Core Insights - Design Therapeutics has announced the nomination of DT-818 as a development candidate for the treatment of Myotonic Dystrophy Type-1 (DM1), highlighting its potential as a best-in-disease treatment due to its ability to selectively reduce transcription of the mutant DMPK gene [2][5] - The company has obtained ex-US regulatory clearance to initiate clinical development of DT-818, with plans to begin a Phase 1 multiple-ascending dose trial in Australia in the first half of 2026 [5] - Ongoing trials for DT-216P2 in Friedreich Ataxia (FA) and DT-168 in Fuchs Endothelial Corneal Dystrophy (FECD) are progressing, with data readouts anticipated in the second half of 2026 [2][5] Corporate Highlights - The appointment of Justin Gover to the Board of Directors, who has over 25 years of experience in the biotechnology industry, including leadership at GW Pharmaceuticals [5] - The company reported a net loss of $17.0 million for the third quarter of 2025, with research and development expenses of $14.6 million and general and administrative expenses of $4.7 million [5][11] Financial Overview - As of September 30, 2025, Design Therapeutics had cash, cash equivalents, and investment securities totaling $206.0 million, supporting continued pipeline advancement [6][12] - The total operating expenses for the third quarter of 2025 were $19.3 million, compared to $16.2 million in the same quarter of the previous year [11] Pipeline Development - DT-818 has shown a greater than 90% reduction in toxic RNA foci in DM1 patient cells during preclinical studies, indicating its potential effectiveness [5] - The ongoing RESTORE-FA Phase 1/2 trial for DT-216P2 is expected to report data on frataxin expression levels in the second half of 2026 [5] - A Phase 2 biomarker trial for DT-168 is also ongoing, with data anticipated in the second half of 2026 [5]

Novo Nordisk A/S ( NVO ) has once again lowered its 2025 outlook . That marks the fourth forecast cut this year as the stock continues to slowly decline. Shares are down 42% year to date. It seemsI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigor and chall ...

Novo Nordisk A/S ( NVO ) has once again lowered its 2025 outlook . That marks the fourth forecast cut this year as the stock continues to slowly decline. Shares are down 42% year to date. It seemsI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigor and chall ...

Core Viewpoint - Tempus AI, Inc. reported strong third-quarter FY25 earnings, leading to a reiterated Buy rating from BTIG analyst Mark Massaro with a price target of $96, despite current selling pressure on the stock [1]. Earnings Details - Tempus AI reported revenue of $334.21 million, exceeding analyst estimates of $328.73 million, representing an 84.7% year-over-year increase [2]. - The adjusted loss per share was 11 cents, better than the estimated loss of 17 cents [2]. - For FY25, the company raised its revenue guidance to $1.265 billion from a previous estimate of $1.260 billion [2]. Analyst View - The analyst anticipates that Tempus will secure additional pharmaceutical contracts for its data and services business [3]. - There is an expectation for average selling prices (ASPs) to increase due to a shift towards higher-priced tests, such as the xT CDx priced at $4,500 per test (up from $2,900 for xT LDT) and the xF liquid biopsy assay at $3,288 per test (up from $2,919) [3]. - Expansion of commercial payor coverage for xF and xT CDx is expected, along with continued development of Tempus's algorithm business [3]. Market Positioning - Tempus is positioned at the intersection of key trends including precision medicine, oncology (including liquid biopsies), AI and machine learning, and the shift towards personalized drug development and companion diagnostics for pharmaceutical companies [4]. - As of the publication date, Tempus shares were down 2.74% at $82.18 [4].

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Taipei, Taiwan, Nov. 05, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (NasdaqGM: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced its support for the global commercialization of OkaiDx™, a research‑use‑only (RUO) blood test for post‑treatment breast cancer monitoring now available through the Company’s affiliate EG Biomed US Inc. (“EG BioMed”)’s CLIA/CAP‑certified laboratory in the United States. ...

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] - The company will host a conference call on November 13, 2025, to discuss its Q3 2025 financial results and business highlights [1][2] Company Overview - BioAtla operates in San Diego, California, and has a partnership with BioDuro-Sundia in Beijing for preclinical development services [3] - The company utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3] - BioAtla holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3]

Core Viewpoint - MediWound Ltd. is set to release its financial results for the third quarter of 2025 on November 20, 2025, and will host a conference call to discuss these results and provide a corporate update [1][2]. Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved product, NexoBrid, is used for the enzymatic removal of eschar in thermal burns and is marketed in multiple regions including the U.S., European Union, and Japan [3]. - The company is also advancing EscharEx, a late-stage investigational therapy aimed at the debridement of chronic wounds, which has shown clinical advantages over existing products and targets a significant global market opportunity [3].

Group 1 - The biotech firm Bio-Techne missed its first-quarter revenue estimates [1] - The company faced challenges due to sluggish demand for its products [1] - The soft biotech funding environment in China negatively impacted the company's performance [1]

Core Insights - Celcuity Inc. is set to release its financial results for Q3 2025 on November 12, 2025, after market close, followed by a webcast and teleconference at 4:30 p.m. Eastern Time [1] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity's clinical trials include: - VIKTORIA-1: A Phase 3 trial evaluating gedatolisib with fulvestrant in HR+/HER2- ABC, which has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - VIKTORIA-2: A Phase 3 trial currently enrolling patients, assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC [3] - CELC-G-201: A Phase 1/2 trial ongoing, evaluating gedatolisib with darolutamide in metastatic castration-resistant prostate cancer patients [3]