Dermata (DRMA) gains on positive FDA response for the further development of DMT310 for treating severe to moderate acne.
VYNE gains on positive preclinical data evaluating VYN201 for treating idiopathic pulmonary fibrosis.
Madrigal Pharmaceuticals (MDGL) gains on receiving Breakthrough Therapy designation from the FDA for resmetirom.
Gamida Cell's (GMDA) shares surge as it receives FDA approval for Omisirge, an allogeneic cell therapy for blood cancer patients.
Humanigen's (HGEN) shares surge after presenting promising early results of its Precision Approach to Chronic Myelomonocytic Leukemia study of lenzilumab in chronic myelomonocytic leukemia.
Alvotech's shares decline as it receives a complete response letter for biosimilar candidate, AVT02, treating autoimmune disorders.
Regulus (RGLS) surges as it completes enrollment in the first cohort to evaluate RGLS8429 for kidney disease.
Panbela (PBLA) surges as it enrolls the first patient in the mid-stage clinical study to evaluate CPP-1X-T (Eflornithine tablets) for treating recent-onset type 1 diabetes.
Regulatory and pipeline updates from Moderna (MRNA) and KALA are the key highlights for the biotech sector.
KALA gets Fast Track Designation from the FDA for lead candidate KPI-012 to treat persistent corneal epithelial defects.