Harmony Biosciences Stock Forum

🔥 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...

Keep an eye on these M&As: 👀
$Biogen (BIIB.US)$ to acquire HI-Bio™
$Johnson & Johnson (JNJ.US)$ to acquire Proteologix
OnKure, Inc. merger with $Reneo Pharmaceuticals (RPHM.US)$
$Harmony Biosciences (HRMY.US)$ acquired Epygenix Tx
What companies will be next? 🤔

$Harmony Biosciences (HRMY.US)$
ADDITIONAL
HARMONY BIOSCIENCES HOLDINGS INC: REITERATES 2024 NET PRODUCT REVENUE GUIDANCE OF $700 - $720 MLN

$Harmony Biosciences (HRMY.US)$
NEWS
HARMONY BIOSCIENCES HOLDINGS INC: POTENTIAL PAYMENTS OF UP TO $515 MLN IF CERTAIN SALES MILESTONES ARE ACHIEVED
HARMONY BIOSCIENCES Q1 PRETAX PROFIT USD 51.785 MILLION VS. IBES ESTIMATE USD 47.9 MILLION

$Pfizer (PFE.US)$  Phase 2
$Leap Therapeutics (LPTX.US)$  Phase 2
$Vera Therapeutics (VERA.US)$  Phase 2b
$4D Molecular Therapeutics (FDMT.US)$  Phase 2
$Adverum Biotechnologies (ADVM.US)$  Phase 2
$Denali Therapeutics (DNLI.US)$  Phase 2
$Akero Therapeutics (AKRO.US)$  Phase 2b
$Spruce Biosciences (SPRB.US)$  Phase 2
$Xencor (XNCR.US)$  Phase 2
$Alnylam Pharmaceuticals (ALNY.US)$  Phase 2
$Harmony Biosciences (HRMY.US)$  Phase 2
$Annexon (ANNX.US)$  Phase 2a
$Roivant Sciences (ROIV.US)$...