The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s TCON lead asset envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. TRACON shares traded as high as 5.26 percent, in a range of $1.9 to $2 on day volume of 111.77 thousand shares, closed regular trading session at $1.9.
Centessa PharmaceuticalsCNTA announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SerpinPC for the treatment of hemophilia B. Centessa shares traded as high as 10.56 percent, in a range of $4.09 to $4.71 on day volume of 180.95 thousand shares, closed regular trading session at $4.64.
Eloxx PharmaceuticalsELOX announced topline results from the Phase 2 clinical trial of ELX-02 in combination with ivacaftor in Class 1 cystic fibrosis (CF) patients with at least one nonsense mutation. The combination trial was well tolerated but did not achieve statistical significance for efficacy endpoints. Eloxx shares traded as high as 10.53 percent, in a range of $0.38 to $0.42 on day volume of 275.93 thousand shares, closed regular trading session at $0.38. The company shares traded at $0.19, down 50 percent in the after-hours trading session.
Adverum BiotechnologiesADVM dosed first subject in the LUNA Phase 2 trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD). Adverum shares traded as high as 7.55 percent, in a range of $1.06 to $1.14 on day volume of 439.06 thousand shares, closed regular trading session at $1.09.
PfizerPFE announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults. Pfizer shares traded in a range of $45.78 to $46.41 on day volume of 16.49 million shares, closed regular trading session at $46.15.
AltimmuneALT announced positive topline results from its 12-week Phase 1b study of pemvidutide1 in subjects with non-alcoholic fatty liver disease (NAFLD). The trial met its primary endpoint and key secondary endpoint in all pemvidutide treatment groups. Altimmune shares traded as low as 18.55 percent, in a range of $11.16 to $16.6 on day volume of 46.79 million shares versus three months average volume of 1.69 million shares, closed regular trading session at $14.87. The company shares traded at $15.1, up 1.55 percent in the after-hours trading session.
Larimar TherapeuticsLRMR announced that the U.S. Food and Drug Administration (FDA) has cleared the initiation of the 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in Friedreich’s ataxia (FA) patients. In a written communication to Larimar, the FDA indicated it was lifting its full clinical hold on the CTI-1601 program and imposing a partial hold. Larimar shares traded as high as 17.14 percent, in a range of $2.95 to $3.69 on day volume of 3.51 million shares versus three months average volume of 232.78 thousand shares, closed regular trading session at $3.64. The company shares traded at $3.5, down 3.85 percent in the after-hours trading session.
AldeyraALDX announced the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA), It remains on schedule to submit an NDA in the fourth quarter of 2022 requesting marketing approval of the novel RASP modulator reproxalap for the treatment of dry eye disease. Aldeyra shares traded in a range of $6.25 to $6.54 on day volume of 429.03 thousand shares, closed regular trading session at $6.38.
eFFECTOR TherapeuticsEFTR has dosed the first patient in the second cohort of its Phase 1b clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. eFFECTOR shares traded as high as 6.25 percent, in a range of $0.61 to $0.68 on day volume of 166.65 thousand shares, closed regular trading session at $0.63.
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