Regulatory decisions
131 filings were classified as regulatory decision in the last 90 days. The most recent was Phathom Pharmaceuticals, Inc. (PHAT) on Oct 23, 2026.
Latest filings
| Filed | Issuer | Event | Classified excerpt | Source |
|---|---|---|---|---|
| PHATPhathom Pharmaceuticals, Inc. | Regulatory decision | “Phathom believes that FDA carefully and correctly evaluated this issue in its June 6, 2025 grant of Phathom's December 11, 2024 Citizen Petition, in which FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032.” | 8-K ↗ | |
| SUPNSupernus Pharmaceuticals, Inc. | Regulatory decision | “The Company issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. The seven-year market exclusivity for ONAPGO began on February 3, 2025, the date of FDA approval.” | 8-K ↗ | |
| CGTXCognition Therapeutics, Inc. | Regulatory decision | “On October 22, 2026, Cognition Therapeutics, Inc. (the "Company") issued a press release announcing the receipt of written feedback from the U.S. Food and Drug Administration (the "FDA") confirming alignment on key elements of a Phase 3 study in dementia with Lewy bodies.” | 8-K ↗ | |
| ABUSArbutus Biopharma Corporation | Regulatory decision | “On October 22, 2026, Arbutus Biopharma Corporation (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has lifted the clinical hold on the Investigational New Drug application for AB-101, the Company's oral PD-L1 inhibitor.” | 8-K ↗ | |
| AARDAardvark Therapeutics, Inc. | Regulatory decision | “On October 22, 2026, Aardvark Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration lifted the clinical hold on the Company's Investigational New Drug application for ARD-101 for the treatment of hyperphagia in Prader-Willi Syndrome.” | 8-K ↗ | |
| BHVNBiohaven Ltd. | Regulatory decision | “The FDA has informed Biohaven that the company's new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review. The FDA communicated that it considers the resubmission a complete response to the November 4, 2025 action letter, and has assigned a user fee goal date in the first quarter of 2027.” | 8-K ↗ | |
| IONSIonis Pharmaceuticals, Inc. | Regulatory decision | “Ionis reported that its partner, GSK, announced that the FDA has approved HIBSAGO™ (bepirovirsen) for the treatment of chronic hepatitis B virus infection in combination with NrtI therapy in specified adult patients without cirrhosis.” | 8-K ↗ | |
| DVDoubleVerify Holdings, Inc. | Regulatory decision | “On October 5, 2026, the Merger received clearance from the German Federal Cartel Office (Bundeskartellamt). On October 7, 2026, the Merger received clearance from the Commission for the Protection of Competition of the Republic of Cyprus. On October 13, 2026, the Merger received clearance from the ACCC... Also on October 13, 2026, the Merger received clearance from the Moroccan Competition Council.” | 8-K ↗ | |
| SRZNSurrozen, Inc. Common | Regulatory decision | “The Second Closing was contingent upon the public announcement of the receipt of clearance from the U.S. Food and Drug Administration of the Company's Investigational New Drug Application for SZN-8141 ... On October 2, 2026, the Company announced that the Second Closing Milestone had been achieved.” | 8-K ↗ | |
| AESAES Corporation | Regulatory decision | “On October 15, 2026, the European Commission unconditionally approved the Merger under Council Regulation (EC) No. 139/2004 (as amended) (the "EU Merger Regulation Approval"). Additionally, on October 19, 2026, the New York Public Service Commission issued a declaratory ruling that the Merger requires no further review under New York Public Service Law Section 70 (the "NYPSC Approval").” | 8-K ↗ | |
| CRMDCorMedix Inc. | Regulatory decision | “On October 19, 2026, CorMedix, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) seeking approval of REZZAYO® (rezafungin for injection) for the prophylaxis of invasive fungal disease.” | 8-K ↗ | |
| No ticker CIK 0001004155 | Regulatory decision | “On October 15, 2026, the Illinois Commerce Commission (the "Illinois Commission") entered an order approving the Stipulation and Settlement... The Illinois Commission's order is subject to a request for rehearing by any party to the proceeding within 30 days of service of the order on such party.” | 8-K ↗ | |
| EDSAEdesa Biotech, Inc. Common Shares | Regulatory decision | “the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for its Phase 2 clinical study of EB06 in vitiligo, enabling the Company to expand recruitment to the United States.” | 8-K ↗ | |
| AQSTAquestive Therapeutics, Inc. | Regulatory decision | “Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027.” | 8-K ↗ | |
| GUREGulf Resources, Inc. (NV) | Regulatory decision | “On October 14, 2026, Gulf Resources, Inc. (the "Company") issued a press release announcing that it has received approval from the Shouguang Municipal Government to resume production at its Factories No. 2 and No. 10.” | 8-K ↗ | |
| RXRXRecursion Pharmaceuticals, Inc. | Regulatory decision | “REC-4881 is a potential first-in-class oral therapy granted FDA Orphan Drug and Fast Track designations.” | 8-K ↗ | |
| CBIOCrescent Biopharma, Inc. | Regulatory decision | “In October 2026, the Company's topoisomerase inhibitor ADC targeting PD-L1, CR-002, received allowance to proceed under an Investigational New Drug Application from the U.S. Food and Drug Administration.” | 8-K ↗ | |
| AVXLAnavex Life Sciences | Regulatory decision | “On October 15, 2026, Anavex Life Sciences Corp. (the "Company") issued a press release announcing that it received notification from the U.S. Food and Drug Administration that the Company may proceed with its planned clinical study under its investigational new drug application for blarcamesine in Fragile X syndrome.” | 8-K ↗ | |
| VSTMVerastem, Inc. | Regulatory decision | “On October 7, 2026, the FDA accepted for review our Blister Pack New Drug Application (the "NDA") for the first quarter of 2027 and notified us that the NDA has been granted priority review.” | 8-K ↗ | |
| QNRXQuoin Pharmaceuticals, Ltd. | Regulatory decision | “QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (the ‘EMA’) for the treatment of Peeling Skin Syndrome.” | 8-K ↗ | |
| RIGTransocean LTD. | Regulatory decision | “On October 13, 2026, the Brazilian competition authorities ("CADE") issued a decision determining that the Business Combination may be put into effect without restrictions. Transocean and Valaris expect this decision to be published in Brazil's Official Journal on October 15, 2026 or October 16, 2026, which will trigger the start of a fifteen-day waiting period before the decision becomes final.” | 8-K ↗ | |
| VALValaris Limited | Regulatory decision | “On October 13, 2026, the Brazilian competition authorities ("CADE") issued a decision determining that the Business Combination may be put into effect without restrictions. Valaris and Transocean expect this decision to be published in Brazil's Official Journal on October 15, 2026 or October 16, 2026, which will trigger the start of a fifteen-day waiting period before the decision becomes final.” | 8-K ↗ | |
| RAREUltragenyx Pharmaceutical Inc. | Regulatory decision | “The Company was awarded the PRV by the U.S. Food and Drug Administration ("FDA") on September 17, 2026 upon approval of FAYUVITM (rebisufligene etisparvovec-hopf) also known as UX111, for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome Type A).” | 8-K ↗ | |
| IBRXImmunityBio, Inc. | Regulatory decision | “On October 14, 2026, ImmunityBio, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors.” | 8-K ↗ | |
| ETONEton Pharmaceutcials, Inc. | Regulatory decision | “The Product has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity ... in patients with epilepsy 2 to 5 years of age and ages 12 and older.” | 8-K ↗ |
GET /stocks/filings/8-K/vX/disclosures?tertiary_category=regulatory_decision&filing_date.gte=2026-07-28&sort=filing_date.desc&limit=1000Each category is a separate request; rows are merged and de-duplicated by filing.
{
"status": "OK",
"results": [
{
"tickers": [
"PHAT"
],
"cik": "0001783183",
"accession_number": "0001193125-26-430621",
"filing_date": "2026-10-23",
"primary_category": "operations_and_strategy",
"secondary_category": "business_developments",
"tertiary_category": "regulatory_decision",
"supporting_text": "Phathom believes that FDA carefully and correctly evaluated this issue in its June 6, 2025 grant of Phathom's December 11, 2024 Citizen Petition, in which FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032.",
"filing_url": "https://www.sec.gov/Archives/edgar/data/1783183/0001193125-26-430621.txt"
},
{
"tickers": [
"AARD"
],
"cik": "0001774857",
"accession_number": "0001193125-26-428943",
"filing_date": "2026-10-22",
"primary_category": "operations_and_strategy",
"secondary_category": "business_developments",
"tertiary_category": "regulatory_decision",
"supporting_text": "On October 22, 2026, Aardvark Therapeutics, Inc. (the \"Company\") issued a press release announcing that the U.S. Food and Drug Administration lifted the clinical hold on the Company's Investigational New Drug application for ARD-101 for the treatment of hyperphagia in Prader-Willi Syndrome.",
"filing_url": "https://www.sec.gov/Archives/edgar/data/1774857/0001193125-26-428943.txt"
}
]
}
// trimmed to 2 resultsShowing the 25 most recent of 131Query this data with the API
What these filings mean
- Regulatory decision
- Regulatory approvals, rejections, complete response letters, or information requests from FDA, EPA, or other agencies.
How this page works
- Every 8-K disclosure from the last 90 days is classified, and those in the categories above are listed here.
- One row per filing: a filing in several categories appears once.
- Labels are assigned automatically from the filing text, so always check the linked 8-K.
Other 8-K events
- Listing deficiency & delisting notices
- CEO departures
- CFO & executive departures
- Stock splits
- Merger agreements & completions
- Share buyback programs
- Dividend declarations
- Earnings releases
- Guidance updates
- Clinical trial results
- Bankruptcy filings
- Financial restatements
- Auditor changes
- Cybersecurity incidents
- Layoffs & restructuring
Frequently asked questions
What is an SEC Form 8-K?
An 8-K is how a public company tells investors about a major event between its quarterly reports. Companies usually have four business days to file one.
How recent is this regulatory decisions list?
It covers 8-K filings from the last 90 days, classified as regulatory decisions and sorted newest first. The Massive 8-K disclosures API has the full, continuously updated record.
Build with AI
Track these filings with your agent
This page is built from the Massive 8-K disclosures endpoint. Ask an agent to watch for new filings:
Using the Massive API (massive.com/docs/llms.txt), check the 8-K disclosures endpoint once a day for new filings classified as regulatory decisions (query tertiary_category=regulatory_decision) and tell me about each new one, with the company, filing date, excerpt and SEC link.
Live market data from the Massive API and MCP.Get a free API key
Nothing on this page is investment advice. All data and content is provided for informational purposes under our Terms of Service.