11.11.2019 09:29:58

What Awaits ASMB, DRRX, EIGR At The Liver Meeting?

(RTTNews) - The announcement of clinical trial results is a major market-moving event for pharma/biotech stocks. Listed below are some of the pharma/biotech stocks to watch out for today and tomorrow.

1. Selecta Biosciences Inc. (SELB)

Selecta is a clinical-stage biopharmaceutical company, and its lead product candidate is SEL-212 for the treatment of chronic severe gout.

What's on tap for today?

The Company will be presenting additional data from its completed phase II dose-ranging study of SEL-21 for the treatment of chronic refractory gout today, November 11, 2019.

Near-term Catalysts:

A phase II head-to-head study of Selecta's SEL-212 vs. KRYSTEXXA in gout patients refractory to conventional therapy, dubbed COMPARE, continues to enroll patients. The interim data from this study is expected in the first quarter of 2020, with top-line statistical superiority data expected by mid-2020.

The Company is scheduled to meet with the FDA regarding the design of the phase III clinical trial of SEL-212 in January 2020.

SELB closed Friday's trading at $1.39, down 9.74%.

2. Assembly Biosciences Inc. (ASMB)

Assembly Biosciences is a clinical-stage biotechnology company developing innovative therapeutics targeting the hepatitis B virus (HBV) and diseases associated with the microbiome, and its lead product candidate is ABI-H0731, a potent core inhibitor, for the treatment of HBV.

What's on tap for today?

Data from the ongoing phase II study evaluating the longer-term safety and efficacy of ABI-H0731 in combination with standard of care therapy, dubbed ABI-H0731-211 are slated to be presented at AASLD (American Association for the Study of Liver Diseases) on November 11, 2019.

The final 24-week data from Studies 201 and 202 are also slated to be presented today. Studies 201 and 202 are phase IIa trials evaluating ABI-H0731 for the treatment of HBV.

Data from the initial dose cohort in the Phase 1b trial of ABI-H2158 in HBV-infected subjects is also expected to be presented today. Full study data is anticipated in Q1 2020.

ASMB closed Friday's trading at $17.08, up 5.30%.

3. DURECT Corp. (DRRX)

DURECT is a biopharmaceutical company developing therapeutics for diseases with significant unmet need, including diseases with no approved treatments like alcoholic hepatitis (AH) and non-alcoholic steatohepatitis (NASH).

The lead product candidate is DUR-928, which in IV form is proposed for the treatment of alcoholic hepatitis, and in oral form is proposed for the treatment of Nonalcoholic steatohepatitis.

What's on tap for tomorrow?

The Company will be discussing the results of its recently completed phase IIa clinical trial of DUR-928 in patients with alcoholic hepatitis on November 12, 2019.

DRRX closed Friday's trading at $1.90, up 2.15%.

4. Kezar Life Sciences Inc. (KZR)

Kezar is a clinical-stage biotechnology company developing novel small molecule therapeutics for patients with autoimmune diseases and cancer. The lead drug candidate is KZR-616, a first-in-class immunoproteasome inhibitor for lupus nephritis.

What's on tap for tomorrow?

The updated results from Phase 1b, open-label, dose-escalation portion of the MISSION Study, are expected to be presented on November 12, 2019.

The MISSION Study is a phase 1b/II multi-center study of KZR-616.

The phase Ib portion is evaluating KZR-616 in patients with systemic lupus erythematosus, and the phase II portion is evaluating three separate doses of KZR-616 in patients with active proliferative lupus nephritis.

5. Eiger BioPharmaceuticals Inc. (EIGR)

Eiger is a late-stage biopharmaceutical company developing targeted therapies for serious rare and ultra-rare diseases.

The Company's lead program in Hepatitis Delta Virus (HDV) infection is Lonafarnib, under a phase III trial, dubbed D-LIVR Study. Lonafarnib is also being explored as a potential treatment for Progeria.

Another HDV drug candidate is Lambda, under a phase II monotherapy trial called LIMT HDV study and a phase IIa combo study, dubbed LIFT.

Last month, the Company reported encouraging interim end of treatment results from the LIFT study. The interim results indicated that in the LIFT study, the combination of oral Lonafarnib 50 mg and Ritonavir 100 mg twice daily resulted in more than 50% of patients achieving undetectable HDV RNA at Week 24 and 95% of patients achieving the primary endpoint.

What's on tap for tomorrow?

The Company will be making a late-breaking oral presentation of the phase II LIFT study on November 12, 2019. Late-Breaking abstracts contain new information.

Near-term Catalysts:

An NDA for Lonafarnib for Progeria and Progeroid Laminopathies is expected to be filed in the U.S. by year-end, followed by MAA submission in Europe in the first quarter of 2020.

The Company is scheduled to meet with the FDA regarding phase II Lambda monotherapy in Hepatitis Delta Virus in the first quarter of 2020.

EIGR closed Friday's trading at $10.97, up 1.57%.

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