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Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201

On January 28, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

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Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

The FDA Breakthrough Therapy designation is based on Phase 2 NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented December 7, 2025 in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, FL.

"We are grateful to FDA for recognizing NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are looking forward to completing enrollment of NEXICART-2 with the goal of delivering this promising therapy to patients upon planned BLA submission this year."

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is expected to enroll 40 patients.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, JAN 28, 2026, View Source [SID1234662326])

Halozyme Raises 2025 Revenue Estimates,
Raises 2026 and Multi-Year Financial Guidance

On January 28, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported a business update, including providing preliminary unaudited 2025 revenue estimates and raising full year 2026 and multi-year financial guidance. The Company also announced it acquired Surf Bio, Inc. ("Surf Bio"), a biopharmaceutical company with an innovative, biologic hyperconcentration technology seeking to transform the delivery of antibodies and biologics, in December 2025.

"Our increased multi-year guidance reflects both the strength of our core ENHANZE business and the exceptional momentum we built in 2025. In 2025, we expect royalty revenue growth to exceed 50% year‑over‑year, a clear demonstration of the strength of our business model and the durable demand for ENHANZE‑enabled products globally. In parallel, we significantly expanded new partnerships, signing three new ENHANZE collaboration and licensing agreements, one new auto-injector commercial licensing and supply agreement and two auto-injector development agreements. In addition, our partner Janssen gained global approvals for Rybrevant Faspro, the tenth ENHANZE-approved product. During 2025, we advanced our strategic growth roadmap with the acquisitions of Elektrofi and their Hypercon technology and of Surf Bio and their hyperconcentration technology. Both hyperconcentration technologies have long-duration IP into the mid-2040s. Our operational accomplishments and acquisitions broaden our drug delivery portfolio and opportunity, amplify and extend our royalty horizons, and diversify the pathways through which we create value," said Dr. Helen Torley, President and Chief Executive Officer.

Dr. Torley added, "In the near-term, our strong 2026 total revenue expectations of 23% to 30% year‑over‑year growth underscore the strength of our royalty revenue, which is projected to exceed $1 billion in 2026, growing at 30% to 35% versus prior year. This is one year earlier than previously projected. By the end of 2026, we project we will have 15 partner programs in development and have signed three or more new drug delivery licensing agreements, expanding the reach and growing our opportunity through our diversified drug delivery portfolio. Taken together, these drivers reinforce our confidence in delivering durable revenue growth well into the 2040s and support our conviction in Halozyme’s long‑term growth profile which will deliver sustained value for shareholders."
The Company acquired Surf Bio for an upfront payment of $300 million, subject to customary purchase price adjustments, and up to $100 million milestone payments contingent on product development and regulatory approval milestones, for a total consideration of up to $400 million.
The Surf Bio hyperconcentration technology is being developed to enable high concentrations of up to 500 mg/mL across a wide range of therapeutics, including monoclonal antibodies and small molecules, for delivery in a single auto-injector shot for at-home or in-HCP office use. These high concentration formulations are achievable using Surf Bio’s proprietary, protective excipient and spray dry approach, enabling accessible and patient-friendly subcutaneous delivery of antibodies and biologics.

Table 1. 2025 Unaudited Preliminary Revenue Estimates for the Twelve Months Ended December 31, 2025

2025 Estimate
Expected YoY Growth1
Total Revenue $1,385 to $1,400 million 36% to 38%
Royalty Revenue $865 to $870 million 51% to 52%

Financial Outlook for 2026
The Company is raising its financial guidance for 2026. For the full year 2026, the Company expects:

•Total revenue of $1,710 million to $1,810 million, representing growth of 23% to 30% over projected 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.
•Revenue from royalties of $1,130 million to $1,170 million, representing growth of 30% to 35% over 2025.
•Adjusted EBITDA of $1,125 million to $1,205 million, including new Hypercon and Surf Bio investment of approximately $60 million, which was not included in prior 2026 guidance.
•Non-GAAP diluted earnings per share of $7.75 to $8.25. The Company’s earnings per share guidance includes new Hypercon and Surf Bio investment of approximately $60 million not included in prior 2026 guidance and does not consider the impact of potential future share repurchases.

Table 2. 2026 Financial Guidance

Previous Guidance Range New Guidance Range
Expected YoY Growth2
Total Revenue $1,430 to $1,530 million
$1,710 to $1,810 million
23% to 30%
Royalty Revenue $900 to $940 million $1,130 to $1,170 million 30% to 35%
Adjusted EBITDA $1,000 to $1,080 million $1,125 to $1,205 million ——
Non-GAAP Diluted EPS $6.50 to $7.00 $7.75 to $8.25 ——

Footnotes:
1 Growth rates calculated from 2024 actual to low end of 2025 range and high-end of 2025 range.
2 Growth rates calculated from 2025 midpoint to low end of 2026 range and high-end of 2026 range.
3 Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures.
4 Including investment of approximately $60 million for Hypercon and Surf Bio not included in prior 2026 guidance.

Webcast and Conference Call
Halozyme will host an Investor Conference Call today, Wednesday, January 28 at 5:30am PT/8:30am ET. Pre-registration of the live call can be accessed via link here: View Source A webcast of the live call and presentation materials will be available through the "Investors" section of Halozyme’s corporate website at ir.halozyme.com.

(Press release, Halozyme, JAN 28, 2026, View Source [SID1234662325])

Enveric Biosciences Announces Closing of $1.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

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.

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])

Enveric Biosciences Announces $1.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

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.

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.

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

Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma

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.

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])