Nasdaq & United States — Food and Drug Administration
31 shared events · Importance 15 · Last updated Aug 21, 2026
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Business
Nasdaq: The combined company is expected to trade on Nasdaq under ticker AMBX, subject to listing requirements. Nasdaq listing provides access to public capital markets.
United States — Food and Drug Administration: The FDA has granted Breakthrough Therapy, Fast Track, and Orphan Drug designations to neridronate, and has aligned that a single successful pivotal trial could support approval. FDA decisions will be pivotal for the combined company's future.
Aug 21, 2026 · 6 articles
Business
Nasdaq: Cellectar is listed on Nasdaq under the ticker CLRB; the exchange is the venue for its stock trading.
United States — Food and Drug Administration: The FDA is the regulatory body for the planned NDA submission of iopofosine I 131 under the Accelerated Approval Program, a critical milestone for Cellectar.
Jul 30, 2026 · 6 articles
Regulatory
Nasdaq: Nasdaq is the exchange where Replimune's stock is listed. The stock's decline is reflected in its trading on Nasdaq.
United States — Food and Drug Administration: The FDA rejected Replimune's BLA and published briefing documents raising concerns about the data package, triggering the stock drop and subsequent lawsuits. The FDA's actions are central to the event.
Jul 29, 2026 · 65 articles
Regulatory
Nasdaq: Nasdaq is the exchange where Capricor is listed, and the stock's dramatic decline reflects the market's reaction. The exchange itself is not directly impacted but serves as the venue for trading.
United States — Food and Drug Administration: Regulator whose briefing documents and advisory committee vote triggered the stock collapse and legal actions.
Jul 27, 2026 · 293 articles
Regulatory
Nasdaq: Nasdaq is the exchange where OKYO Pharma's shares are listed, with no direct impact from the event.
United States — Food and Drug Administration: The FDA provided regulatory clarity and endorsed a streamlined development pathway for urcosimod, including potential single-trial registration. The agency's feedback is crucial for OKYO's accelerated clinical plan.
Jul 08, 2026 · 9 articles
Regulatory
Nasdaq: Unicycive Therapeutics is listed on Nasdaq under the ticker UNCY; the stock price decline occurred on this exchange.
United States — Food and Drug Administration: The FDA issued a second Complete Response Letter for Unicycive's OLC NDA, citing manufacturing deficiencies, which triggered the stock decline and investigation.
Jun 30, 2026 · 13 articles
Regulatory
Nasdaq: Axsome is listed on Nasdaq; the event may influence AXSM stock trading.
United States — Food and Drug Administration: The FDA accepted the NDA and set a PDUFA date; its decision will determine AXS-12's market entry.
Jul 15, 2026 · 9 articles
Regulatory
Nasdaq: Dyne Therapeutics is listed on Nasdaq under ticker DYN. The event may influence its stock price.
United States — Food and Drug Administration: The FDA cleared Dyne's IND application for DYNE-302, enabling the company to proceed with clinical trials. This is a routine regulatory action.
Jul 28, 2026 · 6 articles
Regulatory
Nasdaq: Medline is listed on Nasdaq under ticker MDLN; the stock price fell after the FDA warning.
United States — Food and Drug Administration: The FDA issued a warning letter to Medline citing significant manufacturing violations, which triggered the stock drop and subsequent investigations, reinforcing its regulatory role.
Jul 15, 2026 · 21 articles
Regulatory
Nasdaq: Abivax is also listed on Nasdaq (ticker ABVX), and the event may influence its stock price.
United States — Food and Drug Administration: The FDA provided constructive feedback and alignment on Abivax's NDA submission strategy, playing a critical regulatory role.
Jul 30, 2026 · 8 articles
Regulatory
Nasdaq: Nasdaq is the exchange where NRx Pharmaceuticals is listed; the event may influence the company's stock performance on this exchange.
United States — Food and Drug Administration: The FDA is the regulatory authority that completed the first-cycle review of NRx's ANDA, a critical step in the approval process for the company's ketamine product.
Aug 07, 2026 · 6 articles
Business
Nasdaq: Exchange where AVITA Medical is listed; no direct impact from this event.
United States — Food and Drug Administration: Regulator that approved RECELL; mentioned as part of company background, no new regulatory action.
Aug 09, 2026 · 6 articles
Regulatory
Nasdaq: Nasdaq confirmed VivoSim's compliance with listing rule 5550(b)(1), allowing continued listing.
United States — Food and Drug Administration: The FDA's roadmap favoring non-animal testing methods is mentioned as a potential growth driver for VivoSim's business.
Aug 06, 2026 · 6 articles
Business
Nasdaq: Nasdaq is the exchange where Clearmind's shares are listed; the event may influence trading activity but Nasdaq itself is unaffected.
United States — Food and Drug Administration: The FDA regulates the clinical trial; its oversight framework governs the trial's conduct, though the DSMB approval is an independent milestone.
Aug 06, 2026 · 6 articles
Regulatory
Nasdaq: Alterity is listed on Nasdaq under ticker ATHE; the announcement may influence trading activity.
United States — Food and Drug Administration: The FDA provided regulatory guidance and agreed to a single pivotal trial design for ATH434, facilitating the drug's development for MSA.
Jul 07, 2026 · 7 articles
Regulatory
Nasdaq: Agios is listed on Nasdaq; the stock price movement reflects market reaction to the event.
United States — Food and Drug Administration: The FDA granted priority review to Agios' sNDA, setting a November 1 PDUFA date; its decision will determine mitapivat's market access.
Jul 07, 2026 · 6 articles
Business
Nasdaq: Stock exchange where Innate Pharma is listed in the US (ticker IPHA).
United States — Food and Drug Administration: Granted Fast Track and Breakthrough Therapy designations to lacutamab, facilitating its development and review.
Aug 10, 2026 · 10 articles
Regulatory
Nasdaq: UroGen shares traded on Nasdaq, with a slight pre-market decline.
United States — Food and Drug Administration: The FDA cleared the IND for UGN-501, enabling clinical trials. This is a routine regulatory action.
Jul 08, 2026 · 6 articles
Business
Nasdaq: Fulcrum Therapeutics is listed on Nasdaq under ticker FULC, which experienced a significant price decline.
United States — Food and Drug Administration: The FDA concluded that PRC2 inhibitors carry malignancy risk, leading to the discontinuation of Fulcrum's pociredir program.
Jul 15, 2026 · 6 articles
Business
Nasdaq: The combined company will continue to be listed on Nasdaq, subject to listing requirements.
United States — Food and Drug Administration: The CBGM technology is an investigational device subject to FDA approval.
Jul 14, 2026 · 6 articles
Business
Nasdaq: Nasdaq is the exchange where AVITA Medical's stock is listed. The conference participation does not affect the exchange itself.
United States — Food and Drug Administration: The FDA is mentioned as the regulator that approved AVITA Medical's RECELL product. This event does not involve any regulatory action.
Aug 05, 2026 · 24 articles
Business
Nasdaq: Profound Medical is listed on Nasdaq under ticker PROF.
United States — Food and Drug Administration: FDA has cleared TULSA-PRO and approved Sonalleve in the US.
Jul 16, 2026 · 7 articles
Business
Nasdaq: Nasdaq is the stock exchange where Celcuity is listed (ticker: CELC). The event does not directly affect Nasdaq, but the company's performance may influence its stock price on the exchange.
United States — Food and Drug Administration: The FDA approved Celcuity's product REVTORPYK, which is mentioned in the announcement. The event does not involve new FDA actions, but the approval is part of the company's background.
Aug 06, 2026 · 6 articles
Business
Nasdaq: Stock exchange where Tarsus is listed; no direct impact from the event.
United States — Food and Drug Administration: Regulatory body; provided feedback on Phase 3 study design for IRX-101.
Jul 08, 2026 · 6 articles
Business
Nasdaq: Both Vertex and Crinetics are listed on Nasdaq. The acquisition may affect trading volumes and index composition, but the exchange itself is not materially impacted.
United States — Food and Drug Administration: The FDA approved Palsonify in 2025, enabling its commercial availability. The agency's regulatory decisions are relevant to the value of the acquired assets.
Jul 06, 2026 · 34 articles
Business
Nasdaq: Axsome is listed on Nasdaq under ticker AXSM; the exchange is mentioned as the listing venue.
United States — Food and Drug Administration: The FDA has approved Axsome's products; the company references FDA in forward-looking statements regarding potential approvals.
Jul 14, 2026 · 7 articles
Business
Nasdaq: Nasdaq is the secondary listing venue for Telix, where the results will also be available. The event is routine and does not affect the exchange itself.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as the approver of Gozellix, a product in Telix's portfolio. The event is routine and does not affect the FDA.
Jul 30, 2026 · 7 articles
Business
Nasdaq: Ascentage Pharma is listed on Nasdaq, but this event does not directly impact the exchange.
United States — Food and Drug Administration: The FDA has cleared several of Ascentage Pharma's Phase III trials, but this event does not directly involve the FDA.
Jul 26, 2026 · 6 articles
Business
Nasdaq: Nasdaq is the exchange where Cardiol Therapeutics is listed. The announcement does not affect the exchange.
United States — Food and Drug Administration: The FDA previously granted Orphan Drug Designation to CardiolRx, which is mentioned in the context of the company's pipeline. No new regulatory action is announced.
Aug 05, 2026 · 6 articles
Business
Nasdaq: ARTL is listed on Nasdaq; stock price declined on announcement day.
United States — Food and Drug Administration: No FDA-approved treatments exist for CACS, highlighting unmet need.
Jul 13, 2026 · 7 articles
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