🔔 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...

See FDA PDUFA update 👇
$Applied Therapeutics (APLT.US)$ : 🤔
⇨ Govorestat
‣ Classic Galactosemia
‣ PDUFA: 11/28/24 (NDA)
🗓️ Last Week’s Adcom & PDUFA decisions:
$BridgeBio Pharma (BBIO.US)$ : Approved 11/22 ✅
⇨Attruby (Acoramidis)
‣ ATTR-CM (transthyretin amyloid cardiomyopathy)
‣ PDUFA: 11/29/24 (NDA)
$AstraZeneca (AZN.US)$ : Discussion, no vote
⇨ Andexxa (coagulation factor Xa)
‣ Life-threatening or uncontrolled bleeding
‣ Adcom: 11/21/24 (sBLA)
$Jazz Pharmaceuticals (JAZZ.US)$ & $Zymeworks (ZYME.US)$ : Approve...

See FDA PDUFA update 👇
$Lexicon Pharmaceuticals (LXRX.US)$ : [Adcom] 🤔
⇨ ZYNQUISTA (sotagliflozin)
‣ Type 1 Diabetes
‣ Adcom: 10/31/24
📣 Last Week’s PDUFA Decisions:
$Iterum Therapeutics (ITRM.US)$ : Approved
⇨ Oral Sulopenem
‣ Uncomplicated Urinary Tract Infections
‣ PDUFA: 10/25/24
$Pfizer (PFE.US)$ : Approved
⇨ ABRYSVO® (RSV vaccine)
‣ Approved for adults younger than 50
‣ PDUFA: 10/24/24 (sBLA)

See FDA PDUFA update 👇
$Iterum Therapeutics (ITRM.US)$ : 🤔
⇨ Oral Sulopenem
‣ Uncomplicated Urinary Tract Infections
‣ PDUFA: 10/25/24
$Lexicon Pharmaceuticals (LXRX.US)$ : [Adcom] 🤔
⇨ ZYNQUISTA (sotagliflozin)
‣ Type 1 Diabetes
‣ Adcom: 10/31/24
📣 Last Week’s PDUFA Decisions:
$ZLDPF: CRL 10/8 ❌
⚠️ due to timing of a 3rd-party mfg. facility reinspection
⇨ Dasiglucagon
‣ Congenital Hyperinsulinism
‣ PDUFA: 10/08/24 (NDA)
$RRBHY: Approved 10/11 ✅
⇨ Itovebi™ (inavolis...

Keep an eye on these recently announced & closed M&As: 👀
🟢 Recently Announced:
⇒ $Organon & Co (OGN.US)$ to acquire Dermavant
⇒ $Rafael Holdings (RFL.US)$ to acquire Cyclo Tx
⇒Crown Lab to acquire $Revance Therapeutics (RVNC.US)$
⇒ $Recursion Pharmaceuticals (RXRX.US)$ merger with Exscientia
🔴 Recently Closed:
⇒ $Johnson & Johnson (JNJ.US)$ acquired V-Wave
⇒ Pharmacosmos acquired $GTHX
What companies will be next? 🤔

$Bio-Path Holdings (BPTH.US)$ +39% 🚀
🚨 Initiates Obesity Therapeutic Program
⇒ BP1001-A
⇒ first non-cancer application of DNAbilize technology

See FDA PDUFA update 👀 👇
📌 This Week’s PDUFA:
$ZLDPF: 🤔
‣ Dasiglucagon
‣ Congenital Hyperinsulinism
‣ PDUFA: 10/08/24
📣 Last Week’s PDUFA decisions:
$Biofrontera (BFRI.US)$ : Approved ✅
⇨ Ameluz
‣ Actinic keratosis
‣ PDUFA: 10/04/24 (sNDA)
$Bristol-Myers Squibb (BMY.US)$ : Approved ✅
⇨ Neoadjuvant Opdivo (nivolumab) + Chemo
‣ NSCLC (perioperative treatment)
‣ PDUFA: 10/08/24

🚨 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...