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This update is anchored to the company’s latest filing that laid out (1) the reiterated March 28, 2026 FDA action date for KRESLADI, (2) the resumption plan for Danon dosing in 1H 2026, and (3) the year-end 2025 cash position and runway guidance. The goal is to keep it neutral: what was said, what it implies, and where the remaining uncertainty still lives.
A first full-scope look at MannKind after Q4 2025 results and United Therapeutics’ new soft-mist treprostinil product (“Tresmi”), with focus on revenue mix, 2026 catalysts, balance sheet, insider and institutional positioning, analyst expectations and retail sentiment around the latest 35–40% drawdown.
Q4 2025 finally shows what the long Novavax story on Merlintrader was pointing to: revenue above 1.1 billion dollars for the year, a clean return to GAAP profitability in the quarter, and a 2026–2028 roadmap where Sanofi, Pfizer and other partners, not Novavax alone, carry most of the execution risk around Matrix-M.
FY 2025 marks an inflection point for BioCryst. After years of heavy investment to launch ORLADEYO, the company has finally delivered a clearly profitable year: total revenue reached roughly 875M USD in 2025, versus ~451M USD in 2024, and the P&L flipped from a small operating loss to more than 340M USD of operating profit. The key driver was ORLADEYO net revenue of about 602M USD, up nearly 40% year on year, supported by strong new-patient growth in the U.S. and a better-than-guided performance overall.
As of late February 2026, Teva combines a still-massive generics footprint with a focused innovative portfolio in CNS and immunology. After a lost decade of litigation, write-downs and restructuring, the company is now delivering mid-single-digit top-line growth, expanding non-GAAP margins and generating roughly $2.4B of free cash flow per year while steadily reducing debt.
Follow-up to our previous PLX work: from CHMP’s positive view on the every-four-week Elfabrio regimen to a binary European decision, a new earnings call in mid-March and the next steps for the uncontrolled-gout program PRX-115 – with PLX now trading back into a resistance area close to last year’s highs.
2025 results, CRDF-004 data
The U.S. Food and Drug Administration has approved DESMODA (desmopressin acetate) oral solution for the treatment of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), in adults and pediatric patients. This is the first and only FDA-approved ready-to-use oral solution of desmopressin, a meaningful upgrade in day-to-day management of this rare water-balance disorder.
Phase 3 SOL-1 delivered the first statistically significant superiority versus an approved anti-VEGF in wet AMD, with year-long durability from a single injection and a clean safety profile. The market reaction has been volatile; the strategic picture for the next 24–36 months is clearer than the tape suggests.
The first full commercial year of RYTELO brought ~$184M in revenue and a growing base of prescribing centers, but a softer Q4 versus expectations and unchanged 2026 guidance triggered a sharp pullback in the stock. Here is what actually happened, why the market reacted this way, and how it fits into the long-term thesis we’ve been following on Merlintrader.
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.
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.
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.
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.
