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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
Six verified biotech developments published today: an accepted rare-disease NDA, updated PCNSL response data, the opening of a rolling Wilson-disease application, a positive brain-metastases imaging study, a Canadian ALS regulatory path and a $1.5 billion cell-therapy tools acquisition.
A framework for reading the critical-minerals sector: why the real bottleneck is processing (the midstream), a four-question tool to triage any headline, with $UAMY as the worked example and $MP, $USAR and $TMC on the map.
How Rare Pediatric Disease Priority Review Vouchers turn a single FDA approval into $180-205 million in non-dilutive cash - the mechanism explained, with $RCKT and $DNLI as worked examples.
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.
Congress stripped the provision that would have defunded marijuana rescheduling — the House passed the clean bill 397-28 — and cannabis investors never priced it. Meanwhile the sector fell during the DEA hearing itself.
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.
The July 13–17 tape delivered a sharp semiconductor reset, cooler inflation data, a renewed oil shock and resilient rotation below the headline indices. Next comes Alphabet, Tesla, Texas Instruments and Intel, plus AMD’s AI event, Farnborough, biotech data and a weekend FDA decision.
A full three-company edition covering an early wet-AMD durability signal, a $100 million gene-therapy financing that materially resets per-share ownership, and a traditional FDA approval that raises the evidence standard across the increasingly competitive IgA-nephropathy market.
A U.S.-only defense report covering traditional primes, scaled defense-tech, high-beta drone and AI names, and national-security space companies already followed by Merlintrader. The central question is not whether military demand exists, but which companies can turn budgets and contract ceilings into funded backlog, margins and free cash flow per share.
The space economy has not stopped growing, but its public-market proxies have lost scarcity, absorbed a wave of new securities and broken key technical support. This report separates the common sector shock from each company’s own risks and identifies what would have to change before the decline can credibly reverse.
Jasper has acquired Kira Pharmaceuticals and preserved its Nasdaq ticker, but the company behind that ticker is being rebuilt around Kira’s complement pipeline. The financing solves an immediate liquidity crisis; the ownership math leaves legacy Jasper holders with only 6.68% of the combined company and creates a capital structure that will almost certainly require further corporate action.
How the HALEU enrichment bottleneck decides the advanced-reactor race: the fuel-cycle map, a reusable triage tool, and $OKLO, $LEU and $CCJ as worked examples.
Three biotech updates, three very different evidence problems: an early Parkinson’s disease signal moving toward Phase 2, a post hoc attempt to rescue a pulmonary sarcoidosis program after a missed Phase 3 endpoint, and an FDA-guided protocol optimization that may make a urology study faster and less expensive without yet proving efficacy.
The AI boom is no longer only a semiconductor and cloud-computing story. It is becoming a race for mission-ready software, deployable electricity and secure magnet supply. This report separates the common narrative from the very different financial realities of BigBear.ai, Bloom Energy and MP Materials.
Eli Lilly and AtaiBeckley signed a definitive merger agreement. ATAI holders are entitled to $6.75 per share in cash at closing plus a non-transferable CVR worth up to $2.50 per share tied to VLS-01 Phase 3 initiation and U.S. approval plus DEA rescheduling milestones for BPL-003 and VLS-01. The transaction carries approximately $2.8 billion of upfront equity value and up to $1.0 billion of contingent value.
The July 15 testimony is over. There is no verdict, no vote and no broad Schedule III final rule yet. The hearing nevertheless clarified which parts of the government’s case survived, where the opposition created real legal risk and what investors should watch next.
Phase 2 CELIA produced one of the most intriguing tau signals yet seen in Alzheimer’s disease, but it did not settle the key issue: why did the lowest dose show the most persuasive cognitive benefit while higher doses failed to produce a stronger response?
$BIIB · $IONS
Alzheimer’s · Tau · Antisense
Merlintrader Biotech Radar Biotech Radar July 14, 2026: Biogen, AstraZeneca, GSK and Evotec — $BIIB, $AZN, $GSK, $EVO A deeper four-company edition covering an FDA delivery breakthrough in Alzheimer’s disease, a $1.5 billion lung-cancer licensing deal, a potentially treatment-changing organ-preservation…
Gravity ($GRVY) deep dive: verified Q1 2026 and FY2025 numbers, ~$400M cash and no debt against a ~$440M market cap, the Ragnarok launch engine, GungHo control, and the bull vs bear case. Educational, not advice.