Harmony Biosciences names Peter Anastasiou next CEO

Harmony reiterated its 2026 WAKIX net revenue range and said BP-205 study data remain on track for Q4 2026.

Rhea-AI Filing Summary

Harmony Biosciences Holdings, Inc. (HRMY) announced a planned leadership transition: President and CEO Jeffrey M. Dayno, M.D., will retire and step down as a Class I director effective December 31, 2026, at 11:59 p.m. Eastern Time, and will serve as a non-executive advisor through 2027. The Board appointed current Chief Operating Officer Peter Anastasiou as President and CEO and a Class I director effective January 1, 2027, at 12:00 a.m. Eastern Time; his director term runs until the 2027 Annual Meeting of Stockholders. Anastasiou has served as COO since April 2026 and previously served on Harmony’s Board from November 2023 to April 2026.

Harmony reiterated full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion. The company said it remains on track to report data from the BP-205 multiple ascending dose (MAD) study in Q4 2026 and does not currently expect a change in the timing of key commercial and pipeline milestones. Its stated priorities include growing the pitolisant franchise, advancing its CNS pipeline led by BP-205, strategic capital deployment and protecting WAKIX exclusivity.

8-K Event Classification

3 items: 5.02, 7.01, 9.01

3 items

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance

Key personnel changes including departures, elections, or appointments of directors and executive officers.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

WAKIX net revenue guidance: $1.0 billion to $1.04 billion CEO appointment effective: January 1, 2027, at 12:00 a.m. Eastern Time CEO retirement effective: December 31, 2026, at 11:59 p.m. Eastern Time +1 more

4 metrics

WAKIX net revenue guidance $1.0 billion to $1.04 billion Full-year 2026 guidance, reiterated

CEO appointment effective January 1, 2027, at 12:00 a.m. Eastern Time Peter Anastasiou’s appointment as President and CEO and a Class I director

CEO retirement effective December 31, 2026, at 11:59 p.m. Eastern Time Jeffrey M. Dayno, M.D., retirement as President and CEO and departure from the Board

BP-205 study data Q4 2026 Company said it remains on track to report data from the multiple ascending dose study

Key Terms

multiple ascending dose (MAD) study, orexin agonist, pitolisant franchise, net revenue guidance

4 terms

multiple ascending dose (MAD) study medical

"BP-205 multiple ascending dose (MAD) study"

orexin agonist medical

"potential best-in-class orexin agonist BP-205"

An orexin agonist is a drug that activates the brain’s orexin system, a set of signaling molecules that help control wakefulness, alertness, and appetite. Think of it like turning up a thermostat that keeps you awake; for investors, these drugs matter because successful development or approval can create a new revenue stream for treating sleep disorders and related conditions, while clinical trial results and regulatory decisions drive share price volatility.

pitolisant franchise medical

"growing the pitolisant franchise"

net revenue guidance financial

"full-year 2026 WAKIX net revenue guidance"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Who is becoming CEO of HRMY, and when does the change take effect?

Peter Anastasiou will become President and CEO and a Class I director effective January 1, 2027, at 12:00 a.m. Eastern Time. Jeffrey M. Dayno, M.D., will retire from the CEO role on December 31, 2026, at 11:59 p.m. Eastern Time.

What are HRMY’s 2026 WAKIX guidance and BP-205 timeline?

Harmony reiterated full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion and said it is on track to report data from the BP-205 multiple ascending dose study in Q4 2026.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 10/13/2026 - 08:00 AM EDT Accepted by SEC EDGAR 10/13/2026 - 08:00 AM EDT Learn about SEC filing dates

0001802665false00018026652026-10-122026-10-12

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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): October 12, 2026

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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

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Departure of President and Chief Executive Officer and Director

On October 12, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) announced that Jeffrey M. Dayno, M.D., as part of a leadership succession plan, will be retiring as the Company’s President and Chief Executive Officer and stepping down as a Class I director of the Company’s Board of Directors (the “Board”), in each case, effective as of December 31, 2026, at 11:59 p.m. Eastern Time, and will serve as a non-executive advisor to the Company through 2027.

Appointment of President and Chief Executive Officer and Director

On October 12, 2026, the Company announced that Peter Anastasiou, the Company’s current Chief Operating Officer, has been appointed by the Board to serve as President and Chief Executive Officer of the Company, effective as of January 1, 2027, at 12:00 a.m. Eastern Time (the “Appointment Effective Date”). In addition, the Board appointed Mr. Anastasiou as a Class I director of the Company, effective as of the Appointment Effective Date, to fill the vacancy resulting from Dr. Dayno’s resignation from the Board, with a term expiring at the Company’s 2027 Annual Meeting of Stockholders and until his successor is elected and qualified, or until his earlier death, resignation or removal.

Mr. Anastasiou, age 55, has served as the Company’s Chief Operating Officer since April 2026. He served as Chief Executive Officer and as a member of the board of directors of Capsida Biotherapeutics, a next-generation integrated gene therapy company, from January 2022 to October 2025. Prior to Capsida, from November 2009 to December 2021, Mr. Anastasiou served in various roles at Lundbeck, a pharmaceutical company publicly traded on the Copenhagen Stock Exchange, including most recently as Executive Vice President and President of North America, and prior to that as Chief Commercial Officer for the U.S. and Vice President and General Manager for Psychiatry. In addition, he previously served as a member of the Company’s Board from November 2023 to April 2026, and as a member of the board of directors of Lundbeck’s U.S. legal entities from January 2016 to December 2021. Mr. Anastasiou currently serves on the Global Advisory Board of the Healthcare Businesswomen’s Association and has previously served on the boards of several private organizations, including the Pharmaceutical Research and Manufacturers Association (PhRMA), Kids Above All and Bear Necessities Pediatric Cancer Foundation. Mr. Anastasiou received a B.A. in Economics and Management from Albion College and an M.B.A. from the Kelley School of Business, Indiana University.

There are no arrangements or understandings between Mr. Anastasiou and any other person pursuant to which he was selected as an officer or director. Mr. Anastasiou has no family relationships with any director or executive officer of the Company. There are no transactions involving Mr. Anastasiou that would be required to be reported under Item 404(a) of Regulation S-K. Mr. Anastasiou will not receive any additional compensation for his service as a director.

Item 7.01. Regulation FD Disclosure.

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On October 12, 2026, the Company issued a press release announcing the leadership transition described in Item 5.02 of this Current Report. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section and shall not be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as set forth by specific reference in such filing.

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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 October 12, 2026.
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104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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.
​	​
Date: October 13, 2026	By:	/s/ Christian Ulrich
​	​	Christian Ulrich
​	​	Executive Vice President, General Counsel and Corporate Secretary

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‌Exhibit 99.1

Harmony Biosciences Announces Planned CEO Transition to Support Next Phase of Growth​

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The Board of Directors has appointed Peter Anastasiou, former Harmony board member and current Sr. EVP and COO, to become President, Chief Executive Officer and a member of the Board, effective January 1, 2027.

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Current CEO Jeffrey M. Dayno, M.D., will retire at the end of the year following a nine-year tenure at the Company, including as Chief Medical Officer, and step down as a member of the Board.

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The Company reiterates full-year 2026 WAKIX® net revenue guidance of $1.0 billion to $1.04 billion, remains on track to report data from the multiple ascending dose (MAD) study of BP-205 in Q4 2026, and is focused on executing its previously communicated strategic priorities.

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PLYMOUTH MEETING, Pa. — Oct. 12, 2026 — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) (“Harmony” or the “Company”) today announced that, as part of the Board of Directors’ succession planning, Peter Anastasiou, former Harmony board member and current Sr. EVP and Chief Operating Officer, has been appointed President, Chief Executive Officer and member of the Board of Directors, effective January 1, 2027. He succeeds Jeffrey M. Dayno, M.D., who will retire as President and CEO and step down from the Board of Directors on December 31, 2026. To support the leadership transition, Dr. Dayno will serve as a non-executive advisor to the Company throughout 2027 to support Harmony’s growth objectives.

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The planned succession comes as Harmony enters its next phase of growth from a position of financial and operational strength. The Company remains focused on its strategic priorities: growing the pitolisant franchise; advancing its diversified CNS pipeline, led by potential best-in-class orexin agonist BP-205; deploying capital strategically by transacting on value-creating assets; and protecting WAKIX® exclusivity.

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“Jeff has led Harmony through a period of strong growth, establishing WAKIX as a leading treatment in narcolepsy, advancing the pitolisant lifecycle management strategy, diversifying the pipeline for sustained long-term growth and leaving the Company in a position of financial strength,” said Jeffrey S. Aronin, founder and Chairman of the Board of Harmony. “The Board is grateful for Jeff’s leadership and his commitment to patients, employees and shareholders.”

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“Peter is the right leader for Harmony’s next phase of growth. He has a deep understanding of our business and has been an important contributor to our strategy, pipeline and business development efforts,” continued Aronin. “Peter also brings more than three decades of

biopharmaceutical experience, leading organizations in commercializing, acquiring and developing treatments for both broad and rare CNS diseases to serve patients and create value for shareholders.”

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“It has been a privilege to lead Harmony through a phase of significant growth, and I am grateful to the Board for the opportunity to have served as CEO. It has also been my honor to work alongside such a talented team of individuals who are deeply committed to improving the lives of patients with unmet needs,” said Dayno. “Peter knows Harmony’s business exceptionally well, I have great confidence in his leadership, and I look forward to supporting him, the Board and the Company through this transition.”

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“I am honored to serve as Harmony’s next CEO and am grateful to the Board for this opportunity. Harmony is unique, having strong commercial capabilities, a diverse CNS pipeline with multiple potential value-creating catalysts, and a strong balance sheet that allows us to be self-funded and to invest thoughtfully in additional opportunities,” said Anastasiou. “I look forward to working with the Board, leadership team and our dedicated employees to lead Harmony through our next phase of growth, building on the foundation that Jeff and the team have established.”

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The Company today reiterated its full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion and is on track to report MAD study data for BP-205 in Q4 2026. Harmony remains committed to its previously communicated strategic priorities and does not currently expect any change in the timing of key commercial and pipeline milestones.

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About Peter Anastasiou

Peter Anastasiou has served as Sr. EVP and Chief Operating Officer at Harmony Biosciences and previously served for three years on the company’s Board of Directors. Prior to that, Anastasiou was Chief Executive Officer and a member of the board of directors of Capsida Biotherapeutics for nearly four years. During his tenure, he led Capsida through a period of significant growth, raising more than $165 million in capital and securing partnerships with AbbVie and Lilly.

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Prior to that, Mr. Anastasiou served as Executive Vice President, member of the global executive committee, and President of North America at Lundbeck. In this role, he led an organization of approximately 1,200 employees, delivered annual net revenues exceeding $1.5 billion, and achieved profit margins greater than 60%. He played a central role in building Lundbeck’s cross-functional capabilities in North America and in the development, acquisition/licensing, launch and commercialization of multiple broad and rare CNS therapies. Mr. Anastasiou also represented Lundbeck on the board of Pharmaceutical Research and Manufacturers of America (PhRMA) for more than four years.

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Earlier in his career, he held management roles at Neuronetics, Inc., Bristol-Myers Squibb and Lilly. Anastasiou holds an M.B.A. from the Kelley School of Business at Indiana University and a B.A. in economics and management from Albion College.

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About Harmony Biosciences

Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

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Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full-year 2026 WAKIX net revenue guidance; expectations for the growth and value of WAKIX and the pitolisant franchise; the planned leadership transition, including its expected timing and effects and Dr. Dayno’s anticipated advisory role; our strategic priorities and our ability to execute on them, including advancing our CNS pipeline, deploying capital and transacting on value-creating assets, and protecting WAKIX exclusivity; the potential of our product candidates, including BP-205; our planned and ongoing clinical trials and the expected timing of data readouts, including data from the multiple ascending dose study of BP-205; the expected timing of key commercial and pipeline milestones; anticipated regulatory milestones; our future results of operations and financial position, including our ability to fund our operations and pursue additional opportunities; business strategy products, prospective products, product approvals, and the plans and objectives of management for future operations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100, Pitolisant GR and BP-205; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX;

the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

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Harmony Biosciences Investor Contact:

Brennan Doyle

484-539-9700

bdoyle@harmonybiosciences.com

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Harmony Biosciences Media Contact:

Cate McCanless

202-641-6086

cmccanless@harmonybiosciences.com

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 25.6 KB

Other Documents

• EX-101 EX-101.SCH 2.6 KB
• EX-101 EX-101.LAB 15.6 KB
• EX-101 EX-101.PRE 9.8 KB