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2,359 stories matching this filter · ← front page

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  • Draig Therapeutics raises $65 million Series B to push depression drug targeting synapse repair
    Draig Therapeutics announced it has closed a $65 million Series B financing round that was oversubscribed. The capital will be used to advance its neuropsychiatry pipeline, with the lead program f…
    Endpoints · 3mo agoDealPositive↗ source
  • Lyora Therapeutics launches to revive early-stage genetic eye disease programs from Editas and Biogen
    Lyora Therapeutics announced its formation as a new genetic‑medicine company focused on eye diseases. The firm will take over several early‑stage programs that were previously in the pipelines of E…
    Endpoints · 3mo agoPositive↗ source
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  • Former Akero executives launch Avere Therapeutics, unveiling China-sourced pipeline drug and reverse merger plan
    The former leadership team of Akero Therapeutics announced the creation of a new in‑licensing company called Avere Therapeutics. The launch was made public on Tuesday and includes a pipeline drug…
    Endpoints · 3mo agoDealNeutral↗ source
  • Agenus redirects late-stage colorectal trial to pre-surgery setting, shares double; Oxford Ebola vaccine enters Phase 1
    Agenus announced it will stop financially supporting its late-stage trial of the BOT+BAL immunotherapy combination in late-line colorectal cancer. The company will instead use recent $340 million…
    BioPharma Dive · 4mo agoNeutral↗ source
  • FDA issues final guidance for psychedelic drug developers and announces public hearing
    The FDA has completed a set of clinical guidance documents aimed at companies developing psychedelic medicines. The guidance outlines expectations for trial design, safety monitoring, and data col…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Freenome's updated blood test shows stronger detection of precancerous lesions, boosting Abbott's market prospects
    Freenome announced that its revised SimpleScreen CRC blood test met both primary and secondary goals in a pivotal validation study. The new data indicate better performance than the earlier version…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Q32 Bio’s alopecia drug bempikibart meets Phase 2 goal, driving shares up 80%
    Q32 Bio reported that its experimental alopecia areata therapy, bempikibart, achieved the primary endpoint in the second part of a Phase 2 trial. Two‑fifths of participants grew enough hair to cove…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Digital health funding jumps to $7.4 billion in first half of 2026
    Digital health startups secured $7.4 billion in venture capital during the first six months of 2026, according to research firm Rock Health. This represents a $1 billion increase compared with the…
    Endpoints · 4mo agoDealPositive↗ source
  • Biopharma M&A Surge Sets Tone for 2026 Earnings Season
    The biopharma sector is entering the second half of 2026 after a year marked by unusually high merger and acquisition activity. Companies have been busy negotiating and closing deals, signaling con…
    Endpoints · 4mo agoDealNeutral↗ source
  • FDA issues complete response letter rejecting Tris Pharma’s narcolepsy candidate; Agenus halts Phase 3 colorectal cancer trial
    The U.S. Food and Drug Administration sent Tris Pharma a complete response letter for its experimental treatment for narcolepsy, stating that additional data are required before approval can be con…
    Endpoints · 4mo agoCRLNegative↗ source
  • Biotech venture funding hits $9.1 billion in H1 2026, but small startups lag behind
    Venture capital funding for biotech startups surged in the first half of 2026, with nearly 70 companies securing more than $9.1 billion, according to BioPharma Dive data. The bulk of the money cam…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • FDA proposes new rule to streamline registration of drug manufacturers' factories
    The FDA announced a proposed rule aimed at changing how factories that produce drugs for the U.S. market are registered with the agency. The change is intended to simplify the registration process…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Cayman court orders Apple Tree Partners to lose control of its venture fund
    A Cayman Islands court ruled that Apple Tree Partners' general partner must give up control of its venture fund. The decision follows a dispute with the fund's main limited partner, and the judge…
    Endpoints · 3mo agoNeutral↗ source
  • Weekly roundup highlights Biohaven’s challenge to Eli Lilly and industry competition with China
    The latest Endpoints Weekly issue focuses on a series of recent deals across the biotech sector, offering readers a snapshot of market activity. Among the items highlighted is Biohaven’s strategic…
    Endpoints · 4mo agoDealNeutral↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 4mo agoNeutral↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time over manufacturing issues
    FDA has again turned down a liver cancer drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics. This is the third rejection in roughly two years, with the agency citing per…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • US biotech firms grow more secretive amid rising competition from Chinese industry
    US biotech companies are becoming more secretive as competition from China’s rapidly expanding biotech sector intensifies. Janine Sengstack, a senior scientist at Junevity, says her team may have…
    Endpoints · 4mo agoNegative↗ source
  • German parliament approves cost-cutting health bill, pharma industry warns of exit risk
    German federal parliament voted to pass a bill aimed at reducing domestic healthcare expenditures. The legislation seeks to curb spending on medicines and other health services as part of a broade…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Hansoh reports Phase 3 success for GSK‑partnered ADC in SCLC as FDA clears Sanofi on‑body injector
    Hansoh announced that its Phase 3 trial of the antibody‑drug conjugate Ris‑Rez met the primary endpoint in patients with small cell lung cancer. The study was conducted in partnership with GSK and…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 4mo agoRegulatoryPositive↗ source
  • Apnimed announces IPO plans while FDA reviews its sleep-apnea therapy
    Apnimed, a Cambridge, Massachusetts biotech, disclosed that it will pursue an initial public offering on Nasdaq. The move comes as the company’s lead sleep‑apnea candidate is under review by the U…
    Endpoints · 4mo agoDealPositive↗ source
  • FDA resumes publishing pharma rejection letters, posting 14 new CRLs
    The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website. This marks a return to the agency’s regular practice of mak…
    Endpoints · 4mo agoCRLNeutral↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Pfizer promotes Danna Breen to lead obesity discovery, succeeding Kendra Bence
    Pfizer announced that Danna Breen has been promoted to head of its obesity discovery program, according to a LinkedIn post. Breen takes over from Kendra Bence and brings nearly 14 years of experie…
    Endpoints · 4mo agoNeutral↗ source
  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 4mo agoNeutral↗ source