The FDA completed the first-cycle review of NRx Pharmaceuticals' preservative-free ketamine ANDA with no major deficiencies related to the drug product, ingredients, labeling, or manufacturing. The only remaining issue is a packaging certification for the vial's luer lock system, which is already used in approved products with millions of units shipped without complaints. No new clinical or safety data are required, and the FDA has committed to a rapid review of this packaging certification. This milestone significantly reduces regulatory risk and moves the drug closer to approval amid a national ketamine shortage and increased demand for preservative-free options.
Diodes Incorporated's stock surged 19.27% over the past 30 days, showing strong market momentum despite a recent 12.30% pullback in the last 10 days. This decline has brought the stock to a local low, potentially attracting investors looking for entr...
Alterity Therapeutics Limited is developing experimental drugs ATH434 and PBT2 targeting Parkinson's and Alzheimer's diseases. The consensus analyst price target remains steady at $8.67, reflecting consistent market confidence, while some analysts li...
Canadian Solar reported mixed Q2 2026 results with a GAAP net loss of $1.40 per share, wider than expected, but revenue of $1.21 billion exceeded estimates. Battery-storage shipments grew 73% year-over-year, while solar-module shipments fell 60% year...
Bilibili reported strong Q2 2026 results with adjusted diluted EPS of $0.23 per ADS, matching estimates, and revenue of $1.17 billion, beating expectations by 0.40%. Gross profit rose 10% and net profit increased 55% year-over-year, improving gross m...
SolarEdge Technologies received conflicting analyst ratings: Jefferies downgraded its price target to $31 with a Hold rating, signaling potential downside, while UBS upgraded it to Buy with a $42 target, citing benefits from new US restrictions on fo...
