Search This Blog

Tuesday, June 24, 2025

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.

https://www.msn.com/en-us/money/topstocks/eyenovia-climbs-after-hours-on-revealing-50m-crypto-play-and-validator-node-plans/ar-AA1HidLQ

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. 

https://www.investing.com/news/company-news/onemednet-raises-37-million-in-private-placement-at-042-per-share-93CH-4107971

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.

https://www.fiercebiotech.com/biotech/investors-sweet-nektar-phase-2b-eczema-success-doubles-share-price

Israel Accuses Iran of Breaching Truce Trump Said Was in Effect

 Israel has accused Iran of breaching a ceasefire announced by US President Donald Trump earlier Tuesday to end to the 12-day war.Hours after Trump’s declaration of a truce, Israel detected missile launches. Its defense minister instructed the military to “respond forcefully to Iran’s violation of the ceasefire with powerful strikes against regime targets in the heart of Tehran.”

Iran has yet to confirm publicly that it agreed to the ceasefire.

“THE CEASEFIRE IS NOW IN EFFECT,” Trump said at around 9:10 a.m. Dubai time on Truth Social. “PLEASE DO NOT VIOLATE IT!”

Prime Minister Benjamin Netanyahu had confirmed Israel agreed to a truce and said his country’s achieved its war goals in Iran.

The comments came after Tehran fired several waves of missiles on Israel on Tuesday morning. Israel also further attacked Iran.

The truce followed an extraordinary night in which Tehran retaliated against a US attack over the weekend by launching missiles at an American air base in Qatar. The Islamic Republic’s move was telegraphed — with Qatar and the US being forewarned — and there were no casualties.

Trump said the strike at Qatar was “weak” and that Iran had “gotten it out of their system.” He even thanked Tehran for “giving us early notice.”

Oil prices plunged when it became clear the strikes on Qatar weren’t deadly, with traders taking it as a sign that Iran had no intention of escalating tensions with Washington, let alone engulfing other countries in the oil-rich region in a wider war.

Brent fell more than 3% to around $69.15 a barrel in early trading on Tuesday, following a drop of more than 7% on Monday. It’s now back to the level it was before Israel started attacking Iran on June 13.

Israel was still striking targets in Iran early on Tuesday, but the explosions in Tehran seemed to stop at about 4 a.m. local time, the BBC reported, citing local residents.

While Israeli officials remained silent overnight, a senior White House official said Trump brokered the ceasefire in a direct conversation with Netanyahu on Monday. Vice President JD Vance, Secretary of State Marco Rubio and special envoy Steve Witkoff held direct and indirect talks with the Iranians about the proposal, the official said.

Israel agreed to the truce as long as Iran did not launch further attacks, and the Iranian government signaled it would abide by those terms, according to the official.

“For now, I think this is going to hold, and I think you will have an end to the war,” said Dennis Ross, who was President Bill Clinton’s envoy to the region and is now a fellow at the Washington Institute for Near East Policy. “Iran has no interest in resuming anything soon.”

The developments came about two days after the US suddenly entered the conflict directly by bombing key Iranian nuclear facilities at Fordow, Natanz and Isfahan. Trump said the strikes “completely and totally obliterated” the sites, though battle damage assessments continue and the whereabouts of Iran’s enriched uranium stockpile is unknown.

Trump had warned Iran late Saturday that if a peace deal wasn’t reached quickly following the strikes that the US would go after other targets in Iran with “precision, speed and skill.”

Tehran vowed to respond to the unprecedented US attack. But opted for a mostly symbolic response: firing missiles at the Al Udeid base in Qatar, which hosts the Middle East headquarters for US Central Command, the organization that oversees the American military in the region.

The US has around 9,000 service members in Qatar and 50,000 in the Middle East.

Qatar said the Iranian missile barrage was intercepted and the base had been evacuated in advance.

Iran’s move on Monday appeared to be “a largely symbolic retaliation,” said Ziad Daoud, Bloomberg Economics’ chief emerging-market economist. “Plenty of warning was given — Qatar shut its airspace and the US issued warnings to citizens” in the gas-rich country.

While Iranian state TV said the missile barrage “forced a ceasefire on the enemy,” some Iranian officials also suggested the move had a performative element to it. The number of missiles fired matched the number of bombs deployed by the US against the nuclear sites.

Iran was quick to say that Qatar, which has strong relations with Tehran as well as Washington, was a “friendly and brotherly country.”

A diplomat briefed on the talks said Trump had spoken with Qatar’s Emir Sheikh Tamim bin Hamad and informed him the US got Israel to agree to a ceasefire. Trump asked the Qatari leader for help persuading Iran to do the same. Iran later agreed, according to the diplomat, who asked not to be identified discussing private conversations.

Trump went as far as predicting that a peace agreement between Israel and Iran would be long-lasting, despite decades of enmity between them.

“I think the ceasefire is unlimited — it’s going to go forever,” Trump said, adding that he sees the war as being completely finished and does not believe Israel and Iran “will ever be shooting at each other again.”

Many questions remain, including the state of Iran’s uranium stockpile and whether any ceasefire will lead to discussions about Tehran’s nuclear program. The Islamic Republic, which has denied it’s seeking an atomic weapon, has refused to give up the right to enrich uranium, a condition the US has insisted upon.

Iran says it needs to process uranium at least to the low level needed for civilian purposes such as fueling nuclear power plants. Yet the West and Arab states are wary because it’s enriched uranium almost to the levels needed to build a bomb, without explaining why.

Israel said its war against Iran was to prevent the country from acquiring atomic weapons, a risk also cited by Trump to justify US involvement. Netanyahu’s government has also said it aimed to destroy Iran’s stockpiles of ballistic missiles and its launch sites.

While Israel has denied it is seeking to topple the theocratic government of Supreme Leader Ayatollah Ali Khamenei, it’s officials have said its attacks could bring about such a situation. For now, there’s little sign that will happen.

Speaking to Fox News after Trump announced the ceasefire, US Vice President Vance said that the US bombing over the weekend had met its objectives.

“We know that they cannot build a nuclear weapon,” Vance said, adding that Iran’s existing stock of highly enriched uranium was “buried” by the attack. International monitors have said they don’t know where that material is after Iran said earlier this month it would move it.

“If Iran is desperate to build a nuclear weapon in the future, then they’re going to have to deal with a very, very powerful American military,” Vance said.

https://finance.yahoo.com/news/netanyahu-confirms-israel-agreed-ceasefire-062910250.html

Turkey Rejects Open-Door Policy For Refugees If Iran Falls Apart

 Via Middle East Eye

Israeli and US attacks on Iran risk sparking a regional war or even triggering regime change in the country, a development that has concerned Turkish officials in Ankara since September. The Israeli strikes that began earlier this month initially targeted Iran’s nuclear infrastructure and air defense systems.

Over time, however, Israel shifted its focus toward the Iranian government’s command structure and later moved on to domestic security buildings. For example, on Monday, Israeli forces reportedly targeted the internal headquarters of the Islamic Revolutionary Guard Corps as well as the notorious Evin prison, where political prisoners are held.

One Israeli minister even suggested that Israel was cooperating with the Iranian opposition, reinforcing Defence Minister Israel Katz’s public statements that Israel seeks regime change or at least aims to undermine the Tehran government.

That is a prospect that US President Donald Trump tried to normalize on Sunday night with a post on Truth Social. “If the current Iranian Regime is unable to MAKE IRAN GREAT AGAIN, why wouldn't there be a Regime change???” he asked. 

The Turkish government is acutely aware of the repercussions of regime-change operations and wars, having experienced the destabilizing effects of the 2003 US-led Iraqi invasion and, more recently, the 2011-24 Syrian [proxy] civil war. These conflicts have often resulted in hundreds of thousands of refugees crossing into Turkey and have disrupted key sectors such as energy and trade.

Turkish society remains highly sensitive about the presence of refugees, notably the 2.7 million Syrians, many of whom are now returning to Syria after the fall of Bashar al-Assad's government. Experts and officials emphasize that there is currently no new wave of refugees.

However, several sources familiar with the issue told Middle East Eye that as early as September, the Turkish government conducted in-depth studies on potential migration scenarios. They estimated that a full-scale war between Israel and Iran could push up to one million Iranian refugees towards the Turkish border.

Turkey has the experience. In 2012, then-foreign minister Ahmet Davutoglu attempted to control the influx of Syrian refugees by capping their number at 100,000 and threatening to establish a safe zone in northern Syria. However, the number of refugees quickly surpassed three million in the following years, which taught Ankara a difficult lesson.

Now, sources say Ankara is unlikely to accept any refugees except those in urgent need of emergency assistance.

“If the worst-case scenario were to occur and there was a mass migration from Iran to Turkey, whether permanent or in transit, Ankara would fulfil its obligations under humanitarian law, but it would not implement an open-door policy,” Serhan Afacan, president of the Center for Iranian Studies in Ankara, told Middle East Eye.

A Turkish official, speaking on condition of anonymity, confirmed that Ankara would no longer apply an “open door” policy toward any neighbouring country in the event of a refugee wave. Iranians currently can enter Turkey without a visa.

An elite influx?

Many Turkish citizens are particularly wary of the possible arrival of the 4.5 million Afghans currently living in Iran. However, Afacan noted that millions of Turkish-speaking ethnic Azerbaijanis also live in Iran. He said that if they were to gather at the border, it could shift the debate in Turkey and stir nationalistic sentiments. “But at present, there are no indications that Turks in Iran are planning to migrate,” Afacan added.

Last week, sources from the Turkish defence ministry told journalists there is currently no sign of a refugee influx into Turkey. One source stated that additional security measures have been implemented along all borders, including with Iran, and there is no uncontrolled migration. The Turkish Armed Forces are said to be prepared for all possible scenarios arising from regional developments.

This raises the question of whether Turkey would allow Iranian elites, including government officials, to enter if their government collapses. Many Iranians have already bought homes or acquired Turkish citizenship through investment in recent years.

According to interior ministry data released this year, 76,000 Iranians hold residence permits in Turkey. At least 35,000 have purchased homes since 2019, according to the Turkish Statistical Institute data released in 2024.

Via Stratfor

It is unclear whether all these purchases were made to obtain Turkish citizenship, but a naturalisation consultancy expert told MEE that Iranians are among the top nationalities seeking Turkish citizenship. Between 2012 and 2024, a total of 384,000 homes were sold to foreigners.

Afacan said many Iranian officials and military officers already own property in Turkey. For instance, during the emergency elections following President Ebrahim Raisi’s death in a helicopter crash last year, there was a major controversy over claims that Iranian Parliament Speaker Mohammad Bagher Ghalibaf and his family owned several luxurious apartments in an upscale Istanbul residence.

Afacan added that, as in the aftermath of the 1979 Islamic Revolution, albeit on a much smaller scale, a significant number of Iranian government officials would likely head to Turkey if the government were to fall.

“I do not believe that Turkey would close its doors to such individuals in that kind of scenario,” he said.

https://www.zerohedge.com/geopolitical/turkey-rejects-open-door-policy-refugees-if-iran-falls-apart

Amgen experimental weight-loss drug needs lower dose to limit side effects

 Amgen's long-acting experimental obesity drug MariTide needs to be given at a low starting dose to limit side effects like vomiting,

https://www.reuters.com/business/healthcare-pharmaceuticals/low-start-dose-amgen-experimental-weight-loss-drug-limits-side-effects-2025-06-23/