Biotech catalyst, news and analysis PDUFA tracker
Tickers reports and analysis
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.
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)
Quick EN/IT follow-up after the U.S. Court of Appeals for the Federal Circuit upheld the New Jersey decision that Teva’s proposed generic Korlym does not infringe two Corcept patents, clearing a key legal hurdle for generic competition. We look at what this means for Korlym cash flows, how it interacts with the recent relacorilant CRL and why the ovarian cancer PDUFA remains the central medium-term catalyst.
A deep dive into Hims & Hers after the GLP-1 “pill gambit”, the Novo Nordisk lawsuit, and the transformative acquisition of Eucalyptus: business model, financials, balance sheet, insiders, retail crowd and key catalysts for 2026–2027
NASDAQ: GRCE · Biotech · aSAH / nimodipine IV Grace Therapeutics (GRCE) – GTx-104 and the 2026 FDA Decision Deep dive on Grace Therapeutics ahead of the April 23, 2026 PDUFA date for GTx-104, the company’s IV nimodipine for aneurysmal…
Almost one month after our long-form report at around $1.30, Geron is trading near $1.80. A slow but steady grind higher, driven more by positioning and expectations than by new hard data – with the first catalyst window now approaching: Q4 earnings and the first full-year RYTELO outlook under the new CEO.
NRx Pharmaceuticals is a micro-cap biotech focused on severe psychiatric conditions: suicidal depression, bipolar depression with suicidality, PTSD and related disorders. The core of the story is NRX-100, a preservative-free intravenous ketamine program supported by a large Real-World Evidence dataset, and NRX-101, an oral D-cycloserine + lurasidone combination with Breakthrough designation. Around those assets, the company is building HOPE Therapeutics, a network of interventional psychiatry clinics that should both validate the care model and generate revenue.
Positive 52-week SOL-1 data position AXPAXLI as a potential long-acting option versus aflibercept, yet the stock sells off as investors question trial design, real-world relevance and the regulatory path.
European Commission Grants Final Conditional Marketing Authorization for ANKTIVA® in EU
Decision C(2026)1197: Final, binding authorization allowing commercial launch across 27 EU member states + Iceland, Norway, Liechtenstein for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Two items in one tape-read: (1) a fresh BusinessWire update on Saudi regulatory engagement (rBCG dossier + ANKTIVA/CPI expansion discussions), and (2) a sell-side note in circulation reiterating a $24 price target from D. Boral Capital (note dated Jan 13, 2026 in the sources below).
Release of new clinical data from two Phase 3 trials (COMP005 and COMP006) on COMP360 in TRD + management webcast
Tradable short-term event: additional clinical data (specific portions of studies) and official management narrative. This is the type of event that changes the perception of probability/quality of clinical evidence, and thus volatility too.
Recursion, Tempus AI and Exscientia are three “pure-play” examples of what it really means to put artificial intelligence at the centre of a biotech business model. Used properly, AI can compress timelines, surface non-obvious biology and make better use of messy data. Used badly, it can amplify errors, burn cash faster and create stories the clinic will never confirm.
Next catalyst
H1 2026 – Updated ELIMINATE-B Phase 1/2 data in chronic hepatitis B (PBGENE-HBV), including higher-dose biopsy readouts.
Secondary 2026 catalyst: first sites activated and initial multi-patient data from the FUNCTION-DMD Phase 1/2 trial of PBGENE-DMD after FDA IND clearance (Study May Proceed) in February 2026.
Aldeyra Therapeutics (NASDAQ: ALDX) is a clinical-stage biotechnology company developing modulators of reactive aldehyde species (RASP) for immune-mediated and metabolic diseases. The key late-stage asset is reproxalap, an ophthalmic RASP modulator for dry eye disease (DED) and allergic conjunctiviti
A parallel “year of truth” roadmap for Iovance Biotherapeutics (IOVA), ImmunityBio (IBRX) and Altimmune (ALT), three names with huge retail followings, real science on the table and very little room for execution mistakes.
Wall Street just closed a choppy week where enthusiasm about AI and data-center spend ran into valuation nerves, while inflation data kept the “soft landing” narrative alive. The coming days will be dominated by U.S. GDP, the Fed’s preferred inflation gauge (core PCE), fresh PMIs and a cluster of sector-specific catalysts across biotech, space, defense and AI small/mid caps.
A post-CRL, post-Type A meeting request deep dive on ONS-5010/LYTENAVA, EU/UK launch reality, funding pressure and how much option value is left in a sub-$35M market cap.
Ten US-listed small- and mid-cap biotech stocks with key H2 2026 catalysts, including PDUFA dates, FDA advisory committees and pivotal Phase 3 readouts. Exact dates are separated from company-guided windows; the original H1 2026 analysis remains available as a historical archive.
