Eli Lilly and Co.’s weight-loss drug Zepbound (tirzepatide) made headlines yet again as the Indianapolis-based firm disclosed top-line data from the Surmount-5 phase IIIb study. The open-label, randomized trial found that Lilly’s glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist provided a 47% greater relative weight loss compared to the GLP-1 agonist Wegovy (semaglutide) from Novo Nordisk A/S. On average, Zepbound led to a superior weight loss of 20.2% compared to 13.7% with Wegovy. At 72 weeks, Zepbound beat Wegovy on the primary endpoint and all five key secondary endpoints in the trial, which enrolled adults living with obesity or overweight with at least one weight-related medical problem and without diabetes.

Relmada falls on latest miss in depression with NMDA receptor program

Shares of Relmada Therapeutics Inc. (NASDAQ:RLMD) were trading down 75% Dec. 4 after a pre-planned interim analysis prompted the independent data monitoring committee to conclude the phase III Reliance II study testing REL-1017 in major depressive disorder is unlikely to meet its primary endpoint. The study, which was testing the NMDA receptor channel blocker as an adjunctive treatment in combination with approved antidepressants, is the third phase III study of REL-1017 to fall short. Relmada said it will evaluate next steps for REL-1017 while focusing on an earlier-stage program targeting metabolic disease.

Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept

Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion. Under terms of the deal, Osaka, Japan-based Takeda gains an exclusive worldwide license to develop, manufacture and commercialize elritercept in all indications and territories outside of mainland China, Hong Kong and Macau. Takeda will be responsible for all development, manufacturing and commercialization. In exchange, Keros will receive a $200 million up-front payment and is eligible to receive development, approval and commercial milestone payments worth up to $1.1 billion plus sales-based royalties.

GSK inks $1B option agreement for Dualitybio preclinical ADC candidate

Duality Biologics is out-licensing preclinical antibody-drug conjugate (ADC) candidate DB-1324 under an option agreement with GSK plc potentially worth more than $1 billion. Under terms of the agreement, GSK will pay Suzhou, China-based Dualitybio $30 million up front and additional pre-option milestone payments to obtain an exclusive option for exclusive worldwide rights for Dualitybio's ADC (excluding mainland China, Hong Kong, and Macau). Upon GSK exercising the option, Dualitybio will receive an option exercise fee, as well as potential development, regulatory and commercial milestone payments totaling up to $975 million. Upon commercialization, GSK will pay tiered royalties on DB-1324's global net sales outside mainland China, Hong Kong, and Macau, while it will receive royalties on net sales in those countries.

Elevar nabs Relay’s FGFR2 rare cancer drug in $500M deal

Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd. subsidiary, seeks to diversify its oncology portfolio following the U.S. FDA rejection of its liver cancer drug candidate in May. Under the terms of the exclusive license deal announced Dec. 3, Cambridge, Mass.-based Relay will hand off global development and commercialization rights of lirafugratinib to Elevar, along with all further development and regulatory activities, including NDA submissions, clinical development and commercialization for the indications of FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors. In turn, Fort Lee, N.J.-based Elevar agreed to pay Relay up to $75 million in up-front and regulatory milestones, plus up to $425 million in potential commercial milestone payments, along with tiered royalties up to the low-teens percentage.

Biocom: Advice for adding diversity in clinical trials

At Biocom California’s Let’s Talk About series, panelists discussed the benefits and best practices for adding diversity to clinical trials. From how to recruit people into studies to how to retain them once they’ve signed up, practices need to be adjusted to maximize enrollment and retention of minorities. Methods that may work well for white patients, may not for other ethnic backgrounds.

Sickle cell gene therapies to be part of CMS access model launch

Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. have agreed to participate in CMS’ voluntary Cell and Gene Therapy Access Model to help make their costly sickle cell gene therapies more broadly available across the U.S. CMS Administrator Chiquita Brooks-LaSure called the manufacturers’ agreement and the model, which will launch in January, “a new frontier in providing access for people with sickle cell disease to potentially transformative treatments.” State Medicaid programs will have a year to decide whether to apply to be part of the model.

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