Otsuka Pharmaceutical Co., Ltd.

Drugmakers will likely be able to handle the impacts of the third round of Medicare negotiations, analysts say, even as the biopharma industry continues to criticize the Biden-era program. On Tuesday, CMS unveiled the next 15 drugs up for negotiation, which include AbbVie’s Botox, Eli Lilly’s diabetes drug Trulicity, and Gilead’s HIV treatment Biktarvy. Analysts said some of the drugs were widely anticipated to make the list. They cited past negotiations, upcoming patent losses and new drug development as some reasons why the potential impacts may be modest. “With prior rounds of pricing negotiations reasonable, and several of these medicines set to lose exclusivity in the near-term, we continue to expect that the impacts will be manageable,” BMO Capital Markets analyst Evan Seigerman said in a note to investors. He called out Biktarvy, Botox, Trulicity, Eisai’s Lenvima, Bristol Myers Squibb’s Orencia, Lilly’s Verzenio and Pfizer’s Xeljanz specifically, as they fall under BMO’s coverage. CMS said the 15 new drugs on the list cost Medicare Part B and Part D about $27 billion from November 2024 through October 2025. But Leerink analysts suggested in a note that Biktarvy is “the only one of the 15 drugs that has [estimated] Medicare exposure that is material.” Even so, Leerink analyst Daina Graybosch told Endpoints News in an interview that the impact on Gilead’s revenue is likely “modest.” “Investors are thinking more about the growth beyond Biktarvy anyways,” she said, citing the company’s “really rich HIV pipeline.” Gilead launched its twice-yearly drug for HIV prevention Yeztugo last year, and said earlier this month that it hopes to have up to seven HIV prevention and treatment launches by the end of 2033. A Gilead spokesperson said on Wednesday that the company plans to participate in negotiations, and is “committed to demonstrating the value and innovation of our medicines while supporting patient access and affordability.” Some drugmakers continue to attack the program. Novartis called the program unconstitutional in a statement to Endpoints on Tuesday, and Bristol Myers said “the IRA’s forced sale regime is deeply flawed.” The BMS spokesperson added that the program “creates negative, long-term implications on patient access, R&D and future innovation.” Novartis and BMS are two of six drugmakers that have asked the Supreme Court to review challenges they brought against the first round of Medicare negotiations. PhRMA EVP of policy and research Elizabeth Carpenter said the law is “the wrong approach for Americans,” and is “undermining future medical progress.” Some drugmakers suggested in early statements they would cooperate with CMS. UCB said it is “prepared to work collaboratively” with the agency in discussions for its drug Cimzia. Takeda said it anticipated the inclusion of its drug Entyvio for Crohn’s disease and ulcerative colitis, and has been “actively preparing” for possible negotiations. A spokesperson said the company is “focused on supporting continued access to Entyvio for patients who may benefit from this critical medicine.” Otsuka, which markets the  antipsychotic medicine Rexulti with Lundbeck, told Endpoints that it “remains committed to ensuring patients have access to safe and effective treatments for serious mental illnesses and neurological conditions.” Lundbeck noted that Rexulti’s patent expiration is in mid-2029, and that “approximately 35% of US Rexulti revenue is exposed to Medicare.”

LUND, SE / ACCESS Newswire / January 28, 2026 / Cantargia AB (publ) ("Cantargia") (Nasdaq Stockholm:CANTA)(STO:CANTA) today announced that members of Cantargias management will participate in one-on-one meetings at the Leerink Partners Global Healthcare Conference in Miami, Florida on Wednesday, March 11, 2026. For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . Attachments Cantargia to participate at Leerink Partners Global Healthcare Conference SOURCE: Cantargia View the original press release on ACCESS Newswire

Centanafadine showed significant improvements in ADHD symptoms compared with placebo. Credit: Inna Kot / Shutterstock.com. The US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) submitted for centanafadine, an investigational, once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) treatment. Otsuka’s NDA covers the use of centanafadine as a treatment for ADHD in adolescents, adults, and children. Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is scheduled for 24 July 2026. The application is supported by findings from four pivotal Phase III trials assessing the safety and efficacy across various age groups. In these trials, centanafadine showed significant improvements in ADHD symptoms compared with placebo, using the ADHD Investigator Symptom Rating Scale in adults, and the ADHD Rating Scale-5 in adolescents and children. Centanafadine was found to be generally well-tolerated during the trials. The most common adverse events reported among adolescents and children included abdominal pain, decreased appetite, fatigue, nausea, rash, and somnolence. For adults, headache and decreased appetite were observed. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Otsuka development and commercialisation executive vice-president and chief medical officer John Kraus said: “ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available. “The FDA’s acceptance and priority review designation of our NDA for centanafadine marks an important milestone in our effort to bring forward a novel treatment option for people living with ADHD. “If approved, centanafadine would offer a first-in-class NDSRI option designed to support broad symptom management. We extend our sincere gratitude to the patients, caregivers, and investigators whose participation made this milestone possible.” In November 2025, Otsuka secured accelerated approval from the FDA for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.