FDA Approves 1st Cannabis-Based Drug, TECH Opens Wallet Again, MACK, SPHS Plunge

pharma daily 062518

Today's Daily Dose brings you news about the new additions in the Russell 3000 Index; Citron's take on PolarityTE; Xeris Pharma's promising data from phase 3 clinical studies on liquid glucagon; Bio-Techne's acquisition; FDA approval of the first cannabis-based drug; Merrimack's disappointing CARRIE study results and a patient's death in Sophiris' prostate cancer study.

Read on...

Bio-Techne Corp. (TECH) is all set to acquire Exosome Diagnostics Inc. for $250 million in cash plus contingent consideration of up to $325 million due upon the achievement of certain future milestones. The transaction is expected to close in July or early August 2018.

This acquisition marks the second in the month. On June 7, the Company acquired all of the stock of QT Holdings Corporation d/b/a Quad Technologies.

In January of this year, the Company acquired Atlanta Biologicals Inc. and its affiliated company, Scientific Ventures Inc.

TECH closed Monday's trading at $158.25, down 1.99%.

The FDA has approved GW Pharmaceuticals plc's (GWPH) EPIDIOLEX (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.

EPIDIOLEX is the first cannabis-based drug, and the first in a new category of anti-epileptic drugs. It will be made available after rescheduling which is expected to occur within 90 days.

Epidiolex, which carries an orphan drug designation, is expected to generate sales of $19 million in 2018, $266 million in 2019, and gradually increase, touching sales of $1.191 billion in 2022. (Reference: Clarivate Analytics).

GWPH closed Monday's trading at $144.76, down 4.29%.

Shares of Merrimack Pharmaceuticals Inc. (MACK) cratered more than 43% on Monday, following disappointing results from its CARRIE study.

The CARRIE study is a phase II trial evaluating the addition of MM-141 (istiratumab) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1).

The study did not meet its primary or secondary efficacy endpoints in patients who received MM-141 in combination with nab-paclitaxel and gemcitabine, compared to nab-paclitaxel and gemcitabine alone.

MM-310 is currently being tested in a Phase 1 study in solid tumors, with safety data and the maximum tolerated dose expected in 2H 2018.

MACK closed Monday's trading at $5.14, down 43.83%.

As part of the annual Russell U.S. Index reconstitution, the following are some of the companies that were added to the Russell 3000 Index, effective June 25, 2018.

Palatin Technologies Inc. (PTN); Vital Therapies Inc. (VTL); Endocyte Inc. (ECYT); Evelo Biosciences Inc. (EVLO); PolarityTE Inc. (COOL); Mustang Bio Inc. (MBIO); ADMA Biologics Inc. (ADMA); Zafgen Inc. (ZFGN); T2 Biosystems Inc. (TTOO); Unum Therapeutics Inc. (UMRX); Verastem Inc. (VSTM); AVEO Pharmaceuticals Inc. (AVEO); Apollo Medical Holdings Inc. (AMEH); GTx Inc. (GTXI); Aldeyra Therapeutics Inc. (ALDX); MannKind Corporation (MNKD); Vericel Corp. (VCEL), CymaBay Therapeutics, Inc. (CBAY), and Savara Inc. (SVRA).

Shares of PolarityTE Inc. (COOL) plunged as much as 38% in intraday trading on Monday, following a report by Citron research.

Citron calls PolarityTE a "fraud," and has accused the Company of keeping investors in the dark about the rejection of its key technology by the United States Patent and Trademark Office.

COOL closed Monday's trading at $28.14, down 27.34%.

Sophiris Bio Inc. (SPHS) plunged more than 40% on Monday on news that a patient died upon receiving a second administration of Topsalysin in its ongoing Phase 2b clinical trial in localized prostate cancer.

In the same phase IIb trial, a single administration of Topsalysin continues to demonstrate an ability to ablate targeted prostate cancer cells with 10 of 35 patients (29%) demonstrating a clinical response of which 6 patients had a complete ablation with no detectable cancer on targeted biopsy of the treated area, the Company added.

The cause of the patient's death is currently being investigated, and as a precaution, the patients enrolled in the phase IIb trial won't be receiving the second administration of Topsalysin.

SPHS closed Monday's trading at $2.24, down 40.27%.

Sunesis Pharmaceuticals Inc. (SNSS) has entered into a Common Shares Purchase Agreement of up to $15.5 million with Aspire Capital Fund LLC.

As part of the agreement, Aspire Capital has purchased $500,000 worth of SNSS common shares at a price of $2.19 per common share. But that's not all. Aspire Capital has also committed to purchasing up to an additional $15 million of common shares of Sunesis.

SNSS closed Monday's trading at $2.11, down 1.40%.

Xeris Pharmaceuticals Inc.'s (XERS) two phase 3 clinical studies on its investigational ready-to-use, room-temperature stable liquid glucagon rescue pen have yielded positive results.

The data highlighted the efficacy and safety of Xeris ready-to-use glucagon rescue pen in treating severe hypoglycemia in adults and children with type 1 diabetes compared to the currently marketed Glucagon Emergency Kit (GEK).

Paul Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals said that the ready-to-use glucagon rescue pen has the potential to be a well-tolerated and functionally effective alternative to treat severe hypoglycemia among both adults and children with diabetes.

XERS closed Monday's trading at $19.10, up 1.60%.

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