On January 9, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported preliminary, unaudited fourth quarter and full-year 2025 net revenue.

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"We are encouraged by the growth in Q4 2025, driven in particular by the momentum in our Acute Care franchise with ZYNRELEF and APONVIE," said Craig Collard, Chief Executive Officer of Heron. "In addition to our revenue growth, we are extremely pleased with the continued progress made across all aspects of our business throughout the past year."

Preliminary Fourth Quarter and Full Year 2025 Updates

Net revenue of approximately $40.5 million for the three months ended December 31, 2025.
ZYNRELEF net revenue of approximately $12.5 million for the three months ended December 31, 2025.
APONVIE net revenue of approximately $3.8 million for the three months ended December 31, 2025.
CINVANTI net revenue of approximately $22.9 million for the three months ended December 31, 2025.
SUSTOL net revenue of approximately $1.3 million for the three months ended December 31, 2025.
Net revenue of approximately $154.9 million for full-year 2025.
ZYNRELEF delivered the largest quarter-over-quarter revenue increase within the portfolio in Q4 (up ~35% vs Q3 2025).

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Prevention of Postoperative Nausea and Vomiting ("PONV") Prevention

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for the prevention of PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com.

(Press release, Heron Therapeutics, JAN 9, 2026, View Source [SID1234661893])

On January 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025.

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Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited)

Total fourth quarter and full year revenue expected to be approximately $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue expected to be approximately $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue expected to be approximately $1.7 million and $6.4 million, respectively
628,572 common shares repurchased for $6.0 million through December 31, 2025 under the approved $25.0 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt compared to cash and short-term investments of $88.9 million as of September 30, 2025
Final financial results for the fourth quarter and full year 2025 and a detailed business update will be provided during Delcath’s annual financial results release and business update call.

Recent Business Highlights

Currently 25 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 versus 2024
Independent investigators presented results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
Recent publications have highlighted the application, enhanced outcomes, and associated efficacy of percutaneous hepatic perfusion (PHP) in the management of metastatic uveal melanoma (mUM):
"Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021" in International Journal of Cancer
"Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
"In 2026 we will continue to drive increased adoption and utilization of HEPZATO by raising awareness among treating physicians of the CHOPIN study findings," said Gerard Michel, Chief Executive Officer of Delcath. "Our strong financial position enables us to invest in both commercial expansion and the initiation of additional clinical programs in 2026."

Preliminary and Unaudited Nature of Reported Results

The Company has not yet completed its financial close process for the fourth quarter and full year 2025 and, as a result, actual results may vary from the estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2025, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full, interim or annual audited financial statements.

(Press release, Delcath Systems, JAN 9, 2026, View Source [SID1234661892])

On January 9, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported the closing of its previously announced private placement (the "PIPE financing") for gross proceeds of up to $80.8 million to the Company, including initial gross proceeds to the Company of approximately $20.2 million, in each case before placement agent fees and offering expenses.

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In addition to the healthcare-focused institutional investors listed above, the private placement included participation from other new and existing institutional investors, as well as members of the Company’s management team and board of directors.

Laidlaw & Company (UK) Ltd. acted as sole placement agent for the PIPE financing.

(Press release, Curis, JAN 9, 2026, View Source [SID1234661891])

On January 9, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the development of targeted radiotherapeutics for cancer, reported plans to highlight the company’s 2026 strategic initiatives at the upcoming Biotech Showcase, taking place January 12-15, 2026, in San Francisco during the 44th Annual JP Morgan Healthcare Conference. James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 1:30 pm Pacific Time.

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2025 Achievements

Received feedback from the SAWP supporting a Conditional Marketing Authorization (CMA) filing for iopofosine I 131 in WM based upon our CLOVER WaM study
U.S. Food and Drug Administration (FDA) granted Break Through Designation (BTD) for iopofosine I 131 in relapsed/refractory WM
Confirmed traditional accelerated approval pathway with the FDA for iopofosine I 131 in WM
Presented compelling data from the CLOVER-2 Phase 1b study in relapsed/refractory pediatric high-grade glioma (pHGG), demonstrating extended progression-free survival and favorable safety profile
Initiated a Phase 1b clinical study for CLR 125, an Auger-emitting iodine-125 program for the treatment of triple-negative breast cancer (TNBC)
Strengthened supply chain through strategic supply agreements for our next generation Auger- and alpha-emitting radiotherapeutics
Raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones

CEO Commentary

"Our priorities are clear: secure European conditional marketing approval for iopofosine I 131 for WM in early 2027 with commercialization to follow, further validate our PDC platform by executing on our Phase 1b study evaluating CLR 125 for TNBC, and advance our regulatory strategy with the FDA for iopofosine I 131 approval in the U.S. With an established iopofosine I 131 regulatory strategy for both EMA and FDA, and promising data across our pipeline, we are entering 2026 with strong momentum and multiple opportunities," said James Caruso, president and CEO of Cellectar. "We believe these initiatives position Cellectar to deliver meaningful therapies for patients and create significant value for shareholders."

2026 Strategic Initiatives

Regulatory Milestones:
Submit CMA application to EMA for iopofosine I 131 in WM in 3Q 2026, with potential European market approval in early 2027
Advance NDA preparations for U.S. accelerated approval
Clinical Development:
Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026
Present final findings and subset analysis from the CLOVER WaM Phase 2 study of iopofosine I 131
Prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer
Pipeline Expansion:
Progress additional PDC-based radiotherapeutics into preclinical and IND-enabling studies
Partnerships:
Evaluate strategic collaborations for commercialization of iopofosine I 131
Financial Strategy:
Continue disciplined capital management and explore non-dilutive funding opportunities

"Looking ahead, we are focused on receiving a conditional marketing approval in 2027 from the EMA impacting approximately thirty countries, which collectively possess a larger WM population than the U.S. In parallel, we remain committed to advancing our regulatory strategy with the FDA fully understanding the tremendous incremental value it potentially represents for all Cellectar stakeholders. The FDA-recommended post-BTKi indication positions iopofosine I 131 as a treatment option as early as the second line, substantially expanding the available patients in the U.S. market. Additionally, we are actively recruiting patients for our Phase 1b study evaluating CLR 125, our Auger-based radiotherapeutic for the treatment of TNBC, which builds on strong preclinical data showing growth inhibition and tumor volume reduction in this challenging-to-treat cancer," concluded Mr. Caruso.

Mr. Caruso’s Biotech Showcase presentation will be live webcast and can be accessed HERE. A replay of the presentation will be available on the Events section of the company’s Investor Relations website.

(Press release, Cellectar Biosciences, JAN 9, 2026, View Source [SID1234661890])

On January 9, 2026 Biolexis Therapeutics, a clinical-stage biotechnology company pioneering an all-oral infrastructure for metabolic disease, reported it will present at the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026 at 9:00am PST.

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The presentation will spotlight Biolexis’ differentiated strategy to overcome the maintenance, side effect, scalability, and access crises with existing market therapies for weight loss. To solve these issues, Biolexis has two clinical-stage programs:

• BLX-7006 — A first-in-human oral small-molecule allosteric GLP-1 receptor agonist based on a new chemical scaffold that is not an orforglipron or danuglipron analog like other existing market solutions. Phase 1 data demonstrates a clean safety profile and predictable once-daily pharmacokinetics, and the asset is now advancing to Phase 2

• BLX-0871 — A first-in-class γ3 isoform-selective AMPK activator designed to preserve lean muscle mass and metabolic durability, entering Phase 1 in January 2026

BLX-7006: Redefining GLP-1 Access

BLX-7006 binds a distinct allosteric pocket on the GLP-1 receptor, enabling cooperative activation while reducing receptor desensitization—a key limitation of peptide-based therapies. As a small molecule, BLX-7006 offers transformative advantages: oral administration without fasting requirements, no cold-chain logistics, and a fundamentally lower cost-of-goods structure enabling global-scale deployment.

BLX-0871: Solving the Muscle Loss Problem

Current GLP-1 therapies produce significant weight loss, but up to 40% of lost mass is lean muscle, driving metabolic adaptation and weight regain. BLX-0871 selectively activates γ3-containing AMPK complexes enriched in skeletal muscle, engaging exercise-associated metabolic pathways while sparing cardiac isoforms. The result: preserved lean mass, enhanced glucose uptake, and sustained metabolic rate.

The All-Oral Combination Advantage

Biolexis is developing the only all-oral dual-mechanism combination currently in clinical development. By pairing GLP-1-mediated appetite suppression with muscle-selective AMPK activation, the company aims to deliver what injectable monotherapies cannot: durable weight loss with preserved muscle mass and metabolic function.

"The GLP-1 revolution has proven we can treat obesity—but injectable peptides alone won’t get us to a billion patients," said David J. Bearss, PhD, Co-founder and Chairman of Biolexis Therapeutics. "Our all-oral platform isn’t an incremental improvement—it’s infrastructure for global scale. And by adding muscle-selective AMPK activation, we’re not just helping patients lose weight, we’re helping them keep it off. That’s the durability breakthrough the field has been waiting for."

Conference Availability

Biolexis management will be available throughout the conference for meetings with pharmaceutical companies, institutional investors, and strategic partners to discuss Phase 2 clinical plans, combination development strategy, and partnership opportunities.

(Press release, Biolexis Therapeutics, JAN 9, 2026, View Source [SID1234661889])