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What’s in Today’s Brief? (September 28th Preview)
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Ophthalmology: Phase 3 win for Kodiak’s aflibercept competitor
Kodiak Sciences said its two late-stage eye therapies for wet age-related macular degeneration achieved statistical equivalence to Regeneron’s Eylea in a Phase 3 trial. The company reported that individualized dosing helped sustain efficacy while reducing injection frequency for many patients, positioning Zenkuda as a potential durability-focused alternative in retinal care. Kodiak said more than half of trial participants in the Zenkuda arm received injections only once every six months, compared with once every eight weeks for Eylea. The company also reported its second asset, tabirafusp alfa tedromer, matched Eylea using the same individualized approach. Kodiak plans to seek FDA approval for Zenkuda and expand into additional indications for other eye disorders in the fourth quarter of 2026. The result marks a turnaround for Zenkuda after an earlier Phase 3 readout that failed to match Eylea, which Kodiak linked to patient dosing needs and the trial’s earlier approach to dosing.
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Autoimmune disease: allogeneic CAR-T shows remission signals in lupus nephritis
Adicet Bio reported early efficacy and safety data for its donor-derived, allogeneic CAR-T approach in lupus nephritis, with half of evaluable patients achieving a complete kidney response at one year. The company said 54% met a commonly used remission threshold and that responders were able to stop immunosuppressive drugs. Adicet reported no serious cytokine release syndrome cases and no neurological side effects in its evaluable cohort, addressing two key safety concerns that have slowed progress for some autologous and individualized CAR-T programs in autoimmune disease. The company also said infections occurred in more than half of patients, with about 8% experiencing grade 3 or higher severity. The update supports Adicet’s plan to initiate a pivotal lupus study in the fourth quarter. The program’s “off-the-shelf” gamma delta CAR-T design is intended to reduce manufacturing delays and lower complexity versus personalized cell therapies.
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Regulatory: FDA IND clearance for Nutshell’s NRF2 degrader
Nutshell Therapeutics (Shanghai) said the FDA cleared its IND for NTS-231, a covalent allosteric molecular glue degrader targeting NRF2. The company said it identified NTS-231 using its Allostar AI-driven platform and that the small molecule covalently binds KEAP1 to induce NRF2 degradation. The FDA clearance advances NTS-231 into clinical development and places the program among NRF2 pathway efforts aimed at modulating oxidative stress and related disease biology. Nutshell’s drug discovery approach emphasizes “molecular glue” mechanism design, which differs from conventional small-molecule inhibitors by leveraging protein-protein or protein-complex interactions.
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Infectious disease: Scynexis wins BARDA funding for antifungal development
Scynexis secured a new BARDA contract worth $214 million to develop a treatment for invasive fungal infections. The award expands federal support for SCY-247, which Scynexis is developing with BARDA backing to address serious, drug-resistant fungal disease where treatment options can be limited. The contract underscores continued U.S. government focus on antimicrobials and antifungals through accelerated development funding and lifecycle partnerships. For Scynexis, the agreement strengthens its runway for clinical and manufacturing work required for late-stage progression.
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Respiratory critical care: Vasomune completes Phase 2a enrollment for Tie2-targeting therapy
Vasomune Therapeutics completed enrollment in a randomized Phase 2a trial evaluating pegevongitide (AV-001) in patients hospitalized with pneumonia requiring supplemental oxygen. The company is running AV001-004 as a double-blind, placebo-controlled study and said enrollment completion advances the FDA Fast Track-designated program toward data review. Vasomune described pegevongitide as a Tie2 receptor activator designed to reinforce the endothelial barrier and correct pulmonary vascular response associated with vascular leak and impaired oxygen exchange. Following enrollment completion, the company said it will move into data quality assurance, site closeout, and preparation for database lock. FDA Fast Track designation is intended to expedite development and review for therapies addressing serious conditions with unmet medical need, and the Phase 2a milestone brings Vasomune closer to reporting clinical outcomes.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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