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Latest Biotech News

MRD testing achieves pivotal readouts and consolidation — Signatera proves clinical value

December 22, 2025

The minimal residual disease (MRD) testing market registered high‑impact trial readouts and commercial consolidation in 2025, anchored by positive Phase III IMvigor011 results using Natera’s...

CRO M&A cools — 2025 deals skew smaller, strategic

December 22, 2025

Contract research organization M&A activity decelerated in 2025, with transactions focused on geographic expansion and technology capabilities rather than blockbuster consolidations. Thermo...

Windward secures Qyuns bispecific in $700M ex‑China push

December 22, 2025

Swiss biotech Windward Bio has acquired ex‑China rights to Qyuns Therapeutics’ clinical‑stage bispecific WIN027 (QX027N), in a deal with up to $700 million of potential value. The antibody targets...

Ipsen pays up to $1.06B for Simcere LRRC15 ADC

December 22, 2025

Paris‑based Ipsen agreed an exclusive licensing deal for SIM‑0613, a preclinical LRRC15‑targeting antibody‑drug conjugate (ADC) developed by Simcere Zaiming, with potential payments totaling...

Aktis files for Nasdaq IPO — radiopharma trials to get cash

December 22, 2025

Aktis Oncology filed for an initial public offering to fund its miniprotein radiopharmaceutical pipeline, including a Lilly‑partnered program and an ongoing US Phase 1b study targeting Nectin‑4....

Boehringer inks $448M pact with Rectify to pursue oral CKD drugs

December 22, 2025

Boehringer Ingelheim struck a partnership with Boston startup Rectify Pharmaceuticals to develop oral therapies for chronic kidney disease, a deal with up to $448 million in potential biobucks....

AstraZeneca backs Jacobio pan‑KRAS with $100M upfront

December 22, 2025

AstraZeneca agreed to acquire ex‑China rights to Jacobio Pharma’s clinical‑stage pan‑KRAS inhibitor JAB‑23E73, paying $100 million upfront and underwriting further development globally. The UK...

Gilead picks two Assembly HSV candidates for $35M upfront

December 22, 2025

Gilead Sciences licensed two helicase‑primase inhibitors for recurrent genital herpes—ABI‑1179 and ABI‑5366—from Assembly Biosciences for $35 million upfront. Both candidates are in Phase 1b and...

Shionogi agrees $2.5B buy to acquire approved ALS therapy

December 22, 2025

Japanese drugmaker Shionogi announced it will acquire one of the only approved therapies for amyotrophic lateral sclerosis (ALS) for roughly $2.5 billion, expanding the company’s footprint in rare...

MRD testing validated by IMvigor011... Signatera readout spurs CDx push

December 22, 2025

Minimal residual disease (MRD) testing advanced toward clinical utility in 2025 after key randomized readouts and commercial consolidation, most notably the Phase III IMvigor011 trial. IMvigor011...

Guardant360 CDx clears Japan to select patients for Lilly’s Inluriyo

December 22, 2025

Guardant Health’s Guardant360 CDx received Japanese regulatory approval as a companion diagnostic to identify ESR1 mutations and help select patients eligible for Eli Lilly’s Inluriyo. The...

Early‑stage clinics: Enveda starts obesity IND; Dexoligo advances anemia siRNA

December 22, 2025

Enveda Therapeutics received FDA IND clearance and began dosing a Phase I study of ENV‑308, a once‑daily oral small molecule designed for chronic weight management. The start marks Enveda’s...

Axonal translation switch: eIF5A hypusination eases FUS‑ALS

December 22, 2025

Researchers report that hypusination of the translation factor eIF5A regulates local protein synthesis in axons and mitigates pathology in models of FUS‑linked amyotrophic lateral sclerosis (ALS),...

Ipsen doubles down on ADCs: $1.06B LRRC15 deal with Simcere

December 22, 2025

Ipsen signed an ex‑China agreement to access SIM0613, an LRRC15‑targeting antibody‑drug conjugate (ADC) from Shanghai’s Simcere, in a deal that could be worth as much as $1.06 billion, the company...

Aktis heads for market: IPO to bankroll Lilly‑partnered radiopharma trials

December 22, 2025

Aktis Oncology filed for an initial public offering to finance clinical development of its miniprotein radioconjugates, the company disclosed in regulatory filings and media reports. The...

AstraZeneca bets and stumbles: $100M pan‑KRAS buy amid phase‑3 lung failure

December 22, 2025

AstraZeneca paid $100 million upfront to secure ex‑China rights to Jacobio Pharma’s clinical‑stage pan‑KRAS inhibitor JAB‑23E73, expanding its oncology footprint, company releases show....

Boehringer inks $448M pact with Rectify to develop oral CKD drugs

December 22, 2025

Boehringer Ingelheim agreed to collaborate with Boston startup Rectify to develop oral therapies for chronic kidney disease in a deal worth up to $448 million in biobucks. The partnership names...

Windward buys Qyuns bispecific: up to $700M for dual TSLP–IL‑13 program

December 22, 2025

Windward Bio agreed to acquire ex‑China rights to Qyuns Therapeutics’ WIN027 (QX027N), a long‑acting bispecific targeting TSLP and IL‑13, in a deal with headline value up to $700 million....

FDA clears Cytokinetics’ Myqorzo – first approval and a direct rival to Camzyos

December 22, 2025

The Food and Drug Administration approved Cytokinetics’ Myqorzo, marking the company’s first approved drug and setting up a direct commercial competitor to Bristol Myers Squibb’s Camzyos....

Antisense rescue: therapy reverses developmental defects in SMA organoids

December 22, 2025

A Nature Communications study shows that targeted antisense oligonucleotide (ASO) therapy reverses developmental defects in spinal muscular atrophy (SMA) organoid models. Investigators reported...