Pharmaceuticals & Biotech

SHERIDAN, WYOMING – July 8, 2025 – BrainStorm Cell Therapeutics is once again at the center of the amyotrophic lateral sclerosis (ALS) treatment debate as patients formally petition the FDA to reconsider the approval of its investigational stem cell therapy, NurOwn. Citing new survival data and expanded access outcomes, the Citizens’ Petition seeks regulatory reassessment of the once-rejected therapy, underscoring the shifting landscape of ALS drug development and patient advocacy.

Renewed Push for Regulatory Reevaluation

SHERIDAN, WYOMING – July 8, 2025 – Regeneron has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody linvoseltamab, now branded as Lynozyfic, for the treatment of patients with relapsed or refractory multiple myeloma—unlocking a market potential estimated at $600 million.

SHERIDAN, WYOMING – July 8, 2025 – In a landmark agreement that underscores the growing convergence of artificial intelligence and drug discovery, Tokyo-based Chugai Pharmaceutical has entered into a multi-phase research collaboration with Singapore-headquartered biotech Gero to target age-related diseases using AI-driven insights. The deal could exceed $1 billion in total value, positioning both companies at the forefront of longevity-focused pharmaceutical innovation.

AI-Powered Discovery for High-Impact Biologics

SHERIDAN, WYOMING – July 8, 2025 – Cogent Biosciences is accelerating its strategic trajectory with plans to submit its first New Drug Application (NDA) to the FDA by year-end, following strong Phase II data for its investigational tyrosine kinase inhibitor, bezuclastinib. The move positions Cogent as a serious contender in the systemic mastocytosis treatment landscape, directly challenging Blueprint Medicines' market presence.

Strategic Differentiation in a Competitive Field

SHERIDAN, WYOMING – July 8, 2025 – KalVista Pharmaceuticals has received U.S. FDA approval for its oral treatment Ekterly (sebetralstat), marking a major milestone as the first and only on-demand tablet therapy for hereditary angioedema (HAE) in patients aged 12 and older.

The company confirmed that the drug will be available in the U.S. “immediately” under the brand name Ekterly. According to KalVista’s press release, it is “the first and so far only oral and on-demand treatment for hereditary angioedema (HAE).”

SHERIDAN, WYOMING – July 8, 2025 – The TIGIT immunotherapy landscape has thinned dramatically amid a string of late-stage failures and corporate exits, yet several biopharma players remain committed to unlocking its clinical promise—driven by differentiated approaches and early signals of efficacy. AstraZeneca, Gilead, Agenus, and Mereo BioPharma are now at the forefront of this once-promising immuno-oncology frontier, recalibrating strategies in a space shaped by volatility and unmet potential.

AstraZeneca Bets Big on Dual Checkpoint Innovation

SHERIDAN, WYOMING – July 8, 2025 – A confluence of artificial intelligence and genomics is creating a critical inflection point for the pharmaceutical industry—offering a long-awaited opportunity to reduce adverse drug reactions, improve clinical outcomes, and restore public trust in a sector burdened by scrutiny and skepticism.

SHERIDAN, WYOMING – July 1, 2025 – The U.S. Food and Drug Administration’s recent decision to remove Risk Evaluation and Mitigation Strategies (REMS) from approved CAR T cell therapies marks a pivotal shift that could reshape access to these potentially curative treatments and drive significant market expansion across the cell and gene therapy industry.

SHERIDAN, WYOMING – July 1, 2025 – Neurogene has reached alignment with the FDA regarding the design of a registrational study for the investigational gene therapy NGN-401 for Rett Syndrome, enabling the company to convert its current Phase I/II study into a pivotal trial—a milestone that analysts describe as the “best-case scenario.”

SHERIDAN, WYOMING – July 1, 2025 – Argenx has taken a decisive step to diversify its pipeline beyond its flagship FcRn blocker, signing a multi-target research agreement with Unnatural Products, Inc. (UNP) that could exceed $1.5 billion. The deal aims to harness UNP’s proprietary macrocyclic peptide technology to develop oral therapies for disease targets historically deemed “undruggable,” marking the largest licensing transaction to date in the macrocyclic peptide space.

Strategic Expansion Beyond FcRn Blockade