Viking Therapeutics is seeking $400 million through stock and convertible-note offerings immediately after VK2735 obesity data sent its shares sharply higher, as the company accelerates Phase 3 development and explores monthly and every-other-week maintenance dosing.
Compass Therapeutics shares plunged to a two-year low after the FDA recommended another survival trial before a tovecimig filing, creating a high-stakes disagreement over whether strong tumor-response and progression-free survival results are enough to support an approval application in advanced biliary tract cancer.
GRAIL shares recorded their strongest session in more than a year after FDA reviewers raised no major analytical or primary safety concerns ahead of a September 23 advisory committee vote on Galleri, the blood test designed to screen adults for signals from more than 50 cancers.
Aquestive Therapeutics has resubmitted its Anaphylm application after responding to FDA concerns over packaging and administration, putting the potential needle-free, orally delivered emergency treatment for anaphylaxis back on a regulatory path toward the U.S. market.
Longeveron shares have lost nearly two-thirds of their value in two sessions after laromestrocel failed the primary endpoint in the ELPIS II study for hypoplastic left heart syndrome, forcing the biotechnology company to reassess its development strategy, conserve cash and review options to maximize shareholder value.
Xenon Pharmaceuticals shares suffered their biggest recent sell-off after the company paused new enrollment in late-stage depression studies over neuropsychiatric adverse events, overshadowing an important FDA filing for azetukalner in focal seizures.
Ultragenyx Pharmaceutical has secured full FDA approval for Fayuvi, the first treatment for Sanfilippo syndrome Type A, giving the rare-disease biotech a major commercial catalyst only weeks after a Phase 3 setback erased nearly half its market value.
ZBeats has received FDA 510(k) clearance for ZBPro Diagnostic v2.0, expanding its ECG-analysis platform from short recordings to continuous datasets lasting as long as 14 days.
SMSbiotech has received an FDA “study may proceed” notification for a Phase 1b U.S. trial of nebulized allogeneic SMS Cells in COPD, with first dosing targeted for the fourth quarter.
FDA clears Emboline’s Emboliner for embolic protection during TAVR, opening a U.S. launch after head-to-head testing against Sentinel.