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Thursday, May 15, 2025

Kodiak Sciences Reports Deeper Q1 Loss: What 3 Key Phase 3 Trials Mean for Future Growth



Kodiak Sciences (KOD) reported its Q1 2025 financial results and business updates. The company ended Q1 with $138.9 million in cash, expected to fund operations into 2026. The quarter saw a net loss of $57.5 million ($1.09 per share), compared to $43.0 million ($0.82 per share) in Q1 2024. R&D expenses increased to $43.6 million from $29.9 million year-over-year, while G&A expenses slightly decreased to $15.4 million.

The company is advancing as a precommercial stage retina-focused biotech with three Phase 3 assets targeting topline data in 2026. Kodiak plans to host an Investor R&D Update on July 16, 2025, featuring updates on their pipeline including Tarcocimab (GLOW2 and DAYBREAK studies), KSI-501, and KSI-101's APEX Phase 1b trial results.

Aytu BioPharma Reports Strong Q3 2025 Earnings

Aytu BioScience ( AYTU +39.26% ▲ ) has released its Q3 earnings.

Aytu BioPharma, Inc. is a pharmaceutical company specializing in the commercialization of novel therapeutics, primarily focusing on prescription products for conditions such as ADHD and pediatric allergies.

In its fiscal 2025 third quarter earnings report, Aytu BioPharma announced a significant financial turnaround, reporting a net income of $4.0 million compared to a net loss in the previous year, alongside a 32% increase in total net revenue.

Key financial highlights include a 25% revenue growth in the ADHD portfolio and a remarkable 77% increase in the pediatric portfolio. The company also achieved an adjusted EBITDA of $3.9 million, reflecting improved operational efficiencies and strategic realignment efforts.

Key AI hub China restricts schoolchildren's use of the tech

 China’s latest education policies for the year restrict the extent to which children can use generative artificial intelligence in the classroom, according to a local government report on Thursday.

The guidelines cited in the report, which weren’t publicly available, covered AI education and generative AI use in primary and secondary schools during 2025.

China’s Ministry of Education did not immediately respond to a request for comment.

Primary school students are prohibited from using unrestricted generative AI tools on their own, although an instructor may use the tech to assist with teaching, according to the local government report.

It added that middle schoolers can explore how generative AI reasons and analyzes information, while high schoolers are allowed to use the tech more broadly.

The report said the policies banned students from directly copying AI-generated content into homework and called on schools to establish a list of approved generative AI tools that can be used on school grounds.

The People’s Daily, the official newspaper of the ruling Chinese Communist Party, mentioned the new guidelines on the sixth page of its Thursday edition.

But the national state media report did not discuss specific limits on AI use, and instead focused on how the policies aimed to promote “scientific” and “standardized” promotion of AI education suited to various stages of education, according to a CNBC translation.

Use of generative AI in China has increased significantly after DeepSeek, a homegrown rival to OpenAI, in late January released a chatbot app. Tencent, ByteDance and other companies have released similar chatbots that have surged in popularity in China. 

https://www.cnbc.com/2025/05/15/key-ai-hub-china-restricts-schoolchildrens-use-of-the-tech.html

ADC Therapeutics reports high response in lymphoma trial

 ADC Therapeutics SA (NYSE: ADCT), a pioneer in antibody drug conjugates (ADCs) with a current market capitalization of $131 million, has reported promising results from the LOTIS-7 Phase 1b clinical trial. The trial evaluated the combination of ZYNLONTA and glofitamab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). An overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% were observed among 22 evaluable patients. 

The data, as of January 17, 2025, indicated that the median duration of response (DOR) was not reached. The safety profile was described as manageable, with neutropenia being the most common Grade ≥3 treatment-emergent adverse event. Other Grade 3/4 adverse events included generalized edema, pericardial effusion, and pneumonia, each reported in 3.2% of patients.

The results will be presented at the European Hematology Association 2025 Congress (EHA2025) on Saturday, June 14, and at an oral encore presentation at the International Conference on Malignant Lymphoma (ICML) on Friday, June 20.

The LOTIS-7 study includes a multi-arm design to evaluate ZYNLONTA in combination with different agents for B-cell non-Hodgkin lymphoma (B-NHL). The primary endpoints of the study are safety and tolerability, with secondary efficacy endpoints including ORR, DOR, CRR, PFS, RFS, and OS.

ZYNLONTA, a CD19-directed ADC, has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Its mechanism involves binding to CD19-expressing cells, internalization, and the release of a potent payload leading to tumor cell death.

https://www.investing.com/news/company-news/adc-therapeutics-reports-high-response-in-lymphoma-trial-93CH-4044659

RFK Jr. says he’s ordered a ‘complete review’ of chemical abortion pill

 Health and Human Services Secretary Robert F. Kennedy Jr. revealed Wednesday that he has ordered the Food and Drug Administration (FDA) to conduct a “complete review” of a chemical abortion pill amid reports that the drug isn’t as safe as advertised.  

“It’s alarming,” RFK Jr. said of a recent study conducted by the Ethics & Public Policy Center that found nearly 11% of women who used the popular abortion pill mifepristone experienced a “serious adverse event.” 

“I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,” the HHS secretary revealed during a Senate Health, Labor, Education and Pensions Committee hearing. 

The FDA will conduct a “complete review” of mifepristone after reports that the drug isn’t as safe as advertised.REUTERS

The Ethics & Public Policy Center study – the “largest-known” on the abortion pill – analyzed insurance claims data from 865,727 prescribed mifepristone abortions between 2017 and 2023. 

The study found 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.

Sen. Josh Hawley (R-Mo.) cited the group’s research as he questioned RFK Jr. during the hearing and noted that the study showed the rate of serious adverse health effects “is 22 times higher than the FDA’s current label” for mifepristone, “which says it’s just 0.5%.”

“Clearly [the study] indicates, at the very least, that the label should be changed,” Kennedy Jr. told Hawley. 

Mifepristone was originally approved by the FDA in 2000.

Health and Human Services Secretary Robert F. Kennedy Jr. ordered the FDA to review mifepristone after reports of safety concerns.Jack Gruber-USA TODAY via Imagn Images
Demonstrators rallied in support of abortion rights at the US Supreme Court in Washington, DC, on April 15, 2023.AFP via Getty Images

The Ethics & Public Policy Center, which released its findings last month, argued that the FDA should implement “stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,” in light of its study.

“The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,” the group concluded. 

The FDA initially OK’d mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama.

Former President Joe Biden opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year.

The Washington, DC-based Ethics and Public Policy Center is a conservative think tank and advocacy group that seeks “to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics, in pursuit of America’s continued civic and cultural renewal,” according to the group’s website.

https://nypost.com/2025/05/15/us-news/hhs-chief-rfk-jr-says-hes-ordered-a-complete-review-of-chemical-abortion-pill/

Belite Positive Interim Analysis for Phase 3 Trial of Tinlarebant in Adolescent Stargardt Disease

 Belite Bio, Inc. announced positive developments regarding its lead drug candidate, Tinlarebant, for treating Stargardt disease (STGD1) and ongoing trials for geographic atrophy (GA). Following an interim analysis, an independent Data Safety Monitoring Board (DSMB) endorsed the continuation of the pivotal Phase 3 DRAGON trial without modifications and recommended submitting interim data for regulatory review. The trial is expected to complete by Q4 2025, with a three-month follow-up period. Additionally, Belite is conducting the Phase 3 PHOENIX trial for GA, currently with 464 enrolled subjects out of 500. The firm raised $15 million in funding and reported a net loss of $14.3 million for the first quarter of 2025. A conference call is scheduled for May 14, 2025, to discuss these results and provide further updates.



  • Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended the pivotal Phase 3 trial (DRAGON) of Tinlarebant in adolescent Stargardt disease (STGD1) patients proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period)


  • DSMB also recommended the Company submit the interim data for further regulatory review for drug approval


  • A pivotal global Phase 3 trial (PHOENIX) of Tinlarebant in geographic atrophy (GA) patients is ongoing with 464 of targeted 500 subjects enrolled


  • Raised $15 million in gross proceeds in a registered direct offering on February 5, 2025




  • Conference call and webcast on Wednesday, May 14, 2025, at 4:30 p.m. ET

Webcast Information





Belite Bio will host a webcast on Wednesday, May 14, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please visit

https://events.q4inc.com/attendee/137642555

. A replay will be available for approximately 90 days following the event at the Company’s Investor Relations website at

https://investors.belitebio.com/presentations-events/events

https://www.nasdaq.com/articles/belite-bio-announces-positive-interim-analysis-phase-3-dragon-trial-tinlarebant-adolescent

China pauses rare earth export restrictions on 28 US entities after trade truce

 In a significant step toward easing trade tensions, China on Wednesday lifted export restrictions on rare earths and military-use technologies for 28 U.S. entities.

The move comes just two days after Washington and Beijing struck a breakthrough agreement to temporarily lower tariffs, marking the first major de-escalation in a trade war that had threatened to upend global supply chains and economic stability.\The deal, reached during high-level negotiations in Geneva on May 12, includes a 90-day pause and a sweeping 115-percentage-point reduction in reciprocal tariffs.

The decision is being hailed as a reset in bilateral ties between the world’s two largest economies after months of tit-for-tat escalation.

Reset after retaliation

The suspension of rare earth export curbs took effect Wednesday and will last for 90 days, China’s Ministry of Commerce said in a statement.

During this window, exporters of rare earths and other dual-use goods with military potential can apply for licenses to resume shipments, according to the ministry.\The trade war had entered a particularly volatile phase last month, with U.S. President Donald Trump imposing tariffs of up to 245% on a broad swath of Chinese imports.

Beijing responded in kind with retaliatory measures and a pledge to “fight the tariffs till the end,” a standoff that sent stock markets into a tailspin and raised fears of a global recession.

In retaliation, China halted exports of seven types of rare earth elements to 16 U.S. entities on April 4 and expanded the restrictions to 12 additional firms just five days later.

These included critical materials such as samarium, gadolinium, terbium, dysprosium, lutetium, scandium, and yttrium — essential components in the manufacture of semiconductors, electric vehicles, missile systems, and aerospace technologies.

In a separate announcement on Wednesday, China’s Ministry of Commerce also said it would temporarily lift a trade and investment ban on 17 U.S. companies, signaling further willingness to dial down tensions.

Race for resources

China currently dominates the global supply of rare earths, accounting for about 90% of production. For certain heavy rare earths like dysprosium and terbium, its market share was as high as 99% until recently.

These elements are vital for the production of clean energy technologies, defense equipment, and other high-tech industries.

The U.S. remains particularly exposed to disruptions in these supply chains. According to the U.S. Geological Survey, China supplied half of America’s critical mineral imports in 2024, including rare earths and other strategic materials such as yttrium, antimony, bismuth, and arsenic.

Reducing this dependence has become a strategic priority for Washington. On Inauguration Day in January, President Trump declared a national energy emergency, citing high energy prices and foreign supply vulnerabilities as threats to national security.

In March, he invoked the Defense Production Act to boost domestic mining of critical minerals, unlocking federal support through loans, tax incentives, and investment partnerships.

The administration is also looking beyond U.S. borders—eyeing rare earth deposits in Greenland and Ukraine and pushing forward plans for deep-sea mining in international waters to secure future supplies.

https://www.msn.com/en-us/money/markets/china-pauses-rare-earth-export-restrictions-on-28-us-entities-after-trade-truce/ar-AA1EMLo8