This section highlights FDA-related milestones and regulatory updates for drugs developed by PureTech Health (PRTC).
Over the past two years, PureTech Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Glyph, KarXT, LYT-100, LYT-200, SPT-300, and VE303. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Glyph - FDA Regulatory Timeline and Events
Glyph is a drug developed by PureTech Health for the following indication: lymphatic system.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Glyph
- Announced Date:
- February 12, 2025
- Indication:
- lymphatic system
Announcement
PureTech Health plc noted that its Founded Entity, Seaport Therapeutics announced the publication of new data showcasing the GlyphTM platform's unique ability to enhance drug transport through the lymphatic system for increased therapeutic exposure.
AI Summary
PureTech Health plc recently announced that its Founded Entity, Seaport Therapeutics, published new data demonstrating the unique benefits of the Glyph™ platform. The study, featured in Molecular Pharmaceutics, showed that a novel prodrug attachment point on an immunomodulatory drug resulted in the highest reported lymphatic transport to date—about 55 percent drug absorption via the lymphatic system.
The research revealed that the new linkers released up to twice as much drug in the lymph nodes compared to previous attachment methods, enhancing direct access to the immune system. These findings support the idea that tailoring drug attachment sites can improve lymphatic drug delivery and overall therapeutic exposure, reinforcing the versatility and potential of the Glyph™ platform in the development of more effective treatments.
Read Announcement
KarXT (xanomeline-trospium) - FDA Regulatory Timeline and Events
KarXT (xanomeline-trospium) is a drug developed by PureTech Health for the following indication: Healthy Elderly Volunteers.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- January 17, 2025
- Indication:
- Healthy Elderly Volunteers
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
AI Summary
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted their New Drug Application for KarXT, which is being developed to treat schizophrenia in adults. This important step could bring a new treatment option to over 8 million Chinese patients who currently face challenges with available therapies. Clinical trials have shown that KarXT significantly reduces symptoms of schizophrenia while offering a safety profile that is manageable. The acceptance of the application indicates that regulators see potential in this novel treatment approach, which could help patients experience fewer side effects compared to current medications. If approved, KarXT may pave the way for a fresh and innovative method to manage schizophrenia, potentially improving the quality of life for many patients in China and possibly influencing treatment practices globally.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- September 27, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
PureTech Health plc announced that KarXT (xanomeline and trospium chloride), which was initially invented and advanced by PureTech, has received U.S. Food and Drug Administration ("FDA") approval for the treatment of schizophrenia in adults.
AI Summary
PureTech Health plc announced that its drug KarXT—a combination of xanomeline and trospium chloride—has received U.S. FDA approval for treating schizophrenia in adults. Originally invented and developed by PureTech, KarXT overcomes previous tolerability issues, paving the way for a novel approach to treating neuropsychiatric conditions. With this approval, milestone payments worth $29 million have been triggered under agreements with Royalty Pharma and Karuna Therapeutics, the latter of which was acquired by Bristol Myers Squibb in March 2024.
Marketed by Bristol Myers Squibb under the name Cobenfy, this breakthrough marks a significant advancement in addressing schizophrenia with a treatment that represents the first new drug mechanism approved for the condition in over 50 years. PureTech’s innovation in drug development continues to demonstrate its impact on both clinical outcomes and future financial growth.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- April 6, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
Bristol Myers Squibb announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
AI Summary
Bristol Myers Squibb recently shared promising interim results from the Phase 3 EMERGENT-4 trial. This open-label extension study evaluated KarXT (xanomeline-trospium) in adults with schizophrenia over 52 weeks, focusing on long-term safety, tolerability, and efficacy. The trial showed a steady improvement in schizophrenia symptoms, with over 75% of participants experiencing more than a 30% symptom reduction on the PANSS scale at one year. Patients who switched from placebo in earlier trials began to see significant improvements as early as the second week after starting KarXT, and these gains were maintained throughout treatment. Additionally, improvements were also observed on the Clinical Global Impression-Severity scale. These findings support KarXT as a promising long-term treatment option for managing schizophrenia and add to the growing data from the EMERGENT program.
Read Announcement
LYT-100 - FDA Regulatory Timeline and Events
LYT-100 is a drug developed by PureTech Health for the following indication: Idiopathic Pulmonary Fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYT-100
- Announced Date:
- May 20, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, delivered a late-breaking, oral presentation at the 2025 American Thoracic Society (ATS) International Conference in San Francisco.
AI Summary
PureTech Health plc, a clinical-stage biotherapeutics company focused on improving the lives of patients with serious diseases, presented late-breaking data at the 2025 American Thoracic Society International Conference in San Francisco. In this oral presentation, the company highlighted key findings from its Phase 2b ELEVATE IPF trial, showing that deupirfenidone slowed lung function decline in patients with idiopathic pulmonary fibrosis. The treatment effect was notable for aligning the rate of decline in patients with that seen in healthy older adults, and preliminary open-label extension data suggested that these benefits are durable for at least 52 weeks. The company emphasized the favorable safety and tolerability of deupirfenidone, indicating its potential as a meaningful, differentiated treatment for IPF. PureTech’s data and commitment underline their mission to change patient outcomes in devastating diseases.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- May 1, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that the Company will deliver a late-breaking oral presentation at the upcoming American Thoracic Society (ATS) International Conference, taking place in San Francisco, California, from May 16-21, 2025.
AI Summary
PureTech Health plc announced it will deliver a late-breaking oral presentation at the upcoming American Thoracic Society International Conference in San Francisco, California, from May 16-21, 2025. The presentation will share key data from the Phase 2b ELEVATE IPF trial, which evaluated deupirfenidone as a treatment for idiopathic pulmonary fibrosis (IPF). Early results from the trial suggest that deupirfenidone may help stabilize lung function decline over 26 weeks while maintaining a favorable safety and tolerability profile. This evidence supports the drug’s potential to become a new standard of care for patients suffering from IPF, a serious and progressive lung disease. By highlighting these promising outcomes, PureTech aims to bolster confidence in deupirfenidone’s effectiveness, paving the way for its advancement into Phase 3 development and future discussions with regulatory authorities.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- December 16, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced positive results from ELEVATE IPF, a Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging trial evaluating deupirfenidone (LYT-100) at two dose levels three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health recently announced positive results from its Phase 2b ELEVATE IPF trial studying deupirfenidone (LYT-100) in patients with idiopathic pulmonary fibrosis (IPF). In this study, patients received either 550 mg or 825 mg three times a day for 26 weeks. The trial was carefully designed using both active and placebo controls, and it compared deupirfenidone to the standard treatment pirfenidone.
The results showed a clear dose-dependent effect. The higher dose of 825 mg significantly slowed lung function decline to nearly normal levels, with a treatment effect of 80.9% versus placebo—much greater than the 54.1% effect seen with pirfenidone. Moreover, deupirfenidone was well tolerated, demonstrating a favorable safety profile. These promising findings support the further development of deupirfenidone as a potential new treatment option for IPF.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 9, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- LATE 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the end of 2024
AI Summary
PureTech Health plc announced that topline data from its Phase 2b ELEVATE IPF trial of LYT-100 is expected by the end of 2024. The trial is a randomized, double-blind, placebo-controlled study in patients with idiopathic pulmonary fibrosis (IPF). It uses a prespecified Bayesian approach that leverages historical placebo data to enhance statistical power while reducing the number of patients on placebo. LYT-100, a deuterated form of pirfenidone, is designed to improve tolerability and effectiveness compared to the current standard-of-care treatments. The study will assess the rate of decline in forced vital capacity over a 26-week period and compare two different doses of LYT-100 against placebo. If the results are positive, PureTech intends to advance the program into a Phase 3 trial, potentially offering a new treatment option for IPF patients.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 9, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc presented two oral presentations and one poster supporting its clinical and patient engagement strategies related to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) at the CHEST 2024 Annual Meeting in Boston, Massachusetts.
AI Summary
At the CHEST 2024 Annual Meeting in Boston, PureTech Health plc presented two oral talks and one poster about its work on LYT-100 (deupirfenidone), a treatment in development for idiopathic pulmonary fibrosis (IPF). These presentations highlighted the company’s clinical strategies and patient engagement efforts aimed at addressing the significant challenges faced by individuals with IPF. The research focused on how LYT-100 may improve symptom management and support patient care by providing a potential new treatment option that targets key limitations of current therapies. PureTech’s work is set against the backdrop of a decade since the first antifibrotic drugs were approved, with the company emphasizing the need for better management of IPF symptoms and improved quality of life. The presentations underline PureTech’s commitment to advancing IPF treatment through innovative research and patient-focused clinical strategies.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 1, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced its onsite presence at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9.
AI Summary
PureTech Health announced that it will be onsite at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9, 2024. During the event, the company will showcase key data and insights related to LYT-100 (deupirfenidone), a potential treatment for idiopathic pulmonary fibrosis (IPF). PureTech will deliver two oral presentations and one poster presentation focusing on various aspects of IPF management, including the patient experience and the current challenges associated with treatment. The presentations aim to share valuable research findings that have shaped the clinical and commercial strategies for LYT-100. Additionally, with topline data expected later this year from the Phase 2b ELEVATE IPF trial, the company anticipates that successful outcomes could support further development into a Phase 3 trial. This progress could potentially lead to LYT-100 becoming a registered treatment option in the U.S. and other regions.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- April 16, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that Topline results are expected in Q4 2024
AI Summary
PureTech Health plc announced that topline results from its Phase 2b ELEVATE IPF trial are expected in the fourth quarter of 2024. The trial is testing LYT-100 (deupirfenidone), a modified version of the standard IPF treatment pirfenidone, which is known to be effective yet often hard for patients to tolerate. The study, now fully enrolled, is designed to compare two doses of LYT-100 against a placebo to evaluate its safety, effectiveness, and impact on lung function decline, specifically by measuring changes in forced vital capacity. These results could offer new hope for IPF patients who face challenges with current therapies and may lead to better treatment options that combine proven benefits with improved tolerability.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- April 16, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health plc announced that enrollment is now complete for its Phase 2b ELEVATE IPF clinical trial, which is studying LYT-100 (deupirfenidone) for patients with idiopathic pulmonary fibrosis (IPF). LYT-100 is a modified form of pirfenidone that is intended to offer the same benefits but with an improved tolerability profile. This could be especially important for IPF patients, as current treatments often come with side effects that lead many to stop or avoid treatment altogether.
The trial is a randomized, double-blind, placebo-controlled study comparing two doses of LYT-100 with the standard treatment and a placebo. Its main goal is to assess the drug’s safety, dosing, and impact on lung function over a 26‑week period. Topline results are expected in the fourth quarter of 2024, offering potential hope for better management of IPF in the future.
Read Announcement
LYT-200 - FDA Regulatory Timeline and Events
LYT-200 is a drug developed by PureTech Health for the following indication: Difficult-to-Treat Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYT-200
- Announced Date:
- January 9, 2025
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia ("AML").
AI Summary
PureTech Health announced that the FDA has granted Fast Track designation to LYT-200, a new anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML). This Fast Track status is designed to speed up the development and review process for promising treatments that address serious health conditions. LYT-200 is being studied for its potential to not only kill cancer cells directly but also to boost the immune system’s ability to fight the disease. Early trial results have indicated that the treatment has shown a favorable safety profile and hints of clinical activity, whether used alone or alongside other therapies. The FDA’s decision highlights the need for new, effective treatment options for AML patients, and PureTech remains encouraged about expanding the potential benefits of LYT-200 for those facing this challenging cancer.
Read Announcement- Drug:
- LYT-200
- Announced Date:
- December 9, 2024
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc presented data from the dose escalation phase of its ongoing Phase 1b trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego, California.
AI Summary
PureTech Health plc presented promising data at the 2024 American Society of Hematology Annual Meeting from the dose escalation phase of its ongoing Phase 1b trial. The study is evaluating LYT-200, a new anti-galectin-9 antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
LYT-200 is being tested both alone and in combination with standard treatments like venetoclax and hypomethylating agents. The early results show that the drug is generally well-tolerated with no severe safety issues across all tested doses. As a single treatment, nearly 60% of patients experienced stable disease or better, including some partial responses. When used with other therapies, complete responses were seen, and 80% of patients achieved stable disease or better. These findings suggest that LYT-200 could become a valuable treatment option for patients with these challenging blood disorders.
Read Announcement- Drug:
- LYT-200
- Announced Date:
- April 11, 2024
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
LYT-200 announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers").
AI Summary
PureTech Health announced that the U.S. Food and Drug Administration has granted Fast Track designation for its investigational drug LYT-200 in combination with an anti-PD1 therapy. This designation is aimed at treating recurrent/metastatic head and neck squamous cell carcinomas, a type of aggressive head and neck cancer. The Fast Track status is intended to speed up the development and review process for therapies that address serious conditions with unmet medical needs. LYT-200 is a fully human monoclonal antibody that targets the protein galectin-9, which plays a key role in cancer progression and the suppression of the immune response. With this designation, the FDA recognizes the potential of this combination therapy to offer a new treatment option for patients diagnosed with head and neck cancers, potentially improving outcomes and addressing an important unmet need in oncology.
Read Announcement
SPT-300 - FDA Regulatory Timeline and Events
SPT-300 is a drug developed by PureTech Health for the following indication: For the treatment of mood and anxiety disorders, including anxious depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPT-300
- Announced Date:
- December 11, 2024
- Indication:
- For the treatment of mood and anxiety disorders, including anxious depression
Announcement
PureTech Health plc announced the presentation of additional data from its first-in-human, multi-part Phase 1 study of SPT-300 in healthy volunteers at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix, Arizona. S
AI Summary
PureTech Health plc recently presented new data from its first-in-human, multi-part Phase 1 study of SPT-300 at the American College of Neuropsychopharmacology Annual Meeting in Phoenix, Arizona (December 8-11, 2024). The study involved healthy volunteers and showed that several well-tolerated doses produced clear biological effects. SPT-300 is an oral prodrug designed to turn into allopregnanolone, a substance known for its rapid antidepressant and anxiety-reducing benefits.
The additional data highlighted the drug’s safety profile and its ability to affect brain activity and eye movement, with any side effects being mild and short-lived. Based on these promising results, the company plans a Phase 2b placebo-controlled study to further examine SPT-300’s use for major depressive disorder, potentially offering a new, convenient treatment option.
Read Announcement- Drug:
- SPT-300
- Announced Date:
- May 9, 2024
- Indication:
- For the treatment of mood and anxiety disorders, including anxious depression
Announcement
PureTech Health plc announced two poster presentations detailing the results from multiple clinical trials of SPT-300 at the Society of Biological Psychiatry Annual Meeting in Austin, TX.
Read Announcement
VE303 - FDA Regulatory Timeline and Events
VE303 is a drug developed by PureTech Health for the following indication: Recurrent C. difficile infection (CDI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VE303
- Announced Date:
- January 27, 2025
- Indication:
- Recurrent C. difficile infection (CDI)
Announcement
PureTech Health plc announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI).
AI Summary
PureTech Health plc announced that additional results from the Phase 2 CONSORTIUM study for VE303 have been published in Nature Medicine. The study shows that VE303, a potential new treatment to prevent recurrent Clostridioides difficile infections, is well tolerated by patients. Researchers found that VE303 works through multiple mechanisms, including restoring a healthy balance of gut bacteria, reducing inflammation, and boosting levels of protective chemicals. The treatment, made up of eight carefully selected bacterial strains, was shown to lower the odds of infection coming back. Importantly, the study also identified factors that predict how well the bacteria can colonize the gut, which in turn relates to clinical benefits. These insights have helped guide the design and dose selection for the global Phase 3 RESTORATiVE303 study, with topline results expected in 2026.
Read Announcement- Drug:
- VE303
- Announced Date:
- May 21, 2024
- Indication:
- Recurrent C. difficile infection (CDI)
Announcement
PureTech Health plc announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study of VE303, which is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI).
AI Summary
PureTech Health plc announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 study for VE303. This trial is a pivotal step in developing VE303, an orally administered bacterial consortium candidate designed to prevent recurrent Clostridioides difficile infection (rCDI). Developed by Vedanta Biosciences, a PureTech Founded Entity, VE303 represents a potential first-in-class live biotherapeutic product. The study will assess the efficacy and safety of VE303 in patients at high risk for rCDI and is intended to support a Biologics License Application with the U.S. Food and Drug Administration. This clinical milestone marks a significant advancement in treatment options for rCDI, offering hope for more effective and targeted care compared to traditional, donor-derived fecal therapies.
Read Announcement
Free PRTC Stock Alerts