Week Ahead In Pharmaceuticals: 7 Stocks To Watch (TNXP, REGN, KALA...)

(RTTNews) - As another week comes to a close, it's time to take a quick look at some of the news that made headlines in the pharma sector, and look ahead at the events to keep an ear out for in the coming week.

Barely days after striking down Regeneron Pharmaceuticals Inc.'s (REGN) request for an updated label for EYLEA, the FDA greenlighted the same on Friday, paving way for a 12-week dosing regimen of the drug for patients with wet age-related macular degeneration.

Mylan's (MYL) EpiPen, the most-widely prescribed epinephrine auto-injector in the U.S., and the one mired in a price gouging scandal, has finally got a direct generic competitor. The FDA, on August 16, approved the first generic version of EpiPen and EpiPen Jr auto-injector, made by Teva Pharmaceuticals USA.

CEL-SCI Corp. (CVM) was one of the top gainers of the week, returning over 40%. The NYSE American has accepted the Company's plan to bring itself into compliance with the Exchange's continued listing standards.

OptiNose Inc. (OPTN), whose shares dropped more than 34% in the week, was one of the top losers, despite reporting better-than- expected Q2 financial results.

Now, here are some of the pharma/biotech stocks to watch out for in the week starting August 20.

1. Tonix Pharmaceuticals Holding Corp. (TNXP)

Tonix is a clinical-stage biopharmaceutical company developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense through potential medical counter-measures.

The lead product candidate is Tonmya, or TNX-102 SL, for military-related post-traumatic stress disorder (PTSD).

Watch out for...

The Company will be presenting findings and retrospective analyses from the phase III HONOR study and phase II AtEase Study in a poster at the 2018 Military Health System Research Symposium (MHSRS) on August 21.

AtEase is a phase II dose-finding clinical study of TNX-102 SL in military-related post-traumatic stress disorder. The Company reported positive results from this study in May 2016.

HONOR is a phase III study of TNX-102 SL in military-related posttraumatic stress disorder. In July of this year, the Company had announced that it will stop the HONOR study due to inadequate separation from placebo on the primary endpoint at week 12.

TNXP closed Friday's trading at $1.21, up 1.68%.

2. Mallinckrodt Public Limited Co. (MNK)

Mallinckrodt's Stannsoporfin injection, proposed for the treatment of newborns at risk of developing severe jaundice, is under FDA review, with a decision expected on August 22.

An FDA panel had voted 21 to 3 against approval of Stannsoporfin in May of this year. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

Stannsoporfin injection was developed by InfaCare Pharmaceutical Corp. Mallinckrodt acquired InfaCare Pharmaceutical last August.

Jaundice or hyperbilirubinemia is a common condition seen both in term and pre-term newborns. In the U.S., the total number of term births is estimated at 3.97 million per year, and, of those, approximately 750,000 infants are treated for jaundice, according to reports.

MNK closed Friday's trading at $34.69, up 1.61%.

3. Regeneron Pharmaceuticals Inc. (REGN)

Sanofi and Regeneron have sought expanded approval from the FDA for the use of Praluent with apheresis, an invasive procedure where bad (LDL) cholesterol is removed from the blood, in a process similar to kidney dialysis, and the decision on the same is expected on August 24.

Praluent is already approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for the treatment of patients with heterozygous familial hypercholesterolemia or atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

In clinical studies in patients undergoing LDL apheresis therapy, Praluent when added to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75 percent, compared to placebo.

Apheresis therapy is invasive and burdensome to patients, given that it can take more than three hours. Treatment may also be inconvenient and cost up to $100,000 for each patient per year in the U.S. or up to €60,000 in Germany, where there are 200 centers and LDL apheresis is more frequently used. In the U.S. there are only approximately 60 apheresis centers and many patients must travel significant distances for the procedure, according to Regeneron.

REGN closed Friday's trading at $374.26, up 0.67%.

4. Kala Pharmaceuticals Inc. (KALA)

The FDA decision on Kala Pharma's Inveltys, a product candidate for the treatment of inflammation and pain in ocular surgery patients, is expected on August 24.

If approved, Inveltys could be the first FDA-approved twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.

In the U.S., the current market leaders for topical steroids that are used to manage and prevent complications from post-operative inflammation, are Lotemax products and Durezol.

In February of this year, the FDA approved Icon Bioscience Inc.'s Dexycu, a dropless therapeutic designed to treat inflammation associated with cataract surgery.

H.C. Wainwright analyst Ram Selvaraju estimates peak sales of Inveltys to be $280 million in 2029.

KALA closed Friday's trading at $12.14, down 2.57%.

5. Shionogi & Co. Ltd. (SGIOF.OB)

Shionogi's New Drug Application for Lusutrombopag (S-888711) is under priority review by the FDA, with a decision date set for August 26.

The Company is seeking approval of Lusutrombopag for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with invasive procedures.

In Japan, Lusutrombopag was approved in September 2015 for the improvement of thrombocytopenia associated with chronic liver disease in patients undergoing an elective invasive procedure.

There is one FDA-approved treatment for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, and it is Dova Pharmaceuticals Inc.'s (DOVA) Doptelet. This drug was approved by the FDA as recently as May 21, 2018.

Doptelet was launched in the U.S. on May 31, 2018, and its Wholesale Acquisition Cost (WAC) is $9,000 for the 40mg daily dose and $13,500 for the 60mg daily dose.

SGIOF.OB closed Friday's trading at $56.13, up 2.26%.

6.Shire plc (SHPG)

The FDA decision on Shire's investigational treatment Lanadelumab is expected to be announced on August 26.

The Company is seeking approval of Lanadelumab for the prevention of angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema (HAE).

Lanadelumab is formulated for subcutaneous administration, and has a half-life of approximately 14 days in patients with HAE.

Analysts estimate that annual peak sales of Lanadelumab may reach up to $2 billion.

In May, Shire agreed to be acquired by Japanese drugmaker Takeda Pharmaceutical for $62 billion, representing the biggest deal of the year so far. The transaction is expected to close in the first half of calendar year 2019.

SHPG closed Friday's trading at $170.42, down 0.63%.

7. Esperion Therapeutics Inc. (ESPR)

Esperion is a late-stage pharmaceutical company developing convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C).

The company has two LDL-C lowering therapies in development namely, the Bempedoic acid/Ezetimibe combination pill and Bempedoic acid.

Watch out for...

Top-line results from a 12-week, pivotal phase III study of the Bempedoic acid/ Ezetimibe combination pill in atherosclerotic cardiovascular disease patients on maximally tolerated statin background therapy are expected this month.

ESPR closed Friday's trading at $48.12, up 3.11%.