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

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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%.

Catalyst Biosciences Inc. (CBIO) announced that dosing of first patient cohort in a phase 1/2 proof-of-concept clinical trial of CB 2679d/ISU304 in individuals with severe hemophilia B has been completed.

The trial is being conducted by the Company's collaborator ISU Abxis Co Ltd.

The Companies plan to have top line data from the trial by the end of 2017.

CBIO closed Wednesday's trading at $4.36, up 0.93%.

Epizyme Inc. (EPZM) on Wednesday reported positive interim efficacy data from its ongoing phase II trial of Tazemetostat as a single-agent treatment for relapsed or refractory patients with follicular lymphoma or diffuse large B-cell lymphoma.

According to the interim data as of June 1, 2017, the subset of follicular lymphoma patients with EZH2 activating mutations have a 92 percent objective response rate. Patients with follicular lymphoma with EZH2 wild-type have an objective response rate of 26 percent. Promising activity was also observed in diffuse large B-cell lymphoma patients with EZH2 mutations, which includes recently enrolled patients, with an objective response rate of 29 percent, added the Company.

EPZM closed Wednesday's trading at $12.35, up 10.76%.

Loxo Oncology Inc. (LOXO) has priced its underwritten public offering of 3.15 million shares of common stock at $72.00 per share. The gross proceeds to Loxo Oncology from this offering are expected to be approximately $226.8 million. The offering is expected to close on June 20, 2017.

The underwriters have a 30-day option to purchase up to an additional 472,500 shares of its common stock.

The Company's lead product candidate is Larotrectinib (LOXO-101), and the following clinical trials are underway with this compound.

-- A phase 1/2 study in pediatric patients with advanced solid or primary Central Nervous System tumors, dubbed SCOUT.
-- A phase II study in patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3, dubbed NAVIGATE
-- A phase I study in adult subjects with advanced solid tumors that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.

Also in the pipeline are:

LOXO-292, under phase 1 trial in patients with advanced solid tumors, and LOXO-195 to treat patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as larotrectinib, which is all set to enter into phase 1/2 trial.

LOXO closed Wednesday's trading at $74.76, up 1.51%.

Mallinckrodt plc (MNK) has enrolled the first patient in its phase IIb study designed to assess the efficacy and safety of H.P. Acthar Gel as a treatment for amyotrophic lateral sclerosis.

The study, dubbed PENNANT, will enroll patients ages 18 to 75 with amyotrophic lateral sclerosis and symptom onset who will be randomized on a 2:1 basis to receive subcutaneous (SC) H.P. Acthar Gel 0.2 mL (16 units) daily or SC matching placebo 0.2 mL daily for 36 weeks.

H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications, including infantile spasms and multiple sclerosis. The drug, which used to cost $40 a vial in 2001, is now priced at $34,000 per vial, according to reports.

The net sales of H.P. Acthar Gel were $1.16 billion in fiscal year 2016, up nearly 12% over the prior year.

MNK closed Wednesday's trading at $42.15, down 2.34%.

Pfizer Inc. (PFE) has been granted exclusive commercialization rights in Europe for antifungal CRESEMBA by Basilea Pharmaceutica Ltd.

CRESEMBA is indicated for treatment for adult patients with diagnosed invasive aspergillosis and mucormycosis, two serious infections associated with high morbidity and mortality among immunocompromised patients.

The European countries where Pfizer will have exclusive rights to distribute and commercialize CRESEMBA include Austria, France, Germany, Italy and the United Kingdom, where it is currently available.

In addition, Pfizer will be responsible for additional CRESEMBA launches, predominantly in Europe, which are expected throughout 2017 and 2018. Basilea will remain the marketing authorization holder for the European Union.

PFE closed Wednesday's trading at $32.69, up 0.34%.

Sorrento Therapeutics Inc.'s (SRNE) subsidiary SCILEX Pharmaceuticals Inc. announced that its investigational medicated plaster, ZTlido, has demonstrated superior adhesion against the EU reference product Versatis during a recently completed comparative adhesion performance study.

ZTlido is under development for the treatment of postherpetic neuralgia.

SCILEX plans to resubmit the NDA for ZTlido to the FDA and the MAA to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and other member states (EU countries) in the second half of 2017.

SRNE closed Wednesday's trading at $1.75, up 9.37%.

TG Therapeutics Inc.'s (TGTX) updated clinical data from its ongoing Phase I/Ib trial of TGR-1202 in combination with ibrutinib in patients with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma seems to be promising.

According to the updated data, the combination of TGR-1202 plus ibrutinib appears well tolerated with no Grade 3/4 transaminitis, pneumonitis, diarrhea, or colitis observed, with longest patients on study 29.5+ months.

About 94% of CLL patients achieved a Complete Response (CR), Partial Response (PR), or a Partial Response with lymphocytosis (PR-L), and there was a 79% ORR (objective response rate) in patients with MCL, including 1 patient with a CR and 1 additional patient with a radiographic CR, revealed the Company.

TGTX closed Wednesday's trading at $11.20, up 5.16%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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