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Upfront Briefing
Biotech printed a red day even as the S&P remained flat and Nasdaq edged up, with broad biotech funds giving back some of their recent monster YTD gains.
On the ground, ASH keeps feeding the multiple myeloma arms race, AI just notched an FDA qualification win in MASH trials, and China’s NMPA moved acne and pulmonary fibrosis drugs a step closer to market.
Capital markets stayed wide open: a pack of privates raised fresh cash, another wave of follow-ons priced, and regulators on both sides of the Atlantic kept turning the screws on vaccines, RSV antibodies, and pricing schemes.
Tape Action
| Index |
Last |
1D % |
YTD % |
| S&P 500 |
6,840.5 |
(0.1%) |
16.3% |
| Nasdaq 100 |
25,668.7 |
0.2% |
22.2% |
| Russell 2000 |
2,526.2 |
0.2% |
13.3% |
| XBI |
121.2 |
(2.0%) |
34.6% |
| Nasdaq Biotech (^NBI) |
5,622.4 |
(1.7%) |
30.4% |
| Biotech Clinical Trials ETF (BBC) |
39.3 |
(2.3%) |
64.3% |
- Biotech lagged the broader tape: XBI and NBI sold off while the S&P stayed flat and Nasdaq inched higher.
- BBC stood out on the day’s biotech slide, giving back the biggest chunk after a torrid year-to-date run.
The Big 3
Gilead, J&J, Kelonia reset the multiple myeloma battlefield at ASH
New clinical data from Gilead, J&J, and Kelonia at ASH 2025 are reshaping expectations in multiple myeloma, sharpening the rivalry between bispecific antibodies and CAR-T approaches. The readouts are influencing how investors handicap which modalities and players could dominate future lines of therapy.
Why it matters: New clinical data from major players like Gilead and J&J, alongside Kelonia, are shaping the competitive landscape for multiple myeloma treatments.
Source: Endpoints
More: STAT; BioCentury
D3 Bio, BlossomHill, PsiThera, Bioxodes lead a busy private funding tape
Investors are still writing real checks: D3 Bio, BlossomHill, PsiThera, and Bioxodes all locked in fresh rounds, supporting everything from next-gen KRAS G12C and macrocyclic EGFR programs to oral II drugs and a stroke candidate nearing a pivotal trial. It’s a cross-section of modalities and stages, but the through-line is conviction in these pipelines.
Why it matters: Several biotechs secured significant funding rounds, indicating investor confidence in their pipelines and development strategies.
Source: Endpoints - 1
More: Endpoints - 2; Endpoints - 3; PR
Kymera, Denali, Wave, Dyne, Immix ride strong tape into fresh follow-ons
On the public side, Kymera, Denali, Wave Life Sciences, Dyne, and Immix Biopharma all moved to capitalize on receptive markets with sizable offerings of common stock and pre-funded warrants. The upsized deals suggest demand is there for late-stage and platform stories looking to reload balance sheets for the next leg of development.
Why it matters: Multiple biopharma companies are raising substantial capital through public offerings, indicating active market for funding drug development.
Source: 1
More: 2; 3; 4; 5
Everything Else that broke
- FDA is broadening safety reviews of approved RSV antibodies and COVID-19 vaccines, a move that could ripple through market access and public health strategies. — Endpoints
- China’s NMPA accepted an NDA for denifanstat in moderate-to-severe acne and granted the first regulatory approval for nerandomilast in progressive pulmonary fibrosis, opening new commercial doors. — PR
- PathAI’s AIM-MASH AI Assist became the first AI-powered pathology tool to secure FDA qualification for MASH clinical trials, marking a notable step for AI-assisted drug development. — PR
- Novartis reported positive ianalumab data in immune thrombocytopenia, extending the promise of the MorphoSys-acquired asset to another potential indication. — BioPharma Dive
- Igyxos Biotherapeutics posted encouraging Phase 1 results for IGX12, a first-in-class monoclonal antibody targeting male and female infertility, in an area of high unmet need. — PR
- MediWound released new clinical data showing NexoBrid’s effectiveness in preventing traumatic tattoos after abrasion and blast injuries, potentially broadening its wound care use. — PR
- A new publication underscored aprocitentan’s potential to manage hypertension in chronic kidney disease patients, a group with limited current options. — PR
- Regeneron shares are clawing back after a year defined by regulatory and manufacturing setbacks, as the company works through recent operational headaches. — BioSpace
- The UK will cut its new medicine rebate rate to 14.5% for 2026, a policy shift that could reshape pricing dynamics and access negotiations. — Endpoints
- A congressional stalemate is holding up critical funding for US biotechs, leaving innovation and growth plans exposed to Washington gridlock. — BioCentury
Deal Flow
M&A / BD&L
- Pfizer signaled it still has about $6B earmarked for M&A even after its Metsera deal and is also plowing capital into GLP-1 manufacturing capacity. — BioSpace
- Japanese pharmas are increasingly scouting M&A opportunities in the US and EU, reflecting a more outward-looking global strategy. — BioSpace
- Formation Bio struck a deal with China’s Lynk for a TYK2 candidate, adding another competitive entrant to the crowded immunology race around this target. — Endpoints
VC / Private Financings
- D3 Bio, BlossomHill, PsiThera, and Bioxodes all closed notable raises spanning next-gen KRAS, macrocyclic EGFR, oral II drugs, and a stroke asset heading toward a pivotal trial. — Endpoints - 1; 2; 3; 4
- J&J-backed Cellular Origins pulled in $40M in Series A funding to scale cell therapy manufacturing infrastructure, a key bottleneck for advanced therapies. — Endpoints
IPOs / Follow-Ons
- Kymera, Denali, Wave Life Sciences, Dyne, and Immix Biopharma all priced sizeable public offerings of stock and pre-funded warrants, tapping into strong demand to fund upcoming clinical and platform work. — PR - 1; 2; 3; 4; 5
Academic Corner
- Liquid biopsies across the cancer care continuum — Review of current and emerging liquid biopsy methods, their clinical validity and utility, and how they can be integrated throughout cancer care. — Nature Medicine
- Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults — Randomized trial in ED/ICU patients found ketamine induction did not significantly reduce in-hospital mortality versus etomidate. — NEJM
- Intrathecal onasemnogene abeparvovec for treatment-experienced SMA — Phase 3b STRENGTH trial showed favorable safety consistent with naïve patients and supports intrathecal dosing as a treatment option. — Nature Medicine
- Intrathecal onasemnogene abeparvovec in treatment-naive SMA — Phase 3 STEER trial: single intrathecal dose significantly improved motor function vs sham with acceptable safety in children and adolescents. — Nature Medicine
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Stay sharp,
BioBucks Team
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