BioBucks Newsletter
Big Pharma wants faster approvals, Sanofi juggles setbacks and deals, and CAR-T pushes deeper into autoimmunity.
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Upfront Briefing
Regulators and big pharma are both trying to make approvals faster—just not with the same playbook. Big Pharma is pushing FDA to decouple inspections from approval applications, while FDA is calling for more real-world data and early-phase trial reform.
In pipeline land: Sanofi is absorbing setbacks for an MS program even as it inks an Alzheimer’s deal, and Kyverna’s autoimmune CAR-T logged a win in stiff person syndrome with an FDA submission in sight. (Yes, autoimmunity keeps stealing oncology’s toys.)
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,816.5 |
(0.2%) |
15.9% |
| Nasdaq 100 |
25,067.3 |
(0.5%) |
19.3% |
| Russell 2000 |
2,530.7 |
(2.3%) |
13.5% |
| XBI |
122.8 |
(0.2%) |
36.4% |
| NBI |
5,709.0 |
(0.3%) |
32.4% |
| Clinical Trials ETF (BBC) |
39.8 |
(0.4%) |
66.2% |
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Mostly red at the US close, with small caps taking the hardest hit while biotech held roughly in line with the S&P 500.
The Big 3
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1
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Big Pharma pushes FDA on approvals; FDA seeks real-world data
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Big Pharma is urging the FDA to separate inspections from drug approval applications, while the agency is pushing more real-world evidence and early-phase trial reform.
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Why it matters:
If industry wins on inspections and FDA wins on real-world data and trial design, the whole approval playbook shifts — changing how companies plan timelines, allocate CMC risk, and invest in evidence outside classic Phase 3s.
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Source:
BioSpace
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More:
Endpoints;
BioWorld
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2
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Sanofi’s MS drug faces setbacks; inks Alzheimer’s deal
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Sanofi is taking hits in its multiple sclerosis program—trial disappointments and regulatory friction—while simultaneously landing a notable Alzheimer’s partnership.
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Why it matters:
The contrast between a stumbling MS BTK program and fresh Alzheimer’s BD shows how big caps constantly recycle risk in neurology — and where they still see the most long-term upside.
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Source:
BioPharma Dive
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More:
Fierce Biotech
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3
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Kyverna’s CAR-T posts win in rare autoimmune disease
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Kyverna’s autoimmune CAR-T showed encouraging results in stiff person syndrome, setting up a potential FDA submission and adding momentum to CAR-T’s push beyond oncology.
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Why it matters:
A clean win in stiff person syndrome moves autoimmune CAR-T closer to a first approval and helps de-risk the whole class — with read-through for broader autoimmune indications and future BD interest.
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Source:
Endpoints
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More:
BioCentury
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Everything Else that broke
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Gilead's new HIV drug regimen achieves second Phase 3 win. — Endpoints
- FDA fast-tracks J&J's multiple myeloma combo treatment. — Endpoints
- Enhertu combo approved for metastatic breast cancer. — Endpoints
- Argenx's Vyvgart fails in thyroid eye disease trials. — BioPharma Dive
- Lenz reports retinal tear in presbyopia eye drop patient. — Endpoints
- Aviceda's geographic atrophy drug fails mid-stage study. — Endpoints
- Nicox completes data for NCX 470 NDA submission. — PR
- MHRA expands global strategy with Singapore regulatory pathway. — BioCentury
- Elkedonia develops antidepressants targeting neuroplasticity. — BioCentury
- Biopharma news roundup: clinical, regulatory updates. — BioWorld
- Noom targets lower-BMI group with GLP-1 microdoses. — Endpoints
- AB Science publishes on promising drug candidate AB8939. — PR
- Tiziana Life Sciences CEO purchases shares. — PR
- IO Biotech publishes 5-year clinical outcomes of Phase 1/2 trial. — PR
- Abivax presents Q3 2025 financial results. — PR
- BioSyent renews Normal Course Issuer Bid. — PR
- STAT names top biopharma CEOs of 2025. — STAT
- US vs. China drug discovery: alarming results. — STAT
- BIO-Europe Startup Spotlight returns to Lisbon in March 2026. — Labiotech
Deal Flow
M&A / BD&L
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Sanofi signs $1B biobucks pact for Alzheimer's asset. — Fierce Biotech
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Ipsen completes acquisition of ImCheck Therapeutics. — PR
- Virbac acquires Thyronorm for feline hyperthyroidism. — PR
VC / Private Financings
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No notable VC / Private Financings in the last 24 hours.
IPOs / Follow-Ons
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No notable IPOs / Follow-Ons in the last 24 hours.
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Thanks for reading BioBucks — enjoy the calm before the next guidance update.
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