--- title: "FDA Approvals and Earnings Beats Propel Specialized US-Listed Firms" type: "News" locale: "en" url: "https://longbridge.com/en/news/293841305.md" description: "A diverse cohort of US-listed companies reported critical milestones recently. Several biotech firms secured FDA approvals, while established players like Crown Holdings and RingCentral delivered better-than-expected second-quarter earnings and raised their full-year guidance." datetime: "2026-07-26T09:14:34.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/293841305.md) - [en](https://longbridge.com/en/news/293841305.md) - [zh-HK](https://longbridge.com/zh-HK/news/293841305.md) --- # FDA Approvals and Earnings Beats Propel Specialized US-Listed Firms US-listed companies across the biotech, enterprise software, and packaging sectors reported robust quarterly results and secured crucial regulatory approvals this month, signaling strong operational momentum despite broader market shifts, according to recent company filings and statements. ### Replimune Group (REPL.US) Replimune is targeting an August 2026 FDA action date for its RP1 and nivolumab combination therapy for advanced melanoma. According to company filings, the FDA accepted the resubmission of its biologics license application in late June. The clinical-stage biotech presented IGNYTE trial data at ASCO, showing a 47.8% three-year overall survival rate, though its shares have experienced recent volatility ahead of an expected advisory committee meeting. ### Celcuity (CELC.US) Celcuity secured FDA approval on July 14, 2026, for its cancer therapy Revtorpyk (gedatolisib), targeting advanced breast cancer, according to the regulatory agency. The approval marks the first therapy inhibiting all Class I PI3K isoforms. However, the company's stock experienced a recent pullback after management indicated the commercial launch would likely be delayed until later in the third quarter. ### Outlook Therapeutics (OTLK.US) Outlook Therapeutics received FDA approval for LYTENAVA on July 24, 2026, marking the first ophthalmic formulation of bevacizumab for wet AMD, according to regulatory filings. The stock trended upward following the announcement. The company is actively preparing for its commercial launch later this year, having secured a strategic partnership with Cencora. ### Eterna Therapeutics (ERNA.US) Eterna Therapeutics expects to submit an investigational new drug application for its lead cell therapy candidate, ERNA-101, in the third quarter of 2026. The company recently released preclinical data validating the therapy's anti-tumor activity when combined with PD-1 inhibitors, maintaining its pipeline progress despite recent sector-wide consolidation. ### Crown Holdings (CCK.US) Crown Holdings posted second-quarter 2026 revenue of USD 3.67 billion, topping the USD 3.37 billion average analyst estimate. The packaging supplier raised its full-year adjusted earnings forecast to a range of USD 8.30 to USD 8.50 per share, citing a 5% increase in global beverage can volumes. Following the results, the shares reached a 52-week high recently. ### RingCentral (RNG.US) RingCentral reported second-quarter 2026 revenue of USD 657 million, beating estimates, largely driven by AI tool sales that doubled over the past year. AI solutions now account for 13% of its annual recurring revenue, according to the company. The communications software provider raised its full-year guidance and increased its quarterly dividend by 67%. ### ICICI Bank (IBN.US) ICICI Bank reported a 15.9% year-over-year increase in first-quarter fiscal 2027 net profit to INR 148.05 billion, according to its July earnings release. The major Indian lender maintained a stable net interest margin and recently raised USD 1 billion through its maiden dollar bond issuance. The stock has demonstrated resilience, outperforming broader market indices recently. ### Singapore Telecommunications (SGAPY.US) Singtel is evaluating the creation of a real estate investment trust to fund its data center and AI expansion, according to people familiar with the matter. The telecommunications giant recently divested a 2.8% stake in Thailand's Gulf Development for approximately USD 1 billion to recycle capital, even as the company navigated executive compensation cuts following network outages. ### Trident Digital Tech (TDTH.US) Trident Digital Tech announced plans to terminate its depositary receipt program with Citibank in mid-July 2026. Simultaneously, the Singapore-based IT services firm is expanding its digital infrastructure footprint in Africa, announcing a 20-year public-private partnership in the Democratic Republic of Congo and an investment in Ghana's Sikaflow platform. ### XFLH Capital (XFLH.US) XFLH Capital Corporation completed its USD 100 million initial public offering in February 2026, pricing 10 million units at USD 10.00 each, according to its prospectus. The special purpose acquisition company, incorporated in the Cayman Islands, is actively seeking business combinations and its units are currently trading on the New York Stock Exchange. _This article does not constitute investment advice._ ### Related Stocks - [REPL.US](https://longbridge.com/en/quote/REPL.US.md) - [CELC.US](https://longbridge.com/en/quote/CELC.US.md) - [OTLK.US](https://longbridge.com/en/quote/OTLK.US.md) - [ERNA.US](https://longbridge.com/en/quote/ERNA.US.md) - [CCK.US](https://longbridge.com/en/quote/CCK.US.md) - [RNG.US](https://longbridge.com/en/quote/RNG.US.md) - [IBN.US](https://longbridge.com/en/quote/IBN.US.md) - [SGAPY.US](https://longbridge.com/en/quote/SGAPY.US.md) - [TDTH.US](https://longbridge.com/en/quote/TDTH.US.md) - [XFLH.US](https://longbridge.com/en/quote/XFLH.US.md) ## Related News & Research - [Is Crown Holdings (CCK) Cheap After Strong Earnings, A Dividend, And Buybacks?](https://longbridge.com/en/news/293925095.md) - [Singtel confirms talks with multiple parties over potential Optus stake sale](https://longbridge.com/en/news/294278178.md) - [Major Insider Move Signals Growing Confidence in Outlook Therapeutics](https://longbridge.com/en/news/294298016.md) - [Moody’s assigns Baa3 rating to ICICI Bank USD senior unsecured notes](https://longbridge.com/en/news/293762507.md) - [16:05 ETCROWN HOLDINGS, INC. 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