- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading session at $27.25. The company shares are currently trading down 5 percent at $25.89 in the after-hours session.
- ClearPoint Neuro (NASDAQ:CLPT) announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to its Maestro Brain Model, intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. ClearPoint shares traded in a range of $13.94 to $15.09 on a day volume of 164.36 thousand shares, closed regular trading session at $14.52. The company shares are currently trading at $15.4, up 6.06 percent in the after-hours trading session.
- Reata Pharma (NASDAQ:RETA) announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich's ataxia by three months. The new target action is February 28, 2023. Reata shares traded in a range of $21.1 to $23.8 on a day volume of 2.4 million shares, closed regular trading session at $21.35.
- Verona Pharma (NASDAQ:VRNA) announces its top-line Phase 3 ENHANCE-2) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function. Verona shares traded in a range of $9.04 to $14.69 on a day volume of 37.09 million shares, closed regular trading session at $10.03.
- BeiGene (NASDAQ:BGNE) announced that the global Phase 3 RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior Overall Survival (OS) versus sorafenib as a first-line treatment in adult patients with unresectable hepatocellular carcinoma (HCC). BeiGene shares traded in a range of $192.98 to $204 on a day volume of 110.66 thousand shares, closed regular trading session at $197.62.
- Inmagene Biopharmaceuticals and HUTCHMED (NASDAQ:HCM) have dosed first participant based in the United States in a global Phase I trial of IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor. Inmagene is developing the drug candidate to potentially treat immunological diseases. HUTCHMED shares traded in a range of $12.91 to $13.9 on a day volume of 273.45 thousand shares, closed regular trading session at $13.66.
- Kintara Therapeutics (NASDAQ:KTRA) announced that it has received a Study May Proceed letter from the United States Food and Drug Administration (FDA) to begin its 15 patient study evaluating REM-001 Photodynamic Therapy (PDT) for the treatment of Cutaneous Metastatic Breast Cancer (CMBC). Kintara shares traded in a range of $0.18 to $0.22 on a day volume of 8.95 million shares, closed regular trading session at $0.18.
- Xilio Therapeutics (NASDAQ:XLO) announced encouraging preliminary Phase 1 dose-escalation data for XTX101, a Tumor-Selective Anti-CTLA-4. These data provide initial clinical validation of Xilio's geographically precise solutions (GPS) platform and demonstrate that XTX101 has reached dose levels above the target dose with limited active (unmasked) molecule in peripheral circulation. Xilio shares traded in a range of $2.32 to $2.95 on a day volume of 199.6 thousand shares, closed regular trading session at $2.42.
- Olema Oncology (NASDAQ:OLMA) announced the advancement of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), into Phase 2 clinical development for the treatment of ER+/HER2- metastatic breast cancer. Olema shares traded in a range of $5.37 to $5.94 on a day volume of 133.08 thousand shares, closed regular trading session at $5.61.
- NeuroOne Medical Technologies (NASDAQ:NMTC) has submitted a special 510(k) to the U.S. Food and Drug Administration (FDA) for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use. NeuroOne shares traded in a range of $1.71 to $2.18 on a day volume of 330.28 thousand shares, closed regular trading session at $1.91. The company shares are currently trading at $1.82, down 4.71 percent in the after-hours trading session.
