Mirum beckons Bluejay and its phase 3-stage hepatitis drug for $620M

 Mirum Pharmaceuticals is paying $620 million in cash and stock to buy Bluejay Therapeutics and its phase 3-stage hepatitis drug.

At the heart of the deal is brelovitug, an immunoglobulin G1 monoclonal antibody that targets the surface antigen on both the chronic hepatitis D virus (HDV) and the hepatitis B virus (HBV).

Bluejay read out data from a phase 2 study of brelovitug last month that demonstrated 100% HDV RNA response, along with improvements in liver enzyme levels. Meanwhile, the California-based biotech has been enrolling patients with HDV in a phase 3 trial that’s expected to report top-line data in the second half of next year.

To get its hands on the asset, Mirum is paying out $250 million in cash and $370 million in its own stock. There’s also the chance for Bluejay to receive up to $200 million in tiered sales-based milestones, should brelovitug make it to market.

Mirum—which already markets Livmarli for chronic itching due to Alagille syndrome—is eyeing up a potential FDA approval submission and commercial launch for brelovitug in 2027, according to the Dec. 8 release.

“This acquisition fits squarely with what we do best—advancing high-impact medicines for patients with rare diseases through disciplined development, regulatory innovation, and commercial excellence,” Mirum CEO Chris Peetz said in the release.

“Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and Livmarli programs,” Peetz added. “The Bluejay team has done commendable work advancing brelovitug to this stage and we look forward to building on that progress to bring this important new treatment to people living with HDV.”

Bluejay’s CEO Keting Chu touted the drug as having the “potential to redefine HDV treatment.”

“Mirum’s rare disease leadership, commitment to rare liver communities and commercialization expertise make it the right company to carry this program forward globally,” Chu added.

Brelovitug will join a pipeline at Mirum that also includes the ileal bile acid transporter inhibitor volixibat, which is undergoing a pair of phase 2b studies for different types of cholangitis, as well as MRM-3379, a PDE4D inhibitor in a phase 2 trial for fragile X syndrome.

Alongside this morning’s acquisition, Mirum also announced a private placement of its common stock that is set to bring in around $200 million to the California-based biopharma. This funds will help bankroll the clinical development and commercial activities related to the buyout of Bluejay, Mirum explained.

https://www.fiercebiotech.com/biotech/mirum-nets-bluejay-and-its-phase-3-stage-hepatitis-drug-620m

Kura, Kyowa Kirin Combo Data for KOMZIFTI (Ziftomenib) with Venetoclax and Azacitidine in AML

 – 86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS 

– Median duration of complete response and overall survival not yet reached in newly diagnosed NPM1-m patients as of data cutoff –

– 65% (31/48) ORR in R/R NPM1-m AML, 83% (19/23) ORR in venetoclax-naïve –

– 41% (13/32) ORR in R/R KMT2A-r AML, 70% (7/10) ORR in venetoclax-naïve –

– Triplet combination was well tolerated in both newly diagnosed and relapsed/refractory settings; addition of ziftomenib did not increase toxicity beyond that expected with venetoclax/azacitidine alone –

– Ziftomenib’s broad clinical development program spans multiple front-line and relapsed/refractory regimens across NPM1-m, FLT3-m and KMT2A-r AML subtypes –

– Company-sponsored registrational trials of ziftomenib in front-line AML are ongoing in both intensive chemotherapy-eligible and -ineligible patients –

– Kura Oncology to host a virtual investor event today, December 8, 2025, at 12:30 p.m. ET / 9:30 a.m. PT –

Presentations
Slides from the oral presentations will be available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Ziftomenib section, and in the ASH 2025 online program.

Virtual Investor Event
Kura will host a webcast and conference call today, December 8, 2025, at 12:30 p.m. ET / 9:30 a.m. PT featuring Kura management, Eunice Wang, M.D., Chief of Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Center, and Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies and Professor of Medicine at Yale School of Medicine. The live webcast and replay will be available on the on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

https://www.globenewswire.com/news-release/2025/12/08/3201703/35186/en/Kura-Oncology-and-Kyowa-Kirin-Report-Combination-Data-for-KOMZIFTI-Ziftomenib-with-Venetoclax-and-Azacitidine-in-Newly-Diagnosed-and-Relapsed-Refractory-AML.html

Cullinan Therapeutics Encouraging Phase 1 Leukemia Data

 Cullinan Therapeutics (CGEM) recently disclosed promising results from their Phase 1 clinical trial of CLN-049. This investigational FLT3xCD3 bispecific T cell engager is being tested on patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome. The findings will be shared at the 67th American Society of Hematology Annual Meeting and Exposition, scheduled for December 6-9, with an oral presentation on December 8 at 10:45 a.m. ET.

The data includes multiple complete responses and shows promise in terms of response durability, suggesting that CLN-049 could significantly broaden treatment avenues for AML patients, particularly those with TP53 mutations who typically have a poor prognosis. With its recent Fast Track designation by the FDA, CLN-049 is positioned as a potentially crucial new treatment option in the fight against this challenging disease, highlighting Cullinan's commitment to rapidly advancing its development.

https://www.gurufocus.com/news/3237691/cullinan-therapeutics-cgem-reveals-encouraging-phase-1-data-for-cln049

Orban warns EU 'rebellion begins' over migration pact

 Hungarian Prime Minister Viktor Orban vowed on Monday that Hungary will not implement the European Union's Migration Pact, declaring that "rebellion begins" against the bloc's immigration policies.

Responding to the European Council's decision earlier today to establish the so-called solidarity pool as "one of the main elements of the EU’s Pact on Migration and Asylum," Orban said that "Brussels is attempting to force Hungary to pay even more or take migrants in," calling it "unacceptable."

"We will not take a single migrant in, and we will not pay for other migrants," he concluded.

https://breakingthenews.net/Article/Orban-warns-EU-'rebellion-begins'-over-migration-pact/65315233

US not to publish producer prices data for October

 The United States Bureau of Labor Statistics (BLS) will not publish the Producer Price Index (PPI) data for October, the agency's revised release schedule indicated on Monday.

Initially, the PPI data scheduled for release on October 16 was not published due to the US government shutdown.

The data for November will be released on January 14, 2026.

https://breakingthenews.net/Article/US-not-to-publish-producer-prices-data-for-October/65315447

Paramount proposes $108.4B deal to WBD

 Paramount Skydance Corp. launched an all-cash tender offer on Monday to buy Warner Bros. Discovery Inc. (WBD), offering $30 per share, for an enterprise value of $108.4 billion.

In a statement, Paramount insisted that its offer is superior to Netflix Inc., as the latter's proposal "entails a volatile and complex structure valued at $27.75 mix of cash ($23.25) and stock ($4.50)." Paramount also pointed out that it is interested in buying the entirety of WBD, including the Global Networks segment. "[The Netflix transaction] exposes WBD shareholders to a protracted multi-jurisdictional regulatory clearance process with an uncertain outcome," Paramount said, adding that it is offering the WBD shareholders $18 billion more in cash compared to its rival.

While Paramount sent six proposals in the last 12 weeks, it claims that WBD "never engaged meaningfully." Netflix previously announced that it would be acquiring WBD for $82.7 billion, with the takeover news being met with criticism.

https://breakingthenews.net/Article/Paramount-proposes-dollar108.4B-deal-to-WBD/65314586

Tsunami of up to 3m set to strike Japan's Pacific coast

 A Tsunami that could reach a height of up to 3 meters is expected to hit Japan's Pacific coast, following an earthquake of 7.6 magnitude, the Japan Meteorological Agency said on Monday.

The agency detailed that the areas at risk are Iwate, Aomori, and parts of Hokkaido. A 40-centimeter tsunami has already been registered in Aomori, as well as Hokkaido.

Alerts for evacuation have been sounded in the areas.

BREAKING LIVE | Japan Earthquake Upgraded To 7.6, Tsunami Warnings Issued, Evacuations Underway

https://breakingthenews.net/Article/Tsunami-of-up-to-3m-set-to-strike-Japan's-Pacific-coast/65314992