First Drug For TED Secures Approval, TROV On Watch, EVOK Faces FDA In June
Today’s Daily Dose brings you news about the update on Evoke Pharma’s resubmitted New Drug Application for Gimoti; FDA’s Fast Track Designation for Genprex’ investigational immunogene therapy Oncoprex and Horizon Therapeutics securing FDA approval of TEPEZZA for the treatment of Thyroid Eye Disease, among others.
Evoke Pharma Inc.’s (EVOK) resubmitted 505(b)(2) New Drug Application for Gimoti has been accepted for review by the FDA, with a decision date set for June 19, 2020.
Gimoti, a nasal spray, is being developed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.
The FDA had issued a Complete Response Letter for Gimoti on April 1, 2019, citing issues related to clinical pharmacology and product quality/device quality.
EVOK closed Tuesday’s trading at $1.57, up 13.77%.
Genprex Inc.’s (GNPX) investigational immunogene therapy Oncoprex in combination with AstraZeneca’s blockbuster product Tagrisso for the treatment of non-small cell lung cancer patients with EFGR mutations that progressed after treatment with Tagrisso alone has been granted Fast Track Designation by the FDA.
The Company has treated more than 50 lung cancer patients with Oncoprex in phase I and phase II clinical trials. The safety and efficacy data from these trials are believed to be encouraging.
Genprex is preparing to initiate a phase I/II clinical trial evaluating Oncoprex in combination with Osimertinib, as well as a new phase I clinical trial evaluating Oncoprex in combination with a checkpoint inhibitor.
GNPX closed Tuesday’s trading at $1.15, up 219.44%. In after-hours, the stock gained another 20.87% to $1.39.
GlaxoSmithKline plc’s (GSK) Biologics License Application of belantamab mafodotin has been granted priority review by the FDA.
The Company is seeking approval of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The Biologics License Application of belantamab mafodotin was submitted on December 19, 2019. Since the priority review is completed in 6 months, we estimate that the decision may be announced by June 19, 2020.
GSK closed Tuesday’s trading at $47.50, down 0.81%. In after-hours, the stock was up 0.21% to $47.60.
The FDA, on Tuesday, approved Horizon Therapeutics plc’s (HZNP) TEPEZZA for the treatment of Thyroid Eye Disease, well ahead of the decision date of March 8, 2020.
TEPEZZA is the first and only FDA-approved medicine for the treatment of Thyroid Eye Disease (TED), a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation, and facial disfigurement.
TEPEZZA that is administered to patients once every three weeks for a total of eight infusions is expected to be available in the United States in the coming weeks.
HZNP closed Tuesday’s trading at $38.25, down 0.39%. In after-hours, the stock was up 1.96% to $39.00.
TrovaGene Inc. (TROV) is all set to present new safety and efficacy data from its phase Ib/II study of Onvansertib in combination with FOLFIRI and Avastin for second-line treatment of metastatic colorectal cancer (mCRC) in patients with a KRAS mutation.
On October 22, 2019, Trovagene announced data demonstrating positive response to treatment with Onvansertib in combination with FOLFIRI and Avastin in Metastatic KRAS-Mutated Colorectal Cancer. According to the Company, a decrease in tumor KRAS mutational burden in response to treatment was observed in all four patients who completed their first cycle of therapy with the combination regimen, as measured by quantitative analysis of circulating tumor DNA (ctDNA).
TROV closed Tuesday’s trading at $1.57, up 13.77%. In after-hours, the stock was up 1.91% to $1.60.
Source: Read Full Article