Alaunos Therapeutics (TCRT) FDA Approvals $1.70 -0.06 (-3.35%) Closing price 03:58 PM EasternExtended Trading$1.78 +0.08 (+4.64%) As of 04:27 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOwnershipSEC Filings Alaunos Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Alaunos Therapeutics (TCRT). Over the past two years, Alaunos Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ALN1003. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ALN1003 FDA Regulatory Timeline and Events ALN1003 is a drug developed by Alaunos Therapeutics for the following indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders. 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. Provided Update - June 29,2026Provided Update Drug: ALN1003Announced Date: June 29, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. nnounced a new preclinical statistical analysis of liver weight adjusted for body fat percentage from its previously reported non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO; high fat diet) mouse Study 1 of ALN1003, the Company’s investigational oral, non-hormonal, non-incretin small-molecule metabolic candidate.AI SummaryAlaunos Therapeutics said a new preclinical analysis of its ALN1003 study found that liver weight, when adjusted for body fat percentage, matched earlier signs of activity seen in mice fed a high-fat diet. The company said this result supports its earlier findings from Study 1, including changes in liver tissue, liver-related markers, HOMA-IR, and adipose endocrine biomarkers. ALN1003 is an oral, non-hormonal, non-incretin small-molecule candidate being studied for possible effects on insulin resistance, fat tissue signaling, and liver fat metabolism. Alaunos said the data suggest the drug may be relevant to obesity, metabolic dysfunction-associated steatotic liver disease (MASLD), and related metabolic disorders. The company also noted it is advancing the obesity and metabolic disorders program while seeking additional financing to continue development.Read AnnouncementProvided Update - May 26,2026Provided Update Drug: ALN1003Announced Date: May 26, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. today reported an integrated preclinical readout for ALN1003, the Company's investigational oral, non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders.AI SummaryAlaunos Therapeutics said its preclinical studies of ALN1003, an oral non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders, showed encouraging effects across several signs of metabolic disease. In diet-induced obesity mouse studies, the drug was linked to lower body weight and food intake, improved body composition, and better insulin-resistance markers. One study also found lower fasting insulin and HOMA-IR, plus healthier adipose signals, including higher adiponectin and a better adiponectin-to-leptin ratio. In a second study, the high-dose group showed lower blood glucose and lower total cholesterol than obese controls. The company said these results suggest ALN1003 may affect several drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver fat buildup. Alaunos plans more preclinical work, manufacturing activities, and formulation studies to better define dosing, safety, and how the drug works.Read AnnouncementPreclinical Data - May 18,2026Preclinical Data Drug: ALN1003Announced Date: May 18, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. announced updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's investigational oral metabolic therapeutic candidate.AI SummaryAlaunos Therapeutics said its updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies support further development of ALN1003, an oral metabolic drug candidate. The results suggest the compound may affect several key drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver lipid metabolism. The company said ALN1003 could have potential use in metabolic syndrome and related disorders. To build on these findings, Alaunos plans more preclinical testing focused on finding the best dose, understanding exposure-response relationships, expanding metabolic measurements, and studying liver damage and the biological pathways involved. The company also noted that it has limited cash and expects its current runway to last into the second quarter of 2026, so it plans to seek additional financing to continue its obesity and metabolic disorders program.Read AnnouncementData - March 2,2026Data Drug: ALN1003Announced Date: March 2, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. announced early data from two non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's lead small-molecule drug candidate for treating obesity and related conditions, such as metabolic dysfunction-associated steatotic liver disease (MASLD, a type of fatty liver disease).AI SummaryAlaunos Therapeutics reported early, non‑GLP data from two diet‑induced obesity (DIO) mouse studies of ALN1003, its oral small‑molecule candidate for obesity and related metabolic disease. In Study 1, ALN1003-treated mice showed peak mean weight loss of –12.9% (p<0.0001) on Day 34 and –10.3% (p<0.0001) at Day 48 versus DIO controls. Treated mice ate less overall (347.5 g vs 425.0 g per cage; nominal p<0.05). Study 2 body-composition analysis showed dose-related losses driven mainly by fat but also by lean and fluid mass. At the highest dose, mice had lower blood glucose (197 vs 320 mg/dL; p<0.0001) and lower total cholesterol (162 vs 209 mg/dL; nominal p<0.05); HDL also fell (nominal p<0.05). Tolerability was generally acceptable, with transient, mild hypolocomotion after dosing in Study 1 and two slightly dehydrated high‑dose mice in Study 2. The company noted that drug‑related loss of appetite and thirst may have reduced drinking of medicated water, which can confound weight‑loss attribution. These early results will guide ongoing preclinical work and CMC development.Read Announcement Alaunos Therapeutics FDA Events - Frequently Asked Questions Has Alaunos Therapeutics received FDA approval? As of now, Alaunos Therapeutics (TCRT) has not received any FDA approvals for its therapy in the last two years. What drugs has Alaunos Therapeutics submitted to the FDA? In the past two years, Alaunos Therapeutics (TCRT) has reported FDA regulatory activity for ALN1003. What is the most recent FDA event for Alaunos Therapeutics? The most recent FDA-related event for Alaunos Therapeutics occurred on June 29, 2026, involving ALN1003. The update was categorized as "Provided Update," with the company reporting: "Alaunos Therapeutics, Inc. nnounced a new preclinical statistical analysis of liver weight adjusted for body fat percentage from its previously reported non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO; high fat diet) mouse Study 1 of ALN1003, the Company’s investigational oral, non-hormonal, non-incretin small-molecule metabolic candidate." What conditions do Alaunos Therapeutics' current drugs treat? Currently, Alaunos Therapeutics has one therapy (ALN1003) targeting the following condition: Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ACADIA Pharmaceuticals FDA EventsBriacell Therap FDA EventsBiomea Fusion FDA EventsCapricor Therapeutics FDA EventsPrecision BioSciences FDA EventsErasca FDA EventsGilead Sciences FDA EventsMonte Rosa Therapeutics FDA EventsInsmed FDA EventsLiminatus Pharma FDA EventsPTC Therapeutics FDA EventsREGENXBIO FDA EventsRhythm Pharmaceuticals FDA EventsTiziana Life Sciences FDA EventsUnited Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Corbus Pharmaceuticals FDA Events Acumen Pharmaceuticals FDA Events Coherus Oncology FDA Events MediWound FDA Events Adagene FDA Events Tenaya Therapeutics FDA Events Nkarta FDA Events Caribou Biosciences FDA Events Oncobiologics FDA Events OnKure Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:TCRT last updated on 6/29/2026 by MarketBeat.com Staff. 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Provided Update - June 29,2026Provided Update Drug: ALN1003Announced Date: June 29, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. nnounced a new preclinical statistical analysis of liver weight adjusted for body fat percentage from its previously reported non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO; high fat diet) mouse Study 1 of ALN1003, the Company’s investigational oral, non-hormonal, non-incretin small-molecule metabolic candidate.AI SummaryAlaunos Therapeutics said a new preclinical analysis of its ALN1003 study found that liver weight, when adjusted for body fat percentage, matched earlier signs of activity seen in mice fed a high-fat diet. The company said this result supports its earlier findings from Study 1, including changes in liver tissue, liver-related markers, HOMA-IR, and adipose endocrine biomarkers. ALN1003 is an oral, non-hormonal, non-incretin small-molecule candidate being studied for possible effects on insulin resistance, fat tissue signaling, and liver fat metabolism. Alaunos said the data suggest the drug may be relevant to obesity, metabolic dysfunction-associated steatotic liver disease (MASLD), and related metabolic disorders. The company also noted it is advancing the obesity and metabolic disorders program while seeking additional financing to continue development.Read Announcement
Provided Update - May 26,2026Provided Update Drug: ALN1003Announced Date: May 26, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. today reported an integrated preclinical readout for ALN1003, the Company's investigational oral, non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders.AI SummaryAlaunos Therapeutics said its preclinical studies of ALN1003, an oral non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders, showed encouraging effects across several signs of metabolic disease. In diet-induced obesity mouse studies, the drug was linked to lower body weight and food intake, improved body composition, and better insulin-resistance markers. One study also found lower fasting insulin and HOMA-IR, plus healthier adipose signals, including higher adiponectin and a better adiponectin-to-leptin ratio. In a second study, the high-dose group showed lower blood glucose and lower total cholesterol than obese controls. The company said these results suggest ALN1003 may affect several drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver fat buildup. Alaunos plans more preclinical work, manufacturing activities, and formulation studies to better define dosing, safety, and how the drug works.Read Announcement
Preclinical Data - May 18,2026Preclinical Data Drug: ALN1003Announced Date: May 18, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. announced updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's investigational oral metabolic therapeutic candidate.AI SummaryAlaunos Therapeutics said its updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies support further development of ALN1003, an oral metabolic drug candidate. The results suggest the compound may affect several key drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver lipid metabolism. The company said ALN1003 could have potential use in metabolic syndrome and related disorders. To build on these findings, Alaunos plans more preclinical testing focused on finding the best dose, understanding exposure-response relationships, expanding metabolic measurements, and studying liver damage and the biological pathways involved. The company also noted that it has limited cash and expects its current runway to last into the second quarter of 2026, so it plans to seek additional financing to continue its obesity and metabolic disorders program.Read Announcement
Data - March 2,2026Data Drug: ALN1003Announced Date: March 2, 2026Indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic DisordersAnnouncementAlaunos Therapeutics, Inc. announced early data from two non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's lead small-molecule drug candidate for treating obesity and related conditions, such as metabolic dysfunction-associated steatotic liver disease (MASLD, a type of fatty liver disease).AI SummaryAlaunos Therapeutics reported early, non‑GLP data from two diet‑induced obesity (DIO) mouse studies of ALN1003, its oral small‑molecule candidate for obesity and related metabolic disease. In Study 1, ALN1003-treated mice showed peak mean weight loss of –12.9% (p<0.0001) on Day 34 and –10.3% (p<0.0001) at Day 48 versus DIO controls. Treated mice ate less overall (347.5 g vs 425.0 g per cage; nominal p<0.05). Study 2 body-composition analysis showed dose-related losses driven mainly by fat but also by lean and fluid mass. At the highest dose, mice had lower blood glucose (197 vs 320 mg/dL; p<0.0001) and lower total cholesterol (162 vs 209 mg/dL; nominal p<0.05); HDL also fell (nominal p<0.05). Tolerability was generally acceptable, with transient, mild hypolocomotion after dosing in Study 1 and two slightly dehydrated high‑dose mice in Study 2. The company noted that drug‑related loss of appetite and thirst may have reduced drinking of medicated water, which can confound weight‑loss attribution. These early results will guide ongoing preclinical work and CMC development.Read Announcement
