BOTOX® Cosmetic (onabotulinumtoxinA) Day is Back 5th Year

 Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is celebrating the fifth annual BOTOX® Cosmetic Day on Wednesday, November 15. To commemorate this milestone, the brand is expanding its offerings like never before. New and loyal members of Allē, the Allergan Aesthetics loyalty program, have the opportunity to buy, earn, and win with this year's BOTOX® Cosmetic Day offers. To learn more and join Allē, visit alle.com/botoxcosmeticday.

"Last year, BOTOX® Cosmetic Day prompted over half a million BOTOX® Cosmetic treatments1 and this year we're expecting even more," said Jasson Gilmore, Senior Vice President, Allergan Data Labs. "Every year our team looks forward to celebrating our customers and patients who have helped make BOTOX® Cosmetic the iconic brand it is. This event is an important way that we commemorate the brand and an innovation that launched the aesthetics market."

Celebrate BOTOX® Cosmetic Day during the entire month of November with these exclusive offers for Allē Members:

• BUY-One-Get-One (BOGO) Free Gift Card: On Wednesday, November 15, starting at 9 am Pacific Time and while supplies last, Allē Members who buy a $50 gift card will get a $50 gift card for free, to use for themselves or to gift to others for a discount on future treatments with participating Allē providers.*
• EARN Double Points All Month Long: Allē Members can earn double points on BOTOX® Cosmetic treatments throughout the entire month of November, which doubles the amount of time to earn compared to previous years.*
• WIN $25,000: For the first time, five people will win $25,000 when treated with BOTOX® Cosmetic during the month of November.†

Additionally, the brand is generating further excitement around this holiday through new partnerships. This year, BOTOX® Cosmetic is teaming up with leading augmented reality (AR) platform Snapchat to create an immersive, gamified AR Lens that teaches Snapchatters about the product. Through the AR Lens, available from November 7 to November 14, Snapchatters can play a game that encourages them to make facial expressions associated with the BOTOX® Cosmetic indication areas. For Snapchat, this AR Lens marks the first-ever execution where a large medical aesthetics brand has been able to leverage an interactive AR experience that educates consumers about a product's FDA approved use. Historically, Snapchat AR Lenses have supported disease state awareness or included the brand's name, but not its specific use. BOTOX® Cosmetic and Snapchat's collaboration is a great example of the innovation that is possible within the pharmaceutical marketing space by leveraging advanced technologies like AR to drive awareness and educate consumers.

https://www.prnewswire.com/news-releases/botox-cosmetic-onabotulinumtoxina-day-is-back-like-never-before-301973724.html

Ligand Acquires Royalty on Sanofi’s TZIELD® for $20 Million

 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that it has acquired Tolerance Therapeutics, Inc. (“Tolerance Therapeutics”) for $20 million in cash. Tolerance Therapeutics is a holding company, owned by the inventors of TZIELD (teplizumab-mzwv), that is owed a royalty of less than 1% on worldwide net sales. The transaction will be immediately accretive to Ligand’s royalty revenue.

TZIELD is the first disease-modifying therapy in type 1 diabetes (“T1D”). It is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and children aged 8 years and older with Stage 2 T1D. TZIELD was granted Breakthrough Therapy Designation in 2019 and was approved by the U.S. Food and Drug Administration in November 2022. TZIELD is marketed by Sanofi, following its acquisition of Provention Bio, Inc., the owner of TZIELD, in 2023 for $2.9 billion. Sanofi recently announced new data from TZIELD’s PROTECT Phase 3 trial which showed TZIELD’s potential to slow the progression of Stage 3 T1D in newly diagnosed children and adolescents. TZIELD met the study’s primary endpoint, significantly slowing the decline of C-peptide levels, compared to placebo.

https://www.businesswire.com/news/home/20231101846503/en/

vTv Therapeutics Sell Shares in Reneo Pharmaceuticals for $4.4 M

 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced that it has entered into a common stock repurchase agreement with Reneo Pharmaceuticals, Inc. through which Reneo has purchased all of its common stock that was granted to vTv under the Reneo License Agreement for total proceeds to vTv of approximately $4.4 million.

“The proceeds from the sale of our Reneo stock will provide vTv with important financial support as we continue our preparations for the launch of the cadisegliatin Phase 3 program in T1D. We remain in active discussions related to the financing, partnering and/or licensing of cadisegliatin,” said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. 

https://www.globenewswire.com/news-release/2023/11/01/2771100/0/en/vTv-Therapeutics-Announces-Sale-of-Shares-in-Reneo-Pharmaceuticals-for-Proceeds-of-4-4-Million.html

G1 cuts outlook

 As a result of the ongoing shortage of platinum-based chemotherapy, G1 today lowered its full year 2023 net revenue guidance. The Company expects to generate between $44 million and $47 million in COSELA net revenue in 2023. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the third quarter ended September 30, 2023.

Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

https://www.globenewswire.com/news-release/2023/11/01/2770927/0/en/G1-Therapeutics-Provides-Third-Quarter-2023-Financial-Results-and-Operational-Highlights.html

Ocular Therapeutix: FDA OKs First Pivotal Clinical Trial of OTX-TKI in Wet AMD

 The first subject expected to be dosed by year-end

Company announces OTX-TKI trade name AXPAXLI

https://www.globenewswire.com/news-release/2023/11/01/2771115/0/en/Ocular-Therapeutix-Receives-FDA-Agreement-Under-Special-Protocol-Assessment-SPA-for-its-First-Pivotal-Clinical-Trial-of-OTX-TKI-in-Wet-AMD.html

FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death

 The FDA has lifted its full clinical hold on Mersana Therapeutics’ Phase I study of XMT-2056, its investigational STING-directed antibody-drug conjugate, the company announced Tuesday.

The clinical hold came in March 2023, following a patient death that was deemed related to XMT-2056. At the time, Mersana was assessing the candidate in a Phase I trial, enrolling previously treated patients with HER2-positive recurrent or metastatic solid tumors.

The fatality occurred in the second patient enrolled in the dose-escalation phase of the early-stage study, pushing the biotech to voluntarily suspend the trial and report the incident to the regulator.

In Tuesday’s announcement, Mersana indicated that it was lowering the starting dose of XMT-2056 in its study and that it has “aligned with FDA on the path forward” for the investigational therapy.

Mersana rose 7% in late morning trading following the news, according to Seeking Alpha.

Discovered and developed using Mersana’s proprietary Immunosynthen platform, XMT-2056 is an investigational antibody-drug conjugate (ADC) that targets a novel HER2 epitope and activates the STING signaling cascade in tumors and tumor-resident immune cells, according to the company’s website.

This mode of action allows it to boost the anti-tumor action of the innate immune response, and has the potential to treat cancers with high or low HER2 expression levels. In August 2022, GSK bought into the promise of XMT-2056 in a global collaboration deal worth $100 million upfront and the promise of up to $1.36 billion in development, regulatory and commercial milestones.

Under the agreement, GSK will have the exclusive option for global commercialization rights over XMT-2056, while Mersana will retain the option for profit-sharing and co-promotion in the U.S.

On Wednesday, however, GSK announced in a pipeline update that it was dropping an early-stage in-house STING agonist, dubbed 3745417. The British pharma has not yet exercised its option in the Mersana deal, and it remains unclear whether the discontinuation of 3745417 will affect the prospects of XMT-2056. 

In January 2023, Mersana kicked off the Phase I trial for XMT-2056, with an estimated enrollment target of around 170 patients with advanced or recurrent HER2-expressing solid tumors, including breast, gastric, non-small cell lung and colorectal cancers.

Mersana has two other trials under regulatory pause. In June 2023, the FDA placed the company’s UP-NEXT and UPGRADE-A studies on partial clinical hold following an aggregate safety report from some 560 patients showing a higher rate of serious bleeding events in patients treated with the investigational ADC upifitamab rilsodotin (UpRi).

Most of the bleeds were low-grade, according to Mersana’s announcement at the time, but five were ultimately fatal. UP-NEXT and UPGRADE-A are assessing UpRi in platinum-sensitive ovarian cancer.

https://www.biospace.com/article/fda-lifts-hold-on-mersana-s-antibody-drug-conjugate-following-patient-death/

Humana Shares Fall as Forecast for 2024 Profit Disappoints

 

Humana Inc. shares fell sharply at the US market open after executives said the initial outlook for 2024 profit growth would be at the low end of its forecast.

Adjusted earnings per share for 2024 will be at the lower end of the company’s 11% to 15% long-term growth target, executives said Wednesday on a call with analysts. The shares tumbled as much at 6.1%, the most intraday since June, before paring most of those losses.

https://www.bloomberg.com/news/articles/2023-11-01/humana-shares-fall-as-forecast-for-2024-profit-disappoints