Wednesday's Biotech Catalyst Recap - End of Day Recap

by , Benzinga Staff Writer

July 20, 2022 5:59 p.m. | 5 minute read

Benzinga Biotech Catalysts - End of Day Summary July 20, 2022

Merck MRK announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, with concurrent chemoradiotherapy (CRT) followed by KEYTRUDA as maintenance therapy (the KEYTRUDA regimen ), failed to meet its primary endpoint event-free survival (EFS) for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). Merck shares traded in a range of $89.22 to $92.43 on daily volume of 11.84 million shares, regular trading session closed at $89.65. Adial Pharmaceuticals ADIL announced positive results from its ONWARD trial, a Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with alcohol use disorders (AUD) and selected polymorphisms in serotonin transporter and receptor genes. Adial shares traded in a range of $0.88 to $1.57 on daily volume of 10.25 million shares, closing the regular trading session at $0.98. The U.S. Food and Drug Administration (FDA) has granted accelerated designation to Karyopharm Therapeutics' KPTI lead asset, Eltanexor, as a monotherapy for the treatment of patients with relapsed or refractory myelodysplastic syndromes (MDS). In addition, the European Commission (EC) has adopted the opinion of the Committee for Orphan Medicinal Products (COMP) to designate Eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU). Karyopharm shares traded in a range of $4.69 to $5.24 on daily volume of 2.7 million shares, closing the regular trading session at $4.83. Ionis Pharmaceuticals IONS announced that Novartis has completed patient enrollment for the pivotal Phase 3 Lp(a) HORIZON cardiovascular outcome study of pelacarsen, with 8,325 study participants. Lp(a) HORIZON is evaluating the safety and efficacy of pelacarsen in reducing cardiovascular events in patients with cardiovascular disease and elevated Lp(a) levels. The main data of the study is expected in 2025. Ionis shares traded in the range of $38.65 to $39.77 on a daily volume of 656.83 thousand shares, regular trading session closed at 39, $01. Aytu BioPharma AYTU has initiated the PREVEnt global Phase 3 clinical trial of enzastaurin (AR101) for the treatment of patients with COL3A1-positive Ehlers-Danlos Vascular Syndrome (VEDS). Shares of Aytu BioPharma traded in the range of $0.61-$0.64 on daily volume of 325.77 thousand shares, regular trading session closed at $0.61. Shares of the company are currently trading at $0.63, up 3.69% in the after-hours trading session. Soleno Therapeutics SLNO provided an update regarding the recent meeting, the FDA acknowledged that data from a proposed randomized withdrawal phase of the C602 study would have the potential to address its concerns regarding the adequacy of the study data. overall efficiencies in support of a New Drug Application (NDA) submission for DCCR. Shares of Soleno traded in a range of $0.2 to $0.28 on daily volume of 41.15 million shares, regular trading session closed at $0.20. PTC Therapeutics PTCT Upstaza (eladocagene exuparvovec) has received marketing authorization from the European Commission. Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy infused directly into the brain. Shares of PTC Therapeutics traded in the $43.26-$45.06 range on daily volume of 524,440 shares, regular trading session closed at $44.40. Eiger BioPharmaceuticals EIGR has announced that the European Commission (EC) has granted the...