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 Reports Biotech
Tickers reports and analysis
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.
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.
OMER Omeros Corp
News of the day – FDA approval
The FDA has approved YARTEMLEA (narsoplimab-wuug) for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children 2 years and older. YARTEMLEA is the first and only approved inhibitor of the lectin complement pathway and the only FDA-approved therapy for TA-TMA.
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”.
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.