Browsing Tag
United States Food and Drug Administration
96 posts
IKT-001 gains orphan status, but Inhibikase Therapeutics still faces imatinib’s safety challenge
Inhibikase Therapeutics gains FDA orphan status for IKT-001 after a $50 million raise. See how trial costs and dilution shape the outlook.
Picard Medical can lift PMI’s quoted price 50-fold, but can it repair the balance sheet?
Picard Medical’s share consolidation could strengthen its quoted price and preserve market access, but investors still need evidence of improved equity, liquidity and commercial scale.
Dyne Therapeutics (NASDAQ: DYN) slides as $375m stock sale resets valuation
Dyne Therapeutics strengthens launch funding, but its discounted $375 million share sale tests whether regulatory progress can outrun dilution pressure.
Palvella Therapeutics (NASDAQ: PVLA) rebounds 15% as investors reassess FDA path
Palvella Therapeutics is recovering from a sharp selloff as investors separate its advancing QTORIN rolling application from uncertainty surrounding a second indication.
Telix Pharmaceuticals (ASX: TLX) revenue tops $247m as pipeline spending rises
Telix Pharmaceuticals revenue is accelerating, but rising R&D spending and FDA decisions will determine whether ASX: TLX can regain its premium.
Mesoblast (ASX: MSB; Nasdaq: MESO) CEO invests A$2.73m as Ryoncil growth shifts focus to execution
Mesoblast Chief Executive Silviu Itescu has paid A$2.73 million to increase his ownership, adding an alignment signal as Ryoncil sales and late-stage programs reshape the company.
Dimerix (ASX: DXB) acquires Phase 2-ready DMX-652 as acute kidney injury deal reshapes renal pipeline
Dimerix has acquired a Phase 2-ready acute kidney injury candidate with an open United States clinical application, giving the biotechnology company a nearer-term catalyst beyond its long-running ACTION3 programme.
Takeda’s zasocitinib shows high clearance rates at difficult psoriasis sites
Scalp and palmoplantar clearance rates approached 70% to 77%, but regulatory review, safety labelling and market access will determine the commercial impact.
NeuroLexIQ adds Canary Speech voice AI to injury intake, but can an early signal withstand legal scrutiny?
NeuroLexIQ will use Canary Speech voice analysis to flag possible concussion cases during the first attorney intake call. The pilot could accelerate referrals, but clinical validation, informed consent and evidentiary discipline will determine its credibility.
Mesoblast (ASX: MSB) clears key treatment milestone ahead of mid-2027 back pain trial readout
Mesoblast has treated at least 300 patients in MSB-DR004, starting the final 12-month clock towards a mid-2027 readout and potential United States filing. The milestone strengthens execution visibility, but it does not provide new efficacy data.