- Ligand Pharmaceuticals's (LGND +0.04%) unit Icagen and GlaxoSmithKline (GSK -2.3%) have entered into a collaboration and license agreement that will utilize Icagen discovery technology to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases.
- Ligand will get an upfront payment of $7M, and is eligible to receive additional milestone payments of as much as $154.5M, as well as tiered royalties on net sales of any drug from the collaboration that is commercialized by GSK.
- GSK has the exclusive option to license any identified inhibitors and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration.
- https://seekingalpha.com/news/3646248-ligand-pharmas-icagen-glaxosmithkline-in-licensing-pact-for-neurological-diseases
- The European Commission greenlighted the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), hours after the European Medicines Agency issued a positive opinion to recommend it for conditional marketing authorization.
- The decision by the EU’s executive arm will allow the two companies to roll out the vaccine across the 27-nation bloc. The deliveries are expected to start on Saturday, with inoculations beginning across the EU between December 27-29.
- After receiving the positive opinion from EMA, the CEO of Pfizer’s German partner, BioNTech, said, “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”
- The decision by the Committee for Medicinal Products for Human Use of EMA was based on Phase 3 clinical data published in The New England Journal of Medicine in early December.
- https://seekingalpha.com/news/3646264-pfizer-biontech-covidminus-19-vaccine-cleared-eu
- Employees at meat plants will be included in the front-line workers next in line for COVID-19 vaccine shots, according to guidelines approved by a CDC advisory committee over the weekend.
- While the great meat shortage of 2020 never materialized, COVID-related worker shortages at some plants in the Midwest during the spring caused shutdowns that led to short-term supply chain disruptions.
- The North American Meat Institute called the recommendation a critical step for the long-term safety of employees.
- States can still set their own priorities for vaccination tranches.
- Sector watch: Sanderson Farms (SAFM -1.8%), Pilgrim's Pride (PPC -2.6%), Hormel (HRL -0.9%) and Tyson Foods (TSN -2.1%).
- https://seekingalpha.com/news/3646286-meat-workers-included-in-next-phase-of-large-scale-vaccinations
- Astellas' (OTCPK:ALPMF) Xospata (gilteritinib) in combination with azacitidine did not meet the primary endpoint of overall survival at an interim analysis of Phase 3 trial, LACEWING in acute myeloid leukemia (AML) patients.
- Independent data monitoring committee recommended terminating the study for futility; Astellas has stopped enrollment.
- Trial involved 250 newly diagnosed FLT3 mutation-positive AML patients who were ineligible for intensive induction chemotherapy.
- Janssen Pharmaceutical, a unit of Johnson & Johnson (JNJ -0.9%) has started rolling submission of its marketing application to the FDA seeking approval for ciltacabtagene autoleucel (cilta-cel), for the treatment of adults with relapsed and/or refractory multiple myeloma.
- Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy.
- The submission is based on results from Phase 1b/2 CARTITUDE-1 study, that demonstrated overall response rate of 97%, with 67% of patients achieving a stringent complete response, but 14 deaths were reported during the study, including six due to adverse events related to treatment.
- The event triggered a milestone payment of $75M to its partner Legend Biotech (LEGN -2.0%).
- https://seekingalpha.com/news/3646305-janssen-begins-rolling-submission-of-marketing-application-for-bcma-car-t-therapy-in-multiple
- Vertex Pharmaceuticals (NASDAQ:VRTX) announced that it received the FDA signoff for the expanded use of three of its cystic fibrosis medications.
- TRIKAFTA, previously approved for people with at least one F508del mutation is now approved for 177 additional mutations; authorized for 127 additional mutations, SYMDEKO is now approved for a total of 154 SYMDEKO-responsive mutations; KALYDECO is now eligible for use in a total of 97 KALYDECO-responsive mutations after getting approval for an additional 59 mutations.
- TRIKAFTA is indicated for people with cystic fibrosis aged 12 years and older, while SYMDEKO and KALYDECO are approved for people with CF ages six years and older and age four months and older, respectively
- Cystic fibrosis, due to mutations in the cystic fibrosis transmembrane conductance regulator gene, is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide.
- With the vast majority of CF patients having at least one F508del mutation, the approval for expanded use will benefit more than 600 people with CF, additionally.
- https://seekingalpha.com/news/3646333-vertex-receives-fda-approval-for-expanded-use-of-cystic-fibrosis-therapy
- Provention Bio (PRVB +2.2%), Marinus Pharmaceuticals (MRNS -1.5%), Arcutis Biotherapeutics (ARQT +0.2%) and Kamada (KMDA +1.1%) have been added to the Nasdaq Biotechnology Index, effective market open today (Dec 21).
- "Index inclusion recognizes our clinical progress and heightened investor awareness as we remain committed to rapidly advancing our pipeline in rare epilepsies and neuropsychiatric disorders," says Scott Braunstein, M.D., CEO of Marinus Pharmaceuticals.
- In the past one year, stock price return of PRVB, ARQT, and MRNS remains higher to the the iShares NASDAQ Biotechnology Index (NASDAQ:IBB), which tracks the Nasdaq Biotechnology Index. On the other side, KMDA has posted a decline of 9.70% in the same period.
- https://seekingalpha.com/news/3646366-marinus-pharmaceuticals-provention-bio-take-spot-in-nasdaq-biotechnology-index
