Upfront Briefing
Kodiak went from 2023 cautionary tale to Q4 BLA filer in one readout: Zenkuda matched Eylea in DAYBREAK with most patients on six-month dosing, and the stock nearly tripled. After the bell, AstraZeneca wrote Summit a $2B cheque for roughly 12% of the company — a minority stake and a combo trial, not a takeout. Merck had a split-screen Monday, pulling its I-DXd lung filing after FDA pushback while paying SciBrunch $400M upfront for a preclinical KRAS G12D drug. Overnight, Novo licensed Hengrui's weekly oral GLP-1/GIP for $300M upfront, with EASD under way in Milan and Lilly's retatrutide TRIUMPH-2 symposium due Wednesday.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,683.7 |
(0.8%) |
12.0% |
| Nasdaq 100 |
30,276.8 |
(1.1%) |
20.1% |
| Russell 2000 |
2,817.9 |
(0.7%) |
12.3% |
| Healthcare (XLV) |
171.3 |
0.3% |
10.1% |
| Biotech (XBI) |
156.6 |
1.0% |
28.9% |
| Nasdaq Biotech (NBI) |
7,126.9 |
0.6% |
24.9% |
| Clinical Trials (BBC) |
46.1 |
2.2% |
22.6% |
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- Biotech bucked a red session: XBI +1.0% and NBI +0.6% against the S&P 500's (0.8%), with health care one of only three S&P sectors to close higher.
- Rates and oil drove the selloff: the 10-year Treasury yield hit a fresh 19-year high near 5.2% and Brent pushed toward $98 after President Trump rejected Iran's proposal to end the conflict; Nasdaq 100 (1.1%) and Russell 2000 (0.7%), with Nvidia's historic buyback not enough to offset.
- Market data: U.S. cash close Monday, 28 September 2026.
The Big 3
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1
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Kodiak's Zenkuda matches Eylea in Phase 3, BLA due Q4
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- Zenkuda (tarcocimab tedromer) and tabirafusp-ted both met non-inferiority to aflibercept on one-year vision gains in the ~690-patient DAYBREAK wet AMD trial; 54% of Zenkuda patients held six-month dosing after loading versus Eylea every eight weeks, and KOD nearly tripled from Friday's $32.35 close.
- Why it matters: Durability is the whole commercial argument, and DAYBREAK delivers it: a majority of Zenkuda patients went six months between injections versus Eylea's eight-week cadence, with numerically fewer cataracts than the comparator — the safety signal that shelved tarcocimab in 2023. The Q4 BLA bundles five Phase 3s across wet AMD, diabetic retinopathy and RVO, so the label could be broad from day one. The fight is harder than the stock implies: Eylea biosimilars such as Yesafili are pricing the anti-VEGF floor down, while Eylea HD and Vabysmo already sell extended intervals. Kodiak has not yet published the head-to-head BCVA numbers, and the durability claim lives or dies on them.
- Source: Endpoints
- More: Fierce Biotech; BioPharma Dive
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2
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AstraZeneca buys ~12% of Summit for $2B, stops short of a takeout
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- AstraZeneca will buy $2B of Summit convertible preferred at an $18.36-per-share equivalent, 18.6% above Monday's $15.48 close, for a ~12% stake, and will run trials pairing ivonescimab with its Claudin 18.2 ADC sonesitatug vedotin in GI cancers; announced after the bell, closing expected by 2 October.
- Why it matters: This is a strategic PIPE, not a licence: AstraZeneca takes no ivonescimab rights, only convertible equity and a combination trial, keeping its options open without paying a control premium. The 18.6% premium to Monday's close is the tell — a big pharma paying up for a minority position in the PD-1xVEGF race that Pfizer (3SBio), BMS (BioNTech) and Merck (LaNova) entered via licences. Pairing ivonescimab with sonesitatug vedotin also gives AstraZeneca a live test of the bispecific-plus-ADC backbone across GI tumours. Summit's rights are ex-China only, licensed from Akeso, so the COINS Act overhang on China-sourced assets comes with the stake.
- Source: Endpoints
- More: Investing.com
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| 3 | FDA pushback forces Merck, Daiichi to pull I-DXd lung cancer filing |
- Daiichi Sankyo and Merck withdrew their accelerated-approval filing for B7-H3 ADC ifinatamab deruxtecan in platinum-pretreated extensive-stage SCLC after the FDA said the 187-patient Phase 2 IDeate-Lung01 data fell short; Phase 3 IDeate-Lung02 is nearly fully enrolled.
- Why it matters: This is the third U.S. setback for the three-ADC pact Merck paid Daiichi $4B upfront for in 2023, after HER3-DXd's 2024 CRL and 2025 withdrawal, and it hits the asset meant to carry near-term sales. The FDA is signalling that single-arm response data will not clear a second-line SCLC bar already held by Amgen's Imdelltra, which carries survival data. That hands time to GSK's risvutatug rezetecan, which beat topotecan on overall survival in a China Phase 3, and to Roche/MediLink's tam-peli. I-DXd's Phase 3s in SCLC, prostate and oesophageal cancer have primary completion dates in 2028, pushing the deal's first meaningful U.S. revenue well out.
- Source: Endpoints
- More: Fierce Biotech; BioPharma Dive
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Everything Else that broke
- Novo licensed Hengrui's Phase 1-ready once-weekly oral GLP-1/GIP agonist HRS-1596 ex-Greater China for $300M upfront and up to $2.6B, its second obesity deal in two editions after Nanexa. — Novo (PR)
- Merck paid Shanghai's SciBrunch $400M upfront for worldwide rights to preclinical KRAS G12D inhibitor SPR2015, in a deal worth up to $2.13B, alongside its Phase 3 G12C drug calderasib. — Endpoints
- Adicet's off-the-shelf gamma delta CAR-T prula-cel hit 50% complete renal response and 54% DORIS remission at 12 months in lupus, with all patients off immunosuppressants and a pivotal start-up set for Q4, yet shares fell 27%. — BioPharma Dive
- Mirum's brelovitug hit the Phase 3 AZURE-1 primary endpoint in hepatitis delta, with 56% composite response at 300 mg weekly and 45% at 900 mg monthly versus 0% for delayed treatment. — Endpoints
- The White House sought U.S. manufacturing data on 86 essential medicines, putting domestic capacity back in focus. — Endpoints
- Roche's Gazyva won FDA approval in idiopathic nephrotic syndrome, extending the franchise beyond oncology. — Fierce Pharma
- The FDA approved Egetis' Emcitate (tiratricol), the first U.S. treatment for MCT8 deficiency, along with a rare pediatric priority review voucher. — Endpoints
- Roche handed myostatin antibody emugrobart back to Chugai after a Phase 2 interim with tirzepatide in obesity showed success was unlikely; Chugai will pursue a Phase 3 in SMA and seek partners. — Endpoints
- Fondazione Telethon's Waskyra, the first gene therapy for Wiskott-Aldrich syndrome, launched in the U.S. at a $3.25M list price, with UCSF Benioff the first treatment centre. — Endpoints
- BioNTech will shut three German sites and its Singapore plant after a failed sale process, affecting about 1,800 jobs. — Fierce Pharma
- BARDA awarded Scynexis up to $214M over as long as ten years for oral/IV antifungal SCY-247, with about $18.5M upfront to fund a Phase 2. — Fierce Biotech
- Ascletis reported positive 28-day psoriasis data, including a 48.9% placebo-adjusted PASI reduction at 200 mg. — PR
- The ACT for ALS Reauthorization Act cleared Congress ahead of its September 30 expiration. — PR
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Novo licensed ex-Greater China rights to Hengrui's oral GLP-1/GIP HRS-1596 for $300M upfront and up to $2.6B. — GlobeNewswire
- Merck licensed SciBrunch's preclinical KRAS G12D inhibitor SPR2015 for $400M upfront and up to $2.13B. — Fierce Biotech
- Webster Equity Partners will take CDMO Lifecore Biomedical (LFCR) private for $6.28 per share in cash, a 49.5% premium, plus CVRs worth up to $160M, for up to $663.7M in total, with a 30-day go-shop. — GlobeNewswire
- Tolerance Bio licensed ex-Japan rights to Tanabe's clinical-stage anti-IL-33 antibody MT-2990 (now TLB-33) for up to $560M in milestones, with financials undisclosed. — Fierce Biotech
- 3SBio units will commercialise MindRank's AI-designed oral GLP-1 MDR-001 (in Phase 3 in China) in Greater China for RMB 150M upfront and up to RMB 1.75B ($260M). — GlobeNewswire
VC / Private Financings
- No notable VC / private financings in the last 24 hours.
IPOs / Follow-Ons
- Summit (SMMT): AstraZeneca $2B convertible-preferred PIPE at an $18.36-per-share equivalent (18.6% premium) for a ~12% stake, expected to close by 2 October. — Endpoints
- Viking (VKTX) closed its upsized common stock and 2032 convertible offerings with the underwriters' options exercised in full, taking gross proceeds to about $575M. — PR
Academic Corner - Prime assembly expanded prime editing to larger genome rearrangements with potentially wider clinical applications. — Nature Medicine
- Researchers used data from more than 3 million people to trace inherited EGFR T790M lung cancer risk. — Nature Medicine
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