Rigel Pharmaceuticals Inc.’s shares (NASDAQ:RIGL) were trading at $30.18, up 15%, or $3.98, on word that the company has entered into an exclusive, global license agreement with Arvinas Inc. and Pfizer Inc. to develop, manufacture and commercialize Veppanu (vepdegestrant), the oral proteolysis targeting chimera, or PROTAC, approved for advanced or metastatic breast cancer May 1 by the U.S. FDA. Regulators gave the drug’s go-ahead for ER-positive/HER2-negative, estrogen receptor 1-mutated disease, as detected by an FDA-authorized test, who show disease progression following at least one line of endocrine therapy. In the deal, Rigel gets exclusive global rights to develop, manufacture, and commercialize Veppanu, with Arvinas and Pfizer collecting an up-front payment of $70 million, $15 million when certain development and manufacturing transition activities finish, up to $40 million for development work, and as much as $320 million in milestone payments, plus tiered royalties.
Advancing the 'best of both' – BMS, Hengrui enter $15.2B deal
In a deal potentially worth up to $15.2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. is joining efforts with Bristol Myers Squibb Co. to advance 13 early development programs in the fields of oncology, hematology and immunology. Shanghai-based Hengrui will hold exclusive rights in mainland China, Hong Kong and Macau, while Princeton, N.J.-based BMS will hold exclusive rights in the rest of the world. The deal includes four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five assets that the two companies will jointly discover and develop. “By leveraging Hengrui’s growing R&D capabilities and proven efficiency in discovering and advancing innovative therapies, we are poised to advance the best of both pipelines,” said Frank Jiang, Hengrui’s executive vice president and chief strategy officer.
Roche secures CE mark for Alzheimer’s blood test
Roche Holding AG secured CE marking for the Elecsys plasma phosphorylated-tau 217 (pTau217) blood test designed to rule in and rule out amyloid pathology, a hallmark of Alzheimer's disease. Developed with Eli Lilly and Co., the test brings to the market another much-needed solution to help clinicians diagnose Alzheimer’s patients following the FDA approval of Fujirebio Diagnostics Inc.’s blood test last year.
Commerce gives Rx companies 30 days to submit US onshoring plans
Companies seeking a break in the soon-to-be-implemented U.S. Section 232 biopharma tariffs have 30 days to apply for a company-specific onshoring agreement with the Department of Commerce, according to the procedures the department laid out in a notice to be published in tomorrow’s Federal Register. Instead of the 100% sector tariff that will go into effect Sept. 29 on certain imports of branded drugs and their ingredients, companies with an approved onshoring agreement will face a reduced tariff rate of 20%. And those who have both an onshoring agreement and a most-favored nation pricing deal with the Department of Health and Human Services will be subject to a 0% tariff until Jan. 20, 2029. There are some caveats, though.
Metis Techbio, Impact Tx cleared for Hong Kong IPOs
Metis Techbio Co. Ltd. is seeking a potential HK$2.11 billion (US$270 million) raise through a stock sale May 13, marking the largest biotech raise on the Hong Kong Stock Exchange this year to date. Hangzhou, China-based Metis is an AI-based nanoparticle drug formulation and delivery-focused company. Synthetic lethality-based cancer drugmaker Impact Therapeutics Inc., of Shanghai, plans to debut on the same day with a US$117 million IPO. The two companies will be the first mainland China biotechs to exit on HKEX in the second quarter of 2026, after Ribo Life Science Co. Ltd. completed a HK$1.8 billion (US$230 million) stock sale in the first quarter.
MHRA sets out proposal to redefine gene therapies
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to correct the mismatch between regulatory terminology and modern science, which MHRA says “can lead to uncertainty” over how a product is classified and to “inconsistent oversight and potential barriers for developers." The current U.K. legislation is based on the EU’s Advanced Therapies Medicinal Products regulation of 2007, which reached the U.K. statute books in November 2012.
Two-step HIV vaccine induces broadly neutralizing antibodies
A designed chimeric virus induced broadly neutralizing antibodies against the macaque equivalent of HIV. The strategy works in two steps: first it uses an envelope protein with a mutation that reduces the glycan shield that makes it invisible to the immune system, and then it exposes the part of the protein most likely to generate these antibodies capable of blocking many variants of the virus. The macaques developed potent and diverse antibodies with this approach, which pave the way for the development of an HIV-1 vaccine. “One of the mutations reduces the glycosylation. So, there is not as many sugars in a certain area of the virus. Then that area becomes very easy to target by antibodies,” first author Ashwin Skelly told BioWorld.