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MNK Awaits D-Day, AMEH In Good Health, AXSM To Report ASCEND Data In Jan.

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Today's Daily Dose brings you news about AbbVie's uterine fibroids trial results; Apollo Medical's third quarter financial results; Aldeyra Therapeutics' anticipated milestones; Axsome's progress in its ASCEND trial; BELLUS Health's near-term catalyst, and FDA panel's vote on Mallinckrodt's MNK-812.

Read on...

AbbVie (ABBV) says that two of its replicate pivotal phase III clinical trials evaluating the efficacy and safety of Elagolix in women with uterine fibroids have demonstrated the potential value of the drug as a future treatment for women with uterine fibroids.

In the trials, dubbed ELARIS UF-1 and ELARIS UF-2, at the final month of the six-month treatment period, Elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo.

Elagolix, sold under brand name ORILISSA, was approved by the FDA for the management of moderate to severe pain associated with endometriosis as recently as July 23, 2018.

Based on the phase III clinical trial program, the Company plans to expand the label of Elagolix for use in uterine fibroids, and a regulatory submission is anticipated in mid-2019.

Analysts expect Elagolix to reach blockbuster status by 2022.

ABBV closed Wednesday's trading at $88.31, up 0.10%.

Apollo Medical Holdings Inc. (AMEH) has reported 72% revenue growth in the third quarter of 2018.

Net income attributable to the Company grew to $9.1 million or $0.24 per share for the recent third from $5.6 million or $0.20 in the comparable period of 2017. Total revenue in the third quarter of 2018 was $167.3 million, up from $97.1 million in the comparable period of 2017, an increase of 72%.

AMEH closed Wednesday's trading at $18.77, up 4.86%.

Aldeyra Therapeutics Inc. (ALDX) has a couple of catalysts to watch out for in the coming year.

-- The Company expects results from ALLEVIATE Trial, a phase III clinical trial of topical ocular Reproxalap in an allergen challenge model of allergic conjunctivitis, in early 2019.
-- Results from SOLACE Trial, a phase III clinical trial of topical ocular Reproxalap in noninfectious anterior uveitis are expected in the second half of 2019.
-- Results from the first part of RESET Trial, a two-part, pivotal, randomized, multi-center, double-masked Phase 3 clinical trial of topical dermal reproxalap for the treatment of ichthyosis (scaly, thickened, dry skin) associated with Sjögren-Larsson Syndrome are expected in the second half of 2019.
-- Initiation of a Phase 3 clinical trial of topical ocular reproxalap in dry eye disease is expected in 2019.
-- Phase 1 clinical trial of ADX-629, for the treatment of systemic autoimmune disease, is expected to be initiated in 2019.
-- Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative syndrome expected to be initiated in 2019.
-- Phase 2 clinical trial of ADX-1612 in mesothelioma expected to be initiated in 2019, pending discussion with regulatory authorities.

ALDX closed Wednesday's trading at $8.93, down 11.50%.

Axsome Therapeutics Inc. (AXSM) has completed patient enrollment in ASCEND, a phase II trial of AXS-05 in major depressive disorder.

Topline results from the ASCEND trial are expected early January 2019.

AXSM closed Wednesday's trading at $2.82, down 2.76%.

BioXcel Therapeutics Inc.'s (BTAI) phase Ib study evaluating intravenously administered dexmedetomidine (Dex) for acute treatment of agitation in patients suffering from schizophrenia has yielded positive results.

The trial met its primary endpoint by identifying a safe dose of IV Dex that produced a mild arousable sedation, defined by a RASS1 (Richmond Agitation Sedation Scale) score of -1. Data from this study will guide BTI in selecting the optimal dose for BXCL501, a sublingual thin film formulation of Dex, for the acute treatment of agitation, the Company noted.

Results from the parallel study evaluating IV Dex in patients with senile dementia of Alzheimer's type (SDAT), are expected prior to year-end.

BTAI closed Wednesday's trading at $5.36, down 4.11%.

BELLUS Health Inc. (BLU.TO) expects top-line results from its phase I study of its lead drug candidate BLU-5937 for chronic cough to be reported by the end of this month.

The study is divided in two parts - a single-ascending dose ("SAD") study, which was conducted in 60 healthy subjects, and a multiple-ascending dose ("MAD") study, which was conducted in 30 healthy subjects.

BLU.TO closed Wednesday's trading at C$0.92, down 3.16%.

Celsion Corp.'s (CLSN) phase III study of ThermoDox for the treatment of primary liver cancer, dubbed OPTIMA, is fully enrolled, and the first pre-planned efficacy analysis is expected in mid-2019.

A phase I/II trial of GEN-1 for the localized treatment of ovarian cancer is currently enrolling patients, with data expected in Q1, 2019.

Cash and cash equivalents at September 30, 2018 was $3.37 million.

CLSN closed Wednesday's trading at $2.06, down 4.19%.

EDAP TMS SA (EDAP) has registered 14.2% revenue growth in the third quarter of 2018, thanks to expanding global commercial footprint of its lead device Focal One.

Net loss for the third quarter 2018 was EUR 0.7 million (USD 0.8 million) or EUR 0.02 per share compared to a net loss of EUR 0.5 million (USD 0.6 million) or EUR 0.02 per share in the year-ago period. Total revenue for the third quarter 2018 was EUR 8.1 million (USD 9.5 million), a 14.2% increase compared to EUR 7.1 million (USD 8.4 million) for the third quarter of 2017.

EDAP closed Wednesday's trading at $2.36, down 4.07%.

An FDA panel that reviewed Mallinckrodt plc's (MNK) MNK-812, an abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, has voted 10 to 7 to approve the investigational product.

The panel voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse, and also voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.

MNK-812 is being developed by SpecGx LLC, a subsidiary of Mallinckrodt.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The regulatory agency's final decision is slated for November 16, 2018.

MNK closed Wednesday's trading at $30.91, down 0.51%.

Sutro Biopharma Inc. (STRO) expects to commence a phase I clinical trial for STRO-002 focused on ovarian and endometrial cancers in early 2019.

The Company's lead drug candidate is STRO-001, currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.

The Company went public on The Nasdaq Global Market on September 27, 2018, offering its shares at a price of $15 each.

STRO closed Wednesday's trading at $11.62, down 12.63%.

Ultragenyx Pharmaceutical Inc. (RARE) plans to submit a New Drug Application to the FDA for UX007 for the treatment of patients with long-chain fatty acid oxidation disorders in mid-2019.

Long-chain fatty acid oxidation disorders are a group of autosomal recessive genetic disorders characterized by metabolic deficiencies in which the body is unable to convert long-chain fatty acids into energy. The inability to produce energy from fat can lead to severe depletion of glucose in the body, and serious liver, muscle and heart disease, which can lead to hospitalizations or early death.

RARE closed Wednesday's trading at $48.38, down 0.98%.

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