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QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

On January 29, 2026 Quetzal Therapeutics, a biopharmaceutical company focused on developing treatments for rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to QTX-2101, the company’s investigational oral arsenic trioxide capsule, for the treatment of patients with acute promyelocytic leukemia (APL).

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QTX-2101 is an oral capsule formulation of arsenic trioxide developed with the goal of addressing limitations associated with intravenous administration, including the need for frequent clinic visits. The potential for QTX-2101 to simplify treatment administration while maintaining precise dosing and stability is under investigation. QTX-2101 is currently being evaluated in a global, multicenter, randomized, controlled Phase III clinical trial comparing the investigational oral capsule to standard-of-care therapy in patients with newly diagnosed APL. The trial builds on pharmacokinetic and safety data from prior Phase I studies conducted in the United States.

The Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies for serious conditions, underscoring the severity of APL and the continued unmet medical need despite an effective standard of care therapy. This designation allows for more frequent interaction with the FDA as the clinical development of QTX-2101 progresses, and may enable a more efficient registration filing upon positive data. The therapy remains investigational, and its safety and efficacy have not yet been established. Fast Track designation does not change the standards for approval and does not guarantee that QTX-2101 will receive FDA approval.

About Acute Promyelocytic Leukemia (APL)

APL is a rare and aggressive subtype of acute myeloid leukemia, accounting for approximately 10-15% of all AML cases. It is defined by the PML-RARA gene fusion and is associated with severe bleeding complications and rapid disease progression if untreated. While advances in therapy have transformed outcomes, current treatments often require patients to undergo a large number of lengthy intravenous infusions over the course of therapy. This relentless treatment schedule can disrupt daily life and place a significant burden on both patients and their support networks. There remains a clear need for innovative and more accessible therapies.

(Press release, Quetzal Therapeutics, JAN 29, 2026, View Source [SID1234664175])

Roche reports strong 2025 results with 7% sales growth

On January 29, 2026 Hoffmann-La Roche reported strong 2025 results with 7% sales growth.

(Presentation, Hoffmann-La Roche, JAN 29, 2026, View Source [SID1234664004])

Takeda Quarterly Financial Report For the Quarter Ended December 31, 2025

On January 29, 2026 Takeda reported Quarterly Financial Report For the Quarter Ended December 31, 2025.

(Presentation, Takeda, JAN 29, 2026, View Source [SID1234662534])

Results Q4/FY 2025

On January 29, 2026 Sanofi reported financial results for Q4 and full year 2025.

(Presentation, Sanofi, JAN 29, 2026, View Source [SID1234662533]).

LEXICON ANNOUNCES PRICING OF APPROXIMATELY $94.6 MILLION PUBLIC
OFFERING AND CONCURRENT PRIVATE PLACEMENT

On January 29, 2026 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) ("Lexicon") reported the pricing of its previously announced underwritten public offering of 32,000,000 shares of its common stock, par value $0.001. The shares of common stock being offered pursuant to the public offering are being offered at a public offering price of $1.30 per share. All of the shares are being offered by Lexicon. The gross proceeds from the public offering are expected to be $41.6 million, before deducting underwriting discounts and commissions and other offering expenses. The public offering is expected to close on or about February 2, 2026, subject to the satisfaction of customary closing conditions. In addition, Lexicon has granted the underwriters a 30-day option to purchase up to an additional 4,800,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

In addition to the shares being sold in the underwritten public offering, Lexicon has agreed to sell, in a concurrent private placement for expected aggregate gross proceeds of approximately $41.1 million, (i) at a price of $1.30 per share of common stock, 22,400,000 shares of its common stock and (ii) at a price of $65.00 per share of series b convertible preferred stock (the "Series B Convertible Preferred Stock"), 184,366 shares of Series B Convertible Preferred Stock, which will be convertible into 9,218,290 shares of common stock, to an affiliate (the "Private Placement Purchaser") of Invus, L.P., Lexicon’s largest stockholder, pursuant to its preemptive right under Lexicon’s Sixth Amended and Restated Certificate of Incorporation. The Private Placement Purchaser will also have the option, pursuant to such preemptive right, to purchase up to an additional 94,855 shares of Series B Convertible Preferred Stock, which will be convertible into 4,742,744 shares of common stock, at a price of $65.00 per share of Series B Convertible Preferred Stock, to the extent the underwriters exercise their option to purchase additional shares of common stock. In addition to its purchases pursuant to its preemptive right, the Private Placement Purchaser has also agreed to purchase an additional 182,779 shares of Series B Convertible Preferred Stock, which will be convertible into 9,138,966 shares of common stock, at a price of $65.00 per share of Series B Convertible Preferred Stock, for expected additional aggregate gross proceeds of approximately $11.9 million.

The securities being offered to the Private Placement Purchaser will not be registered under the Securities Act of 1933, as amended (the "Securities Act"). Such issuances are also scheduled to close on or about February 2, 2026, subject to the closing of the public offering and the satisfaction of certain other customary closing conditions. The closing of the underwritten public offering is not conditioned on the closing of the concurrent private placement.

Lexicon currently intends to use the net proceeds that it will receive from the proposed offering and the concurrent private placement (i) to fund the continued research and development of its drug candidates and (ii) for working capital and other general corporate purposes.

Jefferies and Piper Sandler are acting as joint book-running managers for the public offering. H.C. Wainwright & Co. is acting as lead manager for the public offering.

A shelf registration statement on Form S-3 relating to the public offering was filed with the U.S. Securities and Exchange Commission ("SEC") on August 2, 2024 and declared effective by the SEC on August 15, 2024 (File No. 333-281208). The shares of common stock proposed to be issued in the concurrent private placement have not been registered under the Securities Act, or the securities laws of any state or other jurisdiction in the United States, and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States except pursuant to registration under the Securities Act or an applicable exemption from the registration requirements of the Securities Act and, in each case, in compliance with other applicable securities laws. A preliminary prospectus supplement and accompanying prospectus relating to the public offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC and will also be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; or Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, by telephone at (800) 747-3924, or via email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale is not permitted.

(Press release, Lexicon Pharmaceuticals, JAN 29, 2026, View Source [SID1234662398])