- The US Food and Drug Administration (FDA) has granted approval Spectrum Pharma‘ SPPI Lead Asset ROLVEDON (Eflapegrastim-xnst) Injection to Reduce Incidence of Infections Manifested by Febrile Neutropenia. Spectrum Pharmaceuticals shares traded up 3.17 percent, in a range of $1.21 to $1.30 on daily volume of 6.8 million shares versus an average three-month volume of 2.72 million shares, which is the regular Trading session ended at $1.30. The company’s shares traded at $1.44, up 11.2 percent in the after-hours trading session.
- The U.S. Food and Drug Administration (FDA) has accepted the review Pfizer‘s PFE New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years and older with alopecia areata. The regulatory authority is expected to make a decision in the second quarter of 2023. In addition, the European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the alopecia areata patient population, with a decision expected in the fourth-quarter of 2023. Pfizer shares were up as high as 1.93 Trading in a range of $47.11 to $47.99 on daily volume of 17.5 million shares, the stock closed the regular trading session at $47.84 percent.
- Allakos ALLK announced data from the 24-week phase 3 EoDyssey clinical trial of lirentelimab in patients with biopsy-confirmed eosinophilic duodenitis (EoD). The study met its histological co-primary endpoint but failed to reach statistical significance for the patient-reported symptomatic co-primary endpoint. Allakos shares traded up 8.19 percent in a range of $4.17 to $5.02 on daily volume of 3.73 million shares and closed the regular trading session at $4.91. The company’s shares traded at $4.73, down 3.57 percent in the after-hours trading session.
- IMAC holdings THE BACK has completed the third cohort of its Phase 1 clinical trial of its investigational drug, which uses umbilical cord-derived allogeneic mesenchymal stem cells for the treatment of bradykinesia due to…
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