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Week Ahead In Pharmaceuticals - Stocks To Watch

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Another week has passed us by. Biogen Inc.'s (BIIB) successful Alzheimer's drug trial results dominated the headlines in the week, sending its shares up as much as 23%. The news had a positive impact on AC Immune SA (ACIU), which is developing Crenezumab, a drug for the treatment and prevention of Alzheimer's disease. Its stock price touched a new 52-week high on Friday, and was up 30% for the week.

In contrast, MiMedx Group Inc. (MDXG), which has been has been in the news for quite some time for accounting impropriety, was one of the top losers of the week, shedding 47% of its value.

On the regulatory front, Alkermes Plc's (ALKS) ARISTADA INITIO, a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults, won FDA approval on July 2, 2018. ARISTADA INITIO is to be taken in combination with a single 30 mg dose of oral aripiprazole.

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

1. Zogenix Inc. (ZGNX)

Zogenix is a pharmaceutical company developing therapies for the treatment of rare central nervous system disorders like Dravet syndrome and Lennox-Gastaut syndrome.
The lead product candidate is ZX008, a low-dose fenfluramine liquid solution.

The Company reported positive top-line results from its first pivotal phase III trial of ZX008 in Dravet Syndrome, dubbed Study 1, in September 2017.

In Study 1, ZX008 as an adjunctive therapy at a dose of 0.8 mg/kg/day achieved statistically significant convulsive seizure reduction in children and young adults with Dravet syndrome.

Dravet syndrome is a rare form of childhood epilepsy with life threatening consequences, having limited treatment options.

Watch out for...

Top-line data from a second phase III trial of ZX008 as an adjunctive therapy in children and young adults with Dravet Syndrome, dubbed Study 1504, are expected early July.

ZGNX closed Friday's trading at $46.60, up 6.03%.

2. Bristol-Myers Squibb Co.(BMY)

Bristol-Myers Squibb's (BMY) supplemental Biologics License Application for Opdivo in combination with Yervoy for previously treated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer awaits the FDA decision on July 10, 2018.

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum. Approximately 15% of CRC patients and 4-5% of metastatic CRC patients have MSI-H or dMMR biomarkers.

DNA mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors.

The conventional chemotherapy is of little use for patients with MSI-H or dMMR metastatic CRC.

Opdivo and Yervoy are blockbuster drugs of Bristol-Myers. In 2017, the global sales of Opdivo were $4.95 billion, up 31% over 2016, and that of Yervoy totaled $1.24 billion, up 18% over 2016.

BMY closed Friday's trading at $56.56, up 1.09%.

3. GlaxoSmithKline plc (GSK)

On July 12, 2018, an FDA advisory committee is scheduled to review GlaxoSmithKline PLC's single-dose Tafenoquine 150mg for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.

If approved, Tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years.

Tafenoquine is being developed in collaboration by GlaxoSmithKline and the not-for-profit Medicines for Malaria Venture.

GSK closed Friday's trading at $41.02, up 0.71%.

4. KemPharm Inc. (KMPH)

KemPharm is a clinical-stage specialty pharmaceutical company engaged in the development of proprietary prodrugs that are designed to be improved versions of widely prescribed, approved drugs.

The Company's co-lead clinical development candidates are KP415 and KP484, for the treatment of Attention-deficit/hyperactivity disorder (ADHD). It also has one FDA-approved drug APADAZ (benzhydrocodone and acetaminophen) for the short-term management of acute pain, which was greenlighted on February 23, 2018.

Watch out for...

A pivotal efficacy trial of KP415 for the treatment of Attention Deficit, Hyperactivity Disorder (ADHD), initiated last December, is underway. The trial is designed to support a potential label for KP415 for both an early onset and long duration of a KP415 treatment effect in ADHD patients. Final data from this trial due to be reported in mid-2018 is still pending.

KMPH closed Friday's trading at $6.75, up 4.65%.

5. Strongbridge Biopharma plc (SBBP)

Strongbridge is a rare disease biopharmaceutical company with commercial and late-stage product portfolio.

Watch out for...

The top-line results from a phase III trial of investigational drug RECORLEV in endogenous Cushing's syndrome, dubbed SONICS, due to be reported in mid-2018 is still pending.

The commercial launch of MACRILEN, the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency, a rare endocrine disorder, is on track for July 2018. MACRILEN received FDA approval on December 20, 2017.

SBBP closed Friday's trading at $5.65, down 2.59%.

6. Asterias Biotherapeutics Inc. (AST)

Asterias is a biotechnology company developing cellular immunotherapies to treat cancer and cell-based therapeutics to treat neurological conditions associated with demyelination.

Watch out for...

Six-month update for the entire SCiStar study, including Cohort 5, is expected to be provided early third quarter of 2018. SCiStar study is a phase I/II trial of AST-OPC1 in Spinal Cord Injury.

12-month update for Cohort 3 (AIS-A; 20M AST-OPC1 cells) and Cohort 4 (AIS-B; 10M AST-OPC1 cells) are expected this quarter.

AST closed Friday's trading at $1.50, up 7.14%.

7. CorMedix Inc. (CRMD)

CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease.

The Company's lead product candidate is Neutrolin, a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently. It is approved as a CE Marked medical device in Europe, but is not approved in the U.S. yet.

Watch out for...

A phase III trial of Neutrolin in hemodialysis patients with central venous catheters, dubbed LOCK-IT-100, is underway. The Company anticipates Data Safety Monitoring Board Review of the LOCK-IT-100 study in July 2018.

CRMD closed Friday's trading at $0.25, up 6.66%.

8. TRACON Pharmaceuticals (TCON)

TRACON is a clinical stage biopharmaceutical company developing novel targeted therapeutics for cancer and wet age-related macular degeneration.

The Company's lead drug candidate is TRC105 for the treatment of angiosarcoma, under phase III trial called TAPPAS. The interim analysis to determine the final sample size and eligible population for the trial is expected to be conducted in the second half of 2018.

Watch out for...

A phase 1/2 trial of TRC253 for the treatment of prostate cancer that was in-licensed from Janssen is underway. This trial is designed to determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels.

An update regarding the completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer, due in mid-2018, is pending.

TCON closed Friday's trading at $2.70, unchanged from the previous day's close.

9. Acceleron Pharma Inc. (XLRN)

Acceleron is a clinical-stage biopharmaceutical company developing therapeutics to treat serious and rare diseases.

The Company's lead product candidate is Luspatercept that is in multiple phase II and phase III trials in myelodysplastic syndromes (MDS) and beta-thalassemia, as well as in a phase II trial in myelofibrosis. Acceleron and Celgene are jointly developing Luspatercept as part of a global collaboration.

Positive top-line results from a phase III trial of Luspatercept in patients with low-to-intermediate risk myelodysplastic syndromes, dubbed MEDALIST, were reported on June 28, 2018.

Watch out for...

Top-line results from a phase III trial of Luspatercept in patients with beta-thalassemia, dubbed BELIEVE, due in mid-2018, are pending.

XLRN closed Friday's trading at $46.70, up 1.02%.

10. Pulmatrix Inc. (PULM)

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology.

Watch out for...

A single dose escalation phase 1/1b study of Pulmazole (PUR1900) - an inhaled iSPERSE formulation of the anti-fungal drug Itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma is underway.

The Company announced positive top-line results from Parts 1 and 2 of the 3-Part phase 1/1b study of Pulmazole last month.

Watch out for...

Analysis of the preliminary data of Part 3 of the phase 1/1b study of Pulmazole is underway and expected to be complete in mid-July 2018.

PULM closed Friday's trading at $0.56, up 17.03%.

. SCYNEXIS Inc. (SCYX)

SCYNEXIS is focused on developing innovative therapies for patients suffering from difficult-to-treat and often life-threatening infections.

The Company's lead compound is SCY-078, which is believed to have the potential to be an essential therapy in the treatment of multiple serious fungal infections, including vulvovaginal candidiasis, invasive candidiasis, invasive aspergillosis and refractory invasive fungal infections.

Watch out for...

Top line data from a phase 2b, dose-finding study of oral SCY-078 for the treatment of vulvovaginal candidiasis, dubbed DOVE, is expected by July 2018.

SCYX closed Friday's trading at $1.77, up 2.91%.

12. Arcus Biosciences Inc. (RCUS)

Arcus is a clinical-stage biopharmaceutical company focused on developing innovative cancer immunotherapies.

The Company currently has two clinical drug candidates - AB928 and AB122.

AB928 for the treatment of cancer is under a phase 1 trial in healthy volunteers and under a phase 1/2 trial in cancer patients. AB122 is under a phase 1 study in subjects with advanced solid tumors.

Watch out for...

Final data from a phase 1 trial of AB928 in healthy volunteers, due to be reported in mid-2018, is pending.

RCUS closed Friday's trading at $12.94, up 2.78%.

by RTTNews Staff Writer

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