FDA Approval and Launch Readiness of Paltusotine (PALSONIFY)
Crinetics' NDA for paltusotine (PALSONIFY) remains on track with an anticipated FDA approval in September 2025.
The company has assembled a highly experienced launch team and is preparing for a transformational market entry.
Engagement with patient communities and advocacy groups has reinforced confidence that PALSONIFY addresses a critical unmet need in acromegaly treatment.
The launch is expected to be gradual, with formulary placement taking 6-9 months post-approval and patient adoption aligning with infrequent endocrinologist visits (2-4 times/year).
Commercial preparations include a dedicated sales force of approximately 30 representatives and ongoing payer discussions emphasizing PALSONIFY's value proposition of rapid disease control and convenience.
Crinetics is actively working on international expansion, targeting a European launch in 2026.
ANI achieved all-time highs in net revenue, adjusted non-GAAP EBITDA, and EPS in Q2 2025, driven by strong growth across Rare Disease and Generics units.
The company highlighted broad momentum, with Rare Disease demand accelerating, especially for Cortrophin Gel, and positive results in their retina franchise.
Management emphasized that the quarter's performance was driven by underlying demand rather than seasonality or one-time benefits, with new patient starts more than doubling year-over-year.
Expansion of ATTR-CM Study and Its Strategic Implications
The expansion does not impact the previously projected enrollment timeline or cash runway, demonstrating operational efficiency and financial prudence.
The increased enrollment is expected to provide more definitive evidence of nex-z’s efficacy both as a monotherapy and in combination with stabilizers, which is a key market differentiator.
Management emphasizes that this strategic move aligns with their goal of multiple prospective launches by 2030, reinforcing their long-term market strategy.
Cash and equivalents totaled $580 million, with an additional $170 million in committed government funding, providing total available liquidity of around $750 million.
General and administrative expenses were approximately $19 million, down from $20 million, including ongoing intellectual property defense costs.
Net loss for the quarter was roughly $35 million, an improvement from a $37 million loss in Q2 2024.
Research and development expenses were about $39 million, slightly lower than the previous year by $2 million due to timing of program-specific expenses.
Revenue for Q2 2025 was approximately $17 million, up from $7 million in Q2 2024, driven by a $10 million lump sum licensing fee from the Trianni platform.
Sales and marketing expenses decreased slightly to $3 million compared to the prior year.
Adjusted EBITDA was $14.5 million, a 24% increase year-over-year, with adjusted EPS of $0.05 for the quarter.
Adjusted gross margin improved by 140 basis points to 71.5%, reflecting operational efficiencies and favorable test mix.
Average revenue per test grew 2% year-over-year, driven by favorable test mix, sales targeting, revenue cycle projects, and expanding payer coverage.
GeneSight revenue declined 12% year-over-year due to UnitedHealthcare coverage changes but volume growth rebounded to 5% in Q2.
Hereditary cancer testing revenue grew 9% year-over-year, with oncology channel volume up 14%.
Myriad Genetics reported Q2 2025 revenue of $213 million, a 5% increase year-over-year excluding impacts from UnitedHealthcare's GeneSight coverage decision and the divested European EndoPredict business.
Prenatal revenue grew 7% year-over-year despite a 7% volume decline due to order management system issues, which have since been resolved.
Prolaris revenue grew 4% year-over-year, with volume up 6% sequentially from Q1 2025.
The company recognized a noncash goodwill and intangible impairment charge of $317 million due to market capitalization decline, excluded from non-GAAP EPS.
Adjusted EBITDA was $10.7 million, down 2% from prior year, impacted by Pathline acquisition ramp; excluding Pathline, adjusted EBITDA grew 13%.
Adjusted gross profit improved by $4.6 million or 6% over prior year.
Cash flow from operations was positive $20 million, up 44% year-over-year, with cash and marketable securities ending at $164 million.
Clinical revenue grew 16% year-over-year with organic clinical revenue up 13%, driven by a 10% increase in test volumes and a 3% increase in average unit price (AUP).
NeoGenomics reported Q2 2025 revenue of $181 million, representing 10% year-over-year growth but slightly below guidance.
NGS testing accounted for 32% of total clinical revenue and grew 23%, slightly below the 25% target but above market growth rates.
Nonclinical revenue declined 26% year-over-year due to weakness in pharma and biotech customer demand.
The company retired $201 million of convertible notes in Q2, significantly reducing debt.