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By PharmaCompass
2026-03-05
Impressions: 474
February was a month of upheavals. In the US, the Supreme Court ruled that President Donald Trump exceeded his authority by imposing broad tariffs. Soon after the ruling, Trump imposed a temporary 15 percent global tariff under a separate trade law. The month ended with the US and Israel launching a major military operation against Iran, and the region now appears headed for a prolonged conflict.
Despite the turbulent geopolitical environment, the biotech indices continued to grow steadily. The Nasdaq Biotechnology Index (NBI) rose 3.68 percent, moving from 5,852.67 to 6,041.31. The SPDR S&P Biotech ETF (XBI) gained 2.4 percent, rising from 124.75 to 127.27, and the S&P Biotechnology Select Industry Index (SPSIBI) increased 2.4 percent, rising from 9,746.25 to 9,954.51. In comparison, the S&P 500 fell by 0.55 percent — from 6,916.64 to 6,878.88.
Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)
Gilead buys Arcellx for US$ 7.8 billion; Lilly acquires Orna for its circular RNA therapeutics
Eli Lilly announced the acquisition of Orna Therapeutics for up to US$ 2.4 billion in cash. The deal will give Lilly access to a new class of therapeutics, known as circular RNA, that allows patients’ own cells to generate therapies (to treat underlying diseases) inside the body, doing away with the need for cell extraction.
Among other deals, GSK acquired Canadian biotech 35Pharma for US$ 950 million in cash. The acquisition includes HS235, an investigational therapy being studied for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with heart failure with preserved ejection fraction. GSK’s stock was up 14 percent in February.
Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)
FDA approves Vanda’s antipsychotic pill Bysanti; Dupixent okayed for allergic fungal rhinosinusitis
The month saw several key approvals. The US Food and Drug Administration (FDA) approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) tablets, a first-line therapy for acute bipolar I disorder and schizophrenia. This marks the company’s third FDA approval in recent months.
The agency also approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults and pediatric patients with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. AFRS is a chronic inflammatory condition that can cause nasal polyps, persistent congestion, and loss of smell. This is Dupixent’s ninth FDA approval.
Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with paclitaxel, with or without bevacizumab, were approved for treating a form of ovarian cancer. This marks Keytruda’s first FDA approval in ovarian cancer.
Pfizer’s Braftovi (encorafenib) was granted full approval when used in combination with Erbitux (cetuximab) and fluorouracil-based chemotherapy to treat adults with a type of metastatic colorectal cancer. The combo therapy had received accelerated approval in 2024.
FDA also approved AbbVie’s supplemental new drug application for the combination regimen of Venclexta (venetoclax) and AstraZeneca’s Calquence (acalabrutinib) for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). Venclexta is manufactured by AbbVie and Genentech.
Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)
Lilly in another oncology deal with Innovent worth up to US$ 8.85 bn; Novo inks obesity deal with Vivtex
Lilly entered into a strategic collaboration with Chinese drugmaker Innovent Biologics to advance novel medicines in oncology and immunology. This is the seventh collaboration between the two drugmakers. Lilly will pay US$ 350 million upfront and as much as US$ 8.5 billion in milestone payments.
Madrigal Pharmaceuticals entered into a global license agreement with Suzhou Ribo Life Science and its subsidiary Ribocure Pharmaceuticals for six preclinical small interfering RNA programs targeting metabolic dysfunction-associated steatohepatitis (MASH). Madrigal will pay US$ 60 million upfront and US$ 4.4 billion in milestone payments.
Novo Nordisk has inked a deal worth up to US$ 2.1 billion with privately-held American company Vivtex Corp to develop next-generation oral drugs for obesity and diabetes.
Astellas Pharma (stock up 16 percent) has entered into a global strategic collaboration with Vir Biotechnology to advance a T-cell engager targeting prostate-specific membrane antigen and CD3 proteins for the treatment of prostate cancer. The deal involves an upfront payment, milestone payments and royalties that could together add up to US$ 1.7 billion.
There were also a few AI deals. Takeda Pharmaceutical has entered into a multi-year partnership that could be worth over US$ 1.7 billion with San Diego-headquartered Iambic to use AI to design small-molecule drugs for cancer and gastrointestinal diseases. And, Novartis (stock up 13 percent in February) signed a research collaboration and licensing deal worth up to US$ 1.8 billion with American biotech Unnatural Products (UNP) to develop therapeutics with potential applications in cardiovascular diseases. Novartis will license UNP’s AI-enhanced macrocycle platform.
Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)
Roche’s Gazyva scores phase 3 win in rare autoimmune kidney disorder; Novo’s CagriSema beats Wegovy
In a phase 3 trial, Roche’s Gazyva (obinutuzumab) met its primary endpoint, holding the potential to become the first approved therapy for primary membranous nephropathy, a rare autoimmune kidney disorder. According to top-line results, significantly more patients achieved complete remission at two years with Gazyva, compared to immunosuppressant tacrolimus.
Novo Nordisk said its experimental next-generation weight-loss drug CagriSema (cagrilintide and semaglutide) delivered greater reductions in body weight and blood sugar than its blockbuster Wegovy (semaglutide) in a late-stage trial in patients with type 2 diabetes. Novo has positioned CagriSema as a successor to Wegovy and a potential rival to Eli Lilly’s Zepbound (tirzepatide).
Eli Lilly’s Retevmo (selpercatinib), an FDA-approved drug for lung and thyroid cancers that have RET gene alterations, has demonstrated statistically significant improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive non-small cell lung cancer.
In a phase 3 trial, Bayer’s experimental blood thinner — asundexian — reduced the risk of recurrence of stroke by 26 percent. And Compass Pathways’ psilocybin-based therapy — COMP360 — eased symptoms in treatment-resistant depression. This is the second such late-stage trial win for the therapy.
Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)
Our view
The rapidly shifting geopolitical landscape, particularly the conflict in the Middle East and rising trade tensions, is adding a fresh layer of uncertainty for the industry. If the deal-making momentum and progress in clinical trials are maintained, we can safely assume that the innovation pipeline is resilient, the geopolitical turbulence notwithstanding.
Pharma & Biotech Newsmakers in February 2026
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