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Nov 4, 2026 Harmony reported Q3 WAKIX net revenue of $268.9 million and reiterated full-year guidance of $1.0 billion to $1.04 billion. AI-generated summary · Source: company release
NASDAQ: $HRMYBiotech · NeuroscienceProduct concentration and patent risk

HRMY Stock Hub: Harmony Biosciences News, WAKIX and BP-205

WAKIX generated $268.917M of Q3 sales and $54.197M of operating income. Cash and investments totaled $1.052B at September 30. Pitolisant GR is under FDA review, while BP-205 advances after early volunteer data. Patent proceedings and rising royalties remain central to the franchise. Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

Last updated: November 12, 2026Market data: November 11, 2026 regular closeFinancial period: September 30, 2026Currency: USD
Research Library · Biotech
Harmony Biosciences: WAKIX, BP-205 and the Patent Calendar
A profitable neuroscience franchise and the next stages of development · Research as of November 12, 2026
Get the report (PDF)
Next catalyst · announced scientific update · congress window
December 4–8, 2026 · EPX-100 ARGUS extension at AES

Harmony expects updated eighteen-month ARGUS open-label-extension data at the December AES meeting in Denver. This is longer follow-up, distinct from randomized Phase 3 topline data expected around mid-2027. Q3 results and BP-205 MAD data · November 4 AES annual meeting · December 4–8, 2026

Next fixed FDA action date: April 1, 2027 for the accepted pitolisant GR application. A review date is distinct from approval. Q3 results and BP-205 MAD data · November 4
HRMY daily price chart
Daily chart · Finviz (affiliate link on click). Explore HRMY on JC Just Charts.

HRMY stock data: financial position and capital

Reference close
$34.22
November 11 regular session
Basic equity value
$2.010B
Calculated using November 2 shares
Q3 WAKIX sales
$268.917M
Quarter ended September 30
Q3 net income
$48.196M
Diluted EPS $0.81
Cash + investments
$1.052B
September 30; includes long-term securities
Operating cash flow
$196.885M
Nine months ended September 30
Common shares
58.723M
November 2 cover count
2026 sales guidance
$1.00B–$1.04B
WAKIX; company forecast November 4

September resources comprise cash $647.099M, short-term investments $124.039M and long-term investments $280.467M. Debt principal was $150M; the current $20M portion is included, not additional. Q3 2026 Form 10-Q · November 4 In its November 4 statements, management expected resources plus additional operating and financing cash flows to meet needs for at least twelve months from issuance. Q3 2026 Form 10-Q · November 4

HRMY stock: WAKIX funds development, with legal exposure

All current product revenue comes from WAKIX. FDA generic approvals, launch restrictions, settlements and the remaining AET cases are separate elements of the competitive position. Q3 2026 Form 10-Q · November 4 FDA first generic approvals · pitolisant July 21, 2026 FDA competitive generic therapy approvals

▲ The constructive case

Growing WAKIX demand and positive operating cash flow support development of new formulations, EPX-100 and BP-205 without an immediate operating funding gap. Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

▼ The cautious case

Royalties and research costs can compress profit; early volunteer data may not translate into patient benefit, and legal outcomes can change the duration of the franchise. Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

Latest HRMY news

Nov 4, 2026

Harmony Reports Q3 Results, On Track for More Than $1 Billion WAKIX Net Revenue

WAKIX net revenue was $268.9 million for the quarter ended September 30, 2026, up 12% from $239.5 million a year earlier, with 400 net patient adds in the quarter. The company reiterated full-year WAKIX net revenue guidance of $1.0 billion to $1.04 billion. Preliminary 14-day multiple-ascending dose data for orexin agonist BP-205 reinforced its safety, tolerability and pharmacokinetic profile, with Phase 1b data expected in Q1 2027. Peter Anastasiou will succeed Jeffrey Dayno, MD, as President and Chief Executive Officer effective January 1, 2027.

Company release · SEC

HRMY stock catalysts: AES, pitolisant GR and the 2027 studies

Study-completion estimates in registries are distinct from public readouts. The November BP-205 MAD observations are already reported; ZYN002 in fragile X syndrome is being phased out. Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

WAKIX earnings, royalties and patent exposure

Q3 revenue rose from $239.455M to $268.917M, while gross profit moved from $179.805M to $188.231M. Higher Novitium-related royalty costs increased cost of product sold; the separate $25M MSN patent milestone was research expense. Q3 2026 Form 10-Q · November 4

WAKIX is FDA approved for EDS or cataplexy in patients aged six and older with narcolepsy. Its label includes QT-prolongation and drug-interaction precautions. WAKIX U.S. prescribing information · February 2026 FDA pediatric cataplexy approval · February 13, 2026

The consolidated ANDA litigation is in the District of Delaware, case 23-1286; the separate amorphous-form case is 26-cv-00453. The January hearing does not predetermine a result. Harmony’s confidence in exclusivity through March 2030 includes anticipated pediatric exclusivity. District of Delaware consolidated ANDA case identifier · 2025 order Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

FDA lists pitolisant generic approvals in July and August 2026. Regulatory approval is distinct from launch permission under settlements and ongoing proceedings. FDA first generic approvals · pitolisant July 21, 2026 FDA competitive generic therapy approvals Q3 2026 Form 10-Q · November 4

BP-205 and the pitolisant development paths

BP-205 preliminary MAD data covered 94 healthy volunteers after fourteen days of dosing. There were no serious or severe adverse events in that description, but headache and mild on-target events occurred. Patient efficacy remains a separate development question. Q3 results and BP-205 MAD data · November 4

Pitolisant GR is under review, pitolisant HD has two Phase 3 studies, and TEMPO addresses Prader-Willi syndrome. EPX-100 is enrolling Dravet and Lennox-Gastaut Phase 3 studies. Q3 results and BP-205 MAD data · November 4 ONSTRIDE-1 narcolepsy registry ONSTRIDE-2 idiopathic hypersomnia registry TEMPO Prader-Willi syndrome registry ARGUS Dravet syndrome registry LIGHTHOUSE Lennox-Gastaut syndrome registry

Merlintrader Health Score · HRMY

3.90out of 5
Financial position4.5

At September 30, cash and investments totaled $1,051.605M versus $150M debt principal; operating cash generation was $196.885M over nine months. WAKIX supplies the operating funding base. Q3 2026 Form 10-Q · November 4

Catalysts3.5

The accepted pitolisant GR application has an April 1, 2027 FDA target date. BP-205 Phase 1b and several Phase 3 programs have 2027 windows; clinical outcomes and the patent proceedings remain uncertain. Q3 results and BP-205 MAD data · November 4

Dilution3.5

September awards included 8,058,445 options and 862,275 RSUs. Positive operating cash generation reduces immediate funding pressure, while awards and future transactions can expand shareholder exposure. Q3 2026 Form 10-Q · November 4

Trading liquidity4.0

A Nasdaq listing and active daily trading history support market access; patent and clinical announcements can still disrupt trading conditions.

Execution4.0

Q3 WAKIX sales rose to $268.917M, but higher royalties and research charges pressured profit. ZYN002 is being phased out in fragile X syndrome, and the leadership handover takes effect in January 2027. Q3 2026 Form 10-Q · November 4 Planned CEO succession · October 12

Weighted calculation: 4.5 × 30% + 3.5 × 30% + 3.5 × 20% + 4.0 × 10% + 4.0 × 10% = 3.90 out of 5. Editorial assessment as of November 12, 2026. Weights: financial position 30%, catalysts 30%, dilution 20%, trading liquidity 10%, execution 10%. Not an investment recommendation or probability of clinical success.

HRMY red flags

HRMY Stock FAQ: Harmony Biosciences Questions Answered

When is the next HRMY stock catalyst?

As of November 12, 2026, the next announced scientific update is eighteen-month ARGUS extension data at the December 4–8 AES meeting. The company has not announced an exact presentation slot. Pitolisant GR has an April 1, 2027 FDA target action date. Q3 results and BP-205 MAD data · November 4 AES annual meeting · December 4–8, 2026

Is Harmony Biosciences WAKIX FDA approved?

As of November 12, 2026, WAKIX is FDA approved for excessive daytime sleepiness or cataplexy in patients aged six and older with narcolepsy. The separate pitolisant GR formulation remains under review, with an April 1, 2027 target action date; that application is not an approval. WAKIX U.S. prescribing information · February 2026 FDA pediatric cataplexy approval · February 13, 2026 Q3 results and BP-205 MAD data · November 4

How much cash does Harmony Biosciences have?

At September 30, 2026, Harmony held $1,051.605 million of cash and investments, including long-term securities. Cash and short-term investments alone were $771.138 million. Debt principal was $150 million, while nine-month operating cash generation was $196.885 million. Q3 2026 Form 10-Q · November 4 Management expected resources plus additional operating and financing cash flows to cover needs for at least twelve months from statement issuance. Q3 2026 Form 10-Q · November 4

Is HRMY stock exposed to dilution?

At September 30, 2026, Harmony had 8,058,445 options and 862,275 RSUs outstanding alongside 58,720,081 common shares. These awards create potential dilution subject to their terms. Positive operating cash generation reduces immediate funding pressure, while future transactions can change the capital structure. Q3 2026 Form 10-Q · November 4

When did Harmony Biosciences report Q3 earnings?

Harmony reported third-quarter 2026 results on November 4, 2026. WAKIX net revenue was $268.917 million, operating income $54.197 million and net income $48.196 million. Management reiterated full-year WAKIX revenue guidance of $1.0 billion to $1.04 billion. Q3 2026 Form 10-Q · November 4 Q3 results and BP-205 MAD data · November 4

What does Harmony Biosciences do?

As of November 12, 2026, Harmony Biosciences develops and commercializes medicines for neurological conditions. Its current product is WAKIX, a pitolisant treatment for narcolepsy symptoms. Development programs include additional pitolisant formulations, EPX-100 in rare epilepsies and the investigational orexin-2 receptor agonist BP-205.

When will Harmony Biosciences report BP-205 data?

On November 4, 2026, Harmony reported preliminary BP-205 multiple-ascending-dose observations in healthy volunteers. The separate sleep-deprived-volunteer Phase 1b study is expected to report in Q1 2027, and Phase 2 starts are planned by mid-2027. Early volunteer observations do not establish efficacy in patients. Q3 results and BP-205 MAD data · November 4

Are generic versions of Harmony Biosciences WAKIX approved?

As of November 12, 2026, FDA lists Novitium’s pitolisant generic approval on July 21, 2026 and Lupin’s on August 14, 2026. Regulatory approval differs from permission to launch under settlement agreements and ongoing litigation. Harmony’s remaining AET proceedings and its exclusivity expectations are separate legal matters. FDA first generic approvals · pitolisant July 21, 2026 FDA competitive generic therapy approvals Q3 2026 Form 10-Q · November 4

Primary sources

Disclaimer. This content is published by Merlintrader for educational and informational purposes only. It is independent journalism and research. It does not constitute investment advice, an investment recommendation, an offer or a solicitation to buy or sell any security, and it is not a research report within the meaning of applicable United States securities regulation. Nothing here should be read as a recommendation to buy, sell or hold $HRMY or any other security.

Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases, ClinicalTrials.gov and market data, and are stated with their reference dates. Data can change without notice. Readers should verify every figure against the primary source before acting on it.

Clinical-stage biotechnology companies carry high execution, regulatory and financing risk. Trials fail, endpoints miss, enrollment slips, regulators ask for more data or decline to file an application, and companies that spend ahead of revenue raise equity at whatever price the market will bear. Every reader is responsible for their own decisions and should consult a licensed financial adviser where appropriate. Investors may lose part or all of their capital.

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