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BridgeBio Pharma (BBIO) Earnings Call Presentation
2025-06-19 13:29
Corporate Presentation April 29th, 2025 Forward Looking Statements and Disclaimer The presentation contains forward-looking statements. Statements made or presented may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential," "should," " ...
Pulmonx (LUNG) Earnings Call Presentation
2025-06-19 13:28
NASDAQ: LUNG February 2025 © 2025 Pulmonx Corporation 1 Forward Looking Statement This presentation and certain statements made during this presentation contain forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business ...
Coherent Introduces Class-Leading Disposable Surgical Fiber Assemblies for Laser Lithotripsy and Advanced Medical Applications
Globenewswire· 2025-06-18 20:40
SAXONBURG, Pa., June 18, 2025 (GLOBE NEWSWIRE) -- Coherent Corp. (NYSE: COHR), a global leader in photonics, today announced the launch of its new line of disposable surgical fiber assemblies designed specifically for a wide range of precision medical applications. The new product line is suitable for both OEM integration and for direct clinical use. Engineered to meet the rigorous demands of modern surgical environments, the new fiber assemblies deliver exceptional optical performance, robust durability, a ...
Orchestra BioMed Showcases AVIM Therapy as Purpose-Built Solution for Hypertensive Heart Disease at CSI Frankfurt 2025
Globenewswire· 2025-06-18 13:30
Core Insights - Orchestra BioMed Holdings, Inc. presented key clinical insights on AVIM therapy for high-risk hypertension at the CSI 2025 Meeting, emphasizing its potential to address hypertensive heart disease, a significant cardiovascular syndrome affecting an aging population [1][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through risk-reward sharing partnerships with leading medical device companies [5] - The company’s lead product candidate is AVIM therapy, designed for hypertension, which is a leading risk factor for mortality worldwide [5][8] AVIM Therapy Insights - AVIM therapy is a novel, device-based approach specifically targeting patients with hypertensive heart disease, who are at increased risk for major adverse cardiac events and currently lack sufficient therapeutic options [2][3] - The therapy aims to reduce cardiac preload and modulate autonomic nervous system responses to lower blood pressure and improve cardiovascular function, representing a potential paradigm shift in blood pressure management [3][4] Clinical Data and Studies - Pilot studies have shown that AVIM therapy resulted in net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [10] - The BACKBEAT global pivotal study is currently enrolling patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker, in collaboration with Medtronic [7][10] Market Opportunity - Hypertensive heart disease affects over 7.7 million patients in the U.S., highlighting a significant market opportunity for AVIM therapy, especially given its recent FDA Breakthrough Device Designation [6][10]
Outlook Therapeutics to Participate in a Virtual Investor Lunch Break Event
Globenewswire· 2025-06-18 13:05
Core Insights - Outlook Therapeutics, Inc. is participating in a Virtual Investor Lunch Break Event on June 25, 2025, at 12:00 PM ET [1] - Key executives will discuss the company's commercial strategy, upcoming milestones, and current activities during the event [2] - A live video webcast will be available on the company's website, with a replay accessible for 90 days [3] Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD [4] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK [4] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [5] - If approved, it would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5]
AMGEN'S PHASE 2 MARITIDE DATA TO BE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS
Prnewswire· 2025-06-18 13:00
Core Insights - Amgen is presenting full results from the Phase 2 study of MariTide, a peptide-antibody conjugate for obesity and Type 2 diabetes, at the 85th American Diabetes Association Scientific Sessions [1][2] - The company is also sharing new data from the Phase 3 FOURIER study of Repatha® in cardiovascular disease [1] - MariTide shows promising 52-week efficacy, safety, and tolerability data, indicating robust weight loss without a plateau in patients with obesity [3][9] Company Overview - Amgen is focused on innovative medicines for serious diseases, with a strong pipeline that includes treatments for obesity and cardiovascular conditions [20][22] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [23] Product Information - MariTide is a bispecific GLP-1 receptor agonist and GIPR antagonist, designed to provide a dual mechanism of action for weight loss and diabetes management [9] - Repatha® is a monoclonal antibody that lowers LDL cholesterol by inhibiting PCSK9, with extensive clinical trial data supporting its efficacy [13][14] Industry Context - The prevalence of obesity has more than doubled globally from 1990 to 2022, with significant health implications including increased risk for Type 2 diabetes and cardiovascular diseases [7][8] - Despite the recognition of obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. receive pharmacologic treatment for weight management [8]
Lexicon to Present Data at the 85th Scientific Sessions of the American Diabetes Association (ADA)
Globenewswire· 2025-06-18 12:30
Core Insights - Lexicon Pharmaceuticals is set to present data on sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients at the 85th Scientific Sessions of the American Diabetes Association on June 22, 2025 [1][3] - The company will also present topline data from the PROGRESS Phase 2b study on pilavapadin (LX9211) for diabetic peripheral neuropathic pain during the same event [1][3] Sotagliflozin Presentation - The presentation titled "Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function" will take place on June 22, 2025, from 4:00-4:15 p.m. CT [3] - Clinical efficacy data for sotagliflozin will be segmented by kidney function subgroups based on Estimated Glomerular Filtration Rate (eGFR) [2] PROGRESS Study Overview - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe diabetic peripheral neuropathic pain [6] - The study is placebo-controlled, focusing on changes in pain levels over an 8-week period with various dosages of pilavapadin [6][7] About Sotagliflozin - Sotagliflozin is an oral inhibitor targeting SGLT2 and SGLT1 proteins, which are involved in glucose regulation [5] - The drug has been studied in approximately 20,000 patients across various conditions, including heart failure and chronic kidney disease [5] About Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes affecting around 9 million patients in the U.S., causing symptoms like burning pain and numbness [8]
Stonegate Capital Partners Initiates Coverage on Cingulate Inc. (CING)
Newsfile· 2025-06-18 12:00
Stonegate Capital Partners Initiates Coverage on Cingulate Inc. (CING)June 18, 2025 8:00 AM EDT | Source: Reportable, Inc. Dallas, Texas--(Newsfile Corp. - June 18, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners initiates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 1Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on leveraging its proprietary Precision Timed Relea ...
Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML
Globenewswire· 2025-06-18 11:30
Core Viewpoint - Moleculin Biotech is advancing Annamycin, a drug designed to eliminate cardiotoxicity associated with anthracyclines, which are used to treat approximately 60% of children with cancer [1][2] Group 1: Pediatric Study and FDA Interaction - The FDA has recommended including patients as young as 6 months in the pediatric clinical study of Annamycin, which is a younger age than initially proposed by Moleculin [1][2] - The pediatric study will evaluate Annamycin in combination with Cytarabine as a second-line therapy for pediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML) [1][2] - Moleculin plans to submit an updated Initial Pediatric Study Plan (iPSP) to the FDA later this quarter, with the pediatric clinical study expected to start in the second half of 2027 [3] Group 2: Clinical Trials and Data - The ongoing Phase 3 MIRACLE trial is evaluating Annamycin in combination with Cytarabine for adult patients with R/R AML, with initial data readout anticipated in the second half of 2025 [1][4] - An independent review of study data has shown no cardiotoxicity in 84 adult patients treated with Annamycin, reinforcing its potential for pediatric use [2][6] - The FDA has granted Annamycin Fast Track Status and Orphan Drug Designation for treating R/R AML and soft tissue sarcoma [4] Group 3: Company Overview and Pipeline - Moleculin Biotech is a late-stage pharmaceutical company focused on developing therapies for hard-to-treat cancers and viral infections [5] - Annamycin, also known as naxtarubicin, is designed to avoid multidrug resistance mechanisms and eliminate cardiotoxicity common with existing anthracyclines [5][6] - The company is also developing other therapeutic candidates, including WP1066 for various cancers and WP1122 for pathogenic viruses [8]
Axsome Therapeutics to Present Data Spanning the SYMBRAVO® (meloxicam and rizatriptan) Clinical Program at the 67th Annual Scientific Meeting of the American Headache Society (AHS)
Globenewswire· 2025-06-18 11:00
NEW YORK, June 18, 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 that data from across the SYMBRAVO® (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota. Details for the presentations are as follows: Title: Efficacy of SYMBRA ...