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Yahoo
4 days ago
- Business
- Yahoo
NeuroPace Secures Up to $75 Million in Debt Financing
MOUNTAIN VIEW, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that the Company has entered into a new $75 million credit facility with MidCap Financial, consisting of a $60 million term loan and a $15 million revolving credit facility. Proceeds from the new term loan were used to fully repay NeuroPace's term loan with CRG Partners IV, L.P., with proceeds of the new revolving credit facility available for working capital needs and other corporate purposes. 'We are pleased to partner with MidCap Financial on this new credit facility, which provides non-dilutive capital at favorable terms that reduce our cash interest expense and support the continued growth of our business,' said Joel Becker, Chief Executive Officer of NeuroPace. 'The proceeds and improved structure provide us the financial strength and flexibility to continue expanding patient access to the RNS® System and to invest in key growth initiatives, including site-of-service expansion, new indications, direct-to-consumer programs, new product development and real-world evidence generation. We also want to thank CRG for their partnership and support over the past several years. They have been an excellent partner in the Company's development.' The Company's new loan agreement includes a maturity date of five years for both the term loan and revolving credit facility. The annual interest rate is equal to SOFR subject to a floor of 2%, plus (1) 5.5% under the term loan and (2) 3.75% under the revolving loan. Armentum Partners served as financial advisor to NeuroPace on the transaction. Additional detail regarding the foregoing financing is set forth in NeuroPace's Current Report on Form 8-K, filed today with the U.S. Securities and Exchange Commission. About NeuroPace, Inc. Based in Mountain View, Calif., NeuroPace is a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders. About MidCap Financial MidCap Financial is a middle-market focused, specialty finance firm that provides senior debt solutions to companies across all industries. As of March 31, 2025, MidCap Financial provides administrative or other services for approximately $55 billion of commitments*. MidCap Financial is managed by Apollo Capital Management, L.P., a subsidiary of Apollo Global Management, Inc., pursuant to an investment management agreement. Apollo had assets under management of approximately $785 billion as of March 31, 2025, in credit, private equity and real assets funds. For more information about MidCap Financial, please visit For more information about Apollo, please visit *Including commitments managed by MidCap Financial Services Capital Management LLC, a registered investment adviser, as reported under Item 5.F on Part 1 of its Form ADV Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. NeuroPace may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: NeuroPace's expectations, forecasts and beliefs regarding the use of proceeds from the term loan and revolving credit facility with MidCap Financial. NeuroPace may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including those described more fully in the section titled 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and elsewhere in NeuroPace's public filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, as well as any other reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace's views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace. Investor Contact:Scott SchaperHead of Investor Relationssschaper@
Yahoo
6 days ago
- Business
- Yahoo
Rapport Therapeutics Hosts Investor and Analyst Day; Provides Corporate Updates
Phase 2a trial of RAP-219 in refractory focal epilepsy fully enrolled and on track for topline results in September 2025 BOSTON and SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) ('Rapport' or the 'Company'), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorders, today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy. The event's agenda also includes a fireside chat with key opinion leader and professor of Neurology at NYU Langone's Comprehensive Epilepsy Center, Jacqueline French, M.D., hosted by Rapport's Chief Medical Officer, Jeffrey Sevigny, M.D. A livestream of the event and presentation materials will be available starting at 2:45 p.m. Eastern Time (ET) today and can be accessed by visiting 'News & Events' in the Investors section of the Company's website: 'Our Phase 2a trial of RAP-219 in refractory focal epilepsy is now fully enrolled, and we remain on track to report topline results in September 2025,' said Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics. 'This will mark a major milestone for our lead program and an opportunity to demonstrate the strength of our precision neuroscience approach. We're excited to share additional details about the trial ahead of the readout and honored to be joined by Dr. French, principal investigator of our RAP-219 epilepsy trial, who will provide valuable expert insight on the trial design and unmet need in focal epilepsy. Today's event allows us to further underscore the potential of RAP-219 as a differentiated therapeutic with broad clinical and commercial potential.' Highlights of Rapport's Investor and Analyst Day event include the following: Phase 2a trial of RAP-219 in refractory focal epilepsy The Phase 2a trial of RAP-219 in refractory focal epilepsy is now fully enrolled. This proof-of-concept trial, designed with input from leading epilepsy experts, uses intracranial electroencephalography (iEEG) data from the RNS System to access RAP-219's potential effect on long episodes (LEs), an objective biomarker shown to correlate with clinical seizures (CSs). Enrolled patients' baseline characteristicsPreliminary baseline characteristics of the first 14 patients enrolled—those for whom baseline data are available—indicate that the trial population is representative of patients historically enrolled in registrational refractory focal epilepsy trials. Baseline Characteristics of First 14 Patients Enrolled Median(range) Median(1st to 4th quartile range) Age 37 (20-61) CS frequency per 28 days in 4-week prospective baseline 10 (4.25-18.25) Sex (n) 7F/7M LE frequency per 28 days in 12-week baseline (8-week retrospective + 4-week prospective) 51 (21-194) Age at first seizure 19 (0.5-31) Concordance between LEs and electrographic seizure (rated by an independent reviewer) 92% (71-96) Years since RNS implantation 4.4 (1.4-10.2) Concomitant antiseizure medications 3 Anticipated analysis of Phase 2a topline dataThe Company expects to provide the following data analysis when topline results are reported in September 2025: Primary endpoint analysis: Proportion of patients achieving ≥30% reduction in LEs compared with 12-week baseline period Median percent change in LE frequency compared with 12-week baseline period Key secondary endpoint analysis: Median percent change in CS frequency compared with 4-week prospective baseline Proportion of patients achieving ≥50% reduction in CSs compared with 4-week prospective baseline Treatment-emergent adverse event (TEAE) incidence and grade RAP-219 Phase 1 development update Consolidated Phase 1 safety summary As disclosed in January, a total of four Phase 1 trials have been conducted—a single ascending dose trial, two multiple ascending dose trials, and a multiple ascending dose human positron emission tomography (PET) trial. Across these trials, 100 healthy volunteers have been exposed to RAP-219. The Company's update includes data from the three completed Phase 1 multiple dose trials, including the PET trial from which final data were not available at the time of the Company's January disclosure. Final aggregate data (n=64) across the multiple dose trails continue to reinforce RAP-219's differentiated tolerability: All TEAEs were Grade 1 or 2 No serious adverse events (SAEs), nor clinically significant laboratory, vital signs, or electrocardiogram (ECG) abnormalities TEAEs occurred early in dosing and resolved without further action Most common TEAEs: headache (n=12), dry mouth (n=5), brain fog (n=5), and fatigue (n=5) Three discontinuations Upcoming catalysts September 2025: RAP-219 Phase 2a topline readout in focal epilepsy Q3 2025: Initiation of RAP-219 Phase 2a trial in bipolar mania 2H 2025: Update on the Company's diabetic peripheral neuropathic pain program 1H 2027: RAP-219 Phase 2a topline readout in bipolar mania Cash runway guidance As of March 31, 2025, Rapport reported $285.4 million in cash, cash equivalents, and short-term investments, excluding restricted cash. These funds are expected to support operations through the end of 2026. About RAP-219RAP-219 is a clinical-stage AMPA receptor (AMPAR) negative allosteric modulator (NAM) designed to achieve neuroanatomical specificity through its selective targeting of a receptor associated protein (RAP) known as TARPγ8, which is associated with neuronal AMPARs. Whereas AMPARs are distributed widely in the central nervous system, TARPγ8 is expressed only in discrete regions, including the hippocampus and neocortex, where focal seizures often originate. By contrast, TARPγ8 has minimal expression in the hindbrain, where drug effects are often associated with intolerable adverse events. With this precision approach, the Company believes RAP-219 has the potential to provide a differentiated profile as compared to traditional neuroscience medications. Due to the role of AMPA biology in various neurological disorders and the selective targeting of TARPγ8, the Company believes RAP-219 has pipeline-in-a-product potential and is evaluating the compound as a transformational treatment for patients with focal epilepsy, bipolar disorder, and peripheral neuropathic pain. Availability of Other Information About Rapport TherapeuticsRapport Therapeutics uses and intends to continue to use its Investor Relations website and LinkedIn (Rapport Therapeutics) as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website and LinkedIn, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts. The contents of the Company's website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. About Rapport TherapeuticsRapport Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing small molecule precision medicines for patients with neurological or psychiatric disorders. The Company's founders have made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain. Their findings form the basis of Rapport's RAP technology platform, which enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport's precision neuroscience pipeline includes the Company's lead investigational drug, RAP-219, designed to achieve neuroanatomical specificity through its selective targeting of a RAP expressed in only discrete regions of the brain. The Company is currently pursuing RAP-219 as a potential treatment for refractory focal epilepsy, bipolar mania and diabetic peripheral neuropathic pain. Additional preclinical and late-stage discovery stage programs are also underway, including targeting chronic pain and hearing disorders. Forward-Looking StatementsThis press release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of RAP-219 for the treatment of refractory focal epilepsy, bipolar mania and diabetic peripheral neuropathic pain, including the initiation, timing, progress and results of our ongoing and planned clinical trials; expectations for the activity, tolerability, and commercial potential of RAP-219; the potential of Rapport's RAP technology platform; and expectations for Rapport's uses of capital, expenses and financial results, including its cash runway through the end of 2026. Forward looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect Rapport's business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company's research and development activities; Rapport's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company's dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Rapport's ability to attract, integrate and retain key personnel; risks related to the Company's financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Rapport's intellectual property protections; and risks related to the competitive landscape for Rapport's product candidates; as well as other risks described in 'Risk Factors,' in the Company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Rapport's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Rapport's views only as of today and should not be relied upon as representing its views as of any subsequent date. Rapport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. ContactJulie DiCarloHead of Communications & IRRapport Therapeuticsjdicarlo@
Yahoo
6 days ago
- Business
- Yahoo
Rapport Therapeutics Hosts Investor and Analyst Day; Provides Corporate Updates
Phase 2a trial of RAP-219 in refractory focal epilepsy fully enrolled and on track for topline results in September 2025 BOSTON and SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) ('Rapport' or the 'Company'), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorders, today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy. The event's agenda also includes a fireside chat with key opinion leader and professor of Neurology at NYU Langone's Comprehensive Epilepsy Center, Jacqueline French, M.D., hosted by Rapport's Chief Medical Officer, Jeffrey Sevigny, M.D. A livestream of the event and presentation materials will be available starting at 2:45 p.m. Eastern Time (ET) today and can be accessed by visiting 'News & Events' in the Investors section of the Company's website: 'Our Phase 2a trial of RAP-219 in refractory focal epilepsy is now fully enrolled, and we remain on track to report topline results in September 2025,' said Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics. 'This will mark a major milestone for our lead program and an opportunity to demonstrate the strength of our precision neuroscience approach. We're excited to share additional details about the trial ahead of the readout and honored to be joined by Dr. French, principal investigator of our RAP-219 epilepsy trial, who will provide valuable expert insight on the trial design and unmet need in focal epilepsy. Today's event allows us to further underscore the potential of RAP-219 as a differentiated therapeutic with broad clinical and commercial potential.' Highlights of Rapport's Investor and Analyst Day event include the following: Phase 2a trial of RAP-219 in refractory focal epilepsy The Phase 2a trial of RAP-219 in refractory focal epilepsy is now fully enrolled. This proof-of-concept trial, designed with input from leading epilepsy experts, uses intracranial electroencephalography (iEEG) data from the RNS System to access RAP-219's potential effect on long episodes (LEs), an objective biomarker shown to correlate with clinical seizures (CSs). Enrolled patients' baseline characteristicsPreliminary baseline characteristics of the first 14 patients enrolled—those for whom baseline data are available—indicate that the trial population is representative of patients historically enrolled in registrational refractory focal epilepsy trials. Baseline Characteristics of First 14 Patients Enrolled Median(range) Median(1st to 4th quartile range) Age 37 (20-61) CS frequency per 28 days in 4-week prospective baseline 10 (4.25-18.25) Sex (n) 7F/7M LE frequency per 28 days in 12-week baseline (8-week retrospective + 4-week prospective) 51 (21-194) Age at first seizure 19 (0.5-31) Concordance between LEs and electrographic seizure (rated by an independent reviewer) 92% (71-96) Years since RNS implantation 4.4 (1.4-10.2) Concomitant antiseizure medications 3 Anticipated analysis of Phase 2a topline dataThe Company expects to provide the following data analysis when topline results are reported in September 2025: Primary endpoint analysis: Proportion of patients achieving ≥30% reduction in LEs compared with 12-week baseline period Median percent change in LE frequency compared with 12-week baseline period Key secondary endpoint analysis: Median percent change in CS frequency compared with 4-week prospective baseline Proportion of patients achieving ≥50% reduction in CSs compared with 4-week prospective baseline Treatment-emergent adverse event (TEAE) incidence and grade RAP-219 Phase 1 development update Consolidated Phase 1 safety summary As disclosed in January, a total of four Phase 1 trials have been conducted—a single ascending dose trial, two multiple ascending dose trials, and a multiple ascending dose human positron emission tomography (PET) trial. Across these trials, 100 healthy volunteers have been exposed to RAP-219. The Company's update includes data from the three completed Phase 1 multiple dose trials, including the PET trial from which final data were not available at the time of the Company's January disclosure. Final aggregate data (n=64) across the multiple dose trails continue to reinforce RAP-219's differentiated tolerability: All TEAEs were Grade 1 or 2 No serious adverse events (SAEs), nor clinically significant laboratory, vital signs, or electrocardiogram (ECG) abnormalities TEAEs occurred early in dosing and resolved without further action Most common TEAEs: headache (n=12), dry mouth (n=5), brain fog (n=5), and fatigue (n=5) Three discontinuations Upcoming catalysts September 2025: RAP-219 Phase 2a topline readout in focal epilepsy Q3 2025: Initiation of RAP-219 Phase 2a trial in bipolar mania 2H 2025: Update on the Company's diabetic peripheral neuropathic pain program 1H 2027: RAP-219 Phase 2a topline readout in bipolar mania Cash runway guidance As of March 31, 2025, Rapport reported $285.4 million in cash, cash equivalents, and short-term investments, excluding restricted cash. These funds are expected to support operations through the end of 2026. About RAP-219RAP-219 is a clinical-stage AMPA receptor (AMPAR) negative allosteric modulator (NAM) designed to achieve neuroanatomical specificity through its selective targeting of a receptor associated protein (RAP) known as TARPγ8, which is associated with neuronal AMPARs. Whereas AMPARs are distributed widely in the central nervous system, TARPγ8 is expressed only in discrete regions, including the hippocampus and neocortex, where focal seizures often originate. By contrast, TARPγ8 has minimal expression in the hindbrain, where drug effects are often associated with intolerable adverse events. With this precision approach, the Company believes RAP-219 has the potential to provide a differentiated profile as compared to traditional neuroscience medications. Due to the role of AMPA biology in various neurological disorders and the selective targeting of TARPγ8, the Company believes RAP-219 has pipeline-in-a-product potential and is evaluating the compound as a transformational treatment for patients with focal epilepsy, bipolar disorder, and peripheral neuropathic pain. Availability of Other Information About Rapport TherapeuticsRapport Therapeutics uses and intends to continue to use its Investor Relations website and LinkedIn (Rapport Therapeutics) as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website and LinkedIn, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts. The contents of the Company's website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. About Rapport TherapeuticsRapport Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing small molecule precision medicines for patients with neurological or psychiatric disorders. The Company's founders have made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain. Their findings form the basis of Rapport's RAP technology platform, which enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport's precision neuroscience pipeline includes the Company's lead investigational drug, RAP-219, designed to achieve neuroanatomical specificity through its selective targeting of a RAP expressed in only discrete regions of the brain. The Company is currently pursuing RAP-219 as a potential treatment for refractory focal epilepsy, bipolar mania and diabetic peripheral neuropathic pain. Additional preclinical and late-stage discovery stage programs are also underway, including targeting chronic pain and hearing disorders. Forward-Looking StatementsThis press release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of RAP-219 for the treatment of refractory focal epilepsy, bipolar mania and diabetic peripheral neuropathic pain, including the initiation, timing, progress and results of our ongoing and planned clinical trials; expectations for the activity, tolerability, and commercial potential of RAP-219; the potential of Rapport's RAP technology platform; and expectations for Rapport's uses of capital, expenses and financial results, including its cash runway through the end of 2026. Forward looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect Rapport's business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company's research and development activities; Rapport's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company's dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Rapport's ability to attract, integrate and retain key personnel; risks related to the Company's financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Rapport's intellectual property protections; and risks related to the competitive landscape for Rapport's product candidates; as well as other risks described in 'Risk Factors,' in the Company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Rapport's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Rapport's views only as of today and should not be relied upon as representing its views as of any subsequent date. Rapport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. ContactJulie DiCarloHead of Communications & IRRapport Therapeuticsjdicarlo@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
Why Is NeuroPace Stock Falling After Epilepsy Treatment Study Data?
NeuroPace, Inc. (NASDAQ:NPCE) released preliminary primary endpoint one-year results of the two-year NAUTILUS study evaluating safety and effectiveness of the RNS System for drug-resistant idiopathic generalized epilepsy (IGE). The study met its primary 12-week post-implant safety endpoint, demonstrating a low rate of serious adverse events related to the device and implant procedure. The study did not reach statistical significance for the primary effectiveness endpoint in the overall study population, which was to show a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation the data did show a clinically meaningful and statistically significant response in the primary effectiveness endpoint within a subgroup of patients with lower baseline frequency of generalized tonic-clonic seizures, representing most trial participants. Additionally, the company said that within the entire trial population, clinically relevant data, including median percent seizure reduction, responder rates, and improvement in seizure-free days, showed numerically robust and clinically meaningful improvements over the first year of treatment and continued in those who have progressed to the second year. The company will engage with the FDA to discuss regulatory pathways based on the data. These discussions may include the possibility of utilizing the overall median seizure reduction data across the full study population and pursuing a more targeted indication focused on patients with lower baseline seizure frequency who may represent a majority of IGE patients. In April, NeuroPaces terminated its distribution relationship for SEEG products and will begin winding down the relationship in the fourth quarter of 2025 and continuing through the first quarter of 2026. NeuroPace announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS System in April. The data showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy and seizure freedom, with 42% of patients remaining seizure-free for 6+ months. Sales grew 24% to $22.5 million in the first quarter of 2025. RNS System revenue grew 29%, excluding revenue from implants in the NAUTILUS study in the first quarter of 2024. Increased sales of the RNS System primarily drove the company's revenue growth. The company also continued to generate meaningful revenue from sales of SEEG products. NeuroPace raised the fiscal year 2025 sales guidance from $92 million-$96 million to $93 million-$97 million compared to the consensus of $93.64 million. Price Action: NPCE stock is down 33.90% at $11.68 at the last check Tuesday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Why Is NeuroPace Stock Falling After Epilepsy Treatment Study Data? originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
Associated Press
04-03-2025
- Business
- Associated Press
UPDATE – NeuroPace to Present at the Leerink Partners Global Healthcare Conference
MOUNTAIN VIEW, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that its management team will present at the Leerink Partners 2025 Global Healthcare Conference at 4:20pm ET (1:20pm PT) on Monday, March 10, 2025, in Miami, FL. Management will also host investor meetings during the conference. The presentation will be accessible via live webcast here. A webcast replay will be available for two weeks following the presentation in the Events section of NeuroPace's Investor website at About NeuroPace, Inc. Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders. Investor Contact: Jeremy Feffer Managing Director
