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
IOVA Iovance Biotherapeutics Inc
6 November 2025 – Iovance reports Q3 2025 revenue of about $68 million, up 13% sequentially, with Amtagvi driving the growth. Gross margin improves to 43%, but the company still posts a net loss of over $90 million and burns cash.
DCTH Delcath Systems Inc
20 November 2025 – Delcath’s board authorizes a $25 million share repurchase program, at a time when the stock has dropped more than 50% in six months and trades close to its 52-week low around $8 per share. The program can be executed via open-market and privately negotiated transactions, with no fixed end-date, funded from cash and operating cash flow.
BHVN Biohaven Ltd
24 December 2025 – Biohaven reports that BHV-7000 did not meet the primary endpoint in a six-week Phase 2 MDD study (MADRS change vs placebo). Shares fall about 16–17% after hours. Management says it will stop psychiatric trials with BHV-7000 and focus 2026 resources on immunology, obesity and epilepsy.
RZLT Rezolute Inc
Rezolute (RZLT) Crash Story – sunRIZE Phase 3 Failure in Congenital Hyperinsulinism | EN/IT Crash Story · Biotech RZLT · Rezolute, Inc. Educational only – not investment advice EN IT Rezolute (RZLT) – When a Breakthrough Story Breaks Down From…
SMMT Summit Therapeutics Inc
Summit Therapeutics has transformed itself into a single-asset late-stage oncology story around ivonescimab, a PD-1 x VEGF bispecific licensed from Akeso and already approved in China.
Weekly Recap & Next Week Prep dec 29- Jan 2
Reality check: end-of-year sessions are thin and noisy. Spikes and air-pockets are common. Treat this week as “information rich” but structurally fragile in terms of liquidity.
TRAW, ACRV, GUTS – Three speculative near term names to keep on watchlist
Not a buy list, but three stocks where the next 1–3 months could change the narrative: one antivirale COVID ritonavir-free, una storia di oncology DDR quasi-registrativa e un dispositivo endoscopico per mantenere il peso dopo GLP-1.
Nasdaq Delisting & Compliance 101
A practical guide for small traders: how the Nasdaq $1 rule really works, what “extensions” mean, and what the historic market reactions look like.
This article is informational and educational only. It is not legal advice, not investment advice and not a recommendation to buy, sell or hold any security.
CUE Cue Biopharma
This report focuses on three highly sensitive aspects of Cue Biopharma’s situation:
Equity structure and dilution history (last ~24 months) – public offerings, at-the-market (ATM) sales, pre-funded warrants and long-dated warrants.
Nasdaq minimum bid price rule (“$1.00 rule”) – including the deficiency letter sent on 12 May 2025, the initial 180-day window ending 10 November 2025, and Cue’s own statement in its Form 10-Q for the quarter ended March 31, 2025 that it may cure the deficiency via a reverse stock split if necessary.
Forward-looking pressure – what the next months look like, how much time the company realistically has, and in which window a reverse split becomes a likely tool if the share price does not recover.
IMRX Immuneering Corp
On January 7, 2026 Immuneering will host a conference call and webcast to present 12-month overall survival (OS) from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) + modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer. This is the logical follow-up to the 6- and 9-month data that have already attracted significant attention.
VTGN Vistagen Therapeutics Inc
VTGN – From Euphoria to PALISADE-3 Pain and the Road to the Next Readout | VTGN – Dall’euforia al crollo di PALISADE-3 e la prossima speranza Biotech | VTGN VistaGen Therapeutics – Social Anxiety & Pherine Story VTGN – From…
AMRX Amneal Pharmaceuticals Inc
On December 22, 2025 the FDA approved Amneal and mAbxience’s BLAs for Boncresa (denosumab-mobz), a biosimilar referencing Prolia, and Oziltus (denosumab-mobz), a biosimilar referencing XGEVA. The two brands target a combined U.S. market of roughly 5.3 billion dollars over the last 12 months, but join a denosumab biosimilar segment that has been filling up rapidly throughout 2024–2025.
TVTX Travere Therapeutics Inc UPDATE JAN 2
Travere Therapeutics has transitioned in 2025 from a “promising rare-disease biotech” into a genuine kidney franchise story. Filspari is fully approved in IgAN and ramping quickly, while the January 13, 2026 PDUFA on FSGS could make it the first FDA-approved therapy in that indication.
NRXP and the Phantom PDUFA: When ‘By Year-End’ Isn’t a Date
NRX-100 was supposed to be one of those year-end catalysts that keep biotech traders awake at night: fast-track status, fee waivers, a new FDA voucher program, and a decision “by year-end 2025”. Yet, as the calendar runs out, the line between guidance and reality still looks blurry.
Santas Biotech Watchlist: CORT, OTLK, VNDA
Instead of a sterile list of dates, this piece focuses on context: how Corcept Therapeutics (CORT), Vanda Pharmaceuticals (VNDA) and Outlook Therapeutics (OTLK) are approaching their regulatory events, what their cash situation looks like, what the retail chatter is, and what kind of narrative one can realistically expect in a positive or negative outcome.
OTLK Outlook Therapeutics DEC 31 Update CRL
The FDA has accepted a new BLA resubmission for ONS-5010 and set a Class 1 PDUFA goal date on 31 December 2025, after a second CRL in August that focused on lack of substantial evidence of efficacy.
KALA Kala Bio Inc
KALA BIO has gone from Phase 2b hope story to distressed nano-cap in a few months: KPI-012 failed, the lender swept cash after a default, and the company survived via a rescue deal with David Lazar plus a $10M registered direct offering priced at-the-market. Here’s what that actually means for the equity.
DVAX Dynavax Technologies Corp
Sanofi has announced a definitive agreement to acquire Dynavax Technologies Corporation for 15.50 dollars per share in cash, representing a total equity value of approximately 2.2 billion dollars. The offer implies a 39 percent premium to Dynavax’s closing price on December 23, 2025, and the transaction is expected to close in the first quarter of 2026, subject to customary conditions
DRMA Dermata Therapeutics Inc
Dermata Therapeutics (DRMA) – 58% Rally, Low Float and OTC Pivot Deep Dive 2025 | Merlintrader trading Blog Dermata Therapeutics (DRMA) – 58% Rally, Low Float and OTC Pivot Deep Dive 2025 Independent research note on Dermata’s +58% move: financing…
Market backdrop – Christmas Eve mood
Wall Street comes into Christmas Eve with the S&P 500 at fresh record highs after several strong sessions driven mainly by mega-cap tech. Today’s session is shortened, volumes are thin and the mood is a mix of “Santa Claus rally” and “better not break anything before the holidays”.