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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
SoundHound AI started as a voice and music-recognition company and gradually evolved into a broader conversational-AI provider. It now positions itself as a global platform for voice and agentic AI, powering restaurant phone ordering and drive-thrus, in-car voice assistants, smart devices and enterprise customer-service agents across financial services, healthcare, retail and more.
Alpha Tau Medical is trying to build an entire platform around one idea: using very short-range, high-energy alpha particles to burn tumors from inside the lesion, instead of bathing a large region of the body in external radiation. With the Japanese Ministry of Health, Labour and Welfare (MHLW) now granting full Shonin marketing approval for Alpha DaRT in unresectable, locally advanced or locally recurrent head and neck cancer, the company has just obtained its first real proof that regulators outside Israel are willing to treat this as a commercial therapy, not only an experimental one.
Edesa Biotech (NASDAQ: EDSA) is a clinical-stage biopharmaceutical company developing host-directed therapeutics (HDTs) – drugs that modulate the body's own immune response rather than targeting a specific pathogen. The company's lead asset, paridiprubart (EB05), is a first-in-class anti-TLR4 monoclonal antibody being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS).
As of February 24, 2026, Iovance Biotherapeutics is a small-cap oncology company (~$1.5B market cap) focused on TIL cell therapies for solid tumors, with AMTAGVI (lifileucel) already approved in the U.S. for advanced melanoma and a growing pipeline exploring TIL in other indications, including soft-tissue sarcomas.
The stock trades around $3.80 with roughly 364M shares outstanding, after a volatile path that has seen heavy dilution in past years but now combines commercial revenues (~$264M FY25) with a cash runway into Q3 2027 thanks to cost controls and better gross margins on AMTAGVI. The new 50% objective response rate (ORR) in the very difficult setting of advanced UPS/DDLPS sarcomas is what the market is reacting to right now.
ASTS AST SpaceMobile Open chart SEC filings Chart: static image. Click opens Finviz (affiliate link applied only on click). AST SpaceMobile (ASTS) — HALO Europa: $30M SDA prototype award, what it signals, what to watch Deep Dive “ALDX-signed”, mobile-first, light…
Fortress Biotech (NASDAQ: FBIO) is a diversified biopharmaceutical company with a unique portfolio acquisition and value-creation model. Rather than pursuing a single blockbuster drug, Fortress systematically acquires, advances and partners assets across oncology, dermatology and rare diseases, generating returns through product revenue, equity holdings, royalties and strategic asset sales.
SELLAS Life Sciences Group (NASDAQ: SLS) is a clinical‑stage biotechnology company focused on cancer immunotherapies and targeted therapies. The current story is driven by the cancer vaccine galinpepimut‑S (GPS), a Wilms Tumor 1 (WT1)–targeting immunotherapy, and by a CDK9 inhibitor program for hematologic and solid tumors.
The latest BusinessWire release finally puts hard numbers and structure around what we had already been tracking on IBRX: ~113 million USD of ANKTIVA net product revenue in 2025 (~700% year-over-year), ~750% unit growth, a regulatory footprint in 33 countries across four major jurisdictions, the first lung cancer approval in Saudi Arabia in combination with checkpoint inhibitors, and explicit patent protection for ANKTIVA combinations beyond 2035. On top of that, management now frames a clear three-year strategy with ANKTIVA as a “backbone” immunotherapy across multiple tumor types.
Rackspace Technology (NASDAQ: RXT) is a heavily leveraged hybrid multicloud and managed services provider that is trying to reposition itself as an “AI-first” infrastructure and operations partner. After years of revenue decline, recurring losses and a difficult competitive landscape, the February 18, 2026 strategic partnership with Palantir has triggered a violent rerating of the stock and reopened the turnaround debate.
ADMA Biologics (NASDAQ: ADMA) is a commercial-stage biopharmaceutical company specializing in plasma-derived immunoglobulins for the treatment of patients with primary humoral immunodeficiency (PI) and others at risk of certain infections. The company operates a fully integrated business model encompassing plasma collection, fractionation, manufacturing and commercialization.
The market reaction to Ardelyx’s Q4 2025 earnings was simple and brutal: the stock lost roughly fifteen percent in the days after the print, sending a message that “something is wrong”. If you stop at the chart, it looks like a broken story. If you read the filings, the picture is very different: this is a company that is clearly growing, but still paying a high price in operating expenses to sustain that growth.
When people talk about artificial intelligence in trading and investing, I almost always see two opposite – and both wrong – reactions.
On one side you have those who demonise it by default: “it’s dangerous”, “it fills your head with nonsense”, “it’s useless, markets are moved by others anyway”. On the other side you have those who treat it like a modern oracle: “tell me what to buy”, “give me the next 10-baggers”, “build me the perfect watchlist”.
I work with AI every single day to build Merlintrader’s content, and I can tell you something very simple: the truth is neither here nor there. AI is not an enemy to fight, and it’s not a guru to worship. It is a tool. Extremely powerful if you use it well. Dangerous if you use it badly. Useless if you ignore it.
This week’s recap walks through a classic “binary” market: indices inch higher while gold hits new records and oil creeps up on tariff and Iran risk. In biotech we see clean wins (VNDA, Telix) versus brutal setbacks (GRAIL, RGNX), while defense and space keep riding record military spending and drone/missile contracts. The briefing for February 23–28 closes with what really matters next: Nvidia’s earnings, the U.S. PPI print, and the first concrete signs from the Pentagon’s USD 1.1bn drone program.
The FDA has approved BYSANTI™ (milsaperidone) tablets as a first-line atypical antipsychotic for the acute treatment of manic or mixed episodes in bipolar I disorder and for the treatment of schizophrenia in adults. This is Vanda’s second FDA approval in under two months, following NEREUS™ for motion-induced vomiting prevention.
?? English ?? Italiano NASDAQ: LPTH · Optics & Photonics · Defense & Commercial LightPath Technologies (LPTH) – Q2 FY2026 Surge and Strategic Catalysts Comprehensive report on LightPath Technologies: Q2 FY2026 results, financial position, strategic backlog and growth scenarios for…
Tech-enabled health insurer focused on Affordable Care Act individual and small-group markets, trying to recover from a difficult 2025 with a 2026 guidance that points back toward operating profitability, under the shadow of U.S. healthcare policy and subsidy decisions.
ImmunityBio announced a commercial partnership with Biopharma and Cigalah Healthcare to launch ANKTIVA in Saudi Arabia and, over time, across the wider Middle East and North Africa, backed by an SFDA registration certificate with pricing. It’s not a new label approval, but it is a concrete step in the global monetization of the ANKTIVA franchise.
Pure-play Earth observation and satellite delivery name listed on Nasdaq, riding a wave of new government contracts and capital raises. This report looks at the real size of the backlog, the evolving mix between satellite sales and data-as-a-service, the cash runway after multiple offerings, and where the risk/reward sits for event-driven traders.
After crossing 1 billion dollars in annual revenue and reporting record gross margins, Tandem enters 2026 in a delicate transition phase: rolling out a pay-as-you-go pharmacy model, expanding direct international operations and pushing its Control-IQ+ automation to more patients, while still carrying net losses and a sizeable convertible note stack.
Solid Biosciences Inc. (NASDAQ: SLDB) is a precision genetic medicines company developing AAV‑based gene therapies for rare neuromuscular and cardiac diseases, with a lead focus on Duchenne muscular dystrophy (DMD), Friedreich’s ataxia (FA), and catecholaminergic polymorphic ventricular tachycardia (CPVT)