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What’s in Today’s Brief? (May 9th Preview)
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FDA accelerates gene therapy with first-in-class hearing-loss approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning the therapy as the first gene treatment designed to restore neurosensory function in severe-to-profound OTOF-related sensorineural hearing loss. The approval covers children and adults with molecularly confirmed biallelic OTOF variants, preserved outer hair cell function, and no prior cochlear implant in the same ear. The decision was based on hearing sensitivity improvement measured by average pure tone audiometry at week 24 in the Phase I/II CHORD trial (NCT05788536). Regeneron reported that 80% of participants (16 of 20) achieved hearing improvements at ≤70 dB HL by week 24, with additional confirmatory signals from auditory brainstem response endpoints and durability through 48 weeks. Regeneron said it will make Otarmeni available for free in the U.S. The FDA’s accelerated approval framework hinges on verification and characterization of clinical benefit in the confirmatory portion of CHORD.
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FDA reconsiders Ebvallo after initial shock rejection
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said the FDA agreed to reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy for relapsed or refractory EBV+ post-transplant lymphoproliferative disease (EBV+PTLD). The companies said a late-April meeting ended with FDA aligning that a single-arm study, supported by an appropriate historical control, could be considered adequate for review. The shift comes after the FDA’s January complete rejection, when the agency said the same single-arm trial was “not an adequate and well-controlled study.” Instead of launching a new trial, Pierre Fabre and Atara plan to resubmit by adding patients and extending follow-up of the Allele study. European regulators previously approved Ebvallo in 2022 for the same indication, leaving the resubmission path as the near-term catalyst to watch for U.S. patients who currently lack an FDA-approved option.
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Biotech IPOs return with heavy immunology and Nasdaq filings
Odyssey Therapeutics priced an upsized IPO and concurrent private placement to fund autoimmune and inflammatory pipeline assets and complete its return to public markets. The company raised $304 million in gross proceeds by selling 15.5 million shares at $18 each, with an additional $25 million private investment from an affiliate of TPG Life Sciences Innovations. Odyssey’s lead program, OD-001, is an oral small-molecule inhibitor targeting RIPK2, aimed at ulcerative colitis with plans to study the drug as monotherapy and in combination with Takeda’s Entyvio. The company also plans to move a preclinical SLC15A4 program into a phase 1/2a trial. The IPO arrives amid a broader re-acceleration in large biotech financings, as investors show renewed appetite for immunology franchises with near-term clinical catalysts.
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Oncology and diagnostics capital flows: Caris and Guardant operational momentum
Caris Life Sciences took a step to expand access to its blood-based genomic profiling assay by submitting an application to the New York State Department of Health (NYSDOH) for authorization to run Caris Assure on specimens from New York. Caris said the review will be conducted by the Wadsworth Center, initiating the state’s formal Clinical Laboratory Evaluation Program (CLEP) process. Separately, Guardant Health reported strong Q1 2026 revenue growth and lifted full-year guidance, driven by continued momentum in minimal residual disease testing and screening volume. The company highlighted volume expansion across Guardant360 Liquid and Guardant360 Tissue, including an upgrade that will add whole-transcriptome RNA testing as a volume catalyst. Together, the moves underscore how precision oncology platforms are pushing for reimbursement and geographic expansion while scaling assay demand through product updates and clinical adoption.
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Guardant Health Boosts Guidance on Q1 Growth – Minimal Residual Disease Momentum Continues
Guardant Health reported Q1 2026 revenue of $301.7 million, up 48% year over year, and increased its full-year outlook to $1.30 billion–$1.32 billion. Company executives pointed to volume growth in oncology testing, including a 36% increase in oncology revenue and higher Guardant360 Liquid volumes. Management also emphasized pipeline-enabling upgrades, including planned whole-transcriptome RNA testing for Guardant360 Tissue. The firm said it has submitted data packages to CMS’s MolDx program across breast cancer surveillance and treatment monitoring settings, positioning reimbursement decisions as a near-term swing factor. The company’s results reinforce market appetite for liquid biopsy and MRD platforms that translate into both testing volume growth and incremental reimbursement pathways.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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