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NTLA Gains On Amended REGN Deal, GILD Reports SIMPLE Results, MYOV On Watch, NVUS Slumps

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Today's Daily Dose brings you news about Passport Health Plan failing to secure a new Medicaid managed care contract; Gilead's Remdesivir trial results in COVID-19 patients; Iterum missing trial goals in SURE2 study; Ocugen pulling the plug on ocular Graft vs. Host Disease; Novus' disappointing results in acute otitis media study; Intellia expanding its existing collaboration with Regeneron Pharma and Myovant Sciences' near -term catalysts.

Read on…

1. CTI BioPharma Expects COVID-19 Trial Results By Year-end

CTI BioPharma Corp. (CTIC) has enrolled the first patient in its phase III trial evaluating Pacritinib in hospitalized patients with severe COVID-19.

The trial, dubbed PRE-VENT, is designed to compare Pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer.

The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane al membrane oxygenation or die by Day 28.

The topline data from this trial is expected by the end of 2020.

CTIC closed Monday's trading at $1.19, up 16.67%.

. Evolent Health Falls As Partner fails To Win New Medicaid Contract

Shares of Evolent Health Inc. (EVH) slumped more than 23 percent on Monday on news that its partner Passport Health Plan failed to secure a new Medicaid managed care contract for the period commencing on January 1st, 2021.

Passport is currently co-owned by Evolent and local Kentucky-based providers, including the University of Louisville, Norton Healthcare, and other provider groups.

EH closed Monday's trading at $6.82, down 23.20%.

3. Gilead Reports SIMPLE Results

Gilead Sciences Inc. (GILD) has reported topline results from its second phase III trial of Remdesivir in hospitalized patients with moderate COVID-19 pneumonia, dubbed SIMPLE.

In this SIMPLE trial, the safety and efficacy of 5-day and 10-day dosing durations of Remdesivir administered intravenously in hospitalized patients with moderate manifestations of COVID-19, compared with standard of care is being evaluated.

According to the Company, patients in the 5-day Remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group. However, even though the odds of improvement in clinical status with the 10-day treatment course of Remdesivir versus standard of care were also favorable, it did not reach statistical significance.

The results of the first SIMPLE trial, which evaluated the 5-day and 10-day dosing durations of Remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19, were reported in April of this year. The results of this study revealed that patients receiving a 10-day treatment course of Remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.

Remdesivir is approved only for emergency use in the U.S. for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. It is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19.

GILD closed Monday's trading at $75.16, down 3.43%. In after-hours, the stock fell another 0.32% to $74.92.

4. Iterum Disappointed For SURE

Shares of Iterum Therapeutics plc (ITRM) took a hit on Monday, following disappointing results from a phase III trial of oral and IV Sulopenem in complicated urinary tract infections, dubbed SURE 2.

The Company has revealed that Sulopenem did not achieve statistical non-inferiority relative to Merck's approved Ertapenem in the SURE 2 clinical trial in complicated urinary tract infection.

Disappointed by the results, Iterum Therapeutics is evaluating its corporate, strategic and financial alternatives with the goal of maximizing shareholder value while prudently managing its remaining resources.

These alternatives could potentially include the licensing, sale or divestiture of the company's assets or proprietary technologies, a sale of the company, a merger or other business combination, another strategic transaction involving the company, restructuring activities, winding down of operations, dissolving and liquidating assets or seeking protection under bankruptcy laws.

ITRM closed Monday's trading at $1.70, down 59.62%. In after-hours, the stock was up 7.65% at $1.83.

5. Intellia Gains On Amended Deal With Regeneron

Shares of Intellia Therapeutics Inc. (NTLA) gained more than 19 percent on Monday on news that it has expanded its existing collaboration with Regeneron Pharmaceuticals Inc. (REGN), extending its term until April 2024.

As per the expanded agreement, Intellia will provide Regeneron with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets, with the companies jointly developing potential products for the treatment of hemophilia A and B.

Regeneron also receives non-exclusive rights to independently develop and commercialize ex vivo gene-edited products.

Intellia will receive an upfront payment of $70 million, and Regeneron will make an additional equity investment in Intellia of $30 million at $32.42 per share.

In other news, Intellia announced that it has commenced an underwritten public offering of $75 million of shares of its common stock.

NTLA closed Monday's trading at $20.92, up 19.47%.

6. Myovant Sciences In High Spirits

Myovant Sciences (MYOV) has submitted a New Drug Application to the FDA for its once-daily Relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

Relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids is also under review by the European Medicines Agency.

In April of this year, the Company submitted a New Drug Application to the FDA for once-daily, oral Relugolix monotherapy tablet (120 mg) for the treatment of men with advanced prostate cancer.

A phase III study evaluating the safety and efficacy of Relugolix combination therapy over 24 weeks in women with endometriosis, dubbed SPIRIT 1, is underway, with results expected this quarter.

MYOV was trading around $8 when we had alerted our premium subscribers to this stock on April 7, 2020 (Report titled "Will the results lift investors' spirit?)

The stock closed Monday's trading at $16.93, up 38.20%. In after-hours, it was up another 3.48% at $17.52.

7. Novus' Acute Otitis Media Trial Flops

Novus Therapeutics Inc.'s (NVUS) exploratory phase IIa clinical trial of OP0201 in acute otitis media has failed to achieve statistical significance for the primary efficacy endpoints though the statistical trend favored the OP0201 treatment group with regard to the resolution of middle ear effusion.

The primary efficacy endpoints included resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3.

The Company also revealed that it is exploring strategic options such as financing, company sale, merger, asset sale, in-license, out-license, or other business transactions, to maximize shareholder value.

NVUS closed Monday's trading at $0.61, down 51.57%.

8. Ocugen Discontinues Phase 3 Trial Of OCU300

Shares of Ocugen Inc. (OCGN) slumped over 25 percent on Monday, following the Company's decision to discontinue its phase III trial of OCU300 for ocular Graft vs. Host Disease (oGVHD) because of perceived futility.

The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion.

The Company is on track to enter the clinic by next year with its first gene therapy product candidate, OCU400, which targets inherited retinal diseases. The other pipeline products, OCU410 and OCU200, which are focused on major retinal diseases, are targeted to enter the clinic by 2022.

OCGN closed Monday's trading at $0.23, down 25.81%.

9. Stocks That Moved On No News

Dynavax Technologies Corp. (DVAX) closed Monday's trading at $7.92, up 29.41%.

Vermillion Inc. (VRML) closed Monday's trading at $4.14, up 26.61%.

Bellicum Pharmaceuticals Inc. (BLCM) closed Monday's trading at $8.72, up 14.29%.

Harpoon Therapeutics Inc. (HARP) closed Monday's trading at $18.28, down 15.99%.

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