Recap Of Monday’s Biotech Catalysts - End Of the Day Summary - Anixa Biosciences (NASDAQ:ANIX), NexImmune (OTC:NEXI)

Gritstone bio GRTS announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The initial results from the study are expected during second half of 2023. Gritstone shares traded in a range of $3.96 to $4.24 on a day volume of 610.52 thousand shares, closed regular trading session at $4.07. The company shares are currently trading at $4.2, up 3.19 percent in the after-hours trading session.

NexImmune NEXI has received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) submission for NEXI-003, its first solid tumor product candidate for the treatment of HPV-related cancers. NexImmune shares traded in a range of $1.25 to $1.33 on a day volume of 59.94 thousand shares, closed regular trading session at $1.26. The company shares are currently trading at $1.3, up 3.17 percent in the after-hours trading session.

Novavax NVAX submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older. Novavax shares traded in a range of $40.62 to $43.16 on a day volume of 4.69 million shares, closed regular trading session at $42.3.

Genprex GNPX announced that the Safety Review Committee (SRC) has approved continuation of the Acclaim-1 Phase 1/2 clinical trial of REQORSA in combination with Tagrisso(osimertinib) to treat late-stage non-small cell lung cancer (NSCLC) following a review of the first cohort of patients in the Phase 1 portion of the trial. Genprex shares traded in a range of $1.79 to $2.16 on a daily volume of 1.53 million shares, closed regular trading session at $2.09. The company shares are currently trading at $2.14 up 2.39 percent in the after-hours trading session.

Organogenesis ORGO has received U.S. Food and Drug Administration (FDA) 510k Clearance for PuraPly MZ, a brand extension to the PuraPly product portfolio. PuraPly MZ leverages the innovative properties of our PuraPly technology engineered into a micronized (powdered) form to provide surgeons with an option for complex surgical wounds. Organogenesis shares traded in a range of $4.66 to $4.89 on a day volume of 1.13 million shares, closed regular trading session at $4.87.

Moderna MRNA announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted conditional authorization for the use of the Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Moderna shares traded in a range of $171.85 to $179.33 on a day volume of 4.84 million shares, closed regular trading session at $176.78.

Clene CLNN announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8^®, an investigational gold nanocrystal suspension, in participants with stable relapsing remitting multiple sclerosis (RRMS). Clene shares traded in a range of $3.13 to $3.73 on a day volume of 1.51 milion shares, closed regular trading session at $3.65. The company shares are currently trading at $3.37, down 7.67 percent in the after-hours trading session.

Viridian Therapeutics VRDN announced positive initial clinical data from the 10mg/kg cohort in its ongoing Phase 1/2 clinical trial of VRDN-001, an anti-IGF-1R antibody, in patients with active thyroid eye disease (TED). Viridian shares traded in a range of $19.29 to $25.38 on a day volume of 12.74 million shares, closed regular trading session at $22. The company shares are currently trading at $22.72, up 3.27 percent in the after-hours trading session.

The European Commission (EC) has granted orphan medicinal product designation to Inhibrx’s INBX lead asset INBRX-109 for the treatment of chondrosarcoma. Inhibrx shares traded in a range of $23.26 to $24.79 on a day volume of 248.4 thousand shares, closed regular trading session at $24.68.

Ventyx Biosciences VTYX announced positive data from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of VTX958, a novel and selective allosteric TYK2 inhibitor. Ventyx shares traded in a range of $18.17 to $18.86 on a day volume of 175.38 thousand shares, closed regular trading session at $18.6. The company shares are currently trading at $19, up 2.15 percent in the after-hours trading session.

Gilead Sciences GILD announced positive results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer. Gilead shares traded in a range of $63.66 to $66.3 on a day volume of 12.38 million shares, closed regular trading session at $66.21.

Anixa Biosciences ANIX commenced treatment of the first patient in the clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. Anixa shares traded in a range of $4.05 to $4.76 on a day volume of 211.22 thousand shares, closed regular trading session at $4.55.

Virios Therapeutics (Nasdaq: VIRI) has initiated patient dosing in its exploratory Long-COVID trial evaluating drug asset IMC-2 (valacyclovir + celecoxib). Virios shares traded in a range of $8.38 to $9.11 on a day volume of 76.53 thousand shares, closed regular trading session at $8.38.