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
APLD Applied Digital Corporation

Applied Digital is heavily traded and highly volatile:
average daily volume in the tens of millions of shares,
beta comfortably above 2,
double-digit intraday swings on apparently minor news when shorts and options flows interact.
LUNR Intuitive Machines Inc

Moon lander headline magnet – LUNR is the equity proxy for Intuitive Machines’ IM-1 “Odysseus” and IM-2 “Athena” missions: the first U.S. soft landings on the Moon since Apollo 17 and the first commercial landers ever, even if both ended up tilted on their side.
Huge 2025/26 story arc – from tiny SPAC to front-page space company with NASA contracts, multiple CLPS missions and now a planned acquisition of Lanteris (Maxar Space Systems) that would take combined revenue to >850M USD with positive adjusted EBITDA and ~920M USD backlog.
Short-interest powder keg – short interest sits around 22–23% of the free float, with more than 25M shares sold short and days-to-cover in the 3–4 range: structurally squeezed stock by design.
PL Planet Labs PBC

Massive 2025 rerating – Planet’s stock is up almost 4x in 2025, with several single-day jumps of 30–50% after earnings and news. It went from being treated as a broken SPAC to a “space + AI + defence” favourite.
Backlog and cash have exploded – record backlog well above 700M USD, remaining performance obligations multiples of current annual revenue, and end-of-quarter cash and equivalents close to 700M USD.
Adjusted EBITDA finally positive – the latest quarters show positive adjusted EBITDA, with management promising a path toward sustainable profitability, even if GAAP net income is still deeply negative.
OPEN Opendoor Technologies Inc

Huge 2025 comeback – after trading below 1 USD, OPEN staged a massive rebound, with the share price up roughly 400–450% in 2025 on the back of retail enthusiasm, leadership changes and a “short squeeze” narrative.
Real business, real losses – this is not a pre-revenue story. Opendoor generated 3.635B USD of revenue in the first nine months of 2025, but still reported a net loss of 204M USD over the same period.
Heavy balance sheet usage – the company ended Q3 2025 with 962M USD of cash and 1.79B USD of debt, for a net cash position of about −830M USD. This is not an asset-light software-only model.
TMC TMC the metals company Inc

TMC is not a traditional small biotech or junior miner. It is a high-beta small/mid cap trying to open an entirely new segment: harvesting polymetallic nodules on the ocean floor in the Clarion-Clipperton Zone, with the idea of feeding the electric-vehicle and strategic metals supply chain.
In 2025 the stock moved from just above 1 USD to a peak above 11 USD, closing the year still several hundred percent above the starting point. That kind of move puts TMC firmly on any “small caps of the moment” radar: strong narrative, strong retail interest, highly directional.
POET Technologies Inc

Market cap around 900–950M USD with a one-year increase above 200 percent.
Positioned at the intersection of AI, photonics and data centers, with optical engines and interposer technology at the core.
Recent production orders for POET Infinity optical engines, with shipments scheduled from the second half of 2026.
Extra attention after Marvell’s acquisition of Celestial AI, which uses POET’s technology.
ONDS Ondas Holdings Inc

2025 performance in the ballpark of +250–270 percent, among the top performers in the defense group.
Growth story tied to autonomous drones and counter-UAS systems in a context of rising defense and security spending.
Very ambitious guidance: management is targeting revenues of at least 36M USD in 2025 and 110M USD in 2026.
Large free float, growing institutional ownership and high volatility: a classic high-beta small cap where newsflow drives big moves.
BNGO Bionano Genomics Inc

Bionano Genomics is one of those names where the technology and the share price seem to live in different universes. On the lab side, optical genome mapping (OGM) keeps racking up publications, clinical use-cases and even a Category I CPT code with a 47% reimbursement boost for blood cancers.
AXSM Axsome Therapeutics Inc

Axsome Therapeutics is no longer just “the Auvelity company”. In 2025 it quietly turned into a multi-product CNS platform with three marketed drugs, a late-stage pipeline and, now, a Priority Review from the FDA for AXS-05 in agitation associated with Alzheimer’s disease – with a PDUFA action date set for April 30, 2026.
NVAX Novavax, Inc

From going concern to platform story with a cult retail base
For a long stretch of 2023, Novavax was treated as a failed Covid trade. A late vaccine, production issues, a balance sheet that flirted with collapse and a market that moved on to other themes. On paper, the story should have ended there.
CORT Corcept Therapeutics Inc

CRL in one paragraph:
The FDA acknowledged that one of Corcept’s Phase 3 trials in Cushing was successful, but another failed its primary endpoint. Given this mixed picture, the agency said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness and therefore rejected the NDA via CRL. No insurmountable safety issues were cited; the focus is efficacy and consistency.
SLS http://www.sellaslifesciences.com/

News of the day (REGAL): On 29 December 2025, SELLAS reported that the contract research organization running the Phase 3 REGAL trial notified the company that 72 of the 80 required events (deaths) had occurred as of 26 December 2025. REGAL is an overall survival study; the final analysis will be triggered once 80 events are reached. SELLAS remains fully blinded, and this one-time update does not change the statistical plan. Source: SELLAS REGAL update PR (Dec 29, 2025) .
IRWD Ironwood Pharmaceuticals Inc

News of the day: Ironwood maintained FY2025 guidance and issued FY2026 guidance projecting LINZESS U.S. net sales of $1.125–$1.175B, total revenue $450–$475M, and adjusted EBITDA >$300M, citing improved net pricing driven by a January 1, 2026 Linzess list-price reduction. It also reaffirmed that a confirmatory Phase 3 trial for apraglutide is expected to begin in H1 2026, and that the strategic alternatives review is progressing. Source: BusinessWire (Jan 2, 2026).
ONCY Oncolytics Biotech, Inc

Oncolytics Biotech (ONCY) — Pelareorep, GI focus, catalysts into Q1–H1 2026 | Oncolytics Biotech (ONCY) — Pelareorep, focus GI, catalyst Q1–H1 2026 EN IT Oncolytics Biotech (ONCY) Panel-style report (EN/IT): news-first, catalyst timelines, fundamentals/cash runway, pipeline, management/ownership, retail sentiment, risk…
VNDA Vanda Pharmaceuticals Inc

The FDA approved NEREUS (tradipitant) for the prevention of vomiting induced by motion in adults — described as the first new FDA-approved pharmacologic treatment in this area in over 40 years. The company expects a commercial launch “in the coming months.”
DRTS Alpha Tau Medical Ltd Updated jan 8

eep dive on Alpha Tau Medical (DRTS) from a bullish angle: differentiated alpha-radiation platform, multiple late and early-stage trials, solid cash runway and heavy insider ownership. Educational only, not investment advice.
EKSO Ekso Bionics Holdings Inc

On December 29, 2025, Applied Digital (APLD) and Ekso Bionics (EKSO) announced a non-binding term sheet for a proposed business combination between Applied Digital’s cloud computing arm, Applied Digital Cloud, and EKSO.
PALI Palisade Bio Inc

The Japan Patent Office has granted a patent titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug” covering the composition of matter for PALI-2108, Palisade Bio’s lead gut-restricted PDE4 B/D inhibitor for moderate-to-severe ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD). The base patent term runs into 2041 and is eligible for extension based on regulatory review timelines.
ARDX Ardelyx Inc Updated Jan 8

Q3 2025: revenue beat, IBSRELA guidance raised, Street now models ARDX turning profitable in 2026
October–December 2025 – Q3 revenue beat, IBSRELA guidance increased to $270–275M for 2025, XPHOZAH absorbs Medicare shock, analysts talk about 2026 breakeven.
GLSI Greenwich LifeSciences Inc

FLAMINGO-01 open-label arm shows ~80% reduction in breast cancer recurrences; Fast Track in place and lock-up extended to 2026
December 2025 – GLSI reports preliminary ~80% recurrence rate reduction in the 250-patient open-label arm of FLAMINGO-01, completes enrollment, and extends insider/pre-IPO lock-up to September 30, 2026, while the stock breaks to new 52-week highs.