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Upfront Briefing
Oncology owned the tape: Terns is taking a swing at Novartis in CML, BioNTech/OncoC4 posted a big lung cancer win, and FDA quietly raised the bar for future CAR-Ts.
On the policy side, the Biosecure Act is hitching a ride on the US defense bill, while Mirum, Dyne, Kymera, and Wave all dropped data or deals to keep XBI’s hot streak interesting.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,847.8 |
(0.3%) |
16.4% |
| Nasdaq 100 |
25,631.3 |
(0.2%) |
22.0% |
| Russell 2000 |
2,521.4 |
0.0% |
13.0% |
| XBI |
123.7 |
0.2% |
37.3% |
| Nasdaq Biotech Index |
5,722.3 |
(0.3%) |
32.7% |
The Big 3
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1
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Terns leukemia drug rivals Novartis in new study results
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Terns’ leukemia drug shows promise against Novartis’ treatment, suggesting a shift in chronic myeloid leukemia care.
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Why it matters:
Terns’ leukemia drug shows potential to surpass Novartis’ blockbuster, signaling a major shift in chronic myeloid leukemia treatment.
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Source:
STAT
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More:
BioPharma Dive; STAT; Endpoints
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2
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FDA raises approval bar for new CAR-T cancer therapies
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FDA now requires new CAR-T cancer treatments to show superiority over existing therapies, raising approval standards.
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Why it matters:
FDA now requires new CAR-T treatments to prove superiority over existing therapies, raising the bar for cancer drug approvals.
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Source:
Endpoints
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More:
BioCentury
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3
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BioNTech, OncoC4 antibody halves death risk in lung cancer trial
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BioNTech and OncoC4’s antibody more than halves risk of death in Phase 3 lung cancer trial, advancing late-stage options.
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Why it matters:
BioNTech and OncoC4’s antibody significantly reduces risk of death in lung cancer, advancing late-stage treatment options.
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Source:
Endpoints
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Everything Else that broke
- Dyne’s Duchenne drug hit its primary endpoint in a pivotal study and is moving toward FDA accelerated approval. Endpoints
- Kymera’s oral STAT6 degrader showed biologics-like activity in Phase Ib atopic dermatitis, boosting confidence in degraders for immunology. BioCentury
- Wave’s RNA injectable for obesity delivered a 4% fat reduction in Phase I, outperforming semaglutide at a similar time point. BioSpace
- The US defense bill includes the Biosecure Act to reduce reliance on Chinese biotechs, with implications for biopharma supply chains. Endpoints; BioCentury
Deal Flow
M&A / BD&L
- Mirum is acquiring Bluejay in a $620M deal, adding a late-stage hepatitis D candidate and expanding its infectious disease portfolio. BioPharma Dive
VC / Private Financings
- No notable VC / private financings in the last 24 hours.
IPOs / Follow-Ons
- No notable IPOs or follow-on offerings in the last 24 hours.
Academic Corner
- No notable academic headlines in the last 24 hours.
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This content is for information only and is not investment or medical advice.
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