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Friday, May 9, 2025

Melania Trump Secures $25M Investment for Foster Youth

 First lady Melania Trump on Friday announced a $25 million investment from the Trump administration that will be used to support youth aging out of foster care.

The Department of Housing and Urban Development (HUD) allocated the funds toward its Foster Youth to Independence program (FYI) in recognition of the seventh anniversary of the first lady’s Be Best initiative.

“I am proud to have successfully secured $25 million to provide housing for individuals aging out of foster care,” Melania Trump said in a statement. “Secretary Scott Turner’s commitment will provide thousands of youth transitioning out of the foster care system with dedicated rental assistance and other supportive services to promote stability and self-sufficiency.”

HUD’s FYI program offers assistance to individuals under 25 years who are transitioning out of foster care, which amounts to roughly 20,000 individuals each year, according to the Department of Health and Human Services.

“This dedicated funding for foster youth is a game changer in providing young adults with access to short-term housing assistance and supportive services, which will prevent homelessness,” Turner said in the statement.

https://www.newsmax.com/newsfront/melania-trump-investment-foster-youth/2025/05/09/id/1210252/

Tiziana Reduction in Microglia Activation in PET Scan in Alzheimer's Treated Intranasally

Tiziana Life Sciences (NASDAQ: TLSA) reported promising results from a PET scan showing significant reduction in microglia activation in a moderate Alzheimer's disease patient treated with intranasal foralumab for three months under an expanded access program. The scan revealed decreased neuroinflammation, a key factor in Alzheimer's progression. Dr. Howard Weiner presented these findings at the 2025 AD/PD Conference in Vienna. The treatment showed no side effects, and the patient continues receiving foralumab. This breakthrough is particularly significant as no approved therapies currently exist for moderate Alzheimer's. Foralumab, a fully human anti-CD3 monoclonal antibody, works by inducing Tregs that travel to the brain to reduce neuroinflammation. The treatment shows potential both as a standalone therapy and in combination with existing amyloid-targeting treatments.

Lilly expands Purdue University partnership with $250M investment

 Eli Lilly is investing more in its home state of Indiana, pumping up to $250 million more into an existing collaboration with Purdue University over the next eight years.

The boosted pact with the boilermakers will focus on artificial intelligence drug discovery methods, speeding up the process of moving drugs through clinical trials and into regulatory approval and manufacturing and enhancing the Indiana life sciences workforce, according to a May 9 release.

As part of the agreement, Purdue will grant workspace to Lilly researchers on the university’s West Lafayette, Indiana, campus, while Purdue researchers can collaborate with the Big Pharma in Lilly’s facilities in Indianapolis and Lebanon, Indiana.

The overall goal of the partnership is to get medicines to patients faster, accelerate the translation of new science into clinical trials, strengthen the pharmaceutical supply chain and improve the local economy of Indiana, the partners said.

“Accelerating the delivery of life-changing medicines demands a highly skilled workforce and continuous innovation across discovery, process development and manufacturing,” Lilly CEO David Ricks said in the Friday release. “Through this expanded collaboration with Purdue, we look forward to combining our strengths in advanced technologies and cutting-edge science to pioneer new methods of delivering next-generation medicines to advance human health.”

Ricks is an alumnus of Purdue, having earned a bachelor’s degree in industrial management from the university in 1990. Ricks has served on the Big Ten school’s board of trustees since January 2025.

Lilly and Purdue first inked a $52 million five-year R&D pact in 2017, which was then re-upped in 2022 with an additional $50 million. This original deal will extend to 2032 as part of the new investment, which also engages other existing collaborations the two Indiana powerhouses have struck, like the Lilly Scholars at Purdue and the Lilly and Purdue Research Alliance Center, according to the release.

The long-time partners also announced the new Young Institute Pharmaceutical Manufacturing Consortium in January, which will seek to develop new drug manufacturing techniques by harnessing tech like autonomous systems and AI.

https://www.fiercebiotech.com/research/eli-lilly-expands-purdue-university-partnership-250m-investment

Puma Biotech Q1 2025 slides: NERLYNX revenue up 7% YoY despite quarterly decline

 Puma Biotechnology (NASDAQ:PBYI) presented its Q1 2025 earnings call on May 8, 2025, highlighting the commercial performance of its flagship product NERLYNX. Despite missing analyst expectations with revenue of $46 million against a forecasted $47.5 million, the company’s stock rose 4.23% in after-hours trading to $3.20, suggesting investors found positive elements in the presentation.

The $151 million market cap biotech company continues to focus on expanding NERLYNX’s global footprint while optimizing patient dosing strategies to improve adherence. The presentation offered insights into both the challenges and opportunities facing Puma (OTC:PMMAF) as it navigates competitive pressures in the oncology treatment landscape.

Quarterly Performance Highlights

Puma reported NERLYNX net revenue of $43.1 million for Q1 2025, representing a 7% increase compared to Q1 2024 ($40.3 million). However, this figure reflects a significant 21% decrease from Q4 2024 ($54.4 million). The quarterly performance was notably impacted by inventory changes, with a negative $4.7 million inventory adjustment in Q1 2025.

https://www.investing.com/news/company-news/puma-biotech-q1-2025-slides-nerlynx-revenue-up-7-yoy-despite-quarterly-decline-93CH-4035140

FDA grants RMAT status to MeiraGTx’s Parkinson’s treatment

 MeiraGTx Holdings plc (NASDAQ:MGTX), a clinical-stage genetic medicines company, announced today that its gene therapy product AAV-GAD has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease.

The RMAT designation, which expedites the development and review of promising therapies for serious conditions, was based on positive outcomes from three clinical studies. These studies showed AAV-GAD’s potential benefits when administered as a one-time treatment for Parkinson’s disease patients whose symptoms are not adequately controlled with current medications.

Dr. Alexandria Forbes, President and CEO of MeiraGTx, expressed excitement about the designation, emphasizing the clinically meaningful benefits observed in motor function and other Parkinson’s symptoms. Dr. Forbes also highlighted the significant findings from their partnership with Hologen, which applied AI technology to the Phase 2 study data, revealing potential disease-modifying changes in patients’ brain circuitry.

AAV-GAD is designed to target dysfunctional brain circuits by locally producing GABA, a neurotransmitter, through a minimally invasive procedure. The therapy aims to restore normal activity in the subthalamic nucleus, a region implicated in controlling movement.

https://www.investing.com/news/company-news/fda-grants-rmat-status-to-meiragtxs-parkinsons-treatment-93CH-4036177

Anika Therapeutics Posts Wider Loss From Cont. Ops. In Q1

 Anika Therapeutics, Inc. (ANIK) posted a first quarter loss from continuing operations of $3.96 million compared to a loss of $1.96 million, a year ago. Loss from continuing operations per share was $0.28 compared to a loss of $0.13. Adjusted net loss per share was $0.06 compared to profit of $0.13. Adjusted EBITDA was $0.1 million, for the quarter.

First quarter revenue from continuing operations was $26.2 million, a 10% decrease compared to the same period in 2024.

https://www.nasdaq.com/articles/anika-therapeutics-posts-wider-loss-cont-ops-q1

InspireMD eyes approval target

 Business Highlights:

  • Continued engagement with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application for the CGuard Prime carotid stent system in the U.S. Optimistic for an anticipated approval in the third quarter of 2025
  • Advanced commercial infrastructure and operational readiness ahead of anticipated U.S. launch
  • Continued enrollment with excellent pace in the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures