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KalVista Secures FDA Approval for First Oral On-Demand Hereditary Angioedema Treatment

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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).”

HHS Workforce Turmoil Raises Strategic Concerns for U.S. Health Infrastructure

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SHERIDAN, WYOMING – July 8, 2025 – The U.S. Department of Health and Human Services (HHS) faces a period of unprecedented operational uncertainty following sweeping layoffs and partial reinstatements under Health Secretary Robert F. Kennedy Jr., with federal court intervention highlighting the legal and logistical chaos surrounding the department’s restructuring.

Biopharma’s Last Stand in TIGIT: Four Companies Betting on Differentiation and Data

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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

AI-Driven Pharmacogenetics Poised to Reshape Drug Development and Rebuild Industry Trust

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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.

CAR T REMS Removal Poised to Expand Market and Democratize Access

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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.

FDA Greenlights Neurogene’s ‘Best-Case Scenario’ Pivotal Trial Design for Rett Syndrome Gene Therapy

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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.”

Argenx and UNP Forge $1.5B Macrocyclic Peptide Alliance to Target ‘Undruggable’ Diseases

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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

Protagonist Targets Obesity Market with Flexible Oral Triple-G Agonist PN-477

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SHERIDAN, WYOMING – July 1, 2025 – Protagonist Therapeutics has stepped into the fiercely competitive obesity treatment landscape by nominating PN-477, an innovative triple agonist therapy, aiming to deliver flexibility in dosing and a differentiated profile among next-generation anti-obesity drugs.

Pfizer Terminates Phase II Maplirpacept Trial Amid Recruitment Struggles, Keeps Focus on Blood Cancer Pipeline

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SHERIDAN, WYOMING – July 1, 2025 – Pfizer has announced the termination of its Phase II trial evaluating the investigational CD47-targeting fusion protein maplirpacept in diffuse large B-cell lymphoma (DLBCL), citing persistent recruitment difficulties that prevented the study from meeting enrollment targets.

Pharma M&A Reignites in June, Signaling Renewed Momentum Despite Regulatory Headwinds

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SHERIDAN, WYOMING – July 1, 2025 – A late surge of acquisitions in June has reenergized pharmaceutical M&A activity, with six major deals announced that propelled first-half 2025 totals to 32 transactions across the industry. This burst of dealmaking, highlighted by BioNTech’s $1.25 billion acquisition of CureVac and Eli Lilly’s $1.3 billion buyout of Verve Therapeutics, has analysts optimistic that the sector’s cautious stance may finally be easing.

Resilient M&A Amid Regulatory Uncertainty