A deal worth $745 million for two small-molecule programs, with a lucrative option to expand into other modalities, brings together the diabetes and metabolic disease expertise of Novo Nordisk A/S with an artificial intelligence technology platform from Dewpoint Therapeutics Inc. Dewpoint signed on with Novo Nordisk to use the former’s biomolecular condensates discovery engine to find new drugs for diabetic complications. The drugs will target condensates that contribute to the mechanisms of insulin sensitivity and insulin resistance, a key driver of type 2 diabetes and metabolic syndrome. In terms of money, Dewpoint is entitled to $55 million in an up-front payment, research funding and potential research milestone payments for two programs, and up to another $690 million in clinical, commercial and sales milestones, plus royalties. If Novo Nordisk pursues other modalities, Dewpoint could earn even more, up to $107.5 million in additional milestone payments per product.

NASH phase IIb data boost 89bio, support phase III advance 

89bio Inc. shares (NASDAQ:ETNB) were trading at $15.02, up $4.09, or 37%, after the company disclosed phase IIb data from the study called Enliven testing pegozafermin in nonalcoholic steatohepatitis (NASH). Top-line findings showed that 44-mg dosing every two weeks and 30 mg every week met with high statistical significance the primary histology endpoints by analysis in accordance with U.S. FDA guidance. The drug, due next for phase III investigation in NASH, is a glycopegylated analogue of fibroblast growth factor 21.

$123M: Series B round ignites Flare Therapeutics program in urothelial cancer

Flare Therapeutics Inc. raised $123 million in an oversubscribed series B round to take its lead compound, FX-909, a potentially first-in-class peroxisome proliferator-activated receptor gamma inhibitor, into clinical trials in patients with advanced urothelial cancer and to advance additional pipeline candidates acting on other transcription factor targets with genetically validated links to disease biology. It aims to nominate a second development candidate next year and a third the year after.

Astellas’ Claudin 18 inhibitor zolbetuximab meets endpoints in phase III Glow trial

Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint for progression-free survival as well as secondary endpoints for overall survival in the phase III Glow trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The phase III Glow trial evaluated the efficacy and safety of zolbetuximab in 507 patients in combination with chemotherapy regimen CAPOX that includes capecitabine and oxaliplatin. The study showed zolbetuximab plus CAPOX reduced risk of progression or death by 31.3% compared to placebo plus CAPOX (p=0.0007), meeting Glow’s primary endpoint.

Not just Moderna on the HELP hot seat

Besides holding a hearing today to try to shame Moderna Inc. into reversing its plans to hike the list price of its COVID-19 vaccine, Sen. Bernie Sanders (I-Vt.), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, issued a statement yesterday slapping the Biden administration for its refusal, once again, to march-in on the patent rights of Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. While the NIH’s decision to deny the march-in petition wasn’t expressly discussed at the HELP hearing, Sanders suggested a new drug development model in which the government would pay a company to develop a drug, but then assume all the risk and costs while sharing the invention with the world.

US FTC: Apokyn suit has broad implications 

Citing significant implications for patients with advanced Parkinson’s disease, as well as the broader public interest that’s at stake, the U.S. FTC this week filed an amicus brief in Sage Chemical Inc.’s district court challenge of Supernus Pharmaceuticals Inc.’s strategies to block generic competition of its injectable Parkinson’s drug, Apokyn (apomorphine). With the drug having no extant patents listed in the FDA’s Orange Book, Supernus is allegedly leveraging its control over the Apokyn pen injector, provided by Becton Dickinson and Co. under an exclusive supply contract, to stave off generic competition.

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