Week Ahead In Pharmaceuticals: 7 Stocks To Watch (CMRX, VRNA, NITE...)

(RTTNews) - As another week comes to a close, it is time to take a look back at some of the pharma news that made headlines and look ahead at what's coming next over the horizon.

On September 11, Gilead Sciences Inc. (GILD) and Galapagos NV (GLPG) reported positive results from a phase III study of Filgotinib in adults with moderately-to-severely active rheumatoid arthritis, dubbed FINCH 2. The news sent GLPG up about 19% and GILD up nearly 4% that day.

On September 12, shares of medical technology company Nemaura Medical Inc. (NMRD) rose as much as 85%, following positive data from an interim analysis of the first of a number of planned studies of SugarBEAT, a non-invasive affordable and flexible Continuous Glucose Monitor for use by persons with diabetes and pre-diabetics.

For Vital Therapies Inc. (VTL), Wednesday was a dark day as it got pounded on disappointing results of its phase III trial of lead investigational product ELAD System in subjects with severe alcoholic hepatitis. The stock plunged nearly 93% that day.

Clinical trial data is an important catalyst, and any update on the clinical studies can send the biotech stocks soaring or stumbling depending upon the news.

Now, here are some of the pharma/biotech stocks to watch out for in the week starting September 17.

1. Theravance Biopharma Inc. (TBPH)

Theravance is a diversified biopharmaceutical company having one approved drug Vibativ, and a couple of drug candidates in clinical testing.

The most advanced drug candidate in the pipeline is YUPELRI, currently under FDA review for the treatment of chronic obstructive pulmonary disease, with a decision date set for November 13, 2018.

YUPELRI is being developed by Theravance in partnership with Mylan Inc. (MYL).

Watch out for...

New data from a phase III trial of YUPELRI (revefenacin) inhalation solution, highlighting chronic obstructive pulmonary disease (COPD) exacerbation rates, in patients with moderate to very severe COPD, will be presented on September 16 at the European Respiratory Society (ERS) International Congress 2018.

TBPH closed Friday's trading at $27.45, down 1.29%.

2. Verona Pharma plc (VRNA)

Verona Pharma is a clinical stage biopharmaceutical company focused on developing prescription medicines to treat respiratory diseases such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).

The Company's lead product candidate is RPL554, currently being developed in a nebulized formulation for the maintenance treatment of COPD patients and as a treatment for CF. It is also being developed as an add-on therapy to commonly used therapies for the treatment of acute exacerbations of COPD in the hospital setting.

Watch out for...

Expanded dataset from a phase IIb study evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease is scheduled for presentation at the European Respiratory Society International Congress on September 17.

VRNA closed Friday's trading at $12.50, down 4.58%.

3. Nightstar Therapeutics plc (NITE)

Nightstar Therapeutics is a clinical-stage gene therapy company focused on developing one-time treatments for patients suffering from rare inherited retinal diseases that would otherwise progress to blindness.

The Company has two clinical programs - NSR-REP1, under phase III trial, for Choroideremia, and NSR-RPGR, under phase I/II trial, for X-Linked Retinitis Pigmentosa, dubbed XIRIUS.

Watch out for...

Preliminary safety and efficacy data of NSR-RPGR from the first five cohorts out of a total of six cohorts in the dose escalation study in the XIRIUS trial is expected to be presented on September 22.

NITE closed Friday's trading at $26.42, up 3.69%.

4. Chimerix Inc. (CMRX)

Chimerix is a biopharmaceutical company developing novel antivirals to address unmet medical needs.

The Company's lead product candidate is oral Brincidofovir in late-stage development for the treatment of smallpox. Brincidofovir is also under phase II testing for adenovirus. Also in the pipeline are IV Brincidofovir under phase II development for multi-viral prevention, and CMX521 for norovirus in phase I testing.

Watch out for...

Data from phase I trial of CMX521 for norovirus is scheduled for presentation at the European Society for Clinical Virology that will be held Sep.23 - Sep.26.

CMRX closed Friday's trading at $3.73, up 4.19%.

5. Zealand Pharma A/S (ZEAL)

Zealand, based in Copenhagen, Denmark, is a biotechnology company focused on developing peptide-based medicines for gastrointestinal, metabolic and other specialty diseases.

The Company has two marketed products and a couple of clinical programs.

The two marketed products are Lyxumia/Adlyxin, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, and Soliqua 100/33, an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes. These two products are commercialized by Sanofi (SNY).

The lead product candidate is Dasiglucagon, a potential first-in-class stable glucagon analog.

Watch out for...

Results from a pivotal phase III efficacy trial of ready-to-use Dasiglucagon hypo pen, the HypoPal, are expected this month.

HypoPal is designed to offer people with diabetes a fast treatment solution for severe hypoglycemia.

ZEAL closed Friday's trading at $17.80, down 0.61%.

6. Ra Pharmaceuticals Inc. (RARX)

Ra Pharma is a clinical-stage biopharmaceutical company focused on developing drugs for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.

The Company's lead drug candidate is RA101495 that is being developed for convenient self-administered subcutaneous injection for the treatment of paroxysmal nocturnal hemoglobinuria, Myasthenia Gravis, and renal indications such as atypical hemolytic uremic disorder (aHUS) and lupus nephritis.

Watch out for...

Top-line data from a phase Ib study designed to evaluate the pharmacokinetic (PK) profile of RA101495 SC in patients with renal impairment are expected to be reported this month.

RARX closed Friday's trading at $12.99, up 1.25%.

7. Syndax Pharmaceuticals Inc. (SNDX)

Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of combination therapies in multiple cancer indications.

The Company's lead product candidate is Entinostat, and the most advanced clinical program is a phase III trial of endocrine therapy plus Entinostat or placebo in patients with hormone receptor-positive advanced breast cancer, dubbed Study E2112.

The other ongoing trials with Entinostat include:

-- A phase Ib/II study of Entinostat in combination with Keytruda in patients with Non-small Cell Lung Cancer, with expansion cohorts in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer, dubbed ENCORE 601/KEYNOTE 142. -- A phase Ib/II clinical trial evaluating the combination of Entinostat plus Genentech's TECENTRIQ in patients with triple negative breast cancer, dubbed ENCORE 602. -- A phase Ib/II clinical trial evaluating Entinostat in combination with Pfizer/Merck KGaA's BAVENCIO in patients with ovarian cancer, dubbed ENCORE 603.

Also in the pipeline is SNDX-6352, which is under a phase I multiple ascending dose (MAD) clinical trial.

Watch out for...

The progression free survival results from E2112, the ongoing phase III trial of Entinostat plus endocrine therapy in HR+, HER2- breast cancer are expected this month.

SNDX closed Friday's trading at $6.93, up 4.84%.

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