NeuBase Therapeutics to Explore Strategic Alternatives

 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) (“NeuBase” or the “Company”), a biotechnology company developing Stealth Editors™ to perform in vivo gene editing without triggering the immune system, today announced that its Board of Directors (the “Board”) has completed a review of the Company’s business, including the status of its programs, resources, and capabilities. The Board has made the determination to halt further development of the Company’s programs and to conduct a comprehensive exploration of strategic alternatives focused on maximizing shareholder value.

As part of this evaluation process, the Board will explore potential strategic alternatives for the Company that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that this evaluation process will result in NeuBase pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all. The Board has not set a timetable for completion of this evaluation process and does not intend to disclose further updates unless and until it is determined that further disclosure is appropriate or necessary.

https://finance.yahoo.com/news/neubase-therapeutics-explore-strategic-alternatives-110000558.html

CVS to Begin Nationwide In-Store Sales of Biomerica’s EZ Detect™ Colorectal Test

 Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced that CVS Pharmacy has begun in-store sales rollout of the Company’s EZ Detect™ colorectal disease screening test in over 7,000 stores nationwide throughout the CVS Pharmacy retail system. Biomerica has shipped the EZ Detect product to CVS Health distribution centers in the US, and the product is projected to be on store shelves in September. The Company is also working with CVS Health to introduce an additional Biomerica product to be sold in CVS pharmacies.

Colorectal cancer (“CRC”) is the second most common cause of cancer death in the United States. In 2023, an estimated 153,000 Americans are projected to be diagnosed with CRC, and an estimated 52,500 are projected to die from the disease, including 19,500 cases and 3,750 deaths in individuals under the age of 50 [1].

The EZ Detect™ colon disease screening test is the simplest at-home test to detect hidden (occult) blood in a person’s stool, which can be an early warning sign of colorectal diseases, including colon and rectal cancers. The test does not require any handling of stool or dietary restrictions. A person simply places an EZ Detect™ test pad into the toilet after a bowel movement. A change in the test pad’s color to blue/green, which would appear within two minutes, indicates the presence of blood in the stool. The pad is then simply flushed down the toilet. Patients who see a positive result should consult with their physician for next steps.

In a study performed by Johns Hopkins University, EZ Detect™ was preferred 10 to 1 by patients over another test. Published studies have also indicated that the best colorectal screening test is “the one that gets done.” [2] Other colorectal screening tests require handling of the stool and sending the stool sample to a lab for processing. Because of the difficulties of handling and mailing stool samples, a high percentage of these competing tests are never completed by patients[3]. This potentially increases the risk for delayed detection of cancer. The EZ Detect™ test does not require handling of the stool, is simple to perform and provides results at home in just two minutes.

https://finance.yahoo.com/news/cvs-health-begin-nationwide-store-121900577.html

Replimune quarter progress update

 Topline data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo^® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma expected in early Q4 2023 and Biologics License Application submission anticipated in Q1/2 2024

Cost sharing collaboration in cutaneous squamous cell carcinoma in the neoadjuvant setting entered into with Incyte

Data snapshot for all 141 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma expected Q4 2023

RP2 and RP3 Phase 2 programs; third-line colorectal cancer clinical trial initiated, first- and second-line hepatocellular carcinoma trials expected to initiate this quarter; Phase 1 clinical trial update expected at year end

Strong balance sheet with cash runway into H2 2025

https://www.biospace.com/article/releases/replimune-reports-fiscal-first-quarter-2024-financial-results-and-provides-corporate-update/

FDA Clears Taiho’s Lonsurf in Metastatic Colorectal Cancer Ahead of Takeda, Hutchmed

 The FDA on Wednesday approved Taiho Oncology’s Lonsurf (tipiracil) as part of a combination regimen with Roche’s Avastin (bevacizumab) for the treatment of metastatic colorectal cancer.

Lonsurf picked up its first approval in September 2015 as a monotherapy in this indication. Wednesday’s label expansion covers patients who had previously been treated with an anti-VEGF biologic agent and fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Patients harboring the wild-type RAS protein and had previously received an anti-EGFR therapy are also eligible for the newly approved combination regimen.

Lonsurf’s latest approval “provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population,” Marwan Fakih, lead investigator on the SUNLIGHT trial, said in a Taiho statement.

SUNLIGHT, a Phase III, randomized, open-label and global trial, supported the FDA’s decision. Compared with Lonsurf monotherapy, the combination regimen led to a significant improvement in overall survival, reducing the risk of death from any cause by 39%. Patients who received the combo treatment also saw significantly better progression-free survival.

The Lonsurf-Avastin combo also significantly slowed functional decline. In patients receiving the investigational regimen, ECOG performance status worsened from a score of 0 or 1 to 2 or more over a median duration of 9.3 months. In comparators given Lonsurf monotherapy, the same deterioration occurred over only 6.3 months.

In terms of safety, the combination regimen had a manageable adverse event profile. Its most common severe treatment-emergent toxicity was neutropenia.

With Wednesday’s approval, Taiho has edged out Takeda and Hong Kong-based collaborator Hutchmed, which in March 2023 announced that it had completed its rolling New Drug Application for fruquintinib, also being developed for mCRC. In May, the FDA gave its Priority Review designation to the application and is set to come to a decision by November 30.

Fruquintinib was discovered and was originally being developed by Hutchmed but in January 2023 Takeda bought into its promise, dropping $400 million upfront and pledging up to $730 million in additional payments for an exclusive worldwide license to develop and commercialize the candidate outside the greater China region.

Takeda and Hutchmed are also trialing fruquintinib in the second-line setting for gastric cancer, for which Lonsurf won the FDA’s approval in February 2019.

https://www.biospace.com/article/fda-clears-taiho-s-lonsurf-in-metastatic-colorectal-cancer-ahead-of-takeda-hutchmed/

Huge Numbers Of Kids Permanently Damaged By Lockdowns: New Study

 by Steve Watson via Summit News,

Yet another study has found that the pandemic lockdowns had devastating effects on the development of children, with half of all parents in the UK reporting serious deterioration in emotional and social skills of their kids.

The research comes from the Institute of Fiscal Studies and notes that children aged between four and seven were significantly more likely (52%) to be affected than 12- to 15 year-olds (42%).

The research also found that children whose parents were furloughed, mandatorily made to take a leave of absence from their jobs, were “significantly more likely to experience a worsening in their socio-emotional skills than those whose parents had not been furloughed (51% versus 45%)”.

Essentially, kids whose families experienced hardship due to the lockdown were significantly more likely to have serious developmental issues.

The questions in the study included asking whether children had become “easily scared”, “constantly fidgeting or squirming”, or “generally obedient”.

Author of the study Andrew McKendrick, an IFS research economist commented that “During the Covid-19 pandemic, children from all backgrounds saw their social and emotional skills worsen considerably.”

“Children lived through many changes during these years: school closures, lack of contact with friends and family, and potentially devastating severe illness or death among loved ones,” McKendrick continued, adding that the lockdowns have had “multi-generational impacts.”

“Our research shows that another important driver of children’s declining skills was the economic disruptions experienced by their parents, whether or not those disruptions led to a large income loss,” McKendrick added.

Responding to the study, Children’s Commissioner Rachel de Souza said “I am deeply concerned by the findings of this research on children’s social and emotional skills.”

‘This study shows that the disruption the pandemic caused to children’s development has been long-lasting,” de Souza added.

Arabella Skinner, of the parents’ campaign group UsForThem, commented that the research shows how kids became “collateral damage” of lockdowns, noting “There were many occasions when warnings were ignored.”

“It is an unavoidable fact that many of our children’s development has been negatively impacted by the pandemic restrictions,” Skinner asserted, further urging that “The Government must take action now – they need to support all the services which support our children and ensure that this never happens again.”

This research adds to the voluminous examples of prominent studies showing that the enforced restrictions during the pandemic were catastrophically detrimental to society.

Related:

New Johns Hopkins Study: “Lockdowns Have Had Little To No Public Health Effects” And “Imposed Enormous Economic and Social Costs”

Study: Lockdowns Drove 60,000 Children in UK to Clinical Depression

New Study: Babies Born In Lockdown Less Likely To Speak Before First Birthday

Children Suffering From as Many as Three Different Viruses Due to Weakened Immunity Caused by Lockdown

New Study Finds Many Children Unable to Say Their Own Name Due to Impact of Lockdown

Report: Effects of Lockdown May Now Be Killing More People Than COVID

Outbreak of Hepatitis in Children Caused by Lockdowns That Weakened Immunity

Disturbing Lockdown Drawings Show Effect on Children’s Mental Health

Doctors sound alarm over mysterious outbreak of brain infections in Nevada kids – and they believe it’s linked to COVID lockdowns

New Study Concludes Lockdowns Caused AT LEAST 170,000+ Excess Deaths In U.S.

Report: More Than 3000 Diabetics In UK DIED Because Of COVID Lockdowns

Lockdown Advocate Admits Negative Impacts Were Never Considered

Prominent Lockdown Advocate Admits He Got it Wrong

Highest Yearly Increase of Alcohol Deaths in UK on Record During 2020 Lockdown

https://www.zerohedge.com/political/huge-numbers-kids-permanently-damaged-lockdowns-new-study-finds

Cigna stock rises toward a 6-month high after adjusted profit, revenue rise above forecasts

 Shares of Cigna Group rose 0.9% toward a six-month high in premarket trading Thursday, after the health insurer reported second-quarter results that beat expectations, amid growth in pharmacy and medical customers.

Net income came in at $1.46 billion, or $4.92 a share, after $1.56 billion, or $4.89 a share, in the year-ago period. Excluding nonrecurring items, adjusted earnings per share fell to $6.13 from $6.20 but beat the FactSet consensus of $6.03.

Total revenue grew 6.8% to $48.59 billion, topping the FactSet consensus of $47.24 billion.

Total pharmacy customers rose 4.1% to 98.64 million and total medical customers increased 9.5% to 19.51 million.

For 2023, the company (CI)expects adjusted EPS of "at least" $24.70, compared with the FactSet consensus of $24.80.

Cigna's stock has run up 21.7% over the past three months through Wednesday, while the S&P 500 has gained 10.3%.

https://www.morningstar.com/news/marketwatch/20230803285/cigna-stock-rises-toward-a-6-month-high-after-adjusted-profit-revenue-rise-above-forecasts

Aravive phase 3 ovarian cancer trial topline misses

 

• Trial did not meet primary endpoint of progression-free survival

• Cash at the end of Q2 of approximately $18M (unaudited) is expected to be sufficient to fund operations into early Q4 2023

https://finance.yahoo.com/news/aravive-announces-top-line-results-200100598.html