[8-K] News Corporation Reports Material Event

Rhea-AI Filing Summary

Helius Medical Technologies (HSDT) filed an 8-K announcing topline results from its Stroke Registrational Program (SRP) for the Portable Neuromodulation Stimulator (PoNS).

• Three aligned trials (1 double-blind RCT, 1 single-arm sponsor study, 1 investigator-initiated RCT) enrolled 159 chronic-stroke patients; 130 completed 12-week treatment and 12-week follow-up at 10 U.S./Canadian sites.
• The pivotal double-blind RCT met its primary endpoint, delivering statistically significant gait/balance improvement versus sham, both alone and when pooled with open-label data adjusted for baseline differences.
• Multiplicity-controlled secondary endpoints confirmed durability at 12 weeks and reduced fall risk; all studies reported minimal adverse events and good tolerability.

Based on these data, Helius intends to submit a marketing application to the U.S. FDA under its existing Breakthrough Device Designation for a stroke-related gait and balance indication.

The filing reiterates forward-looking risks, including capital requirements, reimbursement access, manufacturing, IP protection and the outcome of regulatory review.

Positive

• Pivotal RCT met primary endpoint, demonstrating statistically significant gait/balance improvement.
• Minimal adverse events across all studies enhance safety narrative.
• Existing Breakthrough Device Designation may accelerate FDA review.
• Clear plan for near-term FDA submission supports timeline visibility.

Negative

• Regulatory approval not yet granted; commercialisation contingent on FDA decision.
• Company cites capital and reimbursement needs as ongoing risks.
• Only 130 of 159 patients completed full protocol, leaving some attrition uncertainty.
• Durability assessed only to 12 weeks; longer-term efficacy unaddressed.

Insights

Medical Device Analyst

TL;DR: Successful trials de-risk PoNS efficacy; FDA submission imminent—positive catalyst.

The SRP’s double-blind RCT achieved statistically significant gait/balance gains, strengthening PoNS’s clinical dossier ahead of FDA review. Breakthrough Device Designation should expedite evaluation and may shorten time-to-market. Safety profile is clean, supporting usability in stroke rehab settings. Although no revenue impact is immediate, efficacy validation materially improves probability of approval and future reimbursement discussions, a key hurdle cited by management. Overall, the data are a meaningful milestone for HSDT shareholders.

Risk Analyst

TL;DR: Positive data, but regulatory, funding and reimbursement hurdles remain.

While the trial met its primary endpoint, monetisation hinges on FDA clearance, Medicare coverage and sufficient capital—risks explicitly flagged in the filing. Only 130 of 159 subjects completed follow-up, and durability was evaluated at 12 weeks; longer-term outcomes are unknown. The company’s ability to build commercial infrastructure and secure distribution licences also presents execution risk. Consequently, impact is tempered, keeping the disclosure broadly neutral until regulatory decisions crystallise.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 18, 2025

NEWS CORPORATION

(Exact name of registrant as specified in its charter) 

Delaware

001-35769

46-2950970

(State or other jurisdiction of incorporation)

(Commission  File Number)

(IRS Employer Identification No.)

1211 Avenue of the Americas, New York, New York 10036

(Address of principal executive offices, including zip code)

(212) 416-3400

(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A Common Stock, par value $0.01 per share

NWSA

The Nasdaq Global Select Market

Class B Common Stock, par value $0.01 per share

NWS

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01    Other Events. 

As previously reported, under each of News Corporation's (the "Company's") stock repurchase programs (the "Repurchase Programs"), the Company is authorized to acquire from time to time up to $1 billion in the aggregate of the Company's outstanding shares of Class A common stock and Class B common stock. Under the rules of the Australian Securities Exchange (the "ASX"), the Company is required to provide to the ASX, on a daily basis, disclosure of transactions pursuant to the Repurchase Programs, if any. The Company also discloses information concerning the Repurchase Programs in the Company's quarterly and annual reports.

Attached as Exhibit 99.1 and Exhibit 99.2 are copies of the information provided to the ASX on the respective dates noted therein. Such information contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the Company's intent to repurchase, from time to time, the Company's Class A common stock and Class B common stock. These statements are based on management's current expectations and beliefs and are subject to uncertainty and changes in circumstances. Actual results may vary materially from those expressed or implied by such statements due to, among other factors, changes in the market price of the Company's stock, general market conditions, applicable securities laws and alternative investment opportunities, as well as the risks, uncertainties and other factors described in the Company's filings with the Securities and Exchange Commission. The "forward-looking statements" included in such information are made only as of the date of this report. We do not have and do not undertake any obligation to publicly update any "forward-looking statements" to reflect subsequent events or circumstances, and we expressly disclaim any such obligation, except as required by law or regulation.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Information provided to the Australian Securities Exchange on the date noted on Exhibit 99.1.
99.2						Information provided to the Australian Securities Exchange on the date noted on Exhibit 99.2.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			NEWS CORPORATION (REGISTRANT)
			By:						/s/ Michael L. Bunder
									Michael L. Bunder
									Senior Vice President, Deputy General Counsel and Corporate Secretary

Dated: July 21, 2025

FAQ

What did Helius Medical (HSDT) report in its 8-K?

Positive top-line results from the PoNS Stroke Registrational Program, with the pivotal RCT meeting its primary endpoint.

How many patients were enrolled in the PoNS stroke studies?

A total of 159 patients were enrolled; 130 completed treatment and follow-up.

What is the next regulatory step for HSDT's PoNS device?

The company plans an FDA submission under its Breakthrough Device Designation seeking a stroke gait/balance indication.

Were there significant safety concerns reported?

No. Trials showed a minimal incidence of adverse events and good tolerability.

What risks did the company highlight in the filing?

Helius cited capital requirements, reimbursement access, manufacturing, IP protection and FDA review outcomes as key risks.

Does the filing include any financial results?

No financial metrics or earnings data were provided in this 8-K.