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TGTX Slumps On UNITY-CLL Trial Update, CKPT On Watch, XBIO Awaits Data This Year

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

1. TG Therapeutics Inc. (TGTX)

Lost 44.32% to close Tuesday's (Sep.25) trading at $5.15.

News: The interim analysis of Overall Response Rate in the Company's UNITY-CLL trial could not be conducted as the data were not sufficiently mature to conduct the analysis.

UNITY-CLL is a global phase III clinical trial comparing the combination of Ublituximab plus Umbralisib, or U2, to an active control arm of Obinutuzumab plus Chlorambucil in patients with both treatment naïve and relapsed or refractory Chronic Lymphocytic Leukemia (CLL).

Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics stated, "While we are disappointed that we were not able to report positive ORR today, we feel that making the decision to focus on PFS, the primary endpoint for the study, is an important step to getting everyone aligned on the endpoint of this study that matters most to the Company and its long-term shareholders. From a timing standpoint, we could have a PFS read out in 2019, and we remain extremely optimistic about the prospects for a successful PFS result".

2. Delcath Systems Inc. (DCTH)

Lost 23.83% to close Tuesday's trading at $3.58.

News: No news

The rights offering subscription period expires Wednesday, September 26, 2018.

Under the terms of the rights offering, Delcath distributed, at no charge, non-transferable subscription rights to purchase 500 shares of its common stock to holders of record for each share of common stock held on the record date, and to holders of its warrants to purchase common stock. Each basic subscription right entitles the right holder of record to purchase 500 shares of common stock at the subscription price of $1.75 per share.

Pipeline:

The Company's investigational product - Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) - is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.

A global phase III trial of Melphalan/HDS for patients with Hepatic Dominant Ocular Melanoma, dubbed FOCUS, and a registration trial, called ALIGN, for intrahepatic cholangiocarcinoma are underway.

Melphalan/HDS is yet to be approved by the FDA. However, in Europe, it has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT Delivery System, where it has been used at major medical centers to treat a wide range of cancers of the liver.

3. Xenetic Biosciences Inc. (XBIO)

Lost 20.60% to close Tuesday's trading at $2.89.

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.

4. Verastem (VSTM)

Lost 19.98% to close Tuesday's trading at $7.15. The stock has gained 200% year-to-date.

News: No news

Recent event:

On September 24, the FDA approved the Company's COPIKTRA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.

COPIKTRA (duvelisib) also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The drug will be available in the U.S. market immediately, the Company noted.

5. Checkpoint Therapeutics Inc. (CKPT)

Lost 19.12% to close Tuesday's trading at $3.68.

News: The Company presented positive preliminary safety and efficacy data from an ongoing phase I/II clinical trial of CK-101 in EGFR mutation-positive NSCLC patients were presented.

The stock has gained 89% in the last two months.

A phase III trial of CK-101 in EGFR mutation-positive NSCLC patients is expected to be initiated in 2019.

Amended : The earlier version incorrectly included XBiotech Inc.'s (XBIT) pipeline under Xenetic Biosciences Inc. (XBIO).

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