fda-and-biotech News

Immix BioPharma Surges 15% on Upsized $100M Offering
FDA & Biotech
2mo ago

Immix BioPharma Surges 15% on Upsized $100M Offering

Strong investor demand, fueled by promising cancer therapy data, allows the biotech to price its offering at a premium, sending shares to a 52-week high.

Structure Therapeutics Poised for Pivotal Oral Obesity Drug Data
FDA & Biotech
2mo ago

Structure Therapeutics Poised for Pivotal Oral Obesity Drug Data

Investors keenly watch Monday's release of Phase 2 results for aleniglipron, a contender in the multi-billion dollar GLP-1 market dominated by injectables.

BeiGene's Sonrotoclax Shows Near-Total Cancer Remission in Leukemia Trial
FDA & Biotech
2mo ago

BeiGene's Sonrotoclax Shows Near-Total Cancer Remission in Leukemia Trial

Experimental BCL2 inhibitor, in combination with Brukinsa, achieves 100% response rate and deep remission in treatment-naive CLL patients at ASH 2025.

Ipsen Pipeline Boosted by Promising AML Data from ImCheck Unit
FDA & Biotech
2mo ago

Ipsen Pipeline Boosted by Promising AML Data from ImCheck Unit

ICT01 drug, from the recently acquired ImCheck Therapeutics, shows durable responses and improved survival signals in hard-to-treat leukemia patients.

Lyell Shares Surge on Impressive Lymphoma Drug Trial Results
FDA & Biotech
2mo ago

Lyell Shares Surge on Impressive Lymphoma Drug Trial Results

Company reports 93% response rate for its Ronde-Cel therapy at the prestigious ASH annual meeting, positioning it as a strong future contender in a competitive cancer market.

Prime Medicine Surges on Landmark Gene Editing Data in NEJM
FDA & Biotech
2mo ago

Prime Medicine Surges on Landmark Gene Editing Data in NEJM

Shares climb as PM359 shows high efficacy in rare disease, yet company seeks partner for the program amid strategic shift to other therapies.

AbbVie Bolsters Oncology Franchise with Strong Epkinly Data
FDA & Biotech
2mo ago

AbbVie Bolsters Oncology Franchise with Strong Epkinly Data

Pivotal Phase 3 results for its blood cancer drug, developed with Genmab, show a 79% reduction in disease progression, solidifying its recent full FDA approval.

Zai Lab Secures Key Drug Renewals on China's Reimbursement List
FDA & Biotech
2mo ago

Zai Lab Secures Key Drug Renewals on China's Reimbursement List

The strategic win provides a long-term catalyst for the biotech firm as its stock trades near a 52-week low following a recent earnings miss.