Replies to post #338425 on Avid Bioservices Inc (CDMO)

[ibelurkin]

Looks real good to me.

Recent Partner Highlights:

Janssen achieved several important successes related to the subcutaneous formulation of DARZALEX® (daratumumab) using ENHANZE® technology during the first quarter and since including:Janssen Pharmaceutical K.K. announced approval fromJapan's Ministry of Health, Labour and Welfare (MHLW) in March for the subcutaneous formulation of DARZALEX® (known as DALACURO® in Japan) for the treatment of multiple myeloma. Accordingly, Halozyme recognized $5 million in milestone revenues.The Janssen Pharmaceutical Companies of Johnson & Johnson announced Health Canada approved DARZALEX® SC (daratumumab injection), a subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd, also known as DCyBorD) in April for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.Janssen Biotech, Inc. received U.S. Food and Drug Administration accelerated approval in January for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.In March, Horizon completed dosing for its first trial exploring a subcutaneous (SC) formulation of TEPEZZA®(teprotumumab-trbw) using ENHANZE® technology. The trial is a small, single-dose Phase 1 pharmacokinetic trial which includes evaluating the use of ENHANZE® drug-delivery technology for a SC formulation, which could potentially shorten drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.Bristol Myers Squibb (BMS) has advanced plans to initiate a Phase 3 study of nivolumab with ENHANZE® technology for patients with advanced or metastatic clear cell renal cell carcinoma during the second quarter of 2021. Accordingly, Halozyme recognized $25 million in milestone revenues.During the first quarter, argenx reached two important achievements related to its development of efgartigimod using ENHANZE® including:In February 2021, argenx announced a "go" decision for its late-stage ADHERE trial evaluating subcutaneous (SC) efgartigimod using ENHANZE® technology in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx plans to continue enrollment to include approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.In January 2021, argenx initiated a Phase 3 study of ARGX-113 using ENHANZE® technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.