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Monday, September 25, 2023

Scynexis to recall GSK-partnered antifungal on cross contamination risk

  Scynexis said on Monday it would voluntarily recall its antifungal pill, which it has licensed to GSK, due to risk of cross-contamination with a potential allergy-inducing compound, sending the drugmaker's shares tumbling 32% premarket.

https://finance.yahoo.com/news/1-scynexis-recall-gsk-partnered-125556041.html

TransCode: Positive Pre-Clinical Glioblastoma Results with Lead Therapeutic Candidate

 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today positive results with its lead therapeutic candidate, TTX-MC138, in murine models bearing human glioblastoma multiforme (GBM) tumors. In this study, the therapeutic candidate was delivered to brain tumors and effectively engaged its target.

GBM is the most common and aggressive form of brain cancer. Its prognosis is poor despite advances in standard-of-care therapy. The 5-year survival rate has remained essentially unchanged over the past 30 years. TransCode believes there is an urgent need to develop more effective therapies. In the study reported by TransCode, mice implanted with tumors derived from human GBM patients were treated with TTX-MC138 and imaged by magnetic resonance imaging (MRI) to determine delivery of the therapeutic candidate to the tumors. In addition, the pharmacodynamic activity of TTX-MC138 was determined by measuring inhibition of the therapeutic target, miRNA-10b, using qRT-PCR. TTX-MC138 was injected intravenously and accumulated efficiently in the tumors. Importantly, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of tumor progression in glioblastoma.

https://finance.yahoo.com/news/transcode-therapeutics-announces-positive-pre-123000102.html

Novo, Valo collaborate on treatments for cardiometabolic diseases using human data, AI

 Collaboration will apply Valo’s Opal Computational Platform™ and real-world patient dataset to enable the discovery and development of novel cardiometabolic drug programmes

Novo Nordisk licenses three preclinical drug discovery programmes in cardiovascular diseases discovered and developed by Valo using the Opal Computational Platform™

Valo will receive an upfront payment and a potential near-term milestone payment, totalling 60 million US dollars, and is eligible to receive milestone payments for up to 11 programmes, totalling up to 2.7 billion dollars, plus R&D funding and potential royalty payments

https://finance.yahoo.com/news/valo-health-novo-nordisk-collaborate-120000717.html

FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy

 The U.S. Food and Drug Administration's staff reviewers raised concerns on Monday over the safety and efficacy of BrainStorm Cell Therapeutics' amyotrophic lateral sclerosis (ALS) therapy, sending the company's shares down 50% in premarket trading.

Brainstrom's therapy NurOwn is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

The FDA, in its briefing documents, said it does not believe there is sufficient evidence to support NurOwn's clinical benefit, adding there were large amounts of missing data.

The health regulator also identified a higher incidence of deaths in the treatment group and said it indicates a lack of survival benefit and warrants further investigation.

A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.

https://www.yahoo.com/news/fda-staff-reviewers-raise-concerns-123824888.html

Used Teslas are on sale for a massive discount thanks to one key factor

 The Used Clean Vehicle Credit is a federal tax credit that was launched at the beginning of 2023 that allows consumers to get up to $4,000 back when purchasing a used electric vehicle. When the list of qualified electric vehicles was first announced, Tesla was nowhere to be found. But now the popular EV company has been added to the list.

The reason that Tesla was initially excluded is that one of the stipulations for qualifying for the tax credit was that the car must cost under $25,000, and few Teslas met that mark, even used. However, as the price of some EVs has dropped this year, it seems that there are enough used Teslas that fall within that price range to get the popular brand on the list.

In addition to needing to cost under $25,000, qualifying cars must be at least two years old; have not already been transferred after August 16, 2022, to a qualified buyer; have a gross vehicle weight of under 14,000 pounds; be an eligible FCV or plug-in EV with a battery capacity of least seven kilowatt hours; and be for use primarily in the United States. See a list of qualifying cars here.

There are also stipulations on the buyer’s side. Qualified buyers must not be the original owner of the car, must be buying it for road use and not resale, not be claimed as a dependant on someone else’s tax returns, not have claimed another Used Clean Vehicle Credit in the last three years, and their modified gross adjusted incomes must not exceed $150,000 for married couples, $112,500 for heads of households, or $75,000 for other filers.

And that’s not all — qualified EVs must be purchased through a dealership. So, if you’re looking for a used Tesla for under $25,000, you should start with used car dealerships in your area and see what they have in stock.

Electrek’s commenters offered some of their own advice to prospective buyers.

“You can get an older S for less than 25k because the risk of needing a new 20k battery is substantial,” wrote one commenter.

Recurrent Auto has more context on the percentages of that risk and the costs associated here. In general, EV batteries are expected to last for 15 to 20 years, which is usually beyond the average time that a car is on the road, but EV innovations will likely expand that lifespan over time. EV battery recycling by companies like Redwood Materials could one day drive down these costs as well.

“2018-2019 model 3s can be found easily under $25k if they have over 100k miles as long as you are willing to shop nationwide,” wrote another commenter.

While there are a number of sites online for finding used cars, Tesla does sell used models on its website.

https://news.yahoo.com/used-teslas-sale-massive-discount-220000001.html

Ardelyx: Tenapanor for Hyperphosphatemia Approved in Japan

 Approval announced by Kyowa Kirin, Ardelyx Collaboration Partner

Ardelyx to receive $30 million from Kyowa Kirin in milestone and license amendment payments and $5 million from HealthCare Royalty Partners under a Financing Agreement

https://finance.yahoo.com/news/tenapanor-hyperphosphatemia-approved-japan-081500514.html

Enovis to buy prosthetic implants maker LimaCorporate for $850 mln

 Enovis Corp, which offers orthopedic bracing, surgical implants and footcare solutions, said on Monday it had agreed to acquire Italian surgical implant manufacturer LimaCorporate for about 800 million euros ($850 million), including debt.

The announcement confirmed Reuters' report, citing people familiar with the matter, earlier on Monday.

The acquisition will bolster the U.S. company's reconstructive business, which makes shoulder, hip and knee implants used in surgeries, and expand its international footprint.

"We've got a lot of experience doing acquisitions and doing them well. And we've got a strong balance sheet that lets us do a large acquisition like this and still have a little bit more room for smaller things in the future," Enovis CEO Matt Trerotola told Reuters in an interview.

Enovis generates most of its revenue through its prevention and recovery business, which produces non-surgical devices and accessories.

Enovis, which has a market value of $2.8 billion, will pay 700 million euros in cash and give Lima's owners 100 million euros worth of stock as part of the deal, the company said.

https://finance.yahoo.com/news/1-enovis-buy-prosthetic-implants-103507648.html