Harmony Biosciences (NASDAQ: HRMY) phase 3 RECONNECT trial misses primary endpoint

Rhea-AI Filing Summary

Harmony Biosciences Holdings, Inc. reported new clinical data from its phase 3 registrational RECONNECT study. The company announced topline results showing that the trial did not meet its primary endpoint, which was based on improvement in social avoidance. According to the company, this outcome was primarily due to a higher than expected placebo response rate, which reduced the measured difference between treatment and placebo groups.

The company furnished a detailed press release with the topline results as an exhibit to this report. The disclosure is provided under Regulation FD, meaning Harmony is sharing this information broadly with the market at the same time.

Positive

• None.

Negative

• Phase 3 registrational RECONNECT trial failed primary endpoint of improvement in social avoidance, which is a materially negative event for that development program.

Insights

Biopharma clinical-stage analyst

Harmony’s phase 3 RECONNECT trial failed its primary endpoint, a materially negative clinical update.

Harmony Biosciences Holdings, Inc. disclosed topline results from its phase 3 registrational RECONNECT study, stating that the trial did not meet the primary endpoint of improvement in social avoidance. Management attributes this outcome primarily to a higher than expected placebo response rate, which can mask a treatment effect by narrowing the gap between active drug and placebo.

Because this was described as a phase 3 registrational trial, the result is significant for the associated development program. A missed primary endpoint in a pivotal study typically forces a reassessment of next steps for that indication, even when a high placebo response is cited as a key factor. Additional detail on secondary endpoints, safety, or potential future plans is referenced only through the accompanying press release furnished as Exhibit 99.1.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

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Date of report (Date of earliest event reported): September 24, 2025

HARMONY BIOSCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

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Delaware	001-39450	82-2279923
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

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630 W. Germantown Pike, Suite 215

Plymouth Meeting, PA 19462

(Address of principal executive offices) (Zip Code)

(484) 539-9800

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report.)

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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)

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

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

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

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

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​		Trading		Name of each exchange
Title of each class	​	Symbol(s)	​	on which registered
Common Stock, $0.00001 par value per share	​	HRMY	​	The Nasdaq Global Market

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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).

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Emerging growth company ☐

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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. ☐

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Item 7.01. Regulation FD Disclosure.

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On September 24, 2025, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing topline data from its phase 3 registrational trial, the RECONNECT study, which did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate.

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The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

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The information contained in Item 7.01 of this Current Report (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

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Note Regarding Forward-Looking Statements

Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward-looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC,”) on February 25, 2025, as well as other factors described from time to time in the Company’s filings with the SEC. Such forward-looking statements are made only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update or revise any forward-looking statement because of new information, future events or otherwise, except as otherwise required by law. If it does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

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Exhibit		​
No.	​	Description
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99.1*	​	Press release issued by the Company, dated September 24, 2025.
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104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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* This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference.

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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.

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​	HARMONY BIOSCIENCES HOLDINGS, INC.
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Date: September 24, 2025	By:	/s/ Christian Ulrich
​	​	Christian Ulrich
​	​	SVP and General Counsel

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FAQ

What did Harmony Biosciences (HRMY) announce in this 8-K?

Harmony Biosciences announced topline data from its phase 3 registrational RECONNECT study, reporting that the trial did not meet its primary endpoint of improvement in social avoidance.

What is the RECONNECT study mentioned by Harmony Biosciences (HRMY)?

The RECONNECT study is described as a phase 3 registrational trial conducted by Harmony Biosciences, with a primary endpoint focused on improvement in social avoidance.

Did Harmony Biosciences’ phase 3 RECONNECT trial meet its primary endpoint?

No. Harmony Biosciences stated that the RECONNECT phase 3 registrational trial did not meet the primary endpoint of improvement in social avoidance.

Why does Harmony Biosciences say the RECONNECT trial missed its endpoint?

Harmony Biosciences attributed the failure to meet the primary endpoint primarily to a higher than expected placebo response rate, which reduced the observed difference between treatment and placebo.

Where can investors find more details on Harmony Biosciences’ RECONNECT results?

More detail is provided in the company’s press release dated September 24, 2025, which is furnished as Exhibit 99.1 to this report and incorporated into Item 7.01 by reference.

Is the Harmony Biosciences (HRMY) RECONNECT topline update considered filed with the SEC?

Harmony Biosciences stated that the information in Item 7.01, including Exhibit 99.1, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference into other filings unless specifically referenced.