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  • Cytokinetics' HCM drug shows positive trial results, potentially doubling market after Bristol Myers' setback
    Cytokinetics announced that its oral therapy for hypertrophic cardiomyopathy (HCM) achieved positive results in a pivotal trial targeting a different form of the disease. The data suggest the drug…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Microbiome startup Kanvas Biosciences secures $48 million to advance immunotherapy and malnutrition therapies
    Kanvas Biosciences announced it has closed a $48 million financing round to fund development of microbiome-based treatments targeting cancer immunotherapy response and severe malnutrition. The cap…
    Endpoints · 4mo agoDealPositive↗ source
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  • J&J advances IBD combo to Phase 3 despite Phase 2 setbacks
    Johnson & Johnson said it will advance its experimental inflammatory bowel disease therapy, JNJ-4804, into Phase 3 trials even though the drug failed to meet primary endpoints in two Phase 2 studie…
    Endpoints · 4mo agoNegative readoutNeutral↗ source
  • Parsley Health joins nationwide insurance networks, expanding access to its primary-care model
    Parsley Health, a decade-old primary-care startup that originally operated on a cash-pay model, announced that it is now in-network with insurers across the United States. The move marks a shift f…
    Endpoints · 4mo agoPositive↗ source
  • Takeda advances gene therapy, UK cancer biotech raises $83M, and new blood test may guide Wegovy use
    A Cleveland‑based biotech announced that a previously halted gene therapy program has been revived, offering a potential new option for patients as the company pursues additional studies. Takeda r…
    Endpoints · 4mo agoNeutral↗ source
  • Swiss pharma manufacturing remains steady despite tariff threats, impact may take years
    Swiss biotech day event highlighted that pharma manufacturing in Switzerland shows no immediate disruption from geopolitical tensions or potential tariffs. Industry representatives said that while…
    Endpoints · 4mo agoNeutral↗ source
  • Healthcare giants increasingly develop in-house AI tools instead of buying from startups
    Panelists at the Digital Healthcare Innovation Summit in Boston highlighted a growing shift among large health‑care organizations toward creating their own artificial‑intelligence solutions. Rather…
    Endpoints · 4mo agoNeutral↗ source
  • Intercept’s next-generation FXR agonist INT-787 fails Phase 2 trial in alcohol-associated hepatitis
    Intercept Pharmaceuticals reported that its experimental FXR agonist INT-787 did not demonstrate efficacy in a Phase 2 study of patients with severe alcohol-associated hepatitis. The trial results…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Celcuity reports positive Phase 3 results for gedatolisib in PIK3CA-mutant breast cancer
    On May 4, 2026 Celcuity announced that its experimental drug gedatolisib achieved success in two treatment regimens for patients whose tumors carry PIK3CA mutations, according to data from its ongo…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • UCB commits $2 billion to Candid's T cell engager program for autoimmune diseases
    UCB, a long standing European pharmaceutical company, announced a $2 billion investment in Candid, a biotech focused on T cell engager therapies aimed at autoimmune conditions. The deal reflects U…
    Endpoints · 4mo agoDealPositive↗ source
  • 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
  • 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
  • Bristol Myers faces pivotal year as Q1 earnings season begins
    The weekly Endpoints newsletter for the last week of April highlighted that several pharmaceutical companies released their first-quarter earnings. Among them, Bristol Myers was singled out as bei…
    Endpoints · 4mo agoEarningsNeutral↗ source
  • FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation
    The U.S. Food and Drug Administration has granted approval to Axsome Therapeutics’ oral medication Auvelity for the treatment of agitation in patients with Alzheimer’s disease. Axsome noted that a…
    Endpoints · 4mo agoApprovalPositive↗ source
  • Summit Therapeutics shares tumble 20% after interim Phase 3 miss for ivonescimab
    Summit Therapeutics saw its shares fall about 20% after the market close on Thursday. The decline came after an interim analysis of a Phase 3 trial for its cancer candidate ivonescimab failed to m…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Moderna discusses post-marketing data with FDA to expand Covid-19 vaccine label
    Moderna announced it is working with US regulators to supply post-marketing data on its Covid-19 vaccines. The effort aims to address the FDA's decision last year to narrow the vaccine label, limi…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • FDA greenlights Pfizer/Arvinas breast cancer therapy vepdegestrant despite modest trial results
    The U.S. Food and Drug Administration announced approval of vepdegestrant, a therapy developed by Pfizer and Arvinas, for a specific subtype of breast cancer. The decision comes even though the cl…
    Endpoints · 4mo agoApprovalNeutral↗ source
  • Amgen initiates three late-stage trials of obesity shot MariTide, including a switch-patient study
    Amgen announced the start of three new Phase 3 trials for its long-acting obesity injection, MariTide. One of the studies will enroll participants who are transitioning away from the GLP-1 therapi…
    Endpoints · 4mo agoCRLPositive↗ source
  • Seaport and Hemab price IPOs as Avalyn soars on Nasdaq debut
    Three biotechnology companies announced the pricing of their initial public offerings between Thursday and Friday, collectively targeting more than $850 million in proceeds. Seaport Therapeutics a…
    Endpoints · 4mo agoDealPositive↗ source
  • Seaport Therapeutics jumps over 20% on Nasdaq debut as former Karuna team outlines CNS research plans
    Seaport Therapeutics began trading on Nasdaq on May 1, 2026, ringing the opening bell. Its shares surged more than 20% on the first day. The company’s leadership, including the CEO and CSO, highli…
    Endpoints · 4mo agoPositive↗ source
  • Samsung Biologics workers launch five-day strike over wage dispute
    On May 1, 2026 union workers at Samsung Biologics began a five-day strike after a rally in April. The walkout is over wage negotiations, with about 95% of the company's union members voting in fav…
    Endpoints · 4mo agoNegative↗ source
  • Cue Biopharma names Shao‑Lee Lin CEO and licenses new allergy asset from Taiwan and China
    Cue Biopharma announced a reboot, bringing in biotech veteran Shao‑Lee Lin as its new chief executive. Lin, founder of Acelyrin, will lead the Boston‑based company as it expands its pipeline. The…
    Endpoints · 4mo agoDealPositive↗ source