Can Q4 Clinical Data Readout Sustain Sol-Gel Rally?

 Sol-Gel Technologies Ltd. (SLGL) touched a new 52-week high of $18.66 yesterday, reflecting growing investor confidence. With a key clinical trial milestone on the horizon, it will be worth watching whether the stock's upward momentum can be sustained.

This dermatology company focuses on skin diseases for which there are no approved therapeutics. It has successfully developed two FDA-approved products, EPSOLAY and TWYNEO, and is advancing two drug candidates in clinical development: SGT-610 (topical Patidegib) and SGT-210 (topical Erlotinib).

SGT-610 is under a phase III clinical trial for the treatment of Gorlin syndrome. Enrollment in the study has been completed, and top-line results are expected in the fourth quarter of 2026.

Gorlin syndrome is a rare genetic disorder, and 90% of individuals with this syndrome develop multiple basal cell carcinomas (BCCs) by age 35, ranging from a few to many thousands of lesions during a patient's lifetime. Mohs surgery is the most common practice for the removal of BCCs. But as these lesions continue to appear, repeated surgical removal becomes impractical. About 11,000 people in the U.S. are affected by this condition.

If approved, SGT-610 has the potential to be the first drug for the prevention of new BCCs in GS patients. The company sees a potential global market opportunity of more than $600 million for SGT-610.

Up next is SGT-210, which is under a proof-of-concept phase 1b clinical trial in patients with Darier disease.

Darier's Disease is a rare genetic skin condition that affects areas typically associated with seborrhea (excessive sebum (oil) production), say the scalp, face, chest, and back. It causes thickened skin, along with scaly, crusty bumps that can be painful and lead to emotional stress.

Current treatments, which are used off-label, include moisturizers, oral retinoids, and corticosteroids. However, these options only provide limited symptom relief.

The completion of the phase 1b trial of SGT-210 and top-line results are expected in the fourth quarter of 2025.

If approved, SGT-210 could achieve net sales of $200 million to $300 million at its peak, according to the company.

In April of this year, Sol-Gel entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (ASX: MYX) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO for a total consideration of $16 million. As part of the agreement, Sol-Gel received $10 million during the second quarter of 2025, and $6 million is expected next quarter (Q4. 2025).

EPSOLAY is a topical cream for the treatment of inflammatory lesions of rosacea in adults. TWYNEO is a topical cream for the treatment of acne vulgaris.

Cash Position

The company ended June 30, 2025, with a total cash balance of $24.2 million, which is expected to be sufficient to fund operations into the first quarter of 2027.

https://www.rttnews.com/amp/3568016/sol-gel-stock-delivers-over-150-gain-can-the-upcoming-q4-clinical-data-readout-sustain-the-rally.aspx

Protagenic Starts Multiple-Dose Phase 1 Trial; Positioning for Phase 2 in Stress & Mood Disorders

 Dosing Completion Expected by End of August; Phase 2 Trial Expected to Begin in 1Q 2026

Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel neuro-active peptide therapies, today announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to complete dosing by the end of August, with topline safety data anticipated by the end of September, supporting advancement into Phase 2 efficacy studies planned for the first quarter of 2026.

PT00114 is the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a naturally occurring brain hormone localized in the amygdala and hippocampus that regulates stress and emotional balance. Unlike existing therapies that blunt symptoms, PT00114 is thought to directly modulate the brain's maladaptive responses to stress-offering a differentiated approach to treating anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD).

Current treatments leave more than half of patients without adequate relief and are burdened by significant side effects.

https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/protagenic-therapeutics-advances-pt00114-into-multiple-dose-phase-1-t-1063654

DiamiR, Aptorum New York State Approval for DiamiR’s APOE Genotyping Test

 DiamiR Biosciences Corp. ("DiamiR”), a developer of innovative blood-based diagnostic tests for brain health and other diseases, and Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group” or "Aptorum”), a clinical stage biopharmaceutical company dedicated to addressing unmet medical needs, today announced that DiamiR received a Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test from the New York State Department of Health (NYSDOH). This milestone allows DiamiR to offer its validated APOE Genotyping molecular testing in a variety of biological samples, such as blood, buccal swab, saliva, and tissue, through its Clinical Laboratory Improvement Amendments (CLIA) certified, College of American Pathologists (CAP) accredited clinical laboratory by licensed healthcare providers in New York State and nationwide.

The APOE test identifies genetic variants associated with risk for late-onset Alzheimer’s disease and other neurological conditions.  The APOE gene exists in three common variants (ε2, ε3, and ε4), with the APOE ε4 allele being the strongest known genetic risk factor for late-onset Alzheimer's disease. Individuals carrying one copy of APOE ε4 have approximately 3-4 times higher risk of developing Alzheimer's disease, while those with two copies have 8-12 times higher risk compared to non-carriers.  APOE testing is often used in conjunction with other diagnostic and biomarker assessments to provide a more comprehensive picture of a patient’s neurological health.

https://www.manilatimes.net/2025/08/21/tmt-newswire/globenewswire/diamir-biosciences-and-aptorum-group-announce-new-york-state-approval-for-diamirs-apoe-genotyping-test/2171639

NYC judge’s slap-on-wrist sentence for convicted rapist dangerous message to sex assault victims

 A Manhattan judge’s “outrageous” decision to send a convicted rapist back on the streets rather than to prison could deliver a chilling message to sexual assault victims, experts said Wednesday — while blasting the move as “a grave miscarriage of justice.”

Advocacy groups who work with sexual abuse victims were horrified after The Post exposed the slap-on-the-wrist sentence for William Hathaway, 33, who had faced up to four years behind bars for the 2020 rape of a 23-year-old woman he met on Tinder.

“This sentence treats rape like shoplifting,” fumed Scott Berkowitz, president and founder of Rape Abuse & Incest Nation Network. “It just doesn’t fit the crime that he was convicted of.

“The FBI ranks rape as the second most violent crime behind only murder,” Berkowitz told The Post. “Any judge who doesn’t understand that doesn’t belong on the bench.”

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William Hathaway was sentenced to 10 years probation on a rape conviction in Manhattan Supreme Court.Steven Hirsch

Manhattan Supreme Court Judge Josh Hanshaft, when handing down the shocking sentence to Hathaway on Tuesday, admitted he wasn’t sure it was the right move.

The judge, who joined the bench in 2017, said he hoped that 10 years of probation and having to partake in a sex offender treatment program would be a “better alternative” to prison for Hathaway, and stop him from re-offending.

Emily Miles, executive director of the New York City Alliance Against Sexual Assault, said the sentence could become a dangerous deterrent for other victims of sexual assault.

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The Post exposed the slap-on-the-wrist for convicted rapist William Hathaway this week.

“The sentencing of William Hathaway to probation, despite his conviction for third-degree rape, represents a grave miscarriage of justice,” she said. “This decision sends a devastating message to survivors of sexual violence that their pain can be disregarded and their experiences minimized by the very system meant to protect them.”

Susan Crumiller, of Crumiller P.C., a well-known feminist litigation firm in New York City, agreed the decision could send a dangerous message.

“Shame on Judge Hanshaft for this farcical decision which will absolutely dissuade others with similar experiences from coming forward,” Crumiller said.

“The survivor in this case sacrificed her time and emotional health to cooperate with the criminal process without any recompense for her suffering. I hope that she and other survivors of his sexual brutality – both known and unknown – sue the hell out of this perpetrator and get the justice they deserve.”

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William Hathaway, second from right, with his attorneys at his sentencing on a rape conviction in Manhattan.Steven Hirsch

It’s not known if the victim in the case, who has not been publicly identified, has retained any legal counsel. Hathaway’s defense attorney said he vehemently denied the charges and was appealing the jury verdict.

Advocates weren’t the only ones fuming over Hanshaft’s decision.

A spokesperson for Gov. Kathy Hochul said she was “outraged by the judge’s sentence,” calling it “a miscarriage of justice for the victim.”

“As New York’s first woman governor, she believes every judge must recognize that women have a right to protection in our judicial system against abusers and rapists,” the spokesperson said.

“That did not happen here. The Governor’s top priority is public safety, and her efforts to hold offenders accountable are undermined when judges let convicted criminals, let alone rapists, off with little to no consequences.”

https://nypost.com/2025/08/20/us-news/victims-advocates-warn-slap-on-the-wrist-sentence-for-convicted-nyc-rapist-could-send-dangerous-message-its-an-outrage/

CVS penalty over Medicare drug fraud upped

 A federal judge has ordered CVS Health’s pharmacy benefit manager, Caremark, to pay nearly $290 million after a whistleblower accused the business of overcharging Medicare on prescription drugs more than a decade ago.

Sarah Behnke, a former Aetna actuary, alleged Caremark defrauded Medicare Part D by causing false drug cost reports to be submitted in 2013 and 2014.

Caremark was found liable in June, and Philadelphia federal court Chief Judge Mitchell Goldberg ordered the company to pay $95 million in damages, deferring final rulings on penalties.

Goldberg, who was appointed by former President George W. Bush, tripled the damages on Tuesday, finding Caremark Rx, CaremarkPCS Health and CVS Caremark Part D Services should pay a total of $289.9 million in damages and penalties, according to court documents.

Goldberg also imposed $4.87 million in civil penalties.

“We are pleased that the Behnke ruling in June was in our favor as to certain issues for CVS Pharmacy and CVS Health Corporation’s liability and disappointed the court found against Caremark on other issues. We plan to appeal,” CVS wrote in a statement to FOX Business.

In 2014, Caremark was accused of manipulating how drug costs were reported, prompting Aetna and SilverScript to submit false direct and indirect remuneration reports in 2013 and 2014, according to court records.

The scheme, which was allegedly designed to hide profits, led to Medicare Part D being overbilled by $95 million.

While Goldberg did not find “actual knowledge” of the fraud, he found reckless disregard and deliberate ignorance warranting the steep penalties, according to a memorandum.

Caremark argued that the 513 false reports submitted did not justify penalties exceeding the $95 million overcharged, citing the excessive fines clause of the Eighth Amendment and the due process clause.

However, Goldberg found a $95 million fraud loss was “certainly significant.”

Citing precedent from a State Farm insurance case in 2003, Goldberg noted due process was not violated because the ratio of penalties to actual damages was substantially lower than previous decisions, according to court documents.

Goldberg also awarded post-judgment interest, which means interest began accruing on the $289.9 million on Tuesday and will continue to accrue until Caremark pays in full.

The interest will compensate Behnke and the government until CVS pays fully, preventing the company from delaying action.

It is unclear how much of the total award Behnke will receive.

Aetna, Sarah Behnke and US Attorney David Metcalf did not immediately respond to FOX Business’ requests for comment.

https://nypost.com/2025/08/21/business/cvs-caremark-ordered-to-pay-290m-after-medicare-fraud-scheme-exposed-by-former-aetna-whistleblower/

US keeping lofty EU car tariffs until levies on American goods lowered

 The US will keep higher tariffs on European carmakers in place until the EU lowers tariffs on American goods — as two of the world’s largest economies on Thursday finally locked in a framework trade deal hammered out last month.

The two sides fired off a joint statement listing the commitments made after President Trump and EU Commission President Ursula von der Leyen announced the deal on July 27 following months of negotiations.

Washington will make moves to reduce the current 27.5% US tariffs on European cars and car parts once Brussels introduces the legislation needed to enact the promised tariff cuts on US goods, they said in a joint statement.

The current tariff that the US puts on European cars and car parts is 27.5%.AFP via Getty Images

As a result, carmakers could see relief from the current tariffs within “hopefully weeks,” a senior administration official told Reuters.

“As soon as they’re able to introduce that legislation — and I don’t mean pass it and fully implement it, but really introduce it — then we will be in a position to provide that relief. And I will say that both sides are very interested in moving quickly,” the official said.

It wasn’t immediately clear when Brussels would start the legislative process.

As part of the framework deal, the EU also pledged to eliminate tariffs on all US industrial goods and to provide preferential market access for a wide range of US seafood and agricultural goods.

The US agreed to apply a 15% US tariff on most EU imports, including autos, pharmaceuticals, semiconductors and lumber.

European Leaders pose with President Trump at the White House in support of President Zelensky following Trump’s meeting with Vladimir Putin.Pool/ABACA/Shutterstock

The joint statement was “a play to hold each other accountable” and ensure that both sides carried out the pledges announced last month, the admin official said.

“We are trying to sequence with the European Union to make sure that … they feel sufficient pressure to obtain the mandate they need to begin the legislative process for reducing their tariffs, as they’ve promised,” the official said.

“We’re confident that they’ll do that. It’s just good for all parties to make sure that everyone’s on the same page and taking actions around the same time.”

https://nypost.com/2025/08/21/us-news/us-keeping-lofty-car-tariffs-on-eu-until-levies-on-american-goods-lowered-as-large-economies-lock-in-trade-deal/

Video captures Carnival Cruise ship brawl breakout ‘over chicken tenders’

 Fried and furious.

Disturbing footage captured the moment a massive melee broke out on a Carnival Cruise ship among fuming passengers seemingly upset over “chicken tenders.”

The violence among about two dozen brawlers erupted aboard the Sunshine at about 2 a.m. Monday — the last day of its voyage — as the ship was heading back to Miami, according to a passenger who filmed the mayhem.

“Where the f–k is security?!” one bystander could be heard yelling in the footage as passengers trade blows and slam each other to the floor.

The violence erupted among about a dozen cruisers who were captured trading blows and slamming each other to the floor.Mike Terra/Instagram

Multiple security guards could be seen trying to break up the fight, with one overwhelmed officer fleeing the chaos and reaching for his radio as shoes went flying.

At one point, Bronx content creator Mike Terra — who filmed the uproar and shared it on his social media channels — flipped the camera to record his own reaction.

The content creator who captured the wild melee said it happened on a Carnival Cruise ship at 2 a.m.AP

“Over chicken tenders is crazy,” Terra said in the video.

The avid cruiser later responded to intrigued commenters, calling the ruckus an “isolated incident” that escalated over “more” than just food around 2 a.m. after the ship set sail from Miami.

And when reached by The Post on Wednesday, Terra admitted: “We weren’t close enough to know why [the fight] really started, we just knew they were in line for food.”

Terra captioned his video: “I always hear carnival is ghetto/ratchet I been cruising for years but this my 1st time seeing some action on a ship I was on YNs was tripping.”

It remains unclear what sparked the commotion.

The ship set sail from Miami last Thursday and made two stops in the Bahamas before returning to the Sunshine State on Monday.

Carnival did not immediately respond to The Post’s request for comment.

https://nypost.com/2025/08/20/us-news/wild-footage-captures-massive-carnival-cruise-ship-brawl-that-erupted-over-chicken-tenders/