There have been no signs of liver damage with Novartis AG’s oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib for treating chronic spontaneous urticaria, top-line results from two phase III trials show, suggesting that faith in the faltering BTK space could be restored.
When Nektar Therapeutics Inc. decided to push ahead with development of Treg stimulator rezpegaldesleukin (rezpeg) in atopic dermatitis despite what appeared to be middling early stage data, investors weren’t exactly jumping up and down. But it turns out those data are more promising than originally thought.
Two biopharma companies entered the public markets on July 14, with Apogee Therapeutics Inc. pricing a $300 million IPO, the second largest U.S. debut this year, and Sagimet Biosciences Inc. raising $85 million. Apogee, of San Francisco, and Waltham, Mass., is advancing APG-777 and APG-808, which are in development for atopic dermatitis (AD) and chronic obstructive pulmonary disease, while San Mateo, Calif.-based Sagimet’s lead candidate is the FASN inhibitor denifanstat for nonalcoholic steatohepatitis.
Less than a week after Eli Lilly and Co.’s $2.4 billion, IL-17-based buyout of Dice Therapeutics Inc., Moonlake Immunotherapeutics Inc. offered more news in the space by way of data from the global phase II trial called Mira evaluating the efficacy and safety of the Nanobody sonelokimab in moderate to severe hidradenitis suppurativa (HS).
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
Aslan Pharmaceuticals Pte Ltd. said it inked a licensing deal with Zenyaku Kogyo Co. Ltd. for its atopic dermatitis-targeting monoclonal antibody, eblasakimab, that could reach $138.5 million in up-front and milestone payments.
Cutia Therapeutics Ltd. raised HK$465 million (US$65 million) in a Hong Kong IPO on June 12, with almost half of the proceeds going toward furthering its lead product to treat adipose accumulation. Cutia’s shares moved a little higher on the first day of trading, opening at HK$21.80, rising 0.46% and closing at HK$21.95.
Promising early data continue to roll out for Intellia Therapeutics Inc.’s hereditary angioedema (HAE) candidate, NTLA-2002, with one of the earliest treated patients in the phase I study remaining attack-free for more than a year. But it was the systemic CRISPR candidate’s potential as a one-time treatment that generated the most discussion on the company’s call as investors tried to assess its potential advantage in a crowded HAE market.
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
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