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An Ear To The Pharma: 15 Stocks To Watch (AKAO, PTIE, ASNS…)

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Only a week left in the quarter, and the week that passed by saw some of the DMD drug stocks make headlines.

Sarepta Therapeutics Inc. (SRPT) touched a new high of $176.50 on June 19, following positive preliminary results from its phase 1/2a gene therapy micro-dystrophin trial for the treatment of Duchenne muscular dystrophy.

Solid Biosciences Inc. (SLDB) touched a new high of $54.83 on June 19, after the FDA lifted the clinical hold on the Company's phase I/II clinical trial of SGT-001 for the treatment of Duchenne muscular dystrophy, dubbed IGNITE DMD.

Another notable gainer of the week was Caladrius Biosciences Inc. (CLBS), a clinical stage development company with cell therapy products in development, whose stock returned as much as 180%.

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

1. Achaogen Inc. (AKAO)

Achaogen's Plazomicin, which won the FDA panel backing for one of the two proposed indications last month, awaits the final decision on June 25, 2018.

The Company is seeking approval of Plazomicin for the treatment of adults with complicated urinary tract infections, including pyelonephritis, and for the treatment of bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment option.

On May 2, 2018, the panel backed Plazomicin for the treatment of complicated urinary tract infections, including pyelonephritis, and was not in favor for the treatment of bloodstream infections (BSI) in adults with limited or no treatment options.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, Plazomicin could contribute $313 million in peak sales by 2022, according to market research firm EvaluatePharma.

AKAO closed Friday's (June 22) trading at $12.42, down 0.24%.

2. Zafgen Inc. (ZFGN)

Zafgen is a clinical-stage biopharmaceutical company developing novel therapies for patients affected by complex metabolic diseases.

The Company's lead product candidate is ZGN-1061, under phase II proof of concept trial for type 2 diabetes. Positive interim data from this ongoing trial were reported in March of this year.

Watch out for…

Top line data from this ongoing phase 2 proof-of-concept trial of ZGN-1061 in type 2 diabetes are expected in mid-year 2018.

ZFGN closed Friday's trading at $7.09, up 5.66%.

3. Pain Therapeutics Inc. (PTIE)

An FDA panel is scheduled to review Pain Therapeutics Inc.'s (PTIE) investigational pain drug Remoxy ER on June 26, 2018.

Remoxy ER is a long-acting abuse-resistant version of oxycodone, a powerful narcotic painkiller, formulated with Durect Corp.'s (DRRX) ORADUR technology. Remoxy is bioequivalent to Purdue Pharma's Oxycontin, meaning the two drugs provide similar levels of oxycodone in people when used as intended.

Last year, Oxycontin brought home sales of $1.94 billion, according to Symphony Health Solutions.

The FDA's final decision on Remoxy ER is expected by August 7, 2018.

The New Drug Application for Remoxy has been rejected thrice by the FDA - i.e., in December 2008, June 2011, and September 2016.

Will Remoxy ER make it to the finish line at least this year?

PTIE closed Friday's trading at $8.23, down 11.51%.

4. GW Pharmaceuticals plc (GWPH)

GW Pharmaceuticals' Epidiolex, which won the unanimous support from an FDA advisory panel in April of this year, now awaits the U.S. regulatory agency's final decision on June 27, 2018.

Epidiolex is an oral pharmaceutical formulation of purified cannabidiol, proposed for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Lennox-Gastaut syndrome and Dravet syndrome are rare, severe childhood-onset epilepsy disorders, and are the most difficult types of epilepsy to treat.

Epidiolex, which carries an orphan drug designation, is expected to generate sales of $19 million in 2018, $266 million in 2019, and gradually increase, touching sales of $1.191 billion in 2022. (Reference: Clarivate Analytics).

GWPH closed Friday's trading at $151.25, up 0.16%.

5. Alder BioPharmaceuticals Inc. (ALDR)

Alder is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm.

The Company's lead investigational product is Eptinezumab, a monoclonal antibody for migraine prevention.

Watch out for…

New 6 month data from PROMISE 2, a phase III global trial of Eptinezumab for chronic migraine prevention, will be presented on June 29, 2018.

The primary and secondary endpoint results of PROMISE 2 trial were reported in January of this year. There was a reduction of 8.2 monthly migraine days from baseline following a single Eptinezumab administration compared to 5.6 days for placebo.

ALDR closed Friday's trading at $16.80, down 2.89%.

6. Dermira Inc. (DERM)

Dermira's New Drug Application for Glycopyrronium tosylate for the treatment of patients with primary axillary hyperhidrosis is under FDA review, with a decision expected by June 30, 2018.

Hyperhidrosis, which refers to a condition of excessive sweating, affects an estimated 4.8% of the U.S. population, or approximately 15 million people. Excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment.

If the cause of the excessive sweating is not known, it falls under the category of primary hyperhidrosis, and if there is heavy sweating due to an underlying medical condition, it is called secondary hyperhidrosis.

Excessive underarm sweating, for which there is no known cause, is called primary axillary hyperhidrosis.

If approved, Glycopyrronium tosylate would be the first FDA-approved topical wipe medication specifically indicated to treat patients with primary axillary hyperhidrosis.

DERM closed Friday's trading at $10.48, down 2.51%.

7. Novo Nordisk A/S (NVO)

Novo Nordisk is a global healthcare company focused on developing drugs to treat diabetes and other serious chronic conditions like adult growth hormone deficiency.

Watch out for…

Data from a phase II study in prepubertal growth hormone deficient (GHD) children evaluating weekly treatment with once-weekly Somapacitan versus daily injections of Norditropin, dubbed REAL 3, is expected this quarter.

NVO closed Friday's trading at $46.84, up 0.95%.

8. Acorda Therapeutics Inc. (ACOR)

Acorda Therapeutics is a biopharmaceutical company marketing two approved products namely AMPYRA and QUTENZA, and has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease and multiple sclerosis.

The lead drug candidate in the pipeline is INBRIJA, an investigational treatment for people with Parkinson's living with OFF periods, or the re-emergence of Parkinson's symptoms.

INBRIJA is under FDA review, with a decision expected on October 5, 2018.

Watch out for…

Data from a phase II trial of BTT1023 as a treatment for primary sclerosing cholangitis (PSC) are expected this quarter.

PSC is a rare, chronic disease that damages the bile ducts over time, leading to accumulation of bile in the liver, eventually resulting in liver failure.

ACOR closed Friday's trading at $29.45, down 1.51%.

9. Array BioPharma Inc. (ARRY)

Array BioPharma's (ARRY) COMBO450, a MEK/BRAF inhibitor combo, proposed for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma is at the FDA altar - with a decision expected by June 30, 2018.

COMBO450 is a combination of two investigational drugs - Binimetinib, a MEK inhibitor, and Encorafenib, a BRAF inhibitor.

In clinical trials, patients with BRAF-mutant melanoma when treated with COMBO450 had median overall survival of 33.6 months compared to median overall survival of 16.9 months in patients treated with Roche's Zelboraf.

ARRY closed Friday's trading at $19.37, down 0.92%.

10. Alkermes plc (ALKS)

Alkermes' Aripiprazole Lauroxil NanoCrystal Dispersion, an investigational product designed to help patients get started with schizophrenia drug Aristada is under FDA review - with a decision expected on June 30, 2018.

Aripiprazole lauroxil, which is Aristada, is an injectable atypical antipsychotic approved in four doses and three dosing durations for the treatment of schizophrenia (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks, and 1064 mg once every two months).

Once in the body, Aristada converts to Aripiprazole. Oral Aripiprazole should be administered for 21 consecutive days in conjunction with the first injection of Aristada.

Aripiprazole Lauroxil NanoCrystal Dispersion, which uses the Company's proprietary NanoCrystal technology, is designed to provide extended-release Aripiprazole lauroxil in a formulation that uses a smaller particle size than Aristada. This enables faster dissolution, and would lead to more rapid achievement of therapeutic levels of Aripiprazole.

If approved, Aripiprazole Lauroxil NanoCrystal Dispersion in conjunction with a single oral dose of 30 mg Aripiprazole will provide an alternative to the 21 day oral Aripiprazole regimen with the first dose of Aristada.

ALKS closed Friday's trading at $44.13, up 1.10%.

11. Global Blood Therapeutics Inc. (GBT)

Global Blood Therapeutics is a clinical-stage biopharmaceutical company, developing its lead product candidate, Voxelotor, as an oral, once-daily therapy for sickle cell disease.

A phase III study evaluating Voxelotor in adults and adolescents with sickle cell disease is known as HOPE Study. This trial consists of two parts - Part A and Part B.

Watch out for…

Top line data from Part A of the HOPE study is expected this month.

GBT closed Friday's trading at $42.05, up 1.69%.

12. Cara Therapeutics Inc. (CARA)

Cara is a biopharmaceutical company focused on developing new drugs to alleviate pruritus and pain.

The Company's lead drug candidate is KORSUVA, a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. KORSUVA is CR845 in combination with kappa opioid receptor agonist Difelikefalin.

Watch out for…

Top line data from a dose-escalating phase I pharmacokinetic (PK), safety and tolerability trial of oral KORSUVA for the treatment of chronic kidney disease-associated pruritus in non-hemodialysis patients is expected this month.

Data from an adaptive phase III trial of I.V. CR845 for the treatment of acute post-operative pain in patients undergoing abdominal surgery are expected this month.

CARA closed Friday's trading at $16.59, down 1.60%.

13. Arsanis Inc. (ASNS)

Arsanis is a clinical-stage biopharmaceutical company focused on developing monoclonal antibody programs that address specific bacterial and viral pathogens.

The Company's lead product candidate is ASN100, a first-in-class mAb therapy that is designed to neutralize the six cytotoxins critical to Staphylococcus aureus pneumonia pathogenesis.

ASN100 is under phase II study for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients.

Watch out for…

Results of a planned interim analysis of the phase II clinical study of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients are expected in late June.

ASNS closed Friday's trading at $18.94, up 14.58%.

14. Gemphire Therapeutics Inc. (GEMP)

Gemphire is a clinical-stage biopharmaceutical company focused on developing therapies for cardiometabolic disorders, including non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and dyslipidemia.

The Company's lead drug candidate is Gemcabene, a first-in-class, once-daily, oral therapy for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins.

Watch out for…

A phase IIb trial investigating Gemcabene in severe hypertriglyceridemia patients, dubbed INDIGO-1, is underway. The top-line data from this trial is expected this month.

GEMP closed Friday's trading at $5.75, down 8.59%.

15. Celsion Corp. (CLSN)

Celsion is an oncology drug development company.

The Company's lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer. Also in the pipeline is an immunotherapy candidate, GEN-1, currently in Phase I/II development for the localized treatment of ovarian cancer, dubbed OVATION II.

Last year, the Company reported impressive results from its phase Ib dose escalating clinical trial combining GEN-1 with neoadjuvant chemotherapy for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer followed by interval debulking surgery, dubbed OVATION I.

Watch out for…

Final progression-free survival data from the OVATION I Study is expected to be reported this month.

CLSN closed Friday's trading at $3.27, up 6.51%.

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