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

Recap of Wednesday's Biotech Catalysts - End of The Day Summary
  • IDEAYA Biosciences IDYA has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397 with Amgen's AMG 193  in a Phase 1 clinical trial. IDEAYA shares traded in a range of $14.59 to $15.82 on a day volume of 130.58 thousand shares, closed regular trading session at $15.67.
  • IN8bio INAB provided a clinical update from the ongoing Phase 1 trial of INB-100, an allogeneic, or donor-derived, gamma-delta T cell therapeutic candidate in development for patients with high-risk leukemias undergoing haploidentical hematopoietic stem cell transplant (HSCT). IN8bio shares traded in a range of $2.37 to $2.88 on a day volume of 45.53 thousand shares, closed regular trading session at $2.40. The company shares are currently trading at $2.3, down 4.17 percent in the after-hours trading session.
  • The U.S. Food and Drug Administration (FDA) has accepted for review Lexicon PharmaceuticalsLXRX New Drug Application (NDA) for sotagliflozin for the treatment of heart failure. The regulatory agency has assigned a standard review with a PDUFA target action date in May 2023. Lexicon shares traded in a range of $3.06 to $3.29 on a day volume of 613.85 thousand shares, closed regular trading session at $3.27. The company shares are currently trading at $2.6, down 20.49 percent in the after-hours trading session.
  • Cortexyme CRTX has completed its Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) clinical trial of COR588 for the treatment of Alzheimer's disease and indications with disease pathology associated with the keystone pathogen P. gingivalis. Cortexyme shares traded in a range of $1.80 to $1.90 on a day volume of 221.2 thousand shares, closed regular trading session at $1.89. The company shares are currently trading at $1.84, down 2.65 percent in the after-hours trading session.
  • Celularity CELU has treated first patient with CYNK-101 in development for the First-Line Treatment of Advanced HER2 Positive Gastric and Gastroesophageal Junction (G/GEJ) Cancers. Celularity shares traded in a range of $3.12 to $3.69 on a day volume of 517.36 thousand shares, closed regular trading session at $3.19. The company shares are currently trading at $3.29, up 3.13 percent in the after-hours trading session.
  • Cidara Therapeutics CDTX has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead asset Rrezafungin for the treatment of candidemia and invasive candidiasis. Cidara shares traded in a range of $0.75 to $0.88 on a day volume of 9.69 million shares, closed regular trading session at $0.76.
  • Palisade Bio PALI announced the first patient has been screened in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. Palisade Bio shares traded in a range of $0.39 to $0.41 on a day volume of 174.92 thousand shares, closed regular trading session at $0.41.
  • Artivion AORT has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial is designed to support the company's forthcoming application to the U.S. Food and Drug Administration (FDA) for premarket approval of the AMDS. Artivion shares traded in a range of $19.62 to $20.24 on a day volume of 177.65 thousand shares, closed regular trading session at $20.12.
  • Ensysce Biosciences ENSC announced the data from the Part B, Bioequivalence (BE) arm of the PF614-102 study examining lead drug PF614, a novel Trypsin-Activated Abuse-Protected (TAAP) Opioid. Ensysce shares traded in a range of $0.54 to $0.61 on a day volume of 518.95 thousand shares, closed regular trading session at $0.55.
  • Mustang Bio MBIO has dosed the first patient successfully received LV-RAG1 in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. LV-RAG1 is exclusively licensed by Mustang for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1-SCID. Mustang Bio shares traded in a range of $0.60 to $0.69 on a day volume of 3.31 million shares, closed regular trading session at $0.66.
  • AbbVie ABBV has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn's disease. AbbVie shares traded in a range of $148.93 to $151.50 on a day volume of 4.14 million shares, closed regular trading session at $151.15.
  • Lexaria Bioscience LEXX has completed dosing with DehydraTECH-processed cannabidiol (DehydraTECH-CBD) in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing. Lexaria shares traded in a range of $2.69 to $2.88 on a day volume of 70.64 thousand shares, closed regular trading session at $2.71.
  • The U.S. Food and Drug Administration (FDA) has approved GSK’s GSK lead asset Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy. GSK shares traded in a range of $42.09 to $43.7 on a day volume of 4.89 million shares, closed regular trading session at $43.54.
  • Turning Point Therapeutics TPTX has received positive feedback from the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting completed in the second quarter. The pre-NDA meeting was convened to discuss its planned NDA for the lead asset Repotrectinib in the treatment of ROS1+ advanced non-small cell lung cancer (NSCLC). Turning Point shares traded in a range of $74.91 to $75.17 on a day volume of 833.25 thousand shares, closed regular trading session at $75.04.

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