Enliven Therapeutics and Imara Announce Merger Agreement

 

• Merger to create Nasdaq-listed, clinical-stage biopharmaceutical company focused on advancing Enliven’s portfolio of precision oncology programs
  
  

• Combined company is expected to have a cash balance of approximately $300 million at close, which is expected to provide cash runway through multiple clinical milestones and into early 2026
  
  

• Planned concurrent financing of approximately $165 million co-led by new investors Fairmount and Venrock Healthcare Capital Partners, with participation from additional new investors including Fidelity Management & Research Company, RA Capital Management, Frazier Life Sciences and Commodore Capital and support from all existing Enliven investors
  
  

• Companies to host conference call today at 5:00 p.m. E.T.

Enliven and Imara will host a conference call today, October 13, 2022, at 5:00 p.m. E.T., to discuss the proposed merger. The conference call may be accessed by dialing (800) 715-9871 (United States and Canada) or (646) 307-1963 (international) and asking to join the Enliven and Imara conference call (conference ID 3259480). A live webcast of the presentation will be available on the Events & Presentations section of Imara’s website at https://imaratx.com. A replay of the webcast will be archived on the Imara website following the presentation.

https://finance.yahoo.com/news/enliven-therapeutics-imara-announce-merger-203500683.html

Travere: FDA action date extended 3 months

 Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that following late-cycle review interactions with the U.S. Food and Drug Administration (FDA), the Company expects the previously assigned Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022 for its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy to be extended by three months.

As part of its late-cycle review, the FDA has requested that the Company update its proposed Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring for sparsentan consistent with certain other approved products in the endothelin receptor antagonist class. The Company anticipates submitting an updated REMS plan in the coming days. Based upon feedback from the FDA, the updated submission is likely to be considered a major amendment to the NDA which is expected to result in a three-month extension of the PDUFA target action date to allow sufficient time to review the information. No additional clinical data or studies have been requested as part of the application review process.

https://finance.yahoo.com/news/travere-therapeutics-provides-regulatory-sparsentan-200500389.html

Large flu outbreak suspected at San Diego high school

 Respiratory and flu-like symptoms among a large number of students at a San Diego County high school are under investigation by health authorities, the county said.

The Public Health Services investigation announced Wednesday involves the San Diego Unified School District’s Patrick Henry High School, which has 2,600 students.

“Although the County reports daily several hundred COVID-19 cases, and is already seeing a rapid and early start to flu season, it is too early to determine the cause of the suspected outbreak at Patrick Henry High School as test results are pending,” the county communications office said in a statement.

The county said that so far no hospitalizations had been linked to the illnesses at Patrick Henry High, but local hospitals including Rady Children’s Hospital have had a recent increase in emergency room visits due to flu and respiratory syncytial virus, which usually causes mild, cold-like symptoms.

“We are coordinating with local school districts and are checking with other school campuses to try and figure out why so many students have been affected so suddenly,” Dr. Cameron Kaiser, deputy public health officer, said in the statement.

The county said that 304 lab-confirmed influenza cases were reported last week, bringing the total for the season that started on July 3 to 1,082. At the same time last year, the county had reported only 200 influenza cases.

Nationally, doctors have been urging vaccine-weary Americans to not skip flu shots this fall. After flu hit historically low levels during the COVID-19 pandemic, it may be poised for a comeback.

Experts say that Australia just experienced its worst flu season in five years and what happens in Southern Hemisphere winters often foreshadows what Northern countries can expect.

In addition, people have largely abandoned masking and distancing precautions that earlier in the pandemic helped prevent the spread of other respiratory bugs.

https://apnews.com/article/health-public-covid-san-diego-flu-aecc578a279e32ba83f1d58e2cb62bf2

How iodine tablets block some nuclear radiation

 The war in Ukraine has heightened fears about nuclear exposure — and interest in iodine pills that can help protect the body from some radiation.

Concerns have grown in recent weeks over periodic power cuts to the Zaporizhzhia nuclear plant that have increased the risk of a meltdown. And threats from Russian President Vladimir Putin that he will use “all means necessary” to win the war in Ukraine has raised the specter of nuclear warfare.

Some countries in Europe have started stockpiling the tablets and pharmacies in Finland began to run low on the pills after that country’s health ministry recommended households buy a single dose in case of emergency.

But what are iodine pills? And what can they do — and what can’t they do — in the case of a nuclear leak or attack?

Potassium iodide, or KI, offers specific protection against one kind exposure. It prevents the thyroid — a hormone-producing gland in the neck — from picking up radioactive iodine, which can be released into the atmosphere in a nuclear accident.

This radioactive material can increase the risk of thyroid cancer if it gets into the body, for example by breathing it in or eating contaminated food. It’s especially dangerous for children, and its health risks can last for many years after exposure, according to the World Health Organization.

Iodine tablets work by filling up the thyroid with a stable version of iodine so that the radioactive kind can’t get in. If the thyroid is already packed with potassium iodide, it won’t be able to pick up the harmful iodine that’s left after a nuclear accident.

The pills are cheap and sold all over the world, and many countries, including the U.S., stockpile them.

But potassium iodide doesn’t protect against other kinds of radioactive threats. A nuclear bomb, for example, can release many different kinds of radiation and radioactive material that can harm many parts of the body.

Health authorities caution that potassium iodide should only be taken in certain nuclear emergencies, and works best if it’s taken close to the time of exposure. It shouldn’t be taken as a preventive measure ahead of time.

Potassium iodide doses can come with some side effects like rash, inflammation or an upset stomach. Those over 40 years old generally shouldn’t take iodine tablets unless their expected exposure is very high, according to guidelines from the U.S. Food and Drug Administration.

https://apnews.com/article/russia-ukraine-putin-science-2b7885caf1f85bf137c3aa9998a5daa5

PepGen Presents Data from its Duchenne Muscular Dystrophy Program at World Muscle Society Congress

 Poster Details:

Title: Unlocking the potential of oligonucleotide therapeutics for Duchenne muscular dystrophy through enhanced delivery

• A single dose of PGN-EDO23 in the murine mdx DMD model achieved up to 93.1% exon skipping and 99.7% dystrophin expression in skeletal muscle, and 62.3% exon skipping and 25.7% dystrophin expression in the heart

• Three doses of the clinical product candidate, PGN-EDO51, in non-human primates achieved up to 78% exon skipping in skeletal muscle and 24% exon skipping in the left ventricle of the heart

• Repeat dosing of the clinical product candidate, PGN-EDO51, in non-human primates demonstrated accumulation of exon skipped transcript with each dose in quadriceps and biceps
  

https://finance.yahoo.com/news/pepgen-presents-data-duchenne-muscular-170000149.html

UniQure corporate presentation

Presented at the European Society of Gene and Cell Therapy (ESGCT) 29th Congress, Edinburgh, UK, October 11th - 14th 2022

Attachments

• Original Link
• Original Document
• Permalink

https://www.marketscreener.com/quote/stock/UNIQURE-N-V-15712155/news/uniQure-N-Enhancing-efficacy-and-specificity-of-AAV5-capsid-via-small-intermediate-and-large-pep-42003023/

Employers rein in health benefits for pre-Medicare and Medicare-eligible retirees

 Employers want alternative ways to provide medical benefits to their retirees over the next three years, with some looking to replace their traditional group plans for pre-Medicare and Medicare-eligible retirees with individual insurance coverage through private marketplaces, according to a survey by Willis Towers Watson.

Employers are motivated by cost, as they expect to pay more in the next three years to provide benefits to this group, the survey found.

(WTW)

Lindsay Hunter, WTW’s senior director for health and benefits, said in a press release that for now, employers “remain committed to offering retiree healthcare benefits and a positive retiree experience. But they’re looking for ways to provide them more cost effectively. Employers are rightfully concerned about this growing burden and are studying all options, including private marketplaces.”

The consulting company’s 2022 Retiree Medical Survey includes information from 122 employers that employ about 1.9 million workers. The survey was taken in July and August.

One in 8 employers (13%) expect to make changes to their retiree medical benefits over the next three years, according to the survey. Some employers have already made moves to cut healthcare costs for this demographic, with 1 in 5 (22%) not offering a traditional group medical plan, and 75% of those companies replacing it with efforts to steer retirees and near-retirees to individual plans in the private insurance marketplace.

Those efforts include financial support.

“Nearly half (49%) expect to introduce change because the benefits are too expensive for the company to maintain,” the press release states. “Over a third (36%) are looking to address unacceptable financial risks, while 33% cited the need to reduce the plan’s administrative burden.”

Trevis Parson, WTW’s chief actuary for Via Benefits, said in the press release that “the recent passage of the Inflation Reduction Act is making private insurance marketplaces for individual coverage an even more attractive option for retiree benefits. In particular, the extension of premium tax credits and the improvements to Part D plans position private marketplaces to better offset rising healthcare costs for both organizations and their retirees.”

The survey asked employers that have already made changes to their retiree health benefits what factors influenced them to a very great extent. They responded:

• The benefit is too expensive for the company to maintain (49%)
• The plan is presenting unacceptable financial risks (36%)
• The administrative burden in terms of cost, talent and time is too excessive (33%)
• To address collectively bargained requirements (23%)
• Need to align the retiree medical plan with changes to our organization’s defined benefit/defined contribution retirement income plan(s) (22%)
• The competition is making changes to which we need to respond to remain competitive (10%)

https://www.fiercehealthcare.com/payers/survey-employers-rein-health-benefits-pre-medicare-and-medicare-eligible-retirees