Align Technology (ALGN) FDA Approvals $163.04 -0.34 (-0.21%) Closing price 05/21/2026 04:00 PM EasternExtended Trading$163.05 +0.01 (+0.01%) As of 07:00 AM 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 EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Align Technology's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Align Technology (ALGN). Over the past two years, Align Technology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Invisalign. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Invisalign Smile Architect™ FDA Regulatory Events Invisalign Smile Architect™ is a drug developed by Align Technology for the following indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side. 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. Highlights - May 21,2026Highlights Drug: Invisalign Smile Architect™Announced Date: May 21, 2026Indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.AnnouncementAlign Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA).AI SummaryAlign Technology said its 2026 Invisalign EMEA Ortho Summit brought together about 400 orthodontists and dental professionals in Barcelona, Spain. The three-day event focused on the company’s next-generation digital tools for treating complex cases in kids, teens, and adults, including Class II malocclusions. Attendees got a hands-on look at the Align Innovation Hub, which showed a full digital patient journey from consultation to treatment and retention. The summit also featured doctor-led sessions on difficult cases, digital workflow improvement, and patient engagement. Align said the event highlighted how its digital platform can connect scanning, treatment planning, appliance production, monitoring, and retention into one system. The company said these tools are meant to improve treatment precision, save time for practices, and make care easier for patients.Read Announcement Align Technology FDA Events - Frequently Asked Questions Has Align Technology received FDA approval? As of now, Align Technology (ALGN) has not received any FDA approvals for its therapy in the last two years. What drugs has Align Technology submitted to the FDA? In the past two years, Align Technology (ALGN) has reported FDA regulatory activity for Invisalign Smile Architect™. What is the most recent FDA event for Align Technology? The most recent FDA-related event for Align Technology occurred on May 21, 2026, involving Invisalign Smile Architect™. The update was categorized as "Highlights," with the company reporting: "Align Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA)." What conditions do Align Technology's current drugs treat? Currently, Align Technology has one therapy (Invisalign Smile Architect™) targeting the following condition: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsAgenus FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA EventsAlign Technology FDA EventsBioCardia FDA EventsBicycle Therapeutics FDA EventsCrescent Biopharma FDA EventsCognition Therapeutics FDA EventsCompass Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsCardiff Oncology FDA EventsDenali Therapeutics FDA EventsPrecision BioSciences FDA EventsAdherex Technologies 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 DexCom FDA Events Quanterix FDA Events Cardinal Health FDA Events Haemonetics FDA Events Merit Medical Systems FDA Events QuidelOrtho FDA Events Cerus FDA Events Anika Therapeutics FDA Events Becton, Dickinson and Company FDA Events Teva Pharmaceutical Industries FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ALGN last updated on 5/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersSystem failure: The strongest leverage for gold…$9 trillion in U.S. debt must be refinanced in 2026 - at current rates - while the largest foreign buyers of T...Golden Portfolio | SponsoredI had never heard of this 1888 accountAn investment account dating back to 1888 has quietly delivered average annual returns of 29% over the last 25...The Oxford Club | Sponsored"Computers are about to become obsolete" - George Gilder. Here’s why.George Gilder predicted the iPhone 16 years early, called Netflix a decade before it dominated streaming, and ...Eagle Publishing | SponsoredSpaceX controls two-thirds of all satellites - and it is about to go publicSpaceX is targeting an IPO on June 11th, with trading set to begin June 12th and the roadshow kicking off June...NXT Wave Research | SponsoredThe SpaceX supplier that shipped 5 billion chips to StarlinkWhen Nvidia surged 770%, its data center cooling supplier Vertiv climbed 1,700%. When Apple ran 2,000%, suppli...Weiss Ratings | SponsoredHey, 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 | SponsoredHow to Profit from Elon’s AI lab before it goes publicElon Musk's AI lab has partnered with the Department of Defense, Oracle, and Palantir - and he just filed conf...InvestorPlace | SponsoredI’m sounding the alarmMeta is cutting 10% of its workforce. Microsoft offered voluntary retirement to 7% of U.S. employees. Oracle, ...Porter & Company | 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 Align Technology, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Align Technology 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.
Highlights - May 21,2026Highlights Drug: Invisalign Smile Architect™Announced Date: May 21, 2026Indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.AnnouncementAlign Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA).AI SummaryAlign Technology said its 2026 Invisalign EMEA Ortho Summit brought together about 400 orthodontists and dental professionals in Barcelona, Spain. The three-day event focused on the company’s next-generation digital tools for treating complex cases in kids, teens, and adults, including Class II malocclusions. Attendees got a hands-on look at the Align Innovation Hub, which showed a full digital patient journey from consultation to treatment and retention. The summit also featured doctor-led sessions on difficult cases, digital workflow improvement, and patient engagement. Align said the event highlighted how its digital platform can connect scanning, treatment planning, appliance production, monitoring, and retention into one system. The company said these tools are meant to improve treatment precision, save time for practices, and make care easier for patients.Read Announcement
