- The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. Pfizer shares traded in a range of $45.39 to $46.21 on day volume of 15.31 million shares, closed regular trading session at $45.76.
- The European Commission has granted an orphan drug designation (ODD) to Viracta’s (NASDAQ:VIRX) lead drug combination nanatinostat and valganciclovir (Nana-val) for the treatment of peripheral T-cell lymphoma (PTCL). Viracta Therapeutics shares traded as high as 13.49 percent, in a range of $4.05 to $4.88 on day volume of 283.49 thousand shares, closed regular trading session at $4.81.
- DBV Technologies (NASDAQ:DBVT) announced the initiation of the Phase 3 study, VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) in peanut-allergic children ages 4 to 7 years. The study was initiated following productive exchanges with the U.S. Food and Drug Administration (FDA). DBV Technologies shares traded as low as 2.98 percent, in a range of $2.12 to $2.28 on day volume of 148.5 thousand shares, closed regular trading session at $2.25. The company shares traded at $2.21, down 1.77 percent in the after-hours trading session.
- Nanobiotix (NASDAQ:NBTX) announced randomization of the first patient in Asia in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy. Nanobiotix shares traded as high as 5.39 percent, in a range of $3.95 to $4.3 on day volume of 2.53 thousand shares, closed regular trading session at $4.29.
- Silk Road Medical (NASDAQ:SILK) has enrollment of the first patient in ROADSTER 3, the first prospective, multi-center, single-arm study to assess real-world treatment of standard surgical risk (SSR) patients with carotid artery disease using TCAR. Silk Road Medical shares traded as high as 6.99 percent, in a range of $38.42 to $41.5 on day volume of 247.65 thousand shares, closed regular trading session at $41.38.
- Erasca (NASDAQ:ERAS) announced promising preliminary Phase 1/1b monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in BRAF-driven and RAS/MAPK-altered solid tumors. Erasca shares traded as high as 11.75 percent, in a range of $8.77 to $9.89 on day volume of 767.19 thousand shares, closed regular trading session at $9.40. The company shares traded at $9.00, down 4.26 percent in the after-hours trading session.
- Seres Therapeutics (NASDAQ:MCRB) has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SER-109 for the prevention of recurrent C. difficile infection (rCDI). Seres shares traded as high as 17.78 percent, in a range of $5.44 to $6.36 on day volume of 2.06 million shares, closed regular trading session at $6.32. The company shares traded at $6.21, down 1.74 percent in the after-hours trading session.
- Bicycle Therapeutics (NASDAQ:BCYC) announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients with advanced solid tumors. Bicycle Therapeutics shares traded as high as 4.62 percent, in a range of $25 to $26.47 on day volume of 356.03 thousand shares, closed regular trading session at $25.33.
- Glaukos (NYSE:GKOS) announced positive topline data for both Phase 3 pivotal trials of iDose TR that successfully achieved its pre-specified primary efficacy endpoints through 3 months in both Phase 3 trials and demonstrated excellent tolerability and a favorable safety profile through 12 months. Glaukos shares traded as high as 26.65 percent, in a range of $51.49 to $60.92 on day volume of 4.56 million shares versus three months average volume of 457.05 thousand shares, closed regular trading session at $57.01. The company shares traded at $58.5, up 2.61 percent in the after-hours trading session.
- Pacira BioSciences (NASDAQ:PCRX) announced positive topline results from its Phase 3 study of EXPAREL as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty. EXPAREL achieved the study's primary endpoint. Pacira BioSciences shares traded as high as 5.25 percent, in a range of $51.01 to $53.93 on day volume of 532.93 thousand shares, closed regular trading session at $53.93.
- ViewRay (NASDAQ:VRAY) announced MRIdian MRI-Guided Radiation Therapy System has received approval from the Chinese regulatory authority National Medical Products Administration (NMPA), allowing for its sale and utilization throughout China. ViewRay shares traded as high as 7.08 percent, in a range of $3.29 to $3.48 on day volume of 725.73 thousand shares, closed regular trading session at $3.48. The company shares traded at $3.31, down 4.89 percent in the after-hours trading session.
- Ionis Pharmaceuticals (NASDAQ:IONS) presented positive results from a planned 35-week interim analysis of the Phase 3 NEURO-TTRansform study of Ionis and AstraZeneca's eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Ionis shares traded as high as 4.99 percent, in a range of $41.29 to $43.73 on day volume of 1.14 million shares versus three months average volume of 894.29 thousand shares, closed regular trading session at $43.45.
