Upfront Briefing
Makary's resignation rewrites the FDA leadership story we flagged Monday — Kyle Diamantas, a lawyer running the food side, is acting commissioner with no permanent successor in sight. BridgeBio delivered the day's big asset story with Attruby besting Pfizer's tafamidis on hospitalisation and mortality, while ECO 2026 turned into an obesity-data deluge across Novo's Wegovy pill, Lilly's Foundayo and Viking's oral VK2735. Healthcare held in better than the broad tape as inflation came in hot and the chip rally cooled.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,401.0 |
(0.2%) |
+6.6% |
| Nasdaq 100 |
29,064.8 |
(0.9%) |
+15.3% |
| Russell 2000 |
2,842.8 |
(1.0%) |
+6.5% |
| Healthcare (XLV) |
145.9 |
+2.0% |
(6.3%) |
| Biotech (XBI) |
134.9 |
+0.1% |
+8.2% |
| Nasdaq Biotech (NBI) |
5,998.2 |
+1.1% |
+1.3% |
| Clinical Trials (BBC) |
44.5 |
(0.3%) |
+9.7% |
|
- Defensives ripped: XLV jumped 2.0% even as the S&P slipped 0.2% and the Nasdaq 100 fell 0.9% — a textbook rotation print after April CPI surprised hot at 3.8% (vs 3.7% consensus) and Micron (-9.9%) plus Broadcom (-4.2%) took the chip rally off the boil. Healthcare's low-beta profile (~0.5) did its job.
- Within the sector the dispersion was wide: NBI +1.1% on large-cap pharma flows, equal-weight XBI essentially flat at +0.1%. BridgeBio and Viking ECO readouts (covered below) drove SMID-specific moves that didn't make it to the index level.
- Market data: U.S. close Tue 12-May-2026.
The Big 3
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1
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Makary resigns from FDA; Diamantas named acting commissioner
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- FDA Commissioner Marty Makary resigned Tuesday after a 13-month tenure, with HHS Secretary Kennedy making the final call. Kyle Diamantas (Deputy Commissioner for Food; lawyer; no medical/drug background) becomes acting commissioner and replaces Makary for Wednesday's Senate Appropriations hearing — which has now been postponed.
- Why it matters: The fourth high-profile HHS departure of 2026 lands during ongoing PDUFA reauthorisation talks. Industry has consistently said it values predictability over speed; a non-clinician acting head and no named permanent pick (HHS confirmed it lacks a CDC director and Surgeon General too) pushes the FDA-volatility premium back into biotech multiples just as the rally was firming. Watch the rare-disease and cell/gene names with pending decisions — they've borne most of the recent unpredictable rejections.
- Source: Endpoints
- More: CNBC; NPR
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2
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BridgeBio's Attruby tops Pfizer's tafamidis in ATTR-CM matched analysis
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- At ESC Heart Failure 2026, BridgeBio (BBIO) presented an indirect anchored-matched comparison of Phase 3 ATTRibute-CM (n>630) showing Attruby (acoramidis) delivered a statistically significant 34% reduction in cardiovascular hospitalisation and a 28% hazard reduction in all-cause mortality vs Pfizer's tafamidis (Vyndaqel/Vyndamax). Attruby Q1 sales hit $180.6m, +24% YoY.
- Why it matters: ATTR-CM is a multi-billion-dollar standard-of-care market that tafamidis has held alone since 2019. A matched comparison isn't a head-to-head and consensus rightly waits on prospective data, but a 28% all-cause mortality delta plus 34% on hospitalisation is enough to underwrite a continued share-shift narrative — supporting Street consensus that BBIO's Q1 launch beat extends through 2026 and pressuring tafamidis ex-US ahead of generic entry. Bayer (acoramidis ex-US partner) is the under-followed read-through.
- Source: BioSpace; Clinical Trials Arena
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| 3 | ECO 2026: oral obesity reads converge — Wegovy pill, Foundayo, Viking VK2735 |
- Three obesity readouts at ECO 2026 on Tuesday: Novo's oral Wegovy delivered 21.6% weight loss in early responders plus doubled mobility improvement; Lilly highlighted Foundayo + low-dose Zepbound as maintenance options after switching from higher injectable doses across two late-phase trials; Viking's oral VK2735 (GLP-1/GIP) Phase 2 VENTURE-Oral hit up to 12.2% mean weight loss at week 13, dose-dependent, no plateau.
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Why it matters:
The obesity competition continues to shift from "which class" to depth, formulation, maintenance and sub-population economics. Maintenance data drives treatment duration and reduces post-loss churn — critical inputs to peak-sales durability. Oral data widens patient access and reduces injectable supply constraints. Viking's 12.2% at 13 weeks on the oral tablet keeps the SMID obesity name in M&A frame as Phase 3 VANQUISH-1 baseline data also debuted at ECO.
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Source:
Novo PR
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More:
Endpoints (Lilly); Viking PR
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Everything Else that broke
- Senate Appropriations FDA budget hearing scheduled for Wednesday postponed after Makary resignation; new date TBA. — CBS
- Valneva reports Q1 2026 results and corporate updates. — PR
- Bavarian Nordic posts first-quarter 2026 interim results. — PR
- European drugmakers' US biotech buying spree draws focus. — BioSpace
- Kelun-Biotech wins CDE IND for SKB118 (PD-1 × VEGF bispecific). — PR
- Cepheid receives IVDR CE marking for Xpert GI Panel. — PR
- BBOT reports Q1 2026 results and corporate progress. — PR
- Eupraxia reports first-quarter 2026 financial results. — PR
- Efsubaglutide alfa Nature Communications publication highlights glycaemia and β-cell effects. — PR
- WuXi Biologics added to Dow Jones Best-in-Class World and Emerging Markets indices. — PR
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Boehringer Ingelheim licensed a preclinical first-in-class antibody program for chronic inflammatory and autoimmune diseases from Waltham-based Immunitas Therapeutics; total deal value up to €407.5M (~$479.6M) in upfront, development, regulatory and commercial milestones plus tiered royalties; global rights to Boehringer. Adds to BI's busy 2026 immunology BD slate (Simcere €1.05B IBD bispecific in Jan; Sitryx $500M+ oral autoimmune in Feb). — PR
- AstraZeneca signs three-year agentic AI licensing deal with Owkin for the K Pro AI Scientist platform; Owkin will build biopharma agents for AZ's IT and decision workflows, including competitive-intelligence agents. — Business Wire
- AndzonBio2, the Alborada Drug Discovery Institute (University of Cambridge) and Cambridge Enterprise form a collaboration to develop first-in-class neuroinflammation therapeutics. — PR
VC / Private Financings
- Isomorphic Labs (London; Alphabet spin-out, AI drug design) closed a $2.1B Series B — led by Thrive Capital, joined by Alphabet, GV, MGX, Temasek and CapitalG (UK Sovereign AI Fund also participated); proceeds to fund the next-generation AI drug design model. Follows the firm's $600M first external round one year ago. — Fierce Biotech
IPOs / Follow-Ons
- No notable IPOs / follow-ons in the last 24 hours. — PR
Academic Corner - Pasteurized Akkermansia muciniphila MucT for weight loss maintenance in people with overweight and obesity: a controlled randomized trial. — Nature Medicine
- Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial. — Nature Medicine
- CRISPR−Cas9 CD33-deleted allogeneic hematopoietic cell transplantation with gemtuzumab ozogamicin maintenance in AML: a phase 1/2 trial. — Nature Medicine
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