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Wednesday, January 3, 2024

GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

 When GSK laid out $90 million upfront to acquire rights to Scynexis’ antifungal Brexafemme last spring, the British pharma threw a lifeline to a company whose blockbuster launch ambitions had hit the skids. But now, as an October recall of the antifungal bleeds into 2024, the scope of GSK’s financial assistance has waned.

GSK and Scynexis have amended their license agreement in connection with the marketing delay on Brexafemme, Scynexis said in a recent securities filing. Under the retooled deal, Scynexis will keep hold of the $90 million it received from GSK in March, plus another $25 million in development milestones.

But the company’s future payouts from GSK—now in charge of development, manufacture and commercialization of Scynexis' medicine outside of China and certain other countries—have diminished.

The news sent Scynexis’ shares tumbling roughly 14.5% on Wednesday morning. It marks the latest downturn for a company whose flagship medication once bore blockbuster sales expectations.

On the regulatory front, Scynexis is now in line to receive approval-related milestone payments of up to $49 million, down from a total of $70 million that GSK had previously floated.

Potential commercial milestones in invasive candidiasis have also been downgraded from an original offer of up to $115 million to a new maximum payout of $57.5 million.

Meanwhile, Scynexis could now clinch up to $179.5 million in potential sales-based milestones, dependent upon the timing of Brexafemme’s re-launch in the U.S. Previously, the company had the potential to receive a $242.5 million payday in connection with Brexafemme’s commercialization.

Under the partners’ original deal in March, GSK was set to make payments of up to $503 million contingent upon Brexafemme reaching certain milestones. Aside from Brexafemme, GSK also got the rights to call dibs on certain other preclinical assets from Scynexis' pipeline.

GSK previously figured it could use its commercial clout to bring Brexafemme to more than $500 million in annual sales, chief commercial officer Luke Miels told reporters last year. The British pharma is interested in both Brexafemme’s original indication in the vaginal infection vulvovaginal candidiasis (VVC), plus a potential expansion into invasive candidiasis fungal infection, which Miels previously said the company expected to launch in 2026.

GSK’s March licensing deal came at a critical time for Jersey City, New Jersey-based Scynexis. In October of 2022, the company had laid out a contingency plan to “refocus its resources” on the clinical development of its antifungal in hospital-based indications, which the company expected to bring “higher long-term returns.”

But a manufacturing review by GSK last fall soured the partners' outlook in the near term after the discovery of cross-contamination risks forced a recall of the product and a pause of all clinical trials testing the medicine.

At the time, Reuters cited Guggenheim analysts who believed it would take “several months” for Scynexis to resolve the production snafu.

https://www.fiercepharma.com/pharma/gsk-downgrades-milestone-payments-scynexis-antifungal-recall-drags-2024

TC BioPharm Announces Additional Cost Reduction Steps

 

  • Cost saving moves are being made to extend runway and prioritize primary goal of clinical success
  • The company is launching the initiative with the target of a reduction in cash-burn at the Company by approximately 50% to become fully effective in Q1 2024

AC Immune Update on Phase 2 Immunotherapy Pipeline for Alzheimer's, Parkinson's

 

  • ABATE Phase 1b/2 AD trial of ACI-24.060 completed enrollment of cohorts 1 and 2 and is expected to complete cohort 3 in January; 6-month and 12-month amyloid PET data expected in H1 & H2 2024, respectively
  • ReTain Phase 2b clinical trial of ACI-35.030 in preclinical AD being launched now by partner
  • VacSYn Phase 2 PD trial of ACI-7104.056 completed enrollment of cohort 1 and commenced cohort 2; safety and immunogenicity update expected in H2 2024
  • Cash for operations extends into 2026 with USD50 million equity financing and ACI-35.030-related milestones

LianBio cut to Underperform from Buy by B of A

 Target to $3 from $5

https://finviz.com/quote.ashx?t=LIAN&ty=c&ta=1&p=d

Esperion, Daiichi: $125 M Amendment to Collaboration, Including Resolution of Pending Litigation

 – Near term payment to Esperion of $100 million plus $25 million in calendar quarter following EMA’s expected decision on Type II(a) variation approval of NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet –

– Amendment also includes transfer of certain manufacturing and supply rights to DSE and expansion of collaboration in Europe and other territories –

https://www.globenewswire.com/news-release/2024/01/03/2803174/0/en/Esperion-and-Daiichi-Sankyo-Europe-Announce-125-Million-Amendment-to-Their-Collaboration-Including-Resolution-of-Pending-Litigation.html

Arcutis upped to Buy from Neutral by Mizuho

 Target to $8 from $4

https://finviz.com/quote.ashx?t=ARQT&ty=c&ta=1&p=d

Kymera cut to Neutral from Buy by B of A

 Target to $30 from $45

https://finviz.com/quote.ashx?t=KYMR&ty=c&ta=1&p=d