- The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ:MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound shares traded in a range of $1.6 to $1.76 on a day volume of 283.18 thousand shares, closed regular trading session at $1.67. The company shares are currently trading at $1.77, up 5.99 percent in the after-hours trading session.
- Alnylam (NASDAQ:ALNY) announced positive results from the APOLLO-B Phase 3 study of Patisiran for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. Alnylam shares traded in a range of $198 to $220.92 on a day volume of 8.54 million shares, closed regular trading session at $212.01.
- The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Glaukos’ (NYSE:GKOS) iStent infinite Trabecular Micro-Bypass System indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy. Glaukos shares traded in a range of $53.13 to $54.39 on a day volume of 590.05 thousand shares, closed regular trading session at $53.35. The company shares are currently trading at $54.5, up 2.16 percent in the after-hours trading session.
- Merck (NYSE:MRK) announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA plus LENVIMA, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). Further, the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA (pembrolizumab) Plus Chemotherapy also did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS), in Patients With Metastatic Castration-Resistant Prostate Cancer. Merck shares traded in a range of $86.76 to $88.02 on a day volume of 7.85 million shares, closed regular trading session at $87.62.
- REGENXBIO (NASDAQ:RGNX) announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. The Company also announced that a pivotal program for RGX-121 is active and enrolling patients. REGENXBIO shares traded in a range of $32.59 to $34.99 on a day volume of 417.06 thousand shares, closed regular trading session at $33.99.
- Landos Biopharma (NASDAQ:LABP) announced positive top-line results from its Phase 1b clinical trial of NX-13 for the treatment of ulcerative colitis (UC) as a once-daily oral therapy. The data showed that NX-13 was well tolerated following evaluation of multiple doses over four weeks compared with a placebo. Landos shares traded in a range of $0.82 to $0.98 on a day volume of 603.38 thousand shares, closed regular trading session at $0.93. The company shares are currently trading at $0.97, up 4.55 percent in the after-hours trading session.
- Merrimack Pharmaceuticals (NASDAQ:MACK) announced that its partner Ipsen, SA has issued a press release reporting the primary analysis of the results of its Phase 3 trial of Onivyde (irinotecan liposomal injection) as a treatment of second line small cell lung cancer (SCLC) that missed the primary endpoint OS in patients treated with Onivyde versus topotecan. Merrimack shares traded in a range of $3.81 to $4.41 on a day volume of 774.8 thousand shares, closed regular trading session at $4.26.
- Syros Pharmaceuticals (NASDAQ:SYRS) announced that the European Medicines Agency (EMA) issued a positive opinion on the application for orphan drug designation for tamibarotene for the treatment of myelodysplastic syndrome (MDS). Tamibarotene is currently being evaluated in combination with azacitidine in the SELECT-MDS-1 Phase 3 trial for RARA-positive patients with newly diagnosed higher-risk MDS (HR-MDS). Syros shares traded in a range of $0.83 to $0.91 on a day volume of 2.24 milion shares, closed regular trading session at $0.88. The company shares are currently trading at $1.16, up 31.94 percent in the after-hours trading session.
