Sacituzumab tirumotecan

An FDA safety probe into Takeda's Adzynma, Otsuka's IgAN approval for Voyxact and Daiichi Sankyo's latest win against Pfizer made our news this week. The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi Sankyo won reversal of an unfavorable ruling in its patent fight against Pfizer’s Seagen. And more.1. FDA launches investigation into Takeda's Adzynma following reported pediatric deathThe FDA is investigating Takeda’s Adzynma following a reported child's death. The drug, approved for the rare blood disorder congenital thrombotic thrombocytopenic purpura, is under scrutiny due to postmarketing reports of patients developing neutralizing antibodies against the drug’s ADAMTS13 protein ingredient. Takeda said it found no confirmed causal link.2. In crowded kidney disease space, Otsuka receives FDA approval for first-in-class VoyxactOtsuka received accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). The monthly self-administered drug is the first biologic cleared for the kidney disease and the first to block the APRIL protein. Before entering a competitive market, Voyxact showed a placebo-adjusted 51% reduction in proteinuria at nine months in a phase 3 trial.3. Daiichi Sankyo prevails on appeal in long-running ADC patent battle with Seagen, flipping prior $41.8M verdictDaiichi Sankyo got a win in its long-running antibody-drug conjugate patent dispute with Pfizer’s Seagen. The U.S. Court of Appeals reversed a prior ruling that found Daiichi infringed a Seagen patent with Enhertu. The new decision nullifies a previous Texas court verdict, which said Daiichi owed Seagen royalties related to the popular ADC.4. Crescent waxes pipeline with $80M Kelun deal, bagging ADC to pair with PD-1xVEGF bispecificCrescent Biopharma struck a $80 million upfront deal for ex-China rights to Kelun-Biotech’s integrin beta-6-directed ADC candidate. Crescent plans to test the new ADC in combination with its own PD-1xVEGF bispecific antibody for solid tumors. In exchange, Kelun will pay $20 million upfront for Chinese right to Crescent’s bispecific. 5. Merck's partner Kelun touts phase 3 win for ADC-Keytruda combo in first-line lung cancerKelun also reported a phase 3 win for its Merck & Co.-partnered TROP2 ADC, sacituzumab tirumotecan (sac-TMT), combined with Keytruda. The combo significantly improved progression-free survival versus Keytruda alone in Chinese patients with first-line PD-L1-positive non-small cell lung cancer, according to Kelun.6. FDA grants game-changing perioperative approval to Padcev, Keytruda combo in bladder cancerA combination of Astellas and Pfizer’s Padcev and Keytruda won an FDA approval as a perioperative treatment for muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy. The regimen, used around surgery, is the first to significantly improve survival over surgery alone in this population, reducing the risk of death by 50% in a phase 3 trial.7. Daiichi Sankyo receives FDA untitled letter taking aim at Turalio patient ambassador videoSK Life Science Xcopri ad meets a roadblock with FDA untitled letterThe FDA issued separate untitled letters to Daiichi Sankyo and SK Life Science over “false or misleading” drug marketing. The letter to Daiichi cited a Turalio patient ambassador video that overstated treatment benefits, while the letter to SK Life Science took aim at a TV ad for the anti-seizure drug Xcopri for omitting major risk warnings and failing to present risk information concurrently in both audio and text.Other News of Note: 8. FDA floats user fee cuts for early-stage US trials, additional fees for overseas development9. After dodging Biosecure threat, WuXi AppTec faces new security scrutiny from Pentagon: Bloomberg10. Tanabe Pharma shifts gears for Bain-backed future, dropping Mitsubishi moniker after $3.3B deal11. Sun Pharma shines a light on diabetic retinopathy in #SeeBeyondSugar campaign12. Pfizer, GSK, Shionogi sponsor London run of musical about antimicrobial resistance13. Eisai finalizes FDA filing for subcutaneous Leqembi starter dose (Regulatory tracker)14. China launches national drug price registration system (Yicai)

Crescent Biopharma made a set of sweeping moves Thursday morning, notably with its strategy of bringing its PD-1xVEGF to China. Boston-based Crescent signed a two-way deal with Kelun-Biotech, in which both companies will have access to some of each others’ assets. Crescent said that clinical trial preparation is underway and that it secured a $185 million private placement. Investors appeared to appreciate Crescent’s moves. Its share price $CBIO rose 15% in premarket trading. The news begins with Crescent out-licensing the Greater China rights to its cancer drug candidate CR-001 to Kelun-Biotech. Kelun will pay Crescent $20 million upfront and up to $30 million in milestones for the rights to the PD-1xVEGF drug candidate. The experimental medicine will enter Phase 1 in the first quarter of 2026. But that’s far behind frontrunners such as Summit Therapeutics, Bristol Myers Squibb and Merck. Among others, UK biotech Ottimo Pharma is also in the race, with expectations of getting IND clearance within the next four weeks. Meanwhile, Crescent will get access to Kelun’s integrin beta-6 (ITGB6)-directed ADC, called SKB105/CR-003, which is also slated to enter Phase 1/2 monotherapy trials in solid tumors next quarter. For ex-Greater China rights to the ADC, Crescent will pay Kelun $80 million upfront and promise up to $1.25 billion in biobucks. The two assets in this deal will first undergo monotherapy studies and then be studied in combination in the first half of 2027, Crescent said. It has other ADCs in development that it will also pair up with CR-001, including the PD-L1-directed CR-002. Also on Thursday morning, Crescent said it nabbed a $185 million private placement from Forbion, Fairmount, ADAR1 and other investors. These updates all take place six months after Crescent became a public biotech via a reverse merger with GlycoMimetics. Crescent is one of multiple spinouts from Paragon, an antibody discovery shop funded by Fairmount that has pumped out other companies like Apogee, Spyre and Jade. Crescent and Kelun’s deal follows a trend of Western biotechs going to China to pick up new medicines. Such deals have accounted for nearly one-third of drug licensing pacts this year. But the two-way deal also marks somewhat of a rarity in that Crescent is out-licensing its PD-1xVEGF to China rather than in-licensing its candidate from the country. Summit, Bristol Myers and Merck all got their investigational medicines in the hot class via Chinese biotechs Akeso , Biotheus and LaNova Medicines, respectively. For Kelun, it marks its latest $1 billion-plus ADC pact. The Chengdu-based drug developer’s main Western partner is Merck, which has forged a couple ADC alliances with the biotech. The duo’s most advanced candidate, called sac-TMT, is now headed to China’s health regulator .