Harmony Biosciences Holdings, Inc.
HRMY evidence brief
What we can confirm
- BioSniper Score:
- 5.8 / 10
- Market Cap:
- $2.45B
- Lead Asset:
- WAKIX (pitolisant) - Prader-Willi Syndrome (PWS) (Phase 3)
What it means
What to watch
Prepared research question
What matters most for HRMY—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · HRMY
Harmony Biosciences Holdings, Inc. is a commercial-stage biopharmaceutical company focused on rare neurological diseases, anchored by its approved product WAKIX (pitolisant) for narcolepsy and a pipeline of late-stage candidates including EPX-100 and BP-205.
Key risk: Single-product revenue dependence
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 12 clinical trials · 1 catalyst for Harmony Biosciences Holdings, Inc..
Similar companies
Harmony Biosciences Holdings, Inc. is a commercial-stage biopharmaceutical company focused on rare neurological diseases, anchored by its approved product WAKIX (pitolisant) for narcolepsy and a pipeline of late-stage candidates including EPX-100 and BP-205.
- Net revenue from WAKIX was $868.5 million in 2025, a 22% year-over-year increase [sec · filed 2026-04-03].
- Cash & equivalents were $549.8M as of 2026-06-30, with total revenue of $261.3M and net income of $75.4M for the period [sec].
- In February 2026, the FDA approved WAKIX for the treatment of cataplexy in pediatric patients six years and older with narcolepsy [sec · filed 2026-04-03].
- EPX-100 (clemizole hydrochloride) is in two Phase 3 registrational trials for Dravet Syndrome and Lennox-Gastaut Syndrome, with topline data expected in 2027 [sec_mda · as of 2026-05-07].
- BP-205, an orexin-2 receptor agonist, completed Phase 1 SAD study with favorable PK and safety profiles; Phase 1b study in sleep-deprived healthy volunteers expected to start Q3 2026 [sec_mda · as of 2026-08-04].
What works
- WAKIX has demonstrated durable commercial growth, with net revenue of $868.5 million in 2025, a 22% increase year-over-year, and approximately 9,000 HCPs prescribing it as of June 30, 2026 [sec · filed 2026-04-03][sec_mda · as of 2026-08-04].
- The company has a strong cash position of $549.8M as of 2026-06-30, providing financial runway to support pipeline development and business development activities [sec].
- Harmony has advanced multiple late-stage pipeline programs, including EPX-100 in Phase 3 for two indications and Pitolisant GR/HD formulations with utility patents extending into the 2040s [sec_mda · as of 2026-08-04].
- The FDA approval of WAKIX for pediatric cataplexy in February 2026 expands the label and supports pediatric exclusivity efforts [sec · filed 2026-04-03].
What to weigh
- The company is heavily reliant on a single product, WAKIX (pitolisant), for the vast majority of its revenue, with risks related to market acceptance and competition [sec_mda · as of 2026-08-04].
- Several pipeline candidates are in early or mid-stage development (e.g., BP-205 Phase 1, EPX-100 Phase 3) and face significant clinical and regulatory uncertainties before potential approval [sec_mda · as of 2026-05-07].
- The company has an accumulated deficit (not explicitly stated in chunks, but net income of $75.4M on $261.3M revenue suggests ongoing R&D investment; no explicit deficit figure available in chunks).
- Patent expiry for PITOLISANT HYDROCHLORIDE is scheduled for 2031-06-21, which could eventually expose the WAKIX franchise to generic competition [catalyst].
From the filings
Quoted directly from source documents.
WAKIX net revenue growth in 2025
“solid year of growth for WAKIX in 2025 with net revenue of $868.5 million, representing an increase of 22% year over year”
SEC filings · April 3, 2026
FDA approval of WAKIX for pediatric cataplexy in February 2026
“In February 2026, the FDA approved WAKIX for the treatment of cataplexy in pediatric patients six years and older with narcolepsy.”
SEC filings · April 3, 2026
EPX-100 Phase 3 registrational trials with topline data expected in 2027
“EPX-100 is currently in two Phase 3 registrational clinical trials, one for each of DS (the ARGUS Study) and LGS (the LIGHTHOUSE Study). We anticipate topline data in 2027 and a potential PDUFA date in 2028.”
SEC MD&A · May 7, 2026
BP-205 Phase 1 SAD study results and Phase 1b initiation
“In August 2026, we announced Phase 1 clinical PK data from the SAD study for BP-205, which demonstrated favorable PK, safety, and tolerability profiles. Topline data from the Phase 1 multiple ascending dose study is expected in the fourth quarter of 2026.”
SEC MD&A · August 4, 2026
Catalyst timeline
- 2031-06-21 · Patent_Expiry · PITOLISANT HYDROCHLORIDE — Patent_Expiry: NDA211150 — The patent expiry for the active ingredient in WAKIX could allow generic competition, potentially impacting revenue from the company's core product.
Risks & what to watch (4)›
Key risks
- Single-product revenue dependence — WAKIX accounts for nearly all revenue; any decline in sales or market share would materially impact financials [sec_mda · as of 2026-08-04].
- Pipeline clinical and regulatory risk — EPX-100 and BP-205 are in Phase 3 and Phase 1 respectively; failure to meet endpoints or regulatory hurdles could delay or prevent approval [sec_mda · as of 2026-05-07].
- Patent expiry for pitolisant — PITOLISANT HYDROCHLORIDE patent expires on 2031-06-21, potentially opening the market to generic competition [catalyst].
- Competitive landscape for pipeline candidates — EPX-100 faces at least 4 competitors in Dravet Syndrome/LGS, and pitolisant for PWS faces multiple Phase 2/3 competitors [pipeline].
What to watch
- Topline data from the Phase 1 multiple ascending dose study for BP-205 expected in Q4 2026 [sec_mda · as of 2026-08-04].
- Topline data from EPX-100 Phase 3 trials (ARGUS and LIGHTHOUSE) expected in 2027, with potential PDUFA in 2028 [sec_mda · as of 2026-05-07].
- NDA submission for Pitolisant GR anticipated in Q2 2026 and PDUFA date in Q1 2027 [sec_mda · as of 2026-05-07].
- Patent expiry for PITOLISANT HYDROCHLORIDE on 2031-06-21, which could affect long-term franchise exclusivity [catalyst].
Sources: Catalysts · News · Pipeline · SEC filings · SEC MD&A · Generated October 9, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.37 · 1% dilution
Lead: Phase 3
1 candidate
1 upcoming, next in ~1711d
No insider transactions in the last 180 days
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
67
Total value held
$169.8M
| Holder | Shares | Value |
|---|---|---|
| goldman sachs group inc | 1,239,207 | $34.7M |
| millennium management llc | 954,359 | $26.7M |
| venbio partners llc | 489,194 | $13.7M |
| man group plc | 461,898 | $12.9M |
| ubs group ag | 447,991 | $12.5M |
| qube research & technologies ltd | 352,637 | $9.9M |
| sei investments co | 194,188 | $5.4M |
| alliancebernstein l.p. | 144,345 | $5.4M |
| los angeles capital management llc | 166,198 | $4.7M |
| ubs am, a distinct business unit of ubs asset management americas llc | 141,540 | $4.0M |
Showing top 10 of 67 institutional holders of Harmony Biosciences Holdings, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 28, 2026- % of float
- 16.9%
- Days to cover
- 10.7
- Shares short
- 7,290,999
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
HRMY short interestGovernance
Frequently asked questions
What is the AI investment thesis for Harmony Biosciences Holdings, Inc.?
Harmony Biosciences Holdings, Inc. is a commercial-stage biopharmaceutical company focused on rare neurological diseases, anchored by its approved product WAKIX (pitolisant) for narcolepsy and a pipeline of late-stage candidates including EPX-100 and BP-205.
What is Harmony Biosciences Holdings, Inc.'s lead drug candidate?
Harmony Biosciences Holdings, Inc.'s most advanced tracked candidate is WAKIX (pitolisant) - Prader-Willi Syndrome (PWS) (Phase 3) for Idiopathic Hypersomnia; Prader-Willi Syndrome; Pregnancy Related.
What is Harmony Biosciences Holdings, Inc.'s next catalyst?
Harmony Biosciences Holdings, Inc.'s next tracked catalyst is a Patent_Expiry event — "Patent_Expiry: NDA211150" — expected June 21, 2031.
Who is the CEO of Harmony Biosciences Holdings, Inc.?
Dr. Jeffrey M. Dayno M.D. is the chief executive officer of Harmony Biosciences Holdings, Inc. (HRMY).
Where is Harmony Biosciences Holdings, Inc. headquartered?
Harmony Biosciences Holdings, Inc. (HRMY) is headquartered in Plymouth Meeting, PA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.