Pimicotinib Hydrochloride

Today, a brief rundown of news involving Replimune, Revolution Medicines and Merck KGaA, as well as updates from Eli Lilly, Otsuka Pharmaceutical and Definium Therapeutics that you may have missed.On Friday, Replimune said that the Food and Drug Administration has accepted the resubmission for its cancer drug RP1, with a decision expected by Aug. 2 and an advisory committee set to convene in July to discuss the twice-rejected application. The latest move is another signal of the changing attitude of the FDA, which was accused of moving the goal post or providing conflicting feedback to companies, leading to delayed or rejected applications under the now-exited leaders Marty Makary and Vinay Prasad. Multiple other companies that faced hurdles under the prior leadership are now gaining new chances for their applications. Delilah AlvaradoRevolution Medicine outlined data from Phase 2 trials of its second RAS-blocking cancer drug, zoldonrasib, showing it can shrink or eliminate tumors in pancreatic cancer patients when combined with chemotherapy or Revolutions lead drug, daraxonrasib. In the chemo-combo trial, 82% of enrollees with RAS-mutated disease who got zoldonrasib and one type of chemotherapy regimen as a first-line treatment responded, as did 61% who got the experimental drug plus another type of chemo. In the trial that combined the two Revolution drugs in a second- or third-line setting in RAS-mutated enrollees, 50% of patients in the second-line setting and 47% in the third-line setting saw their tumors shrink or disappear. The data are scheduled for presentation at the European Society of Medical Oncology Gastrointestinal Cancers meeting next week. Revolution just began dosing patients in a Phase 3 trial with the chemo combination, and is planning to begin a daraxonrasib-zoldonrasib Phase 3 trial later this year. Jonathan GardnerGermany-based Merck KGaA is spending more than $11 billion to acquire Bio-Techne, a U.S. life-sciences analytics and diagnostics provider, the companies said Thursday. Per deal terms, German Merck will pay $73 per share in cash, a 36% premium to Bio-Technes average price over the past month. Merck KGaA executives stated the transaction will help build the companys life science business that serves drugmakers with materials and manufacturing by adding protein analysis, biomarker discovery and diagnostics capabilities. The deal is expected to close later this year, pending regulatory and shareholder approval, and Merck KGaA will finance it with a combination of cash on hand and new debt. Jonathan GardnerPsychedelic drug developer Definium Therapeutics is issuing $805 million worth of stock, proceeds from which will go toward research and development of its pipeline, and potential commercialization of its candidate DT120 against major depression. The public offering closing announced Thursday comes just a few days after the company unveiled positive late-stage results of DT120, an LSD-based oral drug. The company is still awaiting data from a second pivotal trial. Delilah AlvaradoEli Lilly is widening a research collaboration with China-based Abbisko, paying an undisclosed upfront fee and pledging up to $1.9 billion in potential payouts based on achievement of development and commercial milestones for drugs developed under the agreement, Abbisko said Tuesday. The two companies will work on multiple targets, advancing novel drug candidates with global potential, growing from work from a deal signed in 2022 on discovery, development, and potential commercialization of a novel small-molecule therapeutic. Abbisko has established deals with multiple drugmakers, including Merck KGaA and AstraZeneca, with the former company seeking FDA approval for a medicine called pimicotinib thats part of their deal. Jonathan GardnerOtsuka Pharmaceuticals experimental drug met its primary endpoint in a late-stage trial of adults with ADHD and comorbid anxiety, showcasing statistically significant and clinically relevant improvements when compared to placebo, the company said Thursday. Compared to placebo, centanafadine a norepinephrine, dopamine, and serotonin reuptake inhibitor had improved ADHD after eight weeks, as measured by a rating scale. The Phase 3b trial enrolled 315 adults. The experimental therapy is currently under regulatory review in the U.S. as a treatment for ADHD in children and adults, with a decision target of July 24. Delilah Alvarado '

Under new CEO Kai Beckmann, Merck KGaA is emphasizing M&A to stock its early- to mid-stage pharma pipeline, the company said in reporting its first quarter results on Wednesday. Merck KGaA made its largest acquisition in a decade in April 2025, when it snapped up Connecticut rare disease specialist SpringWorks Therapeutics for $3.9 billion. A year later, as the German conglomerate presented its first-quarter earnings, it reiterated its focus on M&A, largely to fuel its pharma pipeline.“We will broaden our M&A scope,” new CEO Kai Beckmann said during a conference call.In laying out the company’s business update (PDF), Beckmann said M&A is a growth lever that is “critical” for innovation and that acquiring external innovation is needed to build a risk-balanced pharma pipeline.“By combining our core strengths in biology, chemistry and physics with data and AI, we will become a more agile company that delivers at greater speed and scale,” Beckmann said.While Merck KGaA has three unrelated phase 3 programs, the company’s Healthcare CEO, Danny Bar Zohar, called its early- to midstage pipeline “rather slim.”“We need to build that in order to sustain, or to ensure, that we grow beyond that low-to-mid single-digit mid-term guidance that we gave you beyond 2030, beyond 2031,” Bar Zohar said. “This is something that we need to start building now.” After the 2024 failure of BTK inhibitor evobrutinib, Merck KGaA is relying heavily on a trio of late-stage oncology assets, including pimicotinib, which is under review by the FDA, and antibody-drug conjugate precemtabart tocentecan. The company is also pointing to a second-half launch in the U.S. of the fertility drug Pergoveris, which is being assessed under the FDA’s new Commissioner’s National Priority Review Voucher (CNPV) program.Merck KGaA reported first-quarter sales of 5.1 billion euros, down from 5.3 billion euros in the same period last year. Healthcare sales fell 3%, driven largely by a 5% decline in oncology product sales and a 9% drop in neurology and immunology treatment sales. That segment includes multiple sclerosis drug Mavenclad, which posted a 7% sales decline. The company raised its revenue projection by 10 million euros at the midpoint of its guidance range, as competition for Mavenclad is expected to arrive two months later than previously anticipated. The company also attributed a 16% increase in Process Solutions revenue to stockpiling of lab supplies by clients anticipating supply chain disruptions tied to the war in Iran.With the upgraded guidance, Merck KGaA’s share price increased by 8%.