The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ 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 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.
AllakosALLK 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 HoldingsBACK 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.
BioNTechBNTX 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.
ImmunocoreIMCR 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.
ArcutisARQT 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.
AstraZenecaAZN and MerckMRK 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.
AdaptimmuneADAP 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.
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