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
Nine months out from landing an additional $35 million in seed funding, Relation has more news – a big pharma collaboration. The group has announced a $45 million upfront deal, including a $15 million equity investment with UK pharma group GSK. 13 December 2024
US biopharma CymaBay Therapeutics traded up as much as 21% to $16.73 yesterday, as the company released encouraging trial results for its primary biliary cholangitis (PBC) candidate after earlier disappointments. 8 September 2023
US clinical-stage biopharma Nurix Therapeutics saw its shares rise almost 11% to $9.19 yesterday morning, after it announced a multi-year, multi-target strategic collaboration agreement with Seagen. 8 September 2023
UK cancer and infectious disease drug developer Scancell Holdings has appointed Dr Mandeep Sehmi as head of business development, effective immediately. 8 September 2023
Acquisitive US biotech Kriya Therapeutics yesterday revealed that it has acquired Tramontane Therapeutics, a private gene therapy company focused on developing treatments for metabolic and neurodegenerative diseases. 7 September 2023
US biotech Star Therapeutics has announced the closing of an oversubscribed $90 million Series C financing to continue growing its antibody therapies and portfolio companies. 5 September 2023
Italy’s privately-held drug developer Italfarmaco Group today revealed that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency. 5 September 2023
Dutch specialty pharma firm Pleco Therapeutics has appointed Dr Henno Welgemoed in the newly created role of chief medical officer (CMO). 5 September 2023
Shares of Swedish enzyme technology firm Hansa Biopharma were up 3% at 43.82 kronor, after it announced the appointment of Dr Hitto Kaufmann as its chief scientific officer (CSO) effective December 1, 2023. 1 September 2023
Reeling from a regulatory setback last month, Sage Therapeutics is to undergo a major restructuring in the run-up to its launch of postpartum depression drug Zurzuvae (zuranolone). 1 September 2023
Ireland-headquartered Ovoca Bio saw its shares plunge 82% to 2.50 pence yesterday, after it revealed disappointing results from a Phase II dose ranging study assessing orenetide conducted in Australia and New Zealand. 1 September 2023
US synthetic DNA producer Twist Bioscience today announced a drug discovery agreement with Japan’s Ono Pharmaceutical to discover and develop novel antibodies for the treatment of autoimmune diseases. 31 August 2023
Privately-held Danish company MC2 Therapeutics today announced an agreement under which a Huadong Medicine unit has been granted exclusive rights in Greater China to develop and commercialize MC2’s drug, Wynzora Cream for the treatment of plaque psoriasis. 31 August 2023
US ophthalmology focused biotech Outlook Therapeutics saw its shares closed down more than 80% at $0.27 yesterday, after it revealed that the US Food and Drug Administration (FDA) has issued a CRL to the company’s biologic license application (BLA) for ONS-5010. 31 August 2023
US biotech BioMarin Pharmaceutical late yesterday announced that an individual in Germany with severe hemophilia A was treated with Roctavian (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has been given commercially in Europe. 31 August 2023
US biopharma Apellis has announced a company restructuring in a bid to focus on making Syfovre (pegcetacoplan injection) a leading treatment for geographic atrophy (GA). 30 August 2023
Shares of US biotech FibroGen were down 22% at $0.995 pre-market today, after it announced top-line data from the Phase III LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. 30 August 2023
Privately-held Dutch immune-mediated inflammatory diseases company Citryll is the latest stop for experienced biotech chief executive Eduardo Bravo. 29 August 2023
A new discovery and development collaboration has been agreed between Boston, USA-based Verastem Oncology and Shanghai's GenFleet Therapeutics. 29 August 2023