FDA Panel Says No To CORV, ITRM For Sure Has Disappointed, ELOX, XERS On Watch

pharma053117 10dec19

Today's Daily Dose brings you news about the FDA panel's vote on Correvio Pharma's anti-arrhythmic drug Brinavess; the near-term catalyst of Eloxx Pharma; the phase III trial results of Iterum's Sulopenem in the treatment of complicated intra-abdominal infections, and Xeris Pharma's phase II study results of ready-to-use (RTU) glucagon.

Read on…

Correvio Pharma Corp.'s (CORV)(CORV.TO) anti-arrhythmic drug Brinavess, proposed for the rapid conversion of recent onset atrial fibrillation in adult patients, has failed to win the backing of the FDA's Cardiovascular and Renal Drugs Advisory Committee.

The Committee jointly voted that the benefit-risk profile was not adequate to support approval. The FDA's final decision is set for December 24, 2019.

While the FDA is not required to follow the Committee's vote, the agency considers the Committee's recommendations when making its decision.

Brinavess is approved for marketing in Europe, Canada, and several other countries worldwide.

In after-hours trading on Tuesday, CORV was down 56.44% to $0.61.

Shares of Eloxx Pharmaceuticals, Inc. (ELOX) have gained more than 40% over the past 5 trading days as the Company awaits topline results from its phase II study of ELX-02 in nephropathic cystinosis later this year.

The phase II cystinosis trial involves two sequential cohorts of three patients with three escalating doses.

To date, based upon preliminary results, ELX-02 has been well-tolerated through the first two dose levels, and at the second 1 mg/kg dose level, ELX-02 demonstrated a statistically significant reduction in white blood cell cystine levels, according to the Company.

ELOX closed Tuesday's trading at $6.92, up 27.21%. In after-hours, the stock gained another 4.77% to $7.25.

Shares of Iterum Therapeutics plc (ITRM) are down over 45% in extended trading on Tuesday, following disappointing topline results from its phase III trial of oral and IV Sulopenem for the treatment of complicated intra-abdominal infections, dubbed SURE.

The primary FDA endpoint was clinical response on Day 28 in the micro-MITT population. (Modified Intent To Treat).

The Company noted that the topline results narrowly missed the primary endpoint.

A phase III trial of oral and IV Sulopenem for the treatment of complicated urinary tract infection, dubbed SURE 2, is underway, with topline results anticipated in the first quarter of 2020.

ITRM closed Tuesday's trading at $4.85, up 21.86%. In after-hours, the stock was down 45.98% to $2.62.

Xeris Pharmaceuticals Inc.'s (XERS) in-clinic stage of a phase II study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery has yielded positive results.

In this study, subjects self-administer a mini dose (300 µg) of RTU glucagon or placebo when they experience hypoglycemia symptoms (e.g., anxiety, nausea, sweating, tremors, palpitations), and blood glucose response is measured after the study drug is self-administered.

The study results have demonstrated that a mini dose of RTU glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration. This effect was maintained at 30 minutes, and hyperglycemia was not observed. The incidence of a follow-on episode of hypoglycemia (rebound hypoglycemia) requiring oral glucose for rescue was less with RTU glucagon compared to placebo, revealed the Company.

The data from the second half of the study, which is outside of the controlled in-clinic environment, is expected to be available in the first half of 2020.

XERS closed Tuesday's trading at $9.00, up 1.47%. In after-hours, the stock was up 20% to $10.80.

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