'Iran negotiators ordered to return after internal rift over Islamabad talks'

 

Sharp disagreements among members of Iran’s negotiating team led them to abandon US talks in Islamabad and return to Tehran on April 11 following an order from Iran's top security official, sources familiar with the deliberations told Iran International.

The sources said that during Friday’s negotiations with the United States, Foreign Minister Abbas Araghchi showed signs of flexibility in some of his positions, particularly regarding reducing or halting financial and military support for the so-called Axis of Resistance, including Lebanon’s Hezbollah.

According to the sources, this approach drew a strong reaction from Mohammad Bagher Zolghadr, the Secretary of the Supreme National Security Council, in Tehran.

The sources said Zolghadr, who was briefed on the talks, submitted a report to the leadership and senior IRGC commanders, which fueled anger at the highest levels. The report reportedly cited “deviation from the delegation’s mandate” and engagement in discussions beyond the leadership’s directives.

Following consultations at the leadership level, and with the involvement of Hossein Taeb, an advisor to the supreme leader, an order was issued on Saturday afternoon for the delegation’s immediate return to Tehran, the sources said.

Reports of similar internal rifts had surfaced earlier. On March 28, accounts emerged of serious disagreements between President Masoud Pezeshkian and IRGC Chief-Commander Ahmad Vahidi.

Informed sources told Iran International that the rifts stemmed from disagreements over the conduct of the war and its impact on livelihoods and the wider economy.

Three days later, reports indicated Pezeshkian was dissatisfied with being in a “complete political deadlock” and had even lost authority over appointing officials killed during the war.

According to those reports, Vahidi had said that due to wartime conditions, all key managerial positions should be directly controlled by the IRGC until further notice.

Despite the diverse composition of Iran’s negotiating delegationin Islamabad, reports suggest representatives aligned with the IRGC held significant influence.

Iran’s insistence on continuing its nuclear program and maintaining control over the Strait of Hormuz ultimately contributed to the failure of the Islamabad talks, according to reports.

Following the breakdown, the United States announced a naval blockade targeting Iran’s southern ports, with US Central Command saying from Monday morning it would prevent ships from entering or leaving Iranian ports. The blockade was implemented as scheduled.

Despite the failure of the first round of talks, Pakistan said on Monday that consultations with both sides were ongoing and another round of talks remained possible.

US President Donald Trump also told the New York Post on Tuesday that talks with Iran “could resume within two days” in Pakistan.

Sources had earlier told Reuters that despite the apparent deadlock, diplomatic channels remain open, with an Iranian embassy official in Pakistan saying the next round of talks could take place later this week or early next week.

https://www.iranintl.com/en/202604149552

'European nations draft post-war plan to free up Hormuz excluding US – WSJ'

 

European countries are putting together a post-war plan for a broad coalition of countries, excluding the United States, to help free up shipping through the Strait of Hormuz, the Wall Street Journal reported citing officials.

https://www.iranintl.com/en/liveblog/202604067622

More than 20 commercial ships transit Hormuz in past 24 hours - WSJ

 

More than 20 commercial vessels passed through the Strait of Hormuz over the past 24 hours, according to two US officials cited by The Wall Street Journal on Tuesday.

https://www.iranintl.com/en/liveblog/202604067622

Over 100 empty oil tankers head to US - White House says

 

More than 100 empty oil tankers are heading to US ports to load crude, the White House said on Tuesday, calling American output a “critical lifeline” amid global energy disruptions linked to the war with Iran, CBS reported.

Of the 103 vessels, 54 are Very Large Crude Carriers, each capable of transporting about two million barrels.

https://www.iranintl.com/en/liveblog/202604067622

FDA asks 2,200 drug developers to make trial results public, ramping up transparency push

 

Some 30% of clinical trials that are mandated to report their findings have not posted results to clinicaltrials.gov, the federal government’s public repository for studies, according to internal data from the FDA.

The FDA has written to more than 2,200 study sponsors reminding them of their obligation to make their results publicly available on a federal clinical trials database—a move that falls in line with the agency’s aim of improving transparency across the industry.

Certain researchers and companies—including those that have received federal funding for their programs—are required by law to post their study results on clinicaltrials.gov within a year after completion, the regulator said in a news release on Monday. An internal accounting, however, has found that 29.6% of these studies have failed their reporting requirements—corresponding to more than 2,200 responsible parties.

Failure to completely report findings, often negative outcomes, leads to “significant gaps in the public record,” the FDA said Monday, and “obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures.”

The FDA is seeking voluntary compliance from these parties. Companies and researchers that fail to comply with reporting requirements are at risk of receiving the FDA’s Notice of Noncompliance, which could incur civil monetary penalties or open them up to injunctions or even criminal prosecution.

The letters, issued March 30, are “an extra step” extended to these trial sponsors, giving them an additional opportunity to fulfill their obligations “before the agency considers whether to take further regulatory action,” according to the FDA’s news release.

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community,” Commissioner Marty Makary said Monday in a prepared statement. Trial sponsors have an “ethical obligation” to make their results publicly available, “regardless of the data’s influence on the company’s share price.”

The FDA is in the midst of a campaign for “radical transparency” across the pharma industry—an initiative that in July 2025 pushed the agency to publish more than 200 complete response letters to give the public a peek into the regulator’s thinking behind drug rejections.

While the rejection letters often feature redactions to help protect intellectual property, they still have helped foster “a level of accountability and professionalism” to the industry, TD Cowen senior biotechnology analyst Ritu Baral told BioSpace in an interview earlier this month.

The transparency has been particularly good for investors, who previously were mostly left in the dark about why a certain drug had been rejected. Drugmakers now can’t easily misrepresent the FDA’s reasoning for a rejection because the CRL would easily contradict them, Baral said.

“The reception from the investment community has been unanimously positive,” she told BioSpace.

https://www.biospace.com/fda/fda-asks-2-200-drug-developers-to-make-trial-results-public-ramping-up-transparency-push

'Kailera eyes record $533M+ IPO to play in competitive obesity space with Chinese drugs'

 

Kailera Therapeutics is advancing a pipeline of obesity drugs, led by the GLP-1/GIP dual agonist ribupatide, which the biotech is developing both as an injectable and as a pill.

After declaring its intent to go public last month, Kailera Therapeutics has now revealed an initial public offering amount that could be the highest the industry has seen in years.

Kailera will put 33 million shares of common stock up for sale for $14 to $16 apiece, according to its updated prospectus, resulting in a raise that could reach as high as $533 million. The biotech has also opened a 30-day option for underwriters to purchase up to 5 million additional shares of common stock at the initial public offering (IPO) price.

If underwriters completely take Kailera up on this offer, the biotech could see an $80 million bump to the IPO raise, bringing the total haul over $610 million. If fully realized, this would be the biggest public market debut in years and put Kailera firmly at the head of this year’s IPO class.

In February, AI-forward Generate:Biomedicines brought in $400 million in an IPO, a sum that had been hailed as a record raise. Generate itself outpaced Eikon Therapeutics’ $381 million earlier that same month, which at the time was called the largest since 2024. Other companies that have declared an intent to go public this year include Seaport Therapeutics, Hemab Therapeutics and Avalyn Pharma.

Whatever the IPO brings in, Kailera will add the sum to its $600 million series B round in October 2025, money that at the time was earmarked to advance its pipeline of obesity assets into late-stage development. Kailera hasn’t yet announced when the IPO window will close, but the company intends to trade on the Nasdaq Global Select Market under the symbol KLRA.

Kailera’s pipeline is led by ribupatide, a GLP-1/GIP receptor dual agonist being developed in partnership with China’s Jiangsu Hengrui Pharmaceuticals. The companies are currently advancing both injectable and oral versions of ribupatide.

Phase 2 data in February demonstrated a 12.1% reduction in weight at 26 weeks for patients on 25-mg or 50-mg ribupatide, whereas the placebo group hit 2.3% weight loss at this time point. The partners were emboldened by these findings to push the drug into late-stage studies.

Kailera expects to allot roughly $625 million for the development of injectable ribupatide, currently in three ongoing Phase 3 studies, into the second quarter of 2028, according to the updated prospectus. Meanwhile, around $150 million will go toward the pill form of ribupatide, for which a late-stage study is in the works and is expected to start in the second quarter of 2028.

Aside from ribupatide, Kailera is also advancing KAI-7535, a daily oral GLP-1 drug. Some $50 million will help push the pill through Phase 2. The rest of Kailera’s money will go toward other R&D activities and support general corporate operations, as per the prospectus.

Kailera was one of the buzziest startups to hit the scene with its October 2024 debut, carrying $400 million in starting funds. The biotech launched as a NewCo featuring Chinese assets, a startup method that has been rising in popularity as investors, pharmas and biotech leaders alike hunt for assets in the country.

Peer obesity startup Metsera sparked a wild bidding war last fall when Pfizer and Novo Nordisk duked it out to seal the M&A deal. Pfizer ultimately walked away with the prize, spending nearly $10 billion to buy Metsera and its pipeline of obesity medications.

https://www.biospace.com/business/kailera-eyes-record-533m-ipo-to-play-in-competitive-obesity-space-with-chinese-drugs

Lilly wants to bridge cancer care gap with $300M ADC biotech buy

 

Eli Lilly is putting its obesity windfall to work again, striking a new deal to acquire CrossBridge Bio, a small Texas biotech known for its cancer tech.

Eli Lilly is hoping to bridge the gap in cancer care, rounding up an early-stage biotech that is working to create next-generation antibody-drug conjugates (ADCs).

The pharma’s acquisition of CrossBridge Bio includes an undisclosed upfront payment and biobucks potential, with the biotech’s shareholders eligible to receive up to $300 million in cash, according to a Tuesday announcement.

Formed in 2023, the Houston startup is working on dual-payload ADC tech in an effort to “transform clinical practice.” The biotech’s lead program CBB-120 is designed to target TROP2, a type of protein that’s often overexpressed in several solid tumors.

CrossBridge hopes CBB-120 will provide a safer and more durable cancer treatment compared to currently available TROP2-targeting ADCs—namely, Gilead Sciences’ Trodelvy. The investigational ADC is also designed to tackle resistance mechanisms.

The biotech is planning on asking the FDA for permission to start testing CBB-120 in humans sometime this year.

“We look forward to seeing how Lilly advances our new generation of dual-payload antibody-drug conjugates, including CBB-120, with the potential to meaningfully improve outcomes for patients with limited treatment options,” CrossBridge Bio CEO Michael Torres said in a statement.

Little else was shared about the buyout, which follows a slew of deals made by the GLP-1 giant. Fueled by its overflowing coffers tied to the success of blockbuster weight loss and diabetes drug tirzepatide, the Big Pharma has penned numerous pacts of late, including a $6.3 billion upfront acquisition of sleep disorder-focused Centessa Pharmaceuticals a few weeks ago.

The pharma is also working to bolster its AI offerings, recently inking a deal potentially worth up to $2.75 billion with Insilico Medicine to use the company’s machine learning platforms for oral drug development.

https://www.biospace.com/deals/lilly-wants-to-bridge-cancer-care-gap-with-adc-biotech-buy