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ARDS On The Move, GLPG Reports Positive Data, PRTO Plunges On PATENCY-2 Results

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Today's Daily Dose brings you news about Aridis Pharma's anticipated milestones; Blueprint Medicines' stock offering; Cardax's financial results; ESSA Pharma's progress in prostate cancer program; Gilead Sciences and Galapagos' Filgotinib trial results; Proteon's disappointing PATENCY-2 study data and Supernus Pharma's ADHD trial results.

Read on...

Aridis Pharmaceuticals Inc. (ARDS) has a couple of catalysts to watch out for in the coming months.

The Company expects to announce the readout of top-line data from its global phase II clinical trial of AR-105 as a treatment for ventilator-associated pneumonia (VAP) caused by Pseudomonas aeruginosa during the third quarter of 2019.

A phase III pivotal study of AR-301 targeting gram-positive Staphylococcus aureus (S. aureus) in critically ill VAP patients is underway. Interim data from the phase III clinical study of AR-301 is expected in Q1 2020 and top-line data is expected in late 2020.

A phase 1/2a clinical study of AR-501 in cystic fibrosis is ongoing. Data from the Phase 1 portion of the study is anticipated in Q1 2020.

ARDS closed Thursday's trading at $10.98, down 0.27%. In after-hours, the stock was up 17.71% to $12.43.

Blueprint Medicines Corp. (BPMC) has offered to sell 4.05 million shares of its common stock to the public at a price of $74.00 per share.

In addition, Blueprint Medicines has granted the underwriters a 30-day option to purchase up to an additional 608,108 shares of its common stock.

Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Guggenheim Securities, LLC and Wedbush Securities Inc. are acting as co-lead managers for the offering.

The offering is expected to close on or about April 2, 2019, subject to the satisfaction of customary closing conditions.

Near-term Catalysts:

-- Submission of a Marketing Authorization Application to the European Medicines Agency for Avapritinib for the treatment of both PDGFRa D842V mutant gastrointestinal stromal tumors (GIST) and fourth-line GIST in the third quarter of 2019.
-- Submission of a New Drug Application to the FDA for Avapritinib for the treatment of advanced systemic mastocytosis in the first quarter of 2020.
-- Submission of a New Drug Application to the FDA for BLU-667 for the treatment of patients with non-small cell lung cancer previously treated with platinum-based chemotherapy in the first quarter of 2020.
-- Submission of a New Drug Application to the FDA for BLU-667 for the treatment of patients with RET-mutant medullary thyroid cancer previously treated with an approved multi-kinase inhibitor in the first half of 2020.

BPMC closed Thursday's trading at $75.71, down 5.22%.

Cardax Inc. (CDXI.OB) has reported a two-fold increase in revenue in 2018, thanks to the strong sell-through of ZanthoSyn in General Nutrition Corporation stores in Hawaii as well as in California, Nevada, and New York where the Company has focused its sales and marketing efforts to date.

ZanthoSyn is a physician recommended anti-inflammatory supplement for health and longevity.

A clinical trial evaluating the effect of low-dose and high-dose ZanthoSyn on cardiovascular inflammatory health over 12 weeks in subjects with documented cardiovascular risk factors, dubbed CHASE, is underway. Interim results from this study are expected later this year.

CDXI.OB closed Thursday's trading at $0.17, unchanged from the previous day's close.

ESSA Pharma Inc. (EPI.V) (EPIX) expects to enter clinical studies with EPI-7386, an Aniten compound, for the treatment of metastatic castration-resistant prostate cancer in the first quarter of 2020.

The Company has successfully completed the phase I portion of its phase I/II clinical trial of EPI-506 for the treatment of metastatic castration-resistant prostate cancer. But further clinical development of EPI-506 was discontinued in September 2017 to focus R&D resources on its next-generation Anitens targeting the androgen receptor- N-terminal domain (AR-NTD).

The next-generation Aniten compounds are designed to improve upon a number of attributes of first-generation compound, EPI-506, and are considerably more potent than EPI-506, according to the Company.

EPIX closed Thursday's trading at $3.50, down 1.13%. In after-hours, the stock was up 10% to $3.85.

Gilead Sciences Inc. (GILD) and Galapagos NV's (GLPG) phase III studies of Filgotinib in adults with moderately-to-severely active rheumatoid arthritis, dubbed FINCH 1 and FINCH 3, have achieved their respective primary endpoints.

FINCH 1 evaluated Filgotinib at dosages of 100 mg or 200 mg versus Humira (adalimumab) or placebo, on a stable background dose of methotrexate in patients with prior inadequate response to methotrexate. The study achieved its primary endpoint for both doses of Filgotinib in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) compared to placebo at Week 12.

FINCH 3 evaluated Filgotinib at dosages of 100 mg or 200 mg in combination with methotrexate and as monotherapy in MTX-naïve patients. The study achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 24.

GLPG closed Thursday's trading at $96.13, up 0.53%.

Shares of Proteon Therapeutics Inc. (PRTO) plunged over 85% on Thursday, following disappointing results from its phase III clinical trial of investigational Vonapanitase in patients with chronic kidney disease (CKD) undergoing creation of a radiocephalic fistula for hemodialysis.

The study, dubbed PATENCY-2, did not meet its co-primary endpoints of fistula use for hemodialysis and secondary patency. (Secondary patency refers to time to fistula abandonment).

According to the trial results, 69.7 % of Vonapanitase-treated patients achieved use of the fistula for hemodialysis, compared to 65.1% of placebo-treated patients, a result that is not statistically significant. Fistula use is defined as use of the fistula for two-needle.

PRTO closed Thursday's trading at $0.50, down 85.60%.

Stealth BioTherapeutics (MITO) has dosed the first patient in its phase II study of Elamipretide in patients with dry age-related macular degeneration with geographic atrophy.

The study, dubbed ReCLAIM-2, involves approximately 180 subjects with non-central geographic atrophy in at least one eye. Subjects will be randomized 2 to 1 to either Elamipretide or placebo, and will receive a 40 mg once-daily injection of Elamipretide or placebo for a 48-week period.

Stealth's ADSs began trading on The Nasdaq Global Market on February 15, 2019, at a public offering price of $12 per ADS.

The stock closed Thursday's trading at $13.25, down 6.69%.

Supernus Pharmaceuticals Inc. (SUPN) has reported topline results from the second phase III study of SPN-812 in adolescents for the treatment of attention deficit hyperactivity disorder, dubbed P304, confirming the positive results of the previous Phase III studies on SPN-812 last year in December.

The phase III program of SPN-812 included four three-arm, placebo-controlled trials namely, P301 and P303 trials in patients 6-11 years old, and P302 and P304 trials in patients 12-17 years old.

In the P304 trial, a total of 297 patients were randomized across placebo and two doses of SPN-812 - 400 mg and 600 mg.

The 400 mg dose of SPN-812 reached statistical significance compared to placebo, consistent with previous Phase III studies while the 600 mg dose narrowly missed the statistical significance. The 600 mg dose is not needed for the submission or approvability of the NDA for children and adolescents.

The Company expects to submit the New Drug Application for SPN-812 in the second half of 2019.

SUPN closed Thursday's trading at $34.31, down 0.20%.

The FDA has approved extending the label for UCB's CIMZIA to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

The approval makes CIMZIA the first and only FDA-approved treatment for nr-axSpA.
The drug is already approved for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Net sales of CIMZIA were €1.45 billion in 2018 compared to €1.42 billion in 2017.

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