July 7, 2025

The need-to-know this morning

The FDA approved a pill from KalVista Pharmaceuticals that treats patients suffering from acute attacks of hereditary angioedema, a painful tissue-swelling disorder. The drug will be marketed under the brand name Ekterly.
Cogent Biosciences reported results from a Phase 3 study of bezuclastinib in indolent systemic mastocytosis, the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.
Jasper Therapeutics said it is investigating a potential manufacturing defect that may have caused its experimental drug briquilimab to lose potency and affect the results of a mid-stage clinical trial.

REGULATION

FDA morale crisis deepens amid a staff exodus

About one in five FDA staffers were pushed out of the agency in April as part of the Trump administration's cuts, and talent has continued to leave since then, tanking morale, STAT's Lizzy Lawrence reports exclusively. Staffing shortages, political upheaval, and distrust in leadership are taking a toll on the FDA's ability to regulate drugs, devices, and food.

Employees describe a chaotic environment at the agency under Commissioner Marty Makary and Chief Medical and Scientific Officer Vinay Prasad, one in which they contend scientific expertise is sidelined and review timelines are missed. While Makary insists morale is improving, 10 of 15 employees who spoke with STAT are actively job-hunting.

"Everything seems to happen very capriciously," one employee said. "There's no sense of stability, and every time you've turned around someone is leaving."

china

Regulatory chill threatens to dampen new investment

The FDA recently announced it would tighten scrutiny of U.S. clinical trials involving Chinese cell therapies — and would reward companies aligned with national health priorities. Though the immediate impact may be limited, the broader message is chilling, STAT contributor Brian Yang writes: Geopolitical tensions are creeping into scientific regulation.

Experts warn the shift could stall cross-border dealmaking, push Chinese firms to go it alone, and move biotech innovation further toward China's domestic market.

"We're seeing this trend of national security as a key term working into a lot of these policies, not just the Department of Justice, but also FDA," said Xin Tao, a health care regulatory expert who is a partner at the law firm Baker McKenzie. "This is something I think is relatively new and subject to interpretations, and this will likely have a chilling effect on how you do business going forward."

dermatology

Apogee reports first data on long-acting eczema drug

Apogee Therapeutics said this morning that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.

The Apogee drug, called APG777, showed similar skin-clearance rates compared to two, antibody treatments already on the market: Sanofi and Regeneron's Dupixent and Ebglyss from Eli Lilly, STAT's Adam Feuerstein reports. If shown to be safe and effective in later clinical trials, however, APG777 could be a more convenient option for patients.

venture capital

Khosla Ventures sets sights on $4 billion in new funds

From my colleague Allison DeAngelis: Khosla Ventures, hoping to rake in more big bucks, has filed paperwork to raise close to $4 billion across three new funds.

The Menlo Park, Calif., VC firm hopes to raise $750 million for a fund focused on seed-stage investments, $1.25 billion for what's known as an opportunity fund — these funds generally center on companies that are growing and in which the firm has already invested — and $1.95 billion for its ninth namesake venture fund.

Khosla has invested in a handful of biotech companies this year, including gene therapy company Stylus Medicine and Vivodyne, which is developing lab-grown, AI-assisted replicas of human tissues to aid in developing and testing new medicines. But keep in mind: Khosla doesn't focus solely on biotech investing. The firm was founded by Vinod Khosla, who made his name at the tech company Sun Microsystems. His investment firm backs startups in the tech, retail, and sustainability sectors, as well as drug and health tech companies.

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