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 (3292 companies, A–Z).
BioCardia said it finished its clinical consultation with Japan's PMDA on application materials for the CardiAMP Cell Therapy System for ischemic heart failure, a step toward submitting a marketing approval application. The company states that completing consultations does not constitute regulatory approval, and the product remains subject to PMDA review.
Consultation with Japan's PMDA on application materials completed, announced November 6, 2026
CardiAMP is intended for ischemic heart failure; CEO Peter Altman targets first patient treatments in Japan and commercial revenues in 2028
Completion does not equal regulatory approval; product remains subject to PMDA review
Polar Power received written confirmation from Nasdaq that it complies with the $2.5 million minimum stockholders' equity requirement. The company also announced Phase 2 of its restructuring, which targets further facility consolidation and lower fixed overhead, and it is evaluating refinancing and other capital-raising options. Nasdaq said the company must keep showing compliance in its next periodic report or it may face delisting proceedings.
Nasdaq staff determined Polar complies with the $2.5 million minimum stockholders' equity requirement, based on its Form 8-K dated October 23, 2026
Phase 1 of the restructuring delivered about $1.03 million in annualized cost reductions; the target is about $2 million in total annualized savings, including Phase 1
Polar is evaluating refinancing and other capital-raising alternatives, and Nasdaq cautioned that delisting proceedings may follow if compliance is not evidenced in the next periodic report
NRx Pharmaceuticals said the FDA approved its Abbreviated New Drug Application for Preservative-Free Ketamine ahead of the November 10, 2026 GDUFA goal date. The company says it now has commercial supply on hand to label the product and sell it to American hospitals and clinics, but the filing gives no sales, revenue or earnings figures.
FDA approved the company's ANDA for Preservative-Free Ketamine, announced October 30, 2026, ahead of the November 10, 2026 goal date.
The company says the product contains no benzethonium chloride, a preservative it describes as not GRAS-designated by the FDA.
Manufacturing is with Nephron Pharmaceuticals in West Columbia, South Carolina.
The company says it can now label the product and supply American hospitals and clinics.
uniQure N.V. said the FDA accepted its Biologics License Application for ifezuntirgene inilparvovec, an investigational gene therapy for Huntington's disease, and granted Priority Review with a PDUFA target action date of May 1, 2027. The FDA also said it is tentatively planning an Advisory Committee meeting, with dates to be set later, and the company and FDA have aligned on the design of a confirmatory trial.
FDA accepted the BLA under the Accelerated Approval pathway and granted Priority Review
PDUFA target action date is May 1, 2027
FDA tentatively plans to discuss the application at an Advisory Committee meeting; the company will be notified once the date is set
Confirmatory trial design: randomized, standard-of-care, about 200 patients in a 2:1 ratio, Total Functional Capacity at 36 months as primary endpoint; U.S. patient screening planned to start by end of 2026
INOVIO announced on October 30, 2026 that the FDA granted accelerated approval for VOCERYQ, a DNA-based immunotherapy, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). The company expects to make the product available to order and ship in about 60 days and to deploy its full field team in the first quarter of 2027, and it must submit a draft confirmatory study protocol by the end of 2026. The filing does not disclose revenue, pricing, or financial projections, so the near-term financial effect on shareholders is not quantified.
FDA granted accelerated approval on October 30, 2026 for VOCERYQ in combination with the CELLECTRA 5PSP delivery device
In the efficacy population of 26 patients, 7 (27%) had a complete response after 12 months of follow-up, based on the RRP-001 study
Order-and-ship availability expected in about 60 days; full field deployment expected in Q1 2027 with Syneos Health support
Continued approval may depend on a confirmatory study; draft protocol due by end of 2026 and final protocol expected by mid-2027
Palvella Therapeutics said the FDA accepted for filing and granted Priority Review to its New Drug Application for QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations, with a Prescription Drug User Fee Act target action date of February 28, 2027. The company says the drug could be the first FDA-approved therapy for this condition and is preparing for a potential U.S. launch in the first half of 2027, but approval is not assured.
FDA accepted the NDA and granted Priority Review for QTORIN 3.9% rapamycin anhydrous gel
PDUFA target action date set for February 28, 2027
Phase 3 SELVA study met all six prespecified efficacy endpoints (all p<0.001)
Potential standalone U.S. commercial launch planned for the first half of 2027, subject to FDA approval
Alaunos Therapeutics said Nasdaq confirmed it has regained compliance with the $2,500,000 minimum stockholders' equity requirement, closing the matter and canceling the November 10, 2026 hearing before the Nasdaq Hearings Panel. Its common stock will continue to be listed and traded on The Nasdaq Capital Market, removing the near-term delisting risk for shareholders.
Nasdaq notified the company on April 9, 2026 that it was not in compliance with the $2,500,000 stockholders' equity requirement.
The company said a private placement completed on October 14, 2026 led it to believe it had regained compliance.
On October 22, 2026, Nasdaq's Office of General Counsel confirmed compliance and closed the matter.
The hearing scheduled for November 10, 2026 was cancelled.
Supernus said the FDA recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for motor fluctuations in adults with advanced Parkinson's disease, with the exclusivity period starting on the February 3, 2025 approval date. The company also submitted a supplemental New Drug Application for a second supplier of ONAPGO and continues to expect potential FDA approval of that supplier by mid-year 2027. The filing gives no financial figures, but the exclusivity period is a regulatory protection for the product.
FDA recognized seven years of orphan-drug exclusive approval for ONAPGO, with the period starting February 3, 2025.
ONAPGO is described as the first and only subcutaneous apomorphine infusion device for motor fluctuations in adults with advanced Parkinson's disease.
Supernus submitted an sNDA for a second supplier of ONAPGO and expects potential FDA approval by mid-year 2027.
The Fifth Circuit Court of Appeals vacated the Texas District Court's order granting class certification in the securities class action against Filana Therapeutics and certain officers and employees. The case returns to the Texas District Court for further class certification proceedings, and the appeals court made no finding on whether the company's securities traded in an efficient market.
On October 16, 2026, the Fifth Circuit vacated the class certification order.
The class covered purchasers or acquirers of the company's securities between September 14, 2020 and October 12, 2023.
The Fifth Circuit found the district court misapplied the legal standard and did not properly evaluate evidence of market inefficiency.
Further class certification proceedings will take place on remand in the Western District of Texas.
ImmunityBio announced on October 14, 2026 that the FDA expanded the approved indication for ANKTIVA plus BCG to include patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors. The company says this is the first FDA approval to cover that group and that access now extends to all patients with BCG-unresponsive NMIBC. The filing contains no revenue, earnings, or guidance figures, so the effect on shareholders depends on future commercial results.
FDA expanded the ANKTIVA plus BCG indication on or before October 14, 2026, adding BCG-unresponsive NMIBC with papillary-only tumors
The company states papillary disease represents approximately 85% of the NMIBC patient population
The prior FDA approval, in April 2024, covered BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors
In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response
BridgeBio announced the FDA accepted its New Drug Application for oral infigratinib for children with achondroplasia with Priority Review, setting a PDUFA target action date of February 4, 2027. The company says the drug met its Phase 3 PROPEL 3 primary endpoint, but the filing does not describe financial results or a financial effect, so the update is mainly a regulatory milestone for shareholders.
FDA accepted the NDA with Priority Review; PDUFA target action date is February 4, 2027
PROPEL 3 met its primary endpoint: LS mean treatment difference of +1.74 cm/year and mean treatment difference of +2.10 cm/year in annualized height velocity (p<0.0001)
Oral infigratinib has Breakthrough Therapy Designation; BridgeBio plans to submit a Marketing Authorization Application to the EMA in Q4 2026
Approval is not assured; the filing notes the FDA may not approve the drug on the anticipated timeline or at all
Gulf Resources received a letter from Nasdaq's Listing Qualifications staff on October 1, 2026, stating it had regained compliance with the periodic filing requirement under Listing Rule 5250(c)(1) and that the staff determined it complies with the rule. The company announced the development in a press release dated October 6, 2026. For shareholders, this means the company's Nasdaq listing is no longer subject to this filing deficiency.
Nasdaq staff letter dated October 1, 2026 confirms compliance with Listing Rule 5250(c)(1)
Press release issued October 6, 2026 and filed as Exhibit 99.1
Company remains listed on The Nasdaq Capital Market per the press release
Nasdaq's Hearings Panel granted SCWorx's request for reconsideration on October 2, 2026, found the company compliant with continued listing requirements, and approved continued listing on The Nasdaq Capital Market. Trading on Nasdaq, suspended since April 14, 2026, will resume on a date Nasdaq has yet to schedule, and the stock trades on the OTCQB until then. The approval carries a one-year Panel Monitor through October 2, 2027, and the company's private placement investors waived termination rights tied to the earlier delisting decision, though those rights revive if the delisting takes effect.
On October 2, 2026, the Panel granted reconsideration of its September 17, 2026 delisting decision and approved continued listing on The Nasdaq Capital Market
Publicly held shares rose to 549,092 as of September 17, 2026, after the September 16, 2026 private placement of 350,000 shares and related warrants
Nasdaq trading has been suspended since April 14, 2026; the stock stays on the OTCQB under WORX until Nasdaq sets a reinstatement date
If all purchasers terminated their purchases, the company would have to return an aggregate of $938,000 and the placement shares and warrants would be cancelled
Japan's Ministry of Health, Labour and Welfare approved Optune Pax for adults with unresectable locally advanced pancreatic cancer, used with gemcitabine and nab-paclitaxel. The approval is based on the Phase 3 PANOVA-3 trial, which met its primary endpoint of statistically significant improvement in median overall survival, and it extends the device's regulatory approvals to another market.
Approval was first announced in a September 15, 2026 press release; the October 1, 2026 exhibit repeats it.
PANOVA-3 showed a statistically significant improvement in median overall survival for patients treated with TTFields.
Optune Pax was previously approved by the U.S. FDA in February 2026 and received a CE Mark in June 2026.
Device-related skin adverse events occurred in 76.3% of Optune Pax-treated participants; 21 (7.7%) had a Grade 3 or higher event.
A federal jury awarded Ramaco Resources' subsidiary $30.0 million in damages on September 25, 2026, in its lawsuit against Federal Insurance Company and ACE American Insurance Company over a denied claim for a 2018 silo failure at the Elk Creek plant. The court entered judgment on the verdict, but attorneys' fees remain to be decided and the defendants may still challenge the award through post-trial motions or an appeal.
Jury awarded $27.5 million for net economic loss and $2.5 million for aggravation and inconvenience.
Judgment was entered on September 25, 2026, against Federal Insurance Company and ACE American Insurance Company.
Attorneys' fees were not decided by the jury and will be determined by the Court.
Defendants may file post-trial motions within 28 days of judgment and a notice of appeal within 30 days of the final judgment.
GT Biopharma received notice from Nasdaq on September 22, 2026, that it has regained compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market. The company's common stock maintained a closing bid price above $1.00 for at least ten consecutive business days, which Nasdaq required. The regained compliance removes the risk of delisting that the company had faced under the earlier deadline of November 16, 2026.
Nasdaq notified GT Biopharma on September 22, 2026 that it regained compliance with the minimum bid price requirement.
The stock had closed below $1.00 for 30 consecutive business days, leading to a Nasdaq notice on November 20, 2025.
On May 20, 2026, Nasdaq granted an additional 180 calendar day compliance period, through November 16, 2026.
The company's common stock closed above $1.00 for at least ten consecutive business days to meet the standard.
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.