Stealth BioTherapeutics Inc. (the „Company“ or „Stealth“), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced completion of the mid-cycle review meeting with the U.S. Food and Drug Administration („FDA“) regarding its New Drug Application („NDA“) for elamipretide for the treatment of Barth syndrome. If approved, elamipretide would be the first therapy for Barth syndrome, an ultra-rare, progressive, life-shortening, cardioskeletal disease that affects approximately 150 individuals in the United States. The FDA has confirmed its intent to hold an advisory committee meeting, which the Company expects will occur this fall. The NDA for elamipretide was granted priority review and has been assigned a Prescription Drug User Fee Act („PDUFA“) action date of January 29, 2025.

According to the CDC, breastfeeding provides many health benefits for both babies and mothers. Despite federal and professional guidelines that recommend exclusive breastfeeding for the first six months of an infant’s life, 60% of mothers do not breastfeed as long as they intend to. Key takeaways from the 2024 State of Breastfeeding Survey include: 52% of parents identified finding places to pump or nurse on the go as their top breastfeeding challenge, closely followed by 47% citing insufficient time for nursing/pumping breaks 43% of parents remain unaware or unclear about the PUMP Act and its legal requirements for workplace lactation support One in three parents lack reliable access to a dedicated lactation space at work, despite federal laws aimed at improving workplace accommodationsOne in three parents feel that public places are not adequately supportive or inclusive of breastfeeding needs

Anixa Biosciences, Inc. („Anixa“ or the „Company“) (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced a presentation on its ovarian cancer CAR-T therapy clinical trial at the International Gynecologic Cancer Society (IGCS) 2024 Annual Global Meeting being held October 16-18, 2024, in Dublin, Ireland.