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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
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.
Three companies serving the same AI data centre demand reported three completely different quarters. Bloom Energy passed $1 billion of revenue and made a profit. CoreWeave doubled revenue and paid $640 million of interest. Nebius grew 454% and spent $5.66 billion on capacity. Meanwhile the nuclear names are down a third this year.
Memory-to-optics rotation and the draft US ban on Chinese modules: Ciena at $1.57B revenue, Lumentum at a 47.9% gross margin, POET at half a million with warrants struck at $26.25.
Between late May and July 29, 2026, RKLB, ASTS, LUNR and RDW lost 60-75% of their value, then rallied 35-75% in seven sessions. Nine defense names beat and raised guidance. Real reversal, or dead cat bounce? The next earnings decide.
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.
The Nebius Vineland AI data center is already under construction while the amended site plan returns to a Planning Board hearing on August 17. Inside $NBIS: the $17.4 billion Microsoft contract, the Bloom Energy power redesign, Michael Burry's short, DA Davidson's cut to $175 and the August 12 earnings call.
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.
ADMA has repurchased about 13.8 million shares in 2026 while ASCENIV keeps growing, gross margin remains near 70%, short interest stays elevated and retail discussion has shifted toward State Street, a possible squeeze, SG-001 and buyout speculation. The useful question is not whether these narratives sound bullish. It is which ones actually change per-share value — and which ones do not.
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.
Oklo, X-Energy, NuScale and Terrestrial Energy are usually traded as one theme. They are four different businesses. A comparison on business model, regulatory status, fuel enrichment, contracts and cash, with a reusable six-question triage tool.
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.
The courtroom has gone quiet, but the federal cannabis story is becoming more complicated—not less. Behind the August 17 deadline, investors are watching an unfinished tax rule, a dangerous court challenge and a Schedule II scenario that few traders appear prepared to discuss.
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.
17,541 US law enforcement agencies, nearly 70% with 24 officers or fewer. The five barriers between a department and a flying drone, with $DPRO, $AXON, $RCAT and $ONDS mapped.