Anaptysbio Inc Stock Price, News & Analysis

AnaptysBio announced the FDA's second approval of GSK's JEMPERLI for advanced solid tumors, expanding treatment options for patients with dMMR cancers. Following the approval, AnaptysBio earned a $20 million milestone payment, adding to $40 million received earlier in 2021. Future milestones include an additional $15 million and $165 million tied to regulatory and commercial achievements, respectively. AnaptysBio is set to receive royalties ranging from 8% to 25% on JEMPERLI's global net sales, with GSK projecting peak sales of £1-2 billion.

AnaptysBio, a clinical-stage biotech firm, reported a net loss of $0.4 million for Q2 2021, down from $21.5 million year-over-year. Collaboration revenue reached $30 million, primarily from JEMPERLI's approval milestones. The FDA has approved JEMPERLI for endometrial cancer, projected to earn AnaptysBio royalties of 8-25% on sales. Looking ahead, the company plans to initiate the GEMINI-1 Phase 3 trial for imsidolimab in Q3 2021 and expects cash reserves to sustain operations through 2024.

AnaptysBio, a clinical-stage biotechnology company, will present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 1:30 p.m. ET. CEO Hamza Suria will share insights into the company’s innovative antibody product candidates, primarily targeting inflammation and immuno-oncology. Their pipeline includes imsidolimab for dermatological conditions and programs aimed at autoimmune diseases and human inflammatory disorders. The audio presentation will be accessible via the company’s website, with a replay available for 60 days post-event.

AnaptysBio, a clinical-stage biotechnology company, reported its Q1 2021 financial results and pipeline updates. The company anticipates commencing a Phase 3 trial for imsidolimab to treat generalized pustular psoriasis (GPP) following a successful FDA meeting. Approval of JEMPERLI for endometrial cancer resulted in $30 million in milestone payments and ongoing royalties. However, the company reported a net loss of $18.2 million for the quarter, and cash reserves decreased from $411.2 million to $387.4 million. AnaptysBio expects cash burn to be around $100 million in 2021, funding operations into 2024.

AnaptysBio announced that its PD-1 antagonist antibody, JEMPERLI (dostarlimab), has received conditional marketing authorization from the European Commission for treating advanced endometrial cancer. This milestone marks JEMPERLI as the first anti-PD-1 therapy approved for this indication in Europe. AnaptysBio earned a $10 million milestone payment and expects additional payments, including $35 million upon future regulatory milestones and $165 million based on sales achievements. The company will also receive royalties ranging from 8% to 25% on global net sales of JEMPERLI.

AnaptysBio announced FDA approval for JEMPERLI (dostarlimab-gxly) to treat recurrent or advanced endometrial cancer with mismatch repair deficiency. This milestone marks the first FDA approval for one of its antibodies, resulting in a $20 million milestone payment. AnaptysBio is eligible for additional milestone payments totaling $210 million and royalties ranging from 8% to 25% on global sales. The drug's approval is based on tumor response rate and durability, but continued approval may depend on confirmatory trials.

AnaptysBio, a clinical-stage biotechnology company, has appointed Oleg Nodelman to its Board of Directors. Nodelman, recognized for his expertise in biotechnology development and financing, is expected to contribute significantly to the company’s antibody discovery and development efforts. AnaptysBio specializes in first-in-class antibody product candidates addressing inflammation and immuno-oncology conditions. The company has advanced eight novel therapeutics into clinical development, leveraging its proprietary somatic hypermutation platform.

On March 8, 2021, AnaptysBio reported that its Phase 2 trial of imsidolimab for moderate-to-severe palmoplantar pustulosis (PPP) did not meet the primary endpoint of statistically significant improvement over placebo at week 16. The treatment was well tolerated, with no serious adverse events reported. AnaptysBio will not pursue further development in PPP but will advance imsidolimab in five other indications, including a Phase 3 trial in generalized pustular psoriasis (GPP) expected in mid-2021. Key results showed similar levels of improvement between treatment and placebo groups, with p-values indicating no significant differences.

AnaptysBio (Nasdaq: ANAB) reported positive topline data from its Phase 2 GALLOP trial of imsidolimab for generalized pustular psoriasis (GPP) in 2020, with Phase 3 initiation expected mid-2021. Additionally, the company is expanding imsidolimab trials into other dermatological conditions and has advanced ANB030 into Phase 1 trials. Key financial updates include a decrease in cash to $411.2 million, while collaboration revenue surged to $75 million due to milestone payments. The net income for Q4 2020 was $33.6 million, reflecting progress despite an annual net loss of $19.9 million.