Dutch gene therapy company uniQure and University of Massachusetts Medical School (UMMS) spin-out Apic Bio have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. 31 January 2023
A rosy future is predicted for Sino-American biotech BeiGene oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib), which recently gained US Food and Drug Administration (FDA) approval for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 31 January 2023
Oxford University spin-out Vaccitech (Nasdaq: VACC today announced the appointment of Nadège Pelletier as chief scientific officer (CSO), to replace Tom Evans, who is retiring but will remain involved as a scientific consultant to the company. 30 January 2023
Privately-held Italian drugmaker Chiesi Farmaceutici today announced the appointment of Giuseppe Accogli as company’ new chief executive (CEO). 30 January 2023
The US Food and Drug Administration (FDA) on Friday announced the approval of the investigational oral selective estrogen receptor degrader (SERD) Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 28 January 2023
US traded shares of AC Immune were up more than 9% at $2.56 in pre-market activity today, as the Swiss biotech said its ACI-24.060 anti-amyloid beta (Abeta) vaccine for Alzheimer's disease (AD) showed positive initial interim safety and immunogenicity in a Phase Ib/II trial dubbed ABATE. 26 January 2023
As global macroeconomic uncertainty hit fundraising across all sectors, investment in UK biotechnology fell from the all-time highs seen in 2021, a new analysis from the industry lobby group UK BioIndustry Association (BIA) and data and insights company Clarivate shows. 26 January 2023
Shares of US retinal eye disorder specialist Ocuphire Pharma slumped more than 29% to $2.66, after it released disappointing top-line efficacy and safety results from its ZETA-1 Phase II trial evaluating oral APX3330 for the treatment of diabetic retinopathy (DR). 26 January 2023
In the second setback in the space of a little over a month, Magenta Therapeutics saw its shares crash 23.3% to $0.38 pre-market today, after the US biotech revealed that the latest participant dosed at the Cohort 3 level (0.08mg/kg) in the ongoing MGTA-117 Phase I/II dose-escalation clinical trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 serious adverse event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117. 26 January 2023
KSQ Therapeutics, a privately-held US biotech developing therapies to treat cancer and autoimmune diseases using its CRISPRomics platform, has announced a deal with Ono Pharmaceutical. 25 January 2023
The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee has voted favorably, by 14 to 1, that Cidara Therapeutics, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin. 25 January 2023
Deciphera Pharmaceuticals’ shares rose 4.4% to $18.85 in after-hours trading yesterday, when the US biopharma company presented additional data from the planned exploratory analysis from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) using circulating tumor DNA (ctDNA) from patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib. 25 January 2023
Boston, USA-based biotech Blueprint Medicines Corporation has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental new drug application (sNDA) for Ayvakit (avapritinib) to treat indolent systemic mastocytosis (SM). 24 January 2023
French therapeutic peptides for rare endocrine and metabolic diseases company Amolyt Pharma today announced it has entered into a research agreement and licensing option with XOMA Corp. 24 January 2023
Pliant Therapeutics, a Californian biopharma focused on discovering and developing fibrosis drugs, closed up by more than a third on Monday. 24 January 2023
Shares of US clinical-stage biotech Axcella Therapeutics were up nearly 70% at $0.72 pre-market this morning, after it announced a regulatory path to registration of AXA1125 in the treatment of long COVID fatigue. 24 January 2023
Israel-based computational disease modelling company CytoReason and French pharma major Sanofi have announced an expansion of their collaboration. 23 January 2023
Japan’s largest drugmaker Takeda has entered into an exclusive licensing agreement with Chinese biotech Hutched for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau. 23 January 2023
A French biotech company claiming to have the first drug that treats the root cause of type 2 diabetes has completed a Series A funding round. 23 January 2023
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
Privately-held Xcovery Holdings, an oncology-focused pharma company, has announced that the US Food and Drug Administration (FDA) has approved Ensacove (ensartinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 19 December 2024
Safi Biotherapeutics, a specialist in stem-cell derived red blood cell products, has received Rare Pediatric Disease designation and Orphan Drug designation from the US regulator. 19 December 2024
BioAge Labs today announced a multi-year research collaboration with Swiss pharma giant Novartis, with the news pushing the US biotech’s shares up 6.1% to $4.35 by early afternoon. 18 December 2024
Marking its second deal this month alone, Novo Nordisk has entered into a multi-year collaboration with Massachusetts, USA-based Photys Therapeutics to develop novel proximity-based therapeutics for a cardiometabolic disease target. 18 December 2024
Cara Therapeutics and Tvardi Therapeutics have announced a definitive agreement to merge, creating a new entity under the Tvardi name. 18 December 2024
SiteOne Therapeutics has announced the completion of a $100 million series C financing, led by Novo Holdings, with participation from OrbiMed, Wellington Management, Mission BioCapital, and others. 18 December 2024
Flagship Pioneering-founded genome engineering biotech Tessera Therapeutics today announced an investment of up to $50 million from the Bill & Melinda Gates Foundation to develop curative, globally accessible in vivo genetic therapies for sickle cell disease. 18 December 2024
San Francisco-based Indapta Therapeutics, a privately held start-up developing next-generation cell therapies, has raised $22.5 million in a new financing round. The firm raised over $50 million in series A funding in 2022. 18 December 2024
French CNS specialist Theranexus saw its shares leap more than 34% to 0.65 euros as it revealed a license and supply agreement with Exeltis to commercialize TX01, its novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases. 18 December 2024
US antivirals giant Gilead Sciences today revealed it has entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets with Californian biotech Terray Therapeutics. 17 December 2024
Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
In a filing with the US financial regulator, German mRNA specialist BioNTech has noted the lifting of a partial clinical hold on its PRESERVE-003 trial. 16 December 2024
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
US biotech Corcept Therapeutics has reported positive results from the Phase IV CATALYST study of Korlym (mifepristone) in people with hypercortisolism and difficult-to-control type 2 diabetes. 13 December 2024