Search This Blog

Monday, May 20, 2024

Dyne DMD Phase 1/2 Trial 'Impact on Key Biomarkers, Improvement in Multiple Functional Endpoints'

 - In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose Dependent 27% Mean Splicing Correction Across All Patients in the 5.4 mg/kg Cohort at 3 Months -

- DYNE-101 Showed Improvement in Myotonia, Muscle Strength, and Timed Function Tests and in DM1-ACTIVc and MDHI Patient Reported Outcomes -

- In Phase 1/2 DELIVER Trial, DYNE-251 Showed 3.2% Mean Unadjusted (7.6% Mean Muscle Adjusted) Dystrophin Expression at 6 Months in 10 mg/kg Cohort Administered Monthly; 10 Times Higher Level of Dystrophin Than Reported for Weekly Administered Standard of Care1-

- DYNE-251 Demonstrated Trends in Functional Improvement in NSAA, Time to Rise from Floor, 10-Meter Walk/Run Time, and Stride Velocity 95th Centile at 6 Months in 10 mg/kg Cohort -

- Favorable Safety Profiles for DYNE-101 and DYNE-251 with Enrollment Complete in the 6.8 mg/kg Cohort of ACHIEVE and 40 mg/kg Cohort of DELIVER -

- Based on Recent Regulatory Interactions, Continuing to Pursue Expedited Approvals for Both Programs with Update on Registrational Pathways Expected by Year-End -

- Virtual Investor Event Today, May 20 at 8:00 a.m. ET -

Virtual Investor Event

Dyne will host a live video webcast event to discuss these ACHIEVE and DELIVER data today, May 20, 2024, at 8:00 a.m. ET. The live webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne’s website and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To access the presentation, register for the live webcast and replay, please visit https://investors.dyne-tx.com/news-and-events/events-and-presentations.

https://www.globenewswire.com/news-release/2024/05/20/2884726/0/en/Dyne-Therapeutics-Announces-New-Clinical-Data-from-ACHIEVE-Trial-of-DYNE-101-in-DM1-and-DELIVER-Trial-of-DYNE-251-in-DMD-Demonstrating-Compelling-Impact-on-Key-Disease-Biomarkers-a.html

'Hims & Hers Access to GLP-1 Injections, Passing Cost Savings On to Customers'

 Hims & Hers unlocks access to injectable GLP-1 medications, expanding its holistic weight loss program focused on personalized and affordable solutions; prices start as low as $199 a month

Hims & Hers Health, Inc., the leading health and wellness platform, today announced the addition of GLP-1 injections to its comprehensive weight loss portfolio, giving customers an affordable way to consistently access safe, high-quality weight loss treatment.

The company now offers access to GLP-1 injections in addition to weight management oral medication kits, so that customers can truly personalize their weight loss experience. Providing access to compounded GLP-1s means eligible customers can use medications with the same active ingredient as Ozempic® and Wegovy® without navigating the shortages and costs that are currently limiting access to the branded medications. Through a partnership with a leading US manufacturer of generic and 503B compounded injectable medications, Hims & Hers can help millions of Americans who have obesity and are looking for help safely managing their weight.

https://www.businesswire.com/news/home/20240520817107/en/Hims

'NY’s MTA Mulls Replacing Build America Bonds With Lower-Cost Debt'

 

  • Transit agency has $3.73 billion of BABs outstanding
  • MTA seeks to use special provision to refund BABs for savings

New York’s Metropolitan Transportation Authority is considering refunding at least a portion of its $3.73 billion of taxable Build America Bonds into tax-exempt debt, even as some investors push back against such transactions.

The MTA’s board is set to meet this Wednesday and could give the transit agency the authority to refinance its BABs if officials see an opportunity to reduce debt-service costs, according to MTA board documents. The transit agency, which runs New York City’s subways, buses and commuter rail lines, has yet to announce a potential refunding sale.

https://www.bloomberg.com/news/articles/2024-05-20/ny-s-mta-mulls-replacing-build-america-bonds-with-tax-exempt-muni-debt

Oragenics, Inc. to Host Webinar Panel on Neurotrauma Medicine

 Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical company specializing in intranasal treatments for neurological disorders, today announced that the company will host a webinar panel on Neurotrauma Medicine Monday, May 20, 2024, at 12:00 PM ET.

The discussion will address the unmet medical need in Traumatic Brain Injury (TBI), commonly known as concussion, explore common causes, and examine its association with other long-term neurological disorders. Additionally, the company will present its lead drug candidate, ONP-002, an innovative neurosteroid designed to treat mild TBI and discuss its outcomes from preclinical and Phase I trials, as well as details of an upcoming Phase II clinical trial to be conducted in acute and emergency departments. Details for the webinar are as follows:

Webinar Topic: Neurotrauma Medicine
When: Monday, May 20, 2024
Time: 12:00 PM Eastern Time
Register: Webinar Link
Speakers: 

  • James P. Kelly, MA, MD, FAAN, FANA, Emeritus Professor of Neurology and PM&R, University of Colorado School of Medicine
  • Frank Peacock, IV, MD, FACEP, FACC, FESC, Vice Chair for Emergency Medicine Research, Baylor College of Medicine

NKGen NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer’s

 SNK01, a cryopreserved, autologous enhanced natural killer cell therapy, delivered in highest dose to date, demonstrates preliminary clinical benefit without any drug-related adverse events.

Company advances SNK01 into Phase 2 in moderate Alzheimer’s disease; first patient enrolled in Phase 2 expected in Q2 2024.

https://www.globenewswire.com/news-release/2024/05/20/2884834/0/en/NKGen-Biotech-s-SNK01-NK-Cell-Therapy-Cleared-to-Start-Phase-2-Clinical-Trial-in-Alzheimer-s-Disease.html

'Target reduces prices on 5000 most popular items'

 US retail giant Target has announced it will lower everyday regular prices on 5,000 frequently shopped products across its offering.

Everyday items include meat and dairy, fruit and vegetables, paper towels, diapers and pet food, which will be marked with red tags for high visibility.

The reduction has already been implemented on 1,500 products, with more price cuts planned for the remainder of 2024.

The pricing strategy is timed to coincide with Memorial Day, the Fourth of July and the 2024 back-to-school season, for which Target offers separate discounts.

The low prices also apply to Target-owned brands such as Good & Gather and Everspring, and on the retailer’s tapp.

Target routinely adjusts its prices to remain competitive within the US retail market.

The retailer recently reintroduced its free-to-join membership programme Target Circle which now applies deals automatically at checkout and features member-exclusive sales throughout the year.

Target executive vice-president and chief food, essentials and beauty officer Rick Gomez commented: "We know consumers are feeling pressured to make the most of their budget, and Target is here to help them save more. These new lower prices across thousands of items will add up to additional big savings for the millions of consumers that shop at Target each week.”

Target is also seeking to venture beyond its physical stores with a new revenue stream for its private-label products.

"Target reduces prices on 5000 most popular items" was originally created and published by Retail Insight Network, a GlobalData owned brand.

https://finance.yahoo.com/news/target-reduces-prices-5000-most-114504701.html

'Hamas' Qatar-based leader Haniyeh named in ICC warrant request'

  Ismail Haniyeh, the Hamas leader based in Qatar, has been the tough-talking face of the Palestinian group's international diplomacy as war has raged back in Gaza, where three of his sons were killed in an Israeli airstrike.

Now he faces the possibility of legal action after the International Criminal Court prosecutor's office said on Monday it had requested arrest warrants for Israeli Prime Minister Benjamin Netanyahu, his defence chief and three Hamas leaders -- including Haniyeh -- for alleged war crimes.

Israel has denied committing war crimes in the Gaza war, triggered by the Hamas-led attack on Israel on Oct. 7 that killed 1,200 people and created a hostage crisis for the far-right government after more than 250 people were taken to Gaza.

The ICC's decision "equates the victim with the executioner", a senior Hamas official told Reuters.

It will be up to the court's pre-trial judges to determine whether there is sufficient evidence to issue warrants.

Appointed to the Hamas top job in 2017, Haniyeh has moved between Turkey and Qatar's capital Doha, escaping the travel curbs of the blockaded Gaza Strip and enabling him to act as a negotiator in ceasefire talks or to talk to Hamas' ally Iran.

"All the agreements of normalisation that you (Arab states) signed with (Israel) will not end this conflict," Haniyeh declared on Qatar-based Al Jazeera television shortly after Hamas fighters launched the Oct. 7 raid.

Israel's response to the strike has been a military campaign that has killed more than 35,000 people inside Gaza so far, according to health authorities in the territory.

SONS KILLED IN AIRSTRIKE

Three of Haniyeh's sons - Hazem, Amir and Mohammad - were killed on April 10 when an Israeli air strike struck the car they were driving, Hamas said. Haniyeh also lost four of his grandchildren, three girls and a boy, in the attack, Hamas said.

Haniyeh denied Israeli assertions that his sons were fighters for the group, and said "the interests of the Palestinian people are placed ahead of everything" when asked if their killing would impact truce talks.

For all the tough language in public, Arab diplomats and officials view him as relatively pragmatic compared with more hardline voices inside Gaza, where the military wing of Hamas planned the Oct. 7 attack.

While telling Israel's military they would find themselves "drowning in the sands of Gaza", he and his predecessor as Hamas leader, Khaled Meshaal, have shuttled around the region for talks over a Qatari-brokered ceasefire deal with Israel that would include exchanging hostages for Palestinians in Israeli jails as well as more aid for Gaza.

Israel regards the entire Hamas leadership as terrorists, accusing Haniyeh, Meshaal and others of continuing to "pull the strings of the Hamas terror organisation."

But how much Haniyeh knew about the Oct. 7 assault beforehand is not clear. The plan, drawn up by the Hamas military council in Gaza, was such a closely guarded secret that some Hamas officials seemed shocked by its timing and scale.

Yet Haniyeh, a Sunni Muslim, had a major hand building up Hamas' fighting capacity, partly by nurturing ties with Shi'ite Muslim Iran, which makes no secret of its support for the group.

During the decade in which Haniyeh was Hamas' top leader in Gaza, Israel accused his leadership team of helping to divert humanitarian aid to the group's military wing. Hamas denied it.

SHUTTLE DIPLOMACY

When he left Gaza in 2017, Haniyeh was succeeded by Yahya Sinwar, a hardliner who spent more than two decades in Israeli prisons and whom Haniyeh had welcomed back to Gaza in 2011 after a prisoner exchange.

"Haniyeh is leading the political battle for Hamas with Arab governments," said Adeeb Ziadeh, a specialist in Palestinian affairs at Qatar University, adding that he had close ties with more hardline figures in the group and the military wing.

"He is the political and diplomatic front of Hamas," he said.

Haniyeh and Meshaal have met officials in Egypt, which has also had a mediation role in the ceasefire talks. Haniyeh travelled in early November to Tehran to meet Iran's supreme leader Ayatollah Ali Khamenei, Iranian state media reported.

Three senior officials told Reuters that Khamenei told the Hamas leader in that meeting, that Iran would not enter the war having not been told about it in advance. Hamas did not respond to requests for comment before Reuters published its report, and then issued a denial after its publication.

As a young man Haniyeh was a student activist at the Islamic University in Gaza City. He joined Hamas when it was created in the First Palestinian intifada (uprising) in 1987. He was arrested and briefly deported.

Haniyeh became a protégé of Hamas' founder Sheikh Ahmad Yassin, who like Haniyeh's family, was a refugee from the village of Al Jura near Ashkelon. In 1994, he told Reuters that Yassin was a model for young Palestinians, saying: "We learned from him love of Islam and sacrifice for this Islam and not to kneel down to these tyrants and despots."

By 2003 he was a trusted Yassin aide, photographed in Yassin's Gaza home holding a phone to the almost completely paralysed Hamas founder's ear so that he could take part in a conversation. Yassin was assassinated by Israel in 2004.

Haniyeh was an early advocate of Hamas entering politics. In 1994, he said that forming a political party "would enable Hamas to deal with emerging developments".

Initially overruled by the Hamas leadership, it was later approved and Haniyeh become Palestinian prime minister after the group won Palestinian parliamentary elections in 2006 a year after Israel's military withdrew from Gaza.

The group took control of Gaza in 2007.

In 2012, when asked by Reuters reporters if Hamas had abandoned the armed struggle, Haniyeh replied "of course not" and said resistance would continue "in all forms - popular resistance, political, diplomatic and military resistance".

https://www.yahoo.com/news/hamas-qatar-based-leader-haniyeh-133543100.html