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GLMD Arrests Investor Attention, SAGE Excited, GEMP On Close Watch

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

1. Galmed Pharmaceuticals Ltd. (GLMD)

Gained 149.50% to close Tuesday's (June 12) trading at $17.59.

News: The Company reported encouraging top-line, 52-week results from its study dubbed ARREST.

ARREST is a phase IIb clinical trial evaluating the Company's lead product candidate Aramchol in patients with biopsy proven non-alcoholic steatohepatitis, or NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic.

You can find more about GLMD in our article titled "Patience Pays Off For Galmed Investors..."

2. Sage Therapeutics Inc. (SAGE)

Gained 19.62% to close Tuesday's (June 12) trading at $175.76.

News: The Company announced pivotal phase III trial status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA breakthrough therapy meeting.

While Sage plans to initiate the placebo-controlled phase III trial of SAGE-217 in Major Depressive Disorder during the second half of 2018, the placebo-controlled trial in women with PPD, now designated a pivotal trial, is already underway.

Near-term Catalyst:

The top-line data from the placebo-controlled pivotal trial of SAGE-217 in Postpartum Depression is expected in the fourth quarter of 2018.

3. Xenon Pharmaceuticals Inc. (XENE)

Gained 15.94% to close Tuesday's trading at $8.00.

News: No news

Pipeline:

The clinical stage drug candidates include XEN1101 and XEN901, both of which are being developed for the treatment of epilepsy, and XEN007 for the treatment of hemiplegic migraine (HM), a rare and debilitating neurological disorder.

Near-term Catalysts:

-- Present complete results from a phase I trial evaluating XEN901's safety, tolerability and pharmacokinetics in both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts of approximately 64 healthy subjects in the second half of this year and initiate a Phase 2 clinical trial thereafter.
-- Interim data from the ongoing phase I trial of XEN1101 were released last month. A phase II trial of XEN1101 in adult patients with focal seizures is expected to start in the second half of this year.
-- XEN007 for the treatment of hemiplegic migraine is a phase II-ready compound.

4. Conatus Pharmaceuticals Inc. (CNAT)

Gained 13.54% to close Tuesday's trading at $5.03.

News: No news

Clinical Trials & Near-term Catalysts:

-- Top-line results from a phase IIb clinical trial of Emricasan in patients with NASH Cirrhosis and severe portal hypertension, dubbed ENCORE-PH, are expected in the fourth quarter of 2018.
-- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF, is ongoing. Top line results are expected in the first half of 2019.
-- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF, is underway. Top-line results are expected in the second half of 2019.
-- A Phase 2 post-treatment follow-up clinical trial to monitor long-term adverse event rates in patients treated with Emricasan or placebo in any of the Phase 2b clinical trials, initiated in February of this year, is ongoing.

5. Tyme Technologies Inc. (TYME)

Gained 11.30% to close Tuesday's trading at $3.35.

News: The Company released detailed patient data and analyses from both the First Human Study (FHS) and Compassionate Use Program of SM-88 in metastatic cancer patients following the completion of review of all available data by blinded radiologists.

The First Human Study was conducted in 2012, and enrolled 30 metastatic cancer patients who had failed or refused all approved/available therapies. The compassionate use program enrolled a total of 77 metastatic cancer patients who failed or refused all approved/available treatments between late 2011 into 2017.
According to the findings, the objective response rate in the FHS and Compassionate use program were 33% and 45%, respectively.

The ORR in all breast cancer patients was 44%, and appeared consistent across patients with different hormonal status, including triple-negative breast cancer (TNBC) where two of five patients (40%) experienced a response.

Patients with stable disease (33 of 83, 40%) had a median Overall Survival of 43 months, according to the Company.

6. Gemphire Therapeutics Inc. (GEMP)

Gained 10.74% to close Tuesday's trading at $7.22.

Gemphire is also developing a drug by the name Gemcabene for the treatment of pediatric nonalcoholic fatty liver disease (NAFLD).

News: The positive results from a phase II study of Galmed's investigational drug for NASH seems to have had a positive rub off impact on shares of Gemphire.

Clinical Trials & Near-term Catalysts:

-- A phase 2b trial investigating Gemcabene in severe hypertriglyceridemia (SHTG) patients, dubbed INDIGO-1, is underway. The top-line data from this trial is expected this quarter (Q2, 2018).
-- A phase IIa proof-of-concept clinical trial of Gemcabene in adults with familial partial lipodystrophy (FPL), a rare genetic disorder characterized by an abnormal distribution of fatty tissue, which can lead to a variety of metabolic abnormalities including NASH was initiated in December 2017. This study is expected to enroll 8 FPL patients with elevated triglycerides and NAFLD, and top line results from the trial are expected in the second half of 2018.
-- A phase IIa proof-of-concept clinical trial investigating Gemcabene as a treatment for pediatric nonalcoholic fatty liver disease (NAFLD), initiated in January of this year, is ongoing.

7. VBI Vaccines Inc. (VBIV)

Gained 10.64% to close Tuesday's trading at $3.64.

News: No news

Clinical Trials & Near-term Catalysts:

-- A pivotal Phase 3 clinical program for Sci-B-Vac, the Company's Hepatitis B vaccine, consisting of two studies, dubbed PROTECT and CONSTANT, is underway.
-- Enrollment in the PROTECT study has been completed while enrollment is ongoing in the CONSTANT study.
-- Topline data from PROTECT and CONSTANT are expected in mid-year 2019.
-- Last month, the Company announced positive final top-line results from its Phase 1 study of VBI-1501, the company's prophylactic cytomegalovirus (CMV) vaccine candidate.
-- A Phase 1/2a clinical study of VBI-1901 for the treatment of recurrent glioblastoma is underway. 6-month overall survival (OS) and progression-free survival (PFS) data from this study are expected in early 2019.

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