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First 2-drug HIV Regimen Gets FDA Nod, Starpharma Shines, ARDX Drops RDX7675


Today's Daily Dose brings you news about FDA approval of the first 2-drug regimen for HIV; share repurchase by SunLink Health; promising early observations from DelMar's phase II trial of VAL-083 in glioblastoma; Starpharma's progress in Bacterial Vaginosis trial and Ardelyx's pipeline update.

Read on...

Ardelyx Inc. (ARDX) has decided to discontinue development of RDX7675, which is under phase III testing, for the treatment of hyperkalemia as an unexpected and drug-related reduction in serum bicarbonate has been observed.

The unanticipated bicarbonate side effect creates a barrier for RDX7675, limiting its chronic use, according to Mike Raab, president and chief executive officer of Ardelyx. This action of the Company is expected to result in a cash savings of about $40 million over the next two years, extending its operating runway into 2019.

There is one more compound for hyperkalemia in the pipeline, i.e. RDX013, which is under pre-clinical testing, and the Company will now focus on this compound.

Additionally, Ardelyx revealed that enrollment in its second registration study for Tenapanor for the treatment of hyperphosphatemia will begin shortly.

In the first Phase 3 study, Tenapanor achieved the primary endpoint of meaningfully reducing serum phosphorus and was well-tolerated, according to the Company.

ARDX closed Tuesday's trading at $6.30, up 12.50%.

Catalyst Pharmaceuticals Inc. (CPRX) has initiated a company-sponsored, proof-of-concept phase II clinical trial of Firdapse as a symptomatic treatment for patients with Spinal Muscular Atrophy (SMA) Type 3.

The study is planned to include approximately 12 patients, and Catalyst anticipates reporting top-line results from the study in the first half of 2019.

To know more about CPRX, please visit our Company Spotlight column.

CPRX touched a new 52-week high of $3.29 on Tuesday, before closing the day's trading at $3.27, up 6.86%.

DelMar Pharmaceuticals Inc. (DMPI) has presented promising early observations from its ongoing phase II clinical trial of VAL-083 as a potential new treatment option for MGMT-unmethylated glioblastoma multiforme, a type of brain cancer.

According to the Company, 96% of patients enrolled were alive at the time of the analysis and 40% of patients enrolled were reported to have achieved stable disease as assessed by MRI following treatment with VAL-083 as a single agent.

DMPI closed Tuesday's trading at $0.96, up 13.05%. In after-hours, the stock was up another 11.46% to $1.07.

Exelixis Inc. (EXEL) will be presenting detailed results from its phase III trial of Cabozantinib in previously treated advanced hepatocellular carcinoma, dubbed CELESTIAL, at the 2018 ASCO-GI Symposium on January 19, 2018.

On October 16, 2017, Exelixis announced that the CELESTIAL trial met its primary endpoint of overall survival, with Cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC.

Cabozantinib, under brand name CABOMETYX, is approved in the United States for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. In the European Union, Norway and Iceland CABOMETYX is approved for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

Exelixis plans to submit supplemental New Drug Application to the FDA, seeking approval of Cabozantinib for the treatment of advanced HCC, in the first quarter of 2018.

EXEL closed Tuesday's trading at $26.05, up 1.56%. In after-hours, the stock was up another 1.27% to $26.38.

Genmab A/S' (GMXAY.OB) licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application to the FDA for the use of DARZALEX in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

Janssen has sought Priority Review from the FDA for the sBLA. Whether or not the request is acceded to will be known within the next 60 days. If the FDA grants Priority Review, the review should be completed within 6 months from the submission date.

GMXAY.OB closed Tuesday's trading at $96.93, up 3.01%.

Starpharma (SPHRY.OB) has commenced submission of its NDA for VivaGel BV for both treatment and prevention of Bacterial Vaginosis with the FDA through a rolling submission process.

VivaGel BV has been granted Fast Track status and Qualified Infectious Disease Product (QIDP) designation, which allows for rolling submission of the NDA and ensures priority regulatory review by the FDA.

The complete NDA will comprise five main data modules. The current submission includes three of the five main modules, noted the Company.

SPHRY.OB closed Tuesday's trading at $10.95, up 2.05%.

SunLink Health Systems Inc. (SSY) has offered to repurchase up to 1.56 million of its common shares at a price of $1.60 each.

The number of shares proposed to be repurchased represents approximately 17.05% of the Company's outstanding common shares as of November 20, 2017, and the total purchase price equates to $2.5 million.

SSY closed Tuesday's trading at $1.52, up 2.01%. In after-hours, the stock was up 1.32% to $1.54.

The FDA has approved ViiV Healthcare's Juluca, a single-tablet, two-drug regimen of dolutegravir and rilpivirine, for the maintenance treatment of HIV-1 infection.

Juluca is the first 2-drug regimen to treat certain adults with human immunodeficiency virus type 1 (HIV-1) while the standard HIV regimens include three or more drugs.

Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients, says Debra Birnkrant, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.

ViiV Healthcare is majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders.

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