Shares of oncology-focused biopharmaceutical company Immuneering Corp. traded 9% higher after the firm reported it received U.S. FDA clearance for its IND Application for a Phase 1/2a clinical trial of IMM-1-104 for use in treatment of advanced solid tumors with RAS mutations. The company expects to enroll the first patient in the study in Q4/22.
Shares of Eisai Co. Ltd. traded 58% higher yesterday after the company reported topline data from its global Phase 3 clinical study demonstrating that its lecanemab significantly met the primary and key secondary endpoints in reducing mild cognitive impairment due to Alzheimer's disease.
The requested approval is specifically for critically ill patients, a population for which the U.S. Food and Drug Administration granted the therapeutic fast track status, noted an H.C. Wainwright & Co. report.
Shares of clinical-stage immuno-oncology company LAVA Therapeutics NV traded nearly 100% higher yesterday after the firm reported that it has entered into a global licensing agreement with Seagen Inc. to advance its LAVA-1223, a preclinical gamma delta bispecific T cell engager designed for use in the treatment of EGFR-expressing solid tumors.
Shares of Fennec Pharmaceuticals Inc. traded 14% higher after the company reported it received approval from the U.S. FDA for its PEDMARK® (sodium thiosulfate injection) for use in reducing the risk of ototoxicity in pediatric patients who are undergoing or completed chemotherapy for non-metastatic solid tumors.
Satsuma Pharmaceuticals Inc. shares traded 12% higher to a new 52-week high after the company reported positive results from its Phase 3 long-term study of STS101 for use in acute treatment of migraine attacks. The company expects to receive further efficacy data from its Phase 3 SUMMIT trial in Q4/22, which it believes will support submission of an NDA with the U.S. FDA in Q1/23.
Shares of Mallinckrodt Plc. traded 28% higher yesterday after the company reported that the U.S. FDA has issued approval for its Terlivaz® (terlipressin) for injection for use in treating hepatorenal syndrome, a serious and life-threatening condition that is accompanied by rapid reduction in kidney function.
One Phase 2 clinical trial showing LSD reduced symptoms of anxiety bodes well for other studies of LSD in this indication. In light of this, Oppenheimer & Co. gave this biotech company a target price that is over six times its current share price.
One biopharma co. is teaming with a much larger pharmaceutical company to develop a fast-dissolving oral tablet to deliver MDMA to patients with Alcohol Use Disorder. Find out why developing an oral tablet could benefit the company in the long run.