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MESO Awaits Next Catalyst, EC Nod For Blincyto, EOLS, BHC To Face FDA In Feb.

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Today's Daily Dose brings you news about Adverum's progress on ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration; European Commission approval of Amgen's expanded indication for BLINCYTO; Bausch Health's regulatory catalyst for February and Mesoblast's fourth quarter financial results.

Read on...

Adverum Biotechnologies Inc. (ADVM) expects to initiate a phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration in the fourth quarter of 2018.

The trial will enroll 18 patients and will evaluate three doses of ADVM-022; first dose: 6 x 10^11 vg/eye, second dose: 2 x 10^12 vg/eye, and third dose: 6 x 10^12 vg/eye. The primary endpoint of the trial is the safety and tolerability of ADVM-022 at 24 weeks after a single IVT injection.

ADVM closed Wednesday's trading at $6.12, up 4.70%.

The European Commission has approved Amgen's (AMGN) expanded indication for BLINCYTO as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative relapsed or refractory B-Cell precursor Acute Lymphoblastic Leukemia.

BLINCYTO was approved in the EU for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL in November 2015.

In the U.S., the drug is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.

AMGN closed Wednesday's trading at $199.75, up 0.57%.

Bausch Health Companies Inc.'s (BHC) (BHC.TO) resubmitted New Drug Application for DUOBRII Lotion for the topical treatment of plaque psoriasis has been accepted for review by the FDA, with a decision expected on February 15, 2019.

DUOBRII Lotion was turned down by the FDA in June of this year. The Complete Response Letter issued by the regulatory agency had not specified any deficiencies related to the clinical efficacy or safety of DUOBRII or issues with Chemistry, Manufacturing and Controls processes. The CRL only noted questions regarding pharmacokinetic data.

BHC closed Wednesday's trading at $23.39, down 0.30%.

Evolus Inc.'s (EOLS) resubmitted Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450) has been accepted for review by the FDA, with a decision date set for February 2, 2019.

PrabotulinumtoxinA is being developed for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan's (AGN) Botox.

In May of this year, the FDA rejected the Company's Biologics License Application for prabotulinumtoxinA citing the deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes. The deficiencies were not related to clinical or non-clinical matters.

EOLS closed Wednesday's trading at $23.80, up 17.65%.

Mesoblast Limited (MESO) has reported strong financial results and provided operational highlights for the fourth quarter and full-year ended June 30, 2018.

The net loss attributable to ordinary shareholders was US$35.3 million, or 7.58 cents loss per share, for FY2018, compared with US$76.8 million, or 19.25 cents loss per share, for FY2017. Revenues were US$17.3 million for FY2018 compared with US$2.4 million for FY2017.

You can find more about MESO in our article titled "Will MESO Have A Blast This Quarter?" posted on August 23.

MESO closed Wednesday's trading at $5.98, up 3.10%.

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