DUBLIN, June 2, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a fireside chat presentation at the Goldman Sachs 46th Annual Global Healthcare Conference on Monday, June 9, 2025 at 10:00 a.m. EDT (3:00 p.m. BST). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.About Alkermes plcAlkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neurosc ...

Core Viewpoint - Rapport Therapeutics is advancing its Phase 2a trial of RAP-219 in refractory focal epilepsy, which is fully enrolled and expected to report topline results in September 2025, marking a significant milestone for the company and its precision neuroscience approach [3][4][10] Group 1: Clinical Trial Updates - The Phase 2a trial of RAP-219 is designed with input from leading epilepsy experts and utilizes intracranial electroencephalography (iEEG) data to assess the drug's potential effect on long episodes (LEs), a biomarker correlated with clinical seizures (CSs) [4] - Preliminary baseline characteristics of the first 14 enrolled patients indicate that the trial population is representative of historical registrational refractory focal epilepsy trials, with a median age of 37 years and a balanced sex distribution of 7 females and 7 males [5][6] - The company anticipates providing detailed analyses of primary and secondary endpoints, treatment-emergent adverse events (TEAEs), and a consolidated safety summary from Phase 1 trials when topline results are reported [9][12] Group 2: Financial and Operational Insights - As of March 31, 2025, Rapport reported $285.4 million in cash, cash equivalents, and short-term investments, which are expected to support operations through the end of 2026 [10] - The company has conducted four Phase 1 trials involving 100 healthy volunteers, reinforcing RAP-219's differentiated tolerability profile [9][10] Group 3: Future Catalysts - Upcoming milestones include the topline readout for RAP-219 in focal epilepsy in September 2025, initiation of a Phase 2a trial in bipolar mania in Q3 2025, and updates on the diabetic peripheral neuropathic pain program in the second half of 2025 [13]

Reviva Pharmaceuticals Holdings (RVPH) Update / Briefing June 02, 2025 08:00 AM ET Speaker0 As a reminder, this call is being recorded, and a replay will be made available on the Reviva website following the conclusion of the event. I'd now like to turn the call over to doctor Lax Bhatt, founder, president, and chief executive officer of Reviva Pharmaceuticals. Please go ahead, Lax. Speaker1 Thank you, Tara. So good morning, everyone. My name is Lax Bart. I am the founder, president, and CEO of Reviva Pharm ...

– Multiple Subgroup Analyses Presented From Long-Term Safety Study of LYBALVI® (olanzapine and samidorphan), Including Data on Lipid and Glycemic Profiles –DUBLIN, June 2, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of accepted research at key scientific conferences this spring, including presentations largely related to its psychiatry products LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil). Several of these meetings coincided with Mental He ...

Summary of Reviva Pharmaceuticals Holdings (RVPH) Conference Call Company Overview - **Company**: Reviva Pharmaceuticals Holdings (RVPH) - **Industry**: Pharmaceuticals, specifically focused on neuropsychiatric disorders - **Key Product**: Duloxazine, currently in phase three development for schizophrenia Core Points and Arguments 1. **Pipeline Development**: Reviva is developing next-generation therapies for neuro dysfunction, with Duloxazine being the most advanced molecule aimed at treating schizophrenia and potentially other psychiatric conditions such as bipolar disorder, major depressive disorder, and ADHD [4][5] 2. **Market Potential**: The indications targeted by Reviva represent a multibillion-dollar market, with over 24 million people suffering from schizophrenia globally, and around 4 million in the US alone [7][8] 3. **Unmet Needs**: Approximately 30% of schizophrenia patients do not respond to current treatments, highlighting the need for better options that address negative symptoms and treatment adherence [8][10] 4. **Efficacy and Safety**: Duloxazine has shown a 12-16% discontinuation rate in trials, significantly lower than the 30-70% seen with existing antipsychotics, indicating better treatment adherence [12][26] 5. **Neuroinflammation**: The drug also targets neuroinflammation, which is a significant factor in disease progression and comorbidities in psychiatric patients [9][21] 6. **Phase Three Data**: The pivotal phase three study involved 411 patients and demonstrated a statistically significant outcome with a 10-point separation from placebo, indicating robust efficacy [14][15] 7. **Negative Symptoms**: Duloxazine showed a 2-point separation in negative symptoms, a chronic condition that is difficult to treat, with only a few existing drugs demonstrating significant outcomes [17][20] 8. **Biomarkers**: The use of digital biomarkers, such as speech patterns, has confirmed the drug's efficacy in patients with severe negative symptoms [19][24] 9. **Safety Profile**: The safety profile of Duloxazine is comparable to placebo, with minimal motor side effects and manageable weight gain, which is often a concern with antipsychotics [26][27] 10. **Future Development**: Reviva plans to initiate a second phase three study (RECOVER 2) to further support the NDA submission, expected by the end of next year [34][43] Additional Important Content - **Mechanism of Action**: Duloxazine directly modulates dopamine and serotonin receptors, addressing both behavioral symptoms and inflammatory cascades, which differentiates it from existing treatments [39][40] - **Long-term Efficacy**: Data from long-term studies indicate sustained efficacy and safety, with dropout rates significantly lower than those of other antipsychotics [31][32] - **Regulatory Pathway**: The company is on track to meet the requirements for NDA submission, having completed necessary trials and safety studies [42][43] This summary encapsulates the key points discussed during the conference call, highlighting Reviva Pharmaceuticals' strategic focus on addressing significant unmet needs in the treatment of schizophrenia and related disorders.

NeurAxis (NRXS) 2025 Conference May 29, 2025 09:30 AM ET Speaker0 Hello, everyone, and thank you all for joining us during the Lithium Partners Spring twenty twenty five Investor Conference. Our next presentation is from Neuraxis. My name is Ben Shamsian, vice president of Lithium Partners. And today, we welcome Brian Karako, CEO, who'll be taking us through a slide presentation followed by a q and a discussion afterwards. Neuraxis trades under the ticker NRXS. Now let's get started. Brian, welcome, and I'l ...

Company Overview - CVRx, Inc. is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Recent Developments - CVRx management will present at the William Blair 45 Annual Growth Stock Conference on June 4, 2025, at 10:00 am Central Time via webcast [1] - A live audio webcast of the conference presentation will be accessible on the investor relations page of the company's website [2] Regulatory Approvals - Barostim has received FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. [3] - The device has also obtained the CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

Core Insights - NeuroPace announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System for idiopathic generalized epilepsy (IGE), marking a significant milestone in neuromodulation therapy [1][2] - The trial's strong enrollment and retention rates position NeuroPace to expand its therapeutic reach and enhance its clinical value proposition, supporting potential FDA submission [2][4] Company Performance - Following the announcement, NeuroPace's shares fell by 28.4%, closing at $12.66, although the stock has gained 13.1% year-to-date compared to the industry's 11.2% decline [3] - The company currently has a market capitalization of $579.9 million and expects earnings to improve by 6.5% in 2025 year-over-year [5] NAUTILUS Trial Details - The NAUTILUS trial is a pivotal Phase 3 study assessing the safety and effectiveness of the RNS System in patients aged 12 and older with drug-resistant seizures, with 87 patients enrolled across 23 centers [6][8] - The trial met its primary safety endpoint, reporting a low incidence of serious adverse events, while a subgroup with lower baseline seizure frequency showed significant therapeutic benefits [9][10] Clinical Outcomes - The one-year data from the trial demonstrated consistent clinical improvements, including a robust median seizure reduction and increased responder rates, with improvements continuing into the second year [10]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

CARMEL, Ind., May 27, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2025 Investor Conference, taking place virtually on Thursday, May 29, 2025. Company Webcast The webcast presentation will take place at 9 ...