Pasithea Therapeutics (NASDAQ: KTTA) has announced updated safety, tolerability, and preliminary efficacy data from its ongoing Phase 1 dose-escalation study of PAS-004 monotherapy in a heavily pre-treated population of patients with MAPK pathway-driven advanced solid tumors harboring RAS, NF1 or RAF mutations, including patients who have failed prior BRAF/MEK inhibitor treatment.

The data, reflecting durable clinical benefit, including prolonged stable disease in four patients, as well as long-term tolerability and flat pharmacokinetics, are being presented today at the ESMO Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

In a statement, Dr. Kartik Krishnan, chief medical officer of Pasithea, commented, “The prolonged stable disease that we’re seeing in some patients across this heavily pre-treated population is highly encouraging, particularly in patients with BRAF V600E-mutant tumors who previously progressed on BRAFi monotherapy and/or BRAFi/MEKi combination therapy. The literature reports a median progression-free survival of approximately five months for combination BRAFi/MEKi rechallenge in this setting, and some patients in the BRAF-mutant subgroup are exceeding that benchmark with our MEKi monotherapy.”

Dr. Krishnan added, “What makes this data especially encouraging is that we’re seeing these signals of durable clinical benefit alongside a long-term tolerability profile that continues to hold up. No patient has discontinued treatment at any dose level due to treatment-related adverse events, and we continue to observe low rates of vomiting and other GI toxicity, low rates of rash, even in patients taking PAS-004 continuously for long periods of time. A tolerability profile like this is exactly what you want to see for the long-term treatment of chronic diseases including neurofibromatosis type 1.”

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Zentalis Pharmaceuticals (NASDAQ: ZNTL) presented results today from an interim analysis of the DENALI Part 1b study as of a May 22, 2026, data cutoff, including the first overall survival (OS) analysis for azenosertib, at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

In a statement, Julie Eastland, CEO of Zentalis, commented, “These data continue to build the body of evidence supporting azenosertib as a potential treatment in Cyclin E1-positive platinum-resistant ovarian cancer, underpinning our development approach through the ongoing registration-intended DENALI Part 2 and ASPENOVA Phase 3 confirmatory trials. For patients with Cyclin E1-positive PROC who have limited effective treatment options, we are working to deliver something that has not existed — a targeted, oral treatment that offers more convenience and choice.”

Fiona Simpkins, MD, professor at the University of Pennsylvania Perelman School of Medicine and lead investigator for the DENALI study and The GOG Foundation, added, “The OS results from DENALI Part 1b are particularly meaningful given the poor prognosis associated with Cyclin E1-positive tumors and the heavily pretreated nature of this trial patient population. The separation in median OS between Cyclin E1-positive and Cyclin E1-negative patients — 15.9 months versus 7.5 months — strongly supports Cyclin E1 protein expression as a clinically relevant and predictive patient selection biomarker for azenosertib. Taken together with the response data and manageable adverse events, these findings provide important evidence supporting continued development of azenosertib in this biomarker-selected population with high unmet need.”

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Profound Medical (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) announced that Emmy Award-winning television host, health advocate and decorated U.S. Navy veteran, Montel Williams, will join the next Let’s Huddle webinar for a discussion with its host, Leonard Wheeler, on November 5th.

Mr. Williams will share his personal perspectives on health advocacy, resilience, informed healthcare decisions and the importance of protecting quality of life. His participation brings a prominent public voice to Let’s Huddle, a global patient community dedicated to helping men and their families navigate the prostate care journey through education, connection and support.

“When we created Let’s Huddle, our goal was to build a community where men and their families could have meaningful conversations, ask difficult questions, share experiences and feel supported as they navigate important healthcare decisions,” said Tom Tamberrino, Chief Commercial Officer of Profound Medical, in a statement. “Montel’s experience as a respected broadcaster, veteran and passionate health advocate makes him a powerful addition to this conversation. His participation reinforces our commitment to putting patients first and helping men feel informed, empowered and supported throughout their prostate care journey.”

Mr. Williams has built a distinguished career spanning military service, television and health advocacy. After graduating from the United States Naval Academy in 1980, he served in the U.S. Navy and Marine Corps, retiring in 1996 with the rank of lieutenant commander. His military honors include two Meritorious Service Medals and two Navy Commendation Medals.

Following his military career, Mr. Williams hosted The Montel Williams Show for 17 years, appearing in more than 4,300 episodes and earning a Daytime Emmy Award for Outstanding Talk Show Host in 1996. After being diagnosed with multiple sclerosis in 1999, he established the Montel Williams MS Foundation to support research and raise public awareness. He continues to advocate for health and wellness, and hosts the podcast Let’s Be Blunt with Montel and Lifetime’s Military Makeover with Montel.

“Montel’s story is a powerful reminder that health challenges can have a lasting impact on quality of life, long after military service or other major life milestones,” stated Arun Menawat, Chief Executive Officer and Chairman of Profound Medical. “Men facing prostate disease deserve access to clear information, meaningful support and treatment options that take their quality of life into account. The TULSA Procedure offers an incision-free, MRI-guided approach to prostate tissue ablation, designed to provide precise, personalized treatment. We believe initiatives like Let’s Huddle play an important role in helping patients become informed participants in their care.”

Profound said that it is also proud to support expanded access to innovative prostate care for veterans, and to that end, the company recently installed the first TULSA-PRO system at a U.S. Department of Veterans Affairs facility to offer veterans access to the TULSA Procedure.

TULSA-PRO enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

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Closely held PharmaJet has announced that their WHO-prequalified Tropis ID Needle-free Injection System has been used to deliver more than 25 million needle-free injections in support of polio eradication.

According to PharmaJet, polio immunization campaigns in Pakistan, Somalia, and Nigeria have demonstrated that Tropis is an effective and preferred solution that can help increase campaign coverage by over 18%. A published study in Vaccines also highlighted that, when compared to the standard of care (full dose with needles), administration with Tropis increased coverage of the second dose of IPV (IPV2) (11.2% higher); decreased total immunization costs up to 47%; and achieved 97% healthcare worker preference. Recently, Tropis has also been adopted for polio vaccination campaigns in Afghanistan and PharmaJet is expanding into additional countries.

In a statement, Paul LaBarre, senior vice president global business development, PharmaJet, commented, “PharmaJet has supported needle-free polio vaccination campaigns in Pakistan since 2018 and we are pleased that, with recent expansion into Afghanistan and Nigeria campaigns, we have reached this important 25 million injections milestone. While our patented needle-free technology has been shown to improve coverage, with high acceptability and cost savings, we are also excited about the new applications our pharmaceutical partners are discovering including a registrational Phase 3 study for Scancell’s oncology immunotherapy delivered with our Stratis Intramuscular System.”

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Cognition Therapeutics (NASDAQ: CGTX) has announced alignment with the FDA on key elements of a Phase 3 study of either 100 mg of oral zervimesine or placebo for nine months in mild-to-moderate dementia with Lewy bodies (DLB) including patient selection, dose, duration, and endpoints.

According to Cognition, the study will use a neuropsychiatric inventory that measures hallucinations and delusions as a primary endpoint.

In a statement, Lisa Ricciardi, president and CEO of Cognition, commented, “Over the course of the year, we have had collaborative discussions with FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience. With FDA’s alignment on trial design, we are completing a protocol to support the planned registrational study in DLB, a disease with no approved treatments.”

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BlossomHill Therapeutics (NASDAQ: BLSM) has announced a collaboration with Foundation Medicine, a wholly owned subsidiary of Roche (SIX: RO, ROP; OTCQX: RHHBY), to develop the first companion diagnostic assay (CDx) for BH-30643 in EGFR C797S-mutated non-small cell lung cancer (NSCLC).

The collaboration will leverage the ongoing Phase 1/2 SOLARA clinical trial evaluating BH-30643 in the targeted treatment of epidermal growth factor receptor (EGFR)-mutant NSCLC patients to validate the assay. EGFR C797S is the most common EGFR mutation driving resistance to osimertinib treatment in EGFR-mutant NSCLC. BH-30643 is a macrocyclic mutant-selective OMNI-EGFR inhibitor that has demonstrated clinical activity against a variety of EGFR mutations, in particular the C797S mutation that drives resistance to standard therapy.

In a statement, Geoff Oxnard, MD, chief medical officer at BlossomHill, commented, “Our near-term development priority for BH-30643 is to address the unmet needs of EGFR-mutant NSCLC patients with known resistance mutations following progression on prior EGFR targeted therapy. Foundation Medicine is the most experienced developer of precision CDx assays and the ideal partner to help us characterize EGFR resistance and validate a CDx assay to support the development of our medicine.”

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Lexaria Bioscience (NASDAQ: LEXX) has announced that full enrollment has been reached and dosing continues on schedule with Human Pilot Study #7 (GLP-1-H26-7) evaluating two oral DehydraTECH-semaglutide (DHT-sema) compositions against Novo’s (NYSE: NVO) commercially available Wegovy tablets, over a 5-week duration.

According to Lexaria, the study is investigating three separate arms to assess safety and tolerability as well as PK properties that will compare SNAC-inclusive, DHT-sema compositions formulated in both tablet and capsule formats to commercially available Wegovy tablets.

The company’s patented drug delivery formulation is DehydraTECH. The study is exploring several new DehydraTECH enhancements not previously evaluated including: an oral tablet DHT-sema composition which will be used by Lexaria for the first time—versus only the capsule compositions administered in all previous DehydraTECH GLP-1 studies; and both the Lexaria DHT-sema tablet and capsule test articles will be formulated with SNAC, which will be the first time these formulations will be evaluated over a multi-dose, multi-week time period in humans.

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INmune Bio (NASDAQ: INMB) has announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel (CORDStrom), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB).

According to INmune, it has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review.

In a statement, Mark Lowdell, chief scientific officer of INmune, commented, “This is a remarkable achievement by the whole CMC team and our external regulatory advisors allowing us to accelerate the potential approval for Ebstrocel for children with RDEB. Our progress allows us to bring forward the anticipated timeline to commercial supply, subject to approval, for children and families waiting for treatment.”

In parallel, INmune Bio has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the FDA. Subject to feedback from that meeting, the Company plans to submit a Biologics License Application in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.

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Valion Bio (NASDAQ: VBIO) has shared the initial findings and priorities from Dean Zikria’s first 30 days as interim chief executive officer (CEO). Mr. Zikria’s strategic review has set a focused agenda built on three priorities:

• Advancing the development of Entolimod and other pipeline assets;
• Pursuing customer and revenue capabilities for Velocity Bioworks (Velocity), the company’s wholly owned contract development and manufacturing organization (CDMO); and
• Evaluating strategic partnerships, co-investment structures, licensing deals, and/or other transactions for Velocity that could unlock additional value from the CDMO.

In a statement, Mr. Zikria commented, “Having served on Valion’s board of directors for more than seven years, I have a deep understanding of the company’s science, assets, and people, and I believe those factors provide a meaningful foundation for future success. It is also clear to me there has been a significant and persistent gap between these and how the stock market has seen and valued our company. My initial review has reinforced the importance of translating our underlying strengths into measurable development progress, commercial traction, and disciplined capital allocation. Our focus is on advancing the opportunities with the greatest potential to create value for shareholders, while remaining pragmatic about how we fund, develop, and commercialize our assets.”

Entolimod: A Government-Backed Lead Asset with Multiple Paths Forward

Entolimod, Valion’s lead biologic drug candidate for Acute Radiation Syndrome (ARS), is designed to activate innate immune pathways and is being investigated for its potential to protect cells and tissues against severe radiation-induced injury in both prophylactic and therapeutic settings. The program has received approximately $35.6 million in non-dilutive funding from U.S. government agencies to date, holds FDA Fast Track and Orphan Drug designations for ARS, and is supported by a substantial body of human safety data that provides an established foundation for continued development.

Entolimod’s development is now advancing on several fronts:

• Gastrointestinal radiation injury: Entolimod is being evaluated by the Armed Forces Radiobiology Research Institute in a U.S. Department of War-funded program focused on radiation-induced gastrointestinal (GI) injury. Current FDA-approved medical countermeasures for ARS address the hematopoietic, or bone-marrow, component of radiation injury in patients exposed to bone-marrow suppressing doses of radiation; no treatment is currently approved for the GI component of ARS. Entolimod is being investigated for its potential to provide broader cytoprotection across both hematopoietic and gastrointestinal tissues.
• Cancer patients receiving high-dose radiation: Valion is working with Sheba Medical Center towards a clinical trial evaluating Entolimod in cancer patients receiving high doses of irradiation, representing another potential development pathway.
• Oral mucosal formulation: In collaboration with Shear Kershman Laboratories (SKL), Valion is pursuing an oral mucosal formulation of Entolimod using SKL’s proprietary BioViscid drug-delivery platform, creating an additional development and deployment pathway alongside the injectable program. Different formulations could ultimately serve different preparedness requirements depending on pharmacokinetics, stability, dosing, regulatory status and procurement needs.

“Entolimod has benefited from substantial government support, human safety experience, and continued interest in its potential applications in radiation injury,” Mr. Zikria remarked. “We are evaluating how to build on that foundation through ongoing research, additional development pathways, and formulation innovation. An oral mucosal formulation, if successfully developed and validated, could offer a differentiated administration option with potential relevance to emergency preparedness and other settings where rapid, scalable deployment may be important.”

Valion believes these complementary efforts could significantly broaden Entolimod’s potential applications and opportunities over time.

Entolasta: Expanding the Therapeutic Opportunity

In parallel, Valion plans to advance Entolasta, a next-generation Toll-like receptor 5 (TLR5) agonist being developed for potential therapeutic applications, including oncology supportive care. Together, Entolimod and Entolasta represent the company’s broader effort to develop biologics targeting innate immune pathways across clinically significant areas of unmet need.

The company’s development priorities will focus on evaluating the evidence, milestones, and resource requirements of each program to guide decisions on advancement and potential partnering opportunities.

Velocity Bioworks: Turning Manufacturing Capabilities into Commercial Momentum

Velocity Bioworks is part of Valion’s own domestic biologics supply chain, supporting the company’s development strategy for Entolimod while also offering traditional CDMO services to biotechnology companies seeking U.S.-based manufacturing for their early-phase biologics programs. Valion is actively pursuing new customer relationships for Velocity, and converting these discussions into customer programs represents a potential near-term commercial opportunity to improve facility utilization, generate service revenue, and establish relationships that may support longer-term business growth.

“Velocity is an important part of Valion’s opportunity to translate technical capabilities into commercial value,” Mr. Zikria stated. “We are actively pursuing new customers and evaluating opportunities to expand the CDMO’s reach. Our priority is to build commercial momentum around the capabilities we have, while determining how best to position Velocity for sustainable growth and greater strategic value.”

Evaluating Strategic Opportunities to Unlock Velocity’s Value

Under Mr. Zikria’s leadership, Valion has begun actively evaluating strategic opportunities for Velocity, which may include, but are not limited to, strategic partnerships, joint ventures, co-investment arrangements, licensing deals, and/or a sale. The objective is to identify the structure that best positions Velocity to expand its commercial reach, access appropriate resources, and maximize its potential while supporting Valion’s broader strategic and financial priorities.

“Commercial execution and strategic flexibility are not mutually exclusive,” Mr. Zikria noted. “We are pursuing customer and licensing opportunities while evaluating the full range of strategic options available to us, whether continued development within Valion, a strategic partnership, co-investment, or another structure that creates value for shareholders.”

The company has not committed to any specific transaction, and there can be no assurance that the review will result in an agreement or transaction on favorable terms, or at all. Valion does not expect to disclose developments with respect to this process unless and until the evaluation of strategic opportunities has been completed or the board of directors has concluded that disclosure is appropriate or legally required.

A Disciplined Focus on Execution and Value Creation

Mr. Zikria’s first 30 days have established a clear agenda centered on clinical development, commercial execution, and strategic flexibility.

“Our responsibility is to translate Valion’s assets and capabilities into tangible progress,” Mr. Zikria concluded. “That means advancing our science, pursuing commercial opportunities with discipline, and remaining open to the strategic structures that can best support our objectives. We intend to approach these priorities with urgency, accountability, and a clear focus on long-term value creation.”

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Inventiva (Euronext Paris and Nasdaq: IVA) is advancing development of an oral treatment for metabolic dysfunction-associated steatohepatitis (MASH) with its investigational next-generation pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, lanifibranor, designed to simultaneously target the fibrosis, inflammation, and metabolic dysfunction that drives disease progression.

“MASH is a growing international health crisis, affecting millions of people worldwide, and it’s expected to become the leading cause of liver transplants in the U.S. alone,” Andrew Obenshain, CEO of Inventiva, says in an interview with BioTuesdays.

“It is a disease that doesn’t occur in isolation. MASH is closely associated with obesity, Type 2 diabetes, dyslipidaemia, and insulin resistance,” he adds.

Formerly known as NASH (nonalcoholic steatohepatitis), the terminology was updated to MASH in 2023 to better reflect the disease’s metabolic origins.

Mr. Obenshain explains that MASH is increasingly understood as far more than a liver disorder. Rather, it is a systemic cardiometabolic disease in which metabolic dysfunction causes fat to accumulate within the liver, triggering inflammation, fibrosis, and ultimately irreversible liver damage. Left untreated, patients can progress from early fibrosis to cirrhosis, liver failure, hepatocellular carcinoma, and the need for a liver transplant.

“These systemic conditions drive fat accumulation in the liver and perpetuate a cycle of inflammation and cellular injury,” he says. “This is why MASH is increasingly viewed not as a purely hepatic disease, but a manifestation of broader cardiometabolic dysfunction with consequences that extend throughout the body.”

Approximately 30% of adults worldwide are estimated to have some degree of fatty liver disease, with roughly one-quarter of those individuals progressing to MASH. The company estimates that roughly 18 million people in the U.S. fall within the broader MASH disease spectrum, although many remain undiagnosed.

Inventiva’s current development focus is patients with stage F2 or F3 fibrosis, where intervention has the greatest potential to prevent progression toward cirrhosis while patients remain relatively asymptomatic.

“Patients at F2 or F3 often look healthy and feel generally well,” Mr. Obenshain notes. “That’s exactly when physicians want to intervene—before they progress to cirrhosis, where the consequences become more serious.”

He points out that MASH diagnosis is expected to improve with the increasing adoption of non-invasive technologies such as FibroScan—a device that measures liver stiffness, allowing physicians to identify patients with progressive fibrosis before irreversible damage takes place.

For Inventiva, this trend reinforces both the medical need and the commercial potential of lanifibranor. “With greater recognition of MASH as a systemic cardiometabolic disease rather than only a liver disorder, we believe physicians will seek therapies that could address both hepatic fibrosis as well as the underlying metabolic abnormalities driving disease progression—a combination lanifibranor was specifically designed to achieve,” Mr. Obenshain explains.

The company estimates that approximately 375,000 MASH patients in the U.S. with F2 or F3 fibrosis are currently diagnosed and under the care of a physician and expects that number to grow by roughly 10% annually as awareness increases and screening becomes more routine.

Inventiva is focused on addressing the underlying biology responsible for disease progression rather than a single pathway. According to Mr. Obenshain, the company’s founders evaluated decades of research and set out to develop a next-generation molecule designed to improve upon the safety or tolerability concerns associated with earlier PPAR therapies.

The result was lanifibranor. Granted FDA Breakthrough Therapy Designation, lanifibranor is a new chemical entity engineered to deliver balanced activation across all three PPAR isoforms—alpha, delta, and gamma. Unlike earlier compounds that primarily activated a single isoform or dual isoforms, lanifibranor was intentionally designed as a next-generation pan-PPAR agonist to produce coordinated engagement of all three isoforms, aiming to address multiple pathways involved in MASH while avoiding receptor dominance.

“We designed what we believe is the physiologic sweet spot,” Mr. Obenshain contends. “We fully activate alpha and delta, and partially activate gamma. We also use a completely different chemical scaffold than earlier PPAR drugs, so while we interact with the same receptors, this is a fundamentally different molecule—designed to deliver balanced receptor activation at a lower potency while maintaining broad biological activity.”

The design was supported by extensive preclinical testing where the company observed no evidence of the cardiovascular, renal, skeletal, muscular, or carcinogenic toxicities that complicated development of some earlier agents within the class. These findings helped support confidence in advancing next-generation PPAR agonists. “Those findings gave us the confidence to advance into clinical studies evaluating both safety and biological activity,” Mr. Obenshain says.

He emphasizes that the subsequent Phase 1 program suggested the strategy was succeeding. “Investigators observed substantially less fluid retention than had historically been associated with PPAR agonists while also demonstrating improvements across several metabolic markers, reinforcing the rationale for advancing into a pivotal efficacy study.”

A Phase 2b trial ultimately provided the first clinical evidence supporting the company’s approach.

Published in The New England Journal of Medicine, the Phase 2b study evaluated lanifibranor over six months in patients with MASH and demonstrated improvements across multiple clinically meaningful measures. Most notably, patients receiving lanifibranor experienced an 18% greater reduction in fibrosis by at least one stage compared with placebo after just 24 weeks of treatment.

Moreover, in the Phase 2b study, lanifibranor demonstrated a 24% improvement compared with placebo in the proportion of patients achieving the combined endpoint of both fibrosis improvement and MASH resolution, something no previous compound studied in Phase 2 had ever demonstrated. Inventiva believes this endpoint provides a more rigorous assessment of treatment effect because achieving both outcomes simultaneously is less likely to occur simultaneously.

“At the time, people didn’t think you could observe that level of fibrosis improvement so quickly,” Mr. Obenshain says. “Those were really dramatic Phase 2 results.”

Importantly, the benefits extended beyond liver histology. Improvements were also observed across liver enzymes, glycaemic control, lipid parameters, and other cardiometabolic biomarkers, supporting the hypothesis that treating the underlying metabolic dysfunction may generate benefits throughout the body rather than exclusively within the liver.

“All of the markers moved in the same direction,” he says. “We weren’t just seeing changes on biopsy—we were seeing evidence that the patient’s overall liver and metabolic health was improving.”

The company views fibrosis as the primary driver of long-term outcomes in MASH, but Mr. Obenshain argues that physicians must also consider the metabolic conditions responsible for disease progression. Patients with Type 2 diabetes, in particular, tend to develop more aggressive fibrosis and progress more rapidly toward cirrhosis, making effective metabolic control an important component of treatment.

“If you’re treating a patient with F3 fibrosis and Type 2 diabetes, the physician isn’t always thinking only about the liver,” he says. “They’re also thinking about controlling the underlying disease that’s driving the fibrosis.”

That is where Inventiva anticipates lanifibranor may offer a differentiated profile. In addition to reducing fibrosis, the therapy has demonstrated improvements in HbA1c, triglycerides, HDL cholesterol, and adiponectin—markers that collectively reflect healthier metabolic function.

“We think physicians are going to want the strongest agent they can find to improve fibrosis, particularly in patients with F3 disease, while also considering the metabolic comorbidities that influence disease progression, such as Type 2 diabetes,” Mr. Obenshain says. “That’s where we believe lanifibranor can be particularly compelling.”

He adds that the principal adverse events observed to date—including modest weight gain, peripheral oedema, and mild anaemia—appear to reflect fluid retention, a known effect of PPAR gamma activation. According to the company, these events have generally been modest in severity, manageable and consistent with the mechanism of action and expected pharmacological effect of lanifibranor, without revealing unexpected safety signals during clinical development.

Leveraging the encouraging results of the Phase 2b study, lanifibranor is currently being evaluated in a Phase 3 study. “We understand the side-effect profile very well,” he says. “We don’t expect to see new safety findings in Phase 3, and we believe physicians will weigh those manageable effects against the potential efficacy, particularly in patients at highest risk of disease progression.”

Inventiva’s pivotal trial is designed to evaluate whether lanifibranor can deliver meaningful improvements in patients with progressive fibrotic MASH, with a focus on the population most likely to benefit from an intervention before irreversible liver damage occurs.

The global Phase 3 trial is enrolling 1,009 patients across 23 countries, including the U.S., Europe, Latin America, South Africa, Australia, and China. The 72-week study is evaluating two doses of lanifibranor and uses paired liver biopsies to measure changes in fibrosis and MASH resolution.

Unlike earlier studies that evaluated fibrosis improvement or MASH resolution as separate measures, Inventiva selected the composite endpoint for its Phase 3 program that reflects what the company sees as the most clinically meaningful outcome for patients and physicians.

“When you think about how physicians treat these patients, they care about two things: reducing the scarring and improving the underlying disease activity,” Mr. Obenshain says. “For the first time, we were able in our Phase 2b to demonstrate improvement in both MASH resolution and fibrosis improvement in the same patients, and that’s why we selected the dual composite endpoint for Phase 3.”

He adds that the Phase 3 population also reflects lessons learned from earlier development. The study includes a greater proportion of patients with Type 2 diabetes and advanced fibrosis, a group considered to have particularly high unmet need and increased risk of progression.

“We designed Phase 3 around the patients who need are the greatest risk of progression to adverse liver outcomes,” Mr. Obenshain says. “Patients with F3 fibrosis and Type 2 diabetes progress faster, and we believe that is where a potential therapy like lanifibranor could have the greatest impact.”

Topline Phase 3 data are expected in the fourth quarter of 2026. If successful, Inventiva plans to submit a New Drug Application to the FDA in the first half of 2027, with commercialization targeted for 2028.

Beyond the initial F2 and F3 MASH population, the company is already exploring the potential of lanifibranor in patients with more advanced disease. Inventiva plans to initiate an outcomes study in compensated advanced chronic liver disease (cACLD) due to MASH, a population with significant unmet need and limited treatment options.

Unlike the Phase 3 registration trial, which relies on biopsy-based endpoints, the outcomes study is designed to evaluate whether lanifibranor can alter the natural history of the disease by reducing clinically meaningful events such as liver decompensation, transplantation, and death.

“We want to go beyond improving a biopsy result,” Mr. Obenshain says. “The ultimate goal is to show that we can change the course of the disease and prevent patients from progressing to the point where they need a transplant.”

The potential opportunity in advanced liver disease reflects Inventiva’s broader vision for lanifibranor as a potential disease-modifying therapy rather than simply a treatment for a specific stage of fibrosis.

Well-financed by a syndicate of life science investors, Mr. Obenshain says Inventiva has the resources in place to complete its Phase 3 program while enabling the company to sharpen its operational focus.

The company believes that its single-asset focus, strengthened balance sheet, and experienced management team provide a clear path forward as it approaches a critical clinical milestone.

“We are a focused company with one product, a strong management team, and the resources needed to execute,” Mr. Obenshain says. “We have a near-term opportunity to potentially bring an important new therapy to patients.”

• • • •

To connect with Inventiva or any other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com.

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