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Dew - is there any way to research if Cowen has sold any of the $125M allotted to them from the "shelf"? And, If so, the total amount purchased as of last Friday?
With all the positives and Daxi approval forthcoming, something is slamming the stock and NOT allowing a steady progression to $50+!
Everything you want to know about "off label" usage, but were afraid to ask -
AMA JOURNAL OF ETHICS:
Excerpts -
The FDA does not prohibit physicians from prescribing drugs off-label [4], and Congress has repeatedly taken legal steps to prevent the FDA from interfering with the practice of medicine [4]. Although many malpractice lawsuits have been filed on behalf of patients arguing that they did not give informed consent to take a drug because they were not informed that use for their particular condition was actually off-label, the law has generally sided with physicians in finding that they have no legal duty to inform patients of a drug’s regulatory status [3, 4]. Such rulings enforce that off-label is an FDA regulatory term that denotes nothing about clinical risks or benefits [4]. The physician’s duty is to provide clinical information and some have argued that taking the time to explain the legal complexities of FDA approval versus off-label drug use could distract from shared clinical decision making [3, 4].
Conclusion
Off-label prescribing is a common and legal practice in medicine. This practice is justified when scientific evidence suggests the efficacy and safety of a medication for an indication for which it does not have FDA approval and when the practice is supported by expert consensus or practice guidelines. Through shared decision making, patients and families are equal partners in clinical decision-making processes, which can help a physician carefully weigh risks and benefits of a given treatment according to the patient’s unique circumstances.
Read more:
https://journalofethics.ama-assn.org/article/prescribing-label-what-should-physician-disclose/2016-06
Changing the Injectable Pricing Game
December 10, 2020
Lisette Hilton
Dustin Sjuts, CCO, Revance, says the company aims to elevate the patient dermal filler experience by emphasizing experience and quality over price.
Consumers price shopping for treatment with one of Revance Therapeutics’ FDA approved Resilient Hyaluronic Acid (RHA) facial fillers might find their online efforts to price-shop providers are stonewalled.
That’s because Revance wants consumers to pick their filler providers based on outcomes and experience, not price.
“We have created a global brand policy that asks that our partners do not advertise the price of RHA to consumers,” says Dustin Sjuts, Revance’s chief commercial officer. “Instead, we partner with experienced aesthetic providers who focus on patient outcomes, creating an elevated patient experience as well as innovation in differentiated products, such as the RHA Collection.”
Revance announced early in 2020 that it had signed a U.S. distribution agreement with TEOXANE SA to become the exclusive commercialization partner for RHA technology. The FDA has approved RHA 2, RHA 3, and RHA 4 for correction of dynamic wrinkles and folds such as nasolabial folds. RHA 1 is in clinical trials, with an anticipated 2021 approval. Revance’s neuromodulator DaxibotulinumtoxinA for Injection (DAXI), which is expected to create a new category of long-lasting neuromodulators lasting an average 24 to 28 weeks, also is awaiting the FDA’s nod.
While Sjuts says he cannot comment on how Revance will handle advertised pricing with still unapproved products, including DAXI, it is the company’s belief that marketing related to its products should focus on innovation and experience rather than price. The select offices that offer RHA fillers can charge what they feel is appropriate and reveal prices to individual patients post-consultation, he says.
Some aesthetic providers advertise price, but some don’t.
Facial plastic surgeon Paul J. Carniol, MD, president of The American Academy of Facial Plastic and Reconstructive Surgery and founder of Carniol Plastic Surgery in Summit, N.J., says it has long been his practice’s policy not to advertise prices. And he realizes that some people who do shop for price might not become patients.
“It is the nature of our office that we do not try to compete on price. We emphasize quality and skills,” Dr. Carniol says. “I think that is an interesting strategy that Revance has. There are certainly consumers that are willing to pay a higher price for filler if they feel they are getting better quality. I think that Revance’s aim is that group.”
https://www.aestheticauthority.com/view/changing-the-injectable-pricing-game
addendum re: EOLS and indirectly POSITIVE for RVNC -
The ITC upheld a judge's determination that Jeaveau is made with a secret process stolen from Medytox, the AbbVie unit's Korean partner, the authors say, noting that a trade judge had recommended an import ban for 10 years.
Read more at:
https://thefly.com/n.php?id=3214650
addendum re:EOLS -
The ITC upheld a judge's determination that Jeaveau is made with a secret process stolen from Medytox, the AbbVie unit's Korean partner, the authors say, noting that a trade judge had recommended an import ban for 10 years.
Read more at:
https://thefly.com/n.php?id=3214650
AbbVie unit wins ITC trade secret case against Evolus, Bloomberg
AbbVie's (ABBV) Allergan unit won an order to block Evolus (EOLS) and partner Daewoong from importing Jeuveau into the U.S. for 21 months, reported Bloomberg's Susan Decker and Christopher Yasiejko. Jeuveau is a rival to Allergan's wrinkle treatment Botox. Following the report, Evolus shares are down 46c, or 11%, to $3.57 in afternoon trading.
AbbVie unit wins ITC trade secret case against Evolus
AbbVie's (ABBV) Allergan unit won an order to block Evolus (EOLS) and partner Daewoong from importing Jeuveau into the U.S. for 21 months, reported Bloomberg's Susan Decker and Christopher Yasiejko. Jeuveau is a rival to Allergan's wrinkle treatment Botox. Following the report, Evolus shares are down 46c, or 11%, to $3.57 in afternoon trading.
Revance's Nashville home base -
Photo tour: Endeavor Real Estate Group debuts Gulch Union office tower, welcomes tenants
Check slideshow:
https://www.bizjournals.com/nashville/news/2020/12/14/gulch-union-gallery.html
Since when does an ad hominem attack invalidate scientific achievement and a Nobel prize?
The man who invented PCR....
Do you live near Nashville?
Time to apply -
Corporate Experience Manager........Nashville, Tennessee
Director, Customer Success.............Nashville, Tennessee
Manager, Commercial Analytics & Reporting
2 Locations
Sr. Analyst – Commercial Analytics & Reporting
3 Locations
Positions @ Wellesley, Dew? Sorry, none - LOL
https://www.revance.com/careers/job-listings/find-your-place-at-revance/
ELLE's 2020 Future of Beauty Awards
SKIN TREATMENTS
Read about their plans with DAXI -
We're calling it "pro-tox", etc.
https://www.elle.com/beauty/a34849644/best-products-2020-future-beauty-awards/#point2
Revance management to meet virtually with Mizuho.
Virtual Meeting to be held on December 7 hosted by Mizuho.
(We might not have access to this since it is not listed on RVNC's EVENTS page.)
6 month delay on FDA inspection & approval?
REVANCE AESTHETICS - new web site -incorporates older information +
This PRESTIGE MARKET was discussed Dec. 1 at the Piper Sandler 32nd Annual Virtual Healthcare Conference. CEO stated RVNC plans to charge additional premiums for DAXI, once approved. Also, increase their sales force to approximately 130 from 100.
https://revanceaesthetics.com/
From a FON (Family Office Networks) report:
https://familyofficenetworks.com/fon-featured-news/revance-therapeutics-the-prestige-medical-aesthetic-biotech/
REVANCE AESTHETICS - new web site - incorporates older information +
This PRESTIGE MARKET was discussed Dec. 1 at the Piper Sandler 32nd Annual Virtual Healthcare Conference. CEO stated RVNC plans to charge additional premiums for DAXI, once approved. Also, increase their sales force to approximately 130 from 100.
https://revanceaesthetics.com/
From a FON (Family Office Networks) report:
https://familyofficenetworks.com/fon-featured-news/revance-therapeutics-the-prestige-medical-aesthetic-biotech/
Revance Therapeutics Inks Long-Term Office Lease in Nashville for New Headquarters
Biotech Firm to Take Over 40,000 Square Feet in Endeavor's Gulch Union Office Tower
https://www.costar.com/article/341648163/revance-therapeutics-inks-long-term-office-lease-in-nashville-for-new-headquarters
HintMD and Marcus Medical Spa
FWIW - Excerpts:
Brokerage Cowen says the U.S. FDA's call to defer its decision on RVNC's experimental frown line treatment was anticipated due to COVID-19-related travel restrictions
** Cowen says a survey of clinicians indicates that co's treatment is differentiated and "poised to disrupt" the market for products to treat forehead wrinkles, such as AbbVie's Botox.
** FDA did not indicate there were any other review issues beyond on-site inspection - RVNC
** Cowen, which rates the stock "outperform", expects the delay to be "modest"; Says facility inspection seems to be the only outstanding issue which could be resolved shortly.
Morgan Stanley
FWIW - Excerpts:
Brokerage Cowen says the U.S. FDA's call to defer its decision on RVNC's experimental frown line treatment was anticipated due to COVID-19-related travel restrictions
** Cowen says a survey of clinicians indicates that co's treatment is differentiated and "poised to disrupt" the market for products to treat forehead wrinkles, such as AbbVie's Botox
** FDA did not indicate there were any other review issues beyond on-site inspection - RVNC
** Cowen, which rates the stock "outperform", expects the delay to be "modest"; Says facility inspection seems to be the only outstanding issue which could be resolved shortly.
Morgan Stanley
H.C. Wainwright keeps Buy rating on Revance, says FDA news 'not surprising'
H.C. Wainwright analyst Douglas Tsao said Revance's announcement that the FDA deferred the approval decision for Daxi's BLA from its PDUFA date of November 25 was "not surprising" given how a required site inspection was unable to be scheduled. While "obviously disappointing," Tsao contends that it is important to recognize this is not a complete response letter and not a reflection of a problem with the Daxi BLA, but a reflection of travel restrictions impacting the FDA. He reiterates a Buy rating on Revance shares with a $33 price target.
H.C. Wainwright keeps Buy rating on Revance, says FDA news 'not surprising'
H.C. Wainwright analyst Douglas Tsao said Revance's announcement that the FDA deferred the approval decision for Daxi's BLA from its PDUFA date of November 25 was "not surprising" given how a required site inspection was unable to be scheduled. While "obviously disappointing," Tsao contends that it is important to recognize this is not a complete response letter and not a reflection of a problem with the Daxi BLA, but a reflection of travel restrictions impacting the FDA. He reiterates a Buy rating on Revance shares with a $33 price target.
Read more at:
https://thefly.com/n.php?id=3202839
Bay Area biotech moving HQ here
Public company leases space on two floors of new Gulch tower -
Nov. 24
https://www.nashvillepost.com/business/health-care/article/21144654/bay-area-biotech-moving-hq-here
Enanta price target lowered to $45 from $52 at RBC Capital
Read more at:
https://thefly.com/n.php?id=3202032
Marlborough, Ma signs off on TIF for California biotech Revance - Nov. 17
MARLBOROUGH — A California-based biotech company will soon call Marlborough home.
Revance Therapeutics Inc.’s request for a 15-year tax increment financing deal with the city was approved by city councilors on Monday, paving the way for the company to build a new facility for commercial aseptic fill operations and research and development on Campus Drive. The company's headquarters will remain in California.
The Economic Assistance Coordinating Council must also approve the deal.
Under the proposed tax increment financing deal, the real property exemption percentage would be 100% in fiscal 2022 and 2023, drops to 90% in fiscal years 2024 and 2025 and 85% in fiscal 2026. The real property exemption percentage will drop 5% each year from fiscal 2025 to fiscal 2031 and then 10% each year until the end of the deal in fiscal 2036.
Marlborough has nine active tax increment financing deals with companies.
“The city claims to be business-friendly and this is why,” said City Councilor David Doucette.
Revance — which employs 460 people — has been looking to expand in recent years and initially considered San Francisco’s Bay Area for a new facility. The company had been considering other areas in Massachusetts — including Northborough — and Ireland before selecting Marlborough.
Company officials said Revance’s primary objectives were to find a location that meets all operational requirements at a site where the company can hire and retain exceptional talent, lower operating costs, operate in a stable and business-friendly environment with an improved tax structure and provide flexibility for future growth.
Doucette last week called the proposed Campus Drive site a “marquee location.” City Councilor Donald Landers said landing a company like Revance will make Marlborough the envy of many surrounding communities.
“I think this tenant will be a home run,” said Landers. “This is a good opportunity for us.”
City leaders have said the deal will bring more high-paying jobs to Marlborough, a new building to the city and eventually generate much-needed tax revenue.
“This is currently a parking lot,” Doucette said of the planned site of Revance’s new facility.
Marlborough, in recent years, has attracted several life science and biotech companies, bringing hundreds of new jobs to the region. The company plans to hire 76 on-site full-time employees at the Marlborough facility by fiscal 2025 under the terms of the tax deal.
The city is rated a Platinum BioReadyTM Community by the Massachusetts Biotechnology Council, which puts Marlborough among the most favorable biotech destinations in the state. Only 7% of Massachusetts communities have achieved platinum status.
https://www.metrowestdailynews.com/story/news/2020/11/17/revance-therapeutics-open-new-facility-marlborough/6322678002/
Enanta Pharmaceuticals to Present at Upcoming Investor Conferences
Wed, November 18, 2020, 7:02 AM EST
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences:
Evercore ISI 3rd Annual Virtual HealthCONx Conference, Fireside Chat at 9:15 a.m. ET on December 1, 2020
Piper Sandler 32nd Annual Virtual Healthcare Conference, One-on-One Meetings on December 2, 2020, with a Fireside Chat available to view beginning November 25
https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-to-Present-at-Upcoming-Investor-Conferences/default.aspx
California-based biotech company Revance takes step toward opening facility in Marlborough - Nov. 14
MARLBOROUGH – A California biotech company’s effort to open a facility in Marlborough has taken a step forward.
Finance Committee members on Monday signed off on Revance Therapeutics Inc.’s request for a 15-year tax increment financing deal to build a facility for commercial aseptic fill operations and research and development on Campus Drive. The full City Council is expected to vote on the tax increment financing deal in coming weeks. The Economic Assistance Coordinating Council must also approve the deal.
“We’re so excited to welcome them to the city,” said Mayor Arthur Vigeant. “We’re so excited they chose Marlborough.”
Revance – which employs 460 people – has been looking to expand in recent years and initially considered San Francisco's Bay Area for its new facility. The company was considering other areas in Massachusetts – including Northborough – and Ireland before selecting Marlborough.
City Councilor David Doucette called the proposed Campus Drive site a "marquee location."
“You guys lucked out as far as location goes,” he said.
Finance Committee Chairman John Irish said area towns and cities would be tripping over each other to attract a company like Revance to their community, especially during the economic downturn caused by the coronavirus pandemic.
Brian Blagg, vice president of engineering, facilities and supply chain at Revance, said the company’s primary objectives were to find a facility that meets all operational requirements at a location where the company can hire and retain exceptional talent, lower operating costs, operate in a stable and business-friendly environment with an improved tax structure and provide flexibility for future growth.
Marlborough, in recent years, has attracted several life science and biotech companies, bringing hundreds of new jobs to the region. Revance plans to hire 76 on-site, full-time employees at its new Marlborough facility by fiscal 2025 under the proposed tax increment financing deal.
"It’s nice to see some of these life science companies do well,” said Meredith Harris, executive director of the Marlborough Economic Development Corp.
Under the proposed tax increment financing deal, the real property exemption percentage would be 100% in fiscal 2022 and 2023, drop to 90% in fiscal years 2024 and 2025 and 85% in fiscal 2026. The real property exemption percentage will drop 5% each year from fiscal 2025 to fiscal 2031 and then 10% each year until the end of the deal in fiscal 2036.
The mayor and City Council President Michael Ossing said the deal will bring a new building to the city, generate much-needed tax revenue in the future and bring more jobs to Marlborough.
“I believe it’s a good deal for the city,” said Ossing.
The city currently has nine active tax increment financing deals with companies.
https://www.metrowestdailynews.com/story/news/2020/11/14/california-based-biotech-company-revance-gets-first-tif-approval/6233393002/
Enanta Pharmaceuticals to Host Conference Call on November 23 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2020
https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-to-Host-Conference-Call-on-November-23-at-430-p.m.-ET-to-Discuss-its-Financial-Results-for-its-Fiscal-Fourth-Quarter-and-Year-Ended-September-30-2020/default.aspx
Revance Therapeutics, Inc. (RVNC) CEO Mark Foley on Q3 2020 Results - Earnings Call Transcript
https://seekingalpha.com/article/4387379-revance-therapeutics-inc-rvnc-ceo-mark-foley-on-q3-2020-results-earnings-call-transcript
Revance to Participate in the Stifel 2020 Virtual Healthcare Conference
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will participate in the Stifel 2020 Virtual Healthcare Conference, a fully virtual management access conference, taking place November 16-18.
President and Chief Executive Officer, Mark Foley, is scheduled to participate in a virtual fireside chat on Tuesday, November 17, at 11:00 a.m. PT / 2:00 p.m. ET.
https://finance.yahoo.com/news/revance-participate-stifel-2020-virtual-210500607.html
Revance to Participate in the Credit Suisse 29th Annual Healthcare Conference
....the company will participate in the Credit Suisse 29th Annual Healthcare Conference, a fully virtual management access conference, taking place November 9-12.
Chief Financial Officer, Toby Schilke, is scheduled to present on Tuesday, November 10, at 7:15 a.m. PT / 10:15 a.m. ET.
https://investors.revance.com/news-releases/news-release-details/revance-participate-credit-suisse-29th-annual-healthcare
Dew & Sir Flo will no longer have to venture to CALI for our in-house FAT & BEAUTIFUL facial treatments. Why, you ask? bc RVNC will soon have an outlet in Marlborough, Ma. employing 76.
Marlborough continues to add to reputation as biotech, life sciences hub
Excerpts:
Revance Therapeutics is seeking a tax increment financing deal to open a facility on Campus Drive. Sartorius announced plans last week to expand its North American manufacturing operations with a new facility on Locke Drive in Marlborough.
MARLBOROUGH – The city is continuing to add to its reputation as a hub for life science and biotech companies.
Newark, California-based Revance Therapeutics Inc. – a biotech company – is seeking a tax increment financing deal with the city to open a facility for commercial aseptic fill operations and research and development on Campus Drive.
Marlborough, in recent years, has attracted several life science and biotech companies, bringing hundreds of new jobs to the region.
“Due to its strong and growing commitment to the life sciences industry, Marlborough is rated a Platinum BioReadyTM Community by the Massachusetts Biotechnology Council (MassBio),” Mayor Arthur Vigeant wrote in a letter to the City Council. “This puts the city among the most favorable biotech destinations in the state, just 7% of Massachusetts communities have achieved ‘Platinum status.’ This investment equates to new job opportunities in our community and additional tax revenue ensuring the tax burden does not fall solely on our residents.”
Revance Therapeutics
Revance plans to lease a 79,000 square-foot single-tenant building on Campus Drive and construct parking facilities, the mayor said in his letter.
“Revance Therapeutics will create and maintain 76 permanent, full-time jobs available to qualified residents of Marlborough at the projected area,” Vigeant wrote. “Additionally, improvements to the Project Area are estimated in an initial capital investment of approximately $115 million in combined soft, real property and personal property costs.”
The company – which has about 430 employees – has been in talks with city leaders about opening a facility for the past few months.
Brian Blagg, vice president of engineering, facilities and supply chain, wrote a letter to city officials saying the company’s primary objectives were to find a facility that meets all operational requirements, a location where the company can hire and retain exceptional talent, lower operating costs, operate in a stable and business-friendly environment with an improved tax structure and provide flexibility for future growth.
“Revance Therapeutics is therefore requesting that you accept this letter as the formal letter of intent required under the Economic Development Incentive Program, (EDIP),” Blagg wrote in his letter.
https://marlborough.wickedlocal.com/news/20201102/marlborough-continues-to-add-to-reputation-as-biotech-life-sciences-hub
Revance to Release Third Quarter 2020 Financial Results on Monday, November 9, 2020
Conference Call Scheduled for Monday, November 9, 2020 at 4:30 p.m. ET
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will release third quarter 2020 financial results on Monday, November 9, 2020 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT/4:30 p.m. ET on the same day to discuss the results and provide a business and pipeline update.
https://investors.revance.com/news-releases/news-release-details/revance-release-third-quarter-2020-financial-results-monday
FWIW -
Enanta price target raised to $107 from $104 at Roth Capital 16:19 ENTA Roth Capital analyst Zegbeh Jallah raised the firm's price target on Enanta to $107 from $104 and keeps a Buy rating on the shares ahead of the company's earnings report due on November 23. In addition to lowering her Q4 revenue projection, Jallah increased her view of the probability of success for Enanta's RSV program, EDP-938, to 30% from 25%, the analyst tells investors.
Read more at:
https://thefly.com/n.php?id=3181989
FWIW -
Enanta price target raised to $107 from $104 at Roth Capital 16:19 ENTA Roth Capital analyst Zegbeh Jallah raised the firm's price target on Enanta to $107 from $104 and keeps a Buy rating on the shares ahead of the company's earnings report due on November 23. In addition to lowering her Q4 revenue projection, Jallah increased her view of the probability of success for Enanta's RSV program, EDP-938, to 30% from 25%, the analyst tells investors.
Read more at:
https://thefly.com/n.php?id=3181989
Revance price target raised to $38 from $35 at Barclays. RVNC Barclays analyst Balaji Prasad raised the firm's price target on Revance to $38 from $35 and keeps an Overweight rating on the shares. The analyst expects to see signs of a broader recovery in Q3 for the U.S. Specialty Pharmaceuticals companies.
Read more at:
https://thefly.com/n.php?id=3181303
Revance price target raised to $38 from $35 at Barclays. RVNC Barclays analyst Balaji Prasad raised the firm's price target on Revance to $38 from $35 and keeps an Overweight rating on the shares. The analyst expects to see signs of a broader recovery in Q3 for the U.S. Specialty Pharmaceuticals companies.
Read more at:
https://thefly.com/n.php?id=3181303
Demand for beauty treatment soars for men and women alike during pandemic....
Sounds a bit like dialogue in Fargo.
FWIW -
Likely To Continue Rising To New Highs: Revance Therapeutics Inc. - 24 October
SIMPLEX TRADING LLC bought a fresh place in Revance Therapeutics Inc. (NASDAQ:RVNC). The institutional investor bought 7.7 thousand shares of the stock in a transaction took place on 9/30/2020. In another most recent transaction, which held on 9/30/2020, ENVESTNET ASSET MANAGEMENT, INC. bought approximately 357.00 shares of Revance Therapeutics Inc. In a separate transaction which took place on 7/31/2020, the institutional investor, WELLINGTON MANAGEMENT CO. LLP sold 13.1 thousand shares of the company’s stock. The total Institutional investors and hedge funds own 83.50% of the company’s stock.
https://bovnews.com/2020/10/24/likely-to-continue-rising-to-new-highs-revance-therapeutics-inc-rvnc-rent-a-center-inc-rcii/