driven by Vaccines and Dupixent; 2024 EPS Guidance Raised

7 months ago

• Sanofi reported a robust 15.7% sales growth in Q3, fueled by strong vaccine sales and the continued success of Dupixent, with sales up 23.8% to €3,476 million. • Pharma launches, including ALTUVIIIO, Nexviazyme, and Rezurock, saw a significant 67.1% increase, contributing €727 million to the overall sales growth. • The company's pipeline advanced with four regulatory approvals, including Dupixent for COPD in the US and China, and four positive Phase 3 data readouts, including tolebrutinib for nrSPMS. • Based on strong Q3 business performance, Sanofi has raised its 2024 business EPS guidance to at least a low single-digit percentage growth at CER.

Ventyx Biosciences' Tamuzimod Shows Promising Long-Term Efficacy in Ulcerative Colitis Phase 2 Trial

7 months ago

• Ventyx Biosciences presented 52-week data from its Phase 2 trial of tamuzimod (VTX002) in ulcerative colitis at UEG Week 2024, showcasing sustained efficacy. • The data reinforce tamuzimod's potential as a best-in-class S1P1R modulator with a favorable safety profile among oral ulcerative colitis therapies. • High rates of clinical remission and endoscopic remission suggest tamuzimod could serve as a foundational therapy in future combination treatments for ulcerative colitis. • The company believes these results support further development and investigation of tamuzimod's role in managing moderate to severe ulcerative colitis.

Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis

8 months ago

• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis. • The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup. • Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation. • The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.

Ventyx Biosciences Initiates Phase 2a Trial of VTX3232 in Early Parkinson's Disease

9 months ago

• Ventyx Biosciences has commenced a Phase 2a clinical trial of VTX3232 in patients with early Parkinson's disease, marking a significant step in neuroinflammatory disease treatment. • The open-label trial aims to enroll approximately ten patients over a 28-day treatment period, primarily assessing the safety and tolerability of VTX3232. • VTX3232, an oral, selective, CNS-penetrant NLRP3 inhibitor, is being evaluated for its potential to disrupt Parkinson’s disease pathology by targeting microglial NLRP3 activation. • Topline results from the Phase 2a trial, which include pharmacokinetic and biomarker assessments, along with exploratory PET neuroimaging, are expected in 2025.