Celcuity Inc. is stepping into the commercial market with its first U.S. FDA approval. The agency cleared gedatolisib, branded Revtorpyk, as the first PAM pathway inhibitor to treat patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting. While the company highlighted its commercial preparations and plans for potentially expanding Revtorpyk into other cancer indications, Wall Street focused on what it viewed as a delayed launch, expected in late third quarter 2026, sending shares of Celcuity (NASDAQ:CELC) down nearly 20% at midday, and marking the second time in two months the company has failed to generate investor excitement despite positive news.

CDC nominee’s qualifications shadowed by Kennedy agenda

U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored today as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response. Several committee members referenced the fact that, in the past 18 months, the CDC has only had a confirmed director for 29 days. And that director was fired for standing up to Kennedy in support of science. While they considered Erica Schwartz well qualified to lead the CDC, they questioned whether Kennedy would let her run the agency without interference.

Hansoh takes newco route to globalize IL-23 asset

Hansoh Pharmaceutical Group Co. Ltd. has taken a new step in the evolution of China’s “newco” strategy, combining its newly created U.S. company, Avere Therapeutics Inc., with Nasdaq-listed Nextcure Inc. in a deal designed less to merge pipelines than to create a public vehicle for global development of a China-originated asset. Unlike many recent China licensing deals, Shanghai-based Hansoh is not simply handing off overseas rights. It will remain a major shareholder, hold board seats and serve as a strategic partner while collecting up-front payments, milestones and royalties via a structure that gives it far more influence over global development than a traditional out-licensing agreement. The transaction underscores how China’s biotech sector is moving beyond conventional licensing agreements toward more sophisticated capital-market structures. Rather than sell an asset to a multinational pharma company, Hansoh has built an overseas development company around HS-20118 (AVR-001), using Nextcure’s Nasdaq listing and a $320 million financing to accelerate global clinical development.

Women’s health investment climbs but funding challenges remain

There is no doubt that investment into women’s health is increasing. According to a new report by W Group, in 2025, $1.55 billion in disclosed equity was raised by 85 women’s health companies, across more than 30 countries. The top areas to attract investment include oncology, fertility & ART, maternal health, menopause and sexual & reproductive health. However, challenges remain including a gap in funding between seed and series A rounds, limited exit opportunities and investment in areas such as cardiovascular diseases, the leading cause of death in women.

GABA signaling linked to immune resistance in some tumors

Certain cancers that contain organized clusters of immune cells known as tertiary lymphoid structures (TLS) do not respond to treatment as well as expected. Even though they have TLS that support the elimination of cancer cells, they remain resistant to immunotherapy. γ-Aminobutyric acid (GABA), better known as the brain’s major inhibitory neurotransmitter, may play a role in this lack of response by acting as an immunoregulatory metabolite, according to a study led by scientists at Sorbonne Université. “It was a surprise for us because neuromediators usually are not there,” co-senior author Wolf-Herman Fridman told BioWorld. Some papers have suggested that they may modulate immune reactions, but “what were they doing there with such a strong impact on resistance to immunotherapy?” Fridman asked.

FTC settling with CVS’ PBM

In an effort to drive down out-of-pocket costs for Americans, the U.S. FTC is resolving an antitrust case through a proposed second settlement with a large pharmacy benefit manager (PBM) and its affiliates. Through a consent order settling the case with Caremark Rx LLC and Zinc Health Services LLC, part of CVS Health Corp., the agreement would delink PBM fees from drug list prices and improves transparency, allowing retail community pharmacies the ability to shift to a cost-plus reimbursement model. In February, the FTC agreed to a similar settlement with Cigna Group’s Express Scripts Inc. and its affiliates. A case against a third PBM, OptumRx, has been withdrawn from adjudication to consider a proposed consent agreement.

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