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Upfront Briefing
Biogen and Ionis pushed diranersen (BIIB080) to registrational despite missing the CELIA dose-response endpoint, leaning on tau-biomarker and cognitive signals to keep a post-amyloid Alzheimer’s shot alive. REGENXBIO’s RGX-202 hit its Phase 3 microdystrophin endpoint in Duchenne but two serious adverse events (including subacute myocarditis) tempered the read-through, while Alumis pulled its would-be Tepezza rival and opened a strategic review.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,501.2 |
+0.8% |
+9.7% |
| Nasdaq 100 |
29,580.3 |
+0.7% |
+19.6% |
| Russell 2000 |
2,863.1 |
+0.7% |
+8.2% |
| Healthcare (XLV) |
146.6 |
(0.1%) |
(6.6%) |
| Biotech (XBI) |
134.9 |
(0.7%) |
+9.8% |
| Nasdaq Biotech (NBI) |
5,988.0 |
(0.7%) |
+1.2% |
| Clinical Trials (BBC) |
44.1 |
(2.0%) |
+10.6% |
|
- Mega-cap tape pushed the S&P 500 above 7,500 for the first time and lifted the Nasdaq 100 as the AI trade re-engaged and the Trump–Xi U.S.–China summit dialled down tariff risk.
- Healthcare and biotech lagged: XBI (-0.7%) and BBC (-2.0%) were dragged by REGENXBIO’s Duchenne SAEs, the Aardvark FDA hold and Biogen’s mixed CELIA tau readout, while XLV barely moved as large-cap pharma held the line.
- Market data: U.S. close Thu 14-May-2026.
The Big 3
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1
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Biogen / Ionis advance diranersen (BIIB080) tau ASO to registrational despite mixed CELIA Phase 2
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- CELIA missed the primary dose-response endpoint, but diranersen showed robust CSF and tau-PET reductions across all doses and pre-specified analyses showed slowing of cognitive decline (strongest at the 60 mg q24w dose); SAE incidence skewed to the highest dose.
- Why it matters: First randomised tau-directed asset to pair biomarker effect with cognitive signal — opens a credible second pillar to Leqembi for Biogen and a meaningful royalty/milestone tail for Ionis, with the Street now resetting around a low-dose registrational design and an AAIC (Jul ’26) data unveil.
- Source: BioCentury
- More: PR
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2
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Alumis pulls lonigutamab and opens strategic review
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- Alumis is shelving lonigutamab — the IGF-1R subQ Tepezza challenger inherited via the Acelyrin merger — citing a tougher commercial differentiation read after assessing the TED competitive set (Viridian veligrotug, Sling, Innovent), and announced a formal strategic review.
- Why it matters: Removes a Phase 3 candidate from the pipeline and re-anchors Alumis to envudeucitinib (TYK2) in psoriasis ahead of a 2H'26 NDA; cash sits at ~$378M (runway into '27), and the strategic-review wrapper now puts a take-out / asset-sale floor under the equity.
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Source:
Fierce Biotech
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More:
PR
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| 3 | REGENXBIO Phase 3 RGX-202 hits microdystrophin endpoint in DMD; safety signal weighs |
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Pivotal AFFINITY DUCHENNE met its primary endpoint with 93% of patients reaching ≥10% microdystrophin at Week 12 (mean 71.1%; 80% >40%; p<0.0001) and signs of NSAA improvement vs. natural history; two SAEs reported (subacute myocarditis and asymptomatic transaminitis), both resolved.
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Why it matters:
Sets up a BLA on accelerated approval and potential 2027 launch into a DMD market reshaped by Sarepta’s Elevidys safety pause — efficacy bar looks competitive, but the cardiac SAE keeps a label/risk-mitigation overhang that the Street will price into peak share assumptions.
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Source:
PR
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More:
BioSpace
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Everything Else that broke
- Ocugen closes $130M of 6.75% convertible senior notes due 2034 (~$112.6M net), repays Avenue debt; runway extends into 2028 ahead of three planned BLAs. — PR
- Astellas (Izervay) post-hoc GATHER1/2 data show benefit on driving-eligibility preservation in geographic atrophy at ARVO 2026. — PR
- Supreme Court preserves mail access for abortion pill. — Endpoints
- Eisai sets Leqembi revenue target of ¥143.5B for FY26 (Apr ’26–Mar ’27). — PR
- Akeso posts Phase II ligufalimab (anti-CD47) combo data in frontline AML at EHA 2026. — PR
- FDA puts clinical hold on Aardvark’s Phase 3 ARD-101 (Prader-Willi). — Fierce Biotech
- Nurix presents preclinical/Phase 1 data for BTK degrader bexobrutideg (NX-5948) in chronic spontaneous urticaria. — PR
- Imviva posts durable Phase 1/2 SLE data for dual CD19/BCMA allogeneic CAR-T CTA313 at ASGCT 2026. — PR
- SN BioScience doses first patient in SNB-101 Phase 1b/2 trial. — PR
- Cardiff says FDA backs planned Phase 3 approach in Q1 update. — PR
- Fortress flags FDA approval (ZYCUBO/Menkes) and $205M PRV sale; consolidated cash $255.8M. — PR
- Sutro points to mid-2026 STRO-004 data in Q1 update. — PR
- Sharps Technology adopts limited-duration stockholder rights plan. — PR
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
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No new biopharma M&A or major BD&L deals announced in the last 24 hours.
VC / Private Financings
- CREATE Medicines closed a $122M Series B to advance its in vivo CAR (mRNA-LNP) pipeline in autoimmune and oncology; co-led by Newpath Partners, ARCH Venture Partners and Hatteras Venture Partners, with Alexandria Venture Investments and existing syndicate. — PR
- Degron Therapeutics closed a $40M Series A extension (total raised ~$95M) to advance lead molecular glue degrader DEG6498 (HuR); led by LAPAM Capital, joined by GTJA Investment Group, Fortune Capital, CSPC & Growth and ApicHope. — PR
IPOs / Follow-Ons
- Impact Therapeutics (PARP/synthetic-lethality) made a strong HK debut, valuing the company at ~HK$6.0B on listing — adds to the 2026 China-biotech IPO momentum. — Benzinga
- XORTX priced a US$5M public offering of common shares and pre-funded warrants at US$1.88, with closing expected May 15. — PR
Academic Corner - Abatacept versus hydroxychloroquine for prevention of rheumatoid arthritis in individuals with palindromic rheumatism: a randomized open-label trial. — Nature Medicine
- Efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam compared with imipenem–cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial. — Lancet
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That’s it for today, see you Monday. — BioBucks Team
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