CASI Pharmaceuticals (CASI) FDA Approvals $0.21 0.00 (0.00%) As of 05/22/2026 Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock CASI Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by CASI Pharmaceuticals (CASI). Over the past two years, CASI Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CID-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. CID-103 FDA Regulatory Timeline and Events CID-103 is a drug developed by CASI Pharmaceuticals for the following indication: Relapsed Or Refractory Multiple Myeloma. 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. Approved - January 15,2026Approved Phase 1/2Drug: CID-103Announced Date: January 15, 2026Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced that China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR).AI SummaryCASI Pharmaceuticals announced that China’s National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to start a Phase 1/2 study of CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR). The trial will be a dose-ranging, safety study designed to evaluate tolerability and preliminary efficacy of CID-103 in patients with renal allograft AMR. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that binds a unique CD38 epitope and is described by CASI as a potentially best-in-class candidate. AMR is a leading cause of kidney transplant failure, with no approved therapies and limited treatment options; severe cases can lead patients back to dialysis. CASI called the NMPA approval a significant milestone in developing a therapy for renal allograft AMR and said it will provide future guidance on the CID-103 development program. The company retains global rights to the candidate.Read AnnouncementAdditional data - January 12,2026Additional Data Phase 1Drug: CID-103Announced Date: January 12, 2026Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced additional data from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP)Read AnnouncementProvided Update - September 8,2025Provided Update Drug: CID-103Announced Date: September 8, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced that the Safety Monitoring Committee (SMC) has completed its review of cohort 4 (600 mg target dose) along with its continued assessment of the first three cohorts of the company's Phase 1 dose-escalating and safety study of CID-103 in adults with chronic immune thrombocytopenia (ITP).AI SummaryCASI Pharmaceuticals announced that its Safety Monitoring Committee completed its review of cohort 4 (600 mg target dose) and continued assessing the first three cohorts of its Phase 1 dose-escalation study of CID-103 in adults with chronic immune thrombocytopenia (ITP). The committee found no serious adverse events or dose-limiting toxicities in the first four cohorts. Based on this safety profile, the SMC recommended proceeding to cohort 5 with a 900 mg target dose. CID-103 is a fully human anti-CD38 monoclonal antibody in clinical development for ITP. The Phase 1 study plans to enroll up to 30 adults across five escalating dose cohorts. Each cohort begins with a lower priming dose followed by the target dose. Early cohorts use a 1+3 design that shifts to a 3+3 format if higher-grade events occur. Cohorts expand for safety monitoring, and dose escalation follows standard rules after a 28-day observation period.Read AnnouncementFDA Clearance - August 4,2025Fda Clearance Drug: CID-103Announced Date: August 4, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR).AI SummaryCASI Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for CID-103. CID-103 is an anti-CD38 monoclonal antibody designed to treat adults with active and chronic active renal allograft antibody-mediated rejection (AMR). CID-103 binds a unique CD38 epitope on immune cells. In preclinical studies, it showed a strong safety and efficacy profile compared to other anti-CD38 antibodies. CASI holds exclusive global rights to develop and commercialize the therapy. AMR is a leading cause of kidney transplant loss, often requiring dialysis or repeat transplant. Current treatment options are limited and may carry safety risks. New therapies like CID-103 aim to improve outcomes for resistant AMR patients. CASI plans a Phase 1, dose-ranging safety study to evaluate CID-103 in adults with active and chronic active renal allograft AMR. The trial will assess tolerability and early signs of efficacy.Read AnnouncementDosing Update - January 6,2025Dosing Update Phase 1/2Drug: CID-103Announced Date: January 6, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China.AI SummaryCASI Pharmaceuticals, Inc. announced that it has dosed the first patient in its Phase 1/2 trial in China. This study is designed to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP), a condition where patients have limited treatment options. CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, is being tested to collect important safety and dose-response data. Dr. Wei-Wu He, Chairman and CEO of CASI, stated that dosing the first patient is a major milestone for the program. The trial underscores the company’s commitment to swiftly advancing clinical development and aims to provide insights that could benefit future studies in treating other autoimmune conditions with significant unmet needs.Read AnnouncementIND Filing - June 26,2024Ind Filing INDDrug: CID-103Announced Date: June 26, 2024Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024.AI SummaryCASI Pharmaceuticals, Inc. announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of 2024. The company will seek approval for CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, as a treatment for antibody-mediated rejection (AMR) in kidney transplant recipients. Early preclinical studies of CID-103 have shown promising safety and efficacy profiles when compared to similar drugs, highlighting its potential as a beneficial therapy for patients facing transplant complications. CASI Pharmaceuticals plans to use proceeds from recent private placement financing along with its existing cash reserves to complete a Phase II clinical trial for AMR. This step reflects the company’s commitment to addressing unmet medical needs in kidney transplant care and advancing innovative treatment options through rigorous clinical evaluation.Read Announcement CASI Pharmaceuticals FDA Events - Frequently Asked Questions Has CASI Pharmaceuticals received FDA approval? As of now, CASI Pharmaceuticals (CASI) has not received any FDA approvals for its therapy in the last two years. What drugs has CASI Pharmaceuticals submitted to the FDA? In the past two years, CASI Pharmaceuticals (CASI) has reported FDA regulatory activity for CID-103. What is the most recent FDA event for CASI Pharmaceuticals? The most recent FDA-related event for CASI Pharmaceuticals occurred on January 15, 2026, involving CID-103. The update was categorized as "Approved," with the company reporting: "CASI Pharmaceuticals, Inc announced that China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR)." What conditions do CASI Pharmaceuticals' current drugs treat? Currently, CASI Pharmaceuticals has one therapy (CID-103) targeting the following condition: Relapsed Or Refractory Multiple Myeloma. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsAgios Pharmaceuticals FDA EventsAssembly Biosciences FDA EventsBriacell Therap FDA EventsBioLineRx FDA EventsFibroBiologics FDA EventsGilead Sciences FDA EventsOncolytics Biotech FDA EventsRegeneron Pharmaceuticals FDA EventsAbbVie FDA EventsMerck & Co., Inc. FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari 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 Reviva Pharmaceuticals FDA Events BioVie FDA Events CDT Equity FDA Events CytoMed Therapeutics FDA Events Genprex FDA Events Liminatus Pharma FDA Events Addex Therapeutics FDA Events Portage Biotech FDA Events NuCana FDA Events Brainstorm Cell Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:CASI last updated on 1/15/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersHey, it's Jon Najarian. The SpaceX IPO is right around the corner. But I discovered Elon may have something BIGGER planned. Check this out before June 9th...After being invited to the SpaceX launch headquarters in Cape Canaveral from one of Elon's top lobbyists… Hall...Banyan Hill Publishing | SponsoredBetter than SpaceX? Grab this ticker instead.Larry Benedict generated $274 million for his clients by finding the trades most investors missed. Now he says...Brownstone Research | SponsoredFrom the man who predicted 2008 crash…Porter Stansberry, founder of one of the largest financial research firms in the world, says he's breaking the...Porter & Company | SponsoredYour computer is about to become a museum pieceFuturist George Gilder - who predicted the smartphone years before the iPhone launched - believes today's AI d...Eagle Publishing | SponsoredGoldman Sachs just told you what to buy (most people missed it)Goldman Sachs just revealed that 40% of AI data centers will be crippled by electricity shortages by 2027 - no...Behind the Markets | SponsoredThe worst mistake you can make with the SpaceX IPOThe $1.75 trillion SpaceX IPO is generating massive hype - but history shows retail investors who pile in on d...Weiss Ratings | SponsoredYour $29.97 book is free todayBill Poulos is giving away his 'Safe Trade Options Formula' book at no charge - the same book that sells for $...Profits Run | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding CASI Pharmaceuticals Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share CASI Pharmaceuticals With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Approved - January 15,2026Approved Phase 1/2Drug: CID-103Announced Date: January 15, 2026Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced that China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR).AI SummaryCASI Pharmaceuticals announced that China’s National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to start a Phase 1/2 study of CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR). The trial will be a dose-ranging, safety study designed to evaluate tolerability and preliminary efficacy of CID-103 in patients with renal allograft AMR. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that binds a unique CD38 epitope and is described by CASI as a potentially best-in-class candidate. AMR is a leading cause of kidney transplant failure, with no approved therapies and limited treatment options; severe cases can lead patients back to dialysis. CASI called the NMPA approval a significant milestone in developing a therapy for renal allograft AMR and said it will provide future guidance on the CID-103 development program. The company retains global rights to the candidate.Read Announcement
Additional data - January 12,2026Additional Data Phase 1Drug: CID-103Announced Date: January 12, 2026Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced additional data from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP)Read Announcement
Provided Update - September 8,2025Provided Update Drug: CID-103Announced Date: September 8, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc announced that the Safety Monitoring Committee (SMC) has completed its review of cohort 4 (600 mg target dose) along with its continued assessment of the first three cohorts of the company's Phase 1 dose-escalating and safety study of CID-103 in adults with chronic immune thrombocytopenia (ITP).AI SummaryCASI Pharmaceuticals announced that its Safety Monitoring Committee completed its review of cohort 4 (600 mg target dose) and continued assessing the first three cohorts of its Phase 1 dose-escalation study of CID-103 in adults with chronic immune thrombocytopenia (ITP). The committee found no serious adverse events or dose-limiting toxicities in the first four cohorts. Based on this safety profile, the SMC recommended proceeding to cohort 5 with a 900 mg target dose. CID-103 is a fully human anti-CD38 monoclonal antibody in clinical development for ITP. The Phase 1 study plans to enroll up to 30 adults across five escalating dose cohorts. Each cohort begins with a lower priming dose followed by the target dose. Early cohorts use a 1+3 design that shifts to a 3+3 format if higher-grade events occur. Cohorts expand for safety monitoring, and dose escalation follows standard rules after a 28-day observation period.Read Announcement
FDA Clearance - August 4,2025Fda Clearance Drug: CID-103Announced Date: August 4, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR).AI SummaryCASI Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for CID-103. CID-103 is an anti-CD38 monoclonal antibody designed to treat adults with active and chronic active renal allograft antibody-mediated rejection (AMR). CID-103 binds a unique CD38 epitope on immune cells. In preclinical studies, it showed a strong safety and efficacy profile compared to other anti-CD38 antibodies. CASI holds exclusive global rights to develop and commercialize the therapy. AMR is a leading cause of kidney transplant loss, often requiring dialysis or repeat transplant. Current treatment options are limited and may carry safety risks. New therapies like CID-103 aim to improve outcomes for resistant AMR patients. CASI plans a Phase 1, dose-ranging safety study to evaluate CID-103 in adults with active and chronic active renal allograft AMR. The trial will assess tolerability and early signs of efficacy.Read Announcement
Dosing Update - January 6,2025Dosing Update Phase 1/2Drug: CID-103Announced Date: January 6, 2025Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China.AI SummaryCASI Pharmaceuticals, Inc. announced that it has dosed the first patient in its Phase 1/2 trial in China. This study is designed to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP), a condition where patients have limited treatment options. CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, is being tested to collect important safety and dose-response data. Dr. Wei-Wu He, Chairman and CEO of CASI, stated that dosing the first patient is a major milestone for the program. The trial underscores the company’s commitment to swiftly advancing clinical development and aims to provide insights that could benefit future studies in treating other autoimmune conditions with significant unmet needs.Read Announcement
IND Filing - June 26,2024Ind Filing INDDrug: CID-103Announced Date: June 26, 2024Indication: Relapsed Or Refractory Multiple MyelomaAnnouncementCASI Pharmaceuticals, Inc. announced that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024.AI SummaryCASI Pharmaceuticals, Inc. announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of 2024. The company will seek approval for CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, as a treatment for antibody-mediated rejection (AMR) in kidney transplant recipients. Early preclinical studies of CID-103 have shown promising safety and efficacy profiles when compared to similar drugs, highlighting its potential as a beneficial therapy for patients facing transplant complications. CASI Pharmaceuticals plans to use proceeds from recent private placement financing along with its existing cash reserves to complete a Phase II clinical trial for AMR. This step reflects the company’s commitment to addressing unmet medical needs in kidney transplant care and advancing innovative treatment options through rigorous clinical evaluation.Read Announcement
