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  • UCB to buy Candid Therapeutics for up to $2.2 billion, targeting bispecific antibodies for autoimmune disease
    UCB announced a deal to acquire Candid Therapeutics, a startup focused on bispecific antibody drugs, for an upfront payment of $2 billion with up to $200 million in future milestones. The transacti…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Celcuity reports positive Phase 3 data for gedatolisib, bolstering broader approval prospects
    Celcuity announced new data from an ongoing Phase 3 trial of its experimental breast cancer drug gedatolisib. The data showed that two- and three-drug combinations that included gedatolisib delaye…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
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  • Supreme Court reverses stay, allowing mail ordering of abortion pill mifepristone
    The U.S. Supreme Court issued a decision on Monday that restores the ability to order the abortion medication mifepristone by mail. This action overturns a stay that had been placed by a federal ap…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Swiss biotech Windward Bio raises $165 million to launch Phase 3 asthma trial for China-derived drug
    Swiss biotech Windward Bio announced it has secured $165 million in financing. The capital will be used to move one of its two experimental medicines, originally discovered in China, into a Phase…
    Endpoints · 4mo agoDealPositive↗ source
  • AI drug repurposing in oncology hampered by fragmented data, curated knowledge needed
    AI tools are being used to look for new cancer indications for existing biologics, but the article notes that fragmented and disparate data sets limit even the most advanced models. Repurposing pr…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Vertex halts mRNA cystic fibrosis program citing tolerability concerns
    Vertex Pharmaceuticals announced it is ending development of its mRNA-based cystic fibrosis therapy after encountering tolerability problems that echo challenges seen elsewhere in the field. The B…
    Endpoints · 4mo agoNegative↗ source
  • FDA narrows search for new CBER chief to three or four finalists
    The FDA announced that its search for a new head of the Center for Biologics Evaluation and Research (CBER) has been narrowed. According to a source familiar with the process, the agency is now fo…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Biotech sees rise of lean startups backed by large funding and Chinese assets
    A new wave of biotech companies is emerging that prioritises lean organizational structures over extensive early‑stage research programs. These firms are being launched with modest employee counts…
    Endpoints · 4mo agoNeutral↗ source
  • UCB bets $2B on Candid's T cell engager ambitions
    Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is…
    Endpoints · 4mo ago↗ source
  • Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more
    Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-brea…
    Endpoints · 4mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 4mo ago↗ source
  • Moderna in talks with FDA over Phase 4 Covid vaccine data
    Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the produ…
    Endpoints · 4mo ago↗ source
  • FDA approves Pfizer and Arvinas' breast cancer drug despite underwhelming data
    The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it. The drug will be ...
    Endpoints · 4mo ago↗ source
  • Amgen launches late-stage obesity trial in patients who switch from rival drugs
    Amgen is launching three new late-stage trials for its long-acting obesity shot MariTide, including one designed to test the drug in patients switching away from Eli Lilly and Novo Nordisk's blockb…
    Endpoints · 4mo ago↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 4mo ago↗ source
  • Summit’s ‘self-inflicted’ stumble; Esperion’s take-private deal
    Summit’s decision to conduct an interim analysis of a closely watched trial backfired. Elsewhere, Axsome got a much-needed label expansion and an FDA committee sided against an AstraZeneca breast c…
    BioPharma Dive · 4mo ago↗ source
  • Moderna sees revenue bump from international COVID vaccine sales
    The company is making up for a decline in U.S. vaccine sales with better results elsewhere, continuing a turnaround that’s vaulted its stock price in 2026.
    BioPharma Dive · 4mo ago↗ source
  • Samsung Biologics workers begin five-day strike over wage disputes
    After holding a rally in April, Samsung Biologics union workers on Friday started a five-day strike over wage negotiations. Around 95% of the company's union members voted on the strike, with the ...
    Endpoints · 4mo ago↗ source
  • Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China
    Cue Biopharma announced a reboot Thursday afternoon, bringing in notable biotech executive Shao-Lee Lin as well as a new allergy asset developed in Taiwan and mainland China. The Boston-based biote…
    Endpoints · 4mo ago↗ source
  • Save the date: Premium subscriber-exclusive Post-Hoc Live
    Q1 earnings recap with Endpoints News After a deal-heavy first quarter, earnings season is in full swing. We're breaking down the news and trends from Big Pharma's first-quarter calls on a special…
    Endpoints · 4mo ago↗ source
  • FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    Endpoints · 4mo ago↗ source
  • Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
    Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
    BioPharma Dive · 4mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$SMMT} tumbled nearly 20% after the closing bell Thursday afternoon, following an apparent statistical miss in part of a Phase 3 trial for its cancer drug ivonesci…
    Endpoints · 4mo ago↗ source
  • Amgen files update to Tavneos label as FDA escalates push to withdraw
    Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...
    Endpoints · 4mo ago↗ source
  • Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut
    A trio of biotechs priced their IPOs on Thursday into Friday morning, setting the stage for their public trading debuts with more than $850 million combined. Seaport Therapeutics, Hemab Therapeutic…
    Endpoints · 4mo ago↗ source