Upfront Briefing
Regulators did the classic two-step: FDA fully released the clinical hold on Intellia’s Phase 3 ATTR CRISPR trials, while uniQure said the agency wants another Huntington’s gene therapy study before any filing path.
On the deal desk, Rallybio and Candid announced a merger alongside an upsized >$505M concurrent financing — a “public by financing” template that’s quietly coming back into fashion.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,881.6 |
0.0% |
+0.5% |
| Nasdaq 100 |
24,992.6 |
+0.1% |
(1.0%) |
| Russell 2000 |
2,655.9 |
+0.9% |
+7.0% |
| Healthcare (XLV) |
158.5 |
(1.0%) |
+2.4% |
| Biotech (XBI) |
126.6 |
(0.6%) |
+3.8% |
| Nasdaq Biotech (NBI) |
6,011.9 |
(0.5%) |
+5.3% |
| Clinical Trials (BBC) |
42.2 |
(0.6%) |
+9.5% |
|
- Small caps outperformed (Russell 2000 +0.9%) as risk rotated toward domestic cyclicals while large-cap defensives lagged.
- Healthcare sold off (XLV (1.0%)) on a tape led outside defensives — a reminder that “risk-on” days don’t always translate into biotech bid.
- Biotech stayed soft (XBI (0.6%)) — catalyst-driven dispersion: FDA wins helped singles, but regulatory friction and de-risking pressure weighed on beta.
- Market data: U.S. close Mon 02-Mar-2026.
The Big 3
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1
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FDA fully releases clinical hold on Intellia’s Phase 3 ATTR CRISPR trials
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- FDA lifted the hold on Intellia’s Phase 3 Magnitude trial (ATTR-CM) after adding safety exclusions and monitoring; Magnitude-2 (ATTRv-PN) had its hold lifted earlier.
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Why it matters:
This removes a major overhang on one of the sector’s highest-profile in vivo gene-editing shots and tightens the “time-to-data” range — but it does so with explicit safety gating. Investors will now focus on (i) enrollment velocity under the new criteria, (ii) whether liver-signal uncertainty persists, and (iii) what the FDA’s risk-mitigation playbook implies for the broader LNP/in vivo editing class.
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Source: Fierce Biotech
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2
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Candid Therapeutics to go public via Rallybio merger with $505M concurrent financing
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- Rallybio and Candid announced a merger; Candid also lined up an oversubscribed upsized private financing of >$505M, implying ~96% ownership for Candid holders (incl. the financing). The financing was committed by a syndicate including Venrock Healthcare Capital Partners, RA Capital Management, Janus Henderson Investors, and accounts advised by T. Rowe Price.
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Why it matters:
This is a “public by financing” template: big crossover-style capital plus a clean public path without a classic IPO window. It also re-validates autoimmune as the next battleground for T-cell engagers — and sets a fresh valuation anchor for the class. Watch (i) Phase 2 execution/CRS tolerability vs efficacy depth, and (ii) whether this deal format accelerates other late-private platforms looking for liquidity + scale capital.
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Source:
Business Wire
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| 3 | uniQure says FDA wants another Huntington's gene therapy study |
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uniQure said the FDA wants another study of its Huntington's gene therapy before a filing.
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Why it matters:
FDA asking for a new controlled study resets the asset’s probability-of-approval and timeline: it extends burn, delays any filing/launch window, and forces investors to reprice the program from “near-term regulatory path” to “multi-year development.” It also raises the bar for single-arm/external control strategies in invasive gene therapy settings — a read-through risk for other CNS programs hoping to file off small datasets.
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Source:
BioPharma Dive
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Everything Else that broke
- Two new members added to ACIP ahead of March meeting. — Endpoints
- BioAtla cuts 70% of staff, explores strategic options. — BioSpace
- HHS bans Claude AI tool; broader Anthropic blacklist sought. — Fierce Biotech
- SNIPR publishes final positive Phase 1 results for SNIPR001. — PR
- BioSpace opinion: navigating FDA interactions after recent changes. — BioSpace
- BioSpace: FDA decisions feel more like 'fiat' as trust shrinks. — BioSpace
- Hua Medicine says dorzagliatin approved in Hong Kong SAR. — PR
- North Carolina emerges as obesity drug production hub, report says. — BioSpace
- Seres names interim CEO/executive chair, provides business updates. — PR
- Myriad launches Precise MRD with select community oncologists. — PR
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
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BioCentury: Aicuris buyout, Gyre/Cullgen merger in deals report. — BioCentury
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Efor acquires Singapore-based No deviation to expand in Asia. — PR
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Congruence and Ono expand multi-target research partnership with two new programs (upfront + milestones + tiered royalties). — PR
VC / Private Financings
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Xsensio raises $7M oversubscribed Series A for continuous biosensing — led by WI Harper; joined by Privilège Ventures, the European Innovation Council, and select private investors. — PR
- BioCentury: Candid's Song eyes NASDAQ path via PIPE, reverse merger. — BioCentury
IPOs / Follow-Ons
- MAIA Biotechnology prices $30M underwritten public offering. — PR
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