With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier. Adzynma (apadamtase alfa, TAK-755) is the first recombinant protein product indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). It is the first and only FDA-approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme that regulates blood clotting.
FDA says yes to Valneva chikungunya vaccine
Valneva SE scored U.S. FDA clearance of Ixchiq, a single-dose, live-attenuated vaccine to prevent disease caused by the chikungunya virus in people 18 and older who are at increased risk of exposure to the bug. It’s the world’s first such product, and Valneva gained the go-ahead based on phase III findings that Ixchiq yielded a 98.9% seroresponse rate at 28 days with a single shot. Commercialization will begin early next year.
Astrazeneca to pay $2B for Eccogene’s oral GLP-1 obesity drug
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide). Under the deal inked on Nov. 9, Shanghai- and Boston-based Eccogene stands to gain $185 million up front from the big pharma and an additional $1.825 billion for clinical, regulatory and commercial milestones, along with tiered royalties on product net sales, for licensing out ECC-5004.
Recurring theme: Recursion and Bayer expand their partnership with $1.5B deal
Recursion Pharmaceuticals Inc. and Bayer AG have upped the ante on their 2020 collaboration deal to include precision oncology, with the possibility of more than $1 billion in potential milestone payments for Recursion. The original agreement called for them to discover and develop treatments for fibrotic disease of the lung, kidney, heart and more. The two companies could then initiate more than 10 fibrosis programs that could culminate in more than $100 million in development and commercial milestone payments plus royalties on future sales for Recursion. The new agreement allows for developing up to seven oncology programs, with Recursion eligible for up to $1.5 billion in milestone payments plus royalties on net sales.
Cargo IPO raises $281M for CD22 CAR T-cell therapy
In one of the larger biopharma IPOs in 2023, Cargo Therapeutics Inc. pulled in $281.3 million on Nov. 10, selling 18.75 million shares at $15 each, the low end of its price range. The market debut comes just eight months after the company raised $200 million in an oversubscribed series A round. Underwriters, which include J.P. Morgan, Jefferies, TD Cowen and Truist Securities, have a 30-day option for 2.8 million additional shares, which could bring the company another $42.19 million. With or without the overallotment exercise, Cargo’s IPO is the fourth largest this year. The company aims to address the durability of effect, safety and supply issues of approved CAR T-cell therapies. Its lead drug, CRG-022, is an autologous CD22 CAR T-cell therapy in phase I and phase II trials.
October 2023 sets new record with biopharma deal value nearing $45B
October marked a historic milestone for the biopharma industry, with deal values hitting an impressive $44.91 billion. It was the highest amount raised ever recorded by BioWorld, topping $42.45 billion deal value in December 2022.