AnaptysBio Inc. (NASDAQ: ANAB) stock gained by 6.6% at last close while the ANAB stock price surges by 7.98% in the after-hours trading session. AnaptysBio is a medical biotechnology business focused on making treatment options for inflammation and creating first-in-class antibody product candidates.
What’s happening in ANAB stock?
The FDA has approved a new indication for GSK’s JEMPERLI (dostarlimab-gxly) for the evaluation of patients with mismatch repair deficient (dMMR) recurrent or progressed solid tumors, as defined by an FDA-approved test, who have progressed on or following prior treatment and have no satisfactory alternative treatment options, according to AnaptysBio.
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JEMPERLI was created by TESARO, Inc., now a part of GSK, under a cooperation agreement after being developed by AnaptysBio utilizing their unique somatic hypermutation antibody technology. So far, eight therapeutic antibodies developed by AnaptysBio have progressed into clinical trials. JEMPERLI was the first AnaptysBio-developed antibody to be authorized by the FDA, and this is the FDA’s second indication for JEMPERLI in 2021. This indication was granted expedited approval based on the rate of tumor response and the duration of the response. Ongoing approval for these indications might be conditional on a confirmatory study demonstrating and documenting clinical benefit.
As a result of this second FDA clearance for JEMPERLI in dMMR persistent or progressed solid tumors, AnaptysBio has received a $20 million milestone payment. Upon fulfillment of certain JEMPERLI regulatory and commercial milestones, they expect to receive a further $15 million and $165 million in milestone payments, respectively. AnaptysBio will earn royalties ranging from 8% to 25% of worldwide net sales for JEMPERLI, with AnaptysBio receiving 8% of yearly global net sales below $1 billion and 12-25 percent of net sales over $1 billion. JEMPERLI’s top year annual sales are expected to be between £1-2 billion, according to GSK.
GSK is also developing JEMPERLI for the treatment of other tumor types and therapeutic scenarios. It covers current phase III studies in recurrent or primary advanced endometrial cancer that are being conducted in conjunction with conventional treatment. In addition, the phase III FIRST trial compared standard of care platinum-based therapy to JEMPERLI plus niraparib as first-line treatment for stage III or IV non-mucinous epithelial ovarian cancer. JEMPERLI is also being tested as a monotherapy and in combination therapy for a variety of tumor types and malignancies, namely platinum-resistant ovarian cancer, non-small cell lung cancer, multiple myeloma, and melanoma, among others.