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ARDX Jumps On PHREEDOM Data, AXSM Is Awesome, CARA On Watch

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Today's Daily Dose brings you news about Ardelyx' PHREEDOM trial results; narcolepsy trial results of Axsome; TRANSCEND trial results of Protagonist Therapeutics and FDA approval of Roche's (RHHBY.OB) Tecentriq for yet another indication.

Read on...

Ardelyx Inc.'s (ARDX) long-term phase III study evaluating the efficacy and safety of Tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease, dubbed PHREEDOM, has met the primary endpoint.

During the 26-week treatment period, 77% of Tenapanor-treated patients in the intent-to-treat population had a mean reduction in serum phosphorus of 2.0 mg/dL from baseline.

The Company is planning to submit the NDA for Tenapanor in mid-2020. If approved, Tenapanor will be the only non-binder treatment for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

As of September 30, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $103.5 million.

ARDX touched a new high of $8.31 in intraday trading on Tuesday, before closing at $8.05, up 11.19%.

Shares of Axsome Therapeutics Inc. (AXSM) jumped 15% on Tuesday, following positive results from its phase II trial of AXS-12 in narcolepsy, dubbed CONCERT.

Narcolepsy is a debilitating, neurological condition characterized by excessive daytime sleepiness (EDS) and cataplexy, a sudden loss of muscle tone triggered by strong emotions.

In the CONCERT trial, AXS-12 met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy. AXS-12 also significantly reduced EDS, and improved cognitive function, sleep quality and sleep-related symptoms.

Based on the positive CONCERT trial results, Axsome intends to initiate phase III trials of AXS-12 in 2020.

Near-term Catalysts:

-- Topline data from a phase III trial of AXS-05 in major depressive disorder, dubbed GEMINI, are due this quarter (Q4, 2019).
-- Topline data from a phase III trial of AXS-07 in migraine, dubbed MOMENTUM, are also due this quarter.
-- Topline data from a phase III trial of AXS-05 in treatment-resistant depression (TRD), known by the name STRIDE-1, is anticipated in Q1, 2020.
-- Topline data from a phase III trial of AXS-07 in migraine, dubbed INTERCEPT, are also scheduled to be reported in Q1, 2020.
-- Topline data from a phase II/III trial of AXS-05 for the treatment of agitation in patients with Alzheimer's disease, dubbed ADVANCE-1, are slated for release in the first half of 2020.

We alerted readers to AXSM on August 29, 2018, when it was trading around $3.

Related Reading

Will Axsome Therapeutics Make Big Strides?

The stock touched an all-time high of $47.24 in intraday trading on Tuesday, before closing at $45.61, up 15.12%.

Aldeyra Therapeutics Inc. (ALDX) announced positive top-line results from Part 1 of the adaptive Phase 3 RENEW Trial of topical ocular Reproxalap in patients with dry eye disease.

In the induction-maintenance dosing group from Weeks 2 to 12, Reproxalap was statistically superior to vehicle in VAS ocular endpoints, Ocular Discomfort & 4-Symptom Questionnaire ocular endpoints. However, the co-primary endpoint of fluorescein nasal region ocular staining did not reach statistical significance in the induction-maintenance dosing group from Weeks 1 to 4 of treatment.

The Company plans to initiate Part 2 of the RENEW trial in the first half of 2020.

ALDX closed Tuesday's trading at $5.06, down 32.44%.

Shares of Cara Therapeutics Inc. (CARA) slumped over 34% on Tuesday, following results from its phase II dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V (moderate-to-severe) chronic kidney disease (CKD).

The study met the primary endpoint with statistically significant reduction in mean worst itching intensity NRS scores with 1 mg tablet strength of Oral KORSUVA compared to placebo after 12-week treatment period.

However, the trial did not meet the secondary endpoints, which included change from baseline in itch-related quality of life scores at the end of Week 12, as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline of a 3 point or greater with respect to the weekly mean of the daily 24-hour Worst Itch NRS score at Week 12.

Commenting on the trial results, Derek Chalmers, President and Chief Executive Officer of Cara Therapeutics, said, "We are pleased that this Phase 2 study has successfully identified an appropriate tablet strength of Oral KORSUVA to carry forward into a pivotal Phase 3 registration program which we expect to initiate next year."

CARA closed Tuesday's trading at $16.93, down 34.56%. In after-hours, the stock was up 1.56% to $17.20.

Protagonist Therapeutics Inc.'s (PTGX) phase II open-label study of PTG-300 in patients with transfusion-dependent beta-thalassemia, dubbed TRANSCEND, has demonstrated dose-related drug exposure and reductions from baseline serum iron and transferrin saturation levels, with significant reductions at the 40 mg and 80 mg weekly doses.

In the study, systemic adverse events were mild to moderate in severity and were typical of patients with TD beta-thalassemia. These events were not dose-related and did not prevent dose escalation. There was one serious adverse event of vomiting and confusion, and the most frequent treatment emergent adverse event observed was transient erythema in 4 out of 33 patients (12 percent), noted the Company.

The Company expects to report results from additional dose regimens and longer follow-up in the study, with clinical efficacy results expected in 2020.

PTGX closed Tuesday's trading at $4.69, down 47.01%.

The FDA has approved Roche's (RHHBY.OB) Tecentriq as a frontline treatment for patients with metastatic nonsquamous non-small cell lung cancer who do not have EGFR or ALK aberrations, in combination with carboplatin and nab-paclitaxel (Abraxane).

Tecentriq in combination with Avastin, carboplatin, and paclitaxel was approved by the FDA last December for the frontline treatment of patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations.

The drug received its initial FDA approval in May 2016 to treat urothelial carcinoma, the most common type of bladder cancer.

Tecentriq's sales were 772 million Swiss francs in 2018 and 1.3 billion Swiss francs in the first nine months of 2019.

RHHBY.OB closed Tuesday's trading at $38.19, down 0.60%.

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