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STOCK RECAP #PipelineProspector

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Pipeline Prospector February 2026 highlights: Gilead buys Arcellx for US$ 7.8 bn; FDA okays Vanda’s psychotic pill
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 The month’s biggest acquisition was made by Gilead Sciences, which acquired its cancer therapy partner Arcellx for US$ 7.8 billion. The two companies have been collaborating on cell therapy development since 2022 through Kite Pharma, Gilead’s subsidiary. The centerpiece of the deal is Arcellx’s investigational CAR-T therapy for multiple myeloma — anitocabtagene autoleucel.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 rhinosinusitisThe 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 VivtexLilly 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 WegovyIn 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 viewThe 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. 

Impressions: 1547

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-february-2026-highlights-gilead-buys-arcellx-for-us-7-8-bn-fda-okays-vanda-s-psychotic-pill

#PharmaFlow by PHARMACOMPASS
05 Mar 2026

WEEKLY NEWS RECAP #Phispers

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Gilead buys Arcellx for US$ 7.8 billion; FDA approves Vanda’s antipsychotic pill for bipolar disorder, schizophrenia
In this week’s news, Gilead Sciences has entered into an agreement to acquire its cancer therapy partner Arcellx for US$ 7.8 billion. Gilead’s cell therapy subsidiary — Kite Pharma — has been working with Arcellx since 2022 on an investigational CAR T-cell therapy, which is the centerpiece of this deal.Novo Nordisk has entered into a US$ 2.1 billion deal with privately-held Vivtex Corp to develop next-generation oral drugs for obesity and diabetes. GSK has struck an up to US$ 1 billion licensing deal with Frontier Biotechnologies to obtain exclusive worldwide rights to develop, manufacture, and commercialize two small interfering RNA (siRNA) pipeline products that target kidney diseases. And Astellas Pharma has entered into global strategic collaboration with Vir Biotechnology to advance a treatment for prostate cancer. The deal is worth up to US$ 1.7 billion.The week saw several approvals granted by the US Food and Drug Administration (FDA). The agency approved Vanda Pharmaceuticals’ Bysanti (milsaperidone), a first-line therapy for acute bipolar I disorder and schizophrenia in adults. The agency also granted full approval to Pfizer’s Braftovi (encorafenib) in combination with Erbitux (cetuximab) and fluorouracil-based chemotherapy for the treatment of adult patients with a type of metastatic colorectal cancer (mCRC). The combo therapy had received accelerated approval in 2024.FDA granted Sanofi and Regeneron’s Dupixent its ninth approval — this time to treat adult and pediatric patients aged six years and older with a chronic inflammatory condition known as allergic fungal rhinosinusitis (AFRS).FDA also approved another combination regimen — of AbbVie’s Venclexta (venetoclax) and AstraZeneca’s Calquence (acalabrutinib) — for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). And Eton Pharmaceuticals’ liquid therapy — Desmoda (desmopressin) — for the management central diabetes insipidus also clinched an FDA approval.Gilead buys Arcellx for US$ 7.8 billion for its multiple myeloma CAR-T therapyGilead Sciences has entered into an agreement to acquire its cancer therapy partner Arcellx for US$ 7.8 billion. The two companies have been in a cell therapy development collaboration since 2022 through Kite Pharma, Gilead’s cell therapy subsidiary. Kite has been co-developing and co-commercializing Arcellx’s lead candidate anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy for patients with multiple myeloma. Anito-cel is the centerpiece of this deal.FDA approves Vanda’s antipsychotic pill for bipolar I disorder, schizophreniaFDA has approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) tablets, a first-line therapy for two mental health conditions — acute bipolar I disorder and schizophrenia. Bysanti is a new chemical entity (NCE), and an atypical antipsychotic. It works by blocking dopamine and serotonin receptors in the brain, which help regulate mood, stress, delusions, and alertness. This is the third FDA approval won by the company in recent months.Dupixent okayed for allergic fungal rhinosinusitis: FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adult and pediatric patients aged six years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. This is Dupixent’s ninth FDA approval. AFRS is a chronic inflammatory condition that can cause nasal polyps, persistent congestion, thick mucus, and loss of smell. FDA evaluated Dupixent under priority review for the treatment of AFRS, and it is the first treatment approved for the condition. Novo inks up to US$ 2.1 bn deal with Vivtex for its next-gen obesity, diabetes drugsEarlier this week, there was news that Novo Nordisk’s next-generation obesity drug CagriSema (cagrilintide and semaglutide) underperformed Eli Lilly’s Zepbound (tirzepatide) in a head-to-head trial. Novo didn’t let the setback weigh it down. It quickly struck an up to US$ 2.1 billion deal with privately-held American company Vivtex Corp to develop next-generation oral drugs for obesity and diabetes. Under the partnership, Vivtex will license some of its oral drug-delivery technology, while Novo Nordisk will take charge of global development and commercialization. The deal covers research funding, milestone payments, and tiered royalties on product sales.Frontier strikes up to US$ 1 billion deal with GSK: Frontier Biotechnologies has struck an exclusive licensing agreement with GSK. Under the terms of the agreement, GSK will obtain exclusive worldwide rights to develop, manufacture, and commercialize two of Frontier Biotechnologies’ small interfering RNA (siRNA) pipeline products that target kidney diseases.Astellas ties up with Vir Biotech: Astellas Pharma has entered into global strategic collaboration with Vir Biotechnology to advance a T-cell engager targeting prostate-specific membrane antigen (PSMA) 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.FDA okays Venclexta-Calquence combo for untreated chronic lymphocytic leukemiaAbbVie has said FDA has approved a supplemental new drug application (sNDA) 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 (a member of the Roche group).Pfizer’s Braftovi combo regimen gets full approval: FDA has granted full approval to Braftovi (encorafenib) in combination with Erbitux (cetuximab) and fluorouracil-based chemotherapy for the treatment of adult patients with a type of metastatic colorectal cancer. The combo therapy had received accelerated approval in 2024.FDA approves Eton’s liquid therapy for managing central diabetes insipidusFDA has okayed Eton Pharmaceuticals’ liquid therapy  — Desmoda (desmopressin) — for the management of a rare hormonal disorder, known as arginine vasopressin deficiency (AVP-D), or central diabetes insipidus. In AVP-D, patients lack the hormone that regulates water balance, causing excessive urination and thirst. This is the first-of-its-kind liquid therapy for AVP-D.Zepbound KwikPen okayed: FDA has approved a label expansion for Eli Lilly’s Zepbound (tirzepatide) to include the four-dose single-patient-use KwikPen that delivers a full month of treatment in one device. Rival Novo Nordisk has been selling its weight loss drug Wegovy (semaglutide) as a single-dose weekly auto-injector pen in the US since 2021.Gossamer’s pulmonary arterial hypertension drug fails late-stage trialGossamer Bio’s experimental treatment seralutinib, which is an inhaled drug, failed to significantly improve exercise capacity in patients with the rare lung condition known as pulmonary arterial hypertension (PAH) in a late-stage study. PAH is caused by constriction of the arteries in the lungs, which leads to high blood pressure.FDA proposes framework to speed up personalized gene therapy approvalsFDA has proposed a new framework to speed up approvals of personalized treatments for rare and life-threatening genetic diseases. It offers clearer rules for drugmakers to develop genome-editing and RNA-based drugs while requiring them to justify why randomized controlled trials are not feasible.

Impressions: 948

https://www.pharmacompass.com/radio-compass-phisper/gilead-buys-arcellx-for-us-7-8-billion-fda-approves-vanda-s-antipsychotic-pill-for-bipolar-disorder-schizophrenia

#Phispers by PHARMACOMPASS
26 Feb 2026

NEWS #PharmaBuzz

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https://www.pfizer.com/news/press-release/press-release-detail/pfizers-braftovi-regimen-nearly-doubles-median-progression

PRESS RELEASE
31 May 2026

https://www.prnewswire.com/news-releases/pierre-fabre-laboratories-receives-chmp-positive-opinion-for-braftovi-encorafenib-in-combination-with-cetuximab-and-folfox-fluorouracil-leucovorin-and-oxaliplatin-for-the-first-line-treatment-of-adult-patients-with-brafv600-302781057.html

PR NEWSWIRE
26 May 2026

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation

FDA
26 Feb 2026

https://www.pharmiweb.com/press-release/2026-02-24/us-fda-grants-full-approval-to-pfizer-s-braftovi-combination-regimen-in-first-line-metastatic-colo

PHARMIWEB
25 Feb 2026

https://www.businesswire.com/news/home/20260122091904/en/Guardant-Health-Receives-FDA-Approval-for-Guardant360-CDx-as-Companion-Diagnostic-for-BRAFTOVI-encorafenib-Combination-in-Patients-with-BRAF-V600E-Mutant-Metastatic-Colorectal-Cancer

BUSINESSWIRE
22 Jan 2026

https://www.indianpharmapost.com/clinical-trials/pfizers-braftovimektovi-shows-sustained-long-term-survival-in-patients-with-advanced-lung-cancer-18042

INDPHARMAPOST
22 Oct 2025