On January 28, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement.

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CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. diagnosed each year, according to the American Cancer Society.

"This NDA reaffirms Elevar’s mission of bringing life-changing medicines to cancer patients worldwide, including for rare indications and for advanced stages where treatment options are limited," said Dong-Gun Kim, the company’s chief executive officer. "We are excited to work with the FDA as it reviews the submission while simultaneously preparing for a potential commercial launch. We could not be more appreciative of the patients who participated in lirafugratinib-focused clinical trials and everyone who brought us to this crucial point in its development."

The NDA is supported by positive clinical data from the phase 1/2 ReFocus trial (NCT04526106), in which lirafugratinib demonstrated clinically meaningful anti-tumor activity, measured by objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), as well as manageable and tolerable safety in patients with advanced/metastatic CCA and other solid tumors with fibroblast growth factor receptor 2 (FGFR2) alterations.

The abstract "Efficacy and safety of lirafugratinib in FGFRi-naïve cholangiocarcinoma (CCA) patients harboring FGFR2 fusions/rearrangements (FGFR2 f/r)" was presented earlier this month at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium.

Independent review committee-assessed ORR was 46.5%, and median DOR was 11.8 months (mos) (95% CI, 7.5-13.0), where 76.2% of responses lasted >6 mos. Median PFS was 11.3 mos (95% CI, 9.2, 14.8), with 12-month rate of 49.2%. Median OS was 22.8 mos (95% CI, 18.1-27.2), with 12-month rate of 74.6%. The disease control rate was 96.5%. Most common Grade ≥3 treatment-related adverse events (TRAEs) were palmar-plantar erythrodysesthesia (32.8%) and stomatitis (12.1%). TRAEs led to dose reduction, dose interruption, and treatment discontinuation were observed in 75.9%, 82.8%, and 4.3%, respectively.

Elevar is also developing lirafugratinib for patients with other FGFR2-altered other solid tumors. The company acquired worldwide rights to develop and commercialize lirafugratinib in December 2024. Earlier that year, Relay Therapeutics met with the FDA to discuss data from the ReFocus trial and potential regulatory pathways. The FDA recommended the company first file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib Lirafugratinib (RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 f/r, who have not treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JAN 28, 2026, View Source [SID1234662322])

On January 28, 2026 WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), and Sinorda Biomedicine reported a strategic collaboration for the development and manufacturing of SND006, a novel bispecific antibody, for the potential treatment of inflammatory bowel disease (IBD) and other autoimmune diseases.

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Under the agreement, Sinorda Biomedicine will leverage WuXi Biologics’ extensive experience and manufacturing capabilities in biologics development and manufacturing to advance SND006’s preclinical pharmacology studies and clinical supply, accelerating the Investigational New Drug (IND) application process. SND006 is an innovative bispecific antibody independently developed by Sinorda Biomedicine, for which the company holds worldwide rights. Sinorda Biomedicine has completed in vitro functional validation studies of SND006 and plans to submit IND applications to both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) in 2026. In the future, the two companies will further expand their collaboration around Sinorda Biomedicine’s potential pipeline, including multiple integrated projects spanning from molecule discovery to clinical manufacturing.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Over the past decade, we have accumulated experience across hundreds of projects in bispecific and multispecific antibodies, which have become one of our fastest‑growing areas. We are pleased to accelerate the development and manufacturing of Sinorda Biomedicine’s innovative bispecific antibody SND006 through our integrated technology platforms and comprehensive capabilities. Looking ahead, we will continue accelerating and transforming biologics discovery, development and manufacturing to empower global partners and make innovative biologics more accessible and affordable for patients worldwide."

Dr. Pingsheng Hu, Chairman and General Manager of Sinorda Biomedicine, commented, "SND006 is a potentially best-in-class innovative bispecific antibody discovered and developed by Sinorda Biomedicine, with the potential to deliver breakthroughs in the treatment of gastrointestinal and multiple autoimmune diseases. WuXi Biologics is a global leader in CRDMO services, offering truly end‑to‑end solutions underpinned by accumulated know-how, comprehensive technology platforms, and a strong track record—particularly in the development and manufacturing of bispecific antibodies. We believe this collaboration will accelerate the IND filings of our innovative biologics in China and worldwide, address unmet medical needs in autoimmune diseases, and ultimately bring safe and effective therapies to patients."

(Press release, WuXi Biologics, JAN 28, 2026, View Source [SID1234662338])

On January 28, 2026 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, reported that it has entered into definitive agreements for the purchase and sale of 328,802 shares of common stock at a purchase price of $4.41 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered series G warrants to purchase up to 328,802 shares of common stock and unregistered series H warrants to purchase up to 328,802 shares of common stock. The series G warrants will have an exercise price of $4.16 per share, will be exercisable immediately and will expire five years after the effective date of a registration statement registering the shares issuable upon exercise of the warrants. The series H warrants will have an exercise price of $4.16 per share, will be exercisable immediately and will expire eighteen months after the effective date of a registration statement registering the shares issuable upon exercise of the warrants. The closing of the offering is expected to occur on or about January 28, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $1.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-280721) that was declared effective by the Securities and Exchange Commission (the "SEC") on April 17, 2025. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Enveric Biosciences, JAN 28, 2026, View Source [SID1234662323])

On January 28, 2026 Repare Therapeutics Inc. ("Repare" or the "Company") reported the completion of the previously announced acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of the Common Shares, the "Shareholders") by XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly "Xeno") a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement"). The Arrangement was approved by the Shareholders at a special meeting held on January 16, 2026, and a final order approving the Arrangement was issued by the Superior Court of Québec (Commercial Division) on January 23, 2026.

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In accordance with the terms of the Arrangement, the Shareholders received a cash payment of approximately US$2.20 per Common Share that was determined based upon the Company’s cash balance immediately prior to the closing of the Transaction after deducting certain transaction costs, the aggregate amount of outstanding liabilities, and a transaction fee to Xeno. In addition, each Shareholder received one non-transferable contingent value right ("CVR") for each Common Share which represents the right to receive a pro rata portion of potential payments, in cash, described in, and subject to and in accordance with the terms and conditions of, the contingent value rights agreement dated January 28, 2026 among Xeno, Broadridge Corporate Issuer Solutions, LLC ("Broadridge"), in its capacity as rights agent, and WT Representative LLC, solely in its capacity as the initial representative, agent and attorney in-fact of the CVR holders.

Consideration for the Common Shares has been remitted by or on behalf of Xeno to Broadridge, in its capacity as depositary under the Arrangement, and will be paid to former Shareholders of the Company as soon as reasonably practicable after the date hereof (or, in the case of registered Shareholders, as soon as reasonably practicable after a properly completed and signed letter of transmittal is received by the depositary together with the share certificate(s) and/or DRS Advice(s) representing Common Shares formerly held by them).

As a result of the completion of the Arrangement, it is expected that the Common Shares will cease trading on the Nasdaq Global Select Market on or about January 28, 2026, and the Company will subsequently file a Form 15 with the SEC requesting suspension of the Company’s reporting obligations under Sections 13 and 15(d) of the U.S. Securities Exchange Act of 1934, as amended (the "Exchange Act"). The Company will also deregister the Common Shares under the Exchange Act. The Company has applied to cease to be a reporting issuer in Québec pursuant to the securities legislation of Québec.

Further details regarding the Arrangement are provided in the definitive proxy statement on Schedule 14A in respect of the Transaction (the "Proxy Statement"), which is available on the Company’s profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca.

(Press release, Repare Therapeutics, JAN 28, 2026, View Source [SID1234662339])

On January 28, 2026 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, reported the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 328,802 shares of common stock at a purchase price of $4.41 per share. In a concurrent private placement, the Company issued unregistered series G warrants to purchase up to 328,802 shares of common stock and unregistered series H warrants to purchase up to 328,802 shares of common stock. The series G warrants have an exercise price of $4.16 per share, are exercisable immediately and will expire five years after the effective date of a registration statement registering the shares issuable upon exercise of the warrants. The series H warrants have an exercise price of $4.16 per share, are exercisable immediately and will expire eighteen months after the effective date of a registration statement registering the shares issuable upon exercise of the warrants.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $1.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-280721) that was declared effective by the Securities and Exchange Commission (the "SEC") on April 17, 2025. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Enveric Biosciences, JAN 28, 2026, View Source [SID1234662324])