Name in SEC filings: Harmony Biosciences Holdings, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| BP-205 | /data readout | Stage not stated | in 2026 | 8-K · |
| Pitolisant GR | target date (company stated) | PDUFA | April 1, 2027 | 10-Q · |
| EPX-100 | Topline/data readout | Stage not stated | in 2027 | 8-K · |
| Pitolisant HD | Topline/data readout | Stage not stated | in 2027 | 10-Q · |
| Pitolisant HD | PDUFA target date (company stated) | PDUFA | in 2028 | 10-Q · |
| BP-205 | Topline/data readout | Phase 1 | in early 2027 | 10-Q · |
| BP-205 | Other | Stage not stated | in mid-2027 | 10-Q · |
| pitolisant | Topline/data readout | Stage not stated | in mid-2027 | 10-Q · |
Source: ORION, orionbiotechai.com/company/HRMY, data as of Oct 17, 2026
https://www.orionbiotechai.com/company/HRMY
BP-205 · Topline/data readout · in Q4 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
Topline/data readoutin Q4 2026
Stage: Not stated
Public float: $1,322,400,000 · as of · SEC filing
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.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
PDUFA target date (company stated)April 1, 2027
Stage: PDUFASEC filing · “PDUFA”) date”
Public float: $1,322,400,000 · as of · SEC filing
In June 2026, we submitted a New Drug Application (“NDA”) for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2027.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-04)
Topline/data readoutin 1H 2027
Stage: Not stated
Public float: $1,322,400,000 · as of · SEC filing
Topline data expected in 1H 2027
SEC timing context:
EPX-100 (clemizole hydrochloride) ● Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies: o Lennox-Gastaut syndrome (LGS) – the LIGHTHOUSE Study o Dravet syndrome (DS) – the ARGUS Study
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-06)
Topline/data readoutin 2027
Stage: Not stated
Public float: $1,322,400,000 · as of · SEC filing
We expect topline data in 2027
SEC timing context:
Pitolisant HD is currently in a Phase 3 registrational trial in narcolepsy, ONSTRIDE1, and a Phase 3 registrational trial in IH, ONSTRIDE2.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
PDUFA target date (company stated)in 2028
Stage: PDUFASEC filing · “PDUFA date”
Public float: $1,322,400,000 · as of · SEC filing
We expect topline data in 2027 and anticipate a target PDUFA date in 2028.
SEC timing context:
Pitolisant HD is currently in a Phase 3 registrational trial in narcolepsy, ONSTRIDE1, and a Phase 3 registrational trial in IH, ONSTRIDE2.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2028-12)
Topline/data readoutin early 2027
Stage: Phase 1SEC filing · “Phase 1b”
Public float: $1,322,400,000 · as of · SEC filing
In July 2026, we submitted an IND for BP-205 to the FDA, which is now open, and are preparing to initiate a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in early 2027.
10-Q · Filed · Last checked
Otherin mid-2027
Stage: Not stated
Public float: $1,322,400,000 · as of · SEC filing
In addition, we plan to initiate Phase 2 trials for BP-205 in mid-2027 to evaluate multiple CNS indications.
10-Q · Filed · Last checked
Topline/data readoutin mid-2027
Stage: Not stated
Public float: $1,322,400,000 · as of · SEC filing
We anticipate topline data from the TEMPO study in mid-2027.
SEC timing context:
In 2024, we initiated the PWS Phase 3 registrational trial, the TEMPO study, in support of these efforts.
10-Q · Filed · Last checked
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| BP-205Clinical results | in Q4 2026“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.” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| BP-205Clinical results | in early 2027“In July 2026, we submitted an IND for BP-205 to the FDA, which is now open, and are preparing to initiate a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in early 2027.” Filed · 10-Q | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| BP-205Other | in mid-2027“In addition, we plan to initiate Phase 2 trials for BP-205 in mid-2027 to evaluate multiple CNS indications.” Filed · 10-Q | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| EPX-100Clinical results | in 1H 2027“Topline data expected in 1H 2027” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| pitolisantClinical results | in mid-2027“We anticipate topline data from the TEMPO study in mid-2027.” Filed · 10-Q | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| Pitolisant GRFDA decision | April 1, 2027“In June 2026, we submitted a New Drug Application (“NDA”) for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| Pitolisant HDFDA decision | in 2028“We expect topline data in 2027 and anticipate a target PDUFA date in 2028.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| Pitolisant HDClinical results | in 2027“We expect topline data in 2027” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Suggest an SEC timing statement to add for HRMY. You can include the original filing link in your note. The founder reads each request by hand.
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