Harmony Biosciences Holdings, Inc. Stock Price, News & Analysis

Harmony Biosciences (HRMY) reported a strong start to 2021, achieving a net product revenue of $59.7 million for Q1, compared to $19.8 million in Q1 2020. This marks profitability with a net income of $7.4 million, a significant turnaround from a net loss of $38.6 million last year. The growth is attributed to increased demand for WAKIX, now approved for both excessive daytime sleepiness and cataplexy in narcolepsy. Cash reserves stand at $141.2 million and clinical trials for other indications are ongoing, positioning the company for future development.

Harmony Biosciences (Nasdaq: HRMY) announced that data from its WAKIX® (pitolisant) clinical development program will be presented at the 2021 American Psychiatric Association Annual Meeting from May 1-3. WAKIX is approved for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. Presentations will cover the efficacy and safety of WAKIX in narcolepsy patients, including data from pivotal clinical trials. Harmony aims to enhance understanding of narcolepsy's impact on mental health, as noted by Chief Medical Officer Jeffrey Dayno.

Harmony Biosciences (Nasdaq: HRMY) announced that clinical results for WAKIX® (pitolisant) will be presented at the 2021 American Academy of Neurology Annual Meeting from April 17-22. These include two analyses: one on the time-to-onset of clinical response during treatment and another on the cardiovascular safety profile of WAKIX in narcolepsy patients. WAKIX, approved for treating excessive daytime sleepiness, has been available since Q4 2019. The meeting presentations aim to enhance understanding of WAKIX's efficacy and safety for patients with narcolepsy.

Harmony Biosciences Holdings, Inc. (HRMY) has launched the Progress at the Heart grant program aimed at addressing disparities in access to healthcare for patients with sleep disorders, especially within underrepresented communities. Announced on April 7, 2021, the initiative will allocate up to $125,000 in grants by September 2021, focusing on community- and education-based solutions. Two application rounds are open from April 7 to May 31 and June 1 to August 20. This program underscores Harmony's commitment to enhancing equality of care for rare disease and sleep disorder patients.

Harmony Biosciences (HRMY) announced total revenue of $160 million for 2020, with $56 million generated in Q4. The FDA expanded the approval of WAKIX for treating cataplexy in adults with narcolepsy. Harmony reported a net loss of $36.9 million for the year but achieved significant growth in net product revenue, increasing from $6 million in 2019. Cash reserves rose to $228.6 million compared to $24.5 million in the prior year. The company is advancing clinical trials, including a Phase 2 trial for Prader-Willi Syndrome.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) published a white paper following its December 2020 Summit on Sleep Disruption, focusing on the challenges of excessive daytime sleepiness (EDS) in patients with rare neurological disorders. The summit gathered patients, caregivers, and advocacy leaders to discuss EDS's impact. Key findings highlight issues like increased anxiety, reduced cognitive abilities, and challenges in diagnosis and treatment. The company aims to raise awareness of EDS in rare diseases, with ongoing collaborations with advocacy groups to share insights.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the publication of a post-hoc analysis of Phase 3 trials of pitolisant (WAKIX) in Sleep Medicine, focusing on patients with high narcolepsy symptom burdens. Results showed significant reductions in excessive daytime sleepiness (EDS) and cataplexy. For patients with high EDS, pitolisant achieved a mean change of –6.1 versus –2.3 for placebo. Moreover, 69% of patients responded positively. The treatment was well-tolerated, with common side effects including headache and nausea.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the appointment of Sandip Kapadia as Chief Financial Officer, effective March 29, 2021. Kapadia brings over 25 years of healthcare finance experience, most recently serving as CFO at Intercept, where he raised over $700 million. He replaces Susan Drexler, who is stepping down for other opportunities. Harmony's leadership expressed confidence that Kapadia's expertise will drive long-term growth and enhance financial strategies.

Harmony Biosciences (Nasdaq: HRMY) announced it will release its fourth quarter and full year 2020 financial results on March 25, 2021 at 8:00 a.m. ET. A conference call will follow at 8:30 a.m. ET, providing insights into the company's performance in the past year. Investors can dial in or access the live webcast on their investor page. A replay will be available within 24 hours. This financial update is crucial for stakeholders tracking the company’s growth in the pharmaceutical sector focusing on rare neurological disorders.