Plus, news about Seres Therapeutics, Nestlé Health Science, Pfizer, Evotec and Relay Therapeutics:
FDA lifts partial hold on Stoke Therapeutics’ Dravet syndrome drug: The antisense oligonucleotide, zorevunersen, is now nearing Phase 3 development for the genetic disease. The FDA had placed higher doses of the drug on partial clinical hold back in 2020 due to safety concerns raised by preclinical data. Stoke said it will provide an update on registrational plans in the second half of the year. — Ayisha Sharma
Recursion Pharmaceuticals gets $30 million as part of 2021 agreement with Roche and Genentech: Recursion said on Tuesday that Genentech exercised its option for the first neuroscience phenomap from the 2021 collaboration, which began with $150 million in cash upfront and up to $300 million in milestones. — Katherine Lewin
Seres reveals numbers for Vowst sale to Nestlé Health Science: In exchange for selling Vowst, an oral pill to treat recurring Clostridioides difficile infections, Seres will receive $175 million in cash, which includes an upfront payment, prepayment of a future commercial milestone and an equity investment in Seres’ stock. More money will come next year for Seres, with installment payments of $50 million in January 2025 and $25 million in July of that year. Seres will also get more milestone payments depending on the drug’s worldwide net sales. — Katherine Lewin
EMA begins review of Pfizer’s sickle cell disease drug Oxbryta following patient deaths: Two clinical trials have the European agency concerned about the safety of the drug, with one trial showing that a higher number of deaths occurred with Oxbryta than with a placebo, and a second trial with the total number of deaths being higher than expected. Pfizer, which owns the drug, has stopped both clinical trials, according to the EMA. — Katherine Lewin
Evotec lowers 2024 guidance following announcement of business plan reset: The German company said in April that it would cut costs with the goal of improving margins following lower-than-expected 2023 profits. Now, Evotec has lowered its 2024 guidance, according to SEC filings, and expects revenues in the range of €790 million to €820 million ($863 million to $896 million). — Katherine Lewin
Relay Therapeutics drops development of migoprotafib: The move comes after Relay’s former partner Genentech returned the rights to the oral SHP2 inhibitor in July. Migoprotafib was being studied in Phase 1 cancer trials in combination with other drugs. — Ayisha Sharma