July 07, 2016 04:54 PM Eastern Daylight Time
BOCA RATON, Fla.--(BUSINESS WIRE) July 07,2016
TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, announced today that it has submitted its New Drug Application (NDA) for Yuvvexy with the U.S. Food and Drug Administration (FDA). The NDA submission is supported by the complete Yuvvexy clinical program, including positive results of the recently completed phase 3 Rejoice Trial. The NDA submission includes all three doses of Yuvvexy (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial.
Yuvvexy, the conditionally-approved trade name for the company’s TX-004HR drug candidate, is an applicator-free, vaginal, estradiol softgel capsule being proposed for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
Press release on Business Wire
TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, announced today that it expects that the New Drug Application (NDA) for Yuvvexy, the conditionally approved trade name for the Company’s TX-004HR drug candidate, will be submitted to the Food and Drug Administration (FDA) on or before July 15, 2016. The NDA is being finalized in Electronic Common Technical Document (eCTD) format and will be submitted to the FDA following electronic publishing activities and technical document validation. Yuvexxy is an applicator-free, vaginal, estradiol softgel capsule being proposed for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. TherapeuticsMD completed the phase 3 Rejoice Trial for Yuvvexy in December 2015.
Represents the 4th Banner Expansion within the 2,778 Store Kroger Group
Includes Distribution to Eight New States for Búcha® Live Kombucha
TORRANCE, CA / ACCESSWIRE / June 16, 2016 / Búcha, Inc. (formerly American Brewing) (ABRW), the California-based owner of the Búcha® Live Kombucha brand today announced that it has expanded its distribution with Smith's Food and Drug in their eight state market area across Utah, Nevada, New Mexico, Idaho, Montana, Wyoming, Arizona, and Tennessee. The expansion chain-wide represents the fourth major banner expansion within the Kroger Company that recently posted sales of $109.8 Billion across 2,778 grocery stores and 784 convenience stores.
The new distribution with Salt Lake City based Smith's includes some of Búcha® Live Kombucha's leading flavors including Raspberry Pomegranate, Yuzu Lemon, Grapefruit Sage, Blood Orange, and Guava Mango. The products are 100% organic and all have an industry leading 9 months of shelf life emanating from Búcha's proprietary production process. Founded in 1911 in Utah, Smith's merged with Fred Meyer in 1997 and was acquired by Kroger in 1999. Smith's will be rolling out the Búcha® Live Kombucha brand in time for the peak summer season, in complement sales already happening in other Kroger banners including Ralphs, Fry's and Kroger stores in various regions of the country.
The Búcha® Live Kombucha brand has recently been expanding distribution nationally and leading the growth of the overall Kombucha category, one of the fastest growing beverage segments worldwide. A key reason behind Búcha's success is its trending and mainstream appealing flavors, recently ranked superior in taste by 43% vs. major competitors. The Hartman group also recently ranked the Búcha® Live Kombucha brand as a breakout brand for 2016.
Búcha® Inc. recently signed a definitive agreement to purchase the $50 million plus New Age Beverages Group, including their XingTea® brand in the RTD Tea category, the new XingEnergy® in Energy Drinks, and Aspen Pure® in Functional Waters. The transaction is expected to close on or about June 30th, after which the company will be renamed The New Age Beverages Corporation.
Brent Willis, Chief Executive of Búcha® Inc. commented, "Smith's is a strong leader in its market areas, is a new flagship account for us, and a world class retailer. We are very pleased and appreciative to be part of their offerings, and will work diligently to drive category sales and profits for them. Smith's provides us excellent penetration to eight new states that will enable more consumers to choose healthier and organic beverages, that just happen to also taste great."
First of an initial 18 planned 365 concept stores to open
Opening event with Daybreaker in LA highlighted Búcha® Live Kombucha
TORRANCE, CA / ACCESSWIRE / June 14, 2016 / Búcha, Inc. (formerly American Brewing) (ABRW), the California-based owner of the Búcha® Live Kombucha brand, today announced that it has been selected by Whole Foods Markets to be sold in their new 365 Concept stores. The first 365 by Whole Foods store had its grand opening on May 25th commemorated by a Yoga Daybreaker celebration held last week that prominently featured Búcha® Live Kombucha.
The Yoga Daybreaker celebration took place on June 7th at the Los Angeles, California opening of the first 365 by Whole Foods Market stores. Daybreaker brings together a global community of millennials who actively seek new experiences. Daybreaker produces monthly events around the globe that merge the worlds of nightlife and festivals with a lifestyle committed to health and wellness. The group selectively partners with brands and companies aligned with their values to spread the word and enhance each experience while consciously building communities, and has almost 200,000 community members in 14 major metropolitan cities all over the world.
The Búcha® Live Kombucha brand has recently been expanding distribution nationally with natural and health food outlets and has also recently become available at select major mainstream retailers. The selection from 365 by Whole Foods Market to distribute in all their new concept stores, of which 18 are currently envisioned, is a testament to the Búcha® Live Kombucha brand's retail throughput and mainstream appeal with consumers. Búcha® was recently ranked as the preferred flavor by 43% of major competitors in the Kombucha category.
Búcha® Inc. recently signed a definitive agreement to purchase the $50 million New Age Beverages Group, including their XingTea® brand in the RTD Tea category, the new XingEnergy® in Energy Drinks, and Aspen Pure® in Functional Waters. The transaction is expected to close on or about June 30th, and brings more than $7.5MM in cost and revenue synergies.
Brent Willis, Chief Executive of Búcha® Inc. commented, "Whole Foods has been and continues to be a great retailer partner. We are fortunate to be able to work with them. Búcha® Live Kombucha being selected to be sold in their new 365 stores is an honor and we expect to drive outstanding sales for them. We were happy to participate in the LA store-opening event. It was unique and great statement and connection between Daybreaker, Whole Foods, and Búcha® for health conscious active consumers."
From today's press release:
"TherapeuticsMD’s Vice President of Marketing, said, “As a leader in healthcare solutions for women, we are continually looking for ways to provide patients with products that embody efficacy, safety, and convenience. In talking with our customers, we found they have generally experienced frustration trying to open currently available child-resistant packages.”
He added, “Our exciting new packaging addresses a longtime need in the prenatal market to offer women more convenient blister packaging for each dose, while also meeting important safety needs. It reflects our commitment to women’s health, strengthens our relationships with Ob/Gyns, and helps to grow trust in our unique products for women.”
Sentiment: Strong Buy
Next week TXMD will be making presentations to institutional investors at Jefferies 2016 Global Healthcare Conference, and at the Goldman Sachs 37th Annual Global Healthcare Conference.
Sentiment: Strong Buy
Data Show Improvement in Female Sexual Function Index with TX-004HR
TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, presented additional secondary endpoint results from the pivotal phase 3 Rejoice Trial for its TX-004HR product candidate at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting held May 14-17, 2016, in Washington, DC.
Yuvvexy™, the conditionally approved trade name for TX-004HR, is an applicator-free vaginal estradiol softgel capsule being investigated for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
Data presented in the poster assess the effect of Yuvvexy on female sexual dysfunction in postmenopausal women using the Female Sexual Function Index (FSFI). The FSFI is a validated, self-reporting questionnaire consisting of 19 questions designed to assess the domains of arousal, desire, satisfaction, orgasm, lubrication, and pain. After 12 weeks, total FSFI scores increased with all three doses of Yuvvexy (4 mcg, 10 mcg, and 25 mcg) and placebo, with a statistically significant difference at the 10 mcg and 25 mcg doses versus placebo. The poster, entitled “Improvement in Postmenopausal Sexual Function with TX-004HR as Measured by FSFI,” may be viewed in the “Investors and Media” section of the company’s website under Events and Presentations.
“We are pleased to present these additional findings from the Rejoice Trial at ACOG as we prepare to file a New Drug Application (NDA) for Yuvvexy as a treatment for dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause,” said TherapeuticsMD co-founder and Chief Clinical Officer Brian Bernick, M.D. “The FSFI data reflect the breadth and depth of our positive phase 3 Rejoice Trial and suggest that Yuvvexy has the potential to be a highly differentiated new therapy for menopausal women, if approved.”
Sentiment: Strong Buy