Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination showing an 83.4% rate of progression-free survival (PFS) at three years vs. 29.7% for standard of care. “You have to know that this is the greatest PFS treatment effect we’ve seen to date, with 83% reduction in the risk of progression or death, with a plateau phase in both PFS and overall survival curves after six months suggesting potential for functional cure,” said Maria-Victoria Mateos, a professor at the University of Salamanca in Spain, who presented the data at a late-breaker abstract session at ASH on Dec. 9.

Exicure riding high on positive mid-stage AHCT data with burixafor

Shares of Exicure Inc. (NASDAQ:XCUR) were trading at $8.46, up $3.19, or 60%, on positive results from its completed phase II trial evaluating burixafor (GPC-100), an agent used with propranolol and granulocyte colony-stimulating factor to mobilize hematopoietic progenitor cells in patients with multiple myeloma undergoing autologous hematopoietic cell transplantation. The data showed that about 90% of participants achieved the primary endpoint: collecting ≥2 × 10⁶ CD34+ cells/kg within two leukapheresis sessions. Findings rolled out during the American Society of Hematology annual meeting in Orlando, Fla.

Immutep shares rocket on AU$528M deal with Dr. Reddy’s

Immutep Ltd.’s stock surged 31% following the news that it out-licensed rights to Dr. Reddy’s Laboratories Ltd. to develop and commercialize eftilagimod (IMP-321, efti) in selected territories in a deal worth AU$528.4 million (US$349.5 million). Under the deal terms, Immutep will receive an up-front payment of AU$30.2 million and is eligible to receive development and commercial milestone payments up to AU$528.4 million plus sales-based royalties. In exchange, Dr. Reddy’s gains exclusive rights to develop and commercialize efti in all countries outside North America, Europe, Japan and greater China.

73 Chinese biotech, med-tech companies file for HK IPOs in 2025

Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half (H2) of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half. Fewer than 20% of filings from Jan. 1 to Dec. 9 resulted in a completed stock sale by December, however.

New recombinant strain of Mpox virus identified in the UK

The UK Health Security Agency (UKHSA) has identified a new recombinant strain of Mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. The UKHSA’s Rare and Imported Pathogens laboratory that carried out the genomic analysis has confirmed the, as yet, unnamed recombinant virus is replication competent. In a paper describing the new strain, the researchers at UKHSA say it is not possible to determine from a single genome how long the recombinant virus has been in circulation, or whether it will have a fitness benefit over currently circulating lineages.

Novartis, Relation join a $1.7B collaboration for atopic disease

Relation Therapeutics Ltd. will collaborate with Novartis AG in a $1.7 billion deal to develop multiple programs find and advance targets for treating atopic diseases. Novartis will pay Relation an up-front amount, an equity investment and R&D funding of $55 million. The $1.7 billion could come will preclinical, development, regulatory and commercial sales milestones, plus tiered royalties on the net sales of products. Relation has an AI-powered discovery platform, which will be paired with Novartis’ experience in immuno-dermatology. A year ago, Relation signed on with GSK plc for two agreements with a potential value of $200 million per target.

Pfizer adds heft to obesity pipeline in $2B Yaopharma deal

A month after besting rival Novo Nordisk A/S in a bidding war for obesity drug developer Metsera Inc., Pfizer Inc. is again adding to its GLP-1 arsenal, this time via a $2 billion licensing and collaboration agreement with Yaopharma, a subsidiary of China’s Fosun Pharmaceutical Co. Ltd. The compound in question, YP-05002, is a small-molecule GLP-1 receptor agonist currently in phase I development for chronic weight management. Yaopharma will complete the ongoing study, with Pfizer picking up an exclusive license for further development, along with manufacturing and commercialization rights worldwide. Financial terms call for a $150 million up-front payment, with up to $1.935 billion linked to milestones, plus tiered royalties on sales should the product gain approval.

FDA ad guidance neuters biosimilar/interchangeable distinction

While the U.S. Congress has yet to address the artificial distinction it created between biosimilars and interchangeables when it passed the Biologics Price Competition and Innovation Act in 2010, the FDA is erasing that distinction for all practical purposes. The agency’s newly released final guidance on promotional labeling and advertising claims for biologics continues that trend. From the offset, the guidance makes it clear that its use of “biosimilar product” refers to both biosimilars and interchangeables. “Biosimilar and interchangeable biosimilar products must meet the same high standard of biosimilarity for approval,” it adds. Consequently, promotional claims should not suggest that a biosimilar not approved as interchangeable is less safe or effective than the reference product, according to the guidance.

RRA asks whether industry is even Remotely Ready for Action

The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results.

Also in the news

Abbvie, Abeona, AL-S, Arcellx, Ascletis, Ayrmid, Biomx, Blue Water, Cerevance, Circular Genomics, Deciphera, Disc, Dyne, Encoded, Evotec, Galapagos, GRI, Immix, Incyte, Innovent, Junshi, Kala, Kamada, Kymera, Medicus, Neurona, Ocular, OSE, Pan Cancer T, Pepgen, Prime, Puretech, Sandoz, Sensorion, Star, Vivacta, Wave Life