MESO News & Events

Mesoblast announced that it has received a Biologics License Application filing number from the U.S. Food and Drug Administration and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device. Rexlemestrocel-L has received Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and has Regenerative Medicine Advanced Therapy designation for this patient population, providing eligibility for rolling and priority reviews of the BLA. The new FDA leadership this past week provided additional guidance to how it approaches regulatory flexibility for products which address orphan rare diseases with high mortality and irreversible morbidity. The new draft guidance to industry titled 'Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products'1 highlights FDA's flexible approach to substantial evidence of effectiveness. This follows the May guidance from FDA titled 'Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application.'

Latest data shows the largest indicative borrow rate increases among liquid option names include: Starfighters Space, Inc. (FJET) 249.83% +3.74, Infosys (INFY) 54.04% +2.30, JBS Usa Holdings LLC (JBS) 2.90% +2.10, Merlin Inc (MRLN) 98.71% +1.79, Ares Capital (ARCC) 7.35% +1.71, ZenaTech Inc (ZENA) 14.62% +1.64, LASER PHOTONICS CORPORATION (LASE) 94.80% +0.93, Direxion S&P Biotech Bear 3X (LABD) 13.20% +0.69, Beyond Meat (BYND) 16.26% +0.65, and Mesoblast (MESO) 8.94% +0.60.

Latest data shows the largest indicative borrow rate increases among liquid option names include: T-REX 2X LONG MSTR DAILY TARGET (MSTU) 19.28% +1.44, Serve Robotics Inc (SERV) 26.46% +0.73, Defiance Daily Target 2x Long OKLO ETF (OKLL) 17.87% +0.73, Everspin Technologies (MRAM) 1.30% +0.72, Entravision (EVC) 1.96% +0.71, Direxion Daily Small Cap Bear 3X Shares (TZA) 6.50% +0.63, Rumble (RUM) 22.20% +0.60, Coursera (COUR) 0.90% +0.46, Xanadu Quantum Technologies Limited Class B (XNDU) 16.58% +0.37, and Mesoblast (MESO) 7.84% +0.32.