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FDA clears Cytokinetics pill Myqorzo — oHCM gains new oral option
The FDA granted marketing clearance to Cytokinetics’ aficamten, branded Myqorzo, for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval, announced Dec. 19 and...
AstraZeneca lands Jacobio's pan‑KRAS in $1.9B pact
AstraZeneca agreed to outlicense ex‑China rights to Jacobio Pharmaceuticals’ clinical‑stage pan‑KRAS inhibitor JAB‑23E73 in a deal worth up to $1.915 billion. Jacobio retains China rights and will...
Ipsen buys Simcere ADC rights — LRRC15 program expands outside China
Ipsen secured global ex‑China rights to Simcere Zaiming’s LRRC15‑targeting antibody‑drug conjugate SIM‑0613, with potential payments up to roughly $1.06 billion. The agreement covers clinical...
CMS proposes two Medicare drug‑pricing demos — mandatory models on the table
The Centers for Medicare & Medicaid Services proposed two mandatory demonstration models intended to lower Medicare drug prices by aligning U.S. payments with international benchmarks and...
Boehringer signs US pact with White House — $10B investment, TrumpRx participation
Boehringer Ingelheim agreed to invest $10 billion in U.S. operations through 2028 and to participate in the TrumpRx.gov direct‑purchase platform under a White House memorandum aimed at lowering...
Aktis files for IPO to fund radiopharma pipeline — big‑pharma backers watch
Aktis Oncology filed for an initial public offering to raise capital for clinical development of its miniprotein radioconjugates, including a Nectin‑4‑targeted lead program in phase 1b. The...
Gilead licenses two HSV candidates from Assembly — $35M upfront grab
Gilead Sciences exercised licensing rights to two helicase‑primase inhibitors for recurrent genital herpes from Assembly Biosciences, paying $35 million up front. Both ABI‑1179 and ABI‑5366 are in...
Guardant360 CDx wins Japanese approval as companion diagnostic for Lilly drug
Japan’s regulatory authorities approved Guardant Health’s Guardant360 CDx as a companion diagnostic to detect ESR1 mutations and guide eligibility for Eli Lilly’s Inluriyo in breast cancer...
MRD testing achieves pivotal readouts and consolidation — Signatera proves clinical value
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
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
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
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
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
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
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
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
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
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
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
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...