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...

📣 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)
‣...

🚀 Buckle up for upcoming PDUFAs in September! 👇
$Travere Therapeutic (TVTX.US)$ : FILSPARI (Sparsentan)
$Avadel Pharmaceuticals (AVDL.US)$ : LUMRYZ (FT218)
$Iterum Therapeutics (ITRM.US)$ : Sulopenem - AdCom 🗓️
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Vanda Pharmaceuticals (VNDA.US)$ : Tradipitant
$Zevra Therapeutics (ZVRA.US)$ : Arimoclomol
$Heron Therapeutics (HRTX.US)$ : ZYNRELEF® Vial Access Needle
$Merck & Co (MRK.US)$ : KEYTRUDA+ chemotherapy
$Bristol-Myers Squibb (BMY.US)$ : KarXT (...

🚨 This Week’s PDUFAs:
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Linvoseltamab
‣ Multiple myeloma
‣ PDUFA: 8/22/24 (BLA)
🗓️ Last Week’s PDUFAs:
$Gilead Sciences (GILD.US)$ : Approved 8/14 🎉
⇨ Livdelzi (Seladelpar)
‣ Primary biliary cholangitis (PBC)
‣ PDUFA: 8/14/24 (NDA)
$Ascendis Pharma A/S (ASND.US)$ : Approved 8/12 🎉
⇨ YORVIPATH (palopegteriparatide) 
‣ Hypoparathyroidism
‣ PDUFA: 8/14/24 (NDA)
$Syndax Pharmaceuticals (SNDX.US)$ & $Incyte (INCY.US)$ : Approved 8/14 🎉
⇨ Nikt...

🚨 This Week’s PDUFA:
$Humacyte (HUMA.US)$ : 🤔
⇨ Human Acellular Vessel (HAV)™
‣ Vascular Trauma
‣ PDUFA: 8/10/24 (BLA)
🗓️ Last Week’s AdCom & PDUFAs:
$Zevra Therapeutics (ZVRA.US)$ : Favorable AdCom 👍
🗳️ 11-5 votes in favor
⇨ Arimoclomol
‣ Niemann-Pick disease type C
‣ AdCom: 8/2/24 (NDA)
$Adaptimmune Therapeutics (ADAP.US)$ : Approved 🎉
⇨ TECELRA (afamitresgene autoleucel)
‣ Synovial sarcoma
‣ PDUFA: 8/4/24 (BLA)
$GlaxoSmithKline (GSK.US)$ : Approved 🎉
⇨ Jemperli
‣ Endometria...