10 Pharma Stocks To Watch This Month

scientists 083118

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).

Listed below are some of the companies that are expected to report their clinical trial results *this month (if the companies stick to their timeline).

1. Arena Pharmaceuticals Inc. (ARNA)

Arena is a biopharmaceutical company with three advanced clinical programs - Ralinepag (APD811) in a phase III program for pulmonary arterial hypertension, Etrasimod (APD334), expected to commence a phase III program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and Olorinab (APD371) in a phase II study for the treatment of visceral pain associated with Crohn's disease.

Also in the pipeline are a couple of other drug candidates in earlier research and development stages.

Watch out for...

Data from the phase II study of Olorinab for the potential treatment of visceral pain, specifically pain associated with Crohn's disease are expected in late September.

Olorinab is an orally available, peripherally restricted, highly-selective, full agonist of the cannabinoid 2 (CB2) receptor, and is designed to provide pain relief without psychotropic effects and without the potential for dependence or abuse.

ARNA closed Friday's trading at $38.84, down 0.08%.

2. Atossa Genetics Inc. (ATOS)

Atossa is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions.

The Company is developing both oral and a topical formulation of Endoxifen with a two-pronged approach to breast cancer: Prevention as well as treatment.

Watch out for...

The preliminary results from a phase I study of topical Endoxifen for gynecomastia (male breast enlargement) in men are expected to be reported by September 30, 2018.

ATOS closed Friday's trading at $2.14, down 0.47%.

3. BioCryst Pharmaceuticals Inc. (BCRX)

BioCryst is a late-stage biotech company developing novel therapeutics for patients with rare and serious diseases.

The Company's core development programs include:

-- BCX7353 and additional 2nd generation oral inhibitors of plasma kallikrein for hereditary angioedema (HAE)
-- BCX9250 and BCX9499 for Fibrodysplasia Ossificans Progressiva (FOP)
-- BCX4430 (galidesivir), a broad-spectrum antiviral for hemorrhagic fevers.

Watch out for...

Part 1 results from a proof-of-concept phase II clinical trial liquid formulation of BCX7353 for treatment of acute HAE attacks are expected this month.

The trial, dubbed ZENITH-1, is structured with up to 3 consecutive cohorts testing single doses of 750 mg (from 12 to 36 subjects), 500 mg (up to 12 subjects) and 250
mg (up to 12 subjects), starting with 750 mg of BCX7353.

BCRX closed Friday's trading at $7.16, unchanged from the previous day's close.

4. Galapagos NV (GLPG)

Galapagos is a clinical-stage biotechnology company developing medicines for cystic fibrosis, inflammation, and other indications.

The Company's lead drug candidate is Filgotinib, a highly selective JAK1 inhibitor. Filgotinib is being evaluated in phase III programs in rheumatoid arthritis, Crohn's disease and ulcerative colitis, and in phase II studies in small bowel Crohn's disease, fistulizing Crohn's disease, Sjögren's syndrome, ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus, lupus membranous nephropathy and uveitis.

Also in the pipeline are GLPG1690 for idiopathic pulmonary fibrosis, a triple combination therapy for cystic fibrosis, MOR106 for atopic dermatitis, GLPG1972 for osteoarthritis, and a number of preclinical drug candidates for various indications.

Watch out for...

Topline results from a phase III study evaluating Filgotinib versus placebo in adults with active rheumatoid arthritis (RA) who have an inadequate response to biologic disease-modifying anti-rheumatic drug(s) (DMARDs) treatment, dubbed FINCH 2, are expected this month.

Interim readout of the FALCON patient trial is also expected this month. The FALCON trial is a phase II study of the investigational triple combination therapy in cystic fibrosis patients. The FALCON trial was initiated in April of this year.

GLPG closed Friday's trading at $101.36, down 0.49%.

5. Geron Corporation (GERN)

Geron is a clinical stage biopharmaceutical company supporting the collaborative development of a first-in-class telomerase inhibitor, Imetelstat, in hematologic myeloid malignancies.

Imetelstat is currently being tested in two clinical trials - IMbark, a phase II trial in myelofibrosis, and IMerge, a phase II/III trial in myelodysplastic syndromes.

Geron entered into an agreement with Janssen in November 2014, under which Janssen acquired exclusive worldwide rights to develop and commercialize Imetelstat for all human therapeutic uses, including hematologic myeloid malignancies.

Watch out for...

By the end of September, Janssen is required to notify Geron whether or not it elects to maintain its license rights and continue to advance the development of Imetelstat in any indication.

GERN closed Friday's trading at $5.73, up 6.11%.

6. Omeros Corp. (OMER)

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The Company's marketed drug is OMIDRIA, indicated for use during cataract surgery or intraocular lens) replacement to maintain pupil size.

The lead drug candidate in the pipeline is OMS721, under phase III trial for atypical Hemolytic Uremic Syndrome, IgA Nephropathy, and Stem Cell Transplant-Associated TMA. OMS721 is also under phase II studies in the indications of Lupus Nephritis & other renal diseases.

Also in the pipeline are OMS824 for Huntington's and Schizophrenia, OMS405 for Opioid and Nicotine Addiction, and OMS201 for Ureteroscopy. The Company also has a couple of pre-clinical programs.

Watch out for...

Data from the phase II trial of OMS721 in IgA nephropathy are expected this month.

OMER closed Friday's trading at $25.88, up 3.98%.

7. Progenics Pharmaceuticals Inc. (PGNX)

Progenics is a commercial-stage company focused on developing innovative medicines and other technologies to target and treat cancer.

The Company has two marketed products - AZEDRA, a radiotherapeutic for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma, and Relistor, in tablet and subcutaneous injection formulation, indicated to treat opioid-induced constipation.

The most advanced product in the pipeline is 1404, a PSMA-targeted small molecule SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases.

Watch out for...

A phase III study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent in patients with newly-diagnosed or low-grade prostate cancer, dubbed ProSPECT-AS, is underway. Top-line data from this study is expected this month.

PGNX closed Friday's trading at $7.83, down 0.13%.

8. Reata Pharmaceuticals Inc. (RETA)

Reata is focused on developing novel therapeutics to address serious and life-threatening diseases by targeting molecular pathways that regulate cellular metabolism and inflammation.

The Company's lead product candidate is Bardoxolone methyl in patients with rare chronic kidney diseases, which is being studied in a phase II trial, dubbed PHOENIX.

The PHOENIX study involves four cohorts of patients - autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, focal segmental glomerulosclerosis and type 1 diabetic Chronic Kidney Disease (T1D CKD).

The Company reported positive final results for the autosomal dominant polycystic kidney disease (ADPKD) cohort of the PHOENIX study in July of this year.

Watch out for...

Full 12-week PHOENIX data from the IgA nephropathy cohort and T1D CKD cohort are expected this month.

RETA closed Friday's trading at $86.36, up 0.03%.

9. Spero Therapeutics Inc. (SPRO)

Spero Therapeutics is a clinical-stage biopharmaceutical company committed to advancing novel treatment approaches for bacterial infections.

The Company's lead product candidate is SPR994 for the treatment of complicated urinary tract infection, which is under an ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial.

In early July, Spero announced positive results from an interim analysis of its ongoing single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial of SPR994.

Watch out for...

The final SPR994 Phase 1 SAD/MAD data are expected this month.

SPRO closed Friday's trading at $11.41, down 0.35%.

10. Therapies Inc. (VTL)

Vital Therapies is a biotherapeutic company developing a cell-based system for the treatment of acute forms of liver failure.

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

Watch out for...

Top line results from a phase III trial evaluating the ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are expected in September.

VTL closed Friday's trading at $8.05, down 3.01%.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT