$111.8B of 2025 oncology blockbuster sales lose US exclusivity by 2037, led by Keytruda, Darzalex, Opdivo. These 45 public biotechs have 67 oncology treatments in Phase 3 or filed with the FDA, 13 of them already filed.
2025 sales each company reports from tracked oncology treatments losing US exclusivity by 2037. Big pharma has spent $102.7B on 20 oncology acquisitions since 2023. See the deals →
Three approved TTFields devices, $710M+ revenue guidance, but GBM expansion just failed; Optune Lua's brain-mets PMA is now the growth thesis
Phase 3 SPA win and RMAT designation point aglatimagene toward a BLA, but market skepticism and a single-arm-free path hinge on FDA's read of DFS as sufficient
Phase 2/3 primary endpoint met, NDA under RTOR; darovasertib approval would create first-ever systemic standard of care in uveal melanoma
Selinexor's myelofibrosis sNDA filed with strong Phase 3 data, but forbearance expires Oct 15; survival past that date resolves everything
Ivonescimab beat Keytruda on OS; November BLA decision and going-concern clock test US approval before balance sheet breaks
Third shot at FDA approval with going-concern clock ticking: does ALLELE data survive a second regulatory reversal?
BTD-backed phospholipid ether radioconjugate eyes EMA conditional approval in rare lymphoma; runway expires before a U.S. decision lands
REZILIENT3 delivers Phase 3 PFS win and a $100M milestone, but the 2L NDA rides single-arm data to a Feb 2027 PDUFA; approvability of that filing is the first gate
BLA filing hinges on whether 25% 12-month durability satisfies FDA after a 50% workforce cut reset expectations
PRAME-targeting TCR cell therapy racing a Phase 3 enrollment clock against a burn rate that consumed €113M in six months
OST-HER2 pursues accelerated approval in pediatric osteosarcoma; BLA acceptance and regulatory conversion will determine whether Phase 2b data translates to a first approval
CAPTAIN data shows TULSA-PRO halves surgical harm vs. robotic prostatectomy; survival to cash-flow breakeven determines whether the commercial story completes
Three Phase 3 failures end Gilead collaboration; quemliclustat pancreatic Phase 3 is sole near-term binary, ~$130M quarterly burn
First China-approved Bcl-2 inhibitor beyond AbbVie's venetoclax, racing five global Phase 3s on four quarters of cash
After a Phase 3 NSCLC failure traced to a manufacturing scale error, efti's survival depends on whether two smaller bets; HNSCC and STS; can carry the program to approval
TScan scrapped its heme TCR-T identity after running out of money mid-Phase 3; what survives is a preclinical in vivo solid tumor bet with runway to Q4 2027
LOQTORZI's commercial trajectory toward $150-200M by 2028 is the thesis; pipeline optionality in casdozokitug and tagmokitug determines whether this becomes a multi-asset story
CB1 inverse agonist posts cleaner GI profile than oral GLP-1s at 5% weight loss; whether Phase 2 scales that signal decides the obesity bet
KIMMTRAK cashflows fund two Phase 3 melanoma bets; TEBE-AM OS readout is the swing factor for the whole expansion story
Keros rebuilt around a muscle-wasting ActA/ActB trap after a PAH safety halt; the case turns on whether Phase 1 PD signals in healthy volunteers translate to functional benefit in DMD
92% ORR in pancreatic cancer sets up a Phase 3 bet; whether randomized data replicates a single-arm signal decides everything
KRAS G12D inhibitor racing three simultaneous Phase 2 trials toward accelerated approval; going-concern doubt tests whether Oberland debt buys enough time
LOTIS-5 met its PFS endpoint, but FDA's mortality concern shifts the expansion case to LOTIS-7 and a new registrational path
Alpha DaRT holds a Japan approval and a pivotal cSCC readout due year-end; the question is whether single-arm data can clear FDA's PMA bar across multiple indications
Firmonertinib holds a second-line NSCLC approval; the thesis turns on whether the FURVENT Phase 3 readout unlocks first-line exon 20 insertion labeling
60% ORR and 15-month PFS in non-classical EGFRm NSCLC set up pivotal talks; FDA alignment on design is the single gate
Cemsidomide's 53% Phase 1 ORR sets up MOMENTUM Phase 2 as the binary that determines whether a cereblon degrader can reach approval in late-line RRMM
Phase 2 hit 72% ORR in RAS-mutant mCRC, but a licensor termination dispute now clouds whether Cardiff owns what it built
Tovecimig beat ORR and PFS in biliary tract cancer, but FDA wants a survival trial before BLA; approval hinges on Compass negotiating past that demand
Varseta-M's registrational path in advanced CRC turns on whether Phase 1 dose-optimization data supports an FDA-aligned trial design
AMPLIFY-7P ITT miss collapses adjuvant PDAC thesis; R0 subgroup and metastatic CRs remain contingent on Q1 2027 financing
17.3-month median OS in pancreatic cancer and Phase 3 now enrolling; all value rests on whether randomization confirms the signal
Phase 2 OS data of 14.7 months beats SoC in ovarian cancer, but going-concern filing puts survival to Phase 3 readout on trial
Instil Bio has no active pipeline after AXN-2510 discontinuation; the thesis now rests entirely on whether capital can acquire a new asset
Ateganosine's Phase 3 in refractory NSCLC tests whether telomere-targeting immunopriming can deliver survival benefit where checkpoint inhibitors have failed
Phase 3 interim CR rates 3× control arm, but runway expires at the unblinding window; survival to data is the bet
Rinzimetostat enters Phase 3 mCRPC; thesis turns on whether Phase 1b rPFS signals translate to registrational benefit over AR inhibitor monotherapy
Personalis's MRD momentum validated at $1.5B acquisition price; deal closing conditions determine whether shareholders capture that value
RAD101 PET met its Phase 2b endpoint in brain metastases, but $4M cash against $13M quarterly burn means Phase 3 lives or dies on imminent financing
TUDRIQEV approved; IGNYTE-3 confirmation and long-term funding are the next tests
FDA independently reviewing non-primary CGM data after Phase 3 miss; upLIFT's 7/8 interim response rate adds a second pathway but neither is confirmed
SELLAS pivots on two AML bets: GPS Phase 3 REGAL final analysis and SLS009 first-line trial define whether either program reaches approval
SGX945's Phase 2a Behçet's endpoint gives SNGX a post-HyBryte pivot candidate; survival to Phase 2b data is the test
TTX-MC138's Phase 2a ctDNA clearance readout in colorectal MRD will determine whether a miRNA-10b inhibitor can become a registrational asset
WEE1 inhibitor seeks accelerated approval in biomarker-selected PROC; single-arm DENALI data must clear FDA's bar
Filed treatments are listed first. This shows where late-stage treatments are being developed, not which companies will be acquired. Pipeline data and summaries from Readouts as of 29 September 2026; companies already acquired are left out.
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