M&A, Deals, Partnerships:
Genentech (SF) Inks Up-to-$1.5B Bispecific Antibody Pact with Earendil Labs
Genentech is paying $55M upfront, with up to $1.445B in development, regulatory and sales milestones plus tiered royalties, for a research collaboration on AI-designed bispecific antibodies against pre-agreed oncology target combinations. Earendil leads antibody discovery and early clinical research; Genentech takes over global development, regulatory work and commercialization for any programs that advance (announced Sept 24).
Amberstone Biosciences (OC) Licenses Tumor-Activated T-Cell Engagers to China’s Henlius
Amberstone will apply its pH-gated T-MATE platform to generate preclinical T-cell-engager candidates against up to two Henlius-selected solid-tumor targets, with Henlius leading development, manufacturing and commercialization worldwide (announced Sept 24). Terms include $4M upfront, up to $232M in R&D and regulatory milestones, up to $652M in sales milestones, and single-digit royalties on net sales.
IPOs:
ADARx Pharmaceuticals (SD) Prices Upsized $446.3M IPO
The late-stage siRNA developer priced 26.25M shares at $17.00 for roughly $446.3M in gross proceeds; shares began trading on Nasdaq under ticker “ADRX” on Sept 25. AbbVie took part in a concurrent private placement at $17.00/share, agreeing to buy up to $100M and end up owning about 4.9% of ADARx post-closing.
Nvidia-Backed AI Biotech Iambic Therapeutics (SD) Files for IPO
The AI-driven, clinical-stage drugmaker filed to list on Nasdaq under ticker “IAM” to fund three early-stage cancer programs, led by IAM1363, an oral HER2 inhibitor in a Phase 1/1b basket trial (coverage Sept 22). Iambic has raised roughly $461.8M to date from backers including Nvidia, Catalio, Nexus Ventures and Coatue; J.P. Morgan, Jefferies, BofA and Citigroup are underwriting.
FDA Approvals:
FDA Approves Mirum’s (SF) Atebrioz (zilurgisertib) for Ultra-Rare Bone Disorder
Mirum, partnered with Incyte, won approval for the oral therapy Atebrioz in fibrodysplasia ossificans progressiva (FOP) for patients aged 12 and up (approved Sept 26). In trials the drug cut lesion volume by an average of 3.2 cm³ at 24 weeks versus a 24.6 cm³ increase on placebo, giving Mirum a foothold in a market also drawing Incyte and Regeneron interest.
Other Interesting News:
Kodiak Sciences (SF) Clinches Phase 3 DAYBREAK Win; Stock Soars ~145%
Zenkuda (tarcocimab tedromer) and tabirafusp/KSI-501 met primary endpoints in the pivotal wet age-related macular degeneration study, positioning a longer-acting rival to Eylea in the ~$15B anti-VEGF market (Sept 28). The candidate showed a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate versus 0.9% for the aflibercept comparator, sending shares up roughly 145%.
Mirum (SF) Posts Phase 3 AZURE-1 Win in Chronic Hepatitis Delta
Brelovitug met the primary endpoint at Week 24 with both a once-weekly 300 mg and a once-monthly 900 mg regimen, setting up a challenge to Gilead’s Hepcludex and Vir’s combination (Sept 28). Mirum expects AZURE-4 data in Q4; a positive readout could support an FDA filing in the first half of next year and a launch by end of 2027.
Ionis (SD) and Otsuka Notch Phase 3 FUSION Win in FUS-ALS
Ulefnersen, an RNA-targeted medicine, showed statistically significant improvement in function and survival versus placebo across 73 patients with the FUS genetic subtype of ALS (Sept 22). Otsuka licensed the drug from Ionis in 2024 and plans to move quickly with the FDA on an expedited submission pathway; Ionis is eligible for regulatory and sales milestones plus tiered royalties.
Amgen’s (LA) Horizon-Acquired Fusion Protein Eases Sjögren’s in Phase 3 Win
The Phase 3 OASIZ-301 study of dazodalibep — a potential first-in-class CD40L antagonist fusion protein Amgen gained in its 2023 Horizon Therapeutics buyout — met its primary endpoint, cutting Sjögren’s disease activity (ESSDAI) at Week 48 with improvement seen as early as Week 4 (Sept 22). A second Phase 3 trial, OASIZ-303 in symptomatic disease, is expected to read out in Q4 2026 to round out a regulatory package.
Viking Therapeutics (SD) Touts Once-Monthly Maintenance Data for VK2735
The GLP-1/GIP agonist drove 16%–19% weight loss over a 21-week induction phase; patients moved to monthly dosing kept an average of 85% of that loss versus 61% on placebo (Sept 22). Every-other-week dosing preserved about 90% of weight loss, and GI-related adverse event rates during maintenance were comparable to placebo.
Kyverna (SF) Says One-Year CAR-T Data Bolster FDA Submission
Mivocabtagene autoleucel (miv-cel) sustained mobility and leg-function gains through one year in 26 stiff person syndrome patients, with no high-grade CRS or ICANS (Sept 24). Durable responses also held in generalized myasthenia gravis; Kyverna’s rolling BLA remains on track for completion in Q4 2026, targeting the first autoimmune CAR-T approval.
Adicet Bio’s (SF) Off-the-Shelf CAR-T Sparks Lupus Remissions in Early Trial
In a Phase 1 study of prula-cel (formerly ADI-001) in 22 systemic lupus patients, 12 achieved remission at one year, and 8 of 16 lupus nephritis patients saw kidney-symptom remission — most off immunosuppressants — pointing to a durable immune reset (Sept 28). The allogeneic, gamma-delta CAR-T showed no cytokine release syndrome above Grade 2 and no ICANS, supporting outpatient dosing; Adicet plans to start a pivotal lupus nephritis trial in Q4 2026.
Acadia’s (SD) Alzheimer’s Psychosis Drug Misses Phase 2 Primary Endpoint
Remlifanserin, a 5-HT2A inverse agonist, produced a 12.6-point drop in hallucinations and delusions at Week 6 versus 10.4 points for placebo, missing the primary endpoint and sending shares down about 11% (Sept 24). Acadia will drop the 30-mg arm but continue the Phase 3 RADIANT program, citing clean tolerability and no negative motor or cognitive signals.
