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For each company we cover: what the investment case depends on, whether each part is still holding, and the next decision that could change it.
Tracking 200+ biotech companies · 21 FDA decisions ahead
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FDA's November 14 decision is next; Datroway collaboration adds breast cancer development
Thesis checklist
Next: FDA's decision and the population covered by any approved label.
Next: HARMONi-3 progression-free survival results, with each histology assessed separately.
Next: Global comparative results, distinguishing HARMONi-3 chemotherapy combinations from HARMONi-2 monotherapy.
Next: Updated cash, spending, and conditional runway guidance incorporating launch preparation and expanded trial commitments.
Next decision point
FDA decision on ivonescimab after EGFR-targeted therapy
November 14, 2026 PDUFA goal action date
Does FDA approve ivonescimab plus chemotherapy for EGFR-mutant lung cancer after a third-generation EGFR inhibitor?
The biggest losses rarely come from a bad thesis.
They come from failing to recognize when the thesis changed. Biotech doesn't drift, it lurches: a CRL, a trial readout, an FDA panel vote. You're left holding a position you haven't re-evaluated in months.
The Terminal catches the change, across everything you follow.
Keros dosed the first patient in rinvatercept's Phase 2 in Duchenne muscular dystrophy, with initial data due in 1H 2027; Takeda's elritercept Phase 3s are paying milestones
Palatin reports going-concern doubt with $7.5 million in cash as it prepares its first MC4R obesity trials for 2027
Recursion raised $200 million and extended its runway into 2029 as REC-4881's polyp data held up; FDA talks will set the 2H 2027 registrational start
NVG-291 enters Phase 3 under partial FDA clinical hold; 2028 trial outcome hinges on hold removal and new capital
Nectin-4 ADC with 43% ORR in OPSCC enters registrational trial; interim readout will determine accelerated approval path
Proof, not a pitch
Replimune Group's history as it appears on its page. Each entry is dated to the event that caused it, and a verdict is never changed after the fact.
Oct 1, 2026 · Challenged · current
TUDRIQEV launched under accelerated approval; RP2's REVEAL transition in Q1 2027 is next
Aug 6, 2026 · Challenged
TUDRIQEV approved; IGNYTE-3 confirmation and long-term funding are the next tests
Jul 30, 2026 · Challenged
Two CRLs overcome by a 10-3 adcom vote, but a third FDA rejection would exhaust both cash and the approval path before RP2 matures
Jun 26, 2026 · Challenged
Two CRLs on single-arm IGNYTE data; a third FDA decision on the same dataset arrives before the cash runs out
May 29, 2026 · Challenged
RP1's third FDA submission tests whether a prioritized resubmission can overcome two CRLs in anti-PD-1-failed melanoma before runway expires
Apr 10, 2026 · Broken
FDA Complete Response Letter for RP1 + nivolumab BLA
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Every covered company, one Thesis — updated as the story changes. Follow what you own, ask what you need to know.
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