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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
NTLA Intellia Therapeutics Inc

As of January 27, 2026, Intellia Therapeutics (NASDAQ: NTLA) is back in the spotlight. The FDA has lifted the clinical hold on MAGNITUDE-2, the Phase 3 study of its in vivo CRISPR therapy nexiguran ziclumeran (“nex-z”, formerly NTLA-2001) in hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), while a separate large cardiomyopathy trial (MAGNITUDE, ATTR-CM) remains on hold after a Grade 4 liver event and a subsequent patient death triggered intense scrutiny.
COYA Therapeutics Holdings Inc

COYA Therapeutics Holdings represents a high-risk opportunity in the biotech sector, focused on developing innovative therapies for neurodegenerative and autoimmune diseases through regulatory T-cell (Treg) modulation. With a pipeline including candidates for ALS, Alzheimer's, and other complex pathologies, the company positions itself in a therapeutic area with significant unmet medical needs but also with high clinical failure rates.
KURA Kura Oncology Inc

Kura Oncology is a precision oncology company built around one central thesis: targeting oncogenic signalling nodes such as menin and farnesyl transferase can reset the biology of hard-to-treat cancers, especially acute myeloid leukemia (AML).
RDW Redwire Corporation

Redwire is moving from niche space supplier to integrated space-and-defense player just as the Golden Dome and SHIELD architectures turn from political slogan into multi-decade procurement programs. The stock has already rerated on expectations; the question now is whether cash flow, backlog and contract wins will catch up with the narrative.
ATYR Atyr Pharma Inc

aTyr Pharma ($ATYR) is a clinical-stage biotech developing first-in-class therapies from its tRNA synthetase platform, targeting fibrotic and inflammatory lung diseases. The company's lead asset, efzofitimod (a selective NRP2 modulator), suffered a major setback with the Phase 3 EFZO-FIT trial miss in pulmonary sarcoidosis (announced Sept 15, 2025), causing an ~80% stock drop from ~$4-5 to sub-$1 levels.
VNDA Vanda Pharmaceuticals Inc

Vanda is not a pre-revenue biotech: it is a commercial-stage CNS company with three marketed products (Fanapt, Hetlioz, Ponvory) and two late stage assets that matter for the next 12–24 months: Nereus (tradipitant) for motion sickness, now approved, and Bysanti (milsaperidone) with a PDUFA target action date on 21 February 2026 for schizophrenia and bipolar I disorder.
VRDN Viridian Therapeutics Inc

Viridian Therapeutics (VRDN) has started 2026 by reaffirming its "transformational" year narrative in the January 6 PR, which serves as a comprehensive roadmap update without any timeline shifts or negative surprises. This builds directly on the December 22, 2025 BLA acceptance for veligrotug (VRDN-001) in TED with Priority Review and PDUFA target of June 30, 2026 (as detailed in the previous report).
Celc Celcuity Inc

Celcuity (CELC) – Gedatolisib PDUFA July 17, 2026: Setup, Risks and RunUP Map | Merlintrader trading Blog English Italiano Celcuity (CELC) – Gedatolisib PDUFA July 17, 2026 PI3K/mTOR inhibitor in HR+/HER2- metastatic breast cancer – binary PDUFA, cash runway and…
RGNX Regenxbio

RGX-121 puts Regenxbio at the threshold of its first potential standalone approval, while the retina (AbbVie) and Duchenne programs build a second and third pillar for 2026–2027. The equity story is a classic “platform + royalty + binary PDUFA” mix, with a balance sheet extended into early 2027 via upfronts and royalty monetization.
CVKD Cadrenal Therapeutics Inc

Cadrenal Therapeutics (NASDAQ: CVKD) is a clinical-stage biopharma headquartered in Ponte Vedra, Florida, focused on anticoagulation solutions for high-risk patients who are poorly served by current therapies. The company was formed in 2022 around tecarfarin and, through two 2025 acquisitions, has expanded into a broader platform combining VKA, Factor XIa and 12-LOX mechanisms.
Weekly Briefing – Fed, Geopolitics, GLP-1 Obesity & Small Caps

Going into the 27–28 January FOMC, the message is basically “don’t expect fireworks”: after the 2025 cuts, the Fed keeps describing policy as “well positioned”, with inflation gliding down towards (but not yet at) target and real growth still positive. Futures now see a very high probability of a clean hold next week and push the bulk of any extra easing into late 2026.
Biotech Catalyst Calendar February 2026: PDUFA, BLA & Clinical Results

Biotech Catalyst Calendar February 2026: PDUFA, BLA & Clinical Results
One-page view of the key February 2026 biotech catalysts: only one line per ticker, grouped by date. Fixed PDUFA and BLA events are listed first; the others are February-window guidance from company and Street sources.
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…
ETON Pharmaceuticals Inc

After years of being “just a pipeline story”, Eton has transitioned into a small but diversified rare-disease platform with multiple approved assets and a focused late-stage pipeline anchored by ET-400 and ET-600.
AQST & PHAR -Countdown Jan 31 PDUFA

We are on Friday, January 23, 2026 (Italy time). For January, in your catalyst tracker there are essentially two PDUFAs still “missing” that matter for this piece: Aquestive (AQST) with Anaphylm and Pharming (PHAR) with the pediatric Joenja sNDA (4–11 years, APDS). Both currently carry a PDUFA target action date of January 31, 2026.
Space Defence & AI

When you line up the numbers on artificial intelligence in space operations, autonomous systems and new-generation missile defence, it becomes very clear we are not looking at a “nice theme” to trade for a few quarters. We are watching the birth of a structural, AI-native arms race that stretches easily over the next 20–30 years.
KPTI Karyopharm Therapeutics

At the dawn of 2026, Karyopharm Therapeutics stands at a critical inflection point that will determine not only near-term share performance, but in many respects the long-term viability of the company. After spending the last five years building a commercial foothold in late-line relapsed/refractory multiple myeloma, Karyopharm has repositioned the selinexor franchise toward two potentially transformative Phase 3 readouts: the SENTRY trial in myelofibrosis and the XPORT-EC-042 trial in endometrial cancer maintenance.
IONS Ionis Pharmaceuticals

Ionis is one of the long-standing pioneers of antisense oligonucleotide (ASO) therapeutics. Founded in 1989, the company has taken antisense from a controversial idea to an approved therapeutic class with multiple marketed products and a deep late-stage pipeline.
HELP Helus Pharma Inc

Helus Pharma is the new brand for Cybin, now trading under the ticker HELP on the Nasdaq Global Market and on Cboe Canada. The company is trying to position itself as a “psychedelic 2.0” / mental-health pure play, built around proprietary novel serotonergic agonists (NSAs) rather than classic psychedelic molecules