ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s diseaseONAPGO is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of OFF timeONAPGO will be available in the U.S. in second quarter 2025 ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and co ...

Core Insights - Supernus Pharmaceuticals has received FDA approval for an updated label for Qelbree, which now includes new pharmacodynamic data and lactation information [1][2][3] Group 1: Product Information - Qelbree (viloxazine extended-release capsules) is approved for treating ADHD in patients aged 6 years and older [4] - The updated label highlights viloxazine's partial agonist activity at the serotonin 5-HT2C receptor and its inhibition of the norepinephrine transporter, emphasizing its multimodal pharmacodynamic profile [1][6] - New lactation data indicates low transfer of Qelbree into breastmilk, with estimated daily infant doses of viloxazine and its metabolite being 0.085 mg/kg and 0.00595 mg/kg, respectively [2] Group 2: Clinical Insights - The updated pharmacodynamic data enhances understanding of Qelbree's effects, aiding treatment decision-making for ADHD [2][3] - The lactation study involved 15 healthy lactating women and followed a multi-dose regimen of viloxazine [2] - The study results support that the transfer of viloxazine into breastmilk is low, although it did not evaluate effects on breastfed infants [2] Group 3: Company Commitment - Supernus Pharmaceuticals aims to empower healthcare providers and patients with updated information to make informed treatment decisions [3] - The company is dedicated to building evidence around Qelbree's use in the ADHD space [3]

Core Insights - Knight Therapeutics Inc. has submitted a New Drug Submission (NDS) for Qelbree® to Health Canada, marking a significant step in expanding its ADHD treatment portfolio [1][4] - Qelbree® is a novel nonstimulant medication for ADHD, already approved in the United States for patients aged 6 and older, with a growing market for non-stimulant ADHD treatments in Canada [2][4] Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company based in Montreal, Canada, focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [6] - The company operates under various subsidiaries in Latin America, including United Medical, Biotoscana Farma, and Laboratorio LKM [6] Product Development - Qelbree® is currently undergoing multiple clinical trials, including studies on its effectiveness in combination with psychostimulants and its impact on preschool-age children and adults with ADHD [3][4] - The first clinical trial reported positive topline results in September 2023, while a second trial for preschool-age children began in March 2024 [3] Market Insights - The Canadian market for non-stimulant ADHD products was valued at $83.5 million in 2023, with a 10% growth in prescriptions compared to 2022 and a compound annual growth rate (CAGR) of 11% over the past four years [4] - ADHD affects approximately 5-9% of children and adolescents and 3-5% of adults, indicating a significant ongoing medical need for effective treatment options [5]

ROCKVILLE, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024, at 9:30 a.m. GMT (4:30 a.m. EST) at the Waldorf Hilton in London, United Kingdo ...

Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE .Today, we are circling back to a small biopharma concern called Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN ) . We looked at this name in the first quarter of this year and noted ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $175.7 million, up from $153.9 million in Q3 2023, driven by net product sales of $170.3 million and royalty and other revenues of $5.4 million [19] - Operating earnings on a GAAP basis for Q3 2024 were $40.9 million, compared to $8.1 million in the same quarter last year, marking a $32.8 million increase [21] - GAAP net earnings were $38.5 million for Q3 2024, or $0.69 per diluted share, compared to a net loss of $16 million or $0.29 loss per diluted share in Q3 2023 [22] Business Line Data and Key Metrics Changes - Qelbree's net sales increased by 68% in Q3 2024, reaching $62 million, with prescriptions growing by 19% [6][8] - GOCOVRI's net sales increased to $36 million in Q3 2024, representing an 8% growth over the same period in 2023 [8] - Oxtellar XR's net sales were $30 million, flat compared to Q3 2023, while Trokendi XR's net sales decreased by 26% to $15 million [9] Market Data and Key Metrics Changes - Qelbree's prescriptions reached an all-time quarterly high of 194,000, with a 14% growth in September compared to June [6][7] - For the first nine months of 2024, Qelbree's prescriptions grew by 25%, outpacing the ADHD market's growth of 9% [8] Company Strategy and Development Direction - The company is focused on advancing its product pipeline, with several catalysts expected in the near to midterm [11] - The company is actively seeking strategic opportunities for growth, particularly in the CNS sector, while also considering other therapeutic areas [18][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the performance of Qelbree and its growth trajectory, indicating strong retention and compliance rates [47] - The company raised its financial guidance for 2024, expecting total revenues to range from $630 million to $650 million [28] Other Important Information - The company had approximately $403.2 million in cash and marketable securities as of September 30, 2024, compared to $271.5 million at the end of 2023, indicating strong financial flexibility [27] - The company expects further erosion in Trokendi XR sales and has raised the target combined net sales for Trokendi XR and Oxtellar XR to approximately $155 million for 2024 [10] Q&A Session Summary Question: Overall seizure reduction for SPN-817 - Management confirmed that the maintenance period showed a 56% seizure reduction, with improvements noted in the post-maintenance period [32][34] Question: Impact of AbbVie's pump approval on the company's pump - Management expressed excitement about the market education that AbbVie's approval could bring and the potential for both products to coexist in the market [36][37] Question: Expectations for SPN-820 in TRD study - Management indicated that while it is difficult to predict, they are hopeful for strong results based on previous data [39][40] Question: Qelbree's growth trajectory and pricing - Management reported strong growth in Qelbree prescriptions and healthy net pricing, with optimism for continued performance into 2025 [41][46] Question: Capital deployment and M&A strategy - The company prioritizes acquiring commercial products for revenue growth, followed by pipeline assets at later stages [52] Question: Competitive landscape for Qelbree - Management acknowledged that competition will arise but emphasized the importance of product profiles and patient demographics in assessing impact [55]

Supernus Pharmaceuticals (SUPN) came out with quarterly earnings of $1.06 per share, beating the Zacks Consensus Estimate of $0.39 per share. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 171.79%. A quarter ago, it was expected that this drugmaker would post earnings of $0.37 per share when it actually produced earnings of $0.36, delivering a surprise of -2.70%.Over the last four quarters, the ...

Core Insights - Supernus Pharmaceuticals presented new data on SPN-820, a novel treatment for major depressive disorder (MDD), at Psych Congress 2024, highlighting its rapid onset and favorable safety profile [1][5][6] Study Results - The Phase 2a study involved 40 subjects with MDD, assessing the efficacy and safety of SPN-820 administered at 2400 mg every three days [7] - Participants showed significant reductions in depressive symptoms, with a decrease of 80% in suicidal ideation from 12.5% at baseline to 2.6% by Day 10 [4] - The Hamilton Depression Rating Scale-6 items (HAM-D6) showed improvements of -6.1 at two hours and -9.6 at Day 10, while the Montgomery Åsberg Depression Rating Scale (MADRS) indicated improvements of -16.6 at four hours and -22.9 at Day 10 [2] Efficacy and Tolerability - Rapid response rates were observed, with 50% of participants achieving a ≥50% reduction in MADRS scores at four hours, increasing to 84.2% by Day 10 [3] - The tolerability profile was favorable, with a low discontinuation rate of 2.5% due to adverse events, which were mostly mild to moderate [4][5] Mechanism of Action - SPN-820 is a first-in-class, orally active small molecule that modulates the mTORC1 pathway, enhancing synaptic function and cellular metabolism in the brain [6] - The compound is designed to provide rapid antidepressant effects without dissociative side effects, with ongoing Phase 2b studies involving approximately 227 patients with treatment-resistant depression [6]

ROCKVILLE, Md., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company expects to report financial and business results for the third quarter of 2024 after the market closes on Monday, November 4, 2024. Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to pre ...

Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression Company to host webcast today at 4:30 p.m. ET to discuss the topline data Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression expected first-half 2025 ROCKVILLE, Md., Oct. 17, 2024 (GLOBE NEWSWI ...