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
Category Reports Biotech
Tickers reports and analysis
Taxing unrealised gains: why the Dutch “experiment

Taxing unrealised gains: why the Dutch “experiment” is a red line for investors A closer look at the Actual Return Box 3 proposal in the Netherlands, why a 36% tax on unrealised portfolio gains is structurally toxic, and what this…
WAR US–Israel vs Iran, 2026 Small & mid-cap potential “winners & losers”

Focus on factual developments of the last few days (Strait of Hormuz, tankers at anchor, oil spike) and on a sector-based watchlist – not on trying to predict the endgame of the conf
Karyopharm Therapeutics ( $KPTI ) ENTRY phase 3 readout approaching

After a challenging 2025 but with a stable revenue base from XPOVIO, Karyopharm enters 2026 with three critical late-stage selinexor shots on goal: the Phase 3 SENTRY readout in myelofibrosis around March, the Phase 3 XPORT-EC-042 trial in endometrial cancer around mid-year, and the Phase 3 XPORT-MM-031 study in multiple myeloma in the second half of the year. This Daily Hit summarizes the latest management commentary and how the near-term risk/catalyst profile is set up.
Aardvark Therapeutics Inc ( $AARD )pause of Phase 3 HERO trial in Prader

A closer look at the decision to voluntarily pause the Phase 3 HERO trial of ARD-101 in Prader–Willi syndrome, the emerging safety signal, the new competitive landscape in hyperphagia and the key milestones that will shape the path forward into and beyond the Q2 2026 update.
EN
IT
BioNTech SE ADR ( $BNTX )From Covid Breakout to Oncology Powerhouse in the Making

How a Mainz-based research project turned into a global vaccine champion, and how the company is now trying to convert an unprecedented Covid cash pile into a multi-product oncology franchise built on mRNA, individualized vaccines and next-generation immunotherapies.
Arcturus Therapeutics Holdings Inc ( $ARCT ) March 3 earnings test

With Q4 2025 results and a strategic update due on March 3, 2026, Arcturus enters a high-stakes phase: the inhaled mRNA program in cystic fibrosis (ARCT-032) must justify its continuation after mixed Phase 2 data, while vaccine royalties, cost controls and a long cash runway are asked to support a pipeline increasingly focused on rare diseases.
War in Iran 2026 – Geopolitics, Oil Shock Risk and Market Winners & Losers

An editorial look at what the new Iran–Israel–US conflict could mean for global power balances, for oil and shipping routes, and for the sectors and individual stocks that tend to benefit or suffer when the Middle East becomes the epicentre of risk.
EN
IT
Weekly Recap & Briefing – Iran War Risk, Energy Shocks and Catalyst Trading (Feb 23–27, 2026)

The new week opens with markets forced to reprice global risk after coordinated US–Israel strikes on Iran and retaliatory missile attacks on US bases across the Gulf and on Israel itself. Oil and shipping risk premia jump, while gold and defense stocks rediscover their role as hedges. At the same time, AI and chips are coming off a volatile stretch after Nvidia’s “beat and fade” reaction, Rocket Lab posts record revenue and backlog, and small-cap biotech continues to trade on single-name catalysts rather than broad factor flows. This recap looks at where we are, how the Iran conflict feeds into energy and risk assets, and which names go on the watchlist for the coming days across defense, energy, space, biotech and AI.
AtaiBeckley Inc. ( $ATAI ) Building a late-stage psychedelics platform Updated March & 2025

AtaiBeckley is no longer just “another psychedelics stock”: after the combination between atai Life Sciences and Beckley Psytech, the company now controls one of the most advanced late-stage pipelines focused on interventional psychiatry for treatment-resistant depression (TRD) and social anxiety disorder (SAD). The three flagship assets — BPL-003, VLS-01 and EMP-01 — are all in Phase 2 or entering Phase 3 planning, which puts AtaiBeckley structurally ahead of most early-stage psychedelics peers still working through small, single-site trials.
Rocket Pharmaceuticals ( $RCKT ) — Q4/FY 2025 results Road to March28-Pdufa

This update is anchored to the company’s latest filing that laid out (1) the reiterated March 28, 2026 FDA action date for KRESLADI, (2) the resumption plan for Danon dosing in 1H 2026, and (3) the year-end 2025 cash position and runway guidance. The goal is to keep it neutral: what was said, what it implies, and where the remaining uncertainty still lives.
Mannkind Corp ( $MNKD ) after the Tresmi shock

A first full-scope look at MannKind after Q4 2025 results and United Therapeutics’ new soft-mist treprostinil product (“Tresmi”), with focus on revenue mix, 2026 catalysts, balance sheet, insider and institutional positioning, analyst expectations and retail sentiment around the latest 35–40% drawdown.
Novavax ( $NVAX ) Q4 2025 and the Matrix-M platform

Q4 2025 finally shows what the long Novavax story on Merlintrader was pointing to: revenue above 1.1 billion dollars for the year, a clean return to GAAP profitability in the quarter, and a 2026–2028 roadmap where Sanofi, Pfizer and other partners, not Novavax alone, carry most of the execution risk around Matrix-M.
Biocryst Pharmaceuticals Inc ( $BCRX )Feb26 2026

FY 2025 marks an inflection point for BioCryst. After years of heavy investment to launch ORLADEYO, the company has finally delivered a clearly profitable year: total revenue reached roughly 875M USD in 2025, versus ~451M USD in 2024, and the P&L flipped from a small operating loss to more than 340M USD of operating profit. The key driver was ORLADEYO net revenue of about 602M USD, up nearly 40% year on year, supported by strong new-patient growth in the U.S. and a better-than-guided performance overall.
Teva- Pharmaceutical Industries ( $TEVA ) Feb26 2026

As of late February 2026, Teva combines a still-massive generics footprint with a focused innovative portfolio in CNS and immunology. After a lost decade of litigation, write-downs and restructuring, the company is now delivering mid-single-digit top-line growth, expanding non-GAAP margins and generating roughly $2.4B of free cash flow per year while steadily reducing debt.
Protalix BioTherapeutics Inc ( $PLX ) March 2026 catalyst window

Follow-up to our previous PLX work: from CHMP’s positive view on the every-four-week Elfabrio regimen to a binary European decision, a new earnings call in mid-March and the next steps for the uncontrolled-gout program PRX-115 – with PLX now trading back into a resistance area close to last year’s highs.
Cardiff Oncology Inc ( $CRDF ) 2025 results CRDF-004 data

2025 results, CRDF-004 data
Eton Pharmaceuticals Inc ( $ETON) Feb25 FDA OK

The U.S. Food and Drug Administration has approved DESMODA (desmopressin acetate) oral solution for the treatment of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), in adults and pediatric patients. This is the first and only FDA-approved ready-to-use oral solution of desmopressin, a meaningful upgrade in day-to-day management of this rare water-balance disorder.
Ocular Therapeutix Inc ( $OCUL) Feb25 Update : superiority achieved, durability confirmed, what comes next

Phase 3 SOL-1 delivered the first statistically significant superiority versus an approved anti-VEGF in wet AMD, with year-long durability from a single injection and a clean safety profile. The market reaction has been volatile; the strategic picture for the next 24–36 months is clearer than the tape suggests.
Geron Corp ( $GERN ) Good Year, Tough Quarter Feb 2026

The first full commercial year of RYTELO brought ~$184M in revenue and a growing base of prescribing centers, but a softer Q4 versus expectations and unchanged 2026 guidance triggered a sharp pullback in the stock. Here is what actually happened, why the market reacted this way, and how it fits into the long-term thesis we’ve been following on Merlintrader.
Alpha Tau Medical Ltd ($DRTS)

Alpha Tau Medical is trying to build an entire platform around one idea: using very short-range, high-energy alpha particles to burn tumors from inside the lesion, instead of bathing a large region of the body in external radiation. With the Japanese Ministry of Health, Labour and Welfare (MHLW) now granting full Shonin marketing approval for Alpha DaRT in unresectable, locally advanced or locally recurrent head and neck cancer, the company has just obtained its first real proof that regulators outside Israel are willing to treat this as a commercial therapy, not only an experimental one.