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 Merlintrader’s Watchlist
Achieve Life Sciences ( $ACHV) — full April 2026 deep dive UPDATED APRIL 15
ACHV is no longer just a development-stage nicotine-dependence story. It is now a very specific FDA review, launch-prep, manufacturing-readiness and balance-sheet story centered on cytisinicline, with a June 20, 2026 PDUFA date and a second optionality leg in vaping cessation.
Neumora Therapeutics Inc ($NMRA) Feb 12 2026
Key idea. In January we framed Neumora as a post-crash special situation: a neuroscience platform that had just blown up its lead asset navacaprant in Phase 3 MDD, wiping out about 80% of the market cap in one session, but still sitting on a sizeable cash pile and a broad pipeline. The weeks since then have added three crucial pieces: (1) full Phase 1b signal-seeking data for NMRA-511 in Alzheimer’s agitation, (2) a more detailed 2026 pipeline strategy, and (3) better visibility on ownership, institutional support and analyst appetite post-crash. This second deep dive doesn’t repeat the full story — it extends it and tries to answer a simple question: is NMRA slowly rebuilding a credible equity story, or just trading on residual hope and short-term speculation?
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.
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.
AARD Aardvark Therapeutics Inc
Aardvark Therapeutics (AARD) is one of the more interesting new names in the rare-disease/obesity intersection: a clinical-stage biotech built around a gut-restricted small-molecule (ARD-101) targeting bitter taste receptors (TAS2Rs) to modulate hunger signaling. The core story is very focused: Prader–Willi syndrome (PWS), an ultra-rare genetic disease dominated by uncontrolled hyperphagia and weight gain, with ARD-101 in a pivotal Phase 3 trial (HERO) that has aligned with the FDA and is intended to support an NDA filing if successful.
TVTX Travere Therapeutics Inc
The FSGS decision remains a high-impact regulatory binary. The piece focuses on the run-up logic but does not remove the fundamental FDA risk from the picture.
NMRA Neumora Therapeutics
Deep dive on Neumora Therapeutics (NMRA): navacaprant reset, NMRA-511 Alzheimer’s agitation data, M4 franchise and a 2026–2027 catalyst map for biotech run-up traders. Educational only, not investment advice.
IOVA Iovance Biotherapeutics Inc
Iovance Biotherapeutics (IOVA) – From first TIL approval to industrial stress-test in solid tumors (Playbook 2026–2027) | Merlintrader trading Blog Merlintrader trading Blog – RunUP Biotech EN IT IOVA – Iovance Biotherapeutics (NASDAQ) Static daily chart from Finviz – click…
BMEA Biomea Fusion Inc
Biomea Fusion has quietly morphed from an oncology story into a pure diabetes and obesity medicines company, with a potentially first-in-class oral menin inhibitor (icovamenib) for insulin-deficient type 2 diabetes and an oral GLP-1 receptor agonist (BMF-650) aimed at obesity. 2026 is all about execution: Phase II programs in T2D, first human weight-loss data for BMF-650 and a cash runway that, after the 2025 down-rounds and cost cuts, now stretches into 2027.
GERN Geron Corp
Geron enters 2026 as a newly minted commercial hematology company with one marketed product, RYTELO (imetelstat), and a late-stage program that could pivot the story from niche LR-MDS anemia to broader myelofibrosis survival if the Phase 3 IMpactMF study delivers.
RCKT Rocket Pharmaceuticals
Focus: FDA PDUFA for KRESLADI™ (LAD-I) on March 28, 2026 – gene therapy, rare pediatric disease.
ALT Altimmune
Key message: the FDA has granted Breakthrough Therapy Designation (BTD) to pemvidutide for the treatment of MASH, based on 24-week data from the Phase 2b IMPACT trial (company press release, Jan 5 2026 and IMPACT publication).
The stock immediately reacts with an intraday move around +15–20% (as reported by outlets like Seeking Alpha and Investing.com). This is not a random bounce, it is a repricing of regulatory risk.
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.