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Analysts initiate coverage on BillionToOne — banks set bullish price targets
JP Morgan, BTIG and Jefferies initiated analyst coverage on molecular diagnostics firm BillionToOne, assigning a range of ratings and price targets that reflect optimism about the company’s...
Ideaya wins IND clearance — IDE‑034 poised for first‑in‑human solid tumor study
Ideaya Biosciences received FDA IND clearance to begin a Phase I study of IDE‑034, a bispecific antibody‑drug conjugate targeting B7H3/PTK7 coupled to a TOP1 payload, in patients with advanced...
RNAi therapeutic shows functional‑cure promise for chronic hepatitis B
A study published in Nature Communications reports that a novel RNA interference (RNAi) therapeutic produced results consistent with a functional cure for chronic hepatitis B in preclinical and...
Regeneron bets $150M on Tessera’s gene writing: partnership signed
Regeneron struck a $150 million partnership with gene-writing startup Tessera Therapeutics to accelerate Tessera’s platform toward clinical testing. The deal expands Regeneron’s commitment to...
Protego raises $130M to advance oral amyloidosis candidate – pivotal trial planned
Protego Biopharma closed a $130 million financing to support a potential pivotal study of its oral small molecule for light chain (AL) amyloidosis. Investors behind the round include executives...
Generate:Biomedicines launches two Phase 3 trials for TSLP antibody – AI-designed drug advances
Generate:Biomedicines announced it is initiating two Phase 3 studies of its lead TSLP (thymic stromal lymphopoietin) antibody, marking a major clinical inflection for an AI‑driven biotech. The...
Belite wins Phase 3 for Stargardt drug – U.S. filing now in sight
Belite Bio reported a Phase 3 victory for tinlarebant in adolescents with Stargardt disease, meeting the trial’s primary endpoint and clearing a major regulatory hurdle. The result strengthens...
RNAi therapy shows functional‑cure potential for chronic hepatitis B in Nature Communications
Researchers reported a novel RNA interference (RNAi) therapeutic that produced results consistent with a functional cure for chronic hepatitis B (HBV) in preclinical and early clinical evaluation,...
Menin inhibitors advance as targeted therapy for KMT2A‑rearranged leukemia
New data spotlight menin inhibitors as a targeted therapeutic strategy for KMT2A‑rearranged acute leukemias, a genetically defined and aggressive subtype. Researchers and early‑stage developers...
Endpoints Signal launches; BPSI Q4 2025 reads 78 – biopharma mood stays dour
Endpoints News launched Endpoints Signal, an intelligence platform led by Tom Randall, and published the inaugural Biopharma Sentiment Index (BPSI) for Q4 2025. The BPSI scored 78—well below a...
FDA biosimilar plan collides with patent office policy – regulatory friction grows
The FDA proposed guidance to streamline biosimilar approvals—aiming to slash time and cost for copycat biologics—while critics say the U.S. Patent and Trademark Office’s tougher stance on inter...
Quantifying α‑synuclein seeds in CSF—new assay could change Parkinson’s trials
Researchers described an endpoint‑dilution seed amplification assay (SAA) that quantifies α‑synuclein seeds in cerebrospinal fluid with improved precision, enabling measurement of pathological...
TCR therapy and vascular research map barriers in ovarian cancer treatment
Researchers outlined both clinical obstacles for T‑cell receptor (TCR) therapies in ovarian cancer and new insights into VEGF‑driven vascular pathways that fuel tumor growth. The TCR review...
RNAi candidate cuts HBV markers — path to functional cure
Researchers published a Nature Communications study demonstrating an RNA interference (RNAi) therapeutic that substantially reduces hepatitis B virus (HBV) markers and supports the prospect of a...
Menin inhibitors: breakthrough targeted option for KMT2A leukemia
New research and clinical interest are converging on menin inhibitors as a targeted strategy for KMT2A-rearranged acute leukemias. Studies show menin blockade disrupts the leukemogenic program...
Endpoint dilution SAA quantifies α-syn seeds — diagnostic advance
Researchers unveiled an endpoint dilution seed amplification assay (SAA) that quantifies cerebrospinal fluid α-synuclein seeds with improved precision, delivering a more granular biomarker for...
Engineered ACE2 decoy neutralizes multi-variant SARS-CoV-2
A study in the Journal of Biomedical Science reported an engineered ACE2 decoy receptor that neutralizes mutant and escape variants of SARS-CoV-2. The decoy binds spike protein across divergent...
FDA biosimilar push runs into patent-office resistance
The FDA announced plans to streamline biosimilar approval pathways to mimic generic regulation, promising lower development costs and faster market entry. Industry leaders touted potential savings...
mTORC1 in ILC2s: neuro-immune axis drives allergic lung inflammation
A Nature Communications 2025 study identified mTORC1 signaling in group 2 innate lymphoid cells (ILC2s) as a central node linking neuronal cues to allergic lung inflammation. The authors used...
AML survival pathways: THRAP3 and RPPH1 drive therapy resistance
Two mechanistic studies chart distinct molecular drivers that enable acute myeloid leukemia (AML) cells to evade cell death and sustain aggressive disease. One report identifies THRAP3 as a...