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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
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.
POET Technologies Inc ( $POET ) 2025–2026 Capital Ramp

Updated overview of POET Technologies after the 2025 production orders, equity financings and the 2026 Lightwave award: technology, product line, financial profile, partnerships, retail sentiment and key risk factors.
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 ~$184M in revenue and a growing base of prescribing centers, but a softer Q4 versus expectations and unchanged 2026 guidance triggered a sharp pullback in the stock. Here is what actually happened, why the market reacted this way, and how it fits into the long-term thesis we’ve been following on Merlintrader.
Rocket Lab and DART AE($RKLB) The night Australia aims for its first hydrogen scramjet flight (Updated feb26)

On many launch days at Wallops, you could drive past Launch Complex 2 and, at a glance, not realise that a rocket is waiting. The Atlantic haze flattens the horizon, the gantry is half-hidden in mist and sodium lights, and only the traffic at the gate and the rhythm of the countdown clocks betray that something is about to happen. Today, that something is a little different from the usual satellite run.
SoundHound AI Inc ($SOUN)

SoundHound AI started as a voice and music-recognition company and gradually evolved into a broader conversational-AI provider. It now positions itself as a global platform for voice and agentic AI, powering restaurant phone ordering and drive-thrus, in-car voice assistants, smart devices and enterprise customer-service agents across financial services, healthcare, retail and more.
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.
Edesa Biotech ($EDSA)

Edesa Biotech (NASDAQ: EDSA) is a clinical-stage biopharmaceutical company developing host-directed therapeutics (HDTs) – drugs that modulate the body's own immune response rather than targeting a specific pathogen. The company's lead asset, paridiprubart (EB05), is a first-in-class anti-TLR4 monoclonal antibody being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS).
Iovance Biotherapeutics Inc ($IOVA)

As of February 24, 2026, Iovance Biotherapeutics is a small-cap oncology company (~$1.5B market cap) focused on TIL cell therapies for solid tumors, with AMTAGVI (lifileucel) already approved in the U.S. for advanced melanoma and a growing pipeline exploring TIL in other indications, including soft-tissue sarcomas.
The stock trades around $3.80 with roughly 364M shares outstanding, after a volatile path that has seen heavy dilution in past years but now combines commercial revenues (~$264M FY25) with a cash runway into Q3 2027 thanks to cost controls and better gross margins on AMTAGVI. The new 50% objective response rate (ORR) in the very difficult setting of advanced UPS/DDLPS sarcomas is what the market is reacting to right now.
AST SpaceMobile ($ASTS) — HALO Europa: $30M SDA prototype award

ASTS AST SpaceMobile Open chart SEC filings Chart: static image. Click opens Finviz (affiliate link applied only on click). AST SpaceMobile (ASTS) — HALO Europa: $30M SDA prototype award, what it signals, what to watch Deep Dive “ALDX-signed”, mobile-first, light…
Fortress Biotech Inc ($FBIO)

Fortress Biotech (NASDAQ: FBIO) is a diversified biopharmaceutical company with a unique portfolio acquisition and value-creation model. Rather than pursuing a single blockbuster drug, Fortress systematically acquires, advances and partners assets across oncology, dermatology and rare diseases, generating returns through product revenue, equity holdings, royalties and strategic asset sales.
SELLAS Life Sciences Group Inc ($SLS) Updated feb 23

SELLAS Life Sciences Group (NASDAQ: SLS) is a clinical‑stage biotechnology company focused on cancer immunotherapies and targeted therapies. The current story is driven by the cancer vaccine galinpepimut‑S (GPS), a Wilms Tumor 1 (WT1)–targeting immunotherapy, and by a CDK9 inhibitor program for hematologic and solid tumors.
ImmunityBio Inc Logbook Feb 23 / It Could Not Be Missing

The latest BusinessWire release finally puts hard numbers and structure around what we had already been tracking on IBRX: ~113 million USD of ANKTIVA net product revenue in 2025 (~700% year-over-year), ~750% unit growth, a regulatory footprint in 33 countries across four major jurisdictions, the first lung cancer approval in Saudi Arabia in combination with checkpoint inhibitors, and explicit patent protection for ANKTIVA combinations beyond 2035. On top of that, management now frames a clear three-year strategy with ANKTIVA as a “backbone” immunotherapy across multiple tumor types.
Rackspace Technology (RXT) – AI Turnaround Story After the Palantir Partnership

Rackspace Technology (NASDAQ: RXT) is a heavily leveraged hybrid multicloud and managed services provider that is trying to reposition itself as an “AI-first” infrastructure and operations partner. After years of revenue decline, recurring losses and a difficult competitive landscape, the February 18, 2026 strategic partnership with Palantir has triggered a violent rerating of the stock and reopened the turnaround debate.
ADMA Biologics ($ADMA) meeting or exceeding guidance Feb25?

ADMA Biologics (NASDAQ: ADMA) is a commercial-stage biopharmaceutical company specializing in plasma-derived immunoglobulins for the treatment of patients with primary humoral immunodeficiency (PI) and others at risk of certain infections. The company operates a fully integrated business model encompassing plasma collection, fractionation, manufacturing and commercialization.