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.
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Biotech catalyst news and analysis. FDA PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
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Important Disclaimer / Avviso Importante
EN: The dates and events shown in this calendar are collected from publicly available sources and company communications, but may change at any time and may contain errors, inaccuracies, delays or omissions. Some dates are estimated, some timelines may be revised, and certain catalysts may be postponed, cancelled or updated without notice. Always verify with official press releases, SEC filings and primary company sources before making any trading or investment decision.
IT: Le date e gli eventi riportati in questo calendario sono raccolti da fonti pubbliche e comunicazioni societarie, ma possono cambiare in qualsiasi momento e possono contenere errori, imprecisioni, ritardi o omissioni. Alcune date sono stimate, alcune tempistiche possono essere riviste e determinati catalyst possono essere rinviati, cancellati o aggiornati senza preavviso. Verifica sempre con comunicati stampa ufficiali, filing SEC e fonti primarie della società prima di prendere qualsiasi decisione operativa o di investimento.
EN
IT
Biotech Catalyst Calendar – Data View (Google Sheet)
This section explains how to use the Google Sheet data view linked to our Biotech Catalyst Calendar.
The sheet does not replace the calendar. It complements it, providing a structured and filterable way to analyze events, especially for traders focused on late-stage catalysts.
Open Google Sheet (read-only)
The sheet is read-only. Each user can apply their own filters
(Phase, Status, Date) without altering the underlying data.
What this is for
- Filter events by Phase (P1 → PDUFA)
- Focus on upcoming / ongoing catalysts via Status
- Sort events by date
- Isolate P2 / P3 / NDA / BLA / PDUFA events
How to use it (30 seconds)
- Open the Google Sheet using the link above
- Click the filter icons on the header row
- Filter by Phase and Status as needed
- Sort the Date column to see upcoming events
Dates may be estimated and subject to change. Always cross-check with official communications.
Disclaimer (data accuracy & completeness):
This calendar and the related table are compiled from publicly available information and communications, but
may contain errors, inaccuracies, or omissions (e.g., estimated dates, timeline changes, missed updates,
cancelled or rescheduled events). Information can change quickly: always verify with official press releases,
filings, and primary sources before making any decisions.
Biotech Catalyst Calendar – Data View (Google Sheet)
Questa sezione spiega come utilizzare la vista tabellare (Google Sheet) collegata al nostro Biotech Catalyst Calendar.
Il foglio non sostituisce il calendario, ma lo affianca: serve per analizzare gli eventi in modo strutturato e filtrabile, soprattutto per chi vuole concentrarsi sui catalyst late-stage.
Apri Google Sheet (read-only)
Il foglio è in sola lettura. Ogni utente può applicare i propri filtri
(Phase, Status, Date) senza modificare i dati originali.
A cosa serve
- Filtrare gli eventi per Phase (P1 → PDUFA)
- Isolare eventi futuri / in corso tramite lo Status
- Ordinare i catalyst per data
- Concentrarsi su P2 / P3 / NDA / BLA / PDUFA
Come usarlo (30 secondi)
- Apri il Google Sheet tramite il link sopra
- Clicca sugli imbuti nella riga di intestazione
- Filtra Phase e Status in base alle tue esigenze
- Ordina la colonna Date per visualizzare i prossimi eventi
Le date possono essere stimate e soggette a variazioni. Verifica sempre con comunicazioni ufficiali.
Disclaimer (dati e completezza):
Questo calendario e la relativa tabella sono costruiti raccogliendo informazioni da fonti pubbliche e comunicazioni disponibili,
ma possono contenere errori, imprecisioni o omissioni (date stimate, cambi di timeline, aggiornamenti non intercettati,
eventi cancellati o spostati). Le informazioni possono cambiare rapidamente: verifica sempre con comunicati ufficiali,
filing e fonti primarie prima di prendere decisioni operative.
Catalyst Calendar Glossary
Quick definitions for FDA, clinical-trial, and “catalyst” terms used in the calendar & trackers. Switch language with the buttons.
1) FDA / Regulatory
| Term | Meaning |
|---|---|
| PDUFA date | FDA target action date for an NDA/BLA decision (often disclosed via filings/press releases). |
| Priority Review | Shorter FDA review timeline (commonly ~6 months). |
| Standard Review | Standard FDA review timeline (commonly ~10 months). |
| AdCom | Advisory Committee meeting with public discussion and a vote (FDA is not bound by it). |
| NDA / BLA | Applications to approve a drug (NDA) or a biologic (BLA). |
| sNDA / sBLA | Supplemental application (label expansion, new population, new formulation, etc.). |
| Filing acceptance | FDA accepts the application as sufficiently complete to start review (often when PDUFA is set). |
| RTF (Refuse-to-File) | FDA declines to accept an application for review (formal/technical deficiencies). |
| CRL (Complete Response Letter) | FDA does not approve at that time and requests additional info/changes before resubmission. |
| Resubmission (Class 1 / Class 2) | Re-file after CRL; Class 1 = minor changes (often shorter), Class 2 = major (often longer). |
| PDUFA delay/extension | FDA pushes the action date (more time needed for review, inspections, analyses, etc.). |
2) FDA Meetings
| Term | Meaning |
|---|---|
| Type A | Urgent/critical meeting (clinical hold, disputes, time-sensitive issues). |
| Type B | Standard “milestone” meeting (End-of-Phase, pre-NDA/BLA, etc.). |
| Type C | Other focused meeting on specific topics; can still be strategically important. |
| EOP (End-of-Phase) | Aligns requirements to move forward (next phase / registrational plan / filing path). |
| SPA | Special Protocol Assessment: FDA agrees in advance on design/endpoint of a key trial (not a guarantee). |
3) Trial Progress vs Data Release
| Term | Meaning | Data released? |
|---|---|---|
| Enrollment Initiation | First sites/patients start enrolling. | NO |
| Enrollment Complete | Enrollment finished (no more new patients). | NO |
| Trial Completed | Study finished operationally (often LPLV / last patient last visit). | NO |
| Database Lock | Dataset is finalized for analysis (internal milestone). | NO |
| Interim Data | Partial analysis/results at a predefined checkpoint. | YES (partial) |
| Topline Data | High-level results release (often via PR/filing). | YES |
| Data Released / Readout | Explicit statement that results are out / analyzed. | YES |
| Full Results / Full Dataset | Detailed data (often conference/paper). | YES |
| Conference Presentation | Results presented at a meeting (abstract/poster/oral). | USUALLY |
| Publication | Peer-reviewed paper / full write-up. | YES |
Key rule: “Trial Completed” ≠ “Data Released”. Completion is an operational milestone; data can come weeks/months later.
4) Common Clinical Metrics
| Term | Meaning |
|---|---|
| OS | Overall Survival. |
| PFS | Progression-Free Survival. |
| ORR | Objective Response Rate (CR + PR). |
| CR / PR | Complete / Partial Response. |
| SD / PD | Stable Disease / Progressive Disease. |
| DOR | Duration of Response. |
| AE / SAE | Adverse Event / Serious Adverse Event. |
| PK / PD | Pharmacokinetics / Pharmacodynamics. |
| Biomarker | Biological marker used for selection/response/target engagement. |
5) “Accelerators” / Designations
| Term | Meaning |
|---|---|
| ODD | Orphan Drug Designation (rare-disease incentives). |
| FTD | Fast Track Designation (more frequent interactions; potential rolling submission). |
| BTD | Breakthrough Therapy Designation (strong early clinical evidence; closer FDA guidance). |
| RMAT | Regenerative Medicine Advanced Therapy designation (cell/gene/regenerative). |
| RPDD / PRV | Priority Review Voucher (can shorten review or be monetized). |
6) Calendar Fields (how to read them)
| Field | Meaning |
|---|---|
| Stage | Program phase (Preclinical, Phase 1/2/3, NDA/BLA Filing, PDUFA, etc.). |
| Status | Operational status (Ongoing, Trial Completed, Data Released, Clinical Hold, etc.). |
| Next catalyst | Next expected milestone (Topline, Interim, Conference, Submission, Regulatory Decision). |
| Catalyst date | Date or time window (exact / month / quarter / half / year / range). |
1) FDA / Regolatorio
| Termine | Significato |
|---|---|
| Data PDUFA | Data obiettivo entro cui la FDA punta a dare una decisione su NDA/BLA (spesso emerge da filing/PR). |
| Priority Review | Revisione più rapida (tipicamente ~6 mesi). |
| Standard Review | Revisione standard (tipicamente ~10 mesi). |
| AdCom | Comitato consultivo con discussione pubblica e voto (la FDA non è obbligata a seguirlo). |
| NDA / BLA | Domande per approvare un farmaco (NDA) o un biologico (BLA). |
| sNDA / sBLA | Domanda supplementare (estensione indicazione, nuova popolazione, nuova formulazione, ecc.). |
| Accettazione al filing | La FDA accetta la domanda come “sufficientemente completa” per iniziare la review (spesso qui nasce la PDUFA). |
| RTF | Refuse-to-File: la FDA non accetta la domanda (mancanze formali/tecniche). |
| CRL | Complete Response Letter: la FDA non approva e chiede informazioni/azioni prima di una ripresentazione. |
| Ripresentazione (Class 1 / 2) | Dopo CRL: Class 1 = modifiche minori (spesso più veloce), Class 2 = maggiori (spesso più lunga). |
| Ritardo/Estensione PDUFA | La FDA sposta la data decisione (serve più tempo per review/ispezioni/analisi, ecc.). |
2) Meeting FDA
| Termine | Significato |
|---|---|
| Type A | Meeting urgente/critico (clinical hold, dispute, temi time-sensitive). |
| Type B | Meeting “milestone” standard (End-of-Phase, pre-NDA/BLA, ecc.). |
| Type C | Meeting su temi specifici; può essere strategicamente importante. |
| EOP (End-of-Phase) | Allinea requisiti per passare alla fase successiva / percorso registrativo. |
| SPA | Special Protocol Assessment: accordo FDA su design/endpoint di un trial chiave (non è garanzia). |
3) Avanzamento studio vs rilascio dati
| Termine | Significato | Dati rilasciati? |
|---|---|---|
| Enrollment Initiation | Inizio arruolamento (centri/pazienti). | NO |
| Enrollment Complete | Arruolamento completato. | NO |
| Trial Completed | Studio completato “operativamente” (spesso LPLV / ultimo paziente ultima visita). | NO |
| Database Lock | Database chiuso per analisi (milestone interna). | NO |
| Interim Data | Dati parziali a checkpoint predefinito. | SÌ (parziali) |
| Topline Data | Risultati principali in sintesi (spesso PR/filing). | SÌ |
| Data Released / Readout | Indicazione esplicita che i risultati sono usciti/analizzati. | SÌ |
| Full Results / Full Dataset | Dataset completo/dettagliato (spesso congresso/paper). | SÌ |
| Conference Presentation | Presentazione a congresso (abstract/poster/orale). | DI SOLITO |
| Publication | Pubblicazione (paper). | SÌ |
Regola chiave: “Trial Completed” ≠ “Data Released”. La completion è operativa; i dati possono uscire molto dopo.
4) Metriche cliniche comuni
| Termine | Significato |
|---|---|
| OS | Sopravvivenza globale. |
| PFS | Sopravvivenza libera da progressione. |
| ORR | Tasso di risposta obiettiva (CR + PR). |
| CR / PR | Risposta completa / parziale. |
| SD / PD | Stabilità / Progressione. |
| DOR | Durata della risposta. |
| AE / SAE | Evento avverso / Evento avverso serio. |
| PK / PD | Farmacocinetica / Farmacodinamica. |
| Biomarker | Marcatore biologico (selezione pazienti/risposta/target engagement). |
5) Designazioni “acceleranti”
| Termine | Significato |
|---|---|
| ODD | Orphan Drug Designation (incentivi per malattie rare). |
| FTD | Fast Track (interazioni più frequenti; possibile rolling submission). |
| BTD | Breakthrough Therapy (evidenza clinica forte; percorso più guidato). |
| RMAT | Designazione per terapie avanzate rigenerative (cell/gene). |
| RPDD / PRV | Priority Review Voucher (accelera review o monetizzabile). |
6) Campi del calendario (come leggerli)
| Campo | Significato |
|---|---|
| Stage | Fase del programma (Preclinical, Phase 1/2/3, NDA/BLA Filing, PDUFA, ecc.). |
| Status | Stato operativo (Ongoing, Trial Completed, Data Released, Clinical Hold, ecc.). |
| Next catalyst | Prossimo milestone atteso (Topline, Interim, Conferenza, Submission, Decisione FDA). |
| Catalyst date | Data o finestra temporale (precisa / mese / trimestre / semestre / anno / range). |
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