Better Botox is coming

Revance says RT002 met primary, secondary endpoints in SAKURA trials

Better Botox coming. See Stockwinners.com
Better Botox coming

Revance Therapeutics (RVNC) announced its next-generation neuromodulator Daxibotulinumtoxin for Injection, or RT002, delivered “positive” top-line results in alleviating moderate-to-severe glabellar lines in two pivotal SAKURA Phase 3 trials.

RT002 appeared generally safe and well-tolerated in both studies. If approved by the U.S. Food and Drug Administration, Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months.

Marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.

Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows.

The percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo at Week 4.

Also at that time point, 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience.

All secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks.

On an additional key secondary endpoint, median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks as assessed by both physicians and patients.

In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018.

Assuming successful completion of SAKURA 3, the company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020.

Shares of Allergan (AGN) are sliding in pre-market trading following the news. If approved by the U.S. FDA, Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months, the company said. The company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020, it added.

RVNC closed at $26.00, it last traded at $33.75.


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Pfizer may buy Bristol-Myers

Senate tax bill raises odds of Pfizer buying Bristol-Myers, says Citi

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Pfizer may buy Bristol-Myers

The Senate tax bill, which lowers the cost of bringing cash back home from outside the U.S., increases the probability of the “often-discussed” potential acquisition of Bristol-Myers Squibb (BMY) by Pfizer (PFE), Citi analyst Andrew Baum tells investors in a research note.

The analyst points out that Pfizer has repeatedly underscored the importance of tax reform both from a competitive angle as well as from a merger perspective.

Further, the analyst says that while Roche’s (RHHBY) IMpower 150 Tecentriq lung cancer data in Geneva will take center stage this week, Bristol-Myers should benefit from two recent positive developments.

The FDA’s and Centers for Medicare and Medicaid Services’ recommendation of Tumor Mutational Burden testing for lung cancer and other tumors will likely materially accelerate adoption and create more favorable reimbursement, Baum writes in a research note partially titled “Stars Converging for BMY.”

The analyst keeps a Buy rating on Bristol shares with a $72 price target. BMY closed at $62.47. PFE ended at $36.06.

On a separate front,  Bristol-Myers Squibb Co.’s blockbuster drug Opdivo had a stunning effect on a lung-cancer patient treated at a Paris hospital: it drained hard-to-reach reservoirs of his HIV infection, too.  The 51-year-old man, who was diagnosed with HIV in 1995, had a “drastic and sustained decrease” in the reservoir of cells where the virus hides to evade existing therapies, researchers wrote in a letter published in the journal Annals of Oncology.

Note that Bristol has a market cap of $102 billion while Pfizer’s market cap is $215 billion.


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Ford to launch 50 new vehicles in China

Ford confirms plans to launch 50 new vehicles in China by 2025

Ford to launch 50 new vehicles in China. See Stockwinners.com
Ford to launch 50 new vehicles in China.

“China is not only the largest car market in the world, it’s also at the heart of electric vehicle and SUV growth and the mobility movement,” said Bill Ford.

“The progress we have achieved in China is just the start. We now have a chance to expand our presence in China and deliver even more for customers, our partners and society.” Added Hackett: ”

Ford’s (F) aspiration is to become the world’s most trusted mobility company, designing smart vehicles for a smart world.

We are very excited to see this vision come to life in China.”

To enable future growth in China, Ford will contain structural cost in the region throughout 2018, aiming to generate greater efficiencies, become more operationally fit and deliver additional value to shareholders.

Even as the team works to streamline, Ford plans to grow its China revenue by 50 percent by 2025 versus 2017 and is focusing its business expansion on three areas: even more smart, connected vehicles; closer connections to Chinese customers, and a streamlined business structure.

The company plans to offer more than 50 new Ford and Lincoln vehicles in China by 2025.

The expanded product portfolio will reflect an even stronger emphasis on SUVs – with eight all-new utilities, along with more electric vehicles.

The company will launch at least 15 new electrified vehicles from Ford and Lincoln. And the new Zotye-Ford joint venture will deliver a separate range of affordable all-electric under a new brand, pending regulatory approvals.

Plus, by the end of 2019, 100 percent of new Ford and Lincoln-badged vehicles in China will be connected through either embedded modems or plug-in devices.

Company leaders also are working on broader infrastructure opportunities to improve future mobility experiences.

In 2019, the company starts producing five additional Ford and Lincoln models in China for Chinese customers, including a new Lincoln premium SUV, and the company’s first global fully electric small SUV.

Ford is strengthening ties with its joint venture partners Changan and Jiangling in 2018, establishing one distribution services division responsible for the marketing, sales and services associated with all Ford vehicles sold in China.

The new distribution services division will seek to offer a simplified, improved and consistent customer experience for all Ford customers in China.

Ford (F) closed at $12.63.


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