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AGTC Awaits Gene Therapy Data, FDA Delays Decision On Elagolix, KPTI On Watch

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Today's Daily Dose brings you news about Applied Genetic's XLRS trial; new PDUFA data of Elagolix in endometriosis-associated pain; Intec Pharma's share offering; Karyopharm's near-term catalyst and disappointing results from Pfizer's ATLAS study.

Read on…

Applied Genetic Technologies Corp. (AGTC) has completed enrollment in its phase I/II study of its gene therapy product candidate for the treatment of x-linked retinoschisis (XLRS).

XLRP is an inherited condition that causes boys to develop night blindness by the time they are ten and progresses to legal blindness by their early forties. There are currently no FDA approved treatment options for this condition.

The gene therapy product candidate is being developed in collaboration with Biogen, and top line data are anticipated by Q4 2018 with the final analysis at the twelve-month time point.

AGTC closed Tuesday's trading at $3.85, up 2.67%.

AbbVie (ABBV) and Neurocrine Biosciences Inc. (NBIX) announced that the FDA has extended the decision date on the New Drug Application for Elagolix in endometriosis-associated pain by three months to Q3 2018.

The FDA decision on Elagolix was originally slated for Q2, 2018. Since the regulatory agency requires extended time to review additional information regarding the results of liver function tests for Elagolix, the decision date has been pushed back.

NBIX closed Tuesday's trading at $77.50, down 2.12%.

Shares of Intec Pharma Ltd. (NTEC) were down more than 12% in after-hours trading on Tuesday, following a proposed public offering of ordinary shares.

The Company also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of ordinary shares being offered to cover over-allotments.

The lead product candidate is Accordion Pill Carbidopa/Levodopa (AP-CD/LD), being developed for the treatment of severe symptoms in advanced Parkinson's disease patients, under phase III testing.

NTEC closed Tuesday's trading at $6.40, up 2.40%. In after-hours, the stock was down 12.50% to $5.60.

Karyopharm Therapeutics Inc. (KPTI) expects to report top-line data from the expanded STORM study cohort of oral Selinexor at the end of April 2018.

In the STORM study, which is a single-arm phase IIb trial, approximately 122 patients with heavily pretreated, penta-refractory myeloma receive 80mg oral Selinexor twice weekly in combination with 20mg low-dose dexamethasone, also dosed orally twice weekly.

KPTI closed Tuesday's trading at $12.76, up 6.33%.

NanoString Technologies Inc. (NSTG) has launched Breast Cancer 360 (BC 360) research panel, which provides a unique 360 degree view of the tumor, microenvironment and immune response.

The BC360 Panel is part of an expanding portfolio of comprehensive cancer research panels for the growing field of translational research and signature development, according to the Company.

NSTG closed Tuesday's trading at $8.74, up 5.43%.

Pfizer Inc.'s (PFE) phase III trial evaluating INLYTA as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy, dubbed ATLAS, has failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival.

An independent Data Monitoring Committee for the ATLAS study has recommended stopping the trial at a planned interim analysis due to futility.

In the U.S., INLYTA is approved for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. INLYTA is also approved by the European Medicines Agency (EMA) for use in the EU in adult patients with advanced RCC after failure of prior treatment with sunitinib or a cytokine.

PFE closed Tuesday's trading at $35.95, up 1.38%.

Zynerba Pharmaceuticals Inc. (ZYNE) has initiated a phase II study of ZYN002 in Developmental and Epileptic Encephalopathy, dubbed BELIEVE 1.

The study is designed to enroll 50 patients with confirmed DEE, about half of whom may have either Dravet or Lennox-Gastaut syndrome.

The Company expects to report top line results from the BELIEVE 1 study in 2019.

ZYNE closed Tuesday's trading at $9.15, up 3.16%.

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