FDA PDUFA Calendar – December 2025 | Merlintrader trading Blog

FDA PDUFA Calendar – December 2025

Fourteen binary biotech and healthcare catalysts clustered between December 5 and December 31, 2025 – from large-cap label expansions to small/mid-cap survival events.

Time window: 5–31 December 2025 14 drugs · 9 small/mid caps · 5 large caps Updated: 31 December 2025 (CET)

Executive Summary

December 2025 is the densest FDA decision month of the year. In only 26 days the agency is expected to rule on fourteen key dossiers across oncology (Breyanzi), cardiology (Aficamten), ophthalmology (EYLEA HD, LYTENAVA), rare diseases (Narsoplimab, Mitapivat), endocrine disorders (Relacorilant), infectious diseases (Zoliflodacin) and more.

Binary profile: for the small and mid caps in this list, each PDUFA is effectively a “make or break” moment with historical ranges often between +100–300% on approval and −50–80% on rejection, especially where balance sheets are already stretched.

Liquidity and volatility: around the key dates (December 5–7, 12–16, 26, 30–31) spreads tend to widen, implied volatility spikes and intraday moves can be violent. All scenarios here are indicative ranges, not price targets.

Quick structure overview

Fourteen cards with trial, efficacy, safety, binary ranges and retail sentiment for each PDUFA.
Retail sentiment sourced from Stocktwits, Reddit and X; it is noisy and changes quickly.
No buy/sell calls, no recommendations; this is an educational catalyst dashboard only.

Sentiment methodology: the “Retail sentiment” snippets inside each card are based on a qualitative scan of comments and message volume on Stocktwits, X (Twitter) and Reddit communities (for example r/biotech, r/biotechplays and similar) as of 4 December 2025, 23:45 CET. These are the opinions of non-professional traders, often highly emotional and speculative. They should never be confused with fundamental research or used in isolation for decisions.

Fourteen December PDUFA Catalysts

BMY

Dec 5, 2025

Breyanzi

Relapsed/refractory large B-cell lymphoma

Trial: TRANSCEND

Efficacy: ORR 97.1%, CR 94.2% in key cohort.

Safety: No new safety signals disclosed.

Status (as of Dec 27, 2025): APPROVED — FDA approval granted 4 December 2025 for relapsed/refractory marginal zone lymphoma (event completed).

Retail sentiment: ~57% bullish – “already priced in for a large cap, limited share price reaction.”

Bull scenario +5–10%

Bear scenario −2–5%

Critical (label, not survival)

AXGN

Dec 5, 2025

Avance Nerve Graft (BLA)

Peripheral nerve regeneration

Transition: From tissue product to full biologic license.

Exclusivity: Up to 12 years if approved as biologic.

Status: Labeling feedback already received in November 2025.

Status (as of Dec 27, 2025): APPROVED — BLA approved 3 December 2025 for AVANCE (acellular nerve allograft–arwx); product now fully licensed in the US.

Retail sentiment: ~89% bullish – “either above 20 or delisting, 12-year exclusivity is huge.”

Bull scenario $18–25

Bear scenario $6–9

Critical

AGIO

Dec 7, 2025

PYRUKYND (mitapivat)

Alpha and beta thalassemia (TD/NTD)

Trial: ENERGIZE / ENERGIZE-T

Regulatory: Proposed REMS and three-month extension; positive CHMP opinion in November 2025.

Status (as of Dec 27, 2025): APPROVED — FDA expanded approval late December 2025 under the brand name Aqvesme (mitapivat) for anemia in adults with alpha- or beta-thalassemia (event completed).

Retail sentiment: ~77% bullish – “CHMP already positive, REMS manageable, triple-digit handle possible.”

Bull scenario +20–40%

Bear scenario −15–25%

High

BCRX

Dec 12, 2025

ORLADEYO (berotralstat) – pediatric

Hereditary angioedema (ages 2–11)

Trial: APeX-P

Attack reduction: More than 90% vs baseline.

Positioning: First oral prophylactic HAE option in this pediatric segment.

Status (as of Dec 27, 2025): APPROVED — sNDA approved 12 December 2025 for Orladeyo oral granules (pellets) for children aged 2 to <12 years with HAE.

Retail sentiment: ~84% bullish – “first oral pediatric HAE, many call for 12–18 after approval.”

Bull scenario $12–18

Bear scenario $6–8

High

MIST

Dec 13, 2025

CARDAMYST (etripamil nasal spray)

Paroxysmal supraventricular tachycardia

Trial: RAPID Phase 3

Formulation: Self-administered intranasal calcium-channel blocker.

IP: Intellectual property protection into July 2042.

Status (as of Dec 27, 2025): APPROVED — FDA approval announced 12 December 2025 for CARDAMYST (etripamil) nasal spray for PSVT (event completed).

Retail sentiment: ~92% bullish – “IP until 2042, could move several multiples on approval.”

Bull scenario +100–200%

Bear scenario −50–70%

Critical

AMGN

Dec 14, 2025

UPLIZNA – generalized myasthenia gravis

gMG patients

Trial: MINT Phase 3

Efficacy: 72% achieved at least 3-point improvement in MG-ADL.

Safety: No new safety signals reported.

Status (as of Dec 27, 2025): APPROVED — FDA approval announced 11 December 2025 for adults with generalized myasthenia gravis (AChR+ and MuSK+).

Retail sentiment: ~54% bullish – “big cap, incremental effect on share price rather than binary shock.”

Bull scenario +3–6%

Bear scenario −2–4%

Moderate

INVA

Dec 15, 2025

Zoliflodacin

Antibiotic-resistant gonorrhea

First-in-class: First new oral therapy for gonorrhea in decades.

Efficacy: 90.9% urethral cure vs 96.2% for standard regimen.

Mechanism: Distinct DNA gyrase inhibitor, important for resistance patterns.

Status (as of Dec 27, 2025): APPROVED — FDA approved 12 December 2025 as Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea (event completed).

Retail sentiment: ~95% bullish – “first new antibiotic in forty years, many comments project 25 or more.”

Bull scenario +120–250%

Bear scenario −50–75%

Critical

ALDX

Dec 16, 2025

Reproxalap (CHAMBER)

Dry eye disease and allergic conjunctivitis

Regulatory: CRL in April 2025, resubmission filed in July after running an additional trial meeting its primary endpoint.

Mechanism: Novel RASP modulator.

Status (as of Dec 27, 2025): DELAYED — FDA has extended the PDUFA target action date to 16 March 2026; no US approval yet, decision formally delayed.

Retail sentiment: ~81% bullish – “third attempt for the same program, many see 10–16 or below 2 if rejected.”

Bull scenario $10–16

Bear scenario $1–2

High

OMER

Dec 26, 2025

Narsoplimab

HSCT-TMA (post-transplant complication)

Mechanism: MASP-2 inhibitor targeting the lectin pathway.

Response rate: Around 61% in pivotal data.

Financing risk: Balance sheet strained; this is a genuine survival-type event.

Status (as of Dec 27, 2025): APPROVED — FDA approval announced 24 December 2025 as Yartemlea (narsoplimab-wuug), the first and only therapy indicated for TA-TMA (event completed).

Retail sentiment: ~87% bullish but extremely polarised – “either 30 plus or almost no equity left.”

Bull scenario $20–40

Bear scenario $1–3

Critical (survival)

CYTK

Dec 26, 2025

Aficamten

Obstructive hypertrophic cardiomyopathy (oHCM)

Trials: SEQUOIA-HCM / MAPLE-HCM

pVO₂: Superior to metoprolol with p < 0.0001.

NYHA class: Improvement in 51% of treated vs 26% control.

Status (as of Dec 27, 2025): APPROVED — FDA approval announced 19 December 2025 as Myqorzo (aficamten) for adults with symptomatic obstructive HCM to improve functional capacity and symptoms.

Retail sentiment: ~88% bullish – “many posts mention 70–100 and a possible take-out by a larger cardio player.”

Bull scenario $70–100

Bear scenario $25–35

Critical

CORT

Dec 30, 2025

Relacorilant

Endogenous Cushing’s syndrome

Trials: GRACE / GRADIENT

Safety: No adrenal insufficiency, no hypokalaemia in pivotal data.

Financials: Around 603M cash and roughly 675M revenue in 2024; not a survival event.

Status (as of Dec 31, 2025): CRL (NOT APPROVED) — on 31 December 2025 the FDA issued a Complete Response Letter (CRL) for relacorilant in endogenous Cushing’s syndrome; the NDA was not approved and Corcept will have to discuss additional data/analyses with the agency before a potential resubmission.

Retail sentiment: ~74% bullish – “cash fortress, many simply assume approval, focus is on how fast launch scales.”

Bull scenario +20–40%

Bear scenario −10–20%

High

VNDA

Dec 30, 2025

Tradipitant (NEREUS)

Prevention of vomiting induced by motion

Novelty: First new dedicated motion sickness drug in roughly forty years.

Regulatory: Partial clinical hold on tradipitant for motion sickness was lifted on 4 December 2025 ahead of the PDUFA date.

Status (as of Dec 31, 2025): APPROVED — FDA approval announced 30 December 2025 under the brand name NEREUS (tradipitant) for the prevention of vomiting induced by motion in adults (event completed).

Retail sentiment: ~79% bullish – “first new option in decades, many model a wide binary range.”

Bull scenario +60–120%

Bear scenario −50–70%

Moderate/high

REGN

Q4 2025 (TBD)

EYLEA HD

Macular edema from retinal vein occlusion (RVO)

Timing: Decision pushed into Q4 2025 after manufacturing issues.

Trial: QUASAR Phase 3

Dosing: Higher-dose formulation supporting less frequent dosing; RVO expansion on top of existing approvals.

Status (as of Dec 27, 2025): APPROVED — indication approved in November 2025; Eylea HD 8 mg now labeled for macular edema following RVO with up to q8-week dosing (event completed).

Retail sentiment: ~52% bullish – “big cap with a very diversified revenue base, most see limited incremental move.”

Bull scenario +4–8%

Bear scenario −3–6%

Moderate

OTLK

Dec 31, 2025

LYTENAVA (bevacizumab-vikg)

Wet age-related macular degeneration

First-in-market: First FDA-approved ophthalmic bevacizumab formulation.

Trial: NORSE EIGHT – week 8 endpoint missed, week 12 met.

EU/UK: Already commercialised since Q2 2025 with emerging real-world data.

Status (as of Dec 31, 2025): CRL (NOT APPROVED) — on 31 December 2025 the FDA issued a Complete Response Letter (CRL) for the resubmitted BLA for ONS-5010/LYTENAVA in wet AMD; the application was not approved and the agency has again requested additional confirmatory efficacy evidence before any potential future approval in the U.S.

Retail sentiment: ~94% bullish – “first ophthalmic bevacizumab, many comments talk about 6–10 pre-market on approval.”

Bull scenario +150–300%

Bear scenario −60–80%

Critical

Tools I personally use

Below are some of the platforms I actually use every day for charts, news flow and community. Some links may include a referral component and can support the site at no extra cost to you.

Finviz – charts and screeners

Seeking Alpha – research and earnings

Stocktwits – live trader sentiment

Medved Trader – advanced charts and tape tools

ChartsWatcher – catalyst scanner and strategy tools

If this type of work helps you and you want to support keeping Merlintrader trading Blog free, you can optionally send a small one-off donation via PayPal.

Legal and risk disclaimer

Nature of this page: this PDUFA calendar is provided exclusively for informational and educational purposes. It does not contain and must not be interpreted as investment advice, individual financial guidance or a solicitation to buy or sell any security.

No recommendations: all tickers mentioned are presented only as examples of upcoming catalysts. Nothing here is a target price, a rating, or a suggestion to open, close or modify positions. Every reader remains fully responsible for his or her own decisions.

Data and accuracy: the information has been built from public sources such as SEC filings, FDA calendars and official company press releases. Even with double-checks, errors, omissions or subsequent changes are always possible. Regulatory dates, labels and trial details can change with new documents.

Risk profile: biotech securities, especially small-cap names around binary FDA events, are among the most volatile instruments in the market. It is possible to lose a substantial part or even the totality of the capital invested in a very short time.

Regulatory compliance: this page is written with the intention of remaining compatible with CONSOB rules for Italian readers and with SEC and Regulation FD principles for readers in the United States. It is not research produced by a regulated broker-dealer or investment firm.

Medical information: descriptions of diseases and therapies are simplified and strictly for context. They are not medical advice and must not be used to make health-related decisions. For any medical matter, always refer to qualified healthcare professionals.

Authors: Merlintrader and Jane.

Independent traders focusing on biotech catalysts and practical tools for individual investors, without marketing spin.

In every report I share things as I personally interpret them, based on the raw data from official filings, company communications, and primary verified sources where available. I do not write to promote enthusiasm or pessimism; these are simply my own views as a trader like you, not as a professional analyst.

Market sentiment can shift quickly. Official documents and numbers remain what they are. It is also possible for me to make mistakes: collecting and cross-checking FDA timelines, clinical data, filings and corporate updates is complex, so inaccuracies may occur. If you spot something that looks off, feel free to let me know and I will correct it.

Remember that I am not a professional; do not expect perfection here, only transparency, data, and consistent effort.

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View the Catalyst Calendar →

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Authors: Merlintrader, Jane and Gemini

Author's note (English)

In every report I share things as I personally interpret them, based on raw data from official company filings, regulatory documents, conference call transcripts and other primary sources where available. Some parts of the research and structure are supported by AI assistants (Jane and Gemini), which help me organise data, cross-check details and improve charts or visuals. However, any interpretation, opinion and final judgement remain entirely my own as a trader like you, not as a licensed financial advisor or registered analyst. Market sentiment can change quickly, while official documents and numbers remain what they are. It is also possible for me to make mistakes: collecting and cross-checking FDA timelines, clinical data, filings and corporate updates is complex, so inaccuracies may occur. If you spot something that looks off, feel free to let me know and I will correct it. Please do not treat this report as professional investment advice, but as one more piece of information to compare with your own research and the opinion of qualified professionals.

AI usage disclosure (English)

This report has been prepared using a human + AI workflow. Drafting, editing and data organisation are supported by generative AI tools, for example large language models provided by third-party vendors, based on prompts and instructions defined by the author. All sources are publicly available, and the final selection of data, checks, opinions and conclusions is carried out by the author, who remains fully responsible for the content.

Legal disclaimer (English) – please read carefully

This report is provided strictly for informational and educational purposes. It is not and must not be interpreted as investment advice, investment research in a regulatory sense, portfolio management, or a recommendation to buy or sell any security or financial instrument. The author is not a licensed investment advisor, not a registered broker, and not a FINRA/SEC-registered analyst or portfolio manager. Any reference to potential scenarios, price levels or catalysts is purely illustrative and reflects a personal, non-professional view based on publicly available information at the time of writing.

Nothing in this document should be considered a solicitation to the public to invest, nor an invitation to raise capital, nor a promise of profit or of capital protection. Biotech and healthcare stocks in particular can be highly volatile and speculative, especially around clinical and regulatory catalysts. Before making any investment or trading decision, always perform your own due diligence and consider consulting a qualified, regulated financial professional who can evaluate your personal situation, objectives and risk tolerance. Past performance and historical examples do not guarantee future results.

The author may hold, or may have held, long or short positions in some of the securities mentioned in this report, and may open, close or modify such positions without notice. This potential alignment of interests may influence the tone or focus of the analysis. No position held by the author changes the fact that this document is not investment advice and should not be used as such.

I testi completi dei disclaimer e delle condizioni d'uso, in versione sia italiana che inglese, sono disponibili nelle pagine legali ufficiali del sito Merlintrader, indicated here sotto.

If you find these reports useful and want to support the project, you can make a voluntary one-time donation via PayPal or Buy Me a Coffee. It helps cover data, tools and hosting costs so that the content can remain independent and freely accessible.

Tools and research platforms used in this report

Below is a shortlist of tools and platforms that I personally use to follow prices, catalysts, fundamentals and sentiment. Links are provided for transparency and convenience only.

Finviz Elite – advanced stock screener and charting, used for heatmaps, relative performance and technical context.
ChartsWatcher – real-time, next-generation scanner for the US stock market. Used to monitor intraday momentum, volume spikes and colour-coded pattern alerts.
Stocktwits – social stream focused on tickers, used only as a sentiment and activity indicator, not as a source of investment recommendations.
Monica.im – AI assistant used for light reports, drafting and quick research; helps with structuring notes and first-pass analysis alongside the deep-dive work published on Merlintrader.
Medved Trader – professional trading and charting platform used for real-time execution, order-flow and detailed intraday analysis. No affiliate link; mentioned because it is part of the actual trading workflow.
Merlintrader trading Blog – the home for biotech-focused reports, dashboards and educational articles that expand on the ideas mentioned in this document.

Some of the links above are affiliate links. If you decide to subscribe or purchase through them, it may generate a small commission for Merlintrader at no extra cost to you. This helps keep the site online and the reports freely accessible. You are under no obligation to use these links; always choose the solution that best fits your needs and your own evaluation.

Full legal information, risk warnings and terms of use (in both Italian and English) are available on the official Merlintrader legal pages:

Italian version: Disclaimer e avvertenze sui rischi | Condizioni d'uso e informativa sulla privacy

The same pages also include the corresponding English text or an English equivalent of the main legal notices, so that international readers can access the core risk disclosures and terms of use.

Biotech Catalyst Calendar

For a broader, continuously updated view of upcoming biotech catalysts (PDUFA dates, major clinical readouts, regulatory events and key conferences), you can consult the dedicated calendar on Merlintrader.

Open the Biotech Catalyst Calendar

Authors: Merlintrader, Jane and Gemini

Nota dell'autore (Italiano)

In ogni report condivido ciò che vedo e come lo interpreto personalmente, partendo dai dati grezzi di documenti ufficiali, comunicazioni delle società, trascrizioni delle call e altre fonti primarie quando disponibili. Alcune parti del lavoro di ricerca e di impaginazione sono supportate da assistenti IA (Jane e Gemini), che mi aiutano a organizzare i dati, verificare i dettagli e migliorare grafici o elementi visivi. Le valutazioni finali, le opinioni e le conclusioni restano comunque esclusivamente mie, da trader come te, non da consulente finanziario abilitato o analista iscritto ad albi professionali. Il sentiment di mercato può cambiare molto rapidamente, mentre i documenti ufficiali e i numeri restano quelli che sono. È anche possibile che commetta errori: raccogliere e confrontare tempistiche FDA, dati clinici, filing e aggiornamenti societari è un lavoro complesso, quindi qualche imprecisione può sfuggire. Se noti qualcosa che non ti torna, segnalamelo e lo correggerò. Non considerare questo report come consulenza personalizzata, ma come materiale informativo da confrontare con le tue ricerche e con il parere di professionisti qualificati.

Informativa sull'uso di IA generativa (Italiano)

Questo report è stato redatto utilizzando un flusso di lavoro combinato umano + IA. La stesura, la revisione e l'organizzazione dei dati sono supportate da strumenti di intelligenza artificiale generativa, ad esempio modelli linguistici di grandi dimensioni forniti da terze parti, sulla base di istruzioni e controlli definiti dall'autore. Le fonti utilizzate sono pubbliche e la selezione finale delle informazioni, le verifiche, le opinioni e le conclusioni restano sotto la responsabilità esclusiva dell'autore.

Disclaimer legale (Italiano) – leggere con attenzione

Questo report ha finalità esclusivamente informative e didattiche. Non costituisce in alcun modo consulenza in materia di investimenti, ricerca in materia di investimenti in senso regolamentare, gestione di portafogli, né raccomandazione personalizzata o generica ad acquistare, vendere o detenere strumenti finanziari. L'autore non è un consulente finanziario abilitato all'esercizio della professione, non è un promotore finanziario, non è un analista iscritto ad albi professionali e non svolge servizi di investimento ai sensi della normativa vigente.

Qualsiasi riferimento a scenari possibili, livelli di prezzo, probabilità o catalyst ha valore puramente illustrativo e riflette una valutazione personale e non professionale basata su informazioni pubbliche disponibili al momento della stesura. Nulla di quanto scritto rappresenta sollecitazione al pubblico risparmio, offerta al pubblico di prodotti finanziari o promessa di rendimento o di protezione del capitale. In particolare, i titoli biotech e healthcare possono essere estremamente volatili e speculativi, soprattutto in prossimità di eventi clinici o regolatori (PDUFA, letture di trial, ecc.).

L'autore può detenere, o aver detenuto, posizioni long o short su alcuni degli strumenti finanziari menzionati nel report e può aprire, chiudere o modificare tali posizioni senza preavviso. Questa possibile coincidenza di interessi può influenzare il taglio o l'attenzione dell'analisi. La presenza di eventuali posizioni personali non trasforma in alcun modo questo documento in consulenza finanziaria e non deve essere interpretata come tale.

Prima di assumere qualsiasi decisione di investimento o di trading, è indispensabile effettuare le proprie analisi e valutazioni e, se necessario, rivolgersi a un consulente finanziario indipendente e abilitato, in grado di considerare la tua situazione personale, gli obiettivi e la propensione al rischio. Le informazioni riportate possono contenere errori, omissioni o non essere aggiornate; né l'autore né Merlintrader possono essere ritenuti responsabili per eventuali perdite, dirette o indirette, derivanti dall'utilizzo di questo contenuto.

I testi completi dei disclaimer e delle condizioni d'uso, in versione sia italiana sia inglese, sono disponibili nelle pagine legali ufficiali del sito Merlintrader, indicate qui sotto.

Se trovi utili questi report e vuoi sostenere il progetto, puoi fare una donazione volontaria una tantum tramite PayPal o Buy Me a Coffee. È un aiuto concreto per coprire i costi di dati, strumenti e hosting, così i contenuti possono restare indipendenti e liberamente accessibili.

Strumenti e piattaforme di ricerca usati in questo report

Qui sotto trovi una selezione di strumenti e piattaforme che uso personalmente per seguire prezzi, catalyst, fondamentali e sentiment. I link sono forniti solo per trasparenza e comodità del lettore.

Finviz Elite – screener avanzato e piattaforma grafica, usato per heatmap, performance relative e contesto tecnico.
ChartsWatcher – scanner real-time di nuova generazione per il mercato azionario USA. Lo uso per monitorare momentum intraday, picchi di volume e alert cromatici sui pattern.
Stocktwits – flusso social focalizzato sui ticker, usato solo come indicatore di sentiment e attività, non come fonte di raccomandazioni di investimento.
Monica.im – assistente AI usato per report leggeri, drafting e ricerche veloci; utile per strutturare note e prime analisi insieme al lavoro di approfondimento pubblicato su Merlintrader.
Medved Trader – piattaforma professionale di trading e charting usata per esecuzione real-time, order-flow e analisi intraday dettagliata. Nessun affiliate link; è citata perché fa parte del workflow operativo reale.
Merlintrader trading Blog – la casa dei report focalizzati sul biotech, delle dashboard e degli articoli educativi che approfondiscono i temi menzionati in questo documento.

Alcuni dei link sopra indicati sono link affiliati. Se decidi di iscriverti o acquistare tramite uno di essi, Merlintrader potrebbe ricevere una piccola commissione senza costi aggiuntivi per te. Questo aiuta a mantenere il sito online e i report liberamente accessibili. Non hai alcun obbligo di usare questi link: scegli sempre la soluzione che ritieni più adatta alle tue esigenze e alla tua valutazione personale.

Le informazioni legali complete, le avvertenze sui rischi e le condizioni d'uso, in versione sia italiana sia inglese, sono disponibili nelle pagine legali ufficiali di Merlintrader:

Versione italiana: Disclaimer e avvertenze sui rischi | Condizioni d'uso e informativa sulla privacy

Le stesse pagine includono anche il testo corrispondente in inglese o un equivalente inglese delle principali avvertenze legali, così anche i lettori internazionali possono consultare le informazioni essenziali su rischi e condizioni d'uso.

Biotech Catalyst Calendar

Per una visione più ampia e continuamente aggiornata dei prossimi catalyst biotech (date PDUFA, principali letture cliniche, eventi regolatori e conferenze chiave), puoi consultare il calendario dedicato su Merlintrader.

Apri il Biotech Catalyst Calendar