AGLE Falls On Analyst Downgrade, CNST On Watch, Busy Q4 Ahead For UMRX

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

1. Aeglea BioTherapeutics Inc. (AGLE)

Lost 15.46% to close Tuesday's (Sep.4) trading at $9.24.

News: Despite the Company presenting positive interim data from its ongoing Phase 1/2 trial of Pegzilarginase, its lead investigational therapy, in patients with the rare genetic disease Arginase 1 Deficiency (ARG1-D), the shares took a hit.

Wells Fargo & Co downgraded Aeglea BioTherapeutics to Market Perform from Outperform, and slashed the price target to $10 from $24.

Near-term Catalyst:

The design of the first pivotal clinical trial of Pegzilarginase in patients with ARG1-D is expected to be announced in the fourth quarter of 2018, with initiation of the trial planned in the first half of 2019.

2. Constellation Pharmaceuticals Inc. (CNST)

Lost 13.06% to close Tuesday's trading at $9.05.

News: The Company announced that Dr. Elizabeth G. Tréhu and Steven L. Hoerter have been appointed to its Board of Directors.

Recent event:

On July 19, 2018, the Company went public on the Nasdaq Global Select Market, offering its shares at a price of $15 each.

Clinical trials & Near-term Catalysts:

The lead product candidate of Constellation Pharma is CPI-1205, currently under a phase Ib/II clinical trial for the treatment of metastatic castration-resistant prostate cancer in combination with Xtandi or Zytiga, dubbed PROSTAR. The phase 1b portion of this trial is designed to enroll up to 36 patients. The proof of concept results of the PROSTAR trial is expected in mid-2019.

CPI-1205 is also being tested in a phase Ib/II clinical trial in combination with immune checkpoint inhibitors to treat solid tumors, dubbed ORIOn-E trial. The safety, pharmacokinetics, maximum tolerated dose and the recommended phase II dose in this trial are expected to be established by early 2019.

Also in the pipeline are:

-- CPI-0610, which is under a phase II clinical trial as a second-line treatment for patients with myelofibrosis, a progressive hematological cancer, as a monotherapy and in combination with ongoing ruxolitinib treatment, and

-- CPI-0209, which is under preclinical testing. The Company plans to initiate a Phase 1 clinical trial of this product candidate in solid tumors and/or hematological malignancies in 2019.

3. Unum Therapeutics Inc. (UMRX)

Lost 10.97% to close Tuesday's trading at $14.52.

News: No news

Near-term Catalysts:

-- Report preliminary data from ATTCK-20-03, a phase I clinical trial of ACTR707 in combination with Rituximab in patients with CD20+ relapsed or refractory non-Hodgkin lymphoma, in the fourth quarter of 2018.
-- The Company expects to have updated data, including preliminary data from the cohort expansion part of the ATTCK-20-2 trial by the end of 2018 and to report these at that time or in early 2019.

ATTCK-20-2 trial is a phase I study evaluating ACTR087 in combination with Rituximab in adult patients with CD20+ relapsed or refractory non-Hodgkin lymphoma.

-- Initiate clinical development of ACTR T cells used in combination with Trastuzumab for the treatment of patients with HER2+ advanced cancers by end of 2018.

4. DarioHealth Corp. (DRIO)

Lost 10.91% to close Tuesday's trading at $0.98.

News: No news

Recent events:

-- On August 22, the Company entered into an agreement with Attain Health, a provider of integrative health coaching for individuals living with cystic fibrosis, to pilot the DarioEngage platform for the management of cystic fibrosis related diabetes (CFRD).
-- On August 9, the Company reported financial results for the second quarter ended June 30, 2018.

In the second quarter of 2018, net loss was $5.8 million or $0.32 per share on revenue of $2.06 million. This compared with a net loss of $4.1 million or $0.43 per share and revenue of $1.2 million in the second quarter of 2017.

As of June 30, 2018, cash and cash equivalents totaled $5 million.

5. Dova Pharmaceuticals Inc. (DOVA)

Lost 8.96% to close Tuesday's trading at $23.17.

News: The Company has submitted a supplemental New Drug Application to the FDA for DOPTELET, seeking approval for the treatment of adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

DOPTELET received FDA approval in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

6. PolarityTE Inc. (COOL)

Lost 8.40% to close Tuesday's trading at $26.18.

News: No news

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.

Near-term Catalyst:

The Company is slated to report its fiscal third quarter 2018 financial results on September 12, 2018 at approximately 7:30 am Eastern Time.

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