- The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB). The regulatory agency has granted Priority Review designation and assigned a target actin date of February 17, 2023. Krystal shares traded in a range of $72.05 to $74.88 on a day volume of 124.24 thousand shares, closed regular trading session at $74.41.
- BioCryst Pharmaceuticals (NASDAQ: BCRX) announced that the Saudi Food and Drug Authority (SFDA) has approved oral, once-daily ORLADEYO® (berotralstat) to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older in Saudi Arabia. BioCryst shares traded in a range of $14.11 to $14.39 on a day volume of 2.11 million shares, closed regular trading session at $14.33.
- Curis (NASDAQ:CRIS) announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing the comprehensive data package submitted by the company. Curis shares traded in a range of $1.23 to $1.77 on a day volume of 75.18 million shares, closed regular trading session at $1.26.
- Aeglea BioTherapeutics (NASDAQ:AGLE) announced that a Marketing Authorization Application (MAA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D) has been submitted to and successfully validated by the European Medicines Agency (EMA). Aeglea shares traded in a range of $0.49 to $0.54 on a day volume of 6.79 million shares, closed regular trading session at $0.5. The company shares are currently trading at $1.03, up 104 percent in the after-hours trading session.
- Jazz Pharmaceuticals (NASDAQ:JAZZ) announced it has initiated a new Phase 3 trial to investigate the efficacy and safety of Epidiolex® (cannabidiol), known as Epidyolex® in Europe, in children and adolescents with Epilepsy with Myoclonic-Atonic Seizures (EMAS). Jazz shares traded in a range of $155.23 to $158.36 on a day volume of 513.63 thousand shares, closed regular trading session at $156.55. The company shares are currently trading at $152.74, down 2.43 percent in the after-hours trading session.
- Valneva (NASDAQ:VALN) has initiated rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of its single-shot chikungunya vaccine candidate in persons aged 18 years and above. This BLA submission follows final pivotal Phase 3 data reported in March 2022. Valneva shares traded in a range of $19.6 to $21.02 on a day volume of 15.01 thousand shares, closed regular trading session at $20.58.
- BridgeBio Pharma (NASDAQ:BBIO) has dosed first patient in its Phase 1 clinical trial of BBP-671, an investigational oral therapy being developed for the potential treatment of conditions caused by coenzyme A (CoA) deficiencies. BridgeBio shares traded in a range of $10.08 to $10.75 on a day volume of 1.74 million shares, closed regular trading session at $10.7.
- 89bio (NASDAQ:ETNB) has completed enrollment in ENLIVEN, the Phase 2b trial of pegozafermin for the treatment of non-alcoholic steatohepatitis (NASH), expects to report topline data in the first quarter of 2023. 89bio shares traded in a range of $4.56 to $5.56 on a day volume of 871.79 thousand shares, closed regular trading session at $5.19. The company shares are currently trading at $5.37, up 3.47 percent in the after-hours trading session.
