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No Respite For MiMedx, CNAT Fails NASH Trial, NDRA On Watch

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The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. MiMedx Group Inc. (MDXG.OB)

Lost 59.32% to close Thursday's (Dec.6) trading at $1.20.

News: Ernst & Young LLP has resigned from the engagement to audit MiMedx Group's financial statements for the years ended December 31, 2017 and 2018, effective immediately.

The Company also announced its plans to implement a broad-based organizational realignment, cost reduction and efficiency program to improve cost structure.
The Company's common stock was delisted from The Nasdaq Capital Market on November 8, 2018.

2. Conatus Pharmaceuticals Inc. (CNAT)

Lost 56.89% to close Thursday's trading at $1.94.

News: The Company's phase IIb clinical trial of Emricasan in patients with NASH Cirrhosis and severe portal hypertension, dubbed ENCORE-PH, did not meet the primary endpoint.

The trial's primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three Emricasan dosing groups (5mg, 25mg or 50mg) compared with placebo.

3. ENDRA Life Sciences Inc. (NDRA)

ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS) system that will help clinicians to visualize tissue function, composition, and monitor a variety of therapeutic interventions at the point of care. The first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease.

Lost 20.82% to close Thursday's trading at $2.32.

News: No news

Recent event:

On November 13, the Company closed its underwritten public offering of 1.21 million shares of common stock at an offering price of $3.90 per share.

The underwriter exercised in full its over-allotment option to purchase an additional 180,750 shares of common stock. The gross proceeds from the public offering were approximately $5.4 million.

Near-term Catalyst:

The first human studies with the TAEUS clinical system targeting Non-Alcoholic Fatty Liver Disease are expected to yield results in December 2018.

4. Novan Inc. (NOVN)

Lost 16.14% to close Thursday's trading at $1.32.

News: No news

Recent event:

On November 14, 2018, the Company announced positive preliminary top line results for three full cohorts of four from its Phase 2 clinical trial to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum.

SB206 gel demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12, with signs of efficacy evident as early as Week 4 for the two highest doses, 8% and 12% twice-daily.

Near-term Catalysts:

Results for Cohort 4, SB206 12% once-daily, are targeted to be announced in December.
End-of-Phase 2 meeting to be requested in 4Q 2018 and Phase 3 program of SB206 gel is expected to begin in 1H 2019.

5. Celyad SA (CYAD)

Lost 13.94% to close Thursday's trading at $21.30.

News: No news

Recent event:

On December 4, the Company presented updated clinical data for the CYAD-01 program in hematological malignancies.

The data involved interim analysis for relapsed or refractory (r/r) acute myeloid leukemia patients across the three dose levels of CYAD-01 without preconditioning from a phase I trial, dubbed THINK.

According to Christian Homsy, CEO of Celyad, preliminary data from 14 patients with relapsed or refractory AML enrolled in the THINK trial have exceeded their expectations with five out of eight patients treated with CYAD-01 without preconditioning demonstrating a relevant anti-leukemic activity.

Near-term Catalysts:

-- Full results from the THINK Phase 1 trial are anticipated during first half 2019.
-- Preliminary data from DEPLETHINK Phase 1 trial are expected in mid-2019.

DEPLETHINK is a phase I trial evaluating A single injection of CYAD-01 following treatment with the standard preconditioning regimen of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu In relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.

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