- Pfizer (NYSE:PFE) announced positive top-line results from its pivotal U.S. Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD). The study met two co-primary objectives, associated with immunogenicity responses. Pfizer shares traded in a range of $48.55 to $50.39 on a day volume of 24.91 million shares, closed regular trading session at $50.11.
- The European Commission has granted orphan medicinal product designation in the EU to Relief Therapeutics and Acer Therapeutics’ (NASDAQ:ACER) lead asset ACER-001 (sodium phenylbutyrate) for the potential treatment of patients with Maple Syrup Urine Disease (MSUD). Acer shares traded in a range of $1.45 to $1.56 on a day volume of 319.36 thousand shares, closed regular trading session at $1.47.
- Aptinyx (NASDAQ:APTX) announced results from a Phase 2b clinical study evaluating the effects of NYX-2925 in patients with fibromyalgia. NYX-2925 missed primary endpoint of the study, statistically significant separation from placebo. Aptinyx shares traded in a range of $0.37 to $0.45 on a day volume of 4.48 million shares, closed regular trading session at $0.41.
- UNITY Biotechnology (NASDAQ:UBX) announced positive 12 and 18-week data from its Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). UBX1325 demonstrated appropriate safety and tolerability profile with no cases of intraocular inflammation, retinal vein occlusion, endophthalmitis, or vasculitis. UNITY Bio shares traded in a range of $1.26 to $1.85 on a day volume of 93.92 million shares, closed regular trading session at $1.31.
- The Korean Ministry of Food and Drug Safety (KMFDS) has approved Novavax’s (NASDAQ:NVAX) post approval change application for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 years. Novavax shares traded in a range of $40.57 to $43.06 on a day volume of 4.99 million shares, closed regular trading session at $41.47.
- Daiichi Sankyo and AstraZeneca's (NASDAQ:AZN) ENHERTU (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). AstraZeneca shares traded in a range of $64.69 to $67.18 on a day volume of 11.22 million shares, closed regular trading session at $66.64.
- The U.S. Food and Drug Administration (FDA) has approved Guardant Health’s (NASDAQ:GH) Guardant360 CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations for treatment with AstraZeneca's (NASDAQ:AZN) ENHERTU. Guardant shares traded in a range of $53.04 to $54.96 on a day volume of 525.91 thousand shares, closed regular trading session at $54.18.
