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592 stories matching this filter · ← front page

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  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 23h agoDealPositive↗ source
  • Tyra Biosciences reports phase 2 bladder cancer data, complete response rates miss analyst targets, shares slide
    Tyra Biosciences disclosed early phase 2 results for its FGFR3‑selective inhibitor dabogratinib in patients with low‑grade, intermediate‑risk non‑muscle‑invasive bladder cancer. The trial evaluate…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
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  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 14h agoNegative readoutNegative↗ source
  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 18h agoDealPositive↗ source
  • TwoStep Therapeutics raises $62.5 million Series A backed by Pfizer and Merck KGaA venture groups
    TwoStep Therapeutics, a cancer biotech, announced a $62.5 million Series A financing to advance its novel approach to antibody-drug conjugates and radioligand therapies. The round was supported by…
    Endpoints · 23h agoDealPositive↗ source
  • Kura Oncology spins out diabetes program into new company with $50M funding and Lilly support
    Kura Oncology, known for its leukemia menin inhibitor Komzifti, announced it is separating its diabetes research into a newly formed company. The new entity will receive $50 million in financing,…
    Endpoints · 23h agoDealPositive↗ source
  • Tyra Biosciences reports Phase 2 success in low-risk bladder cancer, plans pivotal trial
    Tyra Biosciences announced that its experimental therapy for low‑risk bladder cancer has produced encouraging results in a Phase 2 study. The company said the data, released on Wednesday, represen…
    Endpoints · 23h agoPositive readoutPositive↗ source
  • Kura Oncology launches Caspian Therapeutics with $50M funding to develop next-generation diabetes drug
    Kura Oncology has created a new biotech called Caspian Therapeutics and secured $50 million in financing to advance a next-generation diabetes treatment. The spinout will focus on KO-7246, a highl…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Solstice Oncology raises $225M Series A to push next-gen CTLA-4 antibody into Phase 2 colon cancer trial
    Solstice Oncology announced a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners and Forbion. The capital will fund the Phase 2 study of its Fc-e…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • Amgen reports positive lung cancer trial results for Imdelltra combined with checkpoint inhibitor
    Amgen announced that its T-cell engager candidate Imdelltra, when used together with a checkpoint inhibitor, showed a clinical benefit in patients with advanced lung cancer. The trial data indicat…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA finalizes Krazati withdrawal while Wegovy trial shows positive results in children 6-12
    Regulators have officially completed the withdrawal of Krazati, a drug that was being developed for second-line treatment of colorectal cancer. The FDA’s final action ends the product’s availabilit…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 1d agoDealPositive↗ source
  • BMS CAR-T therapy arlo-cel meets primary endpoint in pivotal multiple myeloma trial
    Bristol Myers Squibb reported that its GPRC5D-directed CAR-T cell therapy, arlo-cel, achieved the primary endpoint in the pivotal Quintessential trial for multiple myeloma. The study enrolled pati…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Inhibrx reports promising mid-stage data for OX40 agonist and plans vaccine combos early next year
    Inhibrx Biosciences announced that its OX40 agonist showed encouraging activity in a mid-stage trial involving immunogenic cancers. The data suggest the agent may also enhance responses when paire…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • BrainChild Bio raises $116 million to fund pivotal pediatric brain tumor CAR-T trial
    BrainChild Bio, a Seattle-based biotech, announced it has secured $116 million in financing to support a pivotal clinical trial of its CAR-T therapy aimed at pediatric brain tumors. The funding ro…
    Endpoints · 1d agoDealPositive↗ source
  • Inhibrx reports 9.6-month median PFS for OX40 agonist combo in phase 2 head-neck cancer trial
    Inhibrx Biosciences presented updated data from its phase‑2 HexAgon study of the hexavalent OX40 agonist INBRX‑106 combined with Merck’s Keytruda in patients with untreated metastatic or unresectab…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
    FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients. The approval was issued on Friday even th…
    Endpoints · 2d agoApprovalPositive↗ source
  • Guardant Health receives FDA clearance for Guardant360 CDx to guide AstraZeneca's Etcamah in breast cancer
    Guardant Health announced that the FDA has cleared its Guardant360 CDx test, which is designed to identify patients who may benefit from AstraZeneca's newly approved breast cancer therapy Etcamah.…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 2d agoNeutral↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 5d agoApprovalPositive↗ source