Pepgen Inc. fell slightly short of its phase II dystrophin goal with PGN-EDO51 for patients with Duchenne muscular dystrophy (DMD) whose mutations are amenable to an exon 51-skipping approach, but Wall Street reacted in a big way, sending the Boston-based firm’s stock (NASDAQ:PEPG) down 33%, or $5.55, to close July 31 at $11.43.
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
SK Bioscience Co. Ltd. signed a simple agreement for a future equity (SAFE) deal totaling $2 million with Hingham, Mass.-based Sunflower Therapeutics PBC on July 25 to secure both Sunflower’s equity and its yeast-based protein manufacturing technology. The conditional agreement will grant SK Bioscience future equity rights in Sunflower without the need for immediate valuation, allowing for minimal investment.
Sunbird Bio Inc.’s Neural EV-tau aggregate assay demonstrated 92% correlation with PET scans in identifying individuals with Alzheimer’s disease, a study presented at the Alzheimer’s Association International Conference in Philadelphia, on July 30 found.
The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
Succeeding where others have failed in an indication with high unmet need, Celldex Therapeutics Inc. disclosed top-line data from the phase II trial with barzolvolimab (barzo) against two common forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).
Phase II data showing an 11.1-month improvement in overall survival for advanced ovarian cancer patients treated with the IL-12 immunotherapy IMNN-001 drove up shares of Imunon Inc. by 181% July 30. The results “could usher in the first immune-based therapy for ovarian cancer,” said Stacy Lindborg, president and CEO of the Lawrenceville, N.J.-based company.