$argenx SE (ARGX.US)$
Game-Changing FDA Approval: VYVGART's New 30-Second Self-Injection Transforms Patient Care

$argenx SE (ARGX.US)$
Clinical Data Breakthrough: VYVGART Achieves 75% Success in gMG Patients, Transforms CIDP Treatment

$argenx SE (ARGX.US)$
Can This New Long-term Data Cement VYVGART as the Leading gMG Treatment?

$argenx SE (ARGX.US)$ (ABM FN) China's regulator has approved the Supplemental Biologics License Application for Vyvgart Hytrulo for the treatment of adults suffering from CIDP. The biotech company announced this after the close.
This approval followed the Adhere study.This concerns an injection of 1,000 milligrams that can be administered once a week. About 50,000 people in China suffer from CIDP.
“It is the first and only treatment approved in China for CIDP,”...

$argenx SE (ARGX.US)$ Last quarter, the company recorded a net profit of 91.4 million euros, compared to a net loss of 72.6 million euros in the same period last year. After nine months there is a net profit of 58.9 million euros against a net loss of 195.9 million euros.
The difference between the operational results and the net result is mainly made up of the financial results and the taxes on the result. At the end of September, Argenx still h...

🔥 3 PDUFA decisions this week! 👇
📌 This week’s PDUFAs:
$Merck & Co (MRK.US)$ : 🤔
⇨ Patritumab deruxtecan
‣ Non-small cell lung carcinoma
‣ PDUFA date: 6/26/24 (BLA)
$Verona Pharma (VRNA.US)$ : 🤔
⇨ Ensifentrine (Nebulized)
‣ Chronic obstructive pulmonary disease
‣ PDUFA date: 6/26/24 (NDA)
$Genmab (GMAB.US)$ : 🤔
⇨ EPKINLY® (Epcoritamab)
‣ Follicular lymphoma
‣ PDUFA date: 6/28/24 (sBLA)
🗓️ Last week’s PDUFAs:
$Merck & Co (MRK.US)$ : Approved 6/17 🎉
⇨ CAPVAXIVE (V116)
‣ Pneumo...

$Sarepta Therapeutics (SRPT.US)$ : ELEVIDYS
$Harmony Biosciences (HRMY.US)$ : WAKIX (pitolisant)
$Bristol-Myers Squibb (BMY.US)$ : KRAZATI (Adagrasib) + Cetuximab
$argenx SE (ARGX.US)$ : VYVGART Hytrulo (Efgartigimod)
$Merck & Co (MRK.US)$ : Patritumab deruxtecan
$Verona Pharma (VRNA.US)$ : Ensifentrine (Nebulized)
$Rocket Pharmaceuticals (RCKT.US)$ : KRESLADI (Marnetegragene autotemcel)

» 15+ upcoming FDA decisions to watch: 👀 👇
$GlaxoSmithKline (GSK.US)$ : Arexvy
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : Elafibranor
$Eli Lilly and Co (LLY.US)$ : Donanemab - AdCom meeting 🗓️
$Regeneron Pharmaceuticals (REGN.US)$ : Kevzara (sarilumab)
$Bristol-Myers Squibb (BMY.US)$ : Augtyro™ (Repotrectinib)
$Geron (GERN.US)$ : Imetelstat
$Merck & Co (MRK.US)$ : V116
$Amgen (AMGN.US)$ : BLINCYTO (blinatumomab)
$Sarepta Therapeutics (SRPT.US)$ : ELEVIDYS
$Merck & Co (MRK.US)$ : KEYTRUDA ...

See remaining FDA PDUFAs in May 👀👇
$Bristol-Myers Squibb (BMY.US)$ : Breyanzi
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna (MRNA.US)$ : mRNA-1345
‣ PDUFA date: End of May 2024 (est.) (BLA)
📣 Buckle up & get ready for next month...
June brings 17 PDUFA decisions: 🔥 🔥
$Catalyst Pharmaceuticals (CPRX.US)$ : FIRDAPSE® (Amifampridine)
$GlaxoSmithKline (GSK.US)$ : Arexvy
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : Elafibranor
$Regeneron Pharmaceuticals (REGN.US)$ : Kevzara (sarilumab)
$Bristol-Myers Squibb (BMY.US)$ : Augtyro...

$argenx SE (ARGX.US)$ sell
$Mingteng International (MTEN.US)$ buy