First Wave: Global License Agreement for Capeserod from Sanofi

 First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced an agreement with Sanofi (NASDAQ: SNY) to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for gastrointestinal (GI) indications.

Under the terms of the agreement, First Wave will receive from Sanofi an exclusive, global license for Capeserod and will assume responsibility for all future clinical development. The licensing agreement, which includes a modest upfront payment, backend milestone payments and single digit royalties on net sales, provides a right of first refusal for Sanofi to reacquire Capeserod following certain stages of clinical development and to commercialize the product.

Sanofi’s research on Capeserod and the subsequent artificial intelligence (AI)-empowered analyses suggest that the drug’s mechanism of action has potential applications for several gastrointestinal disorders in multibillion-dollar markets where there are significant unmet clinical needs. Sanofi previously conducted seven Phase 1 and two Phase 2 trials investigating the potential of Capeserod for neurological disorders. In these trials, involving over 600 patients, Capeserod appeared safe and well-tolerated. First Wave will immediately request a meeting with the U.S. Food and Drug Administration (FDA) to establish a development and regulatory pathway for Capeserod in GI diseases with the intent to initiate clinical trials in 2024.

https://finance.yahoo.com/news/first-wave-biopharma-announces-exclusive-100000787.html

Anavex’s Phase 2b/3 Trial of Blarcamesine Slows Alzheimer's Neurodegeneration

 Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did demonstrate a statistically significant slowing in cognitive decline associated with Alzheimer’s disease.

The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma1, as well as a significant slowing in the rate of pathological brain atrophy2 on MRI (Magnetic Resonance Imaging)3 scans.

The trial was a Multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia). Participants were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks.

https://finance.yahoo.com/news/anavex-phase-2b-3-trial-113000676.html

Neurocrine: FDA Accepts Application for INGREZZA Oral Granules Sprinkle Formulation

  Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INGREZZA® (valbenazine) oral granules, a new sprinkle formulation of INGREZZA® (valbenazine) capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

The INGREZZA oral granules capsules (40 mg, 60 mg and 80 mg) are intended to be opened for sprinkling on soft foods prior to administration. The NDA filing included chemistry, manufacturing, and controls (CMC) information and data demonstrating the bioequivalence and tolerability of the INGREZZA oral granule sprinkle capsules compared to the currently approved INGREZZA capsules.

https://finance.yahoo.com/news/neurocrine-biosciences-announces-u-fda-123000864.html

Retail Sales Unexpectedly Soared In August, As Gasoline Costs Jumped

 Following July's buying spree, expectations are for a slowdown in retail sales in August as BofA omnipotent analysts forecast a decline of 0.1% MoM (worse than the consensus +0.1% MoM) with gas prices rising the only saving grace (ex-autos and gas expected to be down 0.5% MoM).,

BUT for once, BofA were wrong (or rather the Census Bureau was given clear political marching orders from the senile administration) as the party kept going in August with retail sales exploding 0.6% MoM (smashing the +0.1% exp) - rising for the 5th month in a row...

Source: Bloomberg

That is a 2.5% YoY gain (thank the lord for credit cards, right?)

Retail sales beat across the board with Core (ex-autos and gas) up 0.2% MoM (+0.1% MoM exp) and the 'control group' - which is used for GDP calcs - rose 0.1% MoM (vs expectations for a 0.1% decline).

Under the hood, the big driver was a 5.2% MoM jump in spending at gasoline stations

Source: Bloomberg

And non-store retailers were flat in August after surging in July on Amazon's Prime Day

Finally, remember this data is 'nominal' not 'real'. So be careful at how excited you get about this data.

https://www.zerohedge.com/personal-finance/retail-sales-unexpectedly-soared-august-gasoline-costs-jumped

Most US dog owners doubt canine vaccines: study

 The anti-vaccination movement, which intensified during the COVID-19 pandemic, appears to also extend to some American dog owners - who are now wary over vaccinating their pets against diseases such as rabies and canine hepatitis.

That's according to a recent poll by Boston University's School of Public Health, which found that 53% of dog owners display some degree of what it calls "Canine Vaccination Hesitancy."

Doctor Matt Motta is an assistant professor at the college and author of the study.

"You know, my co-authors and I were stunned by how prevalent this phenomenon is."

"If there are more unvaccinated dogs out there, the risk of disease transmission grows. And likewise for veterinarian professionals like my sister, for all of us who make come into contact with unvaccinated pets, we are potentially at risk of getting sick if there are more unvaccinated dogs out there."

Polling found that 37% of respondents believe dog vaccines are unsafe, 22% believe they're ineffective, and 30% believe they're not necessary.

Many states require at least a rabies vaccine by law. California is one of them.

Doctor Todd Calsyn is a veterinarian at Laurel Pet Hospital in West Hollywood.

"When I first read the article, I was surprised it was that high now but that makes sense to me based on what I'm kind of seeing coming through here."

"So like for instance, the rabies, obviously if you get rabies, if you don't get treated right away or whatever, you die. It affects your brain. Parvo and distemper, for sure, can be fatal. They can be treated, we can save them but some animals have neurologic disease afterward and some don't do well."

The study was conducted online in partnership with the polling agency YouGov using 2,200 dog owners, and was weighted to approximate the country's demographics.

https://news.yahoo.com/most-us-dog-owners-doubt-175314765.html

CareDx Advances Global Transplant Patient Care

 CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced a leading presence at the 2023 European Society for Organ Transplantation (ESOT) Congress taking place September 17-20, 2023, in Athens, Greece.

The latest scientific advances in global transplantation using CareDx’s AlloSeq cfDNA testing solutions are being showcased across eleven abstracts, including four posters, two moderated e-posters, one focus group, and five oral presentations. CareDx is hosting an educational symposium for medical professionals demonstrating the clinical utility of AlloSeq cfDNA. AlloSeq cfDNA is offered to European and other customers outside of the United States, to detect donor-derived cell-free DNA (dd-cfDNA) for the surveillance of allograft rejection risk in solid organ transplant patients.

https://www.marketscreener.com/quote/stock/CAREDX-INC-16917519/news/CareDx-Advances-Global-Transplant-Patient-Care-at-ESOT-Congress-2023-44839530/

"AI Crusades Have Begun": Robo-Taxi Involved In Hammer Attack In SF After 'Coning' Incidents

 A viral video with over a million views on X shows a person dressed in all-black striking a driverless car repeatedly with a hammer on the streets of crime-ridden San Francisco. 

X user "(((BrokeAssStuart)))" said, "Someone seen destroying a RoboTaxi in San Francisco this weekend." 

\They asked: "What do you think, hero or villain?" 

Back in July, we pointed out that members of Safe Street Rebels, a group that states cars are "polluting, dangerous & murderous," were coning driverless cars across the city, which disables the vehicle and forces it to stop. 

Here is some of the footage of coning incidents:

One X user said, "The AI crusades have begun." 

https://www.zerohedge.com/technology/ai-crusades-have-begun-robo-taxi-involved-hammer-attack-san-fran-following-coning