Browsing Tag
United States Food and Drug Administration
51 posts
Citius Oncology (CTOR) balances LYMPHIR launch momentum with cash runway pressure after Q2 loss
Citius Oncology has LYMPHIR revenue, but cash runway only reaches November 2026. Investors now face launch proof versus dilution risk.
Is biomarker-driven approval the breakthrough ALS drug development has been waiting for?
Can neurofilament light fast-track ALS drug approvals? Explore how Clene Inc.’s FDA signal could reshape timelines, risk, and competition.
Citius Oncology (CTOR) stock in focus as $36.5m financing targets LYMPHIR commercialization
Citius Oncology has capital and an approved CTCL drug. The harder question is whether LYMPHIR can turn niche oncology promise into revenue.
Syntara Limited raises A$8m as ASX:SNT advances amsulostat toward Phase 2b trial
Syntara has capital, catalysts, and dilution. The real question is whether amsulostat data can shift investor trust in ASX:SNT.
Seaport Therapeutics seeks $212m IPO as neuropsychiatry biotech window reopens
Seaport’s IPO tests biotech appetite before key depression data. Here’s why SPTX, PureTech, and psychiatry investors are watching.
Nuvalent (NASDAQ: NUVL) sharpens zidesamtinib case at AACR 2026 with post-TKI ROS1 lung cancer data
Nuvalent’s AACR 2026 zidesamtinib data could reshape the ROS1 NSCLC treatment debate ahead of its FDA decision. Read what it means now.
Could Pixclara become the missing imaging tool in U.S. glioma care after FDA NDA acceptance?
Could Pixclara transform U.S. glioma imaging after FDA NDA acceptance? Explore what Telix Pharmaceuticals Limited’s September catalyst could change next.
Replimune Group (NASDAQ: REPL) plans layoffs after FDA rejects Tudriqev again, forcing a biotech reset
Replimune plans layoffs after the FDA rejected Tudriqev again. Read what the setback means for REPL stock, cash runway, strategy, and rivals.
Why platinum-resistant ovarian cancer remains a high-stakes proving ground for CDH6-targeted ADCs
Can SIM0505 change NextCure’s oncology outlook? Read why platinum-resistant ovarian cancer is the key test case for 2026.
Is Sun Pharmaceutical (NSE: SUNPHARMA) now a wait-for-results stock or an M&A rerating story?
Sun Pharmaceutical (NSE: SUNPHARMA) faces Q4 results, tariff risk, and the Organon bid. Read what could move the stock next.