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Do You Have These Pharma Stocks In Your Portfolio? (EARS, BLRX, OMED...)

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Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost the stock price while unfavorable results can send the stocks plummeting.

The success rate of phase I clinical programs is the highest, say 63%, while it is the lowest for phase II trials - i.e. 30%. The phase III trials, which are the longest and most expensive trials to conduct, are said to have a success rate of 58%, according to a report from the Biotechnology Innovation Organization on "Clinical Development Success Rates" over the past decade (2006-2015).

Let's take a look at the companies that are schedule to report/present clinical trial results this week.

1. Auris Medical Holding AG (EARS)

Auris Medical is focused on developing novel pharmaceutical products for the treatment of inner ear disorders and mental health supportive care.

The Company's lead clinical program is intranasal betahistine program, which includes AM-125 for the treatment of vertigo, and AM-201 for the treatment of antipsychotic-induced weight gain and somnolence.

In addition Auris Medical has two phase III programs under development - AM-111 for acute inner ear hearing loss and Keyzilen (AM-101) for acute inner ear tinnitus.

Watch out for...

The Company will provide an update on its intranasal betahistine program on Wednesday, October 17, 2018. The key results from the second phase I trial of AM-125 in healthy volunteers will also be reported.

EARS closed Monday's trading at $1.38, up 40.82%.

2. BioLineRx Ltd. (BLRX)

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology.

Pipeline:

The Company's lead therapeutic candidates are:

-- BL-8040, which has successfully completed a phase IIa study for relapsed/refractory AML, under phase IIb study as an AML consolidation treatment, under phase IIa study in combination with Merck's KEYTRUDA in patients with metastatic pancreatic adenocarcinoma, dubbed COMBAT, and under phase III study in stem cell mobilization for autologous transplantation in Multiple Myeloma patients, dubbed GENESIS.
-- AGI-134, an immunotherapy treatment in development for multiple solid tumors, under a phase I/IIa study.

Watch out for...

Top-line results from the COMBAT study are slated to be presented at the European Society for Medical Oncology (ESMO) Congress on October 19, 2018.

BLRX closed Monday's trading at $1.38, up 4.55%.

3. Tesaro Inc. (TSRO)

TESARO is an oncology-focused biopharmaceutical company.

Pipeline:

-- TSR-042, under phase I dose escalation study in patients with MSI-high endometrial cancer, dubbed GARNET.
-- ZEJULA in combination with an anti-PD-1 antibody in first-line, non-small cell lung cancer, under phase II development, dubbed JASPER.
-- ZEJULA as monotherapy for patients with first-line ovarian cancer regardless of biomarker status, under phase III study, known as PRIMA.

ZEJULA is approved in the U.S. and Europe for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

-- TSR-022 in combination with TSR-042 in tumor-specific cohorts, including lung cancer patients who have progressed on prior PD-1 therapy, under phase I trial, dubbed AMBER.

Watch out for...

Interim safety data from the PRIMA study will be presented on October 20, 2018.
Preliminary safety, efficacy, and PK/PD characterization from the GARNET trial will also be presented on October 20, 2018.

TSRO closed Monday's trading at $40.94, up 0.84%.

4. OncoMed Pharmaceuticals Inc. (OMED)

OncoMed is a clinical-stage biopharmaceutical company focused on developing novel anti-cancer therapeutics.

Pipeline:

-- Navicixizumab in combination with paclitaxel for the treatment of heavily pretreated, platinum-resistant ovarian cancer patients under phase Ib clinical trial.
-- Etigilimab in combination with Opdivo in patients with advanced or metastatic solid tumors, under phase Ia/b study.
-- OMP-336B11, under phase Ia study, in patients with advanced or metastatic solid tumors.

Watch out for...

Interim results of the ongoing phase Ib study of Navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer are scheduled to be presented on October 20, 2018.

OMED closed Monday's trading at $1.91, down 4.02%.

5. Seattle Genetics Inc. (SGEN)

Seattle Genetics is a global biotechnology company developing and commercializing therapies targeting cancer.

The Company has one approved drug by the name Adcetris (brentuximab vedotin), which is indicated for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides. Adcetris is also being explored in additional indications.

Pipeline:

-- Enfortumab vedotin, under phase a phase II trial in patients with locally advanced or metastatic urothelial cancer who previously received both a checkpoint inhibitor (PD-1/PD-L1) and a platinum-containing regimen, dubbed EV-201.
-- Enfortumab vedotin, under phase a phase III trial in patients with locally advanced or metastatic urothelial cancer who were previously treated with a checkpoint inhibitor (PD-1/PD-L1) and a platinum-containing regimen, dubbed EV-301.
-- Enfortumab vedotin in combination with immune checkpoint inhibitor therapy for treatment of patients with locally advanced or metastatic Urothelial Cancer under phase Ib dose-escalation and dose-expansion study, known as EV-103.
-- Tisotumab vedotin, under phase II trial, in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment, dubbed innovaTV 204.
-- Tisotumab vedotin, under phase II trial, in several types of solid tumors, dubbed innovaTV 207.
-- Tisotumab vedotin, under phase I/II study, in eight types of solid tumors: ovarian, cervical, endometrial, bladder, prostate, esophageal, lung, and head and neck, dubbed innovaTV 201.
-- Tucatinib, in a pivotal trial, for HER2-positive metastatic breast cancer.
Ladiratuzumab vedotin, under a phase II trial, in HER2-negative breast cancer, dubbed I-SPY 2.

Watch out for...

Updated clinical data from innovaTV 201, the phase II study evaluating Tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer, is slated to be presented on October 20, 2018.

SGEN closed Monday's trading at $73.07, up 0.41%.

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