Crinetics Pharmaceuticals, Inc. (CRNX) filed a Marketing Authorization Application (MAA) with Brazil’s National Health Surveillance Agency (ANVISA) for its once‑daily oral therapy PALSONIFY (paltusotine) on March 26, 2026. The filing marks the first regulatory step toward making the drug available to patients with acromegaly in Brazil, extending the company’s reach beyond the United States and Europe.
The MAA is supported by data from 18 clinical trials, including two Phase 3 studies that met all primary and secondary endpoints. PALSONIFY is already approved in the U.S. and has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The global prevalence of acromegaly is estimated at around 60,000 cases, underscoring the potential impact of a new oral therapy in emerging markets.
Brazil represents a significant opportunity for Crinetics, with an estimated acromegaly patient population that, while not specified in the filing, is part of the broader global market. The submission signals the company’s intent to tap into this patient base and accelerate revenue generation as PALSONIFY gains market access in key emerging markets.
Crinetics’ recent financial results highlight the commercial momentum behind PALSONIFY. In the fourth quarter of 2025, the company generated $6.2 million in total revenue, of which $5.4 million came from PALSONIFY net product sales, compared with $0.0 million in the same quarter of 2024. Full‑year 2025 revenue reached $7.7 million, up from $1.0 million in 2024, while net loss widened to $465.32 million from $298.41 million. Cash stood at $1.0 billion as of December 31, 2025, down from $1.4 billion the previous year. Management has guided 2026 operating expenses to $600 million–$650 million, reflecting continued investment in commercialization and infrastructure.
CEO Scott Struthers said, “The submission of our MAA for Palsonify in Brazil represents another important global milestone for this important therapy.” He added, “Once‑daily, oral Palsonify is redefining the treatment paradigm as the next generation of acromegaly care in the U.S., following its approval by the FDA.” In a February 2026 earnings call, Struthers noted that 2025 was a breakout year for Crinetics, as the approval and launch of Palsonify demonstrated the company’s ability to bring an innovative therapy from concept to patients.
Beyond PALSONIFY, Crinetics is advancing a pipeline that includes atumelnant for Cushing’s syndrome, CRN09682 for neuroendocrine tumors, and other endocrine and oncology candidates. The company also maintains a partnership with Sanwa Kagaku Kenkyusho for the development and commercialization of paltusotine in Japan, positioning it for a broader global launch strategy.
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