Upfront Briefing
Friday afternoon WSJ broke that Trump signed off on a plan to fire FDA Commissioner Marty Makary — coming a week after CBER head Vinay Prasad's exit, leaving both biopharma review divisions and the Commissioner's office without permanent leadership in a midterm year.
Elsewhere, argenx hit its PDUFA with an all-serotype gMG label for VYVGART, and Daiichi Sankyo pulls its FY25 results and new 5-year plan together today after pre-flagging a ~$950m ADC supply-chain charge.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,398.9 |
+0.8% |
+6.2% |
| Nasdaq 100 |
29,235.0 |
+2.3% |
+15.7% |
| Russell 2000 |
2,861.2 |
+0.8% |
+6.4% |
| Healthcare (XLV) |
143.5 |
(0.8%) |
(7.8%) |
| Biotech (XBI) |
134.7 |
+0.8% |
+6.8% |
| Nasdaq Biotech (NBI) |
5,926.0 |
+0.4% |
(0.7%) |
| Clinical Trials (BBC) |
44.6 |
+0.9% |
+8.9% |
|
- Biotech outperformed last week on a thaw in the deal tape: XBI ended Friday at 134.7 (+0.8% on the day, ~+1% w/w) and NBI finished roughly flat-to-up, with M&A activity (UCB/Candid, Angelini/Catalyst, Roche/PathAI, Bayer/Perfuse) reinforcing the bid for clinical-stage names.
- Large caps held in: S&P 500 closed Friday at 7,398.9 (+0.8%) after Thursday's risk-off session on Iran-deal headlines and a chip pullback; Nasdaq 100 led the bounce-back (+2.3%), small caps lagged.
- Market data: U.S. close Fri 08-May-2026. Watch for Monday tape reaction to weekend Makary headlines and Daiichi Sankyo's official FY25 results + 5-year plan due today.
The Big 3
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1
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Reports say Trump plans to fire FDA Commissioner Makary
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- WSJ reported Friday afternoon that Trump signed off on a plan to fire FDA Commissioner Marty Makary, citing frustration over drug reviews, vape policy and mifepristone. Plan "isn't final," but the White House did not defend Makary; Reuters reports Deputy Commissioner Kyle Diamantas is under consideration as acting head, with Stephen Hahn and Brett Giroir floated as nominees.
- Why it matters: Comes a week after CBER head Vinay Prasad's exit, leaving both main biopharma review divisions and the Commissioner's seat without permanent leadership in a midterm year. Near-term tape risk concentrates in sponsors with H1 PDUFAs in contentious lanes — accelerated-approval CGT (Capricor, Replimune-style situations), novel modalities and anything vaccine-adjacent. Possible upside read for names previously rejected on Prasad-era benefit/risk calls (see ATRA last week). Watch for a successor signal before pricing in directional review tone.
- Source: STAT
- More: BioSpace; Endpoints; CNN
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2
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FDA approves VYVGART and VYVGART Hytrulo across all gMG serotypes |
- argenx landed approval ahead of its 10-May PDUFA: FDA approved an sBLA expanding VYVGART (efgartigimod) and VYVGART Hytrulo to all adult gMG patients regardless of serotype (anti-AChR-Ab+, anti-MuSK-Ab+, anti-LRP4-Ab+ and triple seronegative). Approval backed by the Phase 3 ADAPT SERON study (largest seronegative gMG trial to date), which met its MG-ADL primary endpoint with consistent benefit across subgroups and a clean safety profile.
- Why it matters: ~15% of gMG patients are seronegative — until today they had no FcRn or C5 option specifically approved. The all-serotype label sits on top of a $1.3B Q1 franchise growing +63% Y/Y and reinforces VYVGART's first-mover lead vs UCB's Rystiggo (rozanolixizumab) and Alexion/AZ's Ultomiris. Read-through for the broader FcRn pipeline (J&J/Momenta's nipocalimab in particular) is that seronegative is a meaningful, monetisable label expansion, not a marketing exercise.
- Source: PR
- More: BioSpace
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3
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Daiichi Sankyo prints FY25 with ~$950m extraordinary ADC charge; reveals 5-year plan today |
- On May 8, Daiichi pre-announced a ¥149.4B (~$950M) non-consolidated extraordinary loss tied to ADC supply-chain rework — ¥75.7B in CDMO compensation plus a ¥19.3B impairment at the Odawara plant — after scaling back planned in-house and contracted ADC capacity. The company is releasing official FY25 (year-end March 2026) results and its new 6th Mid-term Management Plan (FY26–FY30) together today, pulled forward from May 19.
- Why it matters: Headline charge is a clean tell that real-world Enhertu/Datroway uptake is running below earlier base case; underlying topline still beats prior guidance, but the writedown sizes the gap between the 2024 "ADC supercycle" capacity build and what's actually being absorbed. Read-through for the broader ADC complex (AZ as partner, plus Pfizer/Seagen, Merck/Daiichi I-DXd, AbbVie/ImmunoGen successors): expect more cautious CDMO/in-house capacity commentary. Today's plan reveal is the bigger catalyst — watch for revised Enhertu peak-sales framing, the post-I-DXd pipeline ranking, and any signal on capital return given the cleaned-up balance sheet.
- Source: Endpoints
- More: Fierce
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Everything Else that broke
- Genmab: Orbis Investment Management discloses 5.08% stake — a notable new top-five holder for the ADC/bispecifics name. — BioSpace
- MoonLake posts Q1 results and cites a positive pre‑BLA FDA meeting. — PR
- Astellas’ XLMTM gene therapy program gets a new chance. — STAT
- Biopharma M&A is running ahead of last year. — BioPharma Dive
- Medicare spending on new Alzheimer’s drugs trails estimates. — STAT
- Innovent’s IBI363 gets a third NMPA breakthrough tag. — PR
- At‑home subcutaneous furosemide trial backs heart failure use. — PR
- Alvotech says the FDA completed its Reykjavik site inspection. — PR
- ENA advances INNA‑051 after the first part of a Phase II study. — PR
- PulseSight reports positive Phase I data for PST‑611. — PR
- Entera posts Q1 results and updates its oral peptide pipeline. — PR
- Longeveron (LGVN) said the FDA, at a March Type C meeting, rejected right ventricular ejection fraction as an appropriate primary endpoint for ELPIS II in HLHS — FDA will not agree a new primary while the trial is ongoing, and no longer describes the study as pivotal. Top-line data still expected August 2026. — Stock Titan
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- No notable new biotech/biopharma M&A or BD&L deals announced over the weekend. Last week's deals (Angelini–Catalyst, Roche–PathAI, Bayer–Perfuse, UCB–Candid) are captured in the M&A tracker.
VC / Private Financings
- No new private financings disclosed over the weekend. ICYMI CellCentric's $220M Series D was covered last week; full syndicate in the VC tracker.
IPOs / Follow-Ons
- No new biotech IPO pricings or follow-ons over the weekend. Odyssey, Cytokinetics and Mobia Medical priced Friday — see Friday's edition or the IPO tracker.
Academic Corner
- Low‑dose digoxin in patients with heart failure with reduced or mildly reduced ejection fraction: a randomized controlled trial. — Nature Medicine
- The microRNA inhibitor CDR132L in patients with reduced left ventricular ejection fraction after myocardial infarction: a randomized phase 2 trial. — Nature Medicine
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