Biotech catalyst, news and analysis PDUFA tracker
Tickers reports and analysis
LUGANO missed the primary endpoint by a margin nine patients created, met every durability endpoint, and cost EyePoint roughly seventy per cent. The rest of the wet AMD field went up. Why both facts are true.
Biotech Radar for Aug. 15, 2026: CAPR, ABCL and DFTX lead, plus TENX, SION, PDSB, FDA approvals, clinical data, earnings and biotech deals.
Two six-month implants, three one-time gene therapies, one Chapter 11 and a Phase 3 readout due this month. How the wet AMD durability race actually stands, verified against SEC filings and ClinicalTrials.gov.
A source-verified Q2 2026 deep dive into Geron, Novavax and Iovance: revenue quality, cash, dilution, pipelines, regulation, competition, valuation and catalysts.
GRAIL’s Galleri faces an FDA AdCom on September 23. We examine the missed NHS endpoint, Stage IV signal, PATHFINDER 2, cash, reimbursement and risk.
Iovance, Immatics, Replimune and Immunocore compared across development status, efficacy, durability, safety, commercialization, manufacturing, patient journey, balance-sheet strength and upcoming catalysts. At the end: the next contender, Obsidian Therapeutics.
Senseonics jumped 26% the day after a wider loss. The three numbers that actually moved, the dilution that already happened, the break-even arithmetic nobody ran, and where a 365-day sensor sits in a market of 7 to 15 day sensors.
A 3–9 loss, a 10–3 win, an FDA approval one week later — and Capricor’s August 22 PDUFA is still alive. The tempting conclusion is that Replimune just created a precedent for deramiocel. The more useful conclusion is harder, narrower and much more interesting.
Biotech Radar for August 5, 2026: $OBX, $ACRV and $URGN lead, with clinical, commercial and financing news across nine additional biotech names.
PolyPid receives FDA Priority Review for D-PLEX100, Processa rebuilds around VT-7208 with a $200 million financing, and TScan begins pivotal Phase 3 execution.
LYTENAVA’s approval removed the central regulatory risk, but it also exposed a financing structure built around low-strike warrants, resale registration, a large at-the-market program, convertible debt and an already-authorized reverse split. The key question is no longer only what the drug may be worth. It is how much of that value can survive on a per-share basis.
Today’s Radar separates a genuine commercial-plus-clinical rerating at Kiniksa from a material commercialization-timeline reset at Nautilus Biotechnology and a strong but more complex post-acquisition quarter at Alkermes. NeoGenomics and Mirion remain on the closing-bell watchlist, with results scheduled after the market closes.
Four biotech stories moved onto the radar for four very different reasons: a company-changing financing at $ENTX, a first commercial FDA approval at $FRNM, a planned leadership handoff at $SRPT and a sudden CEO departure at $LEGN.
ZEPHYR met its primary endpoint with the twice-daily dose of ML-007C-MA, yet MapLight lost roughly two-thirds of its value intraday. The apparent contradiction disappears once efficacy magnitude, dosing convenience, competitive benchmarks, expectations and the remaining regulatory path are examined together.
Why $SMMT’s PD-1/VEGF bispecific is no longer just a drug story—and how its FDA review could redraw the path from Chinese discovery to global oncology markets, with $MRK’s Keytruda franchise directly in view.
Two damaged regulatory stories return to the same FDA advisory committee on consecutive days. Capricor brings a new randomized Phase 3 dataset in Duchenne muscular dystrophy; Replimune asks the agency to reconsider accelerated approval after two Complete Response Letters in advanced melanoma. This report separates the clinical evidence, the likely pressure points, the retail narrative and the decisions that actually matter.
The July 20–24 tape punished Alphabet and Tesla, pushed Brent above $100 before a late retreat, and kept rotation alive below the mega-cap surface. Next comes the Federal Reserve, GDP, PCE, Microsoft, Meta, Apple, Amazon and back-to-back FDA Advisory Committee meetings.
Kalshi launched a pilot program on July 16, 2026, enabling trading on clinical trial outcomes and FDA decisions linked to biotech firms. This new prediction market offers a public price reflecting the probability of drug approval, but raises ethical concerns and potential manipulation risks due to limited participant knowledge and liquidity challenges.
Three small- and mid-cap biotechnology companies are chasing the same strategic prize—durable retinal-disease control with fewer injections—but they are using different technologies, different delivery routes and radically different levels of clinical evidence.
Insider trading this week (July 13-17, 2026): the 20 biggest open-market buys and 20 biggest executed sells by dollar value, with names, tickers, amounts and next catalysts. Educational, not advice.
