DISCLAIMER — Not financial advice. Educational content only, not an offer or solicitation to buy or sell any security. Biotech and small/mid-cap stocks are highly speculative and volatile and can result in a partial or total loss of capital. Do your own research and consult a licensed advisor where appropriate. / Contenuti a solo scopo informativo e didattico, non costituiscono consulenza finanziaria né offerta o sollecitazione al pubblico risparmio ai sensi delle normative CONSOB e SEC. Le azioni biotech e le small/mid cap sono strumenti altamente speculativi e volatili e possono comportare la perdita parziale o totale del capitale investito. Si raccomanda di effettuare sempre le proprie ricerche e, se necessario, di rivolgersi a un consulente abilitato.
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
? FDA PDUFA Catalyst Report
Comprehensive Biotech Approval Timeline with Price Targets
? Report Date: November 11, 2025
⏰ Report Time: 3:12 AM CET
? Data Updated: Real-time
⚠️ Disclaimer: This report contains analyst price targets and projections based on market data as of November 11, 2025.
Stock prices and analyst targets are subject to change. These projections are for informational purposes only and should not be considered
investment advice. Always conduct your own due diligence before making investment decisions.
? Current Price
Market price as of Nov 11, 2025
? Analyst Target
12-month consensus price target
✅ Success Upside
% gain if FDA approves drug
❌ Failure Scenario
Estimated price if rejected
November 18, 2025
Arrowhead Pharmaceuticals ARWR
? Plozasiran (ARO-APOC3)
Indicazione: Familial chylomicronemia syndrome (FCS)
Prezzo Attuale:
$39.85
Target Analisti (12M):
$47.47
Upside Base:
+19.16%
✅ SCENARIO APPROVAZIONE FDA
Target: $47.47 (+19.16%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $25.00 (-37.25%)
Status: NDA accepted
November 28, 2025
Otsuka Pharmaceutical N/A
? Sibeprenlimab
Indicazione: Immunoglobulin A nephropathy (IgAN)
ℹ️ Data non disponibile per società non quotate negli USA
Status: BLA accepted, Priority Review
Scambio: Japan Stock Exchange
Scambio: Japan Stock Exchange
November 30, 2025
Kura Oncology / Kyowa Kirin KURA
? Ziftomenib
Indicazione: NPM1-mutant AML
Prezzo Attuale:
$10.32
Target Analisti (12M):
$25.08
Upside Base:
+142.92%
✅ SCENARIO APPROVAZIONE FDA
Target: $25.08 (+142.92%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $8.00 (-22.44%)
Status: NDA accepted, Priority Review
November 30, 2025
Ascendis Pharma ASND
? TransCon CNP (navepegritide)
Indicazione: Achondroplasia in children
Prezzo Attuale:
$196.01
Target Analisti (12M):
$249.80
Upside Base:
+27.43%
✅ SCENARIO APPROVAZIONE FDA
Target: $249.80 (+27.43%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $153.00 (-21.94%)
Status: NDA accepted, Priority Review
November 30, 2025
Genmab / AbbVie ABBV
? Epcoritamab + rituximab + lenalidomide
Indicazione: Relapsed/refractory follicular lymphoma
Prezzo Attuale:
$218.71
Target Analisti (12M):
$nan
Upside Base:
+nan%
✅ SCENARIO APPROVAZIONE FDA
Target: $nan (+nan%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $nan (+nan%)
Status: sBLA accepted, Priority Review
December 7, 2025
Agios Pharmaceuticals AGIO
? Pyrukynd (mitapivat)
Indicazione: Alpha- and beta-thalassemia
Prezzo Attuale:
$41.38
Target Analisti (12M):
$51.80
Upside Base:
+25.19%
✅ SCENARIO APPROVAZIONE FDA
Target: $51.80 (+25.19%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $35.00 (-15.39%)
Status: sNDA accepted (extended from Sept 7)
December 11, 2025
GSK GSK
? Gepotidacin
Indicazione: Uncomplicated urogenital gonorrhea
Prezzo Attuale:
$47.36
Target Analisti (12M):
$50.20
Upside Base:
+6.00%
✅ SCENARIO APPROVAZIONE FDA
Target: $50.20 (+6.00%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $40.00 (-15.53%)
Status: sNDA accepted, Priority Review
December 12, 2025
BioCryst Pharmaceuticals BCRX
? Orladeyo (berotralstat) oral granules
Indicazione: HAE in children 2-11 years
Prezzo Attuale:
$7.20
Target Analisti (12M):
$19.00
Upside Base:
+163.89%
✅ SCENARIO APPROVAZIONE FDA
Target: $19.00 (+163.89%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $9.00 (+25.00%)
Status: NDA accepted, Priority Review (extended from Sept 12)
December 14, 2025
Amgen AMGN
? Uplizna (inebilizumab)
Indicazione: Myasthenia gravis
Prezzo Attuale:
$323.66
Target Analisti (12M):
$319.63
Upside Base:
-1.25%
✅ SCENARIO APPROVAZIONE FDA
Target: $319.63 (-1.25%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $315.00 (-2.66%)
Status: Regulatory submission accepted
December 26, 2025
Cytokinetics CYTK
? Aficamten
Indicazione: Obstructive hypertrophic cardiomyopathy (oHCM)
Prezzo Attuale:
$62.20
Target Analisti (12M):
$77.62
Upside Base:
+24.76%
✅ SCENARIO APPROVAZIONE FDA
Target: $77.62 (+24.76%)
❌ SCENARIO RIGETTO / DELAY
Prezzo Stimato: $56.00 (-10.00%)
Status: NDA accepted
| Data PDUFA | Società / Ticker | Prezzo Attuale | Target Analisti | Upside Approvazione | Prezzo se Rigettato |
|---|---|---|---|---|---|
| November 18, 2025 | Arrowhead Pharmaceuticals ARWR | $39.85 | $47.47 | +19.16% | $25.00 (-37.25%) |
| November 30, 2025 | Kura Oncology / Kyowa Kirin KURA | $10.32 | $25.08 | +142.92% | $8.00 (-22.44%) |
| November 30, 2025 | Ascendis Pharma ASND | $196.01 | $249.80 | +27.43% | $153.00 (-21.94%) |
| November 30, 2025 | Genmab / AbbVie ABBV | $218.71 | $nan | +nan% | $nan (+nan%) |
| December 7, 2025 | Agios Pharmaceuticals AGIO | $41.38 | $51.80 | +25.19% | $35.00 (-15.39%) |
| December 11, 2025 | GSK GSK | $47.36 | $50.20 | +6.00% | $40.00 (-15.53%) |
| December 12, 2025 | BioCryst Pharmaceuticals BCRX | $7.20 | $19.00 | +163.89% | $9.00 (+25.00%) |
| December 14, 2025 | Amgen AMGN | $323.66 | $319.63 | -1.25% | $315.00 (-2.66%) |
| December 26, 2025 | Cytokinetics CYTK | $62.20 | $77.62 | +24.76% | $56.00 (-10.00%) |
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