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BLCM Surges As FDA Lifts Hold, SMMT Awaits Data In Q3, GEN Exits Texas

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Today's Daily Dose brings you news about AVITA Medical's investigational RECELL Autologous Cell Harvesting Device for second-degree burns; Arbutus' agreement with privately-held Roivant Sciences to develop RNA-based therapeutics; FDA lifting clinical hold on Bellicum's BPX-501 trials; Intec Pharma's share offering, and CEPI awarding $56 million to Inovio to advance vaccines against Lassa fever and MERS.

Read on…

Arbutus Biopharma Corp. (ABUS) has entered into an agreement with privately-held Roivant Sciences to launch Genevant Sciences, a jointly-owned company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics.

Genevant aims to advance 5-10 product candidates into the clinic by 2020 across RNAi, mRNA, and gene editing modalities using Arbutus' LNP and ligand conjugate platforms.

Genevant will be led by Executive Chairman Paris Panayiotopoulos, former CEO of ARIAD Pharmaceuticals. Bo Rode Hansen, Global Head of RNA Therapeutics at Roche, will be joining Genevant as President, Chief Scientific Officer, and Head of R&D.

ABUS closed Wednesday's trading at $5.25, down 0.94%.

AVITA Medical's (AVMXY.OB) results from a pivotal clinical trial demonstrating the effectiveness and clinical benefits of its RECELL Autologous Cell Harvesting Device in the treatment of deep partial-thickness (second-degree) burns were presented in the plenary session of the American Burn Association (ABA) 50th Annual Meeting in Chicago.

According to the trial results, burn sites treated with the RECELL Device required 97.5 percent less donor skin than burn sites treated with the standard of care, resulting in a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes.

The trial served as one of two pivotal trials used to support AVITA Medical's U.S. PreMarket Approval application for the treatment of burn injuries. The PreMarket Approval application for the RECELL Device for the treatment of burn injuries was submitted to the FDA last December.

AVMXY.OB closed Wednesday's trading at $0.93, down 2.99%.

Shares of Bellicum Pharmaceuticals Inc. (BLCM) rose more than 25% in after-hours trading on Wednesday, following news that the FDA has lifted the clinical hold on studies of BPX-501 in the U.S.

On January 31, 2018, the FDA imposed clinical hold on the Company's U.S. studies of BPX-501 due to three cases of encephalopathy deemed as possibly related to the drug candidate, which sent the shares down as much as 38% to $5.02 that day.

BPX-501 is under multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

BLCM closed Wednesday's trading at $6.85, up 1.48%. In after-hours, the stock was up 25.55% to $8.60.

Genesis HealthCare (GEN) is planning to sell 23 Texas skilled nursing facilities (22 buildings owned by Genesis and one leased) to Regency REIT, LLC.

The transaction is expected to close on or about July 1, 2018 and is subject to additional due diligence, regulatory and licensing approvals, and other customary conditions.

In addition to the 23 facilities expected to be divested in the Regency transaction, Genesis also plans to exit the operations of an additional leased skilled nursing facility. The two transactions will mark the Company's complete exit of its inpatient business in the state of Texas.

GEN closed Wednesday's trading at $1.62, up 10.96%.

Intec Pharma Ltd. (NTEC) slumped more than 17% on Wednesday, following the pricing of an underwritten public offering of 6.75 million of its ordinary shares at $5.25 each.

The gross proceeds of the offering are expected to be approximately $35.4 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

The offering is expected to close on or about April 13, 2018, subject to customary closing conditions. The underwriters have a 30-day option to purchase up to approximately 1.0 million additional ordinary shares 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 Wednesday's trading at $5.25, down 17.97%.

Inovio Pharmaceuticals Inc. (INO) has been awarded up to $56 million by the Coalition for Epidemic Preparedness Innovations to develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome (MERS).

The fund will help to support Inovio's pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine.

This is the second company agreement CEPI has signed since its launch in 2017. Last month, CEPI awarded $37.5 million to Themis Bioscience to advance vaccines against Lassa fever and MERS.

INO closed Wednesday's trading at $4.90, up 2.94%.

Summit Therapeutics plc (SMMT) expects to report 48-week data from its PhaseOut DMD trial in Q3, 2018.

PhaseOut DMD is a phase II 48-week trial evaluating Ezutromid in patients with Duchenne muscular dystrophy.

The Company announced positive 24-week interim data from the PhaseOut DMD trial in January of this year.

The Company had cash and cash equivalents of £20.1 million at January 31, 2018. Last month, gross proceeds of £15.0 million ($21.2 million*) were raised through a placing of new ordinary shares to investors in Europe.

SMMT closed Wednesday's trading at $13.37, down 0.07%.

by RTTNews Staff Writer

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