This company has been marked as potentially delisted and may not be actively trading. Gritstone bio (GRTS) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisCompetitorsFDA EventsInsider TradesTrendsBuy This Stock Gritstone bio's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Gritstone bio (GRTS). Over the past two years, Gritstone bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GRANITE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. GRANITE (GRT-C901/GRT-R902) FDA Regulatory Events GRANITE (GRT-C901/GRT-R902) is a drug developed by Gritstone bio for the following indication: In frontline microsatellite stable colorectal cancer. 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. Survival data - September 30,2024Survival Data Drug: GRANITE (GRT-C901/GRT-R902)Announced Date: September 30, 2024Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: In frontline microsatellite stable colorectal cancerAnnouncementGritstone bio, Inc announced Overall survival data expected in 2H 2025AI SummaryGritstone bio, Inc. recently shared encouraging interim Phase 2 data from its study evaluating GRANITE, an individualized neoantigen targeting immunotherapy for frontline microsatellite stable colorectal cancer. The trial compared GRANITE in combination with immune checkpoint inhibitors, fluoropyrimidine, and bevacizumab to standard treatment. Early results show a reduction in the risk of progression or death, with a 21% overall relative risk reduction and a 38% reduction for patients with lower disease burden as measured by ctDNA. The company emphasized that the treatment was well-tolerated, with patients maintaining stable ctDNA levels and no treatment discontinuations due to side effects. Importantly, Gritstone bio announced that overall survival data from the study are expected in the second half of 2025. Further follow-up is needed to confirm and mature these promising findings.Read AnnouncementInterim Data - September 30,2024Interim Data Phase 2Drug: GRANITE (GRT-C901/GRT-R902)Announced Date: September 30, 2024Indication: In frontline microsatellite stable colorectal cancerAnnouncementGritstone bio, Inc. announced encouraging interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC).AI SummaryGritstone bio, Inc. announced encouraging interim Phase 2 data for GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC). The study compared patients receiving GRANITE plus immune checkpoint inhibitors and other standard treatments against those receiving standard care alone. Overall, patients treated with GRANITE experienced a 21% relative risk reduction in progression or death. Notably, patients with a lower disease burden—indicated by low ctDNA levels at the start of the study—showed a 38% relative risk reduction. The results also showed that stronger neoantigen-specific T cell responses were linked to improved progression-free survival. GRANITE was generally well-tolerated, with no patients discontinuing treatment due to adverse events. Further follow-up is needed to confirm these findings, and overall survival data are expected in the second half of 2025.Read Announcement Gritstone bio FDA Events - Frequently Asked Questions Has Gritstone bio received FDA approval? As of now, Gritstone bio (GRTS) has not received any FDA approvals for its therapy in the last two years. What drugs has Gritstone bio submitted to the FDA? In the past two years, Gritstone bio (GRTS) has reported FDA regulatory activity for GRANITE (GRT-C901/GRT-R902). What is the most recent FDA event for Gritstone bio? The most recent FDA-related event for Gritstone bio occurred on September 30, 2024, involving GRANITE (GRT-C901/GRT-R902). The update was categorized as "Survival data," with the company reporting: "Gritstone bio, Inc announced Overall survival data expected in 2H 2025" What conditions do Gritstone bio's current drugs treat? Currently, Gritstone bio has one therapy (GRANITE (GRT-C901/GRT-R902)) targeting the following condition: In frontline microsatellite stable colorectal cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Allarity Therapeutics FDA EventsAvalo Therapeutics FDA EventsBridgeBio Pharma FDA EventsCellectar Biosciences FDA EventsCytokinetics FDA EventsEupraxia Pharmaceuticals FDA EventsFate Therapeutics FDA EventsHoth Therapeutics FDA EventsKymera Therapeutics FDA EventsPalisade Bio FDA EventsRelmada Therapeutics FDA EventsSensei Biotherapeutics FDA EventsVerrica Pharmaceuticals FDA EventsViridian Therapeutics FDA EventsZentalis Pharmaceuticals 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 Phio Pharmaceuticals FDA Events Traws Pharma FDA Events Citius Pharmaceuticals FDA Events BioLineRx FDA Events Hoth Therapeutics FDA Events Moleculin Biotech FDA Events LianBio FDA Events Ainos FDA Events BioCardia FDA Events BioVie FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:GRTS last updated on 6/20/2025 by MarketBeat.com Staff. 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Survival data - September 30,2024Survival Data Drug: GRANITE (GRT-C901/GRT-R902)Announced Date: September 30, 2024Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: In frontline microsatellite stable colorectal cancerAnnouncementGritstone bio, Inc announced Overall survival data expected in 2H 2025AI SummaryGritstone bio, Inc. recently shared encouraging interim Phase 2 data from its study evaluating GRANITE, an individualized neoantigen targeting immunotherapy for frontline microsatellite stable colorectal cancer. The trial compared GRANITE in combination with immune checkpoint inhibitors, fluoropyrimidine, and bevacizumab to standard treatment. Early results show a reduction in the risk of progression or death, with a 21% overall relative risk reduction and a 38% reduction for patients with lower disease burden as measured by ctDNA. The company emphasized that the treatment was well-tolerated, with patients maintaining stable ctDNA levels and no treatment discontinuations due to side effects. Importantly, Gritstone bio announced that overall survival data from the study are expected in the second half of 2025. Further follow-up is needed to confirm and mature these promising findings.Read Announcement
Interim Data - September 30,2024Interim Data Phase 2Drug: GRANITE (GRT-C901/GRT-R902)Announced Date: September 30, 2024Indication: In frontline microsatellite stable colorectal cancerAnnouncementGritstone bio, Inc. announced encouraging interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC).AI SummaryGritstone bio, Inc. announced encouraging interim Phase 2 data for GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC). The study compared patients receiving GRANITE plus immune checkpoint inhibitors and other standard treatments against those receiving standard care alone. Overall, patients treated with GRANITE experienced a 21% relative risk reduction in progression or death. Notably, patients with a lower disease burden—indicated by low ctDNA levels at the start of the study—showed a 38% relative risk reduction. The results also showed that stronger neoantigen-specific T cell responses were linked to improved progression-free survival. GRANITE was generally well-tolerated, with no patients discontinuing treatment due to adverse events. Further follow-up is needed to confirm these findings, and overall survival data are expected in the second half of 2025.Read Announcement
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