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FDA Places XNCR Trial On Hold, ABIO Abuzz, Mark Your Calendar For SRPT

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Today's Daily Dose brings you news about Achieve Life Sciences' progress in ORCA-1 trial; Agios Pharma's near-term regulatory catalyst; new development related to ARCA biopharma's PRECISION-AF pivotal study; financial outlook of Genomic Health and NuVasive; near-term clinical trial catalyst of Sarepta; and partial clinical hold on Xencor's phase I acute myeloid leukemia trial.

Read on...

Achieve Life Sciences Inc. (ACHV) has completed full enrollment in its ORCA-1 trial.

The ORCA-1 trial is a phase IIb optimization trial evaluating various dosing schedules of Cytisinicline for smoking cessation and potentially other addiction indications.

The topline efficacy and safety data from the ORCA-1 study are expected to be announced in mid-2019.

ACHV closed Wednesday's trading at $1.58, down 9.20%. In after-hours, the stock was up 3.16% to $1.63.

Agios Pharmaceuticals Inc.'s (AGIO) supplemental New Drug Application for TIBSOVO for the treatment of patients with newly diagnosed acute myeloid leukemia with an isocitrate dehydrogenase 1 (IDH1) mutation not eligible for standard therapy has been accepted for priority review by the FDA.

The regulatory agency's decision date action is set for June 21, 2019.

TIBSOVO received FDA approval for the treatment of patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation last July. The drug brought home net revenue of $13.8 million for Agios Pharma in full-year 2018.

AGIOS closed Wednesday's trading at $57.88, up 0.29%.

Shares of ARCA biopharma Inc. (ABIO) rose over 31% on Wednesday, following an agreement with the FDA regarding a Special Protocol Assessment on the design of a pivotal phase III clinical trial, PRECISION-AF.

The PRECISION-AF is evaluating the safety and efficacy of Gencaro as a genetically-targeted treatment for atrial fibrillation (AF) in patients with a specific type of heart failure (HF).

In accordance with the Company's Special Protocol Assessment agreement with FDA, PRECISION-AF is designed as a single, adequate and well-controlled Phase 3 clinical trial that may be sufficient to support a New Drug Application (NDA) submission for an AF indication if the objectives of the trial are achieved consistent with the requirements of the SPA.

ABIO closed Wednesday's trading at $0.50, up 31.27%. In after-hours, the stock was up 8.86% to $0.55.

Genomic Health Inc. (GHDX) has provided a rosy outlook for the full year ending December 31, 2019.

Revenue for 2019 is expected to be in the range of $436 million to $448 million, and non-GAAP EPS is anticipated to range between $1.38 and $1.54. Analysts polled by Thomson Reuters expect the Company to report revenue of $438.82 million and EPS of $1.25 for the full year of 2019.

GHDX closed Wednesday's trading at $83.66, up 1.23%. In after-hours, the stock was up 2.86% to $86.05.

Hoth Therapeutics Inc. (HOTH) has closed its initial public offering of 1.25 million shares of its common stock at an initial offering price of $5.60 per share.

The aggregate gross proceeds from the offering are $7.0 million.

The underwriters have a 30-day option to purchase up to an additional 187,500 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments, if any.

Hoth Therapeutics is a development stage biopharmaceutical company focused on targeted therapeutics for patients suffering from conditions such as atopic dermatitis, also known as eczema.

HOTH closed Wednesday's trading at $7.90, up 11.90%.

Inovio Pharmaceuticals Inc. (INO) announced that the first subject has been dosed as part of the first-ever human study evaluating its DNA-encoded monoclonal antibody (dMAb) INO-A002 to prevent or treat Zika virus infection.

The trial will enroll up to 24 healthy volunteers who will receive up to four doses of INO-A002.

For the Zika dMAb trial, Inovio is partnered with The Wistar Institute with grant funding from the Bill & Melinda Gates Foundation.

INO closed Wednesday's trading at $3.75, up 1.63%.

NuVasive Inc. (NUVA) has forecast 2019 revenue and earnings, which fall short of analysts' estimate.

The Company estimates revenue for the full year 2019 to be in the range of $1.14 billion to $1.16 billion, while analysts are expecting revenue of $1.17 billion. Revenue in 2018 was $1.10 billion.

On a non-GAAP basis, earnings for 2019 are expected to be in the range of $2.20 to $2.30 per share, which are also below analysts' consensus estimate of $2.47 per share. The non-GAAP EPS in 2018 was $2.23.

NUVA closed Wednesday's trading at $55.42, down 3.35%. In after-hours, the stock fell another 1.66% to $54.50.

Sarepta Therapeutics Inc. (SRPT) is all set to announce results from the first 3-patient cohort of its phase I/IIa gene transfer clinical trial of MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy) on February 27, 2019.

Limb-Girdle Muscular Dystrophy Type 2E is a rare genetic disease characterized by childhood to adolescent onset of progressive pelvic- and shoulder-girdle muscle weakness(Source: NIH).

SRPT closed Wednesday's trading at $140.57, up 0.22%. In after-hours, the stock was up 1.91% to $143.25.

Xencor Inc.'s (XNCR) phase I study of XmAb14045 in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies has been placed on partial clinical hold by the FDA due to safety concerns.

There have been two patient deaths in the trial that were considered at least possibly related to XmAb14045. One patient experienced cytokine release syndrome (CRS) after their first dose, the treatment of which was complicated by the patient's decision to withdraw care. One patient developed acute pulmonary edema following several doses of XmAb14045, according to the Company.

Patients currently on treatment and benefiting from treatment may continue treatment on the study. But no new patients will be allowed to enroll in the study until the partial clinical hold is lifted by the FDA.

XNCR closed Wednesday's trading at $33.72, down 6.54%.

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