Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Delta International Services & Logistics, Everlywell, Horiba Medical, Thermo Fisher Scientific, Vax-Immune Diagnostics.
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Electrocore, Front Line Medical Technologies, Insightec, Luminostics, Saladax, Shockwave Medical, Smart Medical.
Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine.
COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson.
