On November 9, 2026 ImmunityBio, Inc. a commercial-stage immunotherapy company, reported continued global expansion, expanded FDA approval, and financial results for the third quarter ended September 30, 2026.

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ImmunityBio continued to advance a broad clinical pipeline spanning bladder cancer, non-small cell lung cancer, and hematologic malignancies with expanded FDA approval and global expansion of ANKTIVA in nonmuscle invasive bladder cancer (NMIBC). ANKTIVA is now approved or authorized in six regulatory jurisdictions, expanding its global footprint to 35 countries, while multiple ongoing clinical and regulatory programs continue to support the Company’s long-term growth strategy.

The Company advanced several key regulatory and clinical programs across its immunotherapy pipeline. It received an expanded label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only tumors. In addition, Cohort A of the randomized QUILT-2.005 trial evaluating ANKTIVA in combination with BCG in patients with BCG-naïve NMIBC met its primary endpoint. The Company also initiated its first sales in Europe in early Q4 and obtained approval in Israel in collaboration with its partner, Rafa Laboratories Ltd.

In this quarter (October 2026), ImmunityBio received FDA approval for expanded use of ANKTIVA plus BCG in subjects with BGC-unresponsive nonmuscle invasive bladder cancer (NMIBC). This expanded FDA approval has already been authorized by the Emirates Drug Establishment (United Arab Emirates) and the Company will now pursue global filings for this expanded indication.

The company reported that the primary endpoint for BCG naïve nonmuscle invasive bladder (NMIBC) cancer has been reached in subjects receiving ANKTIVA plus BCG versus those receiving BCG alone. With this positive result the supplemental BLA (sBLA) for BCG naïve NMIBC patients is on track for submission in this quarter.

Global expansion and operational implementation of the launch of ANKTIVA plus BCG in BCG unresponsive NMIBC continues with the approval of ANKTIVA plus BCG in NMIBC in Israel and the first commercial dose administered in Europe.

On October 16, 2026, The Journal of Urology published long-term outcomes from our Phase 2/3 QUILT-3.032 trial of ANKTIVA in combination with BCG in 100 patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Among responders, cystectomy avoidance was 84% at 36 months. The median duration of complete response (CR) was 26.6 months, with some responses extending beyond 53 months—emphasizing support for ANKTIVA by a mature dataset.

"The FDA’s recent approval of ANKTIVA plus BCG for papillary-only disease, together with data published in The Journal of Urology showing that more than half of responding patients maintained complete responses beyond 3.5 years, further reinforces the clinical potential of our chemotherapy-free immunotherapy approach and ANKTIVA’s novel mechanism of action," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "We look forward to reviewing the final results from our study in BCG-naïve patients and initiating real-world evidence studies to further characterize ANKTIVA’s clinical impact in NMIBC. We also continued to advance our clinical program in metastatic non-small cell lung cancer, GBM, and hematologic malignancies during the quarter."

Quarterly Financial Highlights

"We continue to see more physicians prescribing ANKTIVA to multiple patients and growing physician interest in our chemotherapy-free approach in the U.S. and Europe," said Richard Adcock, President and CEO of ImmunityBio. "The recent label expansion represents an important opportunity to broaden access to ANKTIVA for a significantly larger patient population. Looking ahead, our QUILT-2.005 trial in BCG-naïve patients offers another potential avenue for expanding the eligible patient population and supporting long-term growth, subject to positive clinical and regulatory approval."

Net product revenue reached $48.7 million, representing 53% year-over-year growth. For the first nine months of 2026, net product revenue totaled $143.6 million, up 92% compared with the first nine months of 2025, and building on full-year 2025 net product revenue of $113.0 million. As of September 30, 2026, the Company had $334.3 million in cash and cash equivalents, and marketable securities.

Cash and Marketable Securities Position

As of September 30, 2026, the Company had consolidated cash and cash equivalents, and marketable securities of $334.3 million.

Third Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $17.0 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, due to an increase in sales of ANKTIVA.

Research and Development Expense

Research and development (R&D) expense increased $20.3 million to $71.5 million during the three months ended September 30, 2026, as compared to $51.2 million during the three months ended September 30, 2025, mainly due to increased clinical trial expenses and personnel-related costs, partially offset by decreased manufacturing expenses.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $17.7 million to $54.0 million during the three months ended September 30, 2026, as compared to $36.3 million during the three months ended September 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $94.9 million to $106.6 million during the three months ended September 30, 2026, as compared to $11.7 million during the three months ended September 30, 2025, primarily due to non-cash changes in the fair value of a related-party convertible note, warrant liabilities, and other derivative liabilities mainly driven by an increase in our common stock price during the quarter, and an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026. These changes were partially offset by an increase in interest and investment income combined with a decrease in interest expense due to a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $184.6 million during the three months ended September 30, 2026, as compared to $67.3 million during the three months ended September 30, 2025. The increase in net loss was mainly driven by changes in the fair value of a related-party convertible note, and warrant and derivative liabilities due to an increase in our common stock price during the quarter, higher interest expense related to the revenue interest liability, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $25.5 million to $97.9 million during the three months ended September 30, 2026, as compared to $72.4 million during the three months ended September 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

Nine Months Ended 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $68.9 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, due to an increase in sales of ANKTIVA.

Research and Development Expense

R&D expense increased $45.6 million to $200.3 million during the nine months ended September 30, 2026, as compared to $154.7 million during the nine months ended September 30, 2025, mainly due to increased clinical trial expenses, contract manufacturing costs, personnel-related costs, and facility costs.

Selling, General and Administrative Expense

SG&A expense increased $40.3 million to $151.6 million during the nine months ended September 30, 2026, as compared to $111.3 million during the nine months ended September 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $740.1 million to $838.3 million during the nine months ended September 30, 2026, as compared to $98.2 million during the nine months ended September 30, 2025, primarily due to non-cash changes in the fair value of warrant liabilities, a related-party convertible note, and other derivative liabilities mainly driven by an increase in our common stock price during the period, an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026, and a one-time write off of a convertible note receivable in Q1 2026. These changes were partially offset by an increase in interest and investment income associated with higher treasury securities holdings combined with a decrease in interest expense due to a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $1.0 billion during the nine months ended September 30, 2026, compared to $289.5 million during the nine months ended September 30, 2025. The increase in net loss was mainly driven by changes in the fair value of a related-party convertible note, and warrant and derivative liabilities due to an increase in our common stock price during the period, higher interest expense related to the revenue interest liability, higher other expense, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $20.2 million to $265.2 million during the nine months ended September 30, 2026, as compared to $245.0 million during the nine months ended September 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674474])

On November 9, 2026 ImmunityBio, Inc. (NASDAQ: IBRX) ("ImmunityBio") and Rafa Laboratories Ltd. (TASE: RAFA) ("Rafa") reported that the Israeli Ministry of Health (MoH) has granted approval for ANKTIVA (nogapendekin alfa inbakicept), indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The approval was granted four months after submission under an accelerated review pathway. The registration license is expected within the coming weeks.

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Under the distribution agreement between the companies, Rafa will be the exclusive commercialization partner for ANKTIVA in Israel, bringing together ImmunityBio’s innovative immunotherapy platform and Rafa’s established capabilities and presence in the Israeli healthcare market.

ANKTIVA is a first-in-class IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells and T cells and drive their proliferation. In the United States, ANKTIVA was approved by the U.S. Food and Drug Administration in April 2024 in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The FDA subsequently expanded the label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only disease.

"Patients with BCG-unresponsive bladder cancer have historically faced limited treatment options, underscoring the urgent need for new therapeutic approaches," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "We developed ANKTIVA based on the understanding that the immune system has the innate ability to recognize and destroy cancer, and that activating natural killer cells and memory T cells is fundamental to sustaining an immune response. This approval in Israel represents another important step in our mission to expand global access to a chemotherapy-free immunotherapy combination for patients facing this challenging disease. We look forward to working with Israel’s physicians to bring this innovative treatment option to patients in need."

"The approval of ANKTIVA in Israel represents an important milestone for patients with non-muscle invasive bladder cancer and reflects Rafa’s commitment to bringing meaningful therapeutic innovation to patients in Israel," said Iddo Leshem, CEO of Rafa Laboratories. "We are proud to partner with ImmunityBio to make this novel immunotherapy available locally and to combine their scientific innovation with Rafa’s experience and capabilities in the Israeli healthcare system."

"Expanding access to ANKTIVA internationally is a key part of our mission to transform cancer care by harnessing the power of the immune system," said Richard Adcock, President and CEO of ImmunityBio. "Rafa’s strong presence and experience in the Israeli healthcare market make them an excellent partner to bring ANKTIVA to eligible patients in Israel. This approval represents another step in expanding access to ANKTIVA for patients with BCG-unresponsive NMIBC around the world."

Unmet Medical Need in Israel

Bladder cancer is a significant public health concern in Israel. It has been reported as the fourth most common cancer among Israeli men,¹ and 1,775 patients were diagnosed in 2018, more than 80% of them men.² That same year, 401 deaths from bladder cancer were recorded.² Over the past two decades, the incidence of in situ bladder cancer has increased, while the incidence of invasive bladder cancer has declined.¹ For patients with BCG-unresponsive high-risk NMIBC, radical cystectomy is the standard treatment recommended by the European Association of Urology guidelines.³ It is a major surgical procedure and is not suitable for every patient. Bladder-preserving treatment options for this population therefore remain an area of high unmet medical need.

About ANKTIVA (nogapendekin alfa inbakicept)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT U.S. SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674475])

On November 9, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported positive results from the final analysis of the primary endpoint in Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled, registrational trial evaluating intravesical ANKTIVA (nogapendekin alfa inbakicept-pmln/N-803) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer (NMIBC). The chemotherapy-free combination demonstrated a statistically significant improvement in efficacy compared with BCG alone in patients with carcinoma in situ (CIS), with or without papillary tumors.

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The trial involved over 75 clinical trial sites with three largest enrolling sites at US Urology Partners, Dartmouth-Hitchcock, and University of California Los Angeles. Additional study details will be presented at an upcoming medical congress.

"For nearly 40 years, BCG has been the gold standard for patients newly diagnosed with high-risk NMIBC, with limited innovation in the frontline setting," said Christopher Pieczonka, M.D., Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the QUILT-2.005 trial. "For patients with carcinoma in situ with or without papillary tumors, the meaningful improvement in response rates when intravesical ANKTIVA is administered with BCG represents an important practice-changing advance. By improving responses earlier in the disease course, this combination has the potential to help more patients remain disease-free longer, avoid additional treatments."

"As an NCI-designated Comprehensive Cancer Center, we are committed to advancing innovative research and clinical trials that have the potential to improve outcomes for patients," said Einar F. Sverrisson, MD, Assistant Professor of Surgery at Dartmouth’s Geisel School of Medicine and urologist at Dartmouth Hitchcock Medical Center. "For patients with NMIBC, recurrence following standard-of-care BCG remains a significant challenge. This study was designed to investigate whether adding N-803 to BCG could increase the patient response rate and reduce the risk of early recurrence. We are proud to have contributed to this important research, which has the potential to reshape the treatment landscape for patients living with NMIBC."

"These results build on the clinical findings observed in patients with BCG-unresponsive NMIBC and underscore the potential of ANKTIVA plus BCG to become the first chemotherapy-free immunotherapy combination to improve treatment outcomes for patients with BCG-naïve bladder cancer," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "The statistically significant improvement in efficacy supports our efforts to extend this therapeutic approach to patients earlier in their treatment journey. We are grateful to the patients, families and clinical teams who made this study possible."

Safety of N-803 plus BCG versus BCG Alone

The most common treatment-emergent and treatment-related adverse events were consistent with those observed with BCG alone. No treatment-related deaths were reported.

About the QUILT-2.005 Study

QUILT-2.005 (NCT02138734) is a randomized, controlled registrational trial comparing the intravesical chemotherapy-free combination of ANKTIVA (nogapendekin alfa inbakicept-pmln) with BCG versus BCG alone in patients with BCG-naïve NMIBC. BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for which ANKTIVA is currently approved. Enrollment was completed in February 2026 with 370 randomized patients. Following a protocol-specified interim review in March 2026, the IDMC determined that no additional enrollment was required to maintain the study’s prespecified statistical power. Database lock occurred on October 20, 2026 and the supplemental BLA is on track to be submitted to the FDA before year end 2026. Full details can be found on clinicaltrials.gov.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

In April 2024, ANKTIVA plus BCG was approved for BCG unresponsive NMIBC CIS with or without papillary disease. In October 2026, ANKTIVA plus BCG indication was expanded and approved for BCG unresponsive NMIBC including both CIS and papillary disease.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674473])

On November 9, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three and nine months ended September 30, 2026 and recent corporate updates.

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Business Highlights

•
Heron generated total net revenue of $35.3 million in Q3 2026, compared to $38.2 million in Q3 2025 and $37.7 million in Q2 2026. Heron ended the third quarter with $23.4 million in cash, cash equivalents and short-term investments.

•
Acute Care franchise updates: Net revenue increased 22.5% year-over-year for the three months ended September 30, 2026 and increased 32.4% year-over-year for the nine months ended September 30, 2026. ZYNRELEF contributed $10.6 million and $31.9 million net revenue in the three and nine months ended September 30, 2026, respectively. APONVIE contributed $4.5 million and $12.2 million net revenue in the three and nine months ended September 30, 2026, respectively.

•
Oncology Supportive Care franchise updates: Net revenue was $20.1 million in the three months ended September 30, 2026 and $63.5 million in the nine months ended September 30, 2026. CINVANTI contributed $20.0 million and $62.3 million in the three and nine months ended September 30, 2026, respectively. Commercial sales of SUSTOL ceased on September 30, 2026.

•
Proposed asset sale: In a separate press release issued today, Heron and CorMedix Therapeutics ("CorMedix") announced that they have entered into a definitive asset purchase agreement under which CorMedix will acquire substantially all of the assets of Heron (the "Asset Sale"). The Asset Sale is subject to approval by Heron’s stockholders and other customary closing conditions. Additional information is available in that press release and in the Current Report on Form 8-K to be filed by Heron with the Securities and Exchange Commission ("SEC").

Financial Guidance for 2026

As previously announced, the Company withdrew its full-year 2026 financial guidance in August 2026. The Company is not providing financial guidance at this time.

Net Revenue Performance – Three Months Ended September 30

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 15,128

$ 12,347

$ 2,781

22.5%

APONVIE

$ 4,530

$ 3,034

$ 1,496

49.3%

ZYNRELEF

$ 10,598

$ 9,313

$ 1,285

13.8%

Oncology

$ 20,122

$ 25,866

($ 5,744)

(22.2%)

CINVANTI

$ 19,970

$ 23,955

($ 3,985)

(16.6%)

SUSTOL

$ 152

$ 1,911

($ 1,759)

(92.0%)

Total Net Revenue

$ 35,250

$ 38,213

($ 2,963)

(7.8%)

Net Revenue Performance – Nine Months Ended September 30

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 44,088

$ 33,300

$ 10,788

32.4%

APONVIE

$ 12,200

$ 7,758

$ 4,442

57.3%

ZYNRELEF

$ 31,888

$ 25,542

$ 6,346

24.8%

Oncology

$ 63,539

$ 81,016

($ 17,477)

(21.6%)

CINVANTI

$ 62,298

$ 73,841

($ 11,543)

(15.6%)

SUSTOL

$ 1,241

$ 7,175

($ 5,934)

(82.7%)

Total Net Revenue

$ 107,627

$ 114,316

($ 6,689)

(5.9%)

Conference Call and Webcast

Heron will not host a conference call or webcast in connection with its third quarter 2026 financial results.

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)

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of postoperative 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 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.

Commercial sales of SUSTOL ceased on September 30, 2026.

(Press release, Heron Therapeutics, NOV 9, 2026, View Source [SID1234674472])

On November 9, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a biotechnology company pioneering a new class of medicines against challenging targets in oncology and immunology & inflammation (I&I), reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the third quarter ended September 30, 2026.

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"Our focus is on advancing our wholly owned portfolio, including our novel, oral I&I program in IBD, with potential for first-in-human trials by the end of 2027, and our Selective EP300 degrader which has an IND targeted for next year," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. "We are also advancing a novel induced-proximity approach with the potential to deliver antibody-like efficacy against high-value secreted and transmembrane proteins through small molecules. With cash runway into the second half of 2029, we are well positioned to deliver on this strategy."
Program Overview and Upcoming Milestones
Novel oral I&I program. Foghorn is advancing a novel oral small-molecule inhibitor with an initial focus in IBD. Preclinical data demonstrate robust suppression of disease activity in a T-cell transfer colitis model and an IL-10 knock-out model, with efficacy comparable to an anti-IL-12/23p40 antibody positive control.
•Dose-range finding studies are expected to begin in the fourth quarter of 2026, with potential first-in-human studies by the end of 2027.

Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, and dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in diffuse large b-cell lymphoma (DLBCL), MM, and other heme malignancies.
•EP300 degrader program outperforms clinical benchmark. Preclinical data highlight the therapeutic potential in MM including superior anti-tumor activity with complete responses, compared to clinical benchmark dual CBP/EP300 inhibitor inobrodib. Superior safety by body weight loss and platelet counts over dual inhibition, and tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance were also observed.
•IND targeted in 2027, with a focus in MM and DLBCL.

Endoplasmic Reticulum Induced Proximity (ERIP). Foghorn is advancing a novel small-molecule induced-proximity approach to degrade secreted and transmembrane proteins before they reach the cell surface or circulation. The approach has the potential to address high-value targets in I&I, oncology, and other disease areas with the goal of achieving antibody-like efficacy through small molecules.
Third Quarter 2026 Financial Highlights
•Collaboration Revenue. Collaboration revenue was $83.5 million for the three months ended September 30, 2026, compared to $8.2 million for the three months ended September 30, 2025. The $75.4 million increase was driven by a $74.1 million cumulative catch-up adjustment primarily related to updated estimated future costs for the decision to not advance FHD-909 and the SMARCA2 selective degrader.

•Research and Development Expenses. Research and development expenses were $18.8 million for the three months ended September 30, 2026, compared to $20.0 million for the three months ended September 30, 2025. The $1.2 million decrease is attributed to a decrease in Lilly-partnered program costs, decreases in facilities and IT-related expenses, and decreases in personnel-related costs, partially offset by an increase in early development and other external costs.

•General and Administrative Expenses. General and administrative expenses were $5.8 million for the three months ended September 30, 2026, compared to $6.7 million for the three months ended September 30, 2025. This $0.9 million decrease was due to a decrease in personnel related costs, decreases professional and consulting costs, and lower facilities and IT-related expenses.

•Net Income (Loss). Net income was $58.2 million for the three months ended September 30, 2026, compared to a net loss of $15.8 million for the three months ended September 30, 2025.

•Cash, Cash Equivalents, and Marketable Securities. As of September 30, 2026, the Company had $156.2 million in cash, cash equivalents, and marketable securities, providing cash runway into the second half of 2029.

(Press release, Foghorn Therapeutics, NOV 9, 2026, View Source [SID1234674471])