Filing Flows › Harmony Biosciences Holdings (HRMY) › Guidance & outlook

Harmony Biosciences Holdings (HRMY) guidance and outlook

Harmony Biosciences Holdings (HRMY) reaffirmed its guidance on Nov 4, 2026: Revenue $269M for Q3 2027. Harmony Biosciences Holdings' 10-Q filed Nov 4, 2026 makes 29 forward-looking statements.

Guidance and outlook

Latest guidance

From the earnings release filed Nov 4, 2026 (8-K on EDGAR).

Forward-looking statements, 10-Q filed Nov 4, 2026

• Unless otherwise indicated, information contained in this Quarterly Report on Form 10-Q concerning our industry, including industry statistics and forecasts, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates.
• We anticipate topline data from the TEMPO study in mid-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.
• We expect topline data in 2027 and anticipate a target PDUFA date in 2028.
• We intend to develop BP-205 for the treatment of multiple CNS indications.
• In January 2026, we entered into a license agreement (the “Novitium License Agreement”) with Novitium Pharma LLC (“Novitium”), which includes an exclusive license to additional intellectual property that will expand our patent estate, as well as a co-exclusive license, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake.
• In February 2026, we entered into a license agreement (the “MSN License Agreement”) with MSN Laboratories Private Limited (“MSN”), which includes an exclusive, royalty-bearing license, with the right to grant sublicenses, to additional intellectual property, including licensed patents, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake.
• (“USPTO”), and triggered a $25.0 million milestone payment, which we expect to be paid in the fourth quarter of 2026.
• In June 2026, we submitted an NDA for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target PDUFA date of April 1, 2027.
• In July 2026, we submitted an IND for BP-205 to the FDA, which is now open, and initiated a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in the first quarter of 2027.
• In addition, we plan to initiate Phase 2 trials for BP-205 in mid-2027 to evaluate multiple CNS indications.
• Although we expect net sales to increase over time, provisions for sales discounts and allowances may fluctuate based on the mix of sales to different customer segments and/or changes in our estimates .

Harmony Biosciences Holdings' latest quarter

Questions

Did Harmony Biosciences Holdings raise or lower its guidance?

Harmony Biosciences Holdings (HRMY) reaffirmed its guidance on Nov 4, 2026: Revenue $269M for Q3 2027.

What does Harmony Biosciences Holdings expect?

Unless otherwise indicated, information contained in this Quarterly Report on Form 10-Q concerning our industry, including industry statistics and forecasts, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates. We anticipate topline data from the TEMPO study in mid-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”) dat

Open the interactive view →

Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.