Recent Funding:
Immix Biopharma (LA) Raises $100M to Advance CAR-T Therapy for AL Amyloidosis
Immix Biopharma priced a $100 million public offering to fund development of NXC-201, its BCMA-targeted CAR-T therapy for relapsed and refractory AL amyloidosis. The company expects the proceeds, along with grant support, to extend its runway into mid-2027 as it advances its registrational NEXICART-2 trial in the U.S.
Trial Library (SF) Raises $10M Series A to Expand Clinical Trial Access via Insurer Partnerships
Trial Library, founded by UCSF oncologist Hala Borno, secured $10M in Series A funding led by SemperVirens and Next Ventures to expand its clinical trial matching platform. The startup stands out for partnering with insurers—not just pharma—using patient navigators to remove barriers to enrollment and track engagement, improving trial access and equity.
M&A, Deals, Partnerships:
Mirum will pay $620M upfront to acquire Bluejay and its late-stage antibody bre lovitug for chronic hepatitis D, aiming for potential approval in 2027. The deal strengthens Mirum’s rare liver disease portfolio, adding a first-in-class antibody licensed from Novartis, with most of Bluejay’s team joining Mirum post-acquisition.
The FDA delayed Denali’s approval decision for tividenofusp alfa, its Hunter syndrome enzyme therapy, by three months to April 2026, while also placing a clinical hold on the company’s planned Phase 1 Pompe disease trial due to immune concerns in mice. To strengthen its balance sheet ahead of potential commercialization, Denali signed a $200M deal with Royalty Pharma, with an additional $75M possible upon EU approval, helping fund launch prep and ongoing R&D as it awaits regulatory feedback.
Iolyx Therapeutics (SF) Inks $280M Global Partnership with Théa for Eye Disease Drug
France’s Laboratoires Théa will pay up to $280M plus royalties to develop and commercialize Iolyx’s topical immunomodulator ILYX-002 for autoimmune-related dry eye disease after promising phase 2 results. The deal enables Théa to lead upcoming phase 3 trials, while Iolyx also closed a $15M Series B to advance additional preclinical ocular-inflammation programs.
Other Interesting News:
Helicore Biopharma (CA) Ends Lead Obesity Drug Trial, Refocuses on Next-Gen Incretin Conjugates
Less than a year after launching with $65M in Series A funding, Helicore has halted its Phase 1 trial of monoclonal antibody HCR-188 to prioritize preclinical obesity drug candidates. Backed by Versant, OrbiMed, Longitude, and Wellington, the biotech will shift focus to its incretin conjugate platform, with a detailed pipeline update expected early next year.
Ideaya Biosciences (SF) Regains Rights to Two Cancer Programs After GSK Ends Partnership
After a five-year collaboration, GSK has returned two Phase 1 oncology programs to Ideaya, concluding a 2020 deal originally worth up to billions in potential milestones. Ideaya will now explore strategic options for the returned assets while advancing its broader synthetic lethality pipeline, including its lead drug darovasertib, which could read out Phase 2 data soon.
Structure Therapeutics (SF) Posts Strong Weight-Loss Results for Oral GLP-1 Drug
Structure’s pill aleniglipron helped patients lose 11.3% of body weight in Phase 2, rivaling oral versions of Wegovy and Lilly’s orforglipron. Shares doubled as the company eyes Phase 3 trials and potential partnerships. Analysts called the data a “near-homerun,” positioning Structure as a strong new player in the competitive obesity drug race.
Kura’s oral drug Komzifti, combined with standard chemotherapy, showed a 73% complete response rate in newly diagnosed acute myeloid leukemia patients, strengthening its position against rival Syndax. The results suggest Komzifti could become a frontline cornerstone therapy for AML with specific genetic mutations, as Kura advances into Phase 3 trials.
Kite Pharma (LA) Unveils Strong CAR-T Data, Eyes 2026 Launch for Next-Gen Multiple Myeloma Therapy
Gilead’s Kite unit reported a 96% overall response rate and 74% complete remission in Phase 2 data for anito-cel, its CAR-T rival to Carvykti, with mild side effects and fast 14–17 day manufacturing. Kite plans to bring CAR-T treatment into community clinics and expand studies into earlier treatment lines, as it also invests in in vivo CAR-T and dual-target therapies to broaden patient access.
Star Therapeutics (SF) Reports Strong Early Results for Anti-Bleeding Antibody in VWD
Star’s antibody VGA039 reduced bleeding by up to 87% in early-stage von Willebrand disease patients, showing promising safety and broad efficacy across multiple bleed types. Now in Phase 3 testing, the once-monthly injectable could outperform current factor-based therapies like Takeda’s Vonvendi, with commercialization targeted for 2028.
Encoded Therapeutics (SF) Reports 78% Seizure Reduction in Dravet Syndrome Gene Therapy Trial
Encoded’s ETX101 cut seizures by 78% in young Dravet syndrome patients with no serious side effects, showing early signs of neurodevelopmental improvement. The company plans to launch a pivotal study in 2026, with potential to offer a one-time gene therapy that addresses the root cause of SCN1A-positive epilepsy.
Capricor Therapeutics (SD) Achieves Phase 3 Win in Duchenne Muscular Dystrophy Cell Therapy Trial
Capricor’s cell therapy deramiocel slowed disease progression by 54% in upper limb function and 91% in heart function compared to placebo in its pivotal HOPE-3 Phase 3 study, meeting both primary and secondary endpoints. The results come after the FDA rejected Capricor’s prior submission, and the biotech now plans to resubmit its application using the new data, potentially positioning deramiocel as the first approved cell therapy for Duchenne muscular dystrophy.
Janux Therapeutics (SD) Sees Stock Drop Despite Encouraging Prostate Cancer Trial Data
Janux’s JANX007, a PSMA x CD3 T-cell engager for advanced prostate cancer, showed 86% of patients achieved ≥50% PSA reduction and a 7.9-month median progression-free survival at higher doses, but the company’s stock fell 48% amid lower response rates versus last year’s interim data. Analysts from William Blair and Evercore called the selloff an overreaction, maintaining confidence in JANX007’s best-in-class potential and improved safety profile that could make outpatient treatment possible.
FDA Proposes Fee Cuts to Keep Early-Stage Drug Development in the U.S. Amid Leadership Turmoil
The FDA is proposing reduced user fees for biotechs running Phase 1 trials in the U.S., while adding extra fees for companies conducting early development abroad, aiming to boost domestic innovation under PDUFA reauthorization talks. The proposal comes as regulatory instability grows, following news of CDER head Richard Pazdur’s expected retirement and rising industry concern that leadership turnover and unpredictability could push biotech investment overseas.
FDA Moves to Phase Out Primate Testing for Monoclonal Antibody Safety Studies
The FDA released new draft guidance recommending that monospecific monoclonal antibodies no longer require six-month toxicity testing in primates, marking a major step toward reducing animal use in preclinical studies. The guidance supports three-month studies or alternative “new approach methodologies” (NAMs), citing faster, more humane, and cost-effective drug evaluation. The move aligns with a broader federal shift away from animal testing, following CDC’s directive to end monkey research and NIH’s $87M investment in NAMs and organoid models.
