- The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a target action date of February 17, 2023. Radius Health shares traded in a range of $10.07 to $10.19 on a day volume of 3.81 million shares, closed regular trading session at $10.1.
- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to aTyr Pharma’s (NASDAQ:LIFE) lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis, a major form of interstitial lung disease. aTyr shares traded in a range of $3.58 to $3.87 on a day volume of 643.67 thousand shares, closed regular trading session at $3.65. The company shares are currently trading at $3.73, up 2.19 percent in the after-hours trading session.
- Passage Bio (NASDAQ:PASG) has dosed the first patient in the global Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for the treatment of patients with frontotemporal dementia (FTD) with granulin (GRN) mutations. Passage Bio shares traded in a range of $1.99 to $2.1 on a day volume of 1.65 million shares, closed regular trading session at $2.03. The company shares are currently trading at $2.08, up 2.46 percent in the after-hours trading session.
- ALX Oncology Holdings (NASDAQ:ALXO) has initiated a Phase 2 investigator-sponsored study of evorpacept in combination with Eli Lilly’s (NYSE:LLY) ERBITUX (cetuximab) and Merck’s (NASDAQ:MRK) KEYTRUDA (pembrolizumab) in patients with refractory microsatellite stable metastatic colorectal cancer (mCRC). ALX Oncology shares traded in a range of $12.72 to $13.53 on a day volume of 139.78 thousand shares, closed regular trading session at $12.98.
- The European Commission (EC) has granted marketing authorization for Argenx’s (NASDAQ:ARGX) lead asset VYVGART (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG). Argenx shares traded in a range of $370.69 to $382.03 on a day volume of 164.35 thousand shares, closed regular trading session at $374.14.
- Graphite Bio (NASDAQ:GRPH) announced initiation of patient dosing in the Phase 1/2 CEDAR trial with its asset GPH101 (nulabeglogene autogedtemcel) in people with sickle cell disease (SCD). Graphite Bio shares traded in a range of $3.86 to $4.16 on a day volume of 329.95 thousand shares, closed regular trading session at $3.97.
- Health Canada has granted Authorization under Interim Order for the emergency use and commercialization of Lucira Health’s (NASDAQ:LHDX) first and only at-home test for COVID & Flu. The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab. Lucira shares traded in a range of $3.13 to $3.36 on a day volume of 30.12 thousand shares, closed regular trading session at $3.19. The company shares are currently trading at $3.34, up 4.7 percent in the after-hours trading session.
- AVITA Medical (NASDAQ:RCEL) announced topline results from its pivotal trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction. AVITA shares traded in a range of $7.8 to $8.12 on a day volume of 115.1 thousand shares, closed regular trading session at $7.89. The company shares are currently trading at $8.1, up 2.66 percent in the after-hours trading session.
- Larimar Therapeutics (NASDAQ:LRMR) has received meeting minutes from the U.S. Food and Drug Administration (FDA) following a recent Type C Meeting to obtain its feedback on the information needed to resolve CTI-1601's current clinical hold. The Company plans to submit a complete response in the third quarter of 2022. Larimar shares traded in a range of $1.9 to $2.02 on a day volume of 108.98 thousand shares, closed regular trading session at $1.98. The company shares are currently trading at $2.99, up 51.01 percent in the after-hours trading session.
