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FPRX Advances FIGHT, SIGA Secures BARDA Contract, TRVN Faces FDA Panel In Oct.

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Today's Daily Dose brings you news about Applied Genetic's near-term catalyst; Centric Health's new contract; SIGA's $629 million, multi-year contract with BARDA; the FDA panel review date of Trevena's Oliceridine injection, and Xenon's agreement with Bausch Health related to epilepsy drug candidate.

Read on...

Applied Genetic Technologies Corp. (AGTC) expects to provide topline interim six-month data from its phase I/II clinical trial of its investigational AAV-based gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP) by the end of 2018.
The XLRS product candidate is being developed as part of the Company's collaboration with Biogen.

AGTC closed Monday's trading at $4.30, down 3.37%.

Centric Health Corp. (CHH.TO) has been awarded a new contract to service over 900 new beds with a multi-site regional operator.

Earlier this quarter, the Company secured contracts to service approximately 1,400 new beds. The Company now expects to service approximately 31,000 beds by the end of 2018, representing an increase of 8% in reported beds compared to June 30, 2018.

CHH.TO closed Monday's trading at C$0.34, down 1.45%.

Five Prime Therapeutics Inc. (FPRX) has completed the phase I safety lead-in portion and has initiated the phase III portion of the FIGHT phase I/III clinical trial of Bemarituzumab (FPA144) in combination with chemotherapy in patients with previously untreated, advanced gastric cancer or gastroesophageal junction cancer.

The Company plans to submit Phase 1 lead-in data for presentation at medical conference in the first half of 2019.

FPRX closed Monday's trading at $13.06, down 0.31%.

KalVista Pharmaceuticals Inc. (KALV) has closed its previously announced underwritten public offering of 4.6 million shares, which included the exercise in full by the underwriters of their over-allotment option to purchase 600,000 additional shares of common stock, at a price to the public of $17.00 per share.

The gross proceeds to KalVista were approximately $78.2 million.

Clinical Trials & Near-term Catalysts:

-- The Company's most advanced program is KVD001, an intravitreally administered plasma kallikrein inhibitor, under phase II trial in patients with diabetic macular edema, with data expected to be reported in the second half of 2019.
-- A phase II trial of KVD900 as an on-demand treatment for acute Hereditary Angioedema attacks is expected to be initiated in late 2018, with completion anticipated in mid-2019.

KALV closed Monday's trading at $16.92, down 3.53%.

SIGA Technologies Inc. (SIGA) has signed a $629 million, multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for the delivery of oral and intravenous (IV) formulations of TPOXX to the Strategic National Stockpile.
Oral TPOXX, a small molecule antiviral treatment for smallpox, received FDA approval on July 13, 2018.

The contract also covers advanced development of the IV formulation and post-marketing activities for the oral formulation of TPOXX.

The contract consists of a five-year base period of performance and a total contract period of performance (base period plus option exercises) of up to ten years (if necessary). The contract contains base period activities and a series of options, and is designed to maintain a stockpile of 1.7 million courses of antiviral treatment for smallpox.

SIGA closed Monday's trading at $7.05, down 2.76%.

Trevena Inc.'s (TRVN) New Drug Application for Oliceridine injection for the management of moderate to severe acute pain is scheduled to be reviewed by an FDA panel on October 11, 2018.

As previously announced, the FDA's final decision on Oliceridine injection is set for November 2, 2018.

TRVN closed Monday's trading at $1.71, up 1.18%.

Xenon Pharmaceuticals Inc. (XENE) has entered into an agreement with Valeant Pharmaceuticals Luxembourg S.a.r.l. and Valeant Pharmaceuticals Ireland Limited, indirect subsidiaries of Bausch Health Companies Inc., (BHC), to buy out all milestone payments and royalties with respect to XEN1101, being developed by Xenon for the treatment of epilepsy.

The agreement terminates all of Xenon's future financial obligations to Bausch Health, including up to $39.6 million in potential clinical development, regulatory and sales-based milestones and a mid-to-high single digit percentage royalty on commercial sales in exchange for a one-time payment of $6.0 million.

However, Xenon remains responsible for future potential payments to 1st Order Pharmaceuticals Inc. of $0.5 million in clinical development milestones, up to $6.0 million in regulatory milestones for multiple indications and $1.5 million in other milestones, which may be payable pre-commercially. There are no royalty obligations to 1st Order. XEN1101, previously known as 1OP2198, was acquired by Xenon from 1st Order Pharma in April 2017.

Initiation of a phase II clinical trial of XEN1101 as a treatment for adult focal seizures is expected in the fourth quarter of 2018.

XENE closed Monday's trading at $14.70, up 3.16%.

by RTTNews Staff Writer

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