Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
Implications for Amgen Inc.’s same-class Tepezza (teprotumumab) of positive phase III data from Viridian Therapeutics Inc. with veligrotug in thyroid eye disease became a topic of talk on Wall Street talk. “I’m not drawing any clinical trial comparisons, you’ll have to reach your own conclusions,” CEO Steve Mahoney said during a conference call on the results.
About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.
The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).
Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp.
Wall Street promptly started speculating about the product’s odds in the graft-vs.-host disease (GVHD) marketplace shortly after Syndax Pharmaceuticals Inc. and Incyte Corp. scored U.S. FDA approval – well ahead of the Aug. 29 PDUFA date – of Niktimvo (axatilimab), an anti-CSF-1R antibody for the treatment of chronic disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
Seoul, South Korea-based Adel Inc. raised ₩17 billion (US$12.39 million) in bridge financing to advance its pipeline of Alzheimer’s disease therapies, including its tau antibody-based ADEL-Y01 candidate, currently in a U.S.-based phase I study.
Radiopharm Theranostics Ltd. said it plans to list on Nasdaq by the end of 2024. The company had earlier announced plans to list in February 2023, but it delayed the listing due to market conditions.
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