SAB BIO Announces Founding of Clinical Advisory Board to Guide the Development of SAB-142 for Type 1 Diabetes
Newsfilter· 2024-08-05 19:30
MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (NASDAQ:SABS) (the "Company" or "SAB"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced the founding of a clinical advisory board to provide expert insight and guidance to the Company in the clinical development of SAB-142, its leading therapeutic candidate. The newly formed bo ...
Rezolute Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism
Newsfilter· 2024-08-05 19:30
Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its ...
TG Therapeutics to Host Conference Call on Second Quarter 2024 Financial Results and Business Update
Newsfilter· 2024-08-05 19:30
NEW YORK, Aug. 05, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held, Tuesday August 6, 2024 at 8:30 AM ET to discuss results for the second quarter of 2024 and provide a business outlook for 2024. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter Earnin ...
Generac Strengthens Microgrid and Energy Storage Solutions with Acquisition of Ageto
Prnewswire· 2024-08-05 19:30
文章核心观点 - 通用电力系统(Generac Power Systems)收购了Ageto,这是一家领先的微网控制器提供商,可以无缝集成、优化和管理商业和工业(C&I)市场中的分布式常规资源、可再生能源资源和电动车(EV)充电器[1] - 此次收购增强了Generac为国内C&I客户提供完整能源技术生态系统的能力,通过将Ageto的行业领先的微网控制器和先进软件集成到Generac的系统中,简化了资产集成、控制和优化,为Generac创造了竞争优势[2] - Generac自2021年起就与Ageto合作,将其微网控制器纳入Generac的电池能源储存系统(BESS)解决方案和发电机组[3] Ageto公司概况 - Ageto的微网控制器可以帮助用户从一个简单的界面协调、优化和监控他们微网的所有组件[4] - 将Ageto的软件解决方案与Generac的BESS和微网多资产系统相结合,提供了站点级的系统集成和控制,而不仅仅是硬件[4] Generac公司概况 - Generac Power Systems是一家领先的能源技术公司,为家庭和商业应用提供备用和主电源产品以及能源储存系统,同时还提供能源监测和管理设备及服务,以及其他电力产品[5] - Generac于1959年成立,首次推出了负担得起的备用发电机,随后创造了自动家用备用发电机类别[5] - 该公司一直在扩展其能源技术产品,致力于引领向更有弹性、更高效和更可持续的能源解决方案的演变[5]
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
Newsfilter· 2024-08-05 19:30
Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product. PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in the psilocybin treatment group. NEW YORK and MELBOURNE, Austra ...
MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT)
Newsfilter· 2024-08-05 19:30
YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated t ...
Sotera Health Reports Second-Quarter and First-Half 2024 Results
Newsfilter· 2024-08-05 19:00
公司概况 - 公司是一家全球领先的关键终端到端消毒解决方案、实验室检测和咨询服务提供商,通过Sterigenics、Nordion和Nelson Labs三大业务部门为医疗行业提供服务 [2] - 公司致力于"维护全球健康"的使命 [29] 财务表现 - 2024年第二季度收入为2.77亿美元,同比增长8.3% [3] - 2024年第二季度净利润为900万美元,每股摊薄收益为0.03美元,而2023年同期为2400万美元,每股0.08美元 [3] - 2024年第二季度调整后EBITDA为1.37亿美元,同比增长6.9% [3] - 2024年第二季度调整后每股收益为0.19美元,较2023年同期的0.20美元下降0.01美元 [3] 业务表现 - Sterigenics业务2024年第二季度收入为1.76亿美元,同比增长5.9%;分部利润为9700万美元,同比增长5.8% [6] - Nordion业务2024年第二季度收入为4100万美元,同比增长29%;分部利润为2300万美元,同比增长31.7% [9] - Nelson Labs业务2024年第二季度收入为5900万美元,同比增长4%;分部利润为1700万美元,同比下降11% [11] 财务状况 - 截至2024年6月30日,公司总债务为23亿美元,现金及现金等价物为2.46亿美元 [14] - 2024年5月30日,公司完成债务再融资,将到期日延长至2031年 [15] 2024年展望 - 公司维持此前提供的2024年展望:收入和调整后EBITDA增长4%-6% [16] - 预计利息费用为1.65-1.75亿美元,调整后净收益率为31.5%-34.5%,调整后每股收益为0.67-0.75美元 [16]
BioCryst Reports Second Quarter 2024 Financial Results and Provides Business Update
Newsfilter· 2024-08-05 19:00
—Q2 2024 ORLADEYO net revenue grows 34 percent y-o-y to $108.3 million— —Full-year 2024 ORLADEYO revenue guidance increased to $420-$435 million (previously $390-$400 million)— —Company generates GAAP operating profit of $8.8 million in second quarter ($21.9 million non-GAAP operating profit)— —Pipeline continues to advance— RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today reported financial results for the second quarter ended June 30, 2024, ...
InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment
Newsfilter· 2024-08-05 19:00
CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard caro ...
Breckenridge Brewery Opens New Location in Fort Collins, Colorado
Newsfilter· 2024-08-05 19:00
FORT COLLINS, Colo., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Breckenridge Brewery, a Colorado-based craft brewer with over 30 years of experience brewing approachable, well-balanced beers, announces the opening of its new brewery location in Fort Collins. With doors opening in early August 2024, the new 10,000- square-foot Breckenridge Brewery offers a full restaurant experience and a new vibrant atmosphere in the heart of Fort Collins for all to enjoy. The new location will be a full-service restaurant, upholdin ...