| Drug / Therapy | Pitolisant |
| Indication | — |
| Decision Type | PDUFA |
| Interventions | Pitolisant |
Harmony Biosciences (HRMY) operates in the Neuroscience sector. The current BiotechSign Score is 39 (Grade: D).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for Pitolisant by Harmony Biosciences (HRMY) is scheduled for April 1, 2027. This is the target date for the FDA to make a decision on this application.
Pitolisant is being developed by Harmony Biosciences for the treatment of its target indication. It is under FDA review.
If Pitolisant receives FDA approval, Harmony Biosciences (HRMY) would be able to market the drug in the United States for its target indication. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for HRMY on DilutionWatch at dilutionwatch.com/stock/HRMY.html.
You can view the full BiotechSign company profile for Harmony Biosciences (HRMY) at biotechsign.com/app/company/HRMY, which includes the BiotechSign Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSign is not a registered investment advisor.