The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis that was submitted by New Jersey, USA-based Insmed. 6 February 2025
Shares in US retinal diseases specialist EyePoint Pharmaceuticals recovered from an early nosedive to close trading marginally higher on Wednesday. 6 February 2025
Kura Oncology and Japan’s Kyowa Kirin have announced that their menin inhibitor ziftomenib met the primary endpoint in a Phase II trial for relapsed or refractory acute myeloid leukemia (AML) 6 February 2025
US clinical-stage biotech Qlaris Bio has announced positive top-line results from two U.S. Phase II clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). 6 February 2025
The New England Journal of Medicine has published results from the Phase II eNRGy trial for Bizengri (zenocutuzumab), a novel cancer med from Merus. 6 February 2025
Affinia Therapeutics, a US biotech with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for cardiovascular and neurological diseases, has announced the appointment of Hideo Makimura as its chief medical officer (CMO). 5 February 2025
In Düsseldorf, Algiax Pharmaceuticals is working on a novel analgesic which could provide an effective alternative to opioids, according to new mid-stage data. 5 February 2025
San Diego, USA-based Turnstone Biologics yesterday announced that it has completed an assessment of its business and operations, including the status of its program, resources, and capabilities. 5 February 2025
Spanish plasma-derived medicines specialist Grifols revealed it is collaborating with Dutch biotechnology start-up, FcR Therapeutics, to develop recombinant nanobodies to treat autoimmune diseases. 5 February 2025
AdvanCell announced the successful completion of an oversubscribed $112 million (US) Series C financing, making it the only Australian radiopharma company that has cash to burn. 4 February 2025
German biotech Akribion Therapeutics has emerged from stealth with 8 million euros ($9 million) in seed funding to accelerate the development of its novel RNA-guided precision medicines. 4 February 2025
Sionna Therapeutics hopes to raise $150 million and secure a market capitalization of about $692 million in an initial public offering (IPO). 4 February 2025
French drugmaker Mitem Pharma, which is dedicated to drugs of major therapeutic interest (DMTI), today revealed that has acquired the rights to Flisint (fumagillin) from pharma major Sanofi. 4 February 2025
California-based ImmunityBio has entered into a collaboration and supply agreement with Sino-American biotech BeiGene (to be changed to BeOne Medicines) combining the latter’s lead product Tevimbra (tislelizumab), a PD-1 checkpoint inhibitor (CPI), and ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln). 3 February 2025
UK contract research organization hVIVO is gearing up to test an inhaled antiviral candidate, IN-002, for respiratory syncytial virus (RSV) in a Phase IIa human challenge trial. 3 February 2025
Blackstone, the world’s largest alternative asset manager, is expanding its presence in the life sciences sector with a new multibillion-dollar fund dedicated to drug development. 31 January 2025
Clinical-stage USA-based drug developer Inhibikase Therapeutics saw its shares tumble more than 31% to $1.92, after is revealed that it is pausing development of risvodetinib following disappointing results from a Phase II trial of patients with untreated Parkinson's disease. 31 January 2025
CNS-focused biopharma Axsome Therapeutics has won US Food and Drug Administration (FDA) approval for Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. 31 January 2025
CNS-focused biopharma Axsome Therapeutics has won US Food and Drug Administration (FDA) approval for Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. 31 January 2025
US clinical-stage biotech CARGO Therapeutics’ shares plummeted more than 75% to $3.23 yesterday, after it announced that it has elected to discontinue FIRCE-1, a Phase II clinical study of firicabtagene autoleucel (firi-cel). 31 January 2025
A damaging trial failure in December wiped 70% off the share price of BioAge Labs, a US biopharma developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. 29 January 2025
Leap Therapeutics is discontinuing the development of its anti-DKK1 antibody sirexatamab in gastric cancer after the drug failed to improve survival in a Phase II trial. 29 January 2025
Biopharma start-up Helicore Biopharma has emerged from stealth, with $65 million from a series A round co-led by Versant Ventures and OrbiMed. 29 January 2025
Swedish immuno-oncology firm Alligator Bioscience today announced that clinical data for its 4-1BB agonist, ATOR-1017 (evunzekibart), has been published in the Journal for ImmunoTherapy of Cancer (JITC). 29 January 2025
Boston, USA-based RNA focused biotech Atalanta Therapeutics today announced the completion of a $97 million Series B financing to support Phase I clinical trials of the company’s investigational RNAi therapies for KCNT1-related epilepsy and Huntington’s disease. 28 January 2025
US clinical-stage liver disease focused biotech Akero Therapeutics saw its shares almost double to $51.71 yesterday, after it released positive preliminary top-line week 96 results from SYMMETRY. 28 January 2025
Boston, USA-based biotech Averna Therapeutics (formerly known as Exsilio Therapeutics), revealed yesterday that it has appointed Thomas Barnes as its chief executive (CEO) and director. 28 January 2025
California, USA-based biotech Allakos saw its shares plummet 78.8% to $0.26 yesterday, after it announced disappointing top-line results from its Phase I clinical trial of AK006 in chronic spontaneous urticaria (CSU). 28 January 2025
Obesity-focused Aardvark Therapeutics is hoping to raise $100 million in an initial public offering (IPO), according to a US Securities and Exchange Commission (SEC) filing. 27 January 2025
Shares of Florida-USA-based drug developer Veru plummeted more than 52% to $0.57 in pre-market activity today, despite the company releasing positive top-line results from the Phase IIb QUALITY clinical study. 27 January 2025
Swarm Oncology, a biotech developing novel T cell therapies to achieve long-term remission in patients with advanced solid cancers, has emerged from stealth mode and announced the appointment of Martin Olin as chief executive. 27 January 2025
Privately-held Swiss biotech AB2 Bio has entered into an option and licensing agreement with Japan’s Nippon Shinyak, which it describes as having extensive experience in marketing rare disease therapeutics in the USA. 27 January 2025
US clinical-stage immuno-oncology biotech ALX Oncology Holdings
released positive updated data from the ASPEN-06 Phase II clinical trial demonstrating that its investigational CD47-blocker evorpacept generates a durable clinical response. 25 January 2025
New Jerseyan biopharmaceutical company Tris Pharma has announced encouraging top-line data from its Phase III ALLEVIATE-1 trial testing cebranopadol as an option for acute pain. 24 January 2025
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for elamipretide, a first-in-class mitochondria-targeted therapeutic in development for individuals with Barth syndrome. 24 January 2025