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MARKET INTEL by PharmaCompass
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By PharmaCompass
2025-07-03
Impressions: 644 (Article) || 52 (Video)
This week in Phispers, AbbVie struck a deal worth up to US$ 2.1 billion to acquire Capstan Therapeutics and its innovative in vivo CAR-T technology. India’s Torrent Pharma plans to acquire a controlling stake in JB Chemicals & Pharmaceuticals for US$ 1.4 billion. Vor Biopharma has signed a potential US$ 4 billion licensing agreement with China’s RemeGen for telitacicept, an autoimmune drug already approved in China.
Argenx and Unnatural Products signed a collaboration potentially worth US$ 1.5 billion that leverages AI-designed macrocyclic peptides to target diseases previously deemed “undruggable”. And Hikma Pharmaceuticals unveiled a US$ 1 billion investment plan to expand its US manufacturing and R&D capabilities.
The US Food and Drug Administration (FDA) has scrapped Risk Evaluation and Mitigation Strategies (REMS) requirements for all approved CAR-T therapies, a move that’s expected to ease administrative burdens and improve patient access.
In drug approvals, Regeneron’s monoclonal antibody Lynozyfic was approved for treating relapsed or refractory multiple myeloma for patients who have received at least four prior lines of therapy. And FDA okayed Sobi’s Gamifant for treating rare types of arthritis.
In news from trials, UCB’s Fintepla has shown promise in treating a rare genetic disorder, and Amgen, along with Zai Lab, reported encouraging survival benefits from their antibody therapy bemarituzumab in treating advanced gastric cancer. And Moderna’s experimental mRNA flu vaccine outperformed GSK’s approved shot in a large late-stage trial.
AbbVie strengthens inflammatory pipeline with US$ 2.1 billion Capstan buyout
AbbVie has agreed to acquire Capstan Therapeutics in a deal valued at up to US$ 2.1 billion — a strategic move to fortify its pipeline in autoimmune and inflammatory diseases. Capstan specializes in in vivo CAR‑T therapies.
The acquisition includes Capstan’s proprietary CellSeeker tLNP platform, which opens possibilities for AbbVie beyond autoimmune indications, such as into oncology and fibrotic diseases. AbbVie has invested over US$ 20 billion in acquisitions since Humira lost its patent protection.
Vor Biopharma inks up to US$ 4 bn deal for RemeGen’s autoimmune drug
Vor Biopharma, once on the brink of being dissolved, confirmed a surprise licensing agreement with China’s RemeGen, securing global rights (excluding Greater China) to develop and commercialize telitacicept — an approved autoimmune therapy in China targeting generalized myasthenia gravis, systemic lupus erythematosus, and rheumatoid arthritis. The deal entails US$ 125 million upfront, and offers RemeGen up to US$ 4 billion in potential regulatory and commercial milestones, in addition to tiered royalties. Telitacicept is currently in a phase 3 trial.
Argenx signs US$ 1.5 bn deal with UNP: Argenx has entered into a multi-target research collaboration with Unnatural Products (UNP), a California-based biotech firm specializing in AI-driven macrocyclic peptide therapeutics. The deal includes a “double-digit million-dollar” upfront payment, near-term payments, and up to approximately US$ 1.5 billion in potential milestone payments. The collaboration aims to develop oral macrocyclic peptides targeting disease mechanisms previously considered “undruggable”.
India’s Torrent Pharma to buy controlling stake in JB Chem for US$ 1.4 billion
Torrent Pharmaceuticals has agreed to acquire a 46.39 percent controlling stake in JB Chemicals & Pharmaceuticals from New York‑based private-equity firm KKR for ₹119.17 billion (US$ 1.4 billion), reflecting a full equity valuation of ₹256.9 billion (US$ 3.01 billion). The deal marks a major consolidation, propelling Torrent into the ranks of India’s top five pharmaceutical companies. The transaction is likely to become the second‑largest pharma deal in India.
Hikma to invest US$ 1 bn in United States: London‑listed Hikma Pharmaceuticals has unveiled plans to invest US$ 1 billion by 2030 in expanding its US manufacturing and R&D capabilities, joining a wave of drugmakers ramping up domestic production. The investment encompasses enhancements to Hikma’s sites in Columbus and Cleveland, Ohio, and in Cherry Hill and Dayton, New Jersey.
FDA grants accelerated approval to Regeneron’s Lynozyfic to treat blood cancer
FDA has granted accelerated approval to Regeneron’s Lynozyfic (linvoseltamab-gcpt), a monoclonal antibody that treats adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy. Regeneron hopes to make Lynozyfic commercially available soon and has set a wholesale acquisition cost of US$ 470 per 5 mg vial and US$ 18,800 per 200 mg vial.
Okays Sobi’s Gamifant for arthritic complications: FDA has okayed Sobi’s Gamifant (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic juvenile idiopathic arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
FDA scraps risk evaluation, mitigation strategies for CAR-T therapies
FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved autologous CAR-T cell therapies targeting BCMA and CD19 antigens — such as Breyanzi, Abecma, Carvykti and, Kymriah (tisagenlecleucel). REMS programs are safety protocols for medications with serious safety concerns. However, the FDA has now determined that these risks are adequately managed through existing drug labeling and medication guides.
Moderna’s experimental flu shot outperforms GSK’s approved drug in phase 3 study
Moderna has said that its experimental mRNA-based influenza vaccine, mRNA-1010, has demonstrated superior efficacy compared to GSK’s approved flu shot in a large phase 3 trial. The study, which included over 40,000 adults aged 50 and older across 11 countries, found that Moderna’s vaccine was 26.6 percent more effective overall, with a 27.4 percent higher efficacy observed specifically in adults aged 65 and older.
UCB’s Fintepla shows promise in treating another epilepsy disorder: UCB is advancing regulatory filings for Fintepla (fenfluramine) following positive phase 3 trial results in treating seizures associated with CDKL5 deficiency disorder (CDD), a rare and severe developmental and epileptic encephalopathy (DEE). This development positions Fintepla as a potential treatment for a third epilepsy disorder, alongside its existing approvals for Dravet syndrome and Lennox-Gastaut syndrome (LGS) in patients aged two years and older.
Amgen, Zai’s gastric cancer therapy posts gains: Amgen and Zai Lab have announced that their investigational gastric cancer therapy, bemarituzumab, in combination with chemotherapy (mFOLFOX6) demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer exhibiting FGFR2b over-expression, compared to chemotherapy alone.
Biokin’s ADC scores late-stage win: A phase 3 trial of Biokin’s bispecific antibody-drug conjugate (ADC) has hit at least one primary endpoint. This has come as a boost to Bristol Myers Squibb, since it had paid Biokin US$ 800 million upfront to license the candidate outside of China.
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