Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say (Endpoints)
Tuesday, June 24, 2025
Makary reportedly sought CRL for KalVista drug
In Focus: US
Progyny adds pelvic floor therapy to women’s health offerings
Progyny, Inc. (NASDAQ:PGNY), a $1.78 billion women’s health benefits company currently trading below its InvestingPro Fair Value, announced Tuesday it is expanding its women’s health services to include pelvic floor therapy, addressing a condition that affects one in three women.
The company is adding both in-person and virtual care options by partnering with Origin and Hinge Health to provide specialized pelvic floor physical therapy services. Origin will offer nationwide in-network therapy both virtually and in-person, while Hinge Health will provide digital care supported by physical therapists specializing in pelvic health.
Pelvic floor disorders, which can cause urinary incontinence, pelvic pain, and sexual dysfunction, impact women from young adulthood through menopause. According to information cited in the announcement, urinary incontinence alone costs the healthcare industry $20 billion annually. This market opportunity aligns with Progyny’s strong financial performance, including 9.47% revenue growth in the last twelve months.
"This is another moment when Progyny is stepping up to help women identify and seek care for basic health needs that are going undiagnosed and untreated due to lack of education, lack of care access, and lack of the right benefits coverage," said Dr. Janet Choi, Progyny’s Chief Medical Officer.
The expanded services aim to provide earlier interventions for pelvic conditions and reduce fragmentation in care that can lead to delays in treatment. When left untreated, pelvic floor issues can interfere with quality of life, lead to reduced workplace performance, and result in avoidable health complications including potential infertility.
Progyny, which specializes in fertility and women’s health benefits, stated that the new offering will be part of its comprehensive women’s health and family building solutions.
DOJ Accuses Biden-Named Judge Of 'Unprecedented Defiance' on Nixing SCOTUS Deportation Ruling
by Debra Heine via AmericanGreatness.com,
The U.S. Department of Justice on Tuesday accused an activist Biden-appointed judge of engaging in a “lawless act of defiance” against a Supreme Court decision that came down on Monday.
The Supreme Court ruled that the Trump administration may resume expedited deportations of criminal illegal aliens to countries other than their own.
The 6-3 decision stayed U.S. District Judge Brian Murphy’s May 21 order blocking the administration’s attempt to deport a group of violent criminals to South Sudan.
Late Monday night, Murphy issued an order blatantly defying that ruling.
Last Month, the Department of Homeland Security had conducted a deportation flight from Texas to South Sudan to remove what it called “some of the most barbaric, violent individuals” living illegally in the United States.
“No country on earth wanted to accept them because their crimes are so uniquely monstrous and barbaric,” DHS stated on X on May 21.
Murphy quickly ordered the Trump administration to give the eight deported illegal alien criminals more adequate due process, including a “meaningful opportunity to object” to their removals to a foreign country.
The Boston-based judge also ordered the Department of Homeland Security to give the violent illegals access to phones and attorneys and grant them a minimum of ten days to raise concerns about the “safety risks” of being deported to a third country. If the convicted criminal illegal is found to have a “reasonable fear,” Murphy said, the government would be required to reopen their immigration proceedings.
Murphy’s intervention forced DHS to keep the illegals at a military base in Djibouti, Sudan.
The administration argued in court that its deportation policy already complied with due process and was necessary for removing criminal illegals because their countries of origin often refuse to take them back.
The Supreme Court’s decision Monday lifted Murphy’s order placing restrictions on third-country deportations.
“The Supreme Court’s stay of a left-wing district judge’s injunction reaffirms the president’s authority to remove criminal illegal aliens from our country and Make America Safe Again,” White House spokesperson Abigail Jackson said after Monday’s decision.
“The Supreme Court ruling is a victory for the safety and security of the American people. The Biden Administration allowed millions of illegal aliens to flood our country, and now, the Trump Administration can exercise its undisputed authority to remove these criminal illegal aliens and clean up this national security nightmare,” said Department of Homeland Security Assistant Secretary Tricia McLaughlin in a statement.
“If these activist judges had their way, aliens who are so uniquely barbaric that their own countries won’t take them back, including convicted murderers, child rapists and drug traffickers, would walk free on American streets. DHS can now execute its lawful authority and remove illegal aliens to a country willing to accept them,” McLaughlin added. “Fire up the deportation planes.”
Despite the Supreme Court’s ruling however, Murphy declared in a court order late Monday night that his previous order preventing the deportation of the dangerous criminals to South Sudan “remains in full force and effect.”
In response, White House Deputy Chief of Staff Stephen Miller accused Murphy of trying to “overrule the Supreme Court.”
“A Boston judge openly defying and nullifying a Supreme Court order is a radical escalation of the communist coup taking place within the judiciary,” Miller posted on X.
Attorney General Pam Bondi’s chief of staff at the Department of Justice described Murphy’s defiance as “an Article III insurrection.”
“Last night, hours after the Supreme Court 6-3 blocked a Boston district judge’s lawless preliminary injunction preventing the government from removing the worst of the worst illegal aliens to third countries, the district judge announced business as usual and said its orders enforcing the injunction remained in effect,” said Chad Mizelle. “When a single district judge immediately and flagrantly defies the Supreme Court, that is not the rule of law—it is an Article III insurrection.”
Mizelle added: “Today is Justice Kagan’s ultimate test. She, more than any other Justice, has invoked the rhetoric of respecting the rule of law. She, more than any other Justice, should now recognize that the greatest threat to the rule of law comes from district courts openly defying Supreme Court judgments hours after their issuance.”
Miller told Fox News’ Sean Hannity Monday night to “expect fireworks” when the Trump administration hold’s Murphy “accountable for refusing to obey the Supreme Court.”
On Tuesday, Solicitor General D. John Sauer filed a motion at the Supreme Court addressing Murphy’s “unprecedented defiance” of the court’s authority, calling his order “untenable.”
The district court’s ruling of last night is a lawless act of defiance that, once again, disrupts sensitive diplomatic relations and slams the brakes on the Executive’s lawful efforts to effectuate third-country removals. For over two months now, the Executive has labored under an injunction that this Court yesterday deemed unenforceable.
This Court should immediately make clear that the district court’s enforcement order has no effect, and put a swift end to the ongoing irreparable harm to the Executive Branch and its agents, who remain under baseless threat of contempt as they are forced to house dangerous criminal aliens at a military base in the Horn of Africa that now lies on the borders of a regional conflict.
Sauer also suggested that the court kick Murphy off the case entirely, writing, “given the lower court’s conduct, this Court may consider ordering that the case be reassigned to a different district judge.”
Trinity Biotech Cuts Costs After WHO Approves Offshore Manufacturing for Key HIV Test Product
Trinity Biotech (NASDAQ:TRIB) has secured World Health Organization (WHO) approval for offshoring and outsourcing the upstream manufacturing of its flagship TrinScreen™ HIV rapid test. This strategic move, set to be implemented in Q3 2025, is a crucial part of the company's transformation plan aimed at improving financial performance and achieving sustainable profitability.
The transition from in-house operations to an outsourced model is expected to deliver significant improvements in gross margins, reduce fixed costs, enhance supply chain resilience, and free up working capital. The company will maintain product integrity and regulatory compliance while focusing internal resources on innovation and market expansion.
Eyenovia Climbs After-Hours On $50M Crypto Play And Validator Node Plans
Shares of Eyenovia drew heightened retail attention on Monday after the company disclosed it had acquired more than one million HYPE tokens, Hyperliquid’s native cryptocurrency, at an average price of $34 per token, using proceeds from a newly closed $50 million private placement.
Eyenovia shares jumped 30.2% on Monday to close at $5.48, and rose another 3.3% after hours to $5.66.
The move will help Eyenovia build a strategic cryptocurrency reserve and operate a validator node on the Hyperliquid blockchain.
The company said it aims to generate yield through staking and strengthen its participation in the Hyperliquid ecosystem.
Eyenovia’s validator plans will support blockchain activity on Hyperliquid while allowing the company to access native yield from staked HYPE.
With the pending board approval, the company expects to change its name to “Hyperion DeFi” and its ticker to “HYPD” in the coming days.
The update also included progress on the Optejet User Filled Device (UFD), a novel digital ophthalmic delivery platform.
The company confirmed it remains on track for FDA registration in September and is in discussions with partners targeting over-the-counter applications in artificial tears and lens rewetting.
On Stocktwits, retail sentiment was ‘neutral’ amid ‘high’ message volume.
One user on Stocktwits said they expect Eyenovia to open around $6.50 in the next session.
Another user said that the stock appears to be gaining momentum and could shape up to be a multi-day runner, suggesting the news might take a day or two to fully reflect in the price.
The stock has declined 42.9% so far in 2025.
OneMedNet raises $3.7 million in private placement at $0.42 per share
OneMedNet Corporation (NASDAQ:ONMD) has secured approximately $3.7 million in gross proceeds through private placement transactions with accredited investors at $0.42 per share, the company announced Tuesday. The offering price represents a premium to the current trading price of $0.34, though the stock has declined 75% year-to-date.
The medical imaging Real-World Data provider completed the private placements around June 19, with some of the company’s founders and directors participating in the transactions. The share price exceeded Nasdaq’s minimum price requirements.
OneMedNet plans to use the proceeds for working capital and general corporate purposes, according to the company statement.
During the second quarter of 2025, OneMedNet also took steps to strengthen its balance sheet, reducing its total liabilities by approximately 60% compared to March 31 figures. These improvements were crucial, as InvestingPro analysis shows the company’s Financial Health Score at a concerning 1.1 (WEAK), with short-term obligations exceeding liquid assets. These actions included:
- Settling approximately $3.26 million in deferred underwriter fees
- Settling approximately $1.08 million in additional trade payables
- Converting approximately $6.56 million of principal and interest into common stock
- Redeeming the remaining $250,000 of a convertible promissory note issued to Yorkville Advisors Global
In total, these measures settled or converted about $11 million of the company’s current liabilities.
The securities sold in the private placement have not been registered under the Securities Act of 1933 and were offered in transactions not involving a public offering. OneMedNet has agreed to register these shares with the SEC.
OneMedNet operates a platform that provides de-identified medical imaging and electronic health records from over 1,400 healthcare sites. With a market capitalization of $10.39 million, the company faces significant challenges, including negative gross profit margins and rapid cash burn.
Investors sweet on Nektar phase 2b eczema success
Nektar Therapeutics is enjoying the sweet taste of clinical trial success after years of swallowing bitter pills. The biotech reported a phase 2 win for rezpegaldesleukin in atopic dermatitis, sending its stock up 119% despite the data falling short of the bar set by Regeneron and Sanofi’s major blockbuster immunology drug Dupixent.
Rezpeg, as it is also known, is an IL-pathway agonist and regulatory T-cell (Treg) proliferator. While most atopic dermatitis treatments work by blocking immune activation, rezpeg is designed to stimulate Treg cells the body makes to dampen inflammatory reactions. The idea is to rebalance the immune system to provide lasting relief from the symptoms of atopic dermatitis and other autoimmune and inflammatory diseases.
Nektar tested the idea in a phase 2b trial that randomized 393 patients with moderate to severe atopic dermatitis to receive one of three doses of rezpeg or placebo. After 16 weeks, Nektar reported a 61% improvement in symptoms on the high dose and a 31% improvement on placebo, achieving its primary endpoint. The two lower doses also performed significantly better than placebo.
Symptoms improved by at least 75% on the EASI score in up to 46% of patients taking rezpeg. The middle dose performed numerically better than the high dose on EASI-75 and an investigator scale. Otherwise, the data showed dose-dependent trends, with EASI-90 topping out at 25% on the high dose.
The high dose performed significantly better than placebo against all the endpoints Nektar looked at in its top-line data analysis. But the high level of competition for the atopic dermatitis market means rezpeg will face tougher comparisons than placebo. EASI-75 and EASI-90 for Dupixent were 52% and 30%, respectively, in a phase 2b trial.
Cytokine-, microbiome- and toleragenic-based approaches to restoring immune homeostasis are more directly comparable to rezpeg. OX40 candidates such as Sanofi’s amlitelimab are potential rivals, but Nektar believes it has a differentiated candidate.
“We saw a rapid onset of response for all three endpoints and especially for EASI-75 and itch, separating from placebo quickly within a few doses of receiving rezpeg,” Nektar CEO Howard Robin said on a call with analysts to discuss the data. “This is a key differentiator from other immune-modulation approaches such as OX40 pathway inhibitors.”
Jonathan Zalevsky, Ph.D., chief research and development officer at Nektar, told analysts cross-trial comparisons with OX40 studies are instructive because the trials “were completed in similar time frames, had similar global footprints and had similar statistical designs.” The biotech is now preparing for phase 3.
“This study really gives us everything that we need to design the phase 3 regimen,” Zalevsky said. “I am very confident we're in great shape to have just one dose level and regimen for the phase three 3.”
The data sent Nektar’s share price up 119% to $20.90 in premarket trading. Nektar has endured tough years since its big-ticket Bristol Myers Squibb oncology collaboration collapsed in the face of weak data. Eli Lilly was partnered on rezpeg but exited after a clinical setback. Nektar then accused Lilly of a botched analysis that understated the effect of the drug candidate.
Nektar emerged with full rights to rezpeg, but, with the stock trading below cash, investor hopes were low going into the phase 2b readout. The top-line data prompted a reevaluation of Nektar’s prospects.
Subscribe to:
Comments (Atom)