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Pfizer makes ‘business decision’ to end phase 2 trial of autoimmune drug as program’s future uncertain
Pfizer has called time on a phase 2 trial of its CXCR5 antibody in an autoimmune blood disorder, with the company tight-lipped on whether this marks the end of the road for the asset. The Big Pharma had been evaluating the therapy, dubbed PF-06835375, in a phase 2 study of 61 patients with primary immune thrombocytopenia (ITP) that kicked off in 2022, according to the federal trials register. However, Pfizer confirmed to Fierce on Monday that this study had been terminated “due to a business decision.” “The decision to terminate the trial was not based on any safety concerns,” a spokesperson pointed out. At time of publication, PF-06835375 remained listed on Pfizer’s website for both ITP and lupus. A phase 1 study in lupus wrapped up in 2022, according to the trials database. ITP is an autoimmune disorder characterized by a low platelet count. Novartis was at one point evaluating its B-cell-depleting antibody ianalumab—recently approved as Fabhalta to treat immunoglobulin A nephropathy—as a potential treatment ITP. But the therapy struggled to demonstrate a benefit in the clinic for this indication. When contacted by Fierce, Pfizer wouldn’t confirm whether all work on PF-06835375 has been halted, and whether the company has any other plans to explore C-X-C chemokine receptor type 5 (CXCR5) as a mechanism. CXCR5 is found in blood cancers such as diffuse large B-cell lymphoma and mantle cell lymphoma chemokine receptor. However, there is little expression in normal tissue, which has led some drug developers to explore its potential. Vincerx Pharma had at one point been planning to take an anti-CXCR5 ADC into the clinic to treat B-cell malignancies, but that ambition was scrapped due to cash constraints. Where Big Pharma is placing its bets is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below: [ ](https://qtxasset.com/quartz/qcloud5/media/image/where_big_pharma_is_placing_its_bets.png?VersionId=B8JrRbJ.pFUSK1pJgjeWHLGm_18RdLAy)
eClinical Solutions hosts ENGAGE 2026 with 250+ attendees from 75+ life science firms
eClinical Solutions hosts ENGAGE 2026 with 250+ attendees exploring clinical data management solutions for FDA compliance and trial operations.
Women’s health landscape shifting, but systemic hurdles remain
Closing the data gap with inclusionary research and educating investors on the promise of women’s health innovations remain key steps to health equity.
Patient-Owned Health Data Model Reduces Clinical Trial Recruitment Redundancy
Patient-owned health data model reduces clinical trial recruitment redundancy by enabling persistent consent and longitudinal data sharing across studies.
AB Science’s “Calendar Update” Is a GCP Inspection Disclosure in Disguise
AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three terminated studies deserve a…
ClinicalTrials.gov needs a pregnancy and lactation checkbox
It’s hard to identify which clinical trials pregnant and lactating patients can join. Here’s one fix, experts write.
The Liquid Biopsy That Found Pancreatic Cancer Early Has a Bigger Regulatory Problem Than Its Science
PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle to clinical adoption.
September 17, 2026: IMPACT Collaboratory Seeks Applicants for 2027 Health Care Systems Scholars Program
The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, has announced a request for applications for its […]
September 9, 2026: Embedded Trials in a Learning Health System, in This Week's Rethinking Clinical Trials Grand Rounds
In this Friday’s Rethinking Clinical Trials Grand Rounds, Ryan Zarychanski of the University of Manitoba will present “Embedded Trials in a Learning Health System: A Hospital Policy of Tranexamic Acid […]
Signant Health, Lothar Medical Plan Integrated Respiratory Trial Device
Signant Health and Lothar Medical plan integrated respiratory trial device combining spirometry, oscillometry, and FeNO measurement into a single platform.
ChatGPT for Healthcare unveils Epic integration as part of data consolidation strategy
In addition to providing Epic users with access to the popular LLM, OpenAI said all clinicians that use its platform will be able to access public databases, including ClinicalTrials.gov and PubMed, with the proper plug-ins in place.
Altria sues FDA over tobacco product review system
Altria sued the FDA to overhaul the tobacco product review system, citing delays that hinder growth in the U.S. tobacco market.
Nature Medicine Just Published the AI Mental Health Audit Framework the FDA Hasn’t Written Yet
Nature Medicine's clinically validated AI chatbot audit framework arrives as FDA still lacks generative AI mental health approval standards—here's what trial…
David Sinclair Launches Lifespan Media Platform for Longevity Science
David Sinclair launches Lifespan media platform to improve public understanding of longevity science research and clinical trials.
Sanofi suspends chronic lung disease phase 2 study, tied to ‘strategic business reasons’
Sanofi halted a phase 2 trial testing a monoclonal antibody, SAR445399, in non-cystic fibrosis bronchiectasis, Fierce Biotech has learned. The trial, which began only back in April, was a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score following treatment with SAR445399 compared with placebo in adults aged 18 to 80 years with NCFB, a chronic lung disease. The trial was officially reported as halted on July 29, the day before Sanofi’s second-quarter earnings call. The decision to pause the trial was made “as part of a company-wide portfolio review for strategic business reasons,” and not due to safety concerns, a Sanofi spokesperson told Fierce. The move to pause the NCFB trial comes during a trying time for Sanofi following a year filled with a series of trial fails. In February, the French pharma ousted CEO Paul Hudson and appointed Merck KGaA leader Belén Garijo, M.D., Ph.D., to steer the ship. Since then, Garijo has been doing a deep dive on correcting the company’s strewn R&D and clinical strategies. On July 24, Sanofi scrapped amlitelimab for atopic dermatitis, despite its lore as being a potential $5 billion blockbuster. During its second-quarter report, the company abandoned two more assets, balinatunfib and itepekimab, following failed trial results in psoriasis and chronic obstructive pulmonary disease, respectively. SAR445399, only first revealed by Sanofi in 2023, is an anti-interleukin-1 receptor 3 monoclonal antibody developed to block the interleukin 1, 33, and 36 cytokine pathways. These pathways can be important in chronic immune-related dermatologic diseases, such as atopic dermatitis and hidradenitis suppurativa, as well as respiratory conditions, such as NCFB. Related Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues NCFB affects roughly half a million people in the U.S., with a global incidence of greater than one million cases. In August 2025, Insmed received FDA approval for Brinsupri, a DPP1 inhibitor targeting neutrophil activation, for treatment of NCFB in adults and kids ages 12 and older. The British biotech Infex Therapeutics showed promising NCFB phase 2a data using their monoclonal antibody, INFEX702, which acts by disabling Pseudomonas aeruginosa, a bacteria known to be a major pathogen of NCFB. Sanofi is currently running a separate phase 2 study testing SAR445399 as a potential treatment for the inflammatory skin condition hidradenitis suppurativa.
Capricor’s Duchenne AdCom Didn’t Fail on Science. It Failed on Statistics.
FDA's CTGTAC voted 9-3 against Capricor's deramiocel on July 30, 2026. The science wasn't the problem. The statistical methodology was — and the FDA let it get…
Devonian’s Phase II/III Thykamine paediatric study secures Health Canada approval
Devonian Health Group has received authorisation from Health Canada for its CTA to begin a Phase II/III study of Thykamine cream to treat mild-to-moderate atopic dermatitis in paediatric patients.
Lilly’s $2.8 Billion Bet on Psychedelics Buys Science That Conventional Trial Infrastructure May Not Be Able to Run
Eli Lilly acquires AtaiBeckley for $2.8B, but the FDA's final psychedelic trial guidance reveals an operational crisis Big Pharma hasn't priced in.
Bayer and Henry Ford Health partner to boost clinical trial access
Bayer and Henry Ford Health have entered a strategic research partnership aimed at expanding access to clinical trials for patients.
The Blood-Brain Barrier Has Been Breached. Is Clinical Trial Science Ready?
FDA's March 2026 approval of AVLAYAH marks the first BBB-crossing biologic — but CNS trial design, PK monitoring, and safety frameworks haven't caught up.
GSK’s drops chronic cough drug, dampening $2bn Bellus Health bid
GSK will discontinue camlipixant’s late-stage RCC programme, though it will continue the drug’s development in two forms of IBS.
Benchmark Scores Don’t Break. Clinical Reality Does. The Health AI Readiness Illusion.
Nature Medicine's frontier AI evaluation exposes a dangerous gap: models acing medical benchmarks collapse under adversarial pressure, and the FDA has no…
Efzimfotase alfa demonstrated improvements in bone health in treatment-naïve pediatric patients with hypophosphatasia achieving median difference of 1.67 vs placebo in RGI-C Score at week 25 in MULBERRY Phase III trial
Positive results from the MULBERRY Phase III trial showed that efzimfotase alfa (ALXN1850), an investigational enzyme replacement therapy, demonstrated a statistically significant and clinically meaningful improvement in bone health in children (2 to
Moderna highlights expanding mRNA platform at Science Day
Moderna's Horizon programme contains a variety of mRNA assets in varying stages of development, including a preclinical in vivo candidate.
June 16, 2026: LungSMART Team Uses Bilingual Formative Evaluation to Hone Study's Digital Health Content
The LungSMART research team conducted a bilingual messaging study and usability assessment to evaluate and adapt the study’s digital health content for patients in community health centers in Utah. The […]
Apotex Gets Health Canada Approval for Generic Semaglutide
Apotex receives Health Canada approval for generic semaglutide injection, matching all commercial formats of Novo Nordisk's Ozempic for type 2 diabetes treatmen
Iterative Health banks $77m to level up AI-driven clinical research tech
Google Ventures-backed Iterative will now expand its platform into burgeoning therapeutic areas like cardiology and obesity.
Wave of AI and data science tools set to transform clinical trials
Ahead of Biomed Israel, Ittai Harel highlights a growing cohort of companies leveraging AI and data science tools to revolutionise clinical research.
April 8, 2026: Behavioral Science-Based Electronic Health Record Tools, in This Week's Rethinking Clinical Trials Grand Rounds
In this Friday’s Rethinking Clinical Trials Grand Rounds, Julie Lauffenburger of Harvard Medical School will present on the “Impact of Behavioral Science-Based Electronic Health Record Tools on Deprescribing for Older […]
Immunic COO highlights the importance of science-led innovation to mark World Health Day
Immunic Inc (NASDAQ:IMUX, FRA:10VA) chief operating officer Jason Tardio talked with Proactive's Stephen Gunnion about the importance of science-led innovation in tackling neurological diseases, particularly multiple sclerosis, on World Health Day 2026. Tardio highlighted that the biotech industry is fundamentally grounded in scientific research and data, noting that “everything we do is rooted in science.” He explained that Immunic is focused on developing innovative therapies designed to improve patient outcomes and address significant unmet medical needs. The discussion centred on multiple sclerosis (MS), a complex neurological disease that continues to present challenges despite decades of progress. Tardio pointed out that while advancements have been made, “the disease is not solved for,” with many patients still experiencing disability progression and requiring safer, more tolerable treatments. He emphasised the urgent need for innovation, particularly in progressive forms of MS where treatment options remain extremely limited. Immunic’s lead asset, vidofludimus calcium, is being developed as a novel approach aimed at addressing the full spectrum of the disease. Tardio also reinforced the broader mission of the healthcare and biotech sectors, stating that the ultimate goal is to help individuals “live a better quality of life” and “a healthier life longer.” Watch the full interview to learn more about Immunic’s approach to advancing MS treatment through science. For more videos like this, visit Proactive's YouTube channel, like this video, subscribe to the channel, and enable notifications so you never miss an update. #Immunic #MultipleSclerosis #BiotechInnovation #Healthcare #MSResearch #DrugDevelopment #ClinicalTrials #Neurology #WorldHealthDay #ScienceDriven #VidofludimusCalcium #PharmaNews #BiotechNews
January 27, 2026: Workshop Materials Available From ‘Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions'
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions.” The full-day […]
Advancing Claude in healthcare and the life sciences
Introducing Claude for Healthcare with HIPAA-ready infrastructure, plus expanded Life Sciences tools for clinical trials and regulatory submissions. New connectors to CMS, Medidata, and ClinicalTrials.gov.
Advancing Claude in healthcare and the life sciences
Introducing Claude for Healthcare with HIPAA-ready infrastructure, plus expanded Life Sciences tools for clinical trials and regulatory submissions. New connectors to CMS, Medidata, and ClinicalTrials.gov.
BioAtla and GATC Health to advance Oz-V in Phase III trial
BioAtla and GATC Health have entered into a $40m SPV transaction to advance Oz-V into a Phase III trial for 2L+ OPSCC.
December 22, 2025: Rural Health Symposium Opens Registration, Announces Call for Abstracts
The Duke University School of Nursing will convene healthcare professionals, educators, researchers, community leaders, and policymakers for a 1-day symposium dedicated to reducing rural health disparities across North Carolina through […]
ARCH-backed Paradigm snaps up Flatiron’s clinical research business
The Flatiron acquisition complements a $78m funding round, which will aid Paradigm's efforts to integrate clinical trials into routine care.
Science 37 Honored for Site Innovation in the 2025 Clinical Trials Arena Excellence Awards
Science 37 is the Winner of Research and Development Award in the Site Innovation category in the 2025 Clinical Trials Arena Excellence Awards