The data package for Filsuvez (birch triterpenes), a topical gel aimed at treating partial thickness wounds, satisfied U.S. reviewers the second time around. Chiesi Group said the FDA approved the treatment Dec. 19 for use in patients 6 months and older with rare blistering skin diseases junctional epidermolysis bullosa and dystrophic epidermolysis bullosa.
Pharvaris NV’s phase II top-line data from the Chapter-1 trial testing oral bradykinin B2 receptor antagonist deucrictibant in hereditary angioedema (HAE) wowed Wall Street and sparked speculation regarding where the drug might fit in the increasingly competitive landscape.
Connect Biopharma Holdings Ltd. has been seeking a partner for its atopic dermatitis candidate rademikibart, and it appears to have found the perfect partner in Simcere Pharmaceutical Group, which gains exclusive rights to develop, manufacture and commercialize rademikibart in China in a deal worth $120 million plus royalties.
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.
The atopic dermatitis space gained another player in Triveni Bio Inc., which pulled down a $92 million series A financing co-led by Atlas Venture and Cormorant Asset Management to pay for a proof-of-concept study with lead program, TRIV-509, and boost the Waltham, Mass.-based firm’s broader pipeline.
In what TD Cowen analyst Joseph Thome called an “upside surprise,” Anaptysbio Inc. reported positive top-line data from its phase III Gemini-1 study of imsidolimab, a monoclonal antibody designed to inhibit the interleukin-36 receptor, in patients with generalized pustular psoriasis (GPP), positioning the firm for a potentially productive out-licensing deal.
Acelyrin Inc.’s shares tumbled after its interleukin-17A inhibitor, izokibep, failed to reachstatistical significance in part B of a phase IIb/III trial inmoderate to severe hidradenitis suppurativa (HS), but the company remains undeterred with its plans to advance the drug for the inflammatory skin condition.
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.
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