- The U.S. Food and Drug Administration (FDA) has approved Incyte’s INCY Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. Incyte shares traded in a range of $71.38 to $72.98 on day volume of 1.25 million shares, closed regular trading session at $71.48.
- The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics’ IKT Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro in the treatment of Chronic Myelogenous Leukemia (CML). Inhibikase shares traded as high as 25 percent, in a range of $0.88 to $1.10 on day volume of 8.93 million shares versus three months average volume of 130.03 thousand shares, closed regular trading session at $0.96.
- The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has granted expanded conditional marketing authorization (CMA) for Novavax’s NVAX lead asset Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. Novavax shares traded as high as 1.5 percent, in a range of $34.77 to $37.81 on day volume of 2.8 million shares, closed regular trading session at $35.20.
- Pfizer PFE and BioNTech BNTX announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing Omicron-adapted bivalent vaccines. Pfizer shares traded in a range of $46.7 to $47.96 on day volume of 16.47 million shares, closed regular trading session at $46.82.
- BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that its lead asset BCX9930 has demonstrated >99 percent suppression of the alternative pathway (AP), and that >98 percent suppression was maintained for 24 hours post-dosing, in patients with C3 glomerulopathy (C3G), a rare renal disease that is characterized by dysregulation of the AP of the complement system. BioCryst shares traded as high as 1.15 percent, in a range of $14.24 to $14.96 on day volume of 1.97 million shares, closed regular trading session at $14.26.
- FibroGen FGEN has completed patient enrollment for MATTERHORN, a Phase 3 clinical study of roxadustat for treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS). FibroGen shares traded, in a range of $13.04 to $13.6 on day volume of 595.72 thousand shares, closed regular trading session at $13.25.
- 89bio ETNB announced the presentation of data from ENTRIGUE, its Phase 2 proof-of-concept trial of pegozafermin in severe hypertriglyceridemia (SHTG) at the European Society of Cardiology (ESC) Congress 2022. 89bio shares traded as high as 11.84 percent, in a range of $4.8 to $5.29 on day volume of 874.42 thousand shares, closed regular trading session at $4.95. The company shares traded at $5.09, up 2.83 percent in the after-hours trading session.
- Biomea Fusion BMEA announced presentation of two posters at the 19th International Myeloma Society (IMS) Annual Meeting, which took place August 25-27, 2022 in Los Angeles, California. The clinical data demonstrate the novel and robust anti-tumor activity of BMF-219 in HGBCL and MM preclinical models that represent categories of high unmet need. Biomea shares traded as high as 1.28 percent, in a range of $12.01 to $12.67 on day volume of 77.33 thousand shares, closed regular trading session at $12.24.
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