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XBIT Slumps To New Low, EVFM On Track, EKSO On Watch

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

1. XBiotech Inc. (XBIT)

Lost 16.91% to close Tuesday's (Sep.11) trading at $2.31.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase II clinical trial evaluating MABp1 (Bermekimab) in patients with moderate to severe Atopic Dermatitis is underway.
-- A phase II clinical study evaluating Bermekimab in patients with moderate to severe Hidradenitis Suppurativa is underway.
-- A physician-sponsored clinical research study being conducted to examine the safety of Bermekimab in combination with Onivyde and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients suffering from cachexia is ongoing. Clinical results from this study are expected to be reported later in 2018.

2. Bellerophon Therapeutics Inc. (BLPH)

Lost 16.41% to close Tuesday's trading at $1.07.

News: No news

Recent event:

On August 7, the Company announced that the Data Monitoring Committee has recommended stopping its Phase 3 INOvation-1 study evaluating INOpulse for the treatment of pulmonary arterial hypertension.

Based on the pre-specified interim analysis from the first 75 enrolled subjects in the INOvation-1 study, the Data Monitoring Committee concluded that the overall change in 6 minute walk distance, the primary endpoint of the trial, is insufficient to support the continuation of the study.

3. Evofem Biosciences Inc. (EVFM)

Lost 14.50% to close Tuesday's trading at $3.48.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.

Data from the phase III clinical trial of Amphora for the prevention of pregnancy are now expected in late 2018, ahead of its earlier guidance of Q1, 2019. If all goes well as planned, resubmit Amphora NDA for contraception in the first half of 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.

4. Xenetic Biosciences Inc. (XBIO)

Lost 12.59% to close Tuesday's trading at $2.50.

News: No news

Clinical Trials & Near-term Catalysts:

-- The lead program is XBIO-101, under phase II study for treatment of progesterone resistant endometrial cancer. Preliminary data from this study is expected this year.
-- A biomarker study with XBIO-101 for triple negative breast cancer is also being planned.

5. Ekso Bionics Holdings Inc. (EKSO)

Ekso is a robotic exoskeleton company offering technologies that help those with paralysis to stand up and walk.

Lost 11.52% to close Tuesday's trading at $2.15.

News: No news

Recent event:

On August 7, the Company reported financial results for the second quarter ended June 30, 2018.

Net loss applicable to common stockholders for the quarter ended June 30, 2018 was $8.0 million or $0.13 per share compared to $5.5 million or $0.22 per share for the quarter ended June 30, 2017. Revenue was $3.0 million for the recent second quarter, up from $1.9 million for the quarter ended June 30, 2017.

6. Tricida Inc. (TCDA)

Lost 11.33% to close Tuesday's trading at $34.89.

News: No news

Recent events:

On June 28, 2018, the Company went public on the Nasdaq Global Select Market, offering its shares at a price of $19.00 each.

Pipeline:

The lead drug candidate is TRC101, a non-absorbed, orally-dosed polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), which has completed phase III testing.

Upcoming Events and Projected Milestones:

-- Presentation of results from the pivotal Phase 3 clinical trial, TRCA-301, at the American Society of Nephrology (ASN) Kidney Week 2018 Meeting in October 2018.
-- Initiation of a non-branded disease education campaign focused on metabolic acidosis and the progression of CKD, including a mobile software app focused on helping nephrologists calculate the risk of CKD progression, at the ASN Kidney Week 2018 Meeting in October 2018.
-- Initiation of clinical study sites for the VALOR-CKD trial in the second half of 2018.
-- Completion of the 40-week safety extension trial, TRCA-301E, in the first half of 2019.
-- Availability of New Drug Application enabling 12-month registration stability data for TRC101 in mid-2019.
-- Submission of NDA for TRC101, seeking approval of TRC101 through the FDA's Accelerated Approval Program, in the second half of 2019.

by RTTNews Staff Writer

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