Strategic Signals Weekly

The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Zynyz (retifanlimab-dlwr) for metastatic non-small cell lung cancer (NSCLC). The CRL cited inspection findings at Catalent Indiana, the third-party fill-finish facility, as the sole approvability issue, with no concerns regarding Zynyz's efficacy or safety data. Incyte Corporation is collaborating with the FDA and Catalent Indiana to address the issues and plans for a potential sBLA resubmission.

Drug: Zynyz (retifanlimab-dlwr) · Indication: metastatic non-small cell lung cancer (NSCLC)

Atara Biotherapeutics announced that Pierre Fabre Pharmaceuticals has requested a Type A meeting with the FDA to discuss the Complete Response Letter (CRL) issued on January 9, 2026, for the EBVALLO Biologics License Application. The meeting aims to address the issues raised by the FDA in the CRL.

Drug: EBVALLO

BioAtla announced a formal process to explore strategic alternatives, including asset sales and partnerships, and implemented a 70% workforce reduction to reduce costs. The company is also navigating an ongoing Nasdaq delisting review and is in discussions to revise a previously announced $40 million private placement. Concurrently, the Chief Financial Officer was replaced.

Tenaya Therapeutics entered into a collaboration agreement with Alnylam Pharmaceuticals to discover and validate novel gene targets for the potential treatment of cardiovascular disease. Under the terms, Tenaya granted Alnylam an exclusive worldwide license for these targets and will receive an upfront payment of up to $10.0 million. Tenaya is also eligible for up to $1.13 billion in development, regulatory, and sales-based milestones.

Indication: cardiovascular disease · Partner: Alnylam Pharmaceuticals, Inc.

KALA BIO, Inc. entered into a Platform Development and Exclusive License Agreement with Younet AI, securing a worldwide exclusive license to Younet's proprietary biomedical artificial intelligence research platform, the "Researgency Platform." KALA paid an initial cash fee of $80,000 and issued 5,000,000 shares of common stock, with options for renewal and a potential $55 million acquisition of Younet. This agreement aims to leverage AI for KALA's research and development efforts.

Partner: Younet AI

Zymeworks BC, a subsidiary of Zymeworks Inc., entered into a sale agreement with Royalty Pharma Development Funding, LLC, selling 30% of future royalty payments related to Ziihera (zanidatamab-hrii) for $250.0 million. These royalties are derived from existing license and collaboration agreements with Jazz Pharmaceuticals Ireland Limited and BeOne Medicines Ltd. Zymeworks will retain 70% of Ziihera royalties and all earned regulatory and commercial milestone payments.

Drug: Ziihera (zanidatamab-hrii) · Partner: Royalty Pharma Development Funding, LLC

Day One Biopharmaceuticals announced that Ipsen Pharma SAS received a positive opinion from the EMA's CHMP recommending conditional marketing authorization for OJEMDA (tovorafenib). This recommendation is for the treatment of children with relapsed or refractory BRAF-altered pediatric low-grade glioma. The positive opinion follows an exclusive license agreement entered into in July 2024, granting Ipsen commercialization rights for OJEMDA outside of the United States.

Drug: OJEMDA (tovorafenib) · Indication: relapsed or refractory BRAF-altered pediatric low-grade glioma · Partner: Ipsen

Solid Biosciences Inc. entered into a private placement agreement with institutional investors, including Perceptive Advisors and Bain Capital Life Sciences, to issue common stock and pre-funded warrants. The company expects to raise approximately $240.0 million in gross proceeds from this financing. These proceeds, combined with existing cash, are projected to fund operating expenses and capital expenditure requirements into the first half of 2028, supporting ongoing pipeline development and general corporate purposes.

Alzamend Neuro, Inc. entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC to sell up to $3.0 million of its common stock. This ATM offering will be conducted under the company's existing shelf registration statement. The agreement allows the company to sell shares from time to time based on its instructions, with Ascendiant acting as the sales agent.

Nurix Therapeutics, Inc. entered into Amendment No. 3 to its Equity Distribution Agreement with Piper Sandler & Co., enabling the company to offer and sell up to $413.65 million of common stock through an "at the market" offering. This financing is being conducted under a universal automatic shelf registration statement previously filed with the SEC.

Contineum Therapeutics, Inc. amended its at-the-market (ATM) sales agreement with Leerink Partners LLC, increasing the potential offering capacity. The company can now sell up to an additional $100 million of Class A common stock through Leerink Partners, superseding the prior $75 million offering. Sales under this amended agreement will not commence until after March 11, 2026, following a lock-up period.

AbbVie Inc. completed a public offering of $8.0 billion aggregate principal amount of senior notes on March 4, 2026. The offering included $750 million in floating rate notes due 2028 and $7.25 billion in fixed rate notes with maturities ranging from 2028 to 2066, carrying interest rates from 3.775% to 5.650%. These notes are unsecured, unsubordinated obligations of AbbVie and rank equally with existing and future unsecured debt.