Plus Therapeutics (CNSY) FDA Approvals $1.65 +0.08 (+5.03%) As of 02:53 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsFinancialsNews and TrendsSEC Filings Plus Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Plus Therapeutics (CNSY). Over the past two years, Plus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ReSPECT-LMM. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ReSPECT-LMM FDA Regulatory Events ReSPECT-LMM is a drug developed by Plus Therapeutics for the following indication: in Leptomeningeal Metastases. 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. Poster Presentation - October 27,2026Poster Presentation Drug: ReSPECT-LMMAnnounced Date: October 27, 2026Indication: in Leptomeningeal MetastasesAnnouncementCerenome, Inc. announced that a poster presentation of interim data from its ongoing ReSPECT-LMM multidose study of REYOBIQ™ (rhenium Re186 obisbemeda) will be presented at the Society for Neuro-Oncology ("SNO") 31st Annual Meeting and Education Day, taking place November 12–15, 2026, at the Pennsylvania Convention Center in Philadelphia.Read Announcement Plus Therapeutics FDA Events - Frequently Asked Questions Has Plus Therapeutics received FDA approval? As of now, Plus Therapeutics (CNSY) has not received any FDA approvals for its therapy in the last two years. What drugs has Plus Therapeutics submitted to the FDA? In the past two years, Plus Therapeutics (CNSY) has reported FDA regulatory activity for ReSPECT-LMM. What is the most recent FDA event for Plus Therapeutics? The most recent FDA-related event for Plus Therapeutics occurred on October 27, 2026, involving ReSPECT-LMM. The update was categorized as "Poster Presentation," with the company reporting: "Cerenome, Inc. announced that a poster presentation of interim data from its ongoing ReSPECT-LMM multidose study of REYOBIQ™ (rhenium Re186 obisbemeda) will be presented at the Society for Neuro-Oncology ("SNO") 31st Annual Meeting and Education Day, taking place November 12–15, 2026, at the Pennsylvania Convention Center in Philadelphia." What conditions do Plus Therapeutics' current drugs treat? Currently, Plus Therapeutics has one therapy (ReSPECT-LMM) targeting the following condition: in Leptomeningeal Metastases. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Aclaris Therapeutics FDA EventsArtiva Biotherapeutics FDA EventsCAMP4 Therapeutics FDA EventsCellectis FDA EventsPlus Therapeutics FDA EventsOPKO Health FDA EventsVanda Pharmaceuticals FDA EventsvTv Therapeutics FDA EventsVoyager Therapeutics FDA EventsAbbVie FDA EventsPfizer FDA EventsAkebia Therapeutics FDA EventsArtelo Biosciences FDA EventsHeartBeam FDA EventsBioNTech 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:CNSY last updated on 10/27/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersU.S. Military Expands Orders for This Drone MakerA Nasdaq-listed drone maker is racking up defense contracts on both sides of the border. The Canadian Armed Fo...The Tomorrow Investor | SponsoredThe investigation Porter spent tens of thousands to documentPorter Stansberry flew the Porter and Co. team 3,300 miles to Dublin to investigate a 17-year investing experi...Porter & Company | SponsoredLast call for your free 0DTE reportThe 0DTE Game Plan lays out a simple 3-step framework for trading same-day options: Plan it, profit from it, p...Profits Run | SponsoredWhy Gerardo Del Real says wait before buying uranium stocksGerardo Del Real is calling it the Third Convergence Event, a new catalyst hitting the uranium market that he ...Digest Publishing | SponsoredFirst Look: Elon’s “Starphone”Rumors are swirling that Elon Musk is developing a new mobile device that could rival the iPhone. It's said to...Stansberry Research | SponsoredHow options let you do more with less capitalWould you rather spend $5,000 buying 100 shares of a $50 stock, or control those same 100 shares for a fractio...Base Camp Trading | SponsoredElon Musk… A Total Fraud?Jeff Brown, the former tech executive who picked Nvidia in 2016 before it surged as high as 37,800 percent, ju...Brownstone Research | SponsoredAnd they say the headline number understates what’s really happening.Goldman Sachs just admitted it underestimated central bank gold purchases by more than 500 percent, with buyin...Cedar Gold Group | 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 Plus Therapeutics, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Plus Therapeutics With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access 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.
Poster Presentation - October 27,2026Poster Presentation Drug: ReSPECT-LMMAnnounced Date: October 27, 2026Indication: in Leptomeningeal MetastasesAnnouncementCerenome, Inc. announced that a poster presentation of interim data from its ongoing ReSPECT-LMM multidose study of REYOBIQ™ (rhenium Re186 obisbemeda) will be presented at the Society for Neuro-Oncology ("SNO") 31st Annual Meeting and Education Day, taking place November 12–15, 2026, at the Pennsylvania Convention Center in Philadelphia.Read Announcement
