Prescription Drug User Fee Act (PDUFA) date set for August 25, 2026
Sun Pharma’s $11.75 billion buy will bring Organon’s portfolio of more than 70 products into its orbit, including six manufacturing sites across the EU and emerging markets.
After the deal closes, the India-based generics pharma is expected to become the seventh largest biosimilar player in the world, according to a Sunday release. The Organon acquisition will also make Sun Pharma one of the top three women’s health companies worldwide, the companies said.
Merck spun out Organon in 2021 to take on certain women’s health, biosimilars and established brands businesses. The New Jersey–based company recorded $6.2 billion in revenue for 2025, plus debts of $8.6 billion million.
Now, Sun will pay $14 per Organon share in an all-cash transaction, with the deal designed to create a “stronger cash generating company,” according to the release. The acquisition is expected to close early next year.
“This transaction is a logical next step in strengthening Sun Pharma’s global business,” Sun Pharma Managing Director Kirti Ganorkar said in a statement on Sunday. “Together, we will become a partner of choice for acquiring and launching new products. Our immediate priorities will be business continuity, disciplined integration and responsible value creation.”
The deal is a ray of light for Organon, which had been weighed down by its debt and was examining strategic options.
The announcement comes on the heels of Amneal Pharmaceuticals’ $1.1 billion deal for Kashiv BioSciences, another buyout inked in hopes of becoming a global biosimilar leader.
https://www.biospace.com/deals/sun-pharma-beams-up-organon-in-11-75b-acquisition
Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia
IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions
Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia
First lady Melania Trump savagely criticized ABC late-night host Jimmy Kimmel as a “coward” after he referred to her as “an expectant widow” two days before Saturday’s White House Correspondents’ Dinner.
“Kimmel’s hateful and violent rhetoric is intended to divide our country. His monologue about my family isn’t comedy- his words are corrosive and deepens the political sickness within America,” Trump, 56, wrote in a post on X.
The comic is facing severe backlash after Saturday’s shooting at the gala dinner, in which a Secret Service agent suffered minor injuries after a gunman charged a checkpoint in a bid to kill President Trump and others in his administration.
Kimmel mocked the dinner on his show on Thursday night, giving his own speech in which he said: “Our first lady, Melania, is here. Look at Melania, so beautiful. Mrs. Trump, you have a glow like an expectant widow.”
The first lady also accused the Disney-owned network of protecting the host and called for ABC to step in and yank him off the air.
“A coward, Kimmel hides behind ABC because he knows the network will keep running cover to protect him,” she wrote.
“Enough is enough. It is time for ABC to take a stand. How many times will ABC’s leadership enable Kimmel’s atrocious behavior at the expense of our community?”
It’s a new week, which means a new deal for Eli Lilly. On the heels of buyout offers for CrossBridge Bio and Kelonia Therapeutics, the pharma is now offering up to $2.3 billion for the clinical-stage Ajax Therapeutics.
The focal point of the deal is the biotech’s lead program AJ1-11095, a next-gen JAK2 inhibitor, according to a Monday release. AJ1-11095 is designed to treat myeloproliferative neoplasms (MPNs), rare blood cancers that occur when the bone marrow creates too many blood cells. The asset’s “unique mode of binding JAK2” is supposed to deliver more durable disease control for myelofibrosis and polycythemia vera—two MPN diseases—compared to current therapies, such as Incyte’s Jakafi, per the biotech.
AJ1-11095 is currently being studied in a Phase 1 trial for patients with myelofibrosis who have previously been treated with an approved JAK2 inhibitor. Ajax anticipates sharing proof-of-concept data from the trial later this year, according to the company release.
Ajax’s asset has also secured FDA orphan drug status as the first clinical-stage JAK2 inhibitor that binds to the type II conformation of the JAK2 kinase, versus current therapies that bind to the type I conformation.
The acquisition of AJ1-11095 “could offer a competitive therapy in MPNs where traditional JAK inhibitors have failed,” BMO analyst Evan Seigerman and colleagues wrote in a Monday note to investors.
Lilly has supported Ajax since its creation in 2019, when the biotech debuted with help from founding partner Schrödinger. At the time, Lilly served as a founding strategic investor for the East Coast biotech and more recently invested in Ajax’s $95 million series C in 2024.
“Lilly has long believed in the approach and is excited about the potential for AJ1-11095 to deliver deeper and more durable efficacy than available treatments with a tolerability profile that would allow for patients to remain on therapy longer and be used across both the first- and second-line settings,” Jacob Van Naarden, Lilly’s head of corporate business development and president of Lilly Oncology, said in a Monday statement. He added that the company looks forward to “rapidly advancing AJ1-11095 into registrational clinical trials.”
The $2.3 billion potential sum for the Ajax takeover includes an undisclosed upfront payment, plus certain clinical and regulatory milestone payments.
For Lilly, the buyout is the most recent in a string of cancer acquisitions, with one announced every week for the last three weeks.
On April 14, the Indianapolis pharma giant said it was acquiring CrossBridge Bio, a small Texas biotech known for its antibody-drug conjugates (ADC) tech, for up to $300 million. A week later, Lilly was back at it again, penning a deal for in vivo CAR T company Kelonia Therapeutics and its gene delivery platform.
The Ajax acquisition will expand Lilly’s presence in hematology and oncology, with the pharma’s current cancer portfolio focused largely on solid tumor treatments.
“Therapies like Jaypirca (CLL/B-cell malignancies) have provided some base for the company in hematology/oncology, but today’s acquisition of Ajax Therapeutics looks to further deepen the company’s portfolio development in blood-based myeloproliferative neoplasms (MPNs),” BMO’s Seigerman wrote.
https://www.biospace.com/deals/lilly-lands-third-oncology-deal-in-3-weeks-inking-up-to-2-3b-for-ajax
On April 27, 2026, Ligand Pharmaceuticals agreed to acquire fellow royalty aggregator XOMA Royalty Corporation for $39.00 per share in cash, valuing the target at about $739 million and offering a roughly 14% premium to XOMA’s 30‑day volume‑weighted average price. XOMA shareholders will also receive one non‑transferable contingent value right per share tied to 75% of net proceeds from ongoing litigation with Janssen Biotech over TREMFYA.
The deal, unanimously approved by both boards and backed by voting agreements from BVF Partners and XOMA’s leadership, is expected to close in the third quarter of 2026.
