Recap of Wednesday's Biotech Catalysts - End of The Day Summary

 

• Merck (NYSE:MRK) announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, with concurrent chemoradiation therapy (CRT) followed by KEYTRUDA as maintenance therapy (the KEYTRUDA regimen), did not meet its primary endpoint of 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 a day volume of 11.84 million shares, closed regular trading session at $89.65.


• Adial Pharmaceuticals (NASDAQ:ADIL) announced successful results from its ONWARD trial, a Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Adial shares traded in a range of $0.88 to $1.57 on a day volume of 10.25 million shares, closed regular trading session at $0.98.


• The U.S. Food and Drug Administration (FDA) has granted fast track designation to Karyopharm Therapeutics’ (NASDAQ:KPTI) lead asset Eltanexor as monotherapy for the treatment of patients with relapsed or refractory Myelodysplastic Syndromes (MDS). Additionally, the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion 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 a day volume of 2.7 milion shares, closed regular trading session at $4.83.


• Ionis Pharmaceuticals (NASDAQ:IONS) announced that Novartis has completed patient enrollment of the pivotal Phase 3 Lp(a) HORIZON cardiovascular outcomes 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 levels of Lp(a). Topline data from the study are expected in 2025. Ionis shares traded in a range of $38.65 to $39.77 on a day volume of 656.83 thousand shares, closed regular trading session at $39.01.


• Aytu BioPharma (NASDAQ:AYTU) has initiated the global Phase 3 PREVEnt clinical trial of Enzastaurin (AR101) for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS). Aytu BioPharma shares traded in a range of $0.61 to $0.64 on a day volume of 325.77 thousand shares, closed regular trading session at $0.61. The company shares are currently trading at $0.63, up 3.69 percent in the after-hours trading session.


• Soleno Therapeutics (NASDAQ:SLNO) provided an update regarding recent meeting, the FDA acknowledged that data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a New Drug Application (NDA) submission for DCCR. Soleno shares traded in a range of $0.2 to $0.28 on a day volume of 41.15 million shares, closed regular trading session at $0.20.


• PTC Therapeutics (NASDAQ:PTCT) Upstaza (eladocagene exuparvovec) was granted marketing authorization by 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 directly infused into the brain. PTC Therapeutics shares traded in a range of $43.26 to $45.06 on a day volume of 524.44 thousand shares, closed regular trading session at $44.40.


• Eiger BioPharmaceuticals (NASDAQ:EIGR) announced that the European Commission (EC) has granted marketing authorization for Zokinvy (lonafarnib), a first-in-class breakthrough therapy for children and young adults with Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL). Eiger shares traded in a range of $8.49 to $8.85 on a day volume of 197.82 thousand shares, closed regular trading session at $8.69.


• The French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) have granted pre-marketing authorization AP1 (early access authorization), for Rhythm Pharmaceuticals’ (NASDAQ:RYTM) lead candidate IMCIVREE (setmelanotide) in patients with genetically-confirmed Bardet-Biedl syndrome (BBS) for the treatment of obesity and the control of hunger. Rhythm shares traded in a range of $10.79 to $13.33 on a day volume of 10.59 million shares, closed regular trading session at $13.21.


• Vaxart (NASDAQ:VXRT) reported additional phase 1 clinical data published on medRixv.org, indicating that its Spike/Nucleocapsid (S+N) oral tablet COVID-19 vaccine induced long-lasting mucosal IgA antibodies against SARS-CoV-2 the virus that causes COVID-19, and all tested coronaviruses. Vaxart shares traded in a range of $4.03 to $4.39 on a day volume of 4.09 million shares, closed regular trading session at $4.26.


• Synaptogenix (NASDAQ:SNPX) advanced dosing of first patient in dose optimization clinical trial in preparation for NIH-Sponsored, Phase 2 Alzheimer's Disease trial data. Synaptogenix shares traded in a range of $4.66 to $5.2 on a day volume of 106.04 thousand shares, closed regular trading session at $4.92.


• Soligenix (NASDAQ:SNGX) announced the results of its successful Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) has been published in the Journal of the American Medical Association (JAMA) Dermatology. Soligenix shares traded in a range of $0.73 to $0.91 on a day volume of 1.33 million shares, closed regular trading session at $0.80. The company shares are currently trading at $0.84, up 4.59 percent in the after-hours trading session.


• The Canadian regulatory authority, Health Canada has approved AbbVie’s (NYSE:ABBV) lead drug RINVOQ (upadacitinib, 15 mg), once-daily selective and reversible JAK inhibitor for the treatment of adults with active ankylosing spondylitis (AS). AbbVie shares traded in a range of $147.34 to $150.45 on a day volume of 5.31 million shares, closed regular trading session at $147.69.