NEW YORK, Jan 13, 2026, 16:19 EST — After-hours
- HRMY slid after Harmony published fresh 2026 sales guidance and cut a Fragile X program from its pipeline.
- The company flagged Wakix as on track for “blockbuster” revenue in 2026, but investors also got a clearer end point for ZYN002.
- Traders are looking to Harmony’s J.P. Morgan Healthcare Conference slot later Tuesday for more detail.
Shares of Harmony Biosciences Holdings Inc (HRMY) slid 6.4% on Tuesday to close at $35.82, after trading as low as $34.69.
The move comes as investors work through a pipeline reshuffle and a new revenue outlook that landed just as healthcare executives crowd into San Francisco for the annual J.P. Morgan conference.
Harmony’s stock tends to move on two things: what Wakix can do next, and whether the company can build something that matters beyond it. Tuesday’s update hit both levers, in opposite directions.
Harmony said preliminary, unaudited net product revenue for Wakix was about $243 million in the fourth quarter and about $868 million for 2025, and it forecast 2026 Wakix net revenue of $1.0 billion to $1.04 billion. Chief Executive Jeffrey Dayno said Wakix was “on track to achieve revenue of over $1 billion in narcolepsy in 2026,” while the company said it is phasing out ZYN002 in Fragile X syndrome and is no longer pursuing an indication in 22q deletion syndrome.
On the math, the 2026 range implies roughly 15% to 20% growth off last year’s preliminary figure. “Blockbuster” is industry shorthand for drugs that bring in more than $1 billion a year.
ZYN002 — a transdermal cannabidiol gel — failed to meet its main goal in a late-stage Fragile X study last September, and Harmony’s shares fell about 8% that day. The decision to wind the program down closes a door some investors had kept ajar for a second revenue engine. (Reuters)
In its conference deck, Harmony laid out a familiar sequence: a gastro-resistant pitolisant version with an NDA (a U.S. marketing application) expected in the second quarter of 2026, and an FDA decision target date — the PDUFA date — in the first quarter of 2027. The slides also flagged Phase 3 data in 2027 for a high-dose pitolisant formulation and showed Wakix loss of exclusivity in the first quarter of 2030, with a possible six-month extension through pediatric exclusivity.
The same deck points to Phase 3 topline data in Prader-Willi syndrome in the second half of 2026 and mid-2026 Phase 1 pharmacokinetic data for BP1.15205, an orexin-2 receptor agonist the company is testing in sleep/wake disorders.
Dayno is scheduled to present at the J.P. Morgan Healthcare Conference at 7:30 p.m. ET. Investors will be listening for anything new on timelines, spending and what Harmony does now that ZYN002 is headed off the board.
But the company’s headline figures are still preliminary and unaudited, and Harmony warned they could change as it finishes its year-end close. And the bigger risk hasn’t gone away: growth hinges on clinical readouts and regulators, while the clock is ticking toward exclusivity limits that the company itself puts in 2030.
