- Amgen (NASDAQ:AMGN) announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), the study met primary endpoint. Amgen shares traded in a range of $238.29 to $240.31 on day volume of 2.43 million shares, closed regular trading session at $239.12. The company shares traded at $242, up 1.2 percent in the after-hours trading session.
- The Israeli Ministry of Health has approved Y-mAbs Therapeutics’ (NASDAQ:YMAB) lead Durg DANYELZA in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. Y-mAbs shares traded as high as 1.29 percent, in a range of $14.56 to $15.7 on day volume of 189.45 thousand shares, closed regular trading session at $15.55.
- Jaguar Health (NASDAQ:JAGX) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for Napo's NP-300 drug product candidate for the symptomatic relief of diarrhea from cholera. Jaguar Health shares traded as high as 4 percent, in a range of $0.23 to $0.26 on day volume of 4.81 million shares, closed regular trading session at $0.23.
- OKYO Pharma (NASDAQ:OKYO) planning to file an IND with U.S. Food and Drug Administration (FDA) for OK-101 in the fourth quarter of 2022, to treat dry eye disease (DED), with AmbioPharm playing a key role in peptide manufacturing and development. OKYO Pharma shares traded as high as 22.39 percent, in a range of $2.1 to $2.46 on day volume of 84.04 thousand shares, closed regular trading session at $2.44. The company shares traded at $2.32, down 4.13 percent in the after-hours trading session.
- Journey Medical Corporation (NASDAQ:DERM) has enrolled and randomized over 50 percent of the patients in its Phase 3 clinical program to assess the safety, efficacy and tolerability of DFD-29 (Minocycline Modified Release Capsules 40 mg) for the treatment of papulopustular rosacea. Journey Medical Corporation shares traded as high as 8.2 percent, in a range of $3.21 to $3.43 on day volume of 4.87 thousand shares, closed regular trading session at $3.30.
- Outlook Therapeutics (NASDAQ:OTLK) has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics shares traded as high as 13.39 percent, in a range of $1.13 to $1.27 on day volume of 738.55 thousand shares, closed regular trading session at $1.13. The company shares traded at $1.18, up 4.42 percent in the after-hours trading session.
- Jounce Therapeutics (NASDAQ:JNCE) revealed top line data from the randomized Phase 2 SELECT trial evaluating vopratelimab (vopra), its inducible costimulator (ICOS) agonist, in combination with pimivalimab (pimi) versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. Jounce Therapeutics shares traded as low as 10.26 percent, in a range of $3.2 to $3.85 on day volume of 1.06 million shares versus three months average volume of 270.17 thousand shares, closed regular trading session at $3.61. The company shares traded at $3.56, down 1.39 percent in the after-hours trading session.
- Curis (NASDAQ:CRIS) announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study. The agency has placed partial hold on the study in April 2022. Curis shares traded as low as 2.68 percent, in a range of $1 to $1.09 on day volume of 4.53 million shares, closed regular trading session at $1.01. The company shares traded at $1.03, up 1.98 percent in the after-hours trading session.
- Connect Biopharma (NASDAQ:CNTB) has successfully completed its first-in-human Phase 1 study of CBP-174 designed to evaluate safety, tolerability, and pharmacokinetics (PK) in healthy adults. CBP-174 in development for pruritus associated with allergic and inflammatory skin diseases, including atopic dermatitis, was observed to be safe and well-tolerated. Connect Biopharma shares traded as high as 1.39 percent, in a range of $1.39 to $1.46 on day volume of 77.31 thousand shares, closed regular trading session at $1.41. The company shares traded at $1.47, up 4.26 percent in the after-hours trading session.
- Sangamo Therapeutics (NASDAQ:SGMO) announced updated preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. Sangamo shares traded as high as 6.1 percent, in a range of $5.11 to $5.57 on day volume of 1.52 million shares, closed regular trading session at $5.33. The company shares traded at $5.39, up 1.13 percent in the after-hours trading session.
- The Therapeutic Goods Administration (TGA) in Australia has granted provisional approval for Moderna’s (NASDAQ:MRNA) Omicron-containing bivalent 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 $132.82 to $138 on day volume of 3.55 million shares, closed regular trading session at $135.93.
