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  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 3mo agoRegulatoryNeutral↗ source
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  • Sarepta delays Elevidys study readout while Emergent cuts 90 jobs
    Sarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 3mo agoDealPositive↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Merck KGaA to receive up to €40 million in US tariff refunds for life science business through 2026
    Merck KGaA announced that it expects to receive tariff refunds for its life‑science division after a US Supreme Court ruling. The company estimates the refunds will total roughly €40 million and w…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Centene reports strong enrollment growth but modest scale for its ICHRA offering
    Centene's chief executive Sarah London said the company's individual coverage health reimbursement arrangement (ICHRA) business is experiencing a strong enrollment growth rate, though the total num…
    Endpoints · 3mo agoEarningsPositive↗ source
  • Lilly beats forecasts while Novo Nordisk misses sales and trial targets
    Eli Lilly reported second-quarter revenue of nearly $23 billion, up 48% year-over-year, easily surpassing analysts’ $20.6 billion estimate. The boost came from continued strength of its tirzepatide…
    BioPharma Dive · 3mo agoEarningsNeutral↗ source
  • Eli Lilly Q2 revenue hits $23 billion, topping forecasts as tirzepatide drives two-thirds of sales
    Eli Lilly reported second-quarter revenue of $23 billion, roughly $3 billion above analysts' estimates. Tirzepatide contributed about 64% of the total, highlighting its central role in the company…
    Endpoints · 3mo agoEarningsPositive↗ source
  • FDA approves Takeda's orexin drug for narcolepsy type 1
    Takeda has received FDA approval for its orexin agonist intended to treat narcolepsy type 1. The decision ends a closely watched commercial race to bring an orexin-based therapy to market. With a…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund antibody-drug research for skin and inflammatory diseases
    Attovia Therapeutics completed an IPO raising $289 million, selling 17 million shares at $17 each and valuing the company at $767 million. Shares will begin trading on Nasdaq under the ticker ATTO.…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Novo Nordisk looks to bolt-on acquisitions as pipeline setbacks mount
    Novo Nordisk CEO Maziar Mike Doustdar said on a media call that the pharma industry is tough for those who dislike setbacks and failure. He highlighted recent disappointments in the company's pipe…
    Endpoints · 3mo agoDealNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO, adding third I&I drug to market debut
    Attovia Therapeutics, a biotech focused on immunology and inflammation, completed an initial public offering that raised about $289 million. The funds will support the development of three I&I dru…
    Endpoints · 3mo agoDealPositive↗ source
  • Gilead's HIV prevention shot Yeztugo posts $232 million Q2 sales, beating forecasts
    Gilead reported that its biannual injectable for HIV pre‑exposure prophylaxis, Yeztugo, generated $232 million in revenue during the second quarter. This figure exceeds analysts' consensus estimat…
    Endpoints · 3mo agoEarningsPositive↗ source
  • Arrowhead Pharma to pay $215 million for PRV in its latest acquisition
    Arrowhead Pharmaceuticals disclosed in an SEC filing that it will acquire PRV for $215 million, marking the highest price tag for a deal this year. The purchase aligns with Arrowhead's strategy of…
    Endpoints · 3mo agoDealNeutral↗ source
  • Expedition Therapeutics raises $115M Series B for China-sourced COPD candidate
    Expedition Therapeutics, a US biotech, announced a $115 million Series B financing round. The capital will be used to advance its COPD drug candidate that is being developed from a China-sourced p…
    Endpoints · 3mo agoDealPositive↗ source
  • Expedition Therapeutics secures $115M Series B to advance China-origin COPD drug
    Expedition Therapeutics, a biotech that licenses drugs from Chinese firms, announced a $115 million Series B financing that will fund mid-stage testing of its experimental COPD candidate. The fund…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • WuXi AppTec posts six-month revenue higher than Lonza for first time
    WuXi AppTec, a Chinese contract manufacturing organization, has reported that its revenue over the most recent six-month period exceeded that of Swiss CDMO Lonza for the first time. The increase c…
    Endpoints · 3mo agoPositive↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 3mo agoEarningsNeutral↗ source
  • AstraZeneca and Bristol Myers Squibb abandon merger talks
    Reuters reported that AstraZeneca and Bristol Myers Squibb have ended discussions about a possible merger and will not pursue a deal. The collapse of the talks removes a potential consolidation th…
    Endpoints · 3mo agoDealNegative↗ source
  • Senate confirms Erica Schwartz as new CDC director
    The U.S. Senate voted 51 to 44 on Wednesday to confirm Erica Schwartz as the next director of the Centers for Disease Control and Prevention. Schwartz, a former deputy surgeon general and a vetera…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Atossa Therapeutics CEO Steven Quay likely to become NIAID director
    Steven Quay, founder and CEO of Atossa Therapeutics, is reported to be the likely choice for director of NIH's National Institute of Allergy and Infectious Diseases. The report notes his backgroun…
    Endpoints · 3mo agoNeutral↗ source
  • Fujifilm Biotechnologies appoints COO Maja Pedersen as new president after Lars Petersen steps down
    Fujifilm Biotechnologies announced that its chief executive officer and president, Lars Petersen, has stepped down effective immediately. The company said the transition will be seamless as the cur…
    Endpoints · 3mo agoNeutral↗ source
  • Alphabet reshuffles AI leadership as DeepMind CEO steps down to become chief scientist
    Alphabet announced a reorganization of its artificial intelligence leadership. Demis Hassabis will leave his role as chief executive of Google DeepMind and take on the position of chief scientist f…
    Endpoints · 3mo agoNeutral↗ source
  • Vertex posts strong Q2 earnings, but upcoming Sionna cystic fibrosis data casts a shadow
    Vertex reported Q2 revenue from its cystic fibrosis portfolio exceeding $3.2 billion, beating estimates and prompting an upward revision of full‑year revenue guidance to $13.1‑$13.2 billion. Analy…
    BioPharma Dive · 3mo agoEarningsNeutral↗ source