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On this week’s episode, Tess Cameron, Josh Schimmer, Brian Skorney, and special guest Adam Feuerstein kick off with regulatory updates, including the FDA’s rejection of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ cell therapy, Ebvallo -- a therapy that should have been approvable. The co-hosts then highlight ongoing inconsistencies at the agency and the challenge it creates for investors and companies as the regulatory goal posts continue to shift. Next, they discuss a New York Post editorial from the Alliance for Regenerative Medicine CEO Tim Hunt, who outlined how last‑minute reversals on rare disease and CGT approvals are leaving patients and biotech companies in limbo. The conversation then shifts to deals, including Gilead’s $7.8B acquisition of Arcellx for full control of anito-cel for relapsed/refractory multiple myeloma, and Vir’s pivot to oncology through a $1.7B collaboration with Astellas. In data news, the co-hosts cover CagriSema’s head-to-head trial results against Lilly’s Zepbound, Gossamer Bio’s lung disease drug, seralutinib, which did not meet the primary endpoint in its Phase 3 pulmonary arterial hypertension study, and Palvella Therapeutics’ positive topline results from the Phase 3 study of QTORIN rapamycin in microcystic lymphatic malformations. The episode closes with company updates, including Sarepta CEO Doug Ingram’s retirement and Xenon Pharmaceuticals’ upcoming seizure drug readout. *This episode aired on February 27, 2026.
By Daphne Zohar, Josh Schimmer, Brad Loncar, Tim Opler and more4.4
1818 ratings
On this week’s episode, Tess Cameron, Josh Schimmer, Brian Skorney, and special guest Adam Feuerstein kick off with regulatory updates, including the FDA’s rejection of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ cell therapy, Ebvallo -- a therapy that should have been approvable. The co-hosts then highlight ongoing inconsistencies at the agency and the challenge it creates for investors and companies as the regulatory goal posts continue to shift. Next, they discuss a New York Post editorial from the Alliance for Regenerative Medicine CEO Tim Hunt, who outlined how last‑minute reversals on rare disease and CGT approvals are leaving patients and biotech companies in limbo. The conversation then shifts to deals, including Gilead’s $7.8B acquisition of Arcellx for full control of anito-cel for relapsed/refractory multiple myeloma, and Vir’s pivot to oncology through a $1.7B collaboration with Astellas. In data news, the co-hosts cover CagriSema’s head-to-head trial results against Lilly’s Zepbound, Gossamer Bio’s lung disease drug, seralutinib, which did not meet the primary endpoint in its Phase 3 pulmonary arterial hypertension study, and Palvella Therapeutics’ positive topline results from the Phase 3 study of QTORIN rapamycin in microcystic lymphatic malformations. The episode closes with company updates, including Sarepta CEO Doug Ingram’s retirement and Xenon Pharmaceuticals’ upcoming seizure drug readout. *This episode aired on February 27, 2026.

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