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Significant research news last week included a setback for Pliant Therapeutics, when it paused a Phase IIb trial of its bexotegrast in idiopathic pulmonary fibrosis (IPP). Also, US biotech AnaptysBio released positive new Phase II data on its rosnilimab in rheumatoid arthritis that attracted attention. On the regulatory front, US drug developer BridgeBio Pharma last week gained European Commission (EC) approval for its Beyonttra (acoramidis) for cardiomyopathy (ARRR-CM). The EC also granted approval for Kostaive, an mRNA COVID-19 vaccine developed by US firm Arcturus Therapeutics and licensed to CSL Limited for European marketing. 16 February 2025
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A biotechnology company focused on developing novel antibody therapies targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) as well as novel stem cell transplant conditioning regimes.
Latest News & Features of interest to CSL Limited.
Biotechnology
Initial results from the ALXN1210-TMA-314 Phase III trial showed that UK pharma major AstraZeneca’s Ultomiris (ravulizumab) demonstrated clinically-meaningful overall survival at 26 weeks in pediatric patients (aged 28 days to <18 years of age) with thrombotic microangiopathy (TMA) after hematopoietic stem cell transplantation (HSCT). 16 June 2025
Biotechnology
Notable research news last week included US biopharma Avidity Biosciences announcing a positive update on its muscular dystrophy candidate delpacibart braxlosiran (del-brax), and Dutch firm NewAmsterdam released new Phase III on its investigational Alzheimer’s drug obicetrapib. US Health Secretary Robert F Kennedy Jr announced he has dismissed an independent panel of vaccine experts in order to restore trust in vaccines. Also of note, Merck & Co gained US food and Drug Administration (FDA) for its Enflonsia for the prevention of respiratory syncytial virus (RSV). 15 June 2025
Pharmaceutical
The International Finance Facility for Immunization (IFFIm) has announced the settlement of its £300 million ($407 million), three-year 4.25% fixed-rate bond that was announced on June 3. 14 June 2025
Pharmaceutical
Germany’s Merck KGaA has presented detailed results from cohort B of the global Phase II WILLOW study of enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Pharmaceutical
UK pharma major GSK today revealed that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India’s Bharat Biotech International (BBIL). 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Pharmaceutical
Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal hemoglobinuria (PNH) market and adding momentum to the oral drug’s expanding presence across rare blood and kidney disorders. 13 June 2025
Biotechnology
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Pharmaceutical
Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced new data from the pivotal AUGMENT-101 trial of Revuforj (revumenib), the company’s first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML). 12 June 2025
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Biotechnology
The US Food and Drug Administration (FDA) announced a forthcoming public advisory committee meeting (AdCom) of the Oncologic Drugs Advisory Committee to review GSK’s marketing application for Blenrep (belantamab mafodotin. 16 June 2025
Latest Relevant Ones To Watch News
US pharma major Eli Lilly (today announced a definitive agreement to acquire Verve Therapeutics, a Boston-based clinical-stage company developing genetic medicines for cardiovascular disease, sending Verve’s shares up 77.7% to $11.15 in premarket trading. 17 June 2025
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