- The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients. BioMarin shares traded as high as 2.28 percent, in a range of $91.39 to $93.68 on day volume of 648.08 thousand shares, closed regular trading session at $92.90. The company shares traded at $94.84, up 2.09 percent in the after-hours trading session.
- Ligand Pharmaceuticals (NASDAQ:LGND) announced that the Janssen Biotech (Janssen) received conditional marketing authorization (CMA) from the European Commission for TECVAYLI (teclistamab) as monotherapy for the treatment of patients with relapsed or refractory (R/R) multiple myeloma. Ligand shares traded as high as 2.66 percent, in a range of $99.83 to $104.29 on day volume of 64.59 thousand shares, closed regular trading session at $103.34.
- Surgalign Holdings (NASDAQ:SRGA) announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Cortera Spinal Fixation System. The company noted that the Cortera system was strategically designed to maximize adoption in the spine market and for the future of evolving techniques and technology. Surgalign Holdings, Inc. shares traded as high as 10.05 percent, in a range of $4.15 to $4.6 on day volume of 215.7 thousand shares versus three months average volume of 106.55 thousand shares, closed regular trading session at $4.19. The company shares traded at $4.13, down 1.43 percent in the after-hours trading session.
- Ainos (NASDAQ:AIMD) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for conducting a Phase 2 trial of its drug candidate VELDONA, for treatment of mild symptoms related to COVID-19. Ainos shares traded as high as 6.1 percent, in a range of $2.30 to $2.61 on day volume of 93.54 thousand shares versus three months average volume of 36.93 thousand shares, closed regular trading session at $2.38.
- Annovis Bio (NYSE:ANVS) has initiated patient dosing in the Phase 3 clinical trial evaluating buntanetap in early Parkinson's Disease (PD). The Phase 3 trial is designed to evaluate the efficacy, safety, and tolerability of buntanetap, will enroll a total of 450 early PD patients. Annovis shares traded as high as 9.24 percent, in a range of $11.01 to $11.7 on day volume of 66.19 thousand shares , closed regular trading session at $11.34. The company shares traded at $11.56, up 1.94 percent in the after-hours trading session.
- Apellis Pharmaceuticals (NASDAQ:APLS) revealed top-line data readout at 24 months showing increased effects over time with intravitreal pegcetacoplan in the Phase 3 DERBY and OAKS studies in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Apellis shares traded as low as 7.94 percent, in a range of $60.02 to $64.9 on day volume of 3.49 million shares versus three months average volume of 1.06 million shares, closed regular trading session at $61.12.
- Seelos Therapeutics (NASDAQ:SEEL) announced it was selected to receive a grant from The Michael J. Fox Foundation for Parkinson's Research to advance preclinical research and development of its gene therapy delivered SLS-004 program. Seelos shares traded as high as 17.87 percent, in a range of $1.02 to $1.22 on day volume of 3.45 million shares versus three months average volume of 1.32 million shares, closed regular trading session at $1.22. The company shares traded at $1.20, down 1.64 percent in the after-hours trading session.
