Every 8-K that Harmony Biosciences Holdings, Inc. (HRMY) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow HRMY and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full HRMY filings page.
Harmony Biosciences Holdings, Inc. reported record Q2 2026 results, with net product revenue of $261.3 million for WAKIX, representing 30% year-over-year growth and supporting reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
Average treated patients were about 8,950, an increase of 450. Cost of product sold was $63.2 million, or 24.2% of net product revenue, primarily reflecting new royalties related to the Novitium license agreement. Net income was $75.4 million, or $1.28 per diluted share, compared with $39.8 million, or $0.68, in Q2 2025. As of June 30, 2026, cash, cash equivalents and investments totaled $962.5 million, and stockholders’ equity was $999.2 million versus $870.2 million at year-end 2025.
The company also highlighted pipeline and regulatory progress. Phase 1 single ascending dose data for orexin-2 agonist BP-205 showed favorable pharmacokinetic and safety/tolerability profiles, with additional Phase 1 and Phase 2 studies planned through 2027. The NDA for Pitolisant GR was accepted with a target PDUFA date of April 1, 2027, while Pitolisant HD is expected to deliver Phase 3 topline data in 2027 and has a target PDUFA date in 2028.
Harmony Biosciences reported preliminary, unaudited Q2 2026 net product revenue for WAKIX of approximately $261 million, a record quarterly level, with 30% year-over-year and 21% sequential growth. The company reaffirmed full‑year 2026 net product revenue guidance of $1.0 billion to $1.04 billion, reflecting confidence based on first‑half performance.
Harmony also announced leadership changes. Chief Financial Officer Glenn Reicin stepped down effective July 16, 2026, under a Separation Agreement providing severance and a prorated target bonus consistent with his employment terms; the company stated his departure was not due to any disagreement on operations, policies or practices. Senior Vice President and Controller Stephen Mollichella was appointed Interim Principal Financial Officer, providing continuity in finance leadership. Harmony will report full Q2 2026 financial results and provide a business update on August 4, 2026.
Harmony Biosciences Holdings, Inc. held its 2026 Annual Meeting of Stockholders, with 50,381,309 common shares represented in person or by proxy, constituting a quorum. Stockholders voted on the election of four Class III directors, ratification of the auditor, and an advisory say‑on‑pay proposal.
All four Class III director nominees were elected, including Geno Germano with 44,963,163 votes for and 1,524,142 withheld, and Troy Ignelzi with 32,813,495 votes for and 13,673,810 withheld. Deloitte & Touche LLP was ratified as independent registered public accounting firm with 49,385,510 votes for and 830,697 against.
Stockholders also approved, on a non‑binding, advisory basis, the compensation of the company’s named executive officers, with 33,249,862 votes for, 13,042,898 against, 194,545 abstentions, and 3,894,004 broker non‑votes.
Harmony Biosciences reported a strong start to 2026 with Q1 net product revenue of $215.4 million, up 17% from $184.7 million a year earlier, driven by continued demand for WAKIX in the U.S. narcolepsy market of about 80,000 diagnosed patients.
Despite higher revenue, net income declined to $32.5 million (diluted EPS $0.55) from $45.6 million ($0.78), which the company attributes entirely to licensing agreements signed in Q1 2026. Operating expenses nearly doubled in R&D as Harmony invested in lifecycle extensions and pipeline assets.
The company ended March 31, 2026 with $870.5 million in cash, cash equivalents and investments, only modestly below year-end levels after up-front license and ANDA settlement payments. Harmony reiterated 2026 WAKIX net revenue guidance of $1.0–$1.04 billion, and highlighted progress on pitolisant GR, pitolisant HD, BP-205 and business development to support long-term growth.
Harmony Biosciences Holdings, Inc. announced a chief financial officer transition, with Sandip Kapadia stepping down and Glenn Reicin appointed CFO effective April 14, 2026. Kapadia will receive severance under a Separation Agreement consistent with his employment and award agreements, in exchange for a release of claims and ongoing covenants.
Reicin’s Employment Agreement provides a $500,000 annual base salary, a target annual bonus equal to 50% of salary, and a stock option grant with a grant date fair value of $3,000,000, vesting over four years. In a concurrent press release, Harmony reiterated its 2026 net product revenue guidance for WAKIX of $1.0 to $1.04 billion.
Harmony Biosciences Holdings, Inc. appointed Peter Anastasiou as Senior Executive Vice President and Chief Operating Officer, effective April 2, 2026, and he resigned from the board to assume the executive role. The company also appointed Troy Ignelzi as a Class III director and announced that Antonio Gracias will not stand for re-election at the 2026 annual meeting.
Under his employment agreement, Anastasiou will receive a $600,000 annual base salary, a target annual bonus equal to 55% of salary, and a stock option award with a grant date fair value of $3,700,000, together with severance protections and customary restrictive covenants. Ignelzi will serve on the Audit and Compensation Committees and is deemed an independent director, while the board has nominated Geno J. Germano for election at the 2026 annual meeting.
Harmony Biosciences Holdings, Inc. reported strong 2025 results driven by its narcolepsy drug WAKIX. Net product revenue reached $868.5 million for 2025, up from $714.7 million, while Q4 2025 revenue was $243.8 million, a 21% year-over-year increase.
GAAP net income was $158.7 million for 2025, or $2.71 per diluted share, compared with $145.5 million, or $2.51 per share, in 2024. Non-GAAP adjusted net income rose to $211.0 million, or $3.60 per diluted share. The company ended 2025 with $882.5 million in cash, cash equivalents and investments, up from $576.1 million.
Harmony reiterated 2026 WAKIX net revenue guidance of $1.0–$1.04 billion, highlighting expectations for blockbuster status in narcolepsy. Management also emphasized a late-stage pipeline, including five Phase 3 trials, a planned pitolisant GR NDA submission targeted for Q2 2026, and an ongoing Phase 1 trial of an orexin-2 agonist.
Harmony Biosciences Holdings, Inc. filed a current report describing a new press release with preliminary, unaudited net product revenue for the fourth quarter and full year ended December 31, 2025. The release also includes the company’s guidance for 2026 net product revenue and an update on its clinical programs.
The company will present at the 44th Annual JP Morgan Healthcare Conference on January 13, 2026, and the related presentation is attached to the report. The materials, including the press release and slideshow, are being furnished rather than filed, and the company highlights that they contain forward-looking statements subject to risks and uncertainties described in its prior SEC reports.
Harmony Biosciences (HRMY) filed an 8-K announcing it furnished a press release with financial results for the quarter ended September 30, 2025 and posted an updated investor presentation. The materials are included as Exhibits 99.1 and 99.2 and are provided under Regulation FD.
The company states these exhibits are furnished and not deemed filed under Section 18 of the Exchange Act, and may be used in presentations to investors and analysts. Forward‑looking statements are subject to the risk factors described in prior SEC filings.
Harmony Biosciences (HRMY) announced preliminary net product revenue for the third quarter of 2025 and updated its 2025 net product revenue guidance. The company furnished these details in a press release attached as Exhibit 99.1.
The disclosure falls under Results of Operations and Financial Condition and includes standard forward‑looking statement language.
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.