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21.09.2018 04:15:40

Hot TLRY Cooling Off, ITRM On Watch, OMED To Report Phase Ib Data In Oct.

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

1. Tilray Inc. (TLRY)

Lost 17.62% to close Thursday's (Sep.20) trading at $176.35. The stock had touched an all-time high of $300 in intraday trading yesterday, and that represents a gain of nearly 1,240% in 2 months.

News: No news

Recent events:

On September 20, IntelGenx signed a Letter of Intent with Tilray to enter into a world-wide agreement to produce cannabis-infused VersaFilm products.

On Sep.18, the U.S. Drug Enforcement Administration approved the import of a pharmaceutical-grade medical cannabis product produced by Tilray into the United States for a clinical trial focused on Essential Tremor.

Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol (CBD) and tetrahydrocannabinol (THC).

The study is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation.

RTTNews has been regularly updating the share price movement of Tilray since its market debut on July 19, 2018.

2. Delcath Systems Inc. (DCTH)

Lost 16.94% to close Thursday's trading at $7.21, pulling back from Wednesday's gain of 55%.

News: No news

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.

Recent event:

On August 28, the Company announced that it completed the initial rights offering period and will be extending for an additional 30-day period, until 5:00 PM Eastern time on September 26, 2018.

3. Iterum Therapeutics plc (ITRM)

Lost 16.83% to close Thursday's trading at $6.87.

News: No news

Clinical trials:

Three phase III trials are underway namely, SURE 1, SURE 2, and SURE 3. Top-line results from all the three studies are expected in the second half of 2019.

In SURE 1, oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI).

In SURE 2, IV sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to IV ertapenem followed by oral ciprofloxacin in adults with complicated urinary tract infections (cUTI).

In SURE 3, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults with complicated intra-abdominal infections (cIAI).

Near-term Catalyst:

Clinical data on sulopenem, the Company's novel oral and IV penem antibiotic will be presented in poster sessions at IDWeek 2018 on October 5.

4. OncoMed Pharmaceuticals Inc. (OMED)

Lost 14.29% to close Thursday's trading at $2.40.

News: Due to strategic product portfolio considerations, Celgene has decided not to exercise its option to license OncoMed's bispecific antibody Navicixizumab.

OncoMed is currently conducting a Phase 1b clinical trial of Navicixizumab in combination with paclitaxel in patients with platinum-resistant late-stage ovarian cancer. Interim Phase 1b data will be presented in a poster presentation on October 20, 2018.

Celgene continues to retain its options to license OncoMed's Etigilimab and Rosmantuzumab under the collaboration.

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