- The US Food and Drug Administration (FDA) has granted Mersana Therapeutics’ company Fast Track Designation. MRSN Lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple negative breast cancer (TNBC). Mersana shares traded up 1.79 percent in a range of $7.48 to $7.94 on daily volume of 1.34 million shares and closed the regular trading session at $7.48. The company’s shares traded at $7.40, down 1.07 percent in the after-hours trading session.
- The U.S. Food and Drug Administration (FDA) has accepted the filing of Acadia Pharmaceuticals’ application. ACAD New Drug Application (NDA) of Trofinetide for the Treatment of Rett Syndrome. The regulator has granted priority review and set the PDUFA action date for March 12, 2023. ACADIA shares traded up 4.95 percent in a range of $17.33 to $18.24 on daily volume of 1.35 million shares, closing regular trading session at $17.91.
- BioLineRx BLRX has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product candidate Motixafortide for stem cell mobilization (SCM) for autologous bone marrow transplantation in patients with multiple myeloma. BioLineRx shares traded up just 1.65 percent in a range of $1.63 to $1.79 on daily volume of 387,020 shares and closed the regular trading session at $1.64.
- AVITA Medical RCEL Announces Positive Top-Line Results from a Pivotal Study Evaluating the Safety and Efficacy of the RECELL System for Repigmentation of Stable Vitiligo Lesions. Avita shares traded in a range of $6.20 to $6.43 on daily volume of 73.73 thousand shares, ending the regular trading session at $6.20. The company’s shares traded at $6.50, up 4.84 percent in the after-hours trading session.
- The European Commission (EC) has approved Novavax’s Extended Conditional Marketing Authorization (CMA). NVAX Lead Drug Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union as a homologous and heterologous booster for active immunization against…
