Plus, news about Kaigene, Celltrion, Solid Bio, Terns Pharmaceuticals, Benitec, Pacira, AmacaThera, UCB, Basilea Pharmaceutica, Pfizer, Kura Oncology, Kyowa Kirin, Novavax, Sanofi, Syndexis and Relmada:
🖊️ Prelude signs Incyte deal, trims pipeline:
Prelude will get $35 million in
upfront cash
and a $25 million equity investment from Incyte to partner on what it calls a “JAK2V617F JH2 inhibitor program” for myeloproliferative neoplasms. Incyte will pay $100 million if it exercises an option to acquire the program, and up to another $775 million if all milestones are met. In conjunction, Prelude will be
pausing
development of its SMARCA2 degrader program. —
Max Gelman
💼 Merck regains full rights to Prometheus drug:
Merck will
pay
$150 million to Dr. Falk Pharma to terminate a collaboration from 2020, before Merck acquired Prometheus in 2023. The collaboration involved co-development and co-commercialization of PRA-052, now named MK-8690, an anti-CD30L antibody. Prometheus had intended to study the drug in ulcerative colitis as the lead indication and conducted a
healthy volunteer study
. —
Max Gelman
🤝 Kaigene’s global licensing pact with Celltrion:
Kaigene is set to receive
$8 million upfront
from Celltrion for two preclinical antibodies, codenamed KG006 and KG002, under investigation for autoimmune diseases. There’s up to $736 million in milestone payments on the table, as well as tiered royalties on sales. –
Reynald Castaneda
🕒 Solid Bio postpones FDA meeting in response to “evolving regulatory landscape”:
The biotech was expected to meet with the agency in the fourth quarter of this year to discuss the regulatory pathways for its Duchenne muscular dystrophy gene therapy. “In light of the evolving regulatory landscape and the rapid pace of enrollment in INSPIRE DUCHENNE, we have made the proactive decision to move our planned meeting with the FDA to the first half of 2026,” said CEO Bo Cumbo in a
press release
. —
Lei Lei Wu
📈 Terns Pharmaceuticals’ shares spike on ASH data:
The biotech
reported
that 14 of 22 patients with previously treated chronic myeloid leukemia achieved a major molecular response, good for a 64% response rate. Ten of ten patients maintained that response. The data are for Tern’s BCR::ABL1 blocker. The company’s stock
$TERN
jumped more than 70% Monday. —
Lei Lei Wu
📊 Benitec’s gene therapy for a form of muscular dystrophy shows promise:
Benitec
said
six of six patients who received its treatment met the response criteria, which consisted of various measures of swallowing ability. The therapy, called BB-301, is being developed for oculopharyngeal muscular dystrophy with dysphagia, where progressive muscle weakness makes swallowing increasingly difficult.
However, Benitec’s shares fell 3% on Monday as another drugmaker, UniQure, said the FDA
no longer agreed
to an accelerated approval pathway using a study comparing its gene therapy to natural history, which could signal more trial requirements for other rare-disease genetic medicine makers.
—
Lei Lei Wu
💳 Pacira licenses AmacaThera’s non-opioid candidate:
Pacira is
spending
$5 million upfront to license global rights for AmacaThera’s AMT-143, which is nearing Phase 2 development. AmacaThera could also receive up to $225 million in milestones and tiered royalties. AMT-143 is a long-acting non-opioid anesthetic in development for post-operative pain. –
Ayisha Sharma
✅ FDA approves UCB drug for ultra-rare mitochondrial disease
: Branded as Kygevvi, the powder drug was
approved
to treat thymidine kinase 2 deficiency in adults and kids who start to show symptoms at 12 years or younger. The disease is very rare, with only 120 cases described in medical literature, according to the FDA. The disease causes low levels of mitochondria, which leads to symptoms such as muscle weakness and respiratory failure. The drug was approved based on findings from a Phase 2 study that showed a greater proportion of patients who received the treatment lived compared to those who were not treated. —
Lei Lei Wu
💵 Basilea Pharmaceutica receives $30M milestone from Pfizer:
The payment was for “continued strong sales performance” of Cresemba as part of its licensing deal with Pfizer in Europe. The antifungal drug
collected
$652 million in global sales between July last year and June 2025, which equates to a 27% growth year-on-year, Basilea said. –
Reynald Castaneda
💰 Kura Oncology also records $30M milestone:
It
received
the payment from Kyowa Kirin after the first patient was dosed in a second Phase 3 trial studying ziftomenib in certain acute myeloid leukemia patients. Kura previously
received
another $30 million when it dosed a patient in the first of a pair of registrational studies. –
Reynald Castaneda
💸 Novavax receives $25M milestone from Sanofi:
The milestone was
paid
after Novavax transferred US marketing authorization for its Covid vaccine to the French pharma. The two companies inked their original vaccine licensing and co-commercialization pact in 2024, with Sanofi
paying
$500 million upfront. –
Ayisha Sharma
👁️ Syndexis’ shares Phase 3 data for myopia drug:
The biotech’s SYD-101 eye drops
hit
the primary endpoint of proportion of patients with confirmed progression of -0.75 diopters and the key secondary endpoint of annual progression rate. The placebo-controlled Phase 3 trial enrolled more than 800 children and teens with pediatric progressive myopia. The FDA
rejected
an NDA for SYD-101 last month, stating that the data do not support the effectiveness of the drug. –
Ayisha Sharma
🏷️ Relmada prices $100M offering:
The
raise
will help fund a variety of plans by the company, including clinical trials, pushing the pipeline forward and business development. The funding comes after Relmada
said
it received FDA feedback on the Phase 3 design for its bladder cancer program NDV-01. —
Max Gelman
