BeiGene Stock Discussion

🔔 This Week’s PDUFA:
$Ionis Pharmaceuticals (IONS.US)$ : 🤔
⇨ IONIS-APOCIII-LRx (Olezarsen)
‣ FCS (Familial chylomicronemia syndrome)
‣ PDUFA: 12/19/24 (NDA)
🗓️ Last Week’s PDUFA Decisions:
$Checkpoint Therapeutics (CKPT.US)$ : Approved 12/13/24 ✅
⇨ UNLOXCYT (cosibelimab-ipdl)
‣ metastatic or locally advanced cSCC (cutaneous squamous cell carcinoma)
‣ PDUFA: 12/28/24 (resubmitted BLA)
$Neurocrine Biosciences (NBIX.US)$ : Approved 12/13/24 ✅
⇨ CRENESSITY™ (crin...

Buckle up! See FDA PDUFA update 👇
$Ionis Pharmaceuticals (IONS.US)$ ⇨ IONIS-APOCIII-LRx (Olezarsen)
$ZLDPF ⇨ Glepaglutide
$Rhythm Pharmaceuticals (RYTM.US)$ ⇨ IMCIVREE™ (Setmelanotide)
$Mirum Pharmaceuticals (MIRM.US)$  ⇨ Chenodal® (chenodiol)
$Checkpoint Therapeutics (CKPT.US)$ ⇨ Cosibelimab (CK-301)
$Neurocrine Biosciences (NBIX.US)$ ⇨ Crinecerfont capsule
$Bristol-Myers Squibb (BMY.US)$ ⇨ Opdivo® Subcutaneous (nivolumab + hyaluronidase)
$Neurocrine Biosciences (NBIX.US)$ ⇨ Crinecerfont oral solution
$BeiGene (BGNE.US)$ ⇨ Tisleli...

Buckle up! See FDA PDUFA update 👇🧵
$Ionis Pharmaceuticals (IONS.US)$ ⇨ IONIS-APOCIII-LRx (Olezarsen)
$ZLDPF ⇨ Glepaglutide
$Rhythm Pharmaceuticals (RYTM.US)$ ⇨ IMCIVREE™ (Setmelanotide)
$Mirum Pharmaceuticals (MIRM.US)$  ⇨ Chenodal® (chenodiol)
$Checkpoint Therapeutics (CKPT.US)$ ⇨ Cosibelimab (CK-301)
$Neurocrine Biosciences (NBIX.US)$ ⇨ Crinecerfont capsule
$Bristol-Myers Squibb (BMY.US)$ ⇨ Opdivo® Subcutaneous (nivolumab + hyaluronidase)
$Neurocrine Biosciences (NBIX.US)$ ⇨ Crinece...

🚨 This Week’s PDUFAs:
$Heron Therapeutics (HRTX.US)$ : 🤔
⇨ ZYNRELEF® Vial Access Needle
‣ Postoperative pain
‣ PDUFA: 9/23/24 (sNDA)
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ KarXT (xanomeline-trospium)
‣ Schizophrenia
‣ PDUFA: 9/26/24 (NDA)
$Sanofi (SNY.US)$ $Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Dupixent
‣ Chronic obstructive pulmonary disease
‣ PDUFA: 9/27/24 (sBLA)
$BeiGene (BGNE.US)$ $Merck & Co (MRK.US)$ & $Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ Tislelizumab, KEYTRUDA, OPDIVO & YER...

📣 ITRM AdCom 9/9 meeting ongoing 🚗
👀 stay tuned for updates on meeting  outcomes
See 👇 for further info.
🚨 This Week’s AdCom:
$Iterum Therapeutics (ITRM.US)$ : Meeting ongoing 🤔
⇨ Sulopenem
‣ uUTI (Uncomplicated Urinary Tract Infection)
‣ AdCom: 9/9/24
🚨 Last Week’s PDUFAs:
$Travere Therapeutic (TVTX.US)$ : Approved 9/5 🎉
⇨ FILSPARI (Sparsentan)
‣ IgA nephropathy (IgAN)
‣ PDUFA: 9/5/24
$Avadel Pharmaceuticals (AVDL.US)$ : Awaiting decision 🤔
⇨ LUMRYZ (sodium oxybate)
‣...

$AstraZeneca (AZN.US)$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom: 7/25/24 (sBLA)
$BeiGene (BGNE.US)$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas (1L)
‣ PDUFA: July 2024 (sBLA)

Don't miss out! 🎯👇
$Phathom Pharmaceuticals (PHAT.US)$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA: 7/19/24 (NDA)
$AstraZeneca (AZN.US)$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom:  7/25/24(sBLA)
$BeiGene (BGNE.US)$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas
‣ PDUFA: July 2024 (BLA)

1 PDUFA this week! 🔥
$Arcutis Biotherapeutics (ARQT.US)$ : pending decision 🤔
⇨ ARQ-151 topical roflumilast cream
‣ Atopic Dermatitis (aged 6 & older children)
‣ PDUFA date: 7/7/24 (sNDA)
Upcoming PDUFAs & AdCom in July: 📅👇
$Phathom Pharmaceuticals (PHAT.US)$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA date: 7/19/24 (NDA)
$AstraZeneca (AZN.US)$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom date:  7/25/24(sBLA)
$BeiGene (BGNE.US)$ :...

🔥 July: 3 PDUFAs & 1 AdCom
$Arcutis Biotherapeutics (ARQT.US)$ : ARQ-151 topical roflumilast cream
$Phathom Pharmaceuticals (PHAT.US)$ : VOQUEZNA® (vonoprazan)
$AstraZeneca (AZN.US)$ : Imfinzi + chemotherapy - AdCom
$BeiGene (BGNE.US)$ : TEVIMBRA (tislelizumab)