China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
Roivant Sciences Ltd. has sold another company, this time offering up Dermavant Sciences Ltd. to Organon & Co. for $1.2 billion. The deal brings Organon into a crowded market for plaque psoriasis treatments. The massive amount comprises an up-front $175 million payment, along with a potential $75 million regulatory milestone and up to $950 million in commercial milestones. In the deal, Organon brings in Vtama (tapinarof) cream, a topical, aryl hydrocarbon receptor agonist for mild, moderate and severe plaque psoriasis in adults.
Another failure with allosteric tyrosine kinase 2 (TYK2) inhibitor VTX-958 put an end to internal work with the compound, and shares of Ventyx Biosciences Inc. (NASDAQ:VTYX) fell July 29 to $2.24, down 71 cents or 24%, after the firm disclosed results from the phase II, 109-subject trial in moderately to severely active Crohn’s disease (CD).
Scinai Immunotherapeutics Ltd. has reported successful in vivo preclinical study results for its anti-IL-17A/F VHH antibody fragment (NanoAb) as a local intralesional biological treatment for mild to moderate plaque psoriasis. The NanoAb targets the two isoforms of the cytokine IL-17 (A and F) implicated in plaque psoriasis.
Alumis Inc. began trading (NASDAQ:ALMS) earlier this morning, with the company’s IPO debuting at $16 per share to raise $210 million, with another $40 million coming through a concurrent private placement at the same price. That was the lower end of its previously announced price range, which had stretched as high as $18 per share.
Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis.
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
Scinai Immunotherapeutics Ltd. has released promising preclinical results of its innovative anti‑IL‑17 VHH antibody (NanoAb) as a local treatment for mild to moderate plaque psoriasis.
Having rolled out less-than-stellar phase II data with oral TYK2 inhibitor VTX-958 in moderate to severe plaque psoriasis, Ventyx Biosciences Inc. faces Wall Street speculation regarding the odds for the ongoing effort in Crohn’s disease (CD), due for an interim analysis in the first quarter of next year.
