17. Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY)
Number of Hedge Fund Holders In Q2 2024: 25
Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) is a biotechnology company focusing on developing drugs for neural disorders. It is a revenue generating and profitable biotechnology firm with trailing twelve month revenue and net income sitting at $656 million and $115 million, respectively. However, unlike diversified biotechnology companies, Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY)’s sole commercial drug is its narcolepsy medicine WAKIX. Consequently, Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY)’s hypothesis is substantially dependent on this treatment, and while it holds key patents that will expire in 2029 and 2030, any competitors that offer better outcomes could lead to headwinds for the shares. This fact also increases the role of Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY)’s drug pipeline, and as of H2 2024, the firm has four drugs that could enter phase three trials by 2024 end. These include treatments that target sleep disorders and a neurodevelopmental disorder.
Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY)’s management shared important details about its pipeline during the Q2 2024 earnings call:
“Moving on to Pitolisant [indiscernible] resistant on GR program. We are on track to initiate the dosing optimization study in the fourth quarter of this year and a pivotal bioequivalent study in the first quarter of 2025 with PADUFA 2026. For the Idiopathic Hypersomnia or IH program, we are on track to submit an sNDA in the fourth quarter of this year. The submission will be based on the totality of the data generated from the EPI [ph] study, including data from the ongoing long-term extension study, which strongly support pitolisant efficacy in patients with IH. We have [indiscernible] defined other supporting information that will be included in the sNDA, including real-world evidence from pitolisant use in Idiopathic Hypersomnia in Europe to further strengthen our submission.
We are optimistic and remain committed in bringing the new treatment option to patients living with IH In our neuro behavioral franchise, we remain on track to report top-line data from the Phase 3 reconnect registrational trial of ZYN002 in Fragile X syndrome in mid-2025. In the rare epilepsy franchise, patient enrollment continues in the EPX-100 Phase 3 ARGUS trial for Dravet Syndrome with the top end data expected in 2026. We are also preparing to initiate a Phase 3 study in LGS another rare and severe developmental epileptic encephalopathy with high unmet medical need later this year. In summary, we have made significant progress in advancing our late-stage pipeline across three distinct franchises. If successful, these programs could result in at least one new product or indication launch each year over the next five years, along with the potential to help hundreds of thousands of patients across all the raise neurological disorders we are investigating.”
