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Week Ahead In Pharmaceuticals: 11 Stocks To Watch (MRTX, EPZM, ITCI...)

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Biotech stocks are very volatile as they are driven by clinical trial data and regulatory decisions.

Proteostasis Therapeutics Inc. (PTI), which gained 349%, was the top gainer of last week, thanks to positive preliminary results from its ongoing phase I study of combination therapy doublet, PTI-808 and PTI-801, in subjects with cystic fibrosis.

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 scheduled to report/update their clinical trial results this week.

1. Mirati Therapeutics Inc. (MRTX)

Mirati is a clinical-stage oncology company.

The Company's lead product candidate is Sitravatinib, which is being evaluated as a single agent and in combination with Opdivo in non-small cell lung cancer. Also in the pipeline are MRTX849 and Mocetinostat, both of which are also being developed for non-small cell lung cancer.

Watch out for...

Updated clinical data from the ongoing phase II trial of Sitravatinib in combination with OPDIVO for the treatment of non-small cell lung cancer (NSCLC) patients who have progressed on prior immune checkpoint inhibitor therapy is slated to be presented on October 22.

MRTX closed Friday's trading at $40.01, down 4.42%.

2. CytomX Therapeutics Inc. (CTMX)

CytomX is a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform.

The Company's lead drug candidate is CX-072, which is under a phase I/II clinical trial, dubbed PROCLAIM.

PROCLAIM is evaluating CX-072 as monotherapy and in combination with Yervoy or Zelboraf in patients with advanced or recurrent solid tumors or lymphomas.

Also in the pipeline are:

-- CX-2009, which is being evaluated as monotherapy in a Phase 1/2 clinical trial in patients with select advanced solid tumors and
-- BMS-986249, a CTLA-4-targeting Probody therapeutic partnered with Bristol-Myers Squibb, under a phase 1/2 clinical trial as monotherapy and in combination with Opdivo in solid cancers that are advanced or have spread.

Watch out for...

Additional results from the ongoing monotherapy dose escalation arm and the combination arm with Yervoy of the PROCLAIM-CX-072 trial, each in patients with advanced unresectable solid tumors are expected to be presented on October 22.

CTMX closed Friday's trading at $15.39, down 6.50%.

3. Epizyme Inc. (EPZM)

Epizyme is a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer and other serious diseases. Epigenetic therapy is a novel therapeutic approach that focuses on changes in DNA expression without altering the makeup of the genes themselves.

The Company's lead drug candidate is Tazemetostat, an internally developed first-in-class EZH2 inhibitor.

Watch out for...

Updated efficacy and safety data from the fully enrolled cohort of epithelioid sarcoma (ES) patients in the ongoing phase II trial of Tazemetostat is slated to be presented on October 22.

To know more about EPZM, please visit our In the Spotlight column.

EPZM closed Friday's trading at $8.76, down 0.45%.

4. Kura Oncology Inc. (KURA)

Kura Oncology is a clinical-stage biopharmaceutical company focused on developing precision medicines for the treatment of cancer.

The Company's lead drug candidate is Tipifarnib, which is currently being studied in phase II clinical trials in HRAS Mutant Solid Tumors, Peripheral T-cell Lymphomas, Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia.

Watch out for...

An update from the ongoing phase II trial of Tipifarnib in HRAS mutant head and neck squamous cell carcinomas, dubbed RUN-HN, is slated to be presented on October 22.

KURA closed Friday's trading at $14.38, down 7.52%.

5. Intra-Cellular Therapies Inc. (ITCI)

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.

The Company's lead drug candidate is Lumateperone, which is under phase III clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer's disease.

Also in the pipeline is ITI-214, under phase I study, for the treatment of symptoms associated with Parkinson's disease.

Watch out for...

The top line results from the phase I/II study of ITI-214 in patients with mild to moderate Parkinson's disease (PD) being maintained on stable (concomitant) PD medication are expected to be presented on October 22.

ITCI closed Friday's trading at $18.21, down 2.78%.

6. AVEO Pharmaceuticals Inc. (AVEO)

AVEO Pharma is a biopharmaceutical company developing targeted medicines for oncology and other areas of unmet medical need.

The Company's lead drug candidate is Tivozanib, under a pivotal phase III trial in the U.S. in subjects with refractory advanced renal cell carcinoma, dubbed TIVO-3. Tivozanib is approved in the European Union, as well as Norway and Iceland, under brand name FOTIVDA, for the first-line treatment of adult patients with renal cell carcinoma.

A phase Ib/II multicenter trial of oral Tivozanib in combination with intravenous Bristol-Myers' Opdivo for the treatment of metastatic renal cell carcinoma, dubbed TiNivo, is also underway.

Preliminary results from the phase II portion of the TiNivo study were presented in February of this year.

Watch out for...

Updated interim data from the phase II portion of the TiNivo trial are expected to be presented on October 22.

AVEO closed Friday's trading at $2.49, down 1.58%.

7. Neon Therapeutics Inc. (NTGN)

Neon is a clinical-stage immuno-oncology company developing neoantigen-targeted therapies.

The Company's most advanced product candidate is NEO-PV-01, a personal neoantigen vaccine, under phase I trials.

Neon shares debuted on The Nasdaq Global Select Market on June 27, 2018, at an offering price of $16.00 each.

Watch out for...

Updated data from the ongoing phase Ib clinical trial evaluating NEO-PV-01 in patients with metastatic melanoma, NSCLC, and bladder cancer are expected to be presented on October 22.

NTGN closed Friday's trading at $8.84, up 6.38%.

8. Selecta Biosciences Inc. (SELB)

Selecta Biosciences is a clinical-stage biopharmaceutical company developing biologic therapies for patients with rare and serious diseases.

The Company's lead product candidate is SEL-212, under phase II trial in severe gout patients. A phase I trial is ongoing for a combination therapy consisting of SVP-Rapamycin and LMB-100 (Selecta's SEL-403 product candidate) for the treatment of patients with malignant pleural or peritoneal mesothelioma.

On April 10, 2018, the Company presented new data from its ongoing phase II trial of SEL-212 for the treatment of chronic severe gout.

Watch out for...

New data from the ongoing phase II study of SEL-212 in chronic, severe gout will be presented October 22.

The Company will host a conference call at t 8:00 a.m. ET on Tuesday, October 23.

SELB closed Friday's trading at $13.81, down 8.66%.

9. Trovagene Inc. (TROV)

Trovagene is a clinical-stage oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers.

The Company's lead drug candidate is Onvansertib (PCM-075), under phase I/II clinical trial in patients with Acute Myeloid Leukemia (AML).

Watch out for...

Key data from the ongoing phase Ib Acute Myeloid Leukemia is slated to be provided on October 24.

TROV closed Friday's trading at $1.10, down 5.17%.

10. Dicerna Pharmaceuticals Inc. (DRNA)

Dicerna is a developer of investigational ribonucleic acid interference (RNAi) therapeutics.

The lead product candidate is DCR-PHXC, currently being tested in a phase I trial for the treatment of primary hyperoxaluria, dubbed PHYOX.

PHYOX is comprised of healthy volunteers and patients with primary hyperoxaluria types 1 and 2.

Watch out for...

The clinical data from the ongoing PHYOX study is slated to be presented on October 25.

DRNA closed Friday's trading at $11.76, down 10.09%.

11. FibroGen Inc. (FGEN)

FibroGen is a biopharmaceutical company developing first-in-class therapeutics for the treatment of anemia, fibrotic disease, and cancer.

The most advanced product candidate is Roxadustat for the treatment of anemia in chronic kidney disease.

Watch out for...

The Company will be presenting results of four phase III clinical trials of Roxadustat in anemia of chronic kidney disease (CKD) at the American Society of Nephrology (ASN) Kidney Week 2018 annual meeting on October 25 and October 27.

The 4 phase III trials are:
-- A phase III active-comparator (Darbepoetin Alfa) conversion study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.
-- A phase III active-controlled study of efficacy and safety of Roxadustat for treatment of Anemia in subjects with CKD on dialysis.
-- A phase III placebo-controlled study of efficacy and safety of Roxadustat for treatment of anemia in subjects with CKD not on dialysis.
-- A phase III study of intermittent Oral Roxadustat in Peritoneal Dialysis CKD patients with anemia.

FGEN closed Friday's trading at $52.90, down 3.17%.

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