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ADXS, TROV On Watch, NRBO Soars 95%, DCPH To Face FDA In Aug.

pharma sept27 12feb20 lt

Today's Daily Dose brings you news about Advaxis' upcoming presentation; Deciphera's date with FDA and Trovagene's update on its phase II study of Onvansertib in metastatic castrate-resistant prostate cancer.

Read on…

Advaxis Inc. (ADXS) is slated to present data from a Phase 1/2 clinical trial of ADXS-PSA as a standalone, or monotherapy, and in combination with Keytruda in people with previously treated metastatic castration-resistant prostate cancer, dubbed KEYNOTE-046, on February 13, 2020.

ADXS closed Wednesday's trading at $1.09, up 0.93%. In after-hours, the stock was up 2.75% at $1.12.

Deciphera Pharmaceuticals Inc.'s (DCPH) New Drug Application seeking approval for Ripretinib for the treatment of patients with advanced gastrointestinal stromal tumors has been accepted for priority review by the FDA, with a decision date set for August 13, 2020.

The Company has sought approval for Ripretinib for the above proposed indication in Canada and Australia too.

In other news, Deciphera announced that it has commenced a registered underwritten public offering of $250.0 million in shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $37.5 million in shares of its common stock.

DCPH closed Wednesday's trading at $69.39, up 0.80%.

NeuroBo Pharmaceuticals Inc. (NRBO) soared more than 95% on Wednesday on no news.

The present NeuroBo Pharmaceuticals is the result of the reverse merger between privately-held NeuroBo Pharmaceuticals Inc and NASDAQ-listed Gemphire Therapeutics. The combined company began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019.

The pipeline includes:

-- NB-01 for the treatment of Painful Diabetic Neuropathy, which is expected to enter phase III trial in the first half of this year.
-- NB-02 for Alzheimer's disease and other dementias, which has completed IND-enabling toxicology studies.
-- Gemcabene for the treatment of dyslipidemia, which has been on partial clinical hold since 2004. The Company expects to submit a request to the FDA in the first half of this year, seeking lifting of the partial clinical hold for Gemcabene.

The combined cash as of June 30, 2019, was $28.2 million.

NRBO closed Wednesday's trading at $30.00, up 95.19%. In after-hours, the stock was down 11.67% at $26.50.

Trovagene Inc. (TROV) is scheduled to present new data from its phase II study of Onvansertib in metastatic castrate-resistant prostate cancer on Thursday, February 13th, 2020 at the American Society for Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.

Last month, the Company had announced positive data from an ongoing Phase 1b/2 clinical trial of Onvansertib plus FOLFIRI and Avastin for second-line treatment of KRAS-mutated metastatic colorectal cancer.

According to Trovagene, all colorectal cancer patients showed tumor regression by radiographic scan at 8 weeks and confirmation by further tumor shrinkage at 16 weeks - with clinical benefit having been achieved in 100% of patients.

TROV closed Wednesday's trading at $2.18, up 1.87%. In after-hours, the stock gained 2.75% and was at $2.24.

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