Plus   Neg

In The Red: ZYNE Loses Shine, ESPR To Report Data In Q2, NVLN Touches New Low


The following are some of today's top losers in the pharma/biotech sector.

1. Zynerba Pharmaceuticals Inc. (ZYNE)

Lost 11.15% to close Wednesday's trading at $11.56. The stock has lost nearly 21% in the last three days.

News: No news

Recent event:

-- On December 3, 2017, the Company presented new data from the completed phase II STAR 1 study and ongoing STAR 2 18-month open label extension study evaluating ZYN002 cannabidiol (CBD) transdermal gel in patients with focal seizures.

According to the results, patients who received ZYN002 (195mg during STAR 1 for three months and 390mg for six months in STAR 2) for a total of nine months achieved a median reduction in seizures of 65%. Patients who received ZYN002 (390mg for three months in STAR 1 and six months in STAR 2) achieved a 48% median reduction in seizures from baseline.

Top line results from the STAR 1 study, reported in August of this year, showed that ZYN002 did not demonstrate a statistically significant reduction of focal seizures during the treatment period for either the high or low dose cohorts. (97.5 mg or 195 mg).

The Company is planning a phase II trial of ZYN002 in epilepsy based on the new data.

2. Mersana Therapeutics Inc. (MRSN)

Lost 10.49% to close Wednesday's trading at $15.79.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on June 28, 2017 at an offering price of 15.00 per share.

Near-term catalysts:

-- Interim safety results from phase I trial of lead oncology drug candidate XMT-1522 in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer are expected around the end of this year.
-- Begin phase I dose escalation study of XMT-1536, a potential first-in-class Dolaflexin ADC targeting NaPi2b-expressing tumors, in early 2018.

3. Esperion Therapeutics Inc. (ESPR)

Lost 9.39% to close Wednesday's trading at $53.14.

News: No news

Clinical trials & Near-term catalysts:

The Company's lead drug candidate is Bempedoic acid, a once-daily, oral LDL-C lowering drug that significantly reduces elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies.

Bempedoic acid is under a global pivotal phase III program consisting of 4 studies - Studies 1, 2, 3, 4.

Top-line results from Studies 1, 3 and 4 are expected in the second quarter of 2018, with top-line results from Study 2 expected in the third quarter of 2018.

A pivotal phase III study of Bempedoic Acid / Ezetimibe combination pill in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia was initiated last month. Top-line results are expected by the fourth quarter of 2018.

4. Vital Therapies Inc. (VTL)

Lost 9.38% to close Wednesday's trading at $4.35.

News: No news

The Company's lead investigational product is ELAD, a cell-based therapy for the treatment of acute forms of liver failure.

Near-term catalyst:

-- Top-line data from phase III trial of ELAD System in subjects with severe alcoholic hepatitis are expected in the third quarter of next year.

As of October 24th, the trial was 79% enrolled based on its target of at least 150 subjects. If it is decided more than 150 subjects are needed to reach 55 deaths under the event-driven design of the trial, the top line data could be delayed.

5. Novelion Therapeutics Inc. (NVLN)

Lost 9.02% to close Wednesday's trading at $3.33. The stock touched an all-time low of $3.25 in intraday trading.

News: No news

Recent events:

-- On December 4, 2017, the Company announced the appointment of Michael Price as senior vice president and chief financial officer (CFO), effective December 4, 2017. Gregory Perry has resigned as CFO of Novelion to pursue other opportunities, and will remain with the Company until December 31, 2017 to enable an effective transition.
-- On November 21, 2017, District Judge William Young rejected Aegerion Pharmaceuticals' amended criminal plea agreement which was negotiated with the United States Department of Justice (DOJ).

The plea agreement was regarding a settlement of the ongoing investigations into Aegerion's sales activities and disclosures related to JUXTAPID capsules, an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH).

Aegerion Pharmaceuticals is an indirect subsidiary of Novelion.

-- On November 9, 2017, the Company reported financial results for the third quarter ended September 30, 2017, and reiterated its guidance for the year.

For the year, total net revenues are expected to range between $135 million and $145 million; JUXTAPID net revenues between $70 million and $75 million; and MYALEPT net revenues between $65 million and $70 million.

-- The same day (Nov.9), Mary Szela resigned as CEO of the Company. Novelion is scouting for a new CEO.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT