Biotech news, week of September 28, 2026

Machine summary Biossil's reported $153 million all-equity round, led by OpenAI's Startup Fund, values the three-year-old Toronto startup at $1 billion. The round follows a $43 million co-led financing a year earlier, and a recent filing set new preferred shares at $28.69, triple last year's price.

1. The Globe and Mail reported that OpenAI led a US$153-million all-equity financing of Biossil Inc., with the OpenAI Startup Fund providing the majority; the round values Biossil at US$1-billion.
2. Biossil's prior venture rounds include a $3.7M seed led by Staircase Ventures in 2023, a US$22M round led by Founders Fund in 2024, and a US$43M round co-led by OpenAI and Founders Fund about a year ago.
3. An August Corporations Canada filing created 5.37 million preferred shares valued at US$28.69 each, triple the share value of last year's financing.
4. Existing investors participating include Founders Fund, Quiet Capital, Modern Capital, Golden Ventures, Panache Ventures, Duke University's endowment fund, and Abu Dhabi Investment Council.

Reported by The Globe and Mail.

• OpenAI
• Founders Fund
• OpenAI Startup Fund
• Quiet Capital
• Panache Ventures
• Biossil Inc.

Reports ran between 07:30 and 08:00 UTC on Sep 29.

The outlets that reported this event are listed with links to their reports; no summary of ours passed our automated checks for it, which says nothing about the event (how they work).

Reported by The Hindu and cobrapost.com.

• India
• Specialty Drugs

Machine summary Unicycive Therapeutics announced the resubmission of its New Drug Application for oxylanthanum carbonate, an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. According to the company, the resubmission contains CMC data supplied by a new third-party vendor that manufactures the drug product.

1. Unicycive Therapeutics announced the resubmission of its NDA for oxylanthanum carbonate, according to the company.
2. Per the company, the NDA resubmission includes CMC data supplied by a new third-party vendor that manufactures the drug product.
3. According to the company, the FDA last inspected the new vendor's facility in March 2024, and it received "No Action Indicated" status.
4. According to the company, the FDA neither raised concerns about clinical efficacy or safety data nor asked the company for additional data.

Reported by manilatimes.net and Insider Monkey.

• Unicycive Therapeutics
• Oxylanthanum Carbonate

Machine summary OS Therapies has named Kerry Clem CCO and Frank Knuettel II CFO as it builds commercial and financial infrastructure ahead of planned MHRA, FDA, and EMA filings for Herlystic in osteosarcoma. OS Therapies appointed Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer.

1. OS Therapies appointed Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer on October 1, 2026.
2. OS Therapies is pursuing a MHRA Conditional Marketing Authorization Application under Project Orbis via ILAP, with submission targeted for early Q4 2026.
3. The company also plans a U.S. Biologics License Application under the Accelerated Approval pathway and a Conditional Marketing Authorization Application in Europe in parallel.
4. Herlystic is an immunotherapy under investigation, intended to prevent or delay recurrence among patients whose pulmonary metastatic osteosarcoma has been fully resected.

Reported by finanznachrichten.de and Seeking Alpha.

• MHRA
• OS Therapies, Inc.
• Herlystic

Machine summary A federal judge in Delaware ruled that two claims of U.S. Patent 11,826,327 are valid, according to reports. According to Liquidia, it intends to request that the FDA take the indication off Yutrepia's label, and its chief executive stated the company stands ready to seek options on appeal.

1. Reports indicate that a federal judge determined that U.S. Patent 11,826,327 has two claims that are valid.
2. The reports said United Therapeutics sought an injunction aimed at limiting how available Yutrepia would be.
3. The reports said Liquidia stated that it cannot reasonably estimate possible damages at present and that it intends to request the FDA take the indication off Yutrepia's label.
4. Liquidia chief executive Roger Jeffs said the company respectfully disagrees and is fully prepared to pursue all available appellate options, according to the reports.

Reported by 247wallst.com and aol.com.

• United Therapeutics
• Yutrepia
• U.S. Patent 11,826,327
• Liquidia Corporation

Machine summary Lenacapavir PrEP had zero HIV infections in a trial with more than 2,000 participants. Gilead's US price is $28,000, compared with $40 generics. A report title asks who gets access. WHO made a recommendation and MSF advocated.

1. The World Health Organization has recommended lenacapavir as an additional long-acting injectable form of pre-exposure prophylaxis (PrEP).
2. International HIV funding fell 18 percent in 2025 to $7.3 billion, the lowest level in nearly two decades, according to UNAIDS.
3. Lenacapavir costs about $28,000 per person annually in the US.
4. MSF global HIV lead Carlota Baptista da Silva called lenacapavir 'the closest we have [to] a vaccine.'

Reported by Al Jazeera and grenadachronicle.com.

• World Health Organization
• UNAIDS
• Lenacapavir

Machine summary The ASAC trial found no benefit of aspirin after curative-intent treatment of colorectal cancer liver metastases, according to Newswise. The trial was designed to determine whether aspirin could reduce recurrence risk.

1. The ASAC trial found no benefit of aspirin after treatment of colorectal cancer liver metastases, according to Newswise.

Reported by Newswise and Google News.

• Aspirin
• Colorectal cancer liver metastases
• Newswise
• ASAC trial