→ After outgoing FDA commissioner Scott Gottlieb threw a spanner in the works earlier this year for peanut allergy drug developers — Aimmune $AIMT and DBV Technologies $DBVT — suggesting in a series of tweets that allergenic products are not covered by user-fees, and consequently do not qualify for the PDUFA process, Aimmune on Monday offered some clarity regarding its marketing application. The BLA for its product — AR101 — has been accepted for review and will be mulled over by the FDA over 12 months. This period still keeps it ahead of arch rival DBV, which rescinded its application last December — due to manufacturing concerns — and plans to resubmit in the third quarter. Aimmune had submitted its application to the FDA late last year — but the US government shutdown stuttered the regulator’s acceptance. “The FDA has informed Aimmune that the BLA will be reviewed…as measured from the January 2019 start date. As a consequence, review of the BLA may take until late January 2020. Aimmune is currently engaged in discussions with the FDA regarding the review timeline for the AR101 BLA. The FDA expects to convene an advisory committee meeting to discuss the application,” Aimmune said in statement.
→ A tiny, recently public biotech has reported early data that might serve to revive its shaky fortunes. PhaseBio, which went public last October, showed its experimental drug PB2452 was able to swiftly and sustainably reversed the effects of AstraZeneca’s $AZN anti-clotting drug Brilinta in a Phase I study — data were unveiled on Sunday at the American College of Cardiology (ACC) in parallel to publication in the New England Journal of Medicine. The drug — in-licensed from the British drugmaker — reversed Brilinta’s effects within 5 minutes after administration and was sustained for more than 20 hours (p<0.001). The monoclonal antibody is being developed to reverse the antiplatelet activity of Brilinta in major bleeding and urgent surgery situations. “Since the IPO, PHAS has traded poorly as the story was perceived as ‘early’ and shares got caught up in the biotech sell-off last December. The well-received ACC presentation, and especially the surprise NEJM publication, should right the ship, in our view, as investors learn more about PB2452 and its significant market potential. From here, PHAS plans to launch a P2a study to confirm dosing in an older healthy-for-age population, with data expected around mid-year,” Stifel analysts wrote in a note. Shares of the drug developer $PHAS shot up about 74.5% at $6.49 in early Monday trading.
→ At the Society of Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap Therapeutics offered an early positive snapshot of data from an ongoing mid-stage study testing its drug, DKN-01, as a monotherapy and in combination with chemotherapy paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC) or endometrioid ovarian cancer (EOC). Patients, including those with carcinosarcoma and Wnt pathway alterations, have experienced partial responses and durable clinical benefit in either arm of the study, the company said, adding that the complete data set will become available in the coming months. Shares of the Cambridge, Massachusetts-based drug developer $LPTX jumped about 19% at $2.67 in Monday morning trading.
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