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FDA Panel Backs Xeljanz For UC, ACRX Abuzz, AGLE Awaits Data This Month

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Today's Daily Dose brings you news about AcelRx's resubmission of DSUVIA NDA, Aeglea's progress in Pegzilarginase clinical trials, Medicines Co.'s ORION-10 trial, OncoMed's pending clinical trial catalysts, FDA panel's recommendation of Pfizer's Xeljanz for ulcerative colitis and Progenics' near-term catalyst.

Read on…

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

The Company plans to resubmit its NDA for DSUVIA in the second quarter of this year.

DSUVIA, known as known as DZUVEO outside the United States, is designed to reduce moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator in medically supervised settings. DSUVIA was denied FDA approval last October.

An FDA panel is expected to review the DSUVIA NDA in the third quarter of this year.
The Company expects EMA's Committee for Medicinal Products for Human Use to announce its opinion on the Marketing Authorization Application for DZUVEO in the first half of this year.

Another regulatory event planned for this year is the resubmission of Zalviso NDA in the second half of 2018.

Zalviso is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting. It was turned down by the FDA in July 2014.

ACRX closed Thursday's trading at $1.90, up 11.76%. In after-hours, the stock was up 15.79% to $2.20.

Aeglea BioTherapeutics Inc. (AGLE) has dosed the first uveal and cutaneous melanoma patients in its open-label Phase 1 cohort expansions with Pegzilarginase (AEB1102).

The topline data, including safety and clinical activity, are expected in the fourth quarter of 2018.

A Phase 1/2 trial and a long term extension study of Pegzilarginase in patients with Arginase 1 Deficiency, a rare genetic disease, is underway. This trial is designed to enroll approximately 10 patients, adult and pediatric, with Arginase 1 Deficiency in the United States, Canada, and Europe. The trial investigates both single ascending doses (Part 1) and repeated dosing (Part 2).

The phase 1/2 Adult Repeat Dose Data is expected this month.

AGLE closed Thursday's trading at $8.85, up 16.45%.

Servier and Pfizer Inc. (PFE) announced that the results from CALM and PALL, two phase I trials with UCART19, a CAR T-cell product, will be presented on March 21, 2018 during the European society for Blood and Marrow Transplantation Annual Meeting.

Servier acquired the exclusive rights to UCART19 from Cellectis S.A. (CLLS) in November 2015.

The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL.

CLLS closed Thursday's trading at $33.63, down 0.30%.

The Medicines Co. (MDCO) has reached the enrollment target of randomizing over 1,500 patients in its ORION-10 trial, ten weeks ahead of its schedule.

The ORION-10 is a phase III trial designed to confirm the efficacy and safety of Inclisiran in reducing LDL-cholesterol in patients with atherosclerotic cardiovascular disease.

Two other trials namely ORION-9 in heterozygous familial hypercholesterolemia (HeFH) performed in North America, Europe and South Africa, and ORION-11 in atherosclerotic cardiovascular disease performed in Europe completed enrollment earlier this year - also ahead of schedule.

The data read-out from the three trials is expected in the third quarter of 2019.

A fourth pivotal Phase III study of Inclisiran in patients with homozygous familial hypercholesterolemia (HoFH), ORION-5, is expected to enroll patients beginning later in 2018.

MDCO closed Thursday's trading at $33.60, up 3.26%.

Ocular Therapeutix Inc. (OCUL) is on track for a resubmission of its NDA for DEXTENZA for the treatment of ocular pain following ophthalmic surgery in the first half of 2018.

DEXTENZA was issued a Complete Response Letter last July.

A phase III trial of OTX-TP (travoprost insert) for mild to moderate glaucoma is underway, with topline efficacy results expected in the fourth quarter of 2018.

OCUL closed Thursday's trading at $5.86, down 1.51%.

OncoMed Pharmaceuticals Inc. (OMED) has a couple of catalysts to watch out for in the second half of this year.

A phase Ia single agent study of OMP-313M32 in advanced or metastatic solid tumors continues to enroll patients. Data from this trial is expected in the 4th quarter of 2018.

The Phase 1b portion of this trial, which will evaluate OMP-313M32 in combination with anti-PD1, is expected to begin in the first half of 2018.

The other clinical trials progressing are:

-- A phase 1a single agent study of OMP-336B11 in patients with advanced or metastatic solid tumors. Enrollment in this study is ongoing. The presentation of data from this Phase 1 study is currently planned for 2019.

-- Two phase 1b dose escalation and expansion studies of Navicixizumab in combination with standard-of-care chemotherapies - one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior Avastin and a second in patients with 2nd line metastatic colorectal cancer. Enrollment is continuing in both the studies, and interim data are expected in the 2nd half of 2018.

OMED closed Thursday's trading at $3.08, up 6.94%.

A panel of outside experts convened by the FDA has recommended approval of Pfizer Inc.'s (PFE) Xeljanz in the expanded indication of ulcerative colitis.

Xeljanz, an oral Janus kinase (JAK) inhibitor, is already indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and adult patients with active psoriatic arthritis.

The global annual sales of Xeljanz totaled $1.35 billion in 2017, up from $927 million in 2016.

The final decision of the FDA on Xeljanz in the new indication of ulcerative colitis is expected in June of this year. The FDA usually follows the recommendations of its advisory panels, although it is not obligated to do so.

PFE closed Thursday's trading at $36.50, up 1.59%.

Progenics Pharmaceuticals Inc. (PGNX) has a couple of events to keep an eye on in the coming months.

The Company's NDA for AZEDRA is under FDA review, with a decision expected to be announced on April 30, 2018.

AZEDRA is proposed for the treatment of patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the U.S.

A phase III study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer, is underway, and top-line data is expected in the third quarter of 2018.

Enrollment in a phase 2/3 study of PyL, a PSMA-targeted PET/CT imaging agent, evaluating diagnostic accuracy in patients with recurrent and/or metastatic prostate cancer is expected to be completed in the second half of 2018. A second Phase 3 study of PyL in patients with biochemical recurrence of prostate cancer is expected to be initiated.

A phase 1 open-label dose escalation study of 1095, a small molecule radiotherapeutic that selectively binds to PSMA, in patients with metastatic castration-resistant prostate cancer (mCRPC) is enrolling patients.

The Company expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018.

PGNX closed Thursday's trading at $8.32, up 15.24%.

TherapeuticsMD Inc.'s (TXMD) New Drug Application for TX-001HR has been accepted for review by the FDA - with a decision expected on October 28, 2018.

TX-001HR is the company's investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

TXMD closed Thursday's trading at $5.38, up 3.66%. In after-hours, the stock was up 8.55% to $5.84.

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