- Bristol Myers Squibb BMY received European Medicines Agency (EMA) Positive CHMP Opinion recommending approval for Opdualag (nivolumab and relatlimab) for treatment of patients with Unresectable or Metastatic Melanoma based on results from the Phase 2/3 RELATIVITY-047 trial. Bristol Myers shares traded in a range of $72.48 to $73.61 on a day volume of 6.51 million shares, closed regular trading session at $72.95.
- European Medicines Agency (EMA) CHMP Adopts Positive Opinion Recommending Gilead Sciences’ GILD Veklury (Remdesivir) Received Full Marketing Authorization for the Treatment of Patients With COVID-19. Additionally, Kite received CHMP Positive Opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). Gilead shares traded in a range of $60.58 to $61.8 on a day volume of 4.25 million shares, closed regular trading session at $60.80.
- iRhythm IRTC received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. The ZEUS System is the AI algorithm and solution component of the Zio® Watch: a sensor-based wearable for noninvasive, clinical grade, long-term continuous monitoring for atrial fibrillation (AFib). iRhythm shares traded in a range of $147.79 to $154.51 on a day volume of 305.03 thousand shares, closed regular trading session at $149.95.
- European Medicines Agency (EMA) has adopted Positive CHMP Opinion for Rhythm Pharmaceuticals’ RYTM lead asset IMCIVREE (setmelanotide) recommending to expand the current marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with genetically confirmed Bardet-Biedl syndrome (BBS). Rhythm shares traded in a range of $12.82 to $14.82 on a day volume of 2.92 million shares, closed regular trading session at $13.16. The company shares are currently trading at $13.34, up 1.37 percent in the after-hours trading session.
- European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the conditional marketing authorization (CMA) to include a booster dose of Moderna’s MRNA Spikevax, COVID-19 vaccine, at the 50 µg dose level for adolescents (12-17 years) at least three months after completion of the primary series. Moderna shares traded in a range of $161.44 to $171.11 on a day volume of 2.92 million shares, closed regular trading session at $163.52.
- VistaGen Therapeutics’ VTGN topline results from its PALISADE-1 Phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder. PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale (SUDS) compared to placebo. VistaGen shares traded in a range of $0.14 to $0.21 on a day volume of 161.44 million shares, closed regular trading session at $0.15. The company shares are currently trading at $0.15, up 2.07 percent in the after-hours trading session.
- I-Mab IMAB dosed first patient in Phase 1 Clinical Trial of Claudin 18.2 and 4-1BB Bispecific Antibody TJ-CD4B in Solid Tumors in China. I-Mab shares traded in a range of $9.68 to $10.59 on a day volume of 348.06 thousand shares, closed regular trading session at $10.
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