Aurinia in Agreement with Shareholder MKT Capital

 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ("Aurinia" or the "Company") today announced that its Board of Directors ("the Board") has appointed Dr. Robert T. Foster to the Board. MKT Capital Ltd. (together with its affiliates, "MKT Capital") submitted Dr. Foster as a candidate and worked collaboratively with Aurinia to name him to the Board.

In connection with Dr. Foster’s appointment, MKT Capital has entered into a cooperation agreement with Aurinia. A complete copy of the cooperation agreement will be available on our profiles on EDGAR and SEDAR.

"We are appreciative of MKT’s constructive collaboration efforts. Dr. Foster brings talents which can help strengthen the Board even further. As the doctor who discovered voclosporin, and Aurinia’s founder, he has a wealth of institutional knowledge, deep biotech leadership experience, and has led successful mergers, acquisitions, and commercialization deals. These skills all will be helpful as we conduct our strategic review and continue the successful commercialization of LUPKYNIS," said Dr. Daniel G. Billen, Aurinia’s Chair of the Board.

https://finance.yahoo.com/news/aurinia-board-directors-appoints-dr-100000228.html

Travere Misses Endpoint in Kidney Trial

 

• FILSPARI® (sparsentan) achieved a clinically meaningful difference vs. irbesartan in eGFR total slope (1.0 mL/min/1.73m2 per year) [p= 0.058] and eGFR chronic slope (1.1 mL/min/1.73m2 per year) [p=0.037]. Patients treated with FILSPARI over two years exhibited one of the slowest annual rates of kidney function decline seen in a clinical trial of IgAN patients (-2.7 to -2.9 mL/min/1.73m2 per year)
  

• eGFR chronic slope was statistically significant with respect to the confirmatory endpoint for the EU
  

• All topline efficacy endpoints favored FILSPARI
  

• FILSPARI was well-tolerated with a consistent safety profile comparable to irbesartan across all clinical trials conducted to date, supporting long-term use
  

• The Company will meet with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.

• Company to host conference call and webcast today at 8:30 a.m. ET

Travere Therapeutics will host a conference call and webcast today, Thursday, September 21, 2023, at 8:30 a.m. ET to discuss the Phase 3 PROTECT Study results. To participate in the conference call, dial +1 (888) 254-3590 (U.S.) or +1 (323) 994-2093 (International), confirmation code 5916006. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

https://finance.yahoo.com/news/travere-therapeutics-announces-confirmatory-data-113000437.html

Cyclo Therapeutics, Inc. and Applied Molecular Transport to Merge

 Combined company will operate as Cyclo Therapeutics with primary focus on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1)

At closing combined Company will have approximately $13.7 million cash on hand to fund operations into 2H 2024

Upcoming milestones include completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission

https://finance.yahoo.com/news/cyclo-therapeutics-inc-applied-molecular-120500833.html

89bio Breakthrough Therapy Designation for Pegozafermin in NASH

 Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of pegozafermin–

–Discussions with regulatory agencies regarding the NASH Phase 3 program planned for the fourth quarter of 2023–

https://finance.yahoo.com/news/89bio-announces-u-fda-granted-120000255.html

Rebooted Clinton Global Initiative Licks Chops Over Ukraine 'Humanitarian' Aid

The now-revived Clinton Global Initiative (CGI) has found a new grift - Ukraine.

But first - a short review. The Clintons, through their foundation, fleeced Haiti to the tune of Billions following the 2010 earthquake which killed an estimated 220,000 people.

• Hillary Clinton's State Department pressured Haiti to suppress their minimum wage in sweatshops in order to benefit US clothing manufacturers   

• Clinton Foundation donors were were handed government contracts to clean up in the aftermath of the earthquake.

• Bill Clinton intervened in the jail sentence of Laura Silsby, a convicted child trafficker who attempted to smuggle 33 children out of Haiti.

• A former Haitian government official set to expose the Clinton Foundation's misdeeds in Haiti shot himself in the head a week before he was able to testify.

• The Clinton Foundation even grifted Haiti's lime industry.

• Haiti's former Senate president said Hillary Clinton 'tried to bribe me!'

CGI was shuttered in 2017 after Hillary Clinton lost the 2016 election and donations mysteriously dried up. It was rebooted in 2022.

And now, Ukraine.

According to the ABC News, CGI will launch the "Ukraine Action Network" with the stated mission of delivering 'humanitarian aid' to Ukrainians, which will "mobilize existing CGI partners, as well as new leaders from around the world, to create and finance new commitments for Ukrainians."

Pope Francis kicked off the new initiative in a videoconference with Bill Clinton on Monday, where he said "No challenge is too great if we meet it starting with personal conversion and the personal contribution that each of us can make to solve it... No challenge can be overcome alone — not alone, only together, sisters and brothers, children of God."

The CGI Ukraine Action Network is the result of a collaboration between Hillary Clinton and Olena Zelenska, first lady of Ukraine, that began last year. The new organization, which will be formally announced Tuesday, is designed to mobilize existing CGI partners, as well as new leaders from around the world, to create and finance new commitments for Ukrainians, according to CGI. Numerous monetary commitments for Ukraine are also set to be announced Tuesday. -ABC News

We're sure this will go well, particularly for the children of war-torn Ukraine, and CGI donors.

 

https://www.zerohedge.com/political/rebooted-clinton-global-initiative-licks-chops-over-ukraine-humanitarian-aid

Sellas Positive Topline Data in Lymphoma Cohort in Phase 1 Trial, Supporting Advancement to Phase 2

52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit -

- Responses Observed Across Dose Levelswith a 14.7% Clinical Response Rate Overall, 35.3% Overall Disease Control Rate, and 36.4% Clinical Response Rate in PTCL Patients -

- Decrease in MCL1 and/or MYC Biomarkers Observed in 100% of Patients in a Dose-Dependent Manner in Once Per Week Administration Regimen -

- Recommended Phase 2 Dose for Lymphoma Patients Established at 100 mg Once Per Week-

- No Off-Target Safety Issues at any Dose Level –

https://www.biospace.com/article/releases/sellas-announces-positive-topline-data-in-lymphoma-cohort-from-sls009-phase-1-dose-escalation-trial-supporting-advancement-to-phase-2-clinical-study-primary-and-secondary-endpoints-met/

CymaBay Starts Phase 3b/4 Study in Cirrhosis due to Primary Biliary Cholangitis

 AFFIRM is a unique event-driven, fixed-duration design intended to reduce the challenges for patient participation

Data will be used to support post-marketing regulatory requirements for seladelpar’s accelerated approval pathway

https://www.biospace.com/article/releases/cymabay-initiates-affirm-a-phase-3b-4-study-evaluating-the-effect-of-seladelpar-on-clinical-outcomes-in-patients-with-cirrhosis-due-to-primary-biliary-cholangitis/