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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
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.
Red Cat is positioning itself as a U.S.-based provider of all-domain unmanned and autonomous systems rather than as a simple “drone stock”. The company aggregates several assets under one umbrella:
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.
$10M strategic equity investment in World View and a partnership to integrate persistent stratospheric platforms (Stratollite®) with Ondas’ autonomous UAS and counter-drone capabilities for multi-layer ISR and airspace defense.
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.
With oil back in focus after U.S.–Israeli strikes on Iran and renewed risk around the Strait of Hormuz, U.S. Energy Corp. (USEG) offers a very different angle from the majors: a small, vertically integrated platform trying to combine legacy oil and gas production with a large industrial gas and carbon management project at Kevin Dome in Montana. This is a deep dive into what USEG really is, how Kevin Dome fits into the 2026 energy landscape, and which catalysts matter from here.
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” 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…
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
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.
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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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.
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.
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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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.
UEC is positioning itself as one of the key U.S. uranium names for the new nuclear cycle: in-situ recovery hubs in Texas and Wyoming, a large resource and project base in the United States and Canada, and the launch of a dedicated refining and conversion vehicle designed to move the company beyond the role of “pure miner” into the broader fuel value chain.
IREN Limited, formerly Iris Energy, is rapidly transforming itself from a cyclical Bitcoin miner into a vertically integrated AI infrastructure provider, combining long-duration power contracts, hyperscale data centres and multi-year GPU cloud deals with blue-chip counterparties. The next phase of the story is all about execution: how fast the company can switch its asset base to AI, how stable those cloud revenues become and how it balances growth ambitions with leverage and dilution.
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.
i-80 Gold Corp (IAUX) – Nevada hub-and-spoke gold growth story 2026 Gold & Precious Metals – Deep Dive 2026 i-80 Gold Corp (IAUX) – Nevada hub-and-spoke gold growth story under construction A Nevada-focused gold developer trying to turn a cluster…
BigBear.ai is trying to turn years of work in defense intelligence, mission planning and logistics optimization into a scalable AI platform story, boosted by large capital raises and the acquisition of generative-AI partner Ask Sage. Revenues are meaningful and the cash cushion is large, but the path from contract wins to durable, profitable growth remains complex and execution-dependent.