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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
Aquestive Therapeutics ( $AQST ): Anaphylm after the CRL
Aquestive remains pre-commercial on Anaphylm, with a manufacturing-driven revenue base, a sizeable cash cushion and a clearly negative EBITDA profile in 2026 as it funds the resubmission and maintains a pre-launch infrastructure.
BriaCell Therapeutics Corp ( $BCTX ) Phase 3 BRIA-ABC
BriaCell Therapeutics Corp. is a clinical-stage immuno-oncology company developing cell-based therapies for advanced breast cancer and other solid tumors. The core asset, Bria-IMT™ plus a checkpoint inhibitor, is in a pivotal Phase 3 study (BRIA-ABC) in heavily pre-treated metastatic breast cancer (MBC) under FDA Fast Track designation.
Ocugen Inc ( $OCGN ) MAR 04 Bussines Update
Q4 2025 business update in focus: where Ocugen stands after another loss-making year, how the OCU400/410 platform is evolving, and what really matters for the next 18–24 months in gene therapy and anti-aging.
Klotho Neurosciences Inc. ( $KLTO )
EN IT NASDAQ: KLTO Klotho Neurosciences Inc. Gene Therapy for Neurodegeneration + Strategic Minerals Division Market Cap: ~$39.6M | Price: $0.54 | YTD: -86.2% Chart: 1-year daily bars | Current Price: $0.54 | 52-week range: $0.11–$3.91 Data as of March…
Can-Fite Biopharma Ltd ADR ( $CANF )
Deep dive after the March 4, 2026 Phase IIa update of Namodenoson in advanced pancreatic ductal adenocarcinoma (PDAC), with a full look at pipeline, balance sheet, governance, bull & bear case, and retail sentiment.
Tilray Brands Inc ( $TLRY ) From cannabis hype to beer-and-cannabis conglomerate
From cannabis hype to beer-and-cannabis conglomerate: how Tilray is trying to turn a decade of dilution and volatility into a diversified, cash-generating platform built on craft beverages, medical distribution and North American optionality.
Canopy Growth Corporation ( $CGC )
Canada-based cannabis company with operations spanning adult-use and medical cannabis in Canada and international markets, medical brands (including expanding insured-patient channels) and inhalation hardware via premium vaporizer brand Storz & Bickel.
Strata Critical Medical Inc ( $SRTA ) Q4 2025 results and 2026 guidance
Time-critical logistics and clinical services for organ transplantation, now operating as a pure-play medical services platform after exiting passenger air mobility. Q4 2025 marks the first full quarter including Keystone’s perfusion business and a substantial reset of the 2026 growth trajectory.
uniQure N.V ( $QURE ) FDA says AMT-130 data not enough yet, shares collapse
uniQure’s stock is getting crushed after the company disclosed that the U.S. Food and Drug Administration does not consider current Phase I/II data for AMT-130 in Huntington’s disease sufficient to support a marketing application, and is instead recommending a fresh prospective, randomized, double-blind, sham surgery-controlled Phase III trial.
Outlook Therapeutics Inc ( $OTLK ) Updated march 6 post type A meeting with FDA
Outlook Therapeutics has become a fault line: some investors see a possible turnaround built on LYTENAVA’s European rollout and an FDA dialogue still technically open, others see only years of CRLs, value destruction and structural dilution risk. To really understand the stock you have to hold both sides of the story at the same time.
Intellia Therapeutics Inc ( $NTLA )
The FDA has lifted the clinical hold on MAGNITUDE, the Phase 3 trial of nexiguran ziclumeran (nex-z, ex NTLA-2001) in transthyretin cardiomyopathy. After months of uncertainty following a severe liver event and a patient death, Intellia and Regeneron can enrol again. This update revisits the thesis we outlined in the previous Merlintrader deep dive and asks what this decision really changes for the risk/reward profile of Intellia's in vivo CRISPR platform.
Lantheus ( $LNTH ) 2026: radiopharma at a crossroads with two March FDA decisions
March 6, 2026 – FDA PDUFA for new PSMA PET formulation (prostate cancer imaging) and March 29, 2026 – FDA PDUFA for OCTEVY, a new radiodiagnostic asset. These two decisions define the short-term binary risk / reward for LNTH after the Q4 2025 reset, while a third PDUFA for the tau tracer MK-6240 is scheduled for mid-August.
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.
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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.
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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.