Pfizer taps Dewpoint Therapeutics in $239M dystrophy candidate pact
Privately-held Dewpoint Therapeutics has added Pfizer (PFE -0.2%) to its list of pharma partners by announcing new research collaboration with Pfizer, for the development of potential therapeutics for myotonic dystrophy type 1, DM1, a rare genetic disorder and one of two types of myotonic dystrophy.
Under the agreement, Dewpoint will receive an upfront payment and will be eligible to receive milestones payments, totaling up to $239M. Dewpoint will also be eligible to receive royalties on any approved products.
DM1 is an inherited genetic disorder linked with the DMPK gene. People diagnosed with DM1 experience muscle loss and weakness, difficulty breathing, cataracts, heart conditions, intellectual disability and early death.
Kite, a Gilead Company (GILD +3.1%) and Oxford BioTherapeutics have entered into a research collaboration to evaluate five targets for a number of hematologic and solid tumor indications, using latter’s OGAP target discovery platform.
Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.
Under the terms of the agreement, Oxford will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain discovery, clinical and regulatory milestones, as well as royalties on future potential sales.
Seres’s SER-287 shows encouraging action in early-stage ulcerative colitis study
Seres Therapeutics (MCRB +8.3%) has announced the publication of data analyses from its Phase 1b trial of SER-287 in patients with active mild-to-moderate ulcerative colitis (UC). Results demonstrated that SER-287 administration was associated with positive impacts on clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile.
Highest efficacy was observed in the daily SER-287 arm of the study, with a remission rate of 40% compared to 0% in the placebo group. The results demonstrated no imbalance in adverse events in patients treated with SER-287 compared to patients treated with placebo.
No drug-related serious adverse events associated with SER-287 were observed.
AstraZeneca’s Farxiga nabs U.S. Priority Review for CKD
The FDA has granted Priority Review for AstraZeneca’s (NASDAQ:AZN) Farxiga (dapagliflozin) for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D). Agency’s action date will be during the second quarter of 2021.
Detailed results from Phase 3 DAPA-CKD trial showed that Farxiga on top of standard of care reduced the worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo
In the US, the med is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of hospitalization for heart failure in patients.
RedHill nabs fast track review for RHB-204 in lung infection
The FDA has designated Fast Track status to RedHill Biopharma’s (NASDAQ:RDHL) RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex.
Recently, the treatment was granted Orphan Drug tag, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.