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An Ear To The Pharma: 11 Stocks To Watch (DOVA, SESN, URGN…)

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Another week has gone by, and it was raining FDA approvals.

Aimovig received the U.S. regulatory nod on May 17, 2018. This drug developed by Amgen Inc. (AMGN) is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

On May 16, 2018, the FDA approved Lucemyra, the first non-opioid treatment for management of opioid withdrawal symptoms in adults. Developed by US WorldMeds LLC, Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

Pfizer Inc.'s (PFE) RETACRIT, a biosimilar to Amgen's anemia drugs Epogen and Procrit, was greenlighted by the FDA on May 15, 2018, to become the first approved epoetin alfa biosimilar in the U.S.

However, the FDA rejection of Botox rival DWP-450 for treatment of moderate to-severe glabellar lines, developed by Evolus Inc. (EOLS), was the lone disappointment.

Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.

1. Dova Pharmaceuticals Inc. (DOVA)

Dova Pharma's New Drug Application for Avatrombopag is under Priority Review by the FDA, with a decision expected on May 21, 2018.

The orally administered Avatrombopag is proposed for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure.

Thrombocytopenia is a condition characterized by abnormally low levels of platelets in the blood, and which is a common complication in patients with chronic liver disease. An estimated 1.1 million chronic liver disease patients in the United States are said to be affected by thrombocytopenia.

The primary intellectual property related to Avatrombopag is licensed to Dova from Astellas on an exclusive, worldwide basis under the terms of a license agreement that was acquired from Eisai.

Dova closed Friday's (May 18) trading at $27.84, up 4.47%.

2. Verona Pharma plc (VRNA)

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for patients suffering from respiratory conditions such as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and possibly asthma.

The Company's proprietary lead candidate is RPL554, and positive top line data from a phase IIb study of RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (COPD) were reported in March of this year.

Watch out for…

The Company will present data from its chronic obstructive pulmonary disease (COPD) clinical trial program with RPL554, at the American Thoracic Society International Conference (ATS) on May 21, 2018.

VRNA closed Friday's (May 18) trading at $15.88, down 0.75%.

3. Roche Holding AG (RHHBY.OB)

Roche is the 2nd biggest pharmaceutical company in the world based on revenue, according to reports. The Company reported total revenue of CHF 53.3 billion (US$53.38 billion) in 2017. Some of the world's top-selling drugs like Herceptin, Avastin and Rituxan are from Roche's stable.

Watch out for…

The Company will present new phase III data for Hemlibra in people with haemophilia A at the World Federation of Hemophilia 2018 World Congress on May 21, 2018.

Data include results from HAVEN 3 study in people with haemophilia A without factor VIII inhibitors and HAVEN 4 study in people with haemophilia A with or without factor VIII inhibitors.

RHHBY.OB closed Friday's (May 18) trading at $27.93, down 0.07%.

4. Sesen Bio Inc. (SESN)

Sesen Bio, formerly Eleven Biotherapeutics Inc., is a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer.

Watch out for…

The first, top-line data from the Company's phase III trial of Vicinium in patients with high grade non-muscle invasive bladder cancer, dubbed VISTA, are expected to be presented at this year's American Urological Association Annual Meeting on May 21, 2018.

During the plenary presentation, the Company will share initial efficacy findings and data supporting the favorable safety that has been observed so far with Vicinium.

SESN closed Friday's (May 18) trading at $3.00, down 4.76%.

5. UroGen Pharma Ltd. (URGN)

UroGen is a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology.

The Company's lead investigational therapy is UGN-101 (MitoGel), which is under a phase III trial for the treatment of low-grade Low-Grade Upper Tract Urothelial Carcinoma (UTUC), dubbed OLYMPUS.

Upper tract urothelial cancer, or UTUC, is the cancer affecting the upper urinary tract, which connects the bladder to the kidney and renal pelvis.

Watch out for…

The Company will present an interim analysis from the OLYMPUS pivotal trial of UGN-101 in patients with Low-Grade Upper Tract Urothelial Carcinoma on Monday, May 21, 2018 during the Plenary Session of the 113th American Urological Association's 2018 Annual Meeting.

URGN closed Friday's (May 18) trading at $65.33, up 5.30%.

6. Catalyst Biosciences Inc. (CBIO)

Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications.

The Company's experimental drug for hemophilia B is known as CB 2679d/ISU304, a subcutaneously-administered, prophylactic Factor IX, under Phase 1/2 study.

Positive top-line data from the phase 1/2 study of subcutaneous CB 2679d/ISU304 in individuals with Hemophilia B was reported in February of this year. According to the study results, all individuals with severe hemophilia improved to mild hemophilia activity levels after only six daily doses with a continuous once-daily subcutaneous dosing of CB 2679d.

Watch out for…

The Company will be presenting clinical safety data from the Phase 1/2 study of CB 2679d for the treatment of hemophilia B on May 22, 2018 at the World Federation of Hemophilia (WFH) 2018 World Congress.

CBIO closed Friday's (May 18) trading at $28.27, up 0.96%.

7. INSYS Therapeutics Inc. (INSY)

A panel of outside experts convened by the FDA is scheduled to vote on whether to recommend approval of INSYS Therapeutics Inc.'s (INSY) novel formulation of Buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain on May 22, 2018.

The potential benefits of Buprenorphine include a ceiling effect for respiratory depression and, compared to other opioids, less abuse potential, less cognitive impairment and less constipation, according to the Company.

The FDA's final decision on Buprenorphine Sublingual Spray is expected on July 28, 2018.

INSY closed Friday's (May 18) trading at $6.95, down 5.31%.

8. BioMarin Pharmaceutical Inc. (BMRN)

The FDA will announce its decision on BioMarin Pharmaceutical Inc.'s (BMRN) investigational therapy Pegvaliase on May 25, 2018.

Pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, is proposed for the reduction of blood phenylalanine (Phe) levels in adult patients with phenylketonuria (PKU) who have uncontrolled blood Phe levels on existing management.

Phenylketonuria is a rare, inherited disorder, and in adults, it is associated with behavioral and psychological problems, neurological problems, and other problems like eczema, sensitivity to sunlight and very light skin, and body odor identified as "musty" or "pungent".

Kuvan, also from the stable of BioMarin, is the first ever drug approved for the treatment of phenylketonuria.

Pegvaliase is a daily injection while Kuvan is taken as a tablet or powder for oral solution daily. Kuvan is recommended for adults and pediatric patients of all ages while Pegvaliase is designed only for adult patients. Kuvan generated net product sales of $407.5 million in 2017 compared to $348 million in 2016.

According to the Company, Pegvaliase if approved will offer a new option with the potential to alter the course of lifelong PKU management.

BMRN closed Friday's (May 18) trading at $88.88, up 0.51%.

9. Reata Pharmaceuticals Inc. (RETA)

Reata Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics to address serious and life-threatening diseases with few or no approved therapies.

The Company's lead product candidate is Bardoxolone methyl, under a phase III trial for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, and a phase II study in autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, and type 1 diabetic CKD (T1D CKD) cohorts of the study, dubbed PHOENIX.

Watch out for…

Interim data from the PHOENIX study for the ADPKD and IgA nephropathy cohorts will be presented on May 25, 2018, at the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA) meeting.

RETA closed Friday's (May 18) trading at $31.55, down 1.81%.

. Achillion Pharmaceuticals Inc. (ACHN)

Achillion Pharmaceuticals is a clinical-stage orphan drug company.

The Company is developing small molecule factor D inhibitor compounds like ACH-4471, ACH-5228 and ACH-5548 with potential in the treatment of C3G, immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), and paroxysmal nocturnal hemoglobinuria (PNH).

Watch out for…

The interim biomarker data from an ongoing 14-day Phase 2 study of ACH-4471 in C3G, a devastating disease affecting the kidneys for which there is no FDA approved therapy, will be presented on May 25, 2018 at the 55thEuropean Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress.

ACHN closed Friday's (May 18) trading at $3.70, up 3.06%.

11. Recro Pharma Inc. (REPH)

Recro Pharma's intravenous (IV) Meloxicam 30mg for the management of moderate to severe postoperative pain is under FDA review, with a decision expected on May 26, 2018.

Meloxicam IV belongs to the non-opioid class of drugs, and is believed to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, and devoid of addictive abuse potential while maintaining meaningful analgesic effects for pain relief.

REPH closed Friday's (May 18) trading at $11.72, up 6.26%.

by RTTNews Staff Writer

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