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
Category Archives
Category for old articles
AGIO Agios Pharmaceuticals
From FDA approval of AQVESME in alpha/beta-thalassemia to the next catalysts in sickle cell and MDS: a filings-based look at where Agios really stands now.
RVPH Reviva Pharmaceuticals Update dec 23
On 23 December 2025, reviva confirmed in an 8-K and a press release that the FDA, after the pre-NDA meeting, is strongly encouraging a second Phase 3 trial (RECOVER-2) before any NDA submission for brilaroxazine in schizophrenia.
SAVA Cassava Sciences Inc
As of late 2025, Cassava is a small-cap CNS company trading in the low-single-digit USD range after its lead Alzheimer’s drug, simufilam, failed in Phase 3 and the program was discontinued.
TBPH Theravance Biopharma Inc
Over the last weeks of 2025, several themes have dominated coverage on TBPH: a clearly positive Q3 2025 earnings print (revenue up high-teens percent year-on-year, earnings swinging to a small profit), a sizeable analyst re-rating with average price targets in the mid-to-high twenties per share, and a steady drumbeat of commentary framing Theravance as a “growth” or “momentum” stock again rather than a restructuring situation.
VRDN Viridian Therapeutics Inc
Viridian Therapeutics is trying to become the second major commercial player in thyroid eye disease after Amgen’s Tepezza, with a TED franchise built around veligrotug (IV) and VRDN-003 (subcutaneous), plus an FcRn platform (VRDN-006/008) that targets broader autoimmune indications.
PROK ProKidney Corp
ProKidney is a late clinical-stage cellular therapeutics company focused on a single lead product: rilparencel, also known as REACT (Renal Autologous Cell Therapy).
MBRX Moleculin Biotech
Deep dive on Moleculin Biotech, Inc. (NASDAQ: MBRX), a Phase 3 oncology company built around Annamycin (AnnAraC) in relapsed/refractory AML, with additional programs in STS lung metastases, brain tumors and viral indications. We walk through MIRACLE’s design and timelines, Phase 1b/2 AML data, the latest December 2025 updates, the balance sheet and why the stock still trades like a distressed nano-cap.
ADGM Adagio Medical Holdings
Adagio Medical is not a biotech but a medical device company developing catheter-based ultra-low temperature cryoablation (ULTC) systems for cardiac arrhythmias: atrial fibrillation (AF), atrial flutter and ventricular tachycardia (VT). Its technology uses near-critical nitrogen to reach temperatures as low as −196°C in a linear catheter system, aiming to create rapid, continuous, transmural lesions.
PCSA Processa Pharmaceuticals Inc

Processa Pharmaceuticals is a clinical-stage company built around a simple idea: instead of discovering entirely new oncology molecules, it re-engineers existing, FDA-approved chemotherapies to improve their therapeutic index. The Next Generation Cancer (NGC) platform aims to keep the same cancer-killing mechanism, while changing metabolism and distribution to reduce toxicity and potentially increase efficacy.
MBIO Mustang Bio Inc
Mustang Bio is a clinical-stage biotech focused on CAR-T and oncolytic virus approaches for hard-to-treat cancers and rare diseases. The science is interesting (especially around MB-106 and MB-101), but cash is tight, dilution is heavy and the going-concern risk is real. Here we lay out numbers, pipeline, sentiment and risk without any promotional angle.
SLS SELLAS Life Sciences Group Inc
SELLAS Life Sciences is a late-stage oncology biotech whose near-term equity story is dominated by a single survival-driven Phase 3 trial (REGAL with GPS in AML maintenance) and a rapidly de-risking CDK9 program (SLS009 in AML-MR).
BEAM Beam Therapeutics
Beam Therapeutics is one of the purest listed plays on base editing. Its pipeline spans ex vivo and in vivo programs: risto-cel (BEAM-101) for sickle cell disease, BEAM-201 for aggressive T-cell malignancies, BEAM-301 for glycogen storage disease type Ia (GSD1a) and BEAM-302 for severe alpha-1 antitrypsin deficiency, plus an engineered stem-cell antibody-paired evasion (ESCAPE) platform aimed at non-genotoxic conditioning.
MREO Mereo BioPharma
Mereo BioPharma is now a concentrated bet on setrusumab (UX143), an anti-sclerostin monoclonal antibody partnered with Ultragenyx for osteogenesis imperfecta (OI), plus a back-up program in respiratory alpha-1 antitrypsin deficiency (alvelestat) and an earlier-stage bone asset (vantictumab) licensed to āshibio for autosomal dominant osteopetrosis type 2, where Mereo retains European commercial rights.
ABVX Abivax
Abivax SA is a French biotech now focused almost entirely on chronic inflammatory diseases, with obefazimod as its lead – and effectively only late-stage – asset. Originally developed for HIV, obefazimod was repositioned in ulcerative colitis after mid-stage virology data underwhelmed but immune-modulation readouts looked promising. Over time, the company abandoned its older infectious disease and oncology projects and concentrated resources on inflammatory bowel disease.
CYTK Cytokinetics
Cytokinetics enters 2026 in a very different position from just a year ago. After years as a development-stage muscle biology company – including the high-profile failure of omecamtiv mecarbil in chronic heart failure – the company now has its first approved product: MYQORZO (aficamten) for symptomatic obstructive HCM.
CRSP Crispr Therapeutics

CRISPR Therapeutics enters 2026 as a hybrid story: part royalty-like partner on a first-in-class commercial gene therapy (Casgevy for SCD/TDT), part high-risk platform company pushing CRISPR into autoimmune disease, oncology, cardiovascular disease and regenerative medicine.
ALT Altimmune Inc 22 Dec Update

On December 18, 2025, Altimmune announced 48-week data from the IMPACT Phase 2b trial of pemvidutide for MASH (metabolic dysfunction-associated steatohepatitis). While the company highlighted “key measures of success” including improvements in non-invasive fibrosis markers (ELF, LSM, cT1), sustained weight loss, and favorable safety, the stock fell by more than 20% in the following sessions.
CGTX Cognition Therapeutics
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company (no products on the market yet) headquartered in Purchase, New York (USA). The company develops orally available therapies for age-related neurodegenerative disorders, primarily Alzheimer’s disease and Dementia with Lewy bodies (DLB).
RVPH Reviva Pharmaceuticals Holdings Inc Dec 22

Reviva Pharmaceuticals is a small late-stage clinical company built almost entirely around one asset: brilaroxazine (RP5063), a serotonin-dopamine modulator for schizophrenia and other CNS / inflammatory indications. The company has successfully completed one large global Phase 3 trial (RECOVER-1) and a 1-year open-label extension and is now preparing for a pre-NDA meeting with the FDA in Q4 2025, targeting a full NDA submission in Q2 2026 for schizophrenia.
Premarket Update dec 22 – Tech Strength, Positive Futures and a Focus on Biotech Catalysts
Christmas week: lower liquidity, but often faster and more technical moves. Below you’ll find market movers, Europe/commodities, and a “Biotech Special” built on calendar catalysts (RVPH, ARGX, AARD, plus technical notes on ZLAB and HALO).