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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
AGIO Agios Pharmaceuticals Inc
A year ago, Agios was still mostly a “promise stock”: one approved niche drug for pyruvate kinase deficiency and a lot of hope around sickle cell disease. Today the picture is more complex but also more concrete: mitapivat now has two U.S. approvals, a full rare-disease haematology franchise is forming, and 2026 has a surprisingly busy catalyst map.
PLSE Pulse Biosciences Inc
First-in-human data for the nPulse™ Cardiac Catheter Ablation System show high pulmonary vein isolation durability and low SAE rate in atrial fibrillation – but this is still a pre-commercial, single-platform story.
RCKT Rocket Pharmaceuticals
Gene therapy for ultra-rare immunodeficiency (LAD-I), a hard reset after last year’s CRL and the Danon shock, and a March 28, 2026 PDUFA that could flip sentiment in a name now trading near multi-year lows. This is a classic “platform vs. execution” test in gene therapy – with an additional potential upside lever in the form of a Rare Pediatric Disease Priority Review Voucher (PRV) if approval comes through.
ALVO Alvotech Feb 2026
Alvotech is not a typical development-stage biotech: it is a vertically integrated biosimilar platform that already generates hundreds of millions of dollars in revenue from launched products like AVT02 (adalimumab) and AVT04 (ustekinumab), while also running a crowded late-stage pipeline. The stock sits in that awkward middle ground between “early growth” and “heavy balance sheet”, with over 1B$ of debt but also positive adjusted EBITDA and operating profit in the latest 9-month period.
CRMD Thinking After Hours
This after-hours note starts from a simple, honest message in the comments. A reader who first bought CRMD around 11 USD, then averaged down at 9 USD and again at 6.5 USD, with one clear idea: one day, selling “north of 15” if the CorMedix story plays out.
RNXT RenovoRx Inc
Quick take: RenovoRx brings fresh clinical data on its TAMP™ therapy platform to SIO 2026 (February 6). The event is not a registrational readout, but it is a real-world test of how much the market still cares about this targeted intra-arterial delivery story as the company starts to generate device revenues.
DFTX Definium Therapeutics Inc.
Definium Therapeutics (DFTX) is not a mature commercial pharma story; it is a clinical‑stage CNS and mental health company whose equity behaves like a classic high‑beta biotech: the tape is dominated by expectations around clinical data, regulatory interactions, and the company’s ability to fund its programs through to value‑defining milestones.
ONCY Oncolytics Biotech, Inc
On February 4, 2026, Oncolytics announced that the FDA granted Fast Track designation to pelareorep combined with bevacizumab and FOLFIRI for adults with KRAS-mutant, microsatellite-stable metastatic colorectal cancer (MSS mCRC) in the second-line setting, after progression on a first-line oxaliplatin-based regimen. The designation is based on clinical signals from the REO 022 study and prior pelareorep experience across GI tumors and breast cance
VSTM Verastem Inc
Verastem Oncology enters 2026 as a very different story compared with two years ago. The company now has a commercial product, Avmapki Fakzynja (avutometinib + defactinib), approved under the FDA’s accelerated approval pathway for adult patients with KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) after at least one prior systemic therapy.
ADMA Adma Biologics Inc
Commercial IG platform with three FDA-approved products, a yield-enhanced manufacturing process, and a revenue ramp from <$200M to >$500M in a handful of years. Not a binary biotech story, but an execution and capacity game that the market is finally treating like a growth compounder.
OMER Omeros Corporation
What happened in January: Omeros successfully transitioned from pre-commercial biotech to commercial-stage rare disease company with the FDA approval of YARTEMLEA on December 23, 2025 and first commercial sales announced January 27, 2026.
BFRI Biofrontera Inc
Photodynamic-therapy specialist with a single commercial franchise (Ameluz + RhodoLED) in U.S. dermatology, entering a dense 2026 data and regulatory window while revenues scale from the low–mid $40M range and the balance sheet remains tight.
PHAR Pharming Group Adr-CRL
On February 1, 2026, Pharming announced that the U.S. FDA issued a Complete Response Letter (CRL) to its supplemental New Drug Application (sNDA) for Joenja (leniolisib) in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS). The letter does not question the fundamental clinical benefit of leniolisib in APDS but raises two specific technical concerns
AQST Aquestive Therapeutics Inc
From the January “deficiencies” shock to a Complete Response Letter focused on packaging and administration, why the market is suddenly relieved and why the story is still a multi-quarter grind.
CRMD CorMedix Inc
CorMedix is no longer the pre-revenue story that dialysis investors watched from a distance. After the U.S. launch of DefenCath in 2024, the company has delivered its first profitable quarter, acquired the Melinta anti-infective portfolio, built a meaningful cash position and, as of February 2026, added a $75 million share repurchase program on top.
ARTV Artiva Biotherapeutics Inc
Artiva Biotherapeutics is a clinical-stage biotech company focused on off-the-shelf allogeneic NK cell therapies built on a standardized, donor-derived, manufacturing platform. The lead asset, AlloNK (AB-101), is being developed in combination with anti-CD20 therapy both in B-cell non-Hodgkin lymphoma (NHL) and in autoimmune d
ICU SeaStar Medical Holding Corp
SeaStar Medical is not a typical “pre-clinical biotech on a slide deck”. The company has already crossed the line into real-world use: QUELIMMUNE (the pediatric implementation of the SCD) is approved by the US Food and Drug Administration via HDE and has been adopted by a growing group of leading US children’s hospitals. Early registry data suggest improved survival and kidney recovery in some of the sickest patients in the ICU, with no device-related safety signals reported so far
DRTS Alpha Tau Medical Ltd Jan Update
We wrote our original bullish editorial at the very end of December 2025, when the stock was still trading around five dollars and largely under the radar. January brought ASCO GI pancreatic data, a first PMA module to the FDA, a shareholder letter and a sharp re-rating. Here we revisit the thesis, check the fundamentals and map the next catalysts. Educational only, not investment advice.
ALLO Allogene Therapeutics Inc
Allogene Therapeutics is not the 2+ billion dollar hype story it was a few years ago. After the initial enthusiasm around off-the-shelf CAR T, the stock has been crushed by a sequence of events: an FDA clinical hold in 2021, years of execution risk, pipeline reshuffling and workforce reductions.
AMRN Amarin Corp ADR Update Jan 31
A few years ago, the Amarin story was dominated by a single word: generics. After losing key patent battles on Vascepa, the U.S. business was hit by an aggressive wave of skinny-label competitors, PBM exclusions and net price pressure, to the point where many investors simply filed AMRN under “broken story”. At the start of 2026, the picture is no longer that binary. The company is still far from the glory days, but the trajectory is clearly different: less bleeding, more structure, and a gradual shift from survival mode to controlled recovery.