RETA Surges On Trial Data, RVNC On Track, All Eyes On RLMD Today

pharma 052417 15oct19

Today's Daily Dose brings you news about the delay in FDA decision of Flexion's supplemental New Drug Application for ZILRETTA; launch of NOURIANZ, an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes, in the U.S.; Reata Pharma's Friedreich's Ataxia trial data; and upcoming clinical trial catalyst of Relmada Therapeutics.

Read on…

Flexion Therapeutics Inc. (FLXN) slipped more than 5% in extended trading on Monday, following the delay in FDA decision on the supplemental New Drug Application for ZILRETTA. The original regulatory decision was on October 14, 2019.

ZILRETTA, a sustained-release corticosteroid polymer (PLGA) formulation, was approved by the FDA in October 2017, for the management of osteoarthritis pain of the knee.
Currently, ZILRETTA is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL), and is not intended for repeat administration.

Net sales of ZILRETTA were $22.5 million for full-year 2018 and $27.6 million in the first half of 2019.

The Company has sought to revise the product label for ZILRETTA to allow for repeat administration. Although the FDA did not provide a new action date, the Company has been informed that a decision regarding the repeat administration will be announced in the coming weeks.

FLXN closed Monday's trading at $13.81, up 3.41%. In after-hours, the stock was down 5.90% at $13.00.

The FDA has approved Johnson & Johnson (JNJ) and Bayer's blood thinner XARELTO in the expanded indication of preventing venous thromboembolism, or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

XARELTO already has five approved venous thromboembolism indications, including the treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction of the risk of recurrent DVT and PE, and primary prevention of DVT, which may lead to PE, in people who have just had hip or knee replacement surgery.

In October 2017, the FDA approved a new dose regimen of 10 mg XARELTO once-daily for reducing the continued risk for recurrent VTE after completion of at least six months of initial therapy.

The drug generated global sales of $6.5 billion in 2018, up 5% compared to 2017.

JNJ closed Monday's trading at $130.72, down 0.46%.

Japan-based Kyowa Kirin Inc. has launched NOURIANZ, an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes, in the U.S.

Nourianz received FDA approval in August of this year.

Parkinson's disease is a neurodegenerative brain disorder, in which during the course of the disease, the brain slowly stops producing a neurotransmitter called dopamine. As the dopamine level falls, it becomes difficult for the individual to regulate his/her movements, body and emotions.

Levodopa/carbidopa is the most commonly prescribed treatment for Parkinson's disease. There are times when a patient's medications do not work well, and it causes an increase in Parkinson's disease symptoms, such as tremor and difficulty walking. These are known as "off" episodes.

NOURIANZ becomes the first and only FDA-approved adenosine A2A receptor antagonist treatment for 'off' time associated with Parkinson's disease.

Shares of Reata Pharmaceuticals Inc. (RETA) surged over 34% in after-hours on Monday, following positive Friedreich's Ataxia trial data.

Friedreich's Ataxia is an inherited, debilitating, and degenerative neuromuscular disorder, characterized by progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance. It is typically diagnosed during adolescence and can ultimately lead to premature death.

The reported data was from the registrational Part 2 portion of a phase II trial of Omaveloxolone in patients with Friedreich's ataxia, dubbed MOXIe.

According to the Company, patients treated with Omaveloxolone demonstrated a statistically significant, placebo-corrected 2.40 point improvement in modified Friedreich's Ataxia Rating Scale (mFARS) after 48 weeks of treatment. Omaveloxolone treatment was generally reported to be well-tolerated.

The Company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally based on the positive results and subject to discussions with regulatory authorities.

RETA closed Monday's trading at $100.59, up 4.99%. In after-hours, the stock was up 34.23% at $135.02.

Relmada Therapeutics Inc. (RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system diseases, is all set to release top-line data from its Phase 2 study of REL-1017 in patients with treatment-resistant depression on October 15, 2019, before the market opens.

The Company's common stock was uplisted to The Nasdaq Capital Market from the OTC on October 10, 2019. A 1-for-4 reverse stock split was implemented by the Company on September 30, 2019.

RLMD closed Monday's trading at $11.20, down 0.49%.

Revance Therapeutics Inc. (RVNC) has appointed Mark Foley as President and CEO, replacing Dan Browne, who has stepped down due to a misjudgment in handling an employee matter.

Browne has also resigned from Revance's Board of Directors.

The Company remains on track to file its Biologics Licensing Application for DaxibotulinumtoxinA for Injection (DAXI) for the treatment of glabellar (frown) lines in the Fall of 2019, as previously announced.

DaxibotulinumtoxinA for Injection is also being evaluated for forehead lines and crow's feet, and phase II trials in the two indications are underway. Topline results for both the trials are expected in the first half of 2020.

RVNC closed Monday's trading at $14.02, up 15.11%.

Tranexamic acid, a low-cost, widely available drug, if given within three hours of injury, could reduce deaths in traumatic brain injury patients by as much as 20%, depending on the severity of the injury, suggests a study published in The Lancet.

*Sold under brand names Lysteda and Cyklokapron, Tranexamic acid is used in the treatment of bleeding disorder, Factor IX Deficiency, hemophilia A, melasma, menorrhagia, and menstrual disorders. (*Source: Drugs.com).

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