finance.biggo.com

Celltrion Wins Korea Phase 3 OK for Darzalex Biosimilar; U.S. Phase 3 for Keytruda

Celltrion logoCelltrion
Sig3.25Sen+5.10Env0.00Soc+1.65Gov+1.40

Celltrion said South Korea’s Ministry of Food and Drug Safety approved a Phase 3 protocol amendment for CT-P44, its Darzalex biosimilar, covering a two-year, 394-patient study in refractory or relapsed multiple myeloma with randomization to a CT-P51 arm versus the Keytruda arm. The company also reported the FDA cleared a Phase 3 protocol amendment for CT-P51, enrolling 220 patients with previously untreated metastatic non-squamous non-small cell lung cancer. Darzalex generated about $14.35B in global net sales last year.

Coverage (1)

ABOUT

What is Fimmer?

Most feeds treat all company headlines the same. An executive interview, an office closure, stock analysis, and a data breach can sit side by side with no sense of scale. Fimmer ranks coverage by what matters, so important events stand out and signals are prioritised over noise. We cluster related company news and score each story using a range of metrics, so you see the most crucial stories first.

SCORING

What do the scores mean?

Significance (0–10) measures the scale of the real-world impact. Sentiment and ESG (−10 to +10) indicate the tone of the coverage and whether the change relates to environmental, social, or governance factors. Together, these scores help distinguish meaningful developments from routine company news. More information about our scoring methodology can be found on our About page.

DISCOVERY

Explore more on Fimmer

Search more than 10,000 public companies, browse the company index, explore their scores, and read the coverage behind them, with our core features available to everyone for free.

For more advanced features, Pro gives you access to dynamic feeds, custom sorting, and more ways to track the companies that matter to you.

More with Pro