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ADIL On Track, PGNX Slumps On Phase III Study Failure, VNDA On Watch

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Today's Daily Dose brings you news about disappointing results of Progenics Pharma's 1404, an imaging compound targeting prostate specific membrane antigen,trial; stock offerings of Galapagos and Xenon Pharma and Hetlioz's edge over Zopiclone in driving impairment.

Read on...

Adial Pharmaceuticals Inc.'s (ADIL) study related to the stability testing of the clinical trial material for its lead drug candidate, AD04, a genetically targeted therapeutic agent being developed to treat alcohol use disorder (AUD) has yielded positive results.

The positive results pave way for the Company to commence phase III trial of AD04.

ADIL closed Wednesday's trading at $2.87, up 3.61%.

The FDA has granted Fast Track designation for FibroGen Inc.'s (FGEN) anti-CTGF antibody, Pamrevlumab, for the treatment of patients with idiopathic pulmonary fibrosis.

Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer and has been granted Orphan Drug Designation in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD).

FGEN closed Wednesday's trading at $59.60, up 1.02%.

Galapagos NV (GLPG) has offered to sell 2.57 million new ordinary shares in the form of American Depositary Shares at a price of $116.50 per ADS. The gross proceeds from the offering, which is expected to close on September 17, are estimated to be $300 million.

The underwriters have a 30-day option period to purchase up to an additional 386,266 ADSs, representing 15% of the ADSs placed in the offering.

GLPG closed Wednesday's trading at $119.71, up 16.52%. In after-hours, the stock fell 1.01% to $118.50.

Shares of Progenics Pharmaceuticals Inc. (PGNX) were down 21% in after-hours trading on Wednesday, following disappointing outcome of its phase III study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent in patients with newly-diagnosed or low-grade prostate cancer.

The phase III study did not meet the co-primary endpoint of sensitivity, in sharp contrast to prior phase II data, which showed significantly higher sensitivity rates.

Near-term Catalysts:

-- A phase II/III study evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL (18F-DCFPyL), in prostate cancer, dubbed OSPREY, has completed enrollment. Top-line data are anticipated in the fourth quarter of 2018.

-- Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with metastatic castration-resistant prostate cancer (mCRPC) by year end 2018.

PGNX closed Wednesday's trading at $7.30, down $1.62%. In after-hours, the stock fell 21.23% to $5.75.

The FDA has accepted Sanofi (SNY) and Regeneron Pharmaceuticals Inc.'s (REGN) supplemental Biologics License Application for Praluent, seeking to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events, or MACE.

MACE is an umbrella term that includes heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization.

The regulatory agency's decision on the Praluent sBLA is set for April 28, 2019.

Vanda Pharmaceuticals Inc.'s (VNDA) approved treatment for Non-24-Hour Sleep-Wake Disorder, Hetlioz, demonstrated no next day driving impairment compared to placebo, according to study results.

In the triple crossover study, 48 healthy volunteers drove 100 km in a validated driving simulator the morning after taking a bedtime dose of either Hetlioz 20 mg, Zopiclone 7.5 mg or placebo. The volunteers were instructed to operate the driving simulator for approximately 1 hour with a speed of 55 mph while maintaining lane position.

However, active control, Zopiclone, showed significant impairment in driving in the study.

HETLIOZ, which recorded net product sales of $28.0 million in the second quarter of 2018, is expected to generate net product sales of $108 to $118 million for full year 2018.

VNDA closed Wednesday's trading at $18.45, up 1.10%.

Xenon Pharmaceuticals Inc. (XENE) has offered to sell 4.5 million common at a price of $14.00 per share. The gross proceeds to Xenon from the offering are expected to be $63.0 million.

In addition, Xenon has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 675,000 common shares. The offering is expected to close on or about September 17, 2018, subject to customary closing conditions.

The Company expects to initiate a phase II clinical trial of XEN1101 as a treatment for adult focal seizures in the fourth quarter of 2018.

XENE closed Wednesday's trading at $14.25, down 4.36%.

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