- The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ:SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. Spectrum Pharmaceuticals shares traded as high as 3.17 percent, in a range of $1.21 to $1.30 on day volume of 6.8 million shares versus three months average volume of 2.72 million shares, closed regular trading session at $1.30. The company 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 for review Pfizer’s (NYSE:PFE) New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The regulatory agency is expected to make a decision in the second-quarter 2023. Additionally, The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the alopecia areata patient population with a decision anticipated in the fourth-quarter 2023. Pfizer shares traded as high as 1.93 percent, in a range of $47.11 to $47.99 on day volume of 17.5 million shares, closed regular trading session at $47.84.
- Allakos (NASDAQ:ALLK) announced data from the 24-week EoDyssey, Phase 3 clinical study of lirentelimab in patients with biopsy confirmed eosinophilic duodenitis (EoD). The trial met its histologic co-primary endpoint, but it did not achieve statistical significance on the patient reported symptomatic co-primary endpoint. Allakos shares traded as high as 8.19 percent, in a range of $4.17 to $5.02 on day volume of 3.73 million shares, closed regular trading session at $4.91. The company shares traded at $4.73, down 3.57 percent in the after-hours trading session.
- IMAC Holdings (NASDAQ:BACK) has completed the third cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson's disease. IMAC Holdings shares traded as high as 6.12 percent, in a range of $0.49 to $0.52 on day volume of 127.04 thousand shares, closed regular trading session at $0.52.
- BioNTech (NASDAQ:BNTX) revealed positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company's novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. BioNTech SE shares traded as high as 3.72 percent, in a range of $146.98 to $152.68 on day volume of 780.13 thousand shares, closed regular trading session at $150.91. The company shares traded at $148.25, down 1.76 percent in the after-hours trading session.
- Immunocore (NASDAQ:IMCR) announced initial Phase 1 data for the first off-the-shelf ImmTAC targeting PRAME, demonstrating that IMC-F106C is well tolerated and resulted in durable responses across multiple solid tumor types. Immunocore shares traded as high as 6.75 percent, in a range of $43.27 to $61.32 on day volume of 2.15 million shares versus three months average volume of 246.99 thousand shares, closed regular trading session at $44.75.
- Arcutis (NASDAQ:ARQT) announced new data from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for children ages 9 and above and adults with moderate to severe seborrheic dermatitis were presented orally at the Academy of Dermatology and Venereology (EADV) Congress. Arcutis shares traded in a range of $20.20 to $22.00 on day volume of 864.45 thousand shares, closed regular trading session at $20.43. The company shares traded at $20.09, down 1.66 percent in the after-hours trading session.
- AstraZeneca (NASDAQ:AZN) and Merck (NASDAQ:MRK) announced positive long-term follow-up results from the PAOLA-1 and SOLO-1 Phase III trials of LYNPARZA (olaparib) with or without bevacizumab demonstrated clinically meaningful improvements in overall survival (OS). Astrazeneca shares traded in a range of $60.69 to $61.18 on day volume of 4.43 million shares, closed regular trading session at $60.85.
- Adaptimmune (NASDAQ:ADAP) announced positive aata from its signal-finding SURPASS trial, outlines plans for advanced clinical development in multiple MAGE-A4 positive solid tumors. Adaptimmune shares traded as high as 3.92 percent, in a range of $1.9 to $2.12 on day volume of 695.29 thousand shares, closed regular trading session at $1.92.
