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  • Cytokinetics heart drug scores in closely watched trial
    Myqorzo’s success in “non-obstructive” hypertrophic cardiomyopathy separates it from Bristol Myers Squibb’s rival Camzyos and opens up a multibillion-dollar market opportunity.
    BioPharma Dive · 2mo ago↗ source
  • Cytokinetics succeeds where Bristol Myers failed in heart muscle disease
    Cytokinetics’ pill for a heart muscle disorder called hypertrophic cardiomyopathy could see its addressable market double after it succeeded in a pivotal trial for another form of the disease. The…
    Endpoints · 2mo ago↗ source
  • Cytospire hauls in $83M for a new type of T cell engager
    The British biotechnology startup is making "pan-gamma delta” T cell engagers it says can address the limitations of similar, existing therapies.
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BioPharma Dive · 2mo ago
↗ source
  • Vertex drops mRNA cystic fibrosis program over 'tolerability' issues
    Vertex Pharmaceuticals said it has dropped development of an mRNA-based cystic fibrosis therapy after facing challenges similar to those that have troubled other parts of the field in delivering th…
    Endpoints · 2mo ago↗ source
  • FDA search for new CBER head focused on small group of final candidates
    The FDA has narrowed its search for a new leader of its Center for Biologics Evaluation and Research to three or four final candidates, according to a person familiar with the matter. The agency ho…
    Endpoints · 2mo ago↗ source
  • Celcuity strengthens case for ASCO-spotlighted breast cancer drug
    The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.
    BioPharma Dive · 2mo ago↗ source
  • Supreme Court restores mifepristone access by mail
    The Supreme Court restored mail ordering of mifepristone, reversing a federal appeals court’s stay. The decision Monday came after makers of the pill asked for an immediate response to a ruling ...
    Endpoints · 2mo ago↗ source
  • Celcuity's breast cancer win; Odyssey plans $205M IPO
    Celcuity’s breast cancer drug wins again: The company said two regimens with its experimental drug gedatolisib succeeded in PIK3CA mutant patients as part of its Phase 3 trial. Last year ...
    Endpoints · 2mo ago↗ source
  • With $97M, Latus pursues a different kind of Huntington’s gene therapy
    The therapy is part of a plan to develop gene therapies that can be efficiently delivered at lower doses, enabling them to be used against more than just “ultra-rare” conditions.
    BioPharma Dive · 2mo ago↗ source
  • Biotech has a new startup model: Small team, big check and Chinese assets
    A new flavor of company is shaking up how biotechs are built. Instead of launching with eye-popping early-stage science or a new platform, there's a surge of startups with small teams, large checks…
    Endpoints · 2mo ago↗ source
  • Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial
    A Swiss biotech with two experimental medicines from China, plus an in-house discovery team, has brought in $165 million to advance into late-stage testing. The startup, Windward Bio, has raised a ...
    Endpoints · 2mo ago↗ source
  • UCB to acquire Candid in $2.2B bet on bispecifics for autoimmune diseases
    The buyout involves a portfolio of antibody drugs Candid licensed from China-based biotechs and that UCB sees as part of the “next wave” of care for immunological conditions.
    BioPharma Dive · 2mo ago↗ source
  • What is your AI drug repurposing strategy missing?
    Fragmented data limits even the most advanced oncology AI. Curated knowledge changes that.
    BioPharma Dive · 2mo ago↗ source
  • UCB bets $2B on Candid's T cell engager ambitions
    Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is…
    Endpoints · 2mo ago↗ source
  • Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more
    Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-brea…
    Endpoints · 2mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 2mo ago↗ source
  • Moderna in talks with FDA over Phase 4 Covid vaccine data
    Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the produ…
    Endpoints · 2mo ago↗ source
  • FDA approves Pfizer and Arvinas' breast cancer drug despite underwhelming data
    The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it. The drug will be ...
    Endpoints · 2mo ago↗ source
  • Amgen launches late-stage obesity trial in patients who switch from rival drugs
    Amgen is launching three new late-stage trials for its long-acting obesity shot MariTide, including one designed to test the drug in patients switching away from Eli Lilly and Novo Nordisk's blockb…
    Endpoints · 2mo ago↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source