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ZFGN Hit By Clinical Hold, EQ For The Long Haul, MBOT On Watch

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

1. Zafgen Inc. (ZFGN)

Lost 40.55% to close Monday's (Nov.26) trading at $5.41.

News: The FDA has placed a clinical hold on the Investigational New Drug Application for the Company's first U.S. clinical trial of ZGN-1061 for the treatment of type 2 diabetes, citing the possibility of cardiovascular (CV) safety risk.

However, Zafgen continues to advance its ongoing ex-U.S. phase II clinical trial of ZGN-1061, which includes a 1.8 mg dose cohort. Dosing in this clinical trial was recently completed and, while still blinded, no CV safety signals have been observed to date. The Company remains on track to report topline data from this cohort in early 2019.

2. Tenax Therapeutics Inc. (TENX)

Lost 19.69% to close Monday's trading at $2.61.

News: No news

Clinical Trial:

A phase II trial of Levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF), dubbed H-E-L-P Trial, is underway.

3. ReShape Lifesciences Inc. (RSLS)

ReShape is a medical device company focused on technologies to treat obesity and metabolic diseases. It has two FDA-approved products, ReShape Intragastric Balloon and ReShape vBloc therapy.

Lost 19.20% to close Monday's trading at $1.01.

News: The Company has entered into definitive agreements with two healthcare focused institutional investors for the purchase of 8 million shares of its common stock and warrants to purchase 8 million shares of its common stock, at a purchase price of $1.25 per share and associated warrants, for gross proceeds of approximately $10 million, in a registered direct offering.

The closing of the offering is expected to take place on or about November 28, 2018, subject to the satisfaction of customary closing conditions.

4. Equillium Inc. (EQ)

Lost 14.25% to close Monday's trading at $16.67.

News: No news

Recent event:

On October 12, 2018, the Company went public on the Nasdaq Global Market, offering its shares at a price of $14.00 each.

Pipeline:

The Company's lead drug candidate is EQ001 with the potential for the treatment of acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD), severe asthma and at least one additional indication.

Near-term Catalysts:

-- Initiate a phase Ib/II clinical trial of EQ001 in patients with aGVHD in early 2019.
-- Initiate a phase II clinical trial of EQ001 in patients with cGVHD in the first half of 2019.
-- Initiate a proof-of-concept clinical trial of EQ001 in severe asthma in the first half of 2019.
-- Select a fourth indication for EQ001 in the first half of 2019.

5. Microbot Medical Inc. (MBOT)

Microbot Medical is a medical device company specializing in the design and development of transformational micro-robotic medical technologies.

Lost 13.21% to close Monday's trading at $1.84.

News: No news

Clinical Trials & Near-term Catalyst:

A follow up pivotal study to evaluate the safety and efficacy of the Company's Self-Cleaning Shunt for treating Hydrocephalus, also known as "water in the brain", was initiated as recently as last month. The Company believes the follow up study will continue to support the safety and efficacy of its Self-Cleaning Shunt product and plans to use the findings for its regulatory submissions in the US, Europe and other jurisdictions.

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