Month: May 2025

Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission expected in Q2 2025 High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of April 10, 2025, data cutoff Program update on pivotal trial design, Rett syndrome natural history data analysis and clinical data from cohort two (high dose) and cohort...

WESTBROOK, Maine, May 15, 2025 (GLOBE NEWSWIRE) — Synergy CHC Corp. (NASDAQ: SNYR) (“Synergy” or the “Company”), a provider of consumer health care and lifestyle products, is announcing its financial results for the three months ended March 31, 2025. “We are very pleased to report 30% growth in earnings per share year-over-year, marking our ninth consecutive quarter of profitability,” said Jack Ross, CEO of Synergy. “Additionally, we expanded our EBITDA margins significantly to 24.1% compared to 19.7% in the prior year period. This performance highlights the strength of our operating model and our ongoing discipline around cost management.” “We continue to make meaningful progress toward our 2025 priorities, including preparing for international expansion into three new markets later this year for our FOCUSfactor brand and Ready-To-Drink...

Advancing development of novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat multiple cancer tumors Rounding out executive team with deep oncology experience by appointing new Head of Business Development – Oncology BOSTON and LONDON, May 15, 2025 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads for the treatment of cancer, today reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update. “We remain laser focused on becoming a key player in the ADC space and advancing our novel ADC platform built around immuno-oncology payloads and our lead asset AKTX-101, an ADC targeting Trop2 with our immuno-oncology payload, PH1. We continue to develop...