ACRX Gets EC Nod, AQXP Tanks As LEADERSHIP 301 Fails, ZSAN Catches Eye

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Today's Daily Dose brings you news about AcelRx Pharma's DZUVEO getting approval in the EU; Aquinox Pharma's LEADERSHIP 301 clinical trial missing the primary goals; FDA approval of Array BioPharma's BRAFTOVI/MEKTOVI combo for melanoma; Cara's Phase 2/3 trial results of I.V. CR845, and Summit Therapeutics' disappointing data from PhaseOut DMD study.

Read on...

The European Commission has approved AcelRx Pharmaceuticals Inc.'s (ACRX), DZUVEO (under development in the U.S. as DSUVIA) for the management of acute moderate to severe pain in adults in medically monitored settings.

The resubmitted New Drug Application for DSUVIA is under FDA review with a decision expected on November 3, 2018. DSUVIA was issued a Complete Response Letter last October.

ACRX closed Wednesday's trading at $3.70, down 3.90%.

Shares of Aquinox Pharmaceuticals Inc. (AQXP) cratered on Wednesday, following the failure of its LEADERSHIP 301 clinical trial to meet its primary endpoint.

The LEADERSHIP 301 clinical trial is a phase III trial evaluating once-daily, oral Rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS).

The Company has decided to halt all further development activities with Rosiptor.

AQXP closed Wednesday's trading at $2.34, down 84.72%.

The FDA has approved Array BioPharma Inc.'s (ARRY) combination of BRAFTOVI capsules and MEKTOVI tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.

BRAFTOVI + MEKTOVI can be ordered through select specialty pharmacies in the U.S. market.

ARRY closed Wednesday's trading at $17.60, down 4.86%.

Cara Therapeutics Inc.'s (CARA) adaptive Phase 2/3 trial of I.V. CR845 in patients undergoing abdominal surgeries has yielded positive results.

According to the Company, at the 1.0 mcg/kg dose, I.V. CR845 demonstrated statistically significant reductions in pain intensity compared to placebo at all pre-specified post-operative periods.

Additionally, I.V. CR845 treatment resulted in statistically significant reductions in the incidence of post-operative nausea and vomiting over the 24-hour period post-surgery for both 0.5 and 1.0 mcg/kg doses, noted the Company.

CARA closed Wednesday's trading at $18.06, up 9.85%.

Edge Therapeutics Inc. (EDGE) says that updated results from its ongoing analyses of phase III NEWTON 2 study suggest a clinically meaningful potential benefit for EG-1962 in aneurysmal subarachnoid hemorrhage subjects with WFNS grade 3 or 4.

The Company announced its decision to discontinue the NEWTON 2 study in March of this year based on the independent Data Monitoring Committee's conclusion that the study had a low probability of meeting its primary endpoint.

Edge expects to report the final analysis of data from all 283 subjects in the NEWTON 2 study when the data are available later this year.

As previously announced, the Company is evaluating potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination or other strategic transaction.

EDGE closed Wednesday's trading at $1.03, down 7.21%. In after-hours, the stock was up 17.48% to $1.21.

Eli Lilly and Co.'s (LLY) phase III study of patients with episodic cluster headache treated with Emgality has yielded positive results.

The two-month phase III study met the primary endpoint - with Emgality (300 mg once-monthly) demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across Weeks 1 to 3.

At Week 3, three out of four patients (76%) treated with Emgality (300 mg once-monthly) achieved at least a 50 percent reduction in weekly cluster headache attacks compared to 57 percent for placebo, the gated secondary endpoint.

At Week 4, 73 percent of patients treated with Emgality reported improvements based on the Patient Global Impression of Improvement compared to 46 percent for placebo.

Emgality, a once-monthly, self-administered calcitonin gene-related peptide (CGRP) antibody, is under FDA review for the prevention of migraine in adults, with a decision expected by the end of September 2018.

LLY closed Wednesday's trading at $84.67, down 0.52%.

Foamix Pharmaceuticals Ltd. (FOMX) has completed patient enrollment and has dosed the last patient in its two Phase 3 clinical studies, dubbed FX2016-11 and FX2016-12, evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of rosacea.

The two Phase 3 pivotal studies are being run simultaneously, and the Company currently anticipates reporting top-line results early in the fourth quarter of this year.

FMX101 is also under phase III development for the treatment of acne, and top-line data are expected in the third quarter this year.

FOMX closed Wednesday's trading at $5.00, down 0.60%.

Jazz Pharmaceuticals plc's (JAZZ) supplemental new drug application for Xyrem oral solution, CIII, to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients has been accepted for review by the FDA, with a decision date set for October 27, 2018.

Xyrem oral solution, CIII, is already approved for the treatment of adults with cataplexy (a condition where patients suddenly lose muscle tone, including voluntary muscle control, while awake) and excessive daytime sleepiness in patients with narcolepsy.

The net product sales of Xyrem in 2017 were $1.19 billion compared to $1.11 billion in 2016. For full year 2018, the Company expects Xyrem net sales to range between $1.31 billion and $1.34 billion.

JAZZ closed Wednesday's trading at $174.50, up 0.35%. In after-hours, the stock gained another 0.29% to $175.

Pfizer Inc.'s (PFE) New Drug Application for Glasdegib for the treatment of adult patients with previously untreated acute myeloid leukemia has been accepted for priority review by the FDA.

The U.S. regulatory agency's decision on Glasdegib is expected in December 2018.

PFE closed Wednesday's trading at $36.21, down 0.47%.

Relmada Therapeutics Inc. (RLMD.OB) has dosed the first patient in its phase 2 clinical study evaluating REL-1017 (dextromethadone) as an adjunctive treatment in patients with Major Depressive Disorder.

The phase II trial is designed to enroll 60 subjects at approximately 10 sites in the United States. The top line data from the study is expected in the first half of 2019.

RLMD.OB closed Wednesday's trading at $1.19, down 0.83%.

Summit Therapeutics plc (SMMT) tanked nearly 80% on Wednesday, following disappointing 48-week data from its PhaseOut DMD trial.

The PhaseOut DMD study is a phase II trial evaluating Ezutromid in Duchenne muscular dystrophy. The Company announced positive 24-week interim data from the PhaseOut DMD trial in January of this year.

But the 48 week results of the PhaseOut DMD trial reported on Wednesday have proved disappointing, and the Company is discontinuing its development of Ezutromid.

SMMT closed Wednesday's trading at $2.55, down 79.84%.

Zosano Pharma Corp. (ZSAN) will be presenting additional analyses from its Phase 2/3 clinical study of ADAM zolmitriptan (formerly M207) on pain relief by time and recurrence of migraine in subjects with pain relief at two hours on June 29, 2018.

The Phase 2/3 clinical study of ADAM zolmitriptan, dubbed ZOTRIP, the results of which were announced last February, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours.

A long-term safety study evaluating ADAM zolmitriptan, initiated last November, is underway. The NDA for ADAM zolmitriptan is expected to be filed in the fourth quarter of 2019.

ZSAN closed Wednesday's trading at $3.80, down 4.04%. In after-hours, the stock was up 11.32% to $4.23.

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