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Geron Surges after Winning 1st US FDA Approval for Blood Disorder Drug

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
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Geron Surges after Winning 1st US FDA Approval for Blood Disorder Drug

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights

Shares of Geron surged more than 30% on Friday, a day after the company gained its first approval from the US Food and Drug Administration for its blood disorder drug.

The health regulator's nod allows the injectable drug, branded as Rytelo, to be used for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS), a group of blood cancers.

Rytelo is set to compete with Bristol Myers Squibb's Reblozyl, which received a green light for label expansion from the FDA last year for the same disease indication, Reuters reported.

The California-based company said it had set wholesale prices at $9,884 for the 188 mg vial and $2,471 for the 47 mg vial of Rytelo.

Baird analyst Joel Beatty estimates Rytelo's sales at $933 million in 2029, while B. Riley Securities analyst Kalpit Patel sees $700 million in peak sales.

The 188 mg vial will be available in the distribution channels by the end of June, with 47 mg vial expected to be available by summer 2024.

In March, the FDA's independent panel of advisers overwhelmingly voted in favor of the drug, stating that the treatment's associated risks and toxicities appear manageable.

FDA staff had previously flagged a high rate of low red blood cell count in trial patients.

The biggest victory is the absence of a black box warning or a drug safety program requirement, Patel said, adding that the broad label relieves some investors who were worried about population restrictions.

In a late-stage trial, nearly 40% of the drug-treated patients showed independence from transfusion for eight weeks, compared with 15% of patients on placebo.

MDS are a group of cancers in which blood cells in the bone marrow do not mature or become healthy blood cells, and patients require frequent blood transfusions to manage their anemia.

Geron shares were up about up 31.8% at $5.12 in early trading.

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Caffeinated Beverages May Help Protect the Brain, Study Says

A cup of coffee and a cappuccino are seen at a Juan Valdez store in Bogota, Colombia June 5, 2019. (Reuters)
A cup of coffee and a cappuccino are seen at a Juan Valdez store in Bogota, Colombia June 5, 2019. (Reuters)
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Caffeinated Beverages May Help Protect the Brain, Study Says

A cup of coffee and a cappuccino are seen at a Juan Valdez store in Bogota, Colombia June 5, 2019. (Reuters)
A cup of coffee and a cappuccino are seen at a Juan Valdez store in Bogota, Colombia June 5, 2019. (Reuters)

Drinking a few cups of caffeinated coffee or tea every day may help in a small way to preserve brain power and prevent dementia, researchers reported on Monday.

People with the highest daily intake of caffeinated coffee had an 18% lower risk of developing dementia compared to those with the lowest such intake, according to a study based on responses to questionnaires by 132,000 U.S. adults spanning four decades.

The study, published in JAMA, also found that the people with the highest intake had a lower rate - by nearly 2 percentage points - of ‌self-perceived memory ‌or thinking problems compared to those with ‌the ⁠lowest intake.

Results were ‌similar with caffeinated tea, but not with decaffeinated beverages, the researchers said.

While the findings are encouraging, the study does not prove caffeine helps protect the brain, they said.

The magnitude of caffeine's effect, if any, was small, and there are other better-documented ways to protect cognitive function as people age, study leader Dr. Daniel Wang ⁠of Harvard Medical School said in a statement.

Lifestyle factors linked with lower risks of ‌dementia include physical exercise, a healthy diet ‍and adequate sleep, according to previous ‍research.

"Our study suggests that caffeinated coffee or tea consumption can ‍be one piece of that puzzle," Wang said.

The findings were most pronounced in participants who consumed two to three cups of caffeinated coffee or one to two cups of caffeinated tea daily, the researchers reported.

Those who drank caffeinated coffee also showed better performance on some objective tests of cognitive function, according to the ⁠study funded by the National Institutes of Health.

Further research is needed to validate the factors and mechanisms responsible for the findings, the researchers said.

They noted that bioactive ingredients in coffee and tea such as caffeine and polyphenols have emerged as possible factors that reduce nerve cell inflammation and damage while protecting against cognitive decline.

"We also compared people with different genetic predispositions to developing dementia and saw the same results - meaning coffee or caffeine is likely equally beneficial for people with high and low genetic risk of developing ‌dementia," study coauthor Dr. Yu Zhang of the Harvard T.H. Chan School of Public Health said in a statement.

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AlUla Announces Exceptional Ramadan Experiences

These programs come as part of efforts to enhance AlUla’s tourism experience - SPA
These programs come as part of efforts to enhance AlUla’s tourism experience - SPA
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AlUla Announces Exceptional Ramadan Experiences

These programs come as part of efforts to enhance AlUla’s tourism experience - SPA
These programs come as part of efforts to enhance AlUla’s tourism experience - SPA

AlUla Governorate is welcoming the holy month of Ramadan this year with a wide range of diverse tourism experiences that reflect the area’s distinctive character and rich cultural heritage, reinforcing its position as one of the Kingdom’s most prominent destinations to visit during the holy month.

During Ramadan, AlUla offers an integrated experience catering to different visitor preferences, including guided stargazing experiences, cultural events, and night markets, in addition to traditional dining experiences for Iftar and Suhoor, embodying the depth of AlUla’s cultural heritage and local identity.

The Ramadan programs in AlUla include a variety of standout events, such as Ramadan experiences at Maraya Hall, a cultural market, and live performances in the atmosphere of Ashar Valley, alongside heritage tours in AlUla Old Town that narrate stories of AlUla and its Ramadan customs, including the award-winning Incense Road Experience, SPA reported.

The programs also feature seasonal art exhibitions hosted across multiple cultural venues, including Design Space AlUla, the fourth edition of Desert X AlUla, and the Arduna exhibition at AlUla Oasis, in addition to experiences combining art, nature, and stargazing at Daimumah Oasis in collaboration with AlUla Manara.

Visitors are also offered tours to prominent archaeological sites, including Hegra, Dadan, and Jabal Ikmah, to explore ancient sites dating back centuries BCE and view unique rock inscriptions, as well as adventure experiences ranging from dinner and stargazing in Sharaan, hot-air balloon rides, mountain hiking trails, and safari tours.

These programs come as part of efforts to enhance AlUla’s tourism experience during the holy month of Ramadan and provide diverse options that meet visitor expectations, contributing to the growth of tourism activity and showcasing the governorate’s natural and cultural assets.

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NCW Releases over 10,000 Animals under Reintroduction Programs

The releases carried out by the center over the past years included more than 80 priority wildlife species - SPA
The releases carried out by the center over the past years included more than 80 priority wildlife species - SPA
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NCW Releases over 10,000 Animals under Reintroduction Programs

The releases carried out by the center over the past years included more than 80 priority wildlife species - SPA
The releases carried out by the center over the past years included more than 80 priority wildlife species - SPA

The National Center for Wildlife (NCW) announced that the total number of wildlife animals released under its breeding and reintroduction programs for locally threatened species has exceeded 10,000 animals, an achievement reflecting the scale of the center’s sustained efforts to develop wildlife, restore ecosystems, and enhance biodiversity across various regions of the Kingdom.

The releases carried out by the center over the past years included more than 80 priority wildlife species, including reem gazelles (sand gazelles), Arabian oryx, Idmi gazelles, mountain ibex, houbara bustards, ostriches, and sandgrouse, as part of efforts aimed at supporting the recovery of natural populations of these species and enhancing their sustainability within their environmental and historical ranges, SPA reported.

CEO of NCW Dr. Mohammad Qurban noted that release operations are among the key tools for restoring ecosystems and reducing ecological imbalance, as the return of wildlife to their natural habitats contributes to protecting biodiversity and improving environmental quality, which in turn supports habitat integrity, the continuity of plant and animal components, and the enhancement of ecosystem functions over the long term.

NCW continues to implement its strategic plans to develop wildlife, protect endangered species, and enhance the efficiency of natural habitat management through expanding breeding programs, enhancing applied scientific research, building national capacities, and applying the best international practices in biodiversity management, in addition to raising environmental awareness, engaging local communities, and supporting eco-tourism, thereby contributing to achieving the objectives of the Saudi Green Initiative and Saudi Vision 2030, and the National Environment Strategy, toward thriving and sustainable wildlife, biodiversity, and ecosystems.