ALDX Down But Not Out, BTX On Track, MNK Exploring New Use For Acthar

Today’s Daily Dose brings you news about Aldeyra’s allergic conjunctivitis trial results; BioTime’s HIV-associated lipoatrophy trial results; Catalyst Bio’s progress in hemophilia B program; Epizyme’s encouraging data from a phase II trial of Tazemetostat in follicular lymphoma or diffuse large B-cell lymphoma; Loxo’s follow-on public offering; Mallinckrodt exploring new use for H.P. Acthar Gel and Sorrento’s ZTlido plaster demonstrating superiority over EU reference product Versatis in adhesion.

Read on…

Aldeyra Therapeutics Inc.’s (ALDX) phase 2b clinical trial of topical ocular ADX-102 in patients with allergic conjunctivitis did not meet the primary endpoint of one-point improvement relative to control component.

However, the trial demonstrated statistically significant efficacy of 0.5% ADX-102 over vehicle in reducing ocular itching over one hour post-challenge, noted the Company.

Aldeyra currently plans to initiate phase III clinical testing with 0.5% ADX-102 following discussion with the regulatory authorities in the second half of this year.

ALDX closed Wednesday’s trading at $4.65, down 8.82%.

BioTime Inc.’s (BTX) European pivotal trial of Renevia for the treatment of HIV-associated lipoatrophy has met the primary endpoint of creating a sustained hemifacial volume at six months in the treated patients.

Facial wasting or facial lipoatrophy is the loss of subcutaneous fat from the face and is associated with medication for treatment of HIV infection. Signs of lipoatrophy include the loss of subcutaneous fat primarily in the temporal region and cheeks and this tends to produce an emaciated appearance.

Early data from the study that was reported last November indicated that Renevia was safely administered with no serious adverse events and 3-D imaging suggested that volumetric improvements were sustained through a one-year follow up.

The Company will be filing for Renevia CE Mark by the end of this year.

BTX closed Wednesday’s trading at $3.09, down 8.58%.


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