Latest news with #2025AnnualMeeting
Business Upturn
21 hours ago
- Business
- Business Upturn
COSCIENS Biopharma Inc. Reconstitutes Board for Benefit of Shareholders
Reconstituted Board to Revitalize COSCIENS TORONTO, May 30, 2025 (GLOBE NEWSWIRE) — COSCIENS Biopharma Inc. (NASDAQ: CSCI; TSX: CSCI) today announced that it has entered into a resolution agreement (the 'Resolution Agreement') with Goodwood Inc., Goodwood Fund and Puccetti Funds Management Inc. (collectively, 'Goodwood') to resolve matters relating to the upcoming annual and special meeting of COSCIENS' shareholders that had been scheduled to be held on June 26, 2025 (the '2025 Annual Meeting'). Pursuant to the Resolution Agreement, COSCIENS has today implemented a consensual reconstitution of its board of directors designed to best position COSCIENS to create value for all its shareholders. As a result of that reconstitution, COSCIENS' board of directors now consists of the following six directors: Anthony J. Giovinazzo, Ulrich Kosciessa, Ronald W. Miller, Peter H. Puccetti, Robert A. Seager and David Spear (the 'Reconstituted Board'). To facilitate the timely dissemination of COSCIENS' management information circular for the 2025 Annual Meeting, the meeting date has been postponed for several days and the 2025 Annual Meeting will now occur on June 30, 2025. At the 2025 Annual Meeting, COSCIENS will nominate for re-election as directors the six individuals who are now serving on the Reconstituted Board (and no other nominees). Goodwood has agreed that it will vote all of the 257,257 common shares of COSCIENS, or approximately 8.2% of COSCIENS' outstanding common shares, beneficially owned, or controlled or directed, directly or indirectly, by Goodwood in favour of the re-election of these six directors at the 2025 Annual Meeting. COSCIENS expects to disseminate its management information circular for the 2025 Annual Meeting within the next week. The Reconstituted Board is committed to ensuring that COSCIENS benefits from strong corporate governance and effective board oversight and doing what is in the best interests of COSCIENS and all of its shareholders. As part of that, the Reconstituted Board intends to actively review COSCIENS' prospects and opportunities, and to take the actions necessary to best position COSCIENS to create value for shareholders. Mr. Puccetti has been appointed as Chair of the Reconstituted Board. The Audit Committee now consists of Mr. Spear (Committee Chair), Mr. Kosciessa and Mr. Puccetti. The Human Resources, Nominating and Governance Committee now consists of Mr. Seager (Committee Chair), Mr. Miller and Mr. Giovinazzo. COSCIENS thanks each of its outgoing directors for their service to COSCIENS and acknowledges the contributions they have made to position COSCIENS for success. Details regarding each of the directors of COSCIENS now comprising the Reconstituted Board, each of whom will be nominated for re-election at the 2025 Annual Meeting, are set forth below: Anthony J. Giovinazzo Anthony Giovinazzo has over 45 years of executive experience and is an internationally recognized expert in intellectual property, drug development and commercialization, including numerous licensing agreements, with more than 25 years experience in Central Nervous System diseases. From 2009 until 2017, Mr. Giovinazzo served as the President and Chief Executive Officer of NASDAQ-listed Cynapsus Therapeutics Inc., a specialty pharmaceutical company that developed the first successful sublingual apomorphine thin film strip for Parkinson's disease. The drug was approved for commercialisation by the United States Food and Drug Administration in 2020. Mr. Giovinazzo was a co-inventor of the drug, built Cynapsus' leadership team, and was instrumental in its strategy including its over-subscribed IPO and NASDAQ listing. Mr. Giovinazzo became a director of Cynapsus in 2012. During Mr. Giovinazzo's tenure, Cynapsus attracted the top tier of institutional and venture capital funds in the United States. Mr. Giovinazzo led the negotiations with several pharmaceutical companies that resulted in the Cdn. $841 million all-cash acquisition of Cynapsus by Sunovion Pharmaceuticals (Dainippon Sumitomo Pharmaceuticals) in 2021 (at a 120% premium to Cynapsus' closing price on the day of announcement). From April 2006 to November 2009, Mr. Giovinazzo served as the Chief Executive Officer of Cervelo Pharmaceuticals Inc., a biopharmaceutical company. From 2002 to 2006, he served as Chief Executive Officer of Cita NeuroPharmaceuticals Inc., a biopharmaceutical company. Mr. Giovinazzo is currently a director of TSXV-listed Conavi Medical Inc., a commercial stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. He is also currently the Chair of the Board of TSXV-listed Xortx Therapeutics Inc., a Phase 3 kidney and NDA pending Gout disease company. In 2014, Mr. Giovinazzo was a Canadian finalist in Life Sciences for the E&Y Entrepreneur of the Year. In 2017, he was the recipient of the Finance Monthly Game Changers award as well as the inaugural recipient of the Bloom Burton Award, which honors the best of the best in Canadian Life Sciences as judged by a panel of US experts. Mr. Giovinazzo has completed the Leadership and Strategy in Pharmaceuticals and Biotech from Harvard Business School. Mr. Giovinazzo also holds a Masters of Business Administration from IMD, Geneva Switzerland, a Graduate Certificate Studies in Canadian Law from Osgoode Hall Law School at York University, and a Bachelor of Arts in Economics and Accounting from McMaster University. Ulrich Kosciessa Dr. Kosciessa currently serves as the Chief Executive Officer of Germany-based Photonamic GmbH & Co. KG and as the Chief Operating Officer of Tokyo-based SBI Pharmaceuticals Co. LTD. He has worked for 20 years for Medac GmbH, a global pharmaceutical company with operations in 70 countries where he served as a member of the Executive Management Board, as Managing Director of Medac International and as Chairman of the Board of Medac Pharma Inc., a U.S.-based subsidiary of Medac GmbH focused on specialty pharmaceuticals for autoimmune diseases and cancer. Throughout his career at Medac, Dr. Kosciessa has formed several subsidiaries and affiliates as well as established a network of global partners, growing the Company's international business more than 50% since 2005. In addition, since 2006 Dr. Kosciessa has also served as Chief Executive Officer of Photonamic, a subsidiary of Medac GmbH focused on research and development of photodynamic therapy and diagnostics. He has successfully developed two Photonamic products currently marketed in Europe, North America, South America, the Asian Pacific region and Australia. From 2006 to 2008, Dr. Kosciessa served as Chief Executive Officer at Immune Laboratory of Hannover, a research-based organization focused on autologous dendritic cell-based tumor vaccines. Prior to joining Medac GmbH, Dr. Kosciessa was a postdoctoral researcher at the neuroscience/neurodegenerative diseases division of Schering AG, a multinational pharmaceutical company. He received a in Biology and a Ph.D. in Molecular Biology from Georg-August University of Göttingen, Germany. Ronald W. Miller Ronnie Miller was President and CEO of Hoffmann-La Roche Limited (Roche Canada) for 22 years (until 2022). In this role, he was responsible for the growth and success of the Canadian Pharmaceuticals Division, particularly as it relates to Roche's mandate of developing and delivering innovative healthcare solutions for Canadians. Ronnie has more than 43 years of extensive and varied experience in the pharmaceutical industry. Born in Scotland, Mr. Miller completed his Bachelor of Science in Economics and Geography at the University of Glasgow, then moved to Leeds, England to accept a job as a pharmaceutical sales representative. Mr. Miller advanced through a series of successive sales and management positions across the industry to become the National Sales Manager for Roche in the United Kingdom in 1988 and continued to move globally as a Product Manager in Switzerland and Deputy Divisional Director of the Pharmaceutical Division in Japan. He moved back to Switzerland to head up a global product launch before returning to the UK as Pharmaceuticals Director. Mr. Miller was appointed President and CEO of Roche Pharmaceuticals in Canada in May 2000 and became a Canadian citizen in 2008. Mr. Miller was re-elected as Chairman of the Board of Directors of Innovative Medicines Canada (IMC), the national association representing Canada's research-based pharmaceutical companies, from 2019 to 2022. He served as Chairman of the IMC Board in 2007 and has since fulfilled two subsequent terms as Past Chair. Prior to this, Mr. Miller was the Chair of the IMC Prairies Core Team and sat as Co-Chair of the Health Research Foundation. He also served on several committees including the IMC Public Affairs, Stakeholder Relations, the British Columbia Sub-Committee, and was Chair of the Federal Affairs/FPT Relations Standing Committee. Peter H. Puccetti Peter Puccetti is the founder, Chairman and Chief Investment Officer of Goodwood Inc., a Canadian independent investment management firm that has provided institutional and high-net-worth clients with alternative investment strategies for over 28 years. Mr. Puccetti has managed the flagship Goodwood Fund since its inception, and has over 30 years of investment experience with a focus on special situations value investing. Mr. Puccetti has served on a number of public and private boards of directors. Mr. Puccetti and Goodwood Inc. have become well-known in Canada for leading a variety of activist campaigns to implement positive change and unlock shareholder value with the trust and support of many of Canada's top institutional investment organizations. Prior to founding Goodwood Inc., Mr. Puccetti was an analyst, investment banker and partner of Sprott Securities Limited. Mr. Puccetti holds a Bachelor of Arts in Economics from Dalhousie University. Mr. Puccetti is also a CFA Charterholder. Robert A. Seager Robert Seager is a leading special situations advisor and has been centrally involved in directing high profile shareholder disputes, proxy contests, M&A transactions, special committee mandates, internal and independent corporate investigations and complex restructurings. Mr. Seager is a trusted strategic advisor to institutional and other significant stakeholders, boards of directors and executive management teams with respect to corporate governance matters involving both public and private companies, including providing guidance through crisis situations and critical opportunities. Mr. Seager is a Partner of Voorheis & Co. LLP and Executive Vice President, Seacombe Partners Inc. In 2023, Mr. Seager was appointed to the Securities Advisory Committee of the Ontario Securities Commission (OSC). This committee, comprised of leading securities practitioners and other industry experts, plays a crucial role in advising the OSC and its staff on a variety of matters including policy initiatives and capital markets trends. Prior to joining Voorheis & Co. LLP in 2017, Mr. Seager practiced securities law at Blake, Cassels & Graydon LLP, and completed a secondment with the Office of M&A at the OSC. Mr. Seager received his J.D. from the Schulich School of Law at Dalhousie University with a specialization in corporate law, his International Business Law Certification from the Global Law Program at the Bader International Study Centre, and his Bachelor of Commerce from the Sauder School of Business at the University of British Columbia. Rob has also completed Levels 1 and II of the CFA Program. David Spear David Spear is an accomplished entrepreneur and executive with more than 35 years of experience in the healthcare industry, with a particular focus on the eyecare sector. Mr. Spear is currently the President and Chief Strategy Officer of Advancing Eyecare, a partnership of leaders in the eyecare instrumentation marketplace established to offer the best products and service solutions in the ophthalmic equipment industry. Mr. Spear previously served as a director of Innova Medical Ophthalmics, a supplier to the Canadian ophthalmic community that he co-founded in 1987. Mr. Spear also previously served as a director of Advancing Eyecare from 2017 to 2023. Throughout his career, Mr. Spear has played a pivotal role in launching and leading multiple ventures within the ophthalmic and medical device industries. His entrepreneurial journey includes co-founding and managing S4OPTIK LLC, Blue.S4 Precision Manufacturing, Innovative Excimer Solutions, and S4OPTIK S.A. de C.V. in Mexico. Mr. Spear holds a Bachelor of Commerce from the University of Windsor and a Bachelor of Science in Biology from Western University. A copy of the Resolution Agreement will be made available on COSCIENS' profile on SEDAR+ at in due course. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements. All statements contained in this filing that are not clearly historical in nature or that necessarily depend on future events are forward-looking, and the words 'intends,' 'expects,' and similar expressions are generally intended to identify forward-looking statements. These statements are based on current expectations of COSCIENS and Goodwood and currently available information. They are not guarantees of future performance, involve certain risks and uncertainties that are difficult to predict, and are based upon assumptions as to future events that may not prove to be accurate. Neither COSCIENS nor Goodwood assume any obligation to update any forward-looking statements contained in this press release, except as required by applicable law. For further information contact: Peter H. PuccettiChairman of the BoardCOSCIENS Biopharma Inc. Tel: 416-203-2722 Email: [email protected]
Yahoo
3 days ago
- Business
- Yahoo
Neurocrine Biosciences, Inc. (NBIX)'s M4 Agonist Shows Promise in Schizophrenia Phase 2 Trial, Phase 3 Launched
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has announced promising results from its Phase 2 trial of NBI-1117568, a first-in-class investigational oral muscarinic M4 selective agonist for schizophrenia. Presented at the American Society of Clinical Psychopharmacology 2025 Annual Meeting, the study showed that a 20 mg once-daily dose significantly improved schizophrenia symptoms, achieving a 7.5-point greater reduction on the Positive and Negative Syndrome Scale (PANSS) than placebo at six weeks. Improvements were also seen on the Clinical Global Impression of Severity (CGI-S) scale as early as Week 2, with continued benefit through Week 6. A scientist studying the effects of neurotrophic factors on neuronal survival. NBI-1117568 was generally safe and well tolerated, with somnolence and dizziness as the most common side effects and no significant weight gain or clinically meaningful cardiovascular events. Discontinuation rates due to adverse events were similar to placebo. Higher doses showed greater mean improvements but did not reach statistical significance. These results have prompted Neurocrine Biosciences, Inc. (NASDAQ:NBIX) to launch a global Phase 3 trial to further evaluate the drug's efficacy and safety in adults with acute schizophrenia symptoms. NBI-1117568's novel mechanism offers hope for a more targeted and tolerable treatment option for patients. While we acknowledge the potential of NBIX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than NBIX and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error 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
Business Wire
3 days ago
- Business
- Business Wire
ASCO 2025: XOFIGO ® (radium-223 dichloride) Combination Data Showcases Clinical Benefits in Metastatic Castration-Resistant Prostate Cancer with Bone Metastases
WHIPPANY, N.J.--(BUSINESS WIRE)--New data from two clinical trials evaluating XOFIGO ® (radium-223 dichloride) in patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting on June 3, 2025. The studies in prostate cancer treatment with XOFIGO, offer potential new insights for patients with mCRPC with bone metastases. XOFIGO is indicated for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease. 1 It is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA). An analysis from the pivotal Phase III PEACE III trial, evaluating XOFIGO in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), showed that adding six cycles of XOFIGO to enzalutamide improved prostate-specific antigen (PSA) and alkaline phosphatase (ALP) response rates. 2 Notably, PSA response rates ≥90% at 6 and 12 months were 50.5% and 54.9%, respectively, in the combination arm compared to 34.1% and 37.6%, respectively, in the enzalutamide arm alone. 2 The analysis also showed that for XOFIGO in combination with enzalutamide the median time to ALP normalization was 1.97 months compared to 4.47 months in the enzalutamide arm (HR 1.42; 95% CI, 1.13-1.80). 2 The analysis follows the presentation of the full results from the PEACE III trial, presented as a late-breaking abstract during the Presidential Symposium at ESMO 2024. 3 The results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) among patients with mCRPC with bone metastases, with a 31% reduction in the risk of progression or death (HR 0.69; 95% CI, 0.54-0.87; p=0.0009) compared to enzalutamide alone. 3 At the preplanned interim analysis conducted at 80% of the overall survival (OS) events, the hazard ratio (HR) for OS was 0.69 (95% CI 0.52-0.90; p=0.0031). The safety results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures. 3 The trial was a collaboration between the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG). The results were consistent with the established safety profile of XOFIGO. Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 65.6% of patients in the combination arm compared to 55.8% of patients who received enzalutamide alone. 2 The most frequent Grade 3 or higher TEAEs in the combination arm were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%) and neutropenia (5%). 2 Fractures (either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without BPA use) were reported in 24.3% of patients in the combination arm and in 13.4% of patients in the enzalutamide arm. 2 "The PEACE III trial has provided us with valuable insights into the benefits of combining XOFIGO with enzalutamide for patients with metastatic castration-resistant prostate cancer with bone metastases," said Dr. Murilo Luz, Urologic Oncologist, The Mount Sinai Hospital, New York and trial investigator. "This analysis highlights that the combination therapy achieved improvements on PSA and ALP, beyond the known radiographic progression free survival benefit. We are encouraged by these results with this potential compelling therapeutic option, which could provide an additional treatment option for patients." Data from the Phase II COMRADE trial were also presented at the ASCO 2025 Annual Meeting. Results demonstrated that the combination of olaparib with XOFIGO significantly improved radiographic progression-free survival (rPFS) in mCRPC patients compared to XOFIGO alone, with a median of 8.6 months versus 4.0 months (HR 0.51; 80% CI, 0.37-0.70; 2-sided p=0.005). 4 56% of patients in the olaparib with XOFIGO and 35% of patients in the XOFIGO arms had grade ≥3 treatment-related adverse events, the most common adverse events on the olaparib with XOFIGO and XOFIGO arms were anemia (22.0%/18.0%), lymphocyte decrease (30.5%/9.1%), platelet decrease (6.8%/3.6%), and neutrophil decrease (5.1%/7.3%), respectively. 4 "The results from the PEACE III and COMRADE trials underscore our dedication to exploring combinations, such as XOFIGO with enzalutamide or olaparib. We are hopeful these results will introduce another treatment option for patients with mCRPC and bone metastases who have not progressed viscerally,' said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. About PEACE III (EORTC GUCG-1333) The PEACE III trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. This trial was a collaboration with several cancer cooperative groups: EORTC, CTI, CUOG, LACOG, and GETUG. About COMRADE II COMRADE is an open-label, randomized Phase II investigator-initiated trial in patients with metastatic castration resistant prostate cancer with bone metastases treated with a combination of olaparib, a PARP inhibitor, and XOFIGO compared to XOFIGO alone, 120 patients were randomized 1:1 to receive either olaparib plus XOFIGO or XOFIGO alone. The primary endpoint was radiographic progression-free survival (rPFS). About XOFIGO ® (radium-223 dichloride) Injection 1 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Important Safety Information for Xofigo ® (radium-223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitantchemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the full Prescribing Information for Xofigo (radium 223 dichloride). About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References XOFIGO ® (radium-223) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019. Choudhury A, et al. PSA and alkaline phosphatase changes in the EORTC-1333 PEACE-3 study evaluating the addition of six cycles of radium 223 in metastatic castration-resistant prostate cancer (mCRPC) starting enzalutamide. Abstract 5062. Presented at ASCO 2025. Gillessen S, et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. European Society of Medical Oncology 2025 (ESMO) LBA1. September 9, 2024. McKay RR, et al. A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis. Abstract 5007. Presented at ASCO 2025.
Medscape
3 days ago
- Health
- Medscape
Full Ablation Making a Comeback in Energy-Based Medicine
ORLANDO, Fla. — For years, fully ablative laser skin resurfacing — in which the epidermis is removed using carbon dioxide or erbium lasers — fell out of favor among energy-based medicine specialists and their patients because of long recovery times and the need for general anesthesia. Fractional ablative laser resurfacing, a less invasive procedure that makes tiny holes in the epidermis and leaves surrounding skin intact, became more popular, along with nonablative collagen-stimulating treatments. But at The American Society for Laser Medicine and Surgery (ASLMS) 2025 Annual Meeting, held from April 24 to 26, several presenters spoke about a 'resurgence' of the full ablation approach. They cited two reasons: First, results from fractional treatments have not been as dramatic or durable as hoped for, especially in older patients, and second, newer laser technologies are allowing for ablation to be performed without general anesthesia and with healing times closer to those seen with less-invasive treatments. Echoing many of his colleagues at the conference, Oculofacial Surgeon Brian Biesman, MD, of Vanderbilt University, who is in private practice in Nashville, Tennessee, said that in recent years he has returned to performing fully ablative procedures after having given them a rest. 'The moment for me was when I saw a patient who I knew I had seen several years before,' Biesman said in an interview. 'I didn't remember what [procedure] I had done, and I thought she needed laser resurfacing. I opened her chart and realized that I had done fractional ablative resurfacing on her 3 years before. That was when I decided that for what we put people through, they need to have a better result than this 3 years later. I decided to get back to more aggressive approaches.' Dermatologic Surgeon Thomas Rohrer, MD, who is in private practice in Chestnut Hill, Massachusetts, said in an interview that to treat deeper lines, especially in certain parts of the face, 'we're coming to a consensus that we need that more aggressive treatment. That's why you're seeing a lot of talks this year about fully ablative devices. But with that comes the risks associated with it and the downtime.' Ablative Therapy With Less Pain and Shorter Recovery While ablative procedures using time-tested technologies — CO2 and erbium lasers — are also making a comeback, Rohrer and other specialists pointed to a newer device that they described as a game changer: The UltraClear 2910 nm cold ablative fractional laser, cleared by the US Food and Drug Administration in 2022 to treat photoaging, wrinkles, and acne scars, which has since seen its indications expanded to include some types of pigmented lesions. The device can be used on fractional ablative or fully ablative settings. It does not heat tissue the way traditional ablative lasers do. This results in reduced pain and shorter recovery time, and offers additional protection against hypo- and hyper-pigmentation, a key concern with darker skin types. The 2910 nm laser 'has really revitalized our resurfacing practice in patients aged 50 to 80,' said Paul Friedman, MD, who is in private practice in Houston, 'because of the patient comfort and the quicker recovery process,' which can be as little as a week compared with a month or more for other technologies. Ablative procedures with the 2910 nm laser usually require only 'topical anesthesia and occasional nitrous oxide,' Friedman said at the meeting. 'Prior to this technology, with our traditional resurfacing modalities, we found it more efficient to bring in an anesthesiologist. But obviously there is hesitance from patients about this.' Suzanne Kilmer, MD, a dermatologist at the University of California, Davis, California, who is also in private practice in Sacramento, California, and a widely recognized expert on full ablation, said that she was still getting to know the device. She has yet to use the 2910 nm laser for a fully ablative procedure, she said, sticking to its fractional settings. 'I use it in conjunction with the traditional erbium and CO2 lasers,' Kilmer said in an interview, adding that she is fine with going slow for now. 'There always is a learning curve with devices,' she cautioned. 'And you're learning on risky procedures.' Preventing and Mitigating Complications Full ablation 'is a great procedure — there's nothing else like it,' Kilmer continued. But unlike with fractional treatments, it also means that 'you've taken off the whole top of the skin. There's a huge open wound. You've completely disrupted the dermal-epidermal junction.' During different seminars at the conference, experts offered strategies for avoiding treatment-related complications, including hypo- and hyper-pigmentation, scarring, and infections. They spoke about selecting the patients who are likely to comply with demanding aftercare protocols, highlighting how they rescued cases in which patients did not. And they shared horror stories of patients who went kayaking 3 days after ablative treatment, accidentally vomited on their wounds, who developed severe erythema or scarring, or developed serious infections despite the use of antiviral and antibiotic prophylaxis. With some of these complications, practitioners acknowledged that there is little consensus on how they should be managed. Jacqueline Watchmaker, MD, a dermatologist in private practice in Scottsdale, Arizona, reviewed the case of a patient who developed a severe bacterial infection following ablation because of noncompliance with aftercare recommendations. It is important to know how soon infections are likely to appear, Watchmaker said, and to be aware of signs — especially pain that increases over days. It's also important to select patients carefully for their likelihood of complying, she added. Other presenters discussed ways to improve compliance, such as by making video tutorials. Dermatologist Arisa Ortiz, MD, director of Laser and Cosmetic Dermatology, at UC San Diego Health, San Diego, and the past president of ASLMS, warned that even with antibiotic and antiviral prophylaxis, patients can develop breakthrough infections requiring emergency treatment. The right type of antibiotic prophylaxis remains controversial in fully ablative resurfacing, she noted. Any apparent infections should be cultured before treating them and systemic infections, requiring hospital treatment, can occur. Biesman, in his comments, agreed that antibiotic prophylaxis remains a controversial topic with ablative resurfacing. 'The argument from infectious disease is that you don't need antibiotic prophylaxis,' he told the conference, but in practice it is standard. And while many clinicians use cefalexin, which does not prevent infections from methicillin-resistant Staphylococcus aureus , or MRSA, 'you really need to think about MRSA coverage' when prescribing an antibiotic, he said.
Hamilton Spectator
3 days ago
- Health
- Hamilton Spectator
Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona. Details of the presentations are as follows: AUVELITY Title: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY®) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations Lead Author: Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the University of Virginia Presentation Date and Time: Wednesday, May 28, 11:15 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session I Poster Number: W25 AXS-05 Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized-Withdrawal Double-Blind Placebo-Controlled Study Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T16 Solriamfetol Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at Witten/Herdecke University, Germany Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T15 About AUVELITY® AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of AUVELITY in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if AUVELITY is safe and effective for use in children. AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? AUVELITY and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: Do not take AUVELITY if you: AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY. Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. Symptoms may include: Unusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). AUVELITY may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. AUVELITY may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: COMMON SIDE EFFECTS The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating. These are not all the possible side effects of AUVELITY. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . BEFORE USING Tell your HCP about all your medical conditions, including if you: Review the list below with your HCP. AUVELITY may not be right for you if: HOW TO TAKE LEARN MORE For more information about AUVELITY, call 866-496-2976 or visit . This summary provides basic information about AUVELITY but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about AUVELITY and how to take it. Your HCP is the best person to help you decide if AUVELITY is right for you. AUV CON BS 10/2022 Please see full Prescribing Information , including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide . About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ('NDA') for any of the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@ Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@
