Sangamo Therapeutics, Inc. (SGMO) saw its stock surge by over 33% after the FDA granted an accelerated pathway for its potential gene therapy, ST-920, for the treatment of Fabry disease. This approval allows Sangamo to skip an additional study, potentially accelerating the drug’s approval by three years. Positive safety and efficacy data from an ongoing study, showing improved kidney function, fuel optimism for ST-920’s potential to address renal complications associated with Fabry disease.
Avadel Pharmaceuticals’ Lumryz, a once-at-bedtime extended-release sodium oxybate, has received FDA approval for treating cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy. This expansion in the drug’s indication signifies a significant step forward in pediatric narcolepsy treatment, offering a convenient, single-dose option that aligns with the needs of young patients. The approval is anticipated to drive sales for Avadel, bolstering the company’s position within the narcolepsy treatment market.
The FDA has approved AbbVie’s Vyalev, the first 24-hour subcutaneous infusion of levodopa-based therapy for Parkinson’s disease. This groundbreaking treatment offers hope for patients struggling with motor fluctuations and could significantly improve their quality of life. The article also explores the implications of this approval on AbbVie’s stock price and provides insights into its potential future trajectory.
Baxter International is ramping up recovery efforts at its North Cove facility, which was severely damaged by Hurricane Helene. Over 1,000 employees have returned to work, and the company expects 3,000 people to be involved in recovery by this week. Baxter is prioritizing deep cleaning and equipment assessment, with the first temporary bridge already enabling the transportation of over 350 truckloads of finished products. The FDA has also approved temporary imports from international facilities to alleviate product shortages.
The FDA has approved Exact Sciences Corp.’s Cologuard Plus test, a next-generation stool DNA test for colorectal cancer (CRC) screening in adults aged 45 and older. This approval is based on the BLUE-C study, demonstrating superior performance compared to its predecessor, Cologuard, and other fecal immunochemical tests. Cologuard Plus will be available in 2025, supported by ExactNexus technology and anticipated Medicare coverage.
SciSparc Ltd. (SPRC), a pharmaceutical company specializing in cannabinoid-based treatments, has received FDA approval to proceed with a Phase IIb clinical trial for its Tourette Syndrome (TS) medication, SCI-110. The trial will evaluate the drug’s efficacy, safety, and tolerability in adults, building upon promising results from earlier studies.
Establishment Labs Holdings Inc. (ESTA) shares surged in pre-market trading after receiving FDA approval for Motiva Implants. Other notable movers include Fangdd Network Group Ltd. (DUO), Onconetix, Inc. (ONCO), and The Real Good Food Company, Inc. (RGF). Volato Group, Inc. (SOAR), enVVeno Medical Corporation (NVNO), and Momentus Inc. (MNTS) were among the top decliners.
The FDA has approved FluMist, a nasal spray flu vaccine, for at-home use, offering a convenient and accessible option for individuals ages 18 to 49. This approval expands on the existing use of FluMist for children and adolescents ages 2 to 17, allowing their caregivers to administer the spray. The move comes after clinical trials demonstrated the safety and effectiveness of self-administering the vaccine, making flu protection more accessible for a wider population.
Capricor Therapeutics Inc (CAPR) stock surged on Tuesday after the company announced its intention to file a biologics license application (BLA) with the FDA for full approval of Deramiocel, a potential treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. This move follows positive discussions with the FDA and builds on promising results from previous clinical trials.
Karuna Therapeutics’ experimental drug, KarXT, is poised to receive FDA approval this month, potentially revolutionizing schizophrenia treatment. This innovative drug could offer relief for millions of Americans battling the debilitating disorder, marking the first significant breakthrough in over 70 years. However, concerns remain about accessibility due to high potential costs and systemic issues in the U.S. healthcare system.
