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
SKYX Platforms Corp

SKYX wants to turn the ceiling into the “brain” of the home: a plug & play outlet that makes lights, fans and smart devices safer and easier to install, plus an AI-native platform built on NVIDIA’s cloud ecosystem. Revenues have climbed to record levels through Q3 2025 and the company has just secured new strategic and institutional funding ahead of big launches at Lowe’s and early smart city deployments.
PLX Protalix BioTherapeutics Inc

The core of the Protalix model today is Elfabrio (pegunigalsidase alfa) for Fabry disease, commercialized globally by Chiesi under the two Chiesi agreements described in the FY 2024 release and 10-K. :contentReference[oaicite:2]{index=2} Protalix manufactures the drug substance in Carmiel and sells finished product to Chiesi, receiving tiered payments in the 15–35% ex-US and 15–40% US range on average selling price, linked to purchased volumes, as outlined in the “Chiesi Agreements” and “Revenues from selling goods” sections.
VIVS VivoSim Labs Inc

Real-time news feeds (RTTNews, MarketScreener, StockTitan, QuiverQuant) and broker dashboards show VIVS up roughly +70–100% in pre-market trading on 30 January 2026, with pre-market prices around 3.0 USD and, in some snapshots, higher peaks depending on the exact timestamp. Versus a previous close of 1.70 USD, this is a classic microcap “gap & squeeze” setting, driven by a mix of genuine news and positioning on a very small float.
KYTX Kyverna Therapeutics Inc

Deep dive (as of January 30, 2026) on Kyverna Therapeutics (KYTX): autologous CD19 CAR-T mivocabtagene (miv-cel, KYV-101) in autoimmune diseases, positive registrational KYSA-8 data in stiff person syndrome (SPS), RMAT/Fast Track designations, 2026 BLA ambitions and cash runway into 2027. Educational only, not investment advice
TLSA Tiziana Life Sciences Ltd

Tiziana Life Sciences is building an entire company around one idea: that intranasal delivery of a fully human anti-CD3 antibody, foralumab, can re-educate the immune system and cool down chronic neuroinflammation without broad systemic immunosuppression.
QNCX Quince Therapeutics Inc

Quince Therapeutics (QNCX) released topline results from its pivotal Phase 3 NEAT clinical trial of eDSP (EryDex) in Ataxia-Telangiectasia, a rare pediatric neurodegenerative and immunodeficiency disorder. The press release confirms that the study did not meet its primary endpoint on the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS), with insufficient separation versus placebo despite prior Phase 2 and ATTeST signals
LUNR Intuitive Machines Inc

Intuitive Machines is a Houston-based space infrastructure company working on lunar landers, cislunar communications and defense-focused satellite platforms. The stock is one of the purest public plays on the Artemis + Golden Dome “space infrastructure” theme.
APLD Applied Digital

Applied Digital Corporation (Nasdaq: APLD) has emerged as one of the most talked-about names in the AI infrastructure space in 2026. Following a decisive pivot from Bitcoin mining and blockchain services (2021–2023) to purpose-built data centers for high-performance computing (HPC) and artificial intelligence workloads, the company has delivered explosive revenue growth
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.
GUTS Fractyl Health Inc

“Good headline, bad read” session
Fractyl reported 6-month randomized midpoint data from a blinded, sham-controlled cohort in REMAIN-1. The release highlights less weight regain vs sham, better cardiometabolic profile, and a De Novo pathway discussion. The stock is getting hit because traders are discounting the quality of the signal and the timeline.
KALV KalVista Pharmaceuticals Inc

From “great science” to “great delivery”: Ekterly’s launch is now the purest real-world test of whether KalVista can turn first-in-class oral HAE convenience into durable cash flow before competition closes the gap.
MBRX Moleculin Biotech

Moleculin Biotech, Inc. (NASDAQ: MBRX) is a Phase 3 clinical-stage pharmaceutical company dedicated to developing innovative therapies for hard-to-treat tumors and viruses. The company's lead candidate, Annamycin, is advancing in the pivotal Phase 3 MIRACLE trial for relapsed/refractory acute myeloid leukemia (AML), with the first unblinding of data anticipated in Q1 2026.
SER Serina Therapeutics Inc.

Serina Therapeutics is a clinical-stage biotechnology company based in Huntsville, Alabama, built around its proprietary POZ Platform, a drug optimization technology based on a controlled, water-soluble poly(2-oxazoline) polymer. The platform is designed to tune half-life, exposure and tissue distribution of small molecules, peptides and biologics, with the ambition of generating “best-in-class” dosing profiles versus conventional formulations.
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.
CAPR Capricor Therapeutics Update feb08

FDA asks for the full HOPE-3 clinical study report but does not require new trials, while Capricor prepares a February BLA update. The stock hovers around 23–24 $, with a market cap near 1.16 B$, after a 2025 rally fuelled by Duchenne data and aggressive retail positioning.
RGNX Regenxbio Inc Update Jan28

FDA places a clinical hold on RGX-111 (MPS I) and RGX-121 (MPS II) programs after a single intraventricular CNS tumor in an RGX-111 patient.
Preliminary analysis shows an AAV vector integration event near proto-oncogene PLAG1; causality is still under investigation.
NAVSUNLI (RGX-121) BLA for MPS II remains under priority review with a PDUFA date of February 8, 2026; no public change to that date has been announced as of this report.
Ondas (ONDS) Inc

Ondas Inc. (NASDAQ: ONDS) announced that the Optimus drone from its American Robotics unit has been added to the DCMA “Blue List” of approved unmanned aircraft systems. This confirms compliance with Department of War cybersecurity, supply chain and operational standards and opens a faster lane for U.S. government and defense procurement of Optimus.
At Merlintrader we’ve been following Ondas for a while through this steep progression, and today’s move is another step in the transition from a niche wireless/IoT story towards a more clearly defined dual-use autonomous infrastructure profile.
PDYN Palladyne AI Corp Update Jan 28

Today’s move is all about a fresh U.S. Air Force Research Laboratory contract: the headline is “swarming,” but the real keyword is integration—getting drones, ships, ground systems, and now satellites to share ISR and coordinate as one network. Below: what happened, what it could mean, what can still go wrong, and the key numbers double-checked from SEC filings and official releases.
ROCKET LAB (RKLB)

Rocket Lab is one of the few listed names sitting at the intersection of launch services, space infrastructure and US national security. In the last weeks, three threads have converged: a record defence contract for missile-tracking satellites, a visible test failure on the new Neutron rocket, and a high-visibility hardware milestone with the arrival of the “Hungry Hippo” fairing at the Virginia launch complex.
CRDF Cardiff Oncology Inc

As of January 27, 2026, Cardiff Oncology (NASDAQ: CRDF) is trading around 2 dollars per share after a single-session loss of roughly thirty-two percent. The trigger was a GlobeNewswire press release announcing that long-time Chief Executive Officer Mark Erlander and Chief Financial Officer James Levine are both stepping down, with board member Mani Mohindru becoming interim CEO and Senior Vice President of Finance Brigitte Lindsay moving up as interim CFO.