Today’s Daily Dose brings you news about SCYNEXIS’ Dove study results; termination of the merger agreement between Idera and BioCryst Pharma; withdrawal of Advaxis’ Conditional Marketing Authorization Application in the European Union for Axalimogene filolisbac and stock offering of ArQule.
Advaxis Inc. (ADXS) has decided to withdraw its Conditional Marketing Authorization Application in the European Union for Axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy.
The decision is based on the European Medicines Agency’s feedback following its initial review of the conditional Marketing Authorization Application for Axalimogene Filolisbac. The regulatory agency has indicated that the application will likely need additional data to support a conditional approval.
The Marketing Authorization Application, submitted in February of this year, included data from a phase 2 study of Axalimogene Filolisbac, dubbed GOG-0265 study, which showed an improvement in 12-month survival rates in women with persistent or recurrent cervical cancer.
The Company also announced that it has submitted an IND with the FDA to study ADXS-503 for the treatment of non-small cell lung cancer (NSCLC). If it gets the go-ahead, Advaxis plans to initiate an open-label, Phase 1/2 clinical trial of ADXS-503 by the end of 2018.
ADXS closed Tuesday’s trading at $1.44, down 8.28%. The stock touched a new low of $1.40 in intraday trading.
Shares of ArQule Inc. (ARQL) were down more than 5% in after-hours on Tuesday, following the commencement of proposed public offering of common stock. The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.
The Company’s clinical drug candidates include:
— ARQ 087 (Derazantinib), under phase III trial in Intrahepatic Cholangiocarcinoma (iCCA).
— ARQ 531, under phase I dose escalation study in selected subjects with relapsed or refractory hematologic malignancies. Preliminary results reported from this ongoing trial last month were encouraging.
— Miransertib (ARQ 092) under phase I/II trial for Proteus syndrome, and phase Ib trial in combination with Carboplatin plus Paclitaxel, in combination with Paclitaxel, or in combination with Anastrozole in subjects with selected solid tumors.
— ARQ 751, under phase I dose escalation study in subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations.
ARQL closed Tuesday’s trading at $6.15, down 8.07%.
The news of termination of the merger agreement between Idera Pharmaceuticals Inc. (IDRA) and BioCryst Pharmaceuticals (BCRX) didn’t go down well with investors who sent Idera stock down as much as 8% in after-hours on Tuesday.
The merger agreement between Idera and BioCryst was signed on January 22, 2018. A special meeting was held on July 10, 2018 separately by the two companies. BioCryst’s stockholders voted against the proposed merger while a majority of Idera’s stockholders voted in favor of the merger.
Now that the merger has been called off, BioCryst will reimburse Idera $6 million in connection with the termination.
IDRA closed Tuesday’s trading at $1.37, down 0.72%. In after-hours, the stock was down 8.03% at $1.26. In contrast, BCRX was up 3.42% at $6.35 in extended trading.
Shares of SCYNEXIS Inc. (SCYX) were up more than 9% in extended trading on Tuesday, following positive results from its Phase 2b, dose-finding study of SCY-078 for the treatment of vulvovaginal candidiasis, dubbed DOVE study.
The DOVE study, which enrolled a total of 186 patients with moderate-to-severe acute VVC, evaluated the safety and efficacy of five oral SCY-078 regimens, with total doses of SCY-078 ranging from 600mg to 1800mg and treatment durations of one or three days, compared to Fluconazole (FLU), the standard of care for vulvovaginal candidiasis (VVC).
According to the Company, all five doses of oral SCY-078 demonstrated meaningful clinical and mycological activity, with the lowest SCY-078 dose regimen of 600mg exhibiting the optimal combination of overall clinical and mycological activity and favorable tolerability. The SCY-078 oral dose regimen of 600mg compared favorably to Fluconazole.
SCYX closed Tuesday’s trading at $1.65, down 5.71%. In after-hours, the stock was up 9.09% to $1.80.
by RTTNews Staff Writer
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