2024年第三季度亮点报告

Catalyst Roundup: A Review of Select Catalysts fromLast Quarter’s Outlook Report Biomedtracker’s quarterly Outlook Reports detail important upcoming catalysts not to miss.Here’s a look at the outcome of two catalysts featured in the Q2 2024 Outlook Report. CATALYST OCCURRED:PDUFA for BLA - First Review DRUG: mRESVIA for Respiratory SyncytialVirus (RSV) Prevention May 31, 2024 Moderna, Inc. (MRNA) FDA DECISION The US Food and Drug Administration (FDA)has approved mRESVIA (mRNA-1345), an mRNArespiratory syncytial virus (RSV) vaccine, toprotect adults aged 60 years and older from lowerrespiratory tract disease caused by RSV infection. Moderna:"The FDA approval of our second product, mRESVIA,builds on the strength and versatilityof our mRNA platform. This approvalis also the first time an mRNAvaccine has been approved for adisease other than COVID-19. WithmRESVIA, we continue to deliver forpatients by addressing global publichealth threats related to infectiousdiseases." The FDA's approval of mRESVIA is based ondata from the Phase III clinical trial ConquerRSV, aglobal study conducted in approximately 37,000adults ages 60 years or older in 22 countries. Theprimary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lowerrespiratory tract disease (LRTD) of 83.7% (95.88%CI 66.0%, 92.2%). A follow-up analysis of theprimary endpoint was performed during FDAreview, including cases that started before theprimary analysis cut-off date. The results wereconsistent with the primary analysis [VE 78.7% (CI62.9%, 87.8%)] and were included in the USpackage insert. BIOMEDTRACKER ANALYSES MDNA: 5-DAY STOCK PERFORMANCE DRUG: CATALYST OCCURRED:PDUFA for BLA - First Review CAPVAXIVE for Pneumococcal Vaccines(Antibacterial)Merck & Co., Inc. (MRK) June 17, 2024 FDA DECISION The US Food and Drug Administration (FDA) hasapproved CAPVAXIVE (Pneumococcal 21-valentConjugate Vaccine) for active immunization forthe prevention of invasive disease caused byStreptococcus pneumoniae serotypes 3, 6A, 7F, 8,9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A,20A, 22F, 23A, 23B, 24F, 31, 33F and 35B inindividuals 18 years of age and older; and activeimmunization for the prevention of pneumoniacaused by S. pneumoniae serotypes 3, 6A, 7F, 8,9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A,22F, 23A, 23B, 24F, 31, 33F and 35B inindividuals 18 years of age and older. Merck:“Today’s approval is atestament to our population-specificstrategy behind CAPVAXIVE, whichdemonstrated robust immunogenicityin a range of adult populations and isdriven by a deep understanding ofpneumococcal disease. We are proudto provide CAPVAXIVE as a new optionspecifically designed to help protectagainst the majority of invasivepneumococcal disease-causingserotypes in adults." The approval follows the FDA’s Priority Review ofMerck’s application. This indication for theprevention of pneumonia caused by S.pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A,12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A,23B, 24F, 31, 33F and 35B is approved underaccelerated approval based on immune responsesas measured by opsonophagocytic activity (OPA).Continued approval for this indication may becontingent upon verification and description ofclinical benefit in a confirmatory trial. BIOMEDTRACKER ANALYSESApril 2024 Discover how you can accessBiomedtracker’sQ32024Outlook Report