Accessibility StatementSkip Navigation The majority of adverse events were non-serious and mild or moderate in severity across TEMPO-1 through 3. The incidence of SAEs and deaths were low and comparable between placebo and tavapadon groups. The most common adverse reactions reported in 10% of patients were nausea, headache and dizziness for Parkinson's disease patients without levodopa, and nausea and dyskinesia for patients on adjunctive therapy with levodopa. NORTH CHICAGO, Ill., Sept. 26, 2025 /PRNewswir ...

Financial Data and Key Metrics Changes - The company continues to be profitable even through the transition from legacy products to new growth products [4] - KELBRE has shown a 25% growth in prescriptions year-over-year and a 23% growth in the first half of the current year [16] - GOCOVRI has seen a significant increase in patient retention due to Medicare redesign, with 97% of patients having less than $25 co-pay by June [24] Business Line Data and Key Metrics Changes - KELBRE has grown to 35% of the business, with an 80% satisfaction rate among adult users, significantly higher than Strattera's 53% [13] - ZERZUVEY, the first oral treatment for postpartum depression, is expected to set the standard of care, with 80% of women receiving it as a first-line treatment [7] - Anapco, the new infusion device for Parkinson's, is performing well, with demand matching that of AbbVie's product [30] Market Data and Key Metrics Changes - The back-to-school season has shown a 26% growth in the last four-week rolling average for KELBRE, indicating strong momentum [17] - The company has seen a 36% growth in unit shipments of ZERZUVEY quarter-over-quarter, reflecting a healthy brand performance [36] Company Strategy and Development Direction - The acquisition of Sage allows the company to enter women's health while maintaining its CNS focus, indicating a strategic expansion [5] - The company is prioritizing M&A to fill its portfolio with post-Phase II assets, aiming for launches between 2026 and 2030 [58][59] - The company is taking a pause to reevaluate the Sage pipeline while integrating it with its own discovery programs [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ZERZUVEY to become the standard of care for postpartum depression [8] - The company anticipates a strong second half of the year, driven by back-to-school momentum and continued growth in its product portfolio [19] - Management is confident that the increased demand from Medicare redesign will offset the mandatory rebates on manufacturers [26] Other Important Information - The company is exploring the potential of its pipeline, particularly focusing on SPN-817 for seizures, which has shown promising results [41] - The company is also considering the future of XERZUVEY and its potential new indications in collaboration with Biogen [39] Q&A Session Summary Question: Can you discuss the acquisition rationale for Sage? - The acquisition allows entry into women's health while maintaining CNS focus, addressing a significant unmet need in postpartum depression [5] Question: What are the expectations for the collaboration with Biogen? - The collaboration is expected to be mutually beneficial, with both companies learning from each other across various functions [10] Question: How is KELBRE performing in the adult ADHD market? - KELBRE has achieved 35% of the business in adults, with an 80% satisfaction rate, indicating strong market acceptance [13] Question: What is the outlook for GOCOVRI following Medicare redesign? - The redesign has improved patient retention, with 97% of patients having low co-pays, which is expected to continue [24] Question: How is Anapco performing compared to AbbVie's product? - Anapco's performance is in line with AbbVie's product, with both addressing a significant need in the market for advanced Parkinson's treatment [30] Question: What is the company's approach to M&A? - The company remains focused on acquiring post-Phase II assets to enhance its portfolio and ensure future growth [58][59]

Summary of Supernus Pharmaceuticals (SUPN) Conference Call Company Overview - Supernus Pharmaceuticals is a CNS-focused biopharmaceutical company with a portfolio of about eight to nine products on the market [2][3] - The company is profitable and has a clean balance sheet, recently completing the acquisition of Sage Therapeutics [2][3] - Supernus has transitioned from the loss of exclusivity on two legacy products and is now in a re-accelerated growth phase driven by key products like Qelbree, Gocovri, Onapgo, and ZURZUVAE [3] Key Products and Market Insights Qelbree (ADHD Treatment) - Qelbree is a novel non-stimulant ADHD medication that works as early as week one, addressing a significant market need for effective non-stimulant options [7][8] - The ADHD market consists of approximately 100 million prescriptions annually, with Supernus currently holding less than 2% market share, indicating substantial growth potential [8][19] - The adult segment represents 67% of the ADHD market, and Supernus has seen growth in this segment, with 35% of their business coming from adults [18][19] - Qelbree has shown a growth rate of 20% plus, with recent data indicating a 25-26% growth during the back-to-school season [18][19] Onapgo (Parkinson's Treatment) - Onapgo is a new continuous infusion device for apomorphine, launched in April, aimed at treating off episodes in Parkinson's patients [23][24] - The device has received positive initial responses, and its market potential is still being evaluated, with estimates ranging from $200 to $300 million [29][30] - The product is designed for advanced patients but may also be used for earlier-stage patients, which could expand its market opportunity [29][30] ZURZUVAE (Postpartum Depression) - ZURZUVAE is the first oral medication approved for postpartum depression (PPD), a condition affecting 1 in 7 women [31] - There is a significant lack of awareness and education regarding PPD, with only about 40% of women diagnosed over the years [31][32] - Supernus is actively working on educating healthcare providers and patients about PPD, emphasizing the importance of screening and diagnosis [32][38] Industry Dynamics and Challenges - The ADHD treatment landscape has historically relied on stimulants, which do not work for 15-30% of patients, creating a demand for effective non-stimulant alternatives [9][10] - In the Parkinson's space, approximately 90-95% of patients experience off episodes after five years of diagnosis, highlighting the need for effective treatments [22][25] - The company is addressing the stigma around ADHD and PPD through influencer partnerships and educational initiatives [21][38] Conclusion - Supernus Pharmaceuticals is positioned for significant growth with its innovative product offerings in ADHD, Parkinson's, and postpartum depression - The company is focused on expanding its market share and improving patient outcomes through education and effective treatment options, indicating a strong potential for future success in the biopharmaceutical industry [3][19][31]

Core Viewpoint - Anavex Life Sciences Corp. is advancing its clinical-stage biopharmaceutical developments, particularly focusing on innovative treatments for Alzheimer's disease and other CNS disorders, with promising financial results and clinical data supporting its lead drug candidate, blarcamesine [1][2]. Recent Highlights - Anavex presented open-label extension data for blarcamesine at the AAIC 2025, showing continued clinically meaningful benefits in early-stage Alzheimer's patients [2][7]. - The company participated in the AAIC 2025, emphasizing the importance of sharing knowledge to advance dementia science [7]. Financial Highlights - Cash and cash equivalents stood at $101.2 million as of June 30, 2025, down from $132.2 million at the end of fiscal 2024, indicating a cash runway of over 3 years at current utilization rates [4][7]. - Research and development expenses for the quarter were $10.0 million, a decrease from $11.8 million in the same quarter of fiscal 2024 [4][7]. - General and administrative expenses increased to $4.5 million from $2.8 million in the comparable quarter of fiscal 2024 [4][7]. - The net loss for the quarter was $13.2 million, or $0.16 per share, compared to a net loss of $12.2 million, or $0.14 per share for the same quarter in fiscal 2024 [4][7]. Clinical Development - Blarcamesine has shown benefits over a period of up to 4 years in treated patients, as measured by clinical endpoints ADAS-Cog13 and ADCS-ADL [7]. - The drug candidate is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease [9].

Financial Data and Key Metrics Changes - The company reported a record revenue of $31.1 million for Q2 2025, representing a 37% increase year over year, and a net income of $3.6 million compared to virtually breakeven a year ago [7][20]. - The cash position at the end of the quarter was $60.5 million with no debt [24]. - Gross margin improved to 65%, up from 60.2% a year ago, driven by lower cost inventory and higher e-commerce sales [22]. Business Line Data and Key Metrics Changes - E-commerce business generated $18.1 million in net sales, a 39% increase year over year [7][21]. - The food grade and pharmaceutical grade Niagen ingredient business grew 135% year over year, with revenue of $7.4 million [8][21]. - TRU NIAGEN revenue increased by 22% to $22.7 million, primarily driven by e-commerce revenues [21]. Market Data and Key Metrics Changes - The company is expanding its presence in wellness clinics, onboarding over 800 clinics nationwide to offer the Niagen Plus product line [8]. - The partnership with Watsons in Hong Kong is contributing to steady revenues, with plans for joint marketing efforts to grow brand presence [22]. Company Strategy and Development Direction - The company is focusing on expanding its Niagen Plus product line and exploring telehealth functionality on its website [9][8]. - A worldwide exclusive license agreement was signed with Haukeland University Hospital for the development of nicotinamide riboside as a potential therapy for Parkinson's disease [17]. - The company aims to maintain its position as the gold standard in NAD science and is committed to scientific innovation in the dietary supplement industry [14][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory and strategic goals, highlighting the strong demand for NAD products [19][20]. - The company raised its revenue growth expectation for the full year from 20%-25% to a range of 22%-27% year over year [27]. - Management noted ongoing scrutiny from California regarding outsourcing facility practices but remains optimistic about the partnership with Wells Pharmacy Network [9][10]. Other Important Information - The company has been featured in major media outlets and events, increasing awareness of its products [10][12]. - There is ongoing research into the effects of NAD supplementation on long COVID and fertility, with studies expected to be published soon [15][16][51]. Q&A Session Summary Question: Regarding the initiative for Parkinson's disease - Management indicated that if the NOPARC trial results are positive, they may pivot to nicotinamide riboside triacetate for FDA approval in the U.S. [30][32]. Question: Volume and pricing for NIAGEN IV in clinics - Management noted that while clinics are currently charging high prices for IV experiences, they believe prices need to come down to increase accessibility and volume [36][39]. Question: Steps for treating long COVID - The key milestone to watch is the publication of the Harvard study on NAD supplementation for long COVID, which could lead to a marketing campaign if results are positive [49][54].

Core Viewpoint - Knight Therapeutics Inc. is advancing its neurology portfolio by submitting a marketing authorization application for CREXONT in Mexico, addressing the high unmet medical need in Parkinson's disease treatment [1][3]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America [9]. - The company operates through its Latin American subsidiaries, including United Medical, Biotoscana Farma, and Laboratorio LKM [9]. Product Information - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, featuring both immediate-release granules and extended-release beads [2][4]. - The product was developed in collaboration with Amneal Pharmaceuticals, which holds exclusive rights for regulatory approval and commercialization in Canada and Latin America [2]. Clinical Study - CREXONT was evaluated in the RISE-PD clinical study, a 20-week phase 3 trial involving 630 patients, which successfully met its primary and secondary endpoints [5][6]. - The study demonstrated that CREXONT significantly improved daily "Good On" time by 0.53 hours with fewer doses compared to immediate-release CD/LD, with an average dosing frequency of three times per day versus five times per day for IR CD/LD [6]. Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with approximately 1 million diagnosed patients in the U.S. and an estimated 500,000 affected individuals in Mexico aged 45 to 60 [7][8]. - The average age of diagnosis for Parkinson's disease is 60, and the number of patients is expected to grow significantly as life expectancy increases [8].

Core Insights - Knight Therapeutics Inc. has announced that its New Drug Submission (NDS) for CREXONT has been accepted for review by Health Canada [1] - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, with a market potential exceeding $50 million in Canada and $120 million in Brazil [2][3] - The RISE-PD clinical study demonstrated that CREXONT significantly improves "Good On" time with fewer doses compared to immediate-release CD/LD [7] Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [11] - The company has entered into an agreement with Amneal Pharmaceuticals for exclusive rights to seek regulatory approval and commercialize CREXONT in Canada and Latin America [3] Product Details - CREXONT combines immediate-release granules and extended-release beads, allowing for rapid onset and prolonged drug release [4][5] - The product was studied in a 20-week phase 3 clinical trial involving 630 patients, which met its primary and secondary endpoints [6] Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with over 100,000 diagnosed patients in Canada and an estimated 6,600 new cases annually [9][10] - The controlled release segment of the Parkinson's treatment market in Canada was valued at $15 million for the twelve-month period ending September 2024 [2]

Core Insights - Roche (RHHBY) is advancing its pipeline candidate prasinezumab into phase III development for early-stage Parkinson's disease based on data from phase IIb PADOVA study and ongoing open-label extensions [1][7] - The candidate is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson's disease progression [3] - Year-to-date, Roche's shares have increased by 20.9%, outperforming the industry growth of 4% [1] Development Details - The PADOVA study evaluated prasinezumab's safety and efficacy in 586 randomized patients, although it missed its primary endpoint of time to confirmed motor progression [4][5] - Despite missing statistical significance, positive trends toward reduced motor progression were observed at 104 weeks, with expectations of sustained effects based on additional open-label extension data [5][6] - The ongoing PASADENA and PADOVA open-label studies are assessing the long-term safety and efficacy of prasinezumab in over 750 individuals with early-stage Parkinson's disease [3] Licensing and Financials - Roche holds exclusive rights to prasinezumab under a licensing agreement with Prothena (PRTA) established in December 2013, which includes paying double-digit teen royalties on net sales [7][9] - Prothena has earned $135 million to date, with potential for up to $620 million in additional milestone payments [9] Industry Context - Developing treatments for Parkinson's disease is challenging due to its chronic and progressive nature, with both motor and non-motor symptoms [10] - Other companies, such as UCB and Novartis, are also working on treatments, with UCB's recent investigational drug failing to meet clinical endpoints [11]

Core Insights - BioVie Inc. is hosting a virtual key opinion leader event to discuss the unmet needs and treatment landscape for Parkinson's disease on May 28, 2025 [1] - The event will provide updates on BioVie's Phase 2 trial (SUNRISE-PD) evaluating bezisterim (NE3107) for Parkinson's disease treatment [2] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and Long COVID [12] - The company's drug candidate, bezisterim, is designed to inhibit inflammatory activation and insulin resistance, which are key drivers of neurodegenerative diseases [12] Clinical Trials and Research - BioVie is currently enrolling patients for the Phase 2 SUNRISE-PD trial, which aims to evaluate bezisterim's safety and efficacy in patients recently diagnosed with Parkinson's disease [9] - Previous Phase 2 studies indicated significant improvements in motor control and "morning on" symptoms when bezisterim was combined with levodopa, with no drug-related adverse events reported [9] Key Opinion Leaders - The event will feature Dr. Suzanne de la Monte and Dr. Mark Stacy, both of whom have extensive backgrounds in neurology and Parkinson's disease research [4][5] - Dr. de la Monte has published over 300 peer-reviewed articles and is known for her research on brain insulin resistance and neurodegenerative disorders [4] - Dr. Stacy has also published extensively on Parkinson's disease and has held various leadership roles in related research centers [5] Parkinson's Disease Insights - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact patients' quality of life [6] - Chronic inflammation and insulin resistance are emerging as critical factors in the onset and progression of Parkinson's disease, highlighting the potential for anti-inflammatory and insulin-sensitizing therapies [7] Bezisterim Overview - Bezisterim is an orally bioavailable modulator that can cross the blood-brain barrier, targeting inflammation and insulin resistance without immunosuppression [8] - The drug has shown promise in treating not only Parkinson's disease but also Alzheimer's disease and neurological symptoms associated with Long COVID [8][10]

Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition, which is focused on developing a new class of drugs to alleviate cognitive symptoms associated with Parkinson's disease [6][2]. - The company is a Nordic life sciences investment firm that identifies and invests in breakthrough medical innovations, aiming to create and grow companies that advance these innovations into commercial products [7][8]. Research Grant Announcement - Umecrine Cognition has been awarded a research grant of USD 420,000 from The Michael J. Fox Foundation to finance preclinical studies evaluating the treatment effect of golexanolone in Parkinson's disease [1][5]. - The grant will support further studies to confirm golexanolone's effects on sleep dysfunction and cognitive impairments related to Parkinson's disease, as well as its impact on disease progression [2][5]. Parkinson's Disease Context - Parkinson's disease is characterized by progressive neurodegeneration, primarily affecting motor functions, but non-motor symptoms like sleep disorders and cognitive impairments often appear earlier and have been historically overlooked [4]. - Current treatments primarily target motor dysfunction, with no approved therapies available for non-motor symptoms, highlighting a significant medical need in this area [4][5].