Each material 8-K filed by a company listed on a US stock exchange (NYSE, Nasdaq, Cboe), read and summarized: what happened, the key numbers, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). This page lists the last 45 days; every brief stays on its company's 8-K page (4787 companies, A–Z).
TMC USA, a subsidiary of TMC the metals Co Inc., received a letter from NOAA stating it expects to notify TMC USA of its final determination on certification of its consolidated application for an exploration license and commercial recovery permit by mid-December 2026. The filing notes the timing is an estimate, DSHMRA sets no mandatory deadline, and certification is an intermediate step that is not an approval or issuance of a license or permit.
NOAA letter received by TMC USA on November 3, 2026
NOAA expects to notify TMC USA of its final determination on certification by mid-December 2026
Application covers an exploration license and a commercial recovery permit under DSHMRA
Filing states certification does not constitute approval or issuance of a license or permit
Vistagen reported constructive FDA feedback from a Type C meeting on registrational paths for its lead product candidate, fasedienol, in social anxiety disorder. The company plans to use interim assessments, submit a revised protocol, and focus development on the general SAD population rather than acute treatment alone.
FDA gave constructive feedback on using the Liebowitz Social Anxiety Scale as the primary endpoint in a future Phase 3 study.
Vistagen plans to add interim assessments using eDiaries and qualitative patient surveys and to submit a revised protocol to the FDA.
The company plans to pursue fasedienol for overall, not only acute, treatment of SAD, and cited the FDA's recognition of its reported safety profile.
The filing contains no financial results, and the company states that future FDA feedback may not lead to a successful registrational pathway.
On November 5, 2026, the Public Service Commission of Wisconsin approved rate changes in rate cases filed in April 2026 by Wisconsin Electric Power Company, Wisconsin Gas LLC and Wisconsin Public Service Corporation. The presentation slides attached to the filing list an authorized return on equity of 9.50% and an equity ratio of 53.0%, and say a final written order is expected before year-end.
PSCW approved rate changes on November 5, 2026 for Wisconsin Electric, Wisconsin Gas and Wisconsin Public Service
Authorized return on equity of 9.50% and equity ratio of 53.0%
Earnings sharing: no sharing on the first 15 basis points above the allowed ROE, 50/50 on the next 25 basis points, and 100% to customers beyond 40 basis points
Essential Utilities disclosed that American Water, Essential Utilities and their affiliates filed a Stipulation of Settlement with the New Jersey Board of Public Utilities (NJBPU) on November 2, 2026, in the proceeding to approve the proposed merger. The stipulation was entered into with all parties, including NJBPU staff and the New Jersey Division of Rate Counsel, and is subject to review and approval by the NJBPU. The filing shows progress on regulatory approval, but the merger still requires the NJBPU's approval before it can proceed.
Stipulation of Settlement filed November 2, 2026, with all parties in the NJBPU proceeding
Stipulation posted to the NJBPU website as of November 5, 2026, and remains subject to NJBPU review and approval
Merger agreement with American Water was signed October 26, 2025; Essential Utilities would become a wholly owned subsidiary
Spire Missouri filed a general rate case with the Missouri Public Service Commission on November 2, 2026, requesting a total revenue requirement increase of $228 million. The filing is based on an average fiscal 2028 future test year rate base of $5.1 billion, and the commission has 11 months to review it, with new rates expected by October 2027. For shareholders, the outcome will determine how much of the utility's infrastructure investment is recovered through customer rates.
Total requested revenue increase of $228 million, including $57 million through the Infrastructure System Replacement Surcharge and $171 million in net new revenues
Proposed rates are based on an average fiscal 2028 future test year rate base of $5.1 billion, assuming a 55.0% common equity ratio and 10.5% return on equity
Company estimates the average residential bill would rise about $10 per month (11%) in western Missouri and about $13 per month (15%) in eastern Missouri if approved as filed
Missouri Public Service Commission has 11 months to consider the filing; new rates expected to be effective by October 2027
Allarity Therapeutics entered a Settlement and Release Agreement with Novartis Pharma AG on October 28, 2026, resolving a liability of $4.9 million plus interest tied to a license agreement that was terminated effective January 26, 2024. Novartis agreed to accept $1.0 million as full payment, and both parties will release claims once the payment is received. Separately, the company announced on October 30, 2026 its first revenue-generating contract under its CLIA-certified laboratory services strategy, but the filing does not disclose the contract's value.
Liability owed to Novartis: $4.9 million plus interest, arising under a license agreement between Novartis and Allarity Therapeutics Europe ApS, an affiliate
Settlement payment: $1.0 million, accepted by Novartis as full payment of the liability upon receipt
Mutual releases of claims take effect upon receipt of the payment, subject to claims relating to enforcement of the agreement
October 30, 2026 press release: first revenue-generating contract under the CLIA-certified laboratory services strategy; contract value not disclosed
A Delaware Court of Chancery granted FBB Holdings I's motions and enjoined Destination XL from terminating its merger agreement with FBB while the court makes further expedited determinations. The order is temporary and not a ruling on the merits, and DXL says it believes FBB's claims are without merit and will defend against them.
The Court of Chancery held a hearing on October 29, 2026 and granted both motions after it.
The merger agreement, dated December 11, 2025, allows either party to terminate if the merger is not completed by October 30, 2026.
FBB filed its complaint on October 26, 2026; DXL filed an answer and counterclaims on October 28, 2026.
DXL's preliminary proxy statement was filed July 17, 2026 and amended most recently on October 19, 2026.
Greenland Energy Company received a Nasdaq letter after director Roderick McIllree resigned on October 20, 2026, leaving it out of compliance with Nasdaq's majority independent director and audit committee requirements. The company says it appointed Melanie Furlan to the audit committee on October 27, 2026, curing the audit committee deficiency, and its common stock and warrants remain listed. The company must still regain majority independence within the cure period, which runs to the earlier of its next annual meeting or October 20, 2027, with an April 19, 2027 deadline if that meeting occurs before then.
Director Roderick McIllree resigned October 20, 2026, triggering the non-compliance.
Nasdaq letter dated October 28, 2026 set a cure period ending the earlier of the next annual meeting or October 20, 2027.
Audit committee deficiency cured October 27, 2026 by appointing Melanie Furlan; committee now includes Furlan, Scott Wollney and Carol Craig.
Common stock (GLND) and public warrants (GLNDW) continue trading on the Nasdaq Global Market.
Eureka Acquisition Corp, a Cayman Islands blank-check style company listed on Nasdaq, received a Nasdaq letter on October 26, 2026 granting it until January 31, 2027 to regain compliance with the public float requirement. The company had not met Nasdaq Listing Rule 5450(a)(4) and submitted a compliance plan on October 12, 2026. The extension means the stock stays listed for now, but the company must still meet the rule by the new deadline.
Nasdaq notice of non-compliance with Public Float Rule (Listing Rule 5450(a)(4)) was received August 27, 2026
Company submitted its compliance plan to Nasdaq on October 12, 2026
On October 26, 2026, Nasdaq granted an extension through January 31, 2027 to regain compliance
Zillow Group entered a settlement agreement on October 27, 2026, to resolve the consolidated securities class action Jaeger v. Zillow Group, Inc. The company will pay $212.5 million in cash into an escrow fund within 20 business days after preliminary court approval, with about $48 million expected to come from insurance proceeds. The settlement is subject to court approval and does not affect the related shareholder derivative actions, which remain pending.
Settlement payment totals $212.5 million, with about $48 million expected from insurance proceeds
Payment due within 20 business days after the court preliminarily approves the settlement
Class covers stock purchases from August 5, 2021, to November 2, 2021; agreement includes no admission of liability
Related shareholder derivative actions remain pending and are not resolved by this settlement
Beneficient and certain subsidiaries filed a motion to intervene in Delaware Court of Chancery litigation brought by HCLP Nominees against Delaware Trust Company, seeking to invalidate HCLP credit agreements and cancel the purported obligations. The company says success would eliminate about $130 million of purported HCLP debt and leave it with an unleveraged balance sheet, but the motion is subject to court approval and no definitive agreement has been reached.
The motion to intervene was filed October 23, 2026, and the company seeks to recover about $211 million it previously paid on the purported debt.
If successful, the action would eliminate about $130 million of purported HCLP debt and establish that HCLP has no valid right to the related collateral.
Former CEO Brad Heppner was convicted of securities fraud and wire fraud in May 2026; his sentencing is rescheduled for January 11, 2027.
No definitive agreement on a consensual resolution with Heppner has been reached, and the filing states that negotiations and litigation do not assure a particular outcome.
TXNM Energy disclosed that hearing examiners at the New Mexico Public Regulation Commission published a revised procedural schedule for the merger application on October 27, 2026. Evidentiary hearings are set for January 19 to February 1, 2027. TXNM still expects the merger with Troy ParentCo to close in the first half of 2027, but says it cannot predict the outcome.
NMPRC hearing examiners set evidentiary hearings for January 19 to February 1, 2027
The merger still requires NMPRC approval and satisfaction or waiver of customary conditions
TXNM continues to anticipate the merger closing in the first half of 2027
Nasdaq granted Rekor Systems an additional 180 calendar days, until April 26, 2027, to regain compliance with its minimum $1.00 bid price requirement. The notice has no immediate effect, and the common stock continues to trade on The Nasdaq Capital Market under REKR, but the company must close at or above $1.00 for at least ten consecutive business days by that date or face delisting.
Initial compliance period expired October 26, 2026; extension runs to April 26, 2027
Nasdaq first notified the company on April 27, 2026 after the stock closed below $1.00 for 30 consecutive business days
To regain compliance, the closing bid price must be at least $1.00 for ten consecutive business days
If not compliant by April 26, 2027, Nasdaq will issue a delisting notice; a hearing request would not stay trading suspension
The NYSE has begun proceedings to delist Eve Holding's public warrants, ticker EVEXW, and suspended trading in them because of an abnormally low selling price. The filing says the common stock, ticker EVEX, is not affected and continues to trade on the NYSE.
NYSE notified the company on October 21, 2026 and the company announced it publicly on October 22, 2026.
Warrants (EVEXW) are suspended from trading and the NYSE will apply to the SEC to delist them once procedures are complete.
Each warrant is exercisable for one share of common stock at $11.50 per share.
Common stock (EVEX) continues to trade on the NYSE, subject to the company's other listing requirements.
Charlton Aria Acquisition Corp notified Nasdaq that its audit committee did not meet a listing rule from at least August 25, 2026, because a director was indirectly paid $30,000 through an accounting firm he is a partner in. The board reconstituted the audit committee on October 22, 2026, and the company believes it regained compliance that day, with no Nasdaq notice received and its securities still listed.
Director Kyoung Tak Kim's firm, Leading Edge Advisory Inc., was paid $30,000, settled in full on August 25, 2026.
Audit committee was out of compliance from at least August 25, 2026, per the filing; the matter was identified on October 20, 2026.
On October 22, 2026, Kim left the audit committee; Wang Jo Cha joined it. The audit committee is now Stephen Markscheid, Umesh Patel and Wang Jo Cha.
As of the filing date, no Nasdaq notice had been received, and the units, Class A ordinary shares and rights continue to trade on Nasdaq.
Biohaven said the FDA accepted its new drug application resubmission for Vyglxia (troriluzole) in spinocerebellar ataxia (SCA) and considers it a complete response to the November 4, 2025 action letter. The FDA set a user fee goal date in the first quarter of 2027 and plans an advisory committee meeting, with the date to be announced later, so approval is not assured.
FDA accepted the NDA resubmission for Vyglxia (troriluzole) in SCA, which includes new supportive analyses.
FDA considers the resubmission a complete response to the November 4, 2025 action letter.
User fee goal date set for the first quarter of 2027; advisory committee meeting date to be announced in the near term.
Cognition Therapeutics said the FDA has aligned with it on key elements of a Phase 3 study of zervimesine in dementia with Lewy bodies, including patient selection, dose, duration and endpoints. The company is now completing a protocol for the planned registrational study, which the filing describes as covering a disease with no approved treatments. The filing contains no financial figures, so the update's effect on shareholders depends on the trial's future results and regulatory path.
Planned study will randomize participants with mild-to-moderate DLB to 100 mg once-daily oral zervimesine or placebo for nine months
Primary endpoint is the NPI-2 neuropsychiatric inventory measuring hallucinations and delusions
Key secondary endpoint is the ADCS-ADL scale, which evaluates effects on daily function
The announcement was made October 22, 2026, in a press release filed as Exhibit 99.1
Medalist Diversified filed a Certificate of Correction with Maryland on October 19, 2026, stating that a charter amendment approved at its June 16, 2026 annual meeting is of no force or effect. The company said the amendment, which restricted certain stock transfers to protect net operating loss and net capital loss tax benefits, did not receive the required stockholder vote. The board says it intends to seek stockholder approval again at a special meeting.
Certificate of Correction filed with Maryland SDAT on October 19, 2026
Charter Amendment originally filed with SDAT on June 17, 2026, after June 16, 2026 annual meeting
Amendment would have limited transfers that raise a holder's stake from under 4.9% to 4.9% or more
Over 95% of votes cast supported the proposal, but the required vote was not met
Collegium Pharmaceutical agreed on October 15, 2026 to settle all disputes with Grünenthal GmbH, including a patent infringement lawsuit over the Nucynta ER authorized generic. As part of the settlement, the company's license agreement with Grünenthal was terminated in its entirety, and the company made a $17 million payment, after which no further royalties are due under that license.
Settlement agreement dated October 15, 2026 resolves all disputes, including the Nucynta Litigation filed in February 2026 in the District of New Jersey
Collegium paid Grünenthal $17 million; the Grünenthal License terminated effective October 15, 2026
No further royalties will be due under the Grünenthal License; Grünenthal assigned certain Nucynta-related patents to Collegium and moved to dismiss the lawsuit
BioCardia said the FDA has accepted its revised De Novo pre-submission package for marketing clearance of its Helix catheter, and it expects FDA substantive review and a meeting this quarter. The filing does not report any financial results, and clearance is not yet granted, so the update is a regulatory milestone rather than a change in reported financial performance.
FDA accepted the revised De Novo pre-submission package, announced October 19, 2026
Company met with FDA in May 2026 and FDA confirmed and accepted the meeting minutes in August 2026
Revised package was re-submitted in September 2026 and BioCardia expects FDA substantive review and a meeting this quarter
Company cites clinical data from fifteen clinical trials including nearly five hundred patients
Ultragenyx and Baylor Research Institute settled patent litigation with Navinta LLC over patents covering DOJOLVI oral liquid. Navinta will receive a non-exclusive, royalty-free license to market a generic version starting January 1, 2033, which would extend to July 1, 2033 if pediatric exclusivity is granted. The filing does not give a financial impact, and other ANDA patent litigation on DOJOLVI remains pending.
Settlement with Navinta LLC resolves patent litigation filed in the U.S. District Court for the District of New Jersey
Navinta's generic DOJOLVI license begins January 1, 2033, or July 1, 2033 if pediatric exclusivity is granted
Similar patent litigation against other ANDA filers remains pending in the same court
Settlement agreement will be submitted to the FTC and the U.S. Department of Justice
Clene Inc. announced that it submitted a New Drug Application to the FDA earlier in October 2026 seeking accelerated approval of CNM-Au8 for amyotrophic lateral sclerosis (ALS). The filing contains no financial figures and does not state a review timeline. For shareholders, the submission advances the company's lead program toward a possible FDA decision, but approval is not assured.
NDA submitted earlier in October 2026 seeking accelerated approval of CNM-Au8 for ALS
Application is based on neurofilament light chain biomarker data and clinical outcomes
Company says it continues preparing for the confirmatory Phase 3 RESTORE-ALS study
Press release dated October 19, 2026, furnished as Exhibit 99.1
The FDA accepted for filing a supplemental New Drug Application for REZZAYO (rezafungin) for the prophylaxis of invasive fungal disease and granted Priority Review, with a PDUFA target action date in Q1 2027. The application was submitted by partner Mundipharma and is supported by the Phase III ReSPECT study. Acceptance does not assure approval, and CorMedix is targeting promotional efforts beginning in H2 2027 if the indication is approved.
FDA accepted the sNDA for filing and granted Priority Review
PDUFA target action date is in Q1 2027
Application was submitted by Mundipharma, CorMedix's global development partner
If approved, CorMedix is targeting promotional efforts beginning in H2 2027
Conduent and two subsidiaries entered a class action settlement agreement on October 16, 2026, to resolve a consolidated lawsuit over the company's January 2025 cybersecurity incident. The settlement requires a non-reversionary $80 million fund and takes effect only if the U.S. District Court for the District of New Jersey approves it. The company says it maintains cyber insurance and does not expect a material impact on its financial position, results of operations or cash flows.
Company will fund $80 million into a non-reversionary settlement fund, its total monetary obligation under the agreement
Fund covers class member recovery, credit and medical data monitoring, plaintiffs' counsel fees and administration costs
Settlement releases the company, affected clients and their customers from claims tied to the cyber incident upon final approval
Agreement is not an admission of fault and remains subject to Court approval
On October 15, 2026, Sanara MedTech and MiMedx each received a Second Request from the Federal Trade Commission as part of its review of the proposed merger in which Sanara would become a wholly-owned subsidiary of MiMedx. Under the Hart-Scott-Rodino Act, the Second Request extends the waiting period until 30 days after the parties substantially comply, so closing is likely to take longer, and completion still depends on regulatory and other conditions.
FTC issued a Second Request to Sanara and MiMedx on October 15, 2026.
The Second Request extends the HSR Act waiting period until 30 days after substantial compliance, unless extended or terminated earlier.
Completion remains subject to HSR waiting period expiration and other closing conditions in the Merger Agreement.
The filing does not state a expected closing date or any financial figures for the deal.
MiMedx and Sanara MedTech each received a Second Request from the Federal Trade Commission on October 15, 2026, as part of the FTC's review of their proposed merger. The request extends the Hart-Scott-Rodino waiting period until 30 days after the parties substantially comply, which could delay closing; the filing gives no expected timing.
FTC issued Second Requests to MiMedx and Sanara on October 15, 2026.
Second Request extends the HSR Act waiting period until 30 days after substantial compliance, unless extended voluntarily or ended earlier by the FTC.
Completion still depends on HSR waiting period expiration and other closing conditions; MiMedx says it continues to work constructively with the FTC.
Nathan's Famous said it is voluntarily supplementing its definitive proxy statement for the proposed $102.00-per-share merger with Smithfield Foods, after two stockholder lawsuits and fifteen demand letters challenged the proxy's disclosures. The company and its board deny the claims, but say the supplements aim to moot the disclosure claims and reduce litigation costs and risks before the October 23, 2026 special meeting of stockholders.
Two lawsuits were filed September 30, 2026, in the Supreme Court of the State of New York against the company and its board, and seek to enjoin the merger.
Purported stockholders delivered fifteen demand letters and two Section 220 books-and-records demands under Delaware law.
The supplemental disclosures cover executive retention discussions with the buyer and Jefferies LLC's selected companies analysis.
The special meeting of stockholders is scheduled for October 23, 2026; the merger consideration is $102.00 per share.
Brightline Interactive said Nasdaq confirmed on October 12, 2026 that it has regained compliance with the $1.00 minimum bid price rule, and the matter is closed. The company stated that compliance followed a 1-for-8 reverse stock split effective September 28, 2026, and that its common stock continues to trade on the Nasdaq Capital Market as BTLN, so the filing removes the delisting threat tied to the bid price issue.
Nasdaq letter dated October 12, 2026 confirmed compliance; the closing bid price was at $1.00 or greater for 10 consecutive business days
Company effected a 1-for-8 reverse stock split, effective September 28, 2026
Nasdaq issued a Staff Determination to delist on September 11, 2026; the company requested a hearing on September 17, 2026, which stayed any delisting action
Stock continues to trade on the Nasdaq Capital Market under the symbol BTLN
On October 13, 2026, Xeris Biopharma, through subsidiary Xeris Pharmaceuticals, filed patent infringement lawsuits in federal court in New Jersey against several makers of generic dichlorphenamide, the active ingredient in its KEVEYIS product. The suits follow the grant of U.S. Patent No. 12,758,502, and the company seeks an injunction, monetary and enhanced damages, and attorneys' fees. The filing does not include financial figures, so the effect on shareholders will depend on the outcome of the litigation.
Two separate actions filed October 13, 2026, in the U.S. District Court for the District of New Jersey.
Defendants include Torrent Pharma Inc., Torrent Pharmaceuticals Limited, Cycle Pharmaceuticals Limited, Lemed Pharmacy III, LLC, Lemed Specialty Pharmacy Arizona, LLC, Rising Pharma Holdings, Inc., and Rising Pharma Specialties Pvt. Ltd.
The suits concern U.S. Patent No. 12,758,502, related to the KEVEYIS (dichlorphenamide) product.
The company seeks a judgment of infringement, injunctive relief, monetary and enhanced damages, attorneys' fees, and costs.
Quoin Pharmaceuticals said on October 14, 2026 that the European Medicines Agency granted Orphan Drug Designation to its lead product candidate QRX003 for treating Peeling Skin Syndrome. If QRX003 is approved for marketing by the EMA, the company would receive 10 years of market exclusivity in Europe for similar medicines for this indication, and the company plans to start the first-ever formal clinical study for the condition before year end.
EMA granted Orphan Drug Designation to QRX003 for Peeling Skin Syndrome, announced October 14, 2026
Designation brings scientific advice on study protocols, various fee reductions and access to EU grants
If approved by the EMA, QRX003 would receive 10 years of market exclusivity in Europe for this indication
The company intends to initiate the first-ever formal clinical study for Peeling Skin Syndrome before year end
SS Innovations said it submitted its response to an FDA request for additional information on its 510(k) application for the SSi Mantra surgical robotic system on October 5, 2026. The response includes final data from an expanded human clinical and human factors validation study and a bridging study, and the company expects the FDA to complete its review in the first quarter of 2027. The filing describes a regulatory milestone toward U.S. market entry but gives no financial results or timing guarantees.
Response to the FDA's request for additional information was submitted on October 5, 2026.
The response includes final data from an expanded human clinical and human factors validation study and a bridging study completed in August 2026 at Hospital Internacional de Colombia in Bucaramanga.
The company expects the FDA to complete its review of the response and the 510(k) submission in the first quarter of 2027.
The 510(k) submission covers the initial indication of cholecystectomy (gallbladder removal).
American Express and its bank subsidiary consented to orders from the Federal Reserve and the Office of the Comptroller of the Currency to resolve regulatory reviews of parts of its financial crimes compliance program. The bank unit also agreed to pay a $350 million civil money penalty, part of which was already reserved for in prior periods. The company says the penalty does not affect its 2026 guidance, and the orders impose no asset cap and are not expected to affect 2027 guidance.
Consent orders issued October 8, 2026 by the Federal Reserve and the OCC resolve previously disclosed reviews of financial crimes compliance.
American Express National Bank agreed to pay a $350 million civil money penalty to the OCC.
A portion of the penalty was reserved for in prior periods; the company says it does not affect full-year 2026 guidance.
The orders do not impose an asset cap, and remediation costs are not anticipated to affect 2027 guidance.
Perspective Therapeutics (NYSE American: CATX) announced on October 8, 2026 that the U.S. Food and Drug Administration granted Fast Track Designation for PSV359 for adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors. The filing says the designation is intended to facilitate development and expedite review, and that PSV359 is in an ongoing Phase 1/2a study, but it does not describe any financial effect.
FDA granted Fast Track Designation for PSV359 on or before October 8, 2026, per the press release dated October 8, 2026.
The designation covers adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors.
PSV359 is an investigational FAP-targeted alpha-particle therapy being evaluated in an ongoing Phase 1/2a study (NCT06710756).
The press release is filed as Exhibit 99.1; the filing reports no financial figures.
On October 7, 2026, NextNRG completed its reincorporation from Delaware to Nevada under a plan approved by stockholders on December 29, 2025, and filed new Nevada charter documents and certificates of designation for its Series A, B and C convertible preferred stock. The company said the move did not change its business, management, assets, liabilities or net worth, and its common stock continues to trade on Nasdaq under NXXT. Shareholders should note that stockholder rights are now governed by Nevada law and the new Nevada bylaws.
Reincorporation effective October 7, 2026; each common share and preferred share converted one-for-one into the Nevada corporation's equivalent
Amended and Restated Voting Agreement dated October 7, 2026, effective September 30, 2026, terminates on the later of required approvals (other than the Split Authorization) or December 31, 2028
Series A preferred carries a $10.00 stated value and a 10% annual dividend paid in common stock; holders are capped at 9.99% beneficial ownership
On October 6, 2026, HeartSciences said the FDA granted 510(k) clearance (K260005) for its MyoVista wavECG device as a 12-lead resting electrocardiograph, but the clearance does not include the AI-ECG algorithm. The company does not intend to commercialize the device without a cleared algorithm and has no timeline for doing so, and it will evaluate options for the device and related intellectual property. The proposed business combination with Fortitude Mining Holdings continues, with closing expected in Q4 calendar 2026, subject to shareholder approval.
FDA granted 510(k) clearance K260005 for the MyoVista wavECG device as a 12-lead resting electrocardiograph, covering adult and pediatric patients in hospitals and healthcare facilities.
The clearance does not include the AI-ECG algorithm, and the company has no commercialization timeline for the device.
The Proposed Transaction with Fortitude, under a merger agreement dated June 23, 2026, is expected to close in Q4 calendar 2026, subject to shareholder approval.
Endovia Health Sciences announced that the FDA's Center for Veterinary Medicine determined CannEpil qualifies as a minor use for controlling bone cancer pain in dogs, making it eligible to pursue the conditional approval pathway. The product remains investigational and is not approved or conditionally approved, and the company has not given revenue or financial figures in this filing.
FDA Center for Veterinary Medicine determined CannEpil qualifies as a minor use under the MUMS program
Endovia and Lupvindol are scheduled to meet the FDA for a Pre-Submission Conference on November 19, 2026
Company is working toward a potential veterinary launch in 2027, subject to FDA approval
American Battery Technology Company received approval from the U.S. Department of Commerce's Bureau of Industry and Security for a license to export recycled black mass, allowing sales of up to $100 million under specified terms. The license follows newly enacted federal export controls on critical battery materials, and the company says it supports current operations and its market position.
BIS approved a license allowing sales of up to $100 million of recycled black mass material
The approval follows the implementation of recently enacted federal export controls on critical battery materials
The press release, dated October 1, 2026, cites over 400% year-over-year revenue growth and references the company's fiscal year 2026 results
The filing is a Form 8-K under Item 8.01 with the press release attached as Exhibit 99.1
BioMarin entered into a Settlement and License Agreement with Ascendis Pharma on September 24, 2026, replacing an August 2026 binding term sheet. Ascendis receives a non-exclusive license to BioMarin patents covering TransCon CNP (navepegritide, Yuviwel), and BioMarin receives royalties on net sales until May 2030. The filing says the parties will dismiss all pending litigation between them over the patents, and it does not disclose dollar amounts.
Agreement dated September 24, 2026, deemed effective August 28, 2026, and supersedes the term sheet reported on August 31, 2026
Royalty of 20% of annual net sales in the United States and 18% in the EU, Brazil and South Korea, until May 2030
Pending litigation between the parties relating to the BioMarin patent rights to be dismissed with prejudice
Ascendis agreed not to challenge BioMarin's patent rights; no dollar figures disclosed
MoonLake Immunotherapeutics said it submitted a Biologics License Application to the U.S. Food and Drug Administration on September 30, 2026, seeking approval of its tri-specific nanobody sonelokimab for moderate-to-severe hidradenitis suppurativa in adults and patients 12 years and older. The filing marks a regulatory step toward a possible approval, but the FDA has not yet decided whether to accept the application for review.
BLA submitted to the FDA on September 30, 2026 for sonelokimab in moderate-to-severe hidradenitis suppurativa
FDA acceptance decision expected within approximately 60 days of submission
Planned review timeline expected from the FDA within approximately 74 days of submission
AEON Biopharma received official minutes from its FDA Type 2b meeting on the development path for ABP-450, a proposed biosimilar to BOTOX. The FDA agreed in principle with the company's two-stage pharmacodynamic study design and said previously completed Daewoong comparative studies may be submitted as supportive evidence, while the company will not start a standalone comparative efficacy study for now. The filing also says the Two-Year Milestone Warrants will expire on November 16, 2026, which affects warrant holders.
FDA agreed in principle with the two-stage CMAP pharmacodynamic study design; company expects to file an IND in Q4 2026 and start the study in Q1 2027
Previously completed Daewoong comparative studies may be considered as supportive evidence, subject to scientific bridging
No standalone comparative efficacy study planned at this time; company plans to return to the FDA in 2027
Two-Year Milestone Warrants will expire on November 16, 2026, unless exercised before that date
DBV Technologies said it has submitted a Biologics License Application to the U.S. Food and Drug Administration for its VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years, and has requested Priority Review. The application is supported by results from the Phase 3 VITESSE trial, which enrolled 654 children, and the FDA previously granted the patch Breakthrough Therapy Designation. The filing reports a regulatory milestone, not revenue or approval, and the company states the product has not been authorized for sale in any country.
BLA submitted to the FDA for VIASKIN Peanut Patch in children aged 4 through 7 years, announced September 29, 2026
DBV has requested Priority Review; the FDA previously granted Breakthrough Therapy Designation
VITESSE Phase 3 trial enrolled 654 children, randomized 2:1 to active patch or placebo
The company states the product has not been authorized for sale in any country
Meridian Holdings disclosed a September 25, 2026 provisional measure signed by Brazil's President that bans operating, intermediating and advertising online betting and online casino services in Brazil and requires funds to be returned to bettors. The company says Brazil is an immaterial share of Group revenue and that its exposure is limited because it did not commit large marketing spending before licensing, but the filing gives no dollar figures for the affected business.
Brazil's President signed the Provisional Measure on September 25, 2026, prohibiting online betting and online casino operation, intermediation and advertising in Brazil.
The measure requires that funds be returned to bettors.
The company says Brazil is an immaterial share of Group revenue and does not quantify the exposure.
Subsidiary Meridian Gaming Brasil SPE Ltda's authorization runs until December 31, 2029, and the measure must be approved by the Brazilian Congress within 120 days of adoption to remain in effect.
CapsoVision said the U.S. Food and Drug Administration cleared AI Highlights, an AI-assisted reading feature for its CapsoCam Plus capsule endoscopy system, on September 25, 2026. The company announced the clearance on September 28, 2026, and the filing contains no revenue, profit, or guidance figures, so its direct financial effect on shareholders is not quantified.
FDA clearance received September 25, 2026; announced September 28, 2026
Tool flags suspected abnormal lesions in small bowel capsule studies to reduce physician review time
Intended for adult and pediatric patients over two years old with suspected small bowel bleeding; does not replace gastroenterologists' diagnosis
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Frequently asked questions
Which filings get a brief?
Form 8-K filings by companies listed on a US stock exchange (NYSE, Nasdaq, Cboe; not over-the-counter stocks) that report a material event: results (Item 2.02), deals (1.01, 2.01), executive changes (5.02), restructuring (2.05), impairments (2.06), delisting notices (3.01), restatements (4.02), cybersecurity incidents (1.05), bankruptcy (1.03) and Regulation FD or other events (7.01, 8.01). Routine filings such as vote results or exhibits only are skipped.
How is the impact score set?
The AI rates each filing from 1 (routine) to 5 (major, such as a merger, bankruptcy or restatement) based only on what the filing says. It is a reading aid for sorting the day's filings, not a prediction of how the stock will move.
How quickly do briefs appear?
On weekdays the SEC filing feed is checked every 5 minutes from 6 am to 5:45 pm Eastern, when nearly all 8-Ks come in, and every hour after that until 10 pm. Briefs of the 1,000 largest companies follow within minutes; the others usually within the hour, or later the same day when many filings arrive at once.
Which companies are covered?
Every company with shares listed on the NYSE, Nasdaq or Cboe that files 8-Ks, about 4,500 of them. Foreign companies that report on Form 6-K instead are not included. The S&P 1500 only filter above narrows the list to the large, mid and small caps of the S&P Composite 1500.
Are older briefs kept?
Yes. This page shows the last 45 days, but every brief ever published stays online: each has its own page, and each company has an 8-K page listing all of its briefs, newest first, linked from its stock page and from the A-Z list of companies.