Historical archive · December 2025

All events on this FDA and PDUFA calendar have been completed

This article is preserved as a historical record of the December 2025 regulatory calendar. The original analysis and the final outcome shown for every catalyst remain available below.

For upcoming decisions, use the current FDA and PDUFA Calendar. For the regulatory framework, read what a PDUFA date means.

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 Finviz – charts and screeners
Seeking Alpha Seeking Alpha – research and earnings
Stocktwits Stocktwits – live trader sentiment
Medved Trader Medved Trader – advanced charts and tape tools
ChartsWatcher ChartsWatcher – catalyst scanner and strategy tools

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.

Merlintrader

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.

FDA PDUFA Calendar – December 2025 | Fourteen biotech and healthcare catalysts with binary profiles.

Sentiment snapshots as of 4 December 2025, 23:45 CET – may change at any time.

© 2025 Merlintrader trading Blog – All rights reserved.

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