Hoth Therapeutics Delivers 100% Clinical Response with ~50% Reduction in Disease Severity in Open-Label PK Cohort of EGFR-Treated Cancer Patients

On January 22, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, reported positive interim results from the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy.

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In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by a ~50% reduction in investigator-assessed disease severity from baseline. In addition to the primary endpoint, supportive clinical endpoints showed meaningful improvements, including a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures.

Primary Endpoint: Marked Improvement in Disease Severity (ARIGA)

The primary endpoint of CLEER-001 assessed disease severity using the ARIGA scale. In the open-label PK cohort, mean ARIGA scores improved from 1.67 at baseline to 0.83 at Week 6, representing an approximate 50% reduction in severity.

Importantly, all evaluable patients reached ARIGA ≤1 by Week 6, placing the entire evaluable cohort within the low-severity disease range. Improvements were observed as early as Week 3 and were maintained through Week 6, demonstrating both rapid onset and durability of response.

Additional Endpoints: Improvement in Oncology Toxicity and Patient-Reported Symptoms

Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints:

Oncology Toxicity (CTCAE):
Investigator-assessed CTCAE scores improved from 2.0 at baseline to 1.33 at Week 6, representing an approximate 34% improvement in treatment-related toxicity. CTCAE is a core oncology toxicity scale frequently used to guide dose modification, interruption, or discontinuation of cancer therapies.
Pruritus (Patient-Reported NRS):
Mean pruritus scores improved from 4.22 at baseline to 2.67 at Week 6, representing approximate 37% reduction in symptom severity. This level of improvement exceeds commonly accepted thresholds for clinically meaningful benefit and is directly relevant to patient comfort, quality of life, and treatment adherence.
Favorable Tolerability and PK-Supported Dosing

HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. The PK portion of CLEER-001 was designed to evaluate exposure, tolerability, and early clinical signal, and the observed consistent improvements across investigator-assessed and patient-reported endpoints support the selected dosing regimen and continued clinical development.

Oncology Context and Unmet Need

EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. However, treatment-related toxicity and symptom burden remain among the most common and dose-limiting challenges, often impacting treatment continuity and outcomes. The CLEER-001 results highlight HT-001’s potential to serve as an important oncology supportive-care therapy, helping patients remain on effective, life-extending cancer treatments.

Management Commentary

"These results represent a meaningful milestone for HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Seeing 100% clinical response in the open-label PK cohort, along with a ~50% reduction in disease severity and additional improvements in oncology toxicity and patient-reported symptoms, underscores the potential of HT-001 to improve the treatment experience for cancer patients receiving EGFR inhibitors. We are encouraged by the breadth and consistency of these findings as the CLEER-001 trial continues."

About HT-001

HT-001 is Hoth Therapeutics’ proprietary topical therapy under investigation for the management of treatment-related toxicity and symptom burden in cancer patients receiving targeted therapies, including EGFR inhibitors.

(Press release, Hoth Therapeutics, JAN 22, 2026, View Source [SID1234662173])

PAQ Therapeutics Announces Series B Extension, Bringing Total Series B Financing to $77 Million; First Patient Dosed in Phase 1 Trial of PT0511, a Pan-KRAS Degrader

On January 22, 2026 PAQ Therapeutics, a clinical-stage oncology company developing novel targeted protein degradation therapies for KRAS-driven cancers, reported the closing of a Series B extension, bringing the company’s total Series B financing to $77 million, and the dosing of the first patient in a Phase 1 clinical trial evaluating PT0511, the company’s pan-KRAS degrader.

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The Series B extension builds on PAQ’s previously announced Series B financing, with participation from existing as well as new investors, and further strengthens the company’s balance sheet to advance multiple clinical programs. Proceeds from the financing will support the ongoing Phase 1 development of PT0253, PAQ’s KRAS G12D degrader, as well as the clinical advancement of PT0511.

"Completing this Series B extension and dosing the first patient in our PT0511 Phase 1 study represent important milestones for PAQ," said Nan Ji, PhD, Chief Executive Officer of PAQ Therapeutics. "Together, these achievements highlight our continued execution against a multi-program clinical strategy and our focus on addressing significant unmet need across KRAS-driven cancers."

PT0511 is a pan-KRAS degrader designed to target multiple oncogenic KRAS variants. The Phase 1 study is a first-in-human, open-label, dose-escalation trial evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PT0511 in patients with advanced solid tumors harboring KRAS alterations.

"The initiation of clinical dosing with PT0511 expands our clinical portfolio beyond single-mutation KRAS targeting," said Andrew Krivoshik, MD, PhD, Chief Medical Officer of PAQ Therapeutics. "A pan-KRAS degradation approach has the potential to address key limitations for patients observed with existing KRAS- or pan-RAS inhibitor therapies."

PAQ continues to advance a differentiated KRAS pipeline by leveraging targeted protein degradation to achieve deep and selective suppression of oncogenic signaling, while maintaining favorable safety and combinability profiles.

(Press release, PAQ Therapeutics, JAN 22, 2026, View Source [SID1234662174])

Israel Cancer Research Fund and Cancer Research Institute Announce Co-Funding of Grant to Address Immunotherapy Resistance in Melanoma

On January 22, 2026 Israel Cancer Research Fund (ICRF) and the Cancer Research Institute (CRI) reported to have partnered on a new award, the ICRF-CRI Immunotherapy Collaborative Project Grant, given to Dr. Asaf Madi, PhD, of Tel Aviv University. Dr. Madi was awarded $180,000 over a three-year period to support his research on refining tumor-infiltrating lymphocyte (TIL) therapy to predict response and overcome drug resistance in melanoma.

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"We are honored to once again partner with CRI, a world-class immunotherapy research organization, on this cutting-edge project," said Alan Herman, ICRF’s Executive Director. "There is a clear, unmet need for personalized treatments like TIL therapy, and Dr. Madi’s research into adoptive cell transfer could offer new hope to melanoma patients in urgent need of better options."

Adoptive cell transfer (ACT) using TILs is a promising personalized immunotherapy for melanoma, shown to improve survival in advanced cases. However, many patients do not respond, and others develop resistance, limiting the long-term effectiveness of this approach. Dr. Madi’s research aims to address these challenges by identifying predictive biomarkers, uncovering mechanisms of tumor resistance, and optimizing TIL selection and expansion to improve therapeutic outcomes.

Dr. Madi and his team are studying the gene circuits that program immune cells, controlling their differentiation, activation, and regulation. By examining how T cells behave in tumors, particularly following immunotherapy, they aim to determine why some T cells sustain anti-tumor activity while others become exhausted or suppressed. Insights from this work will guide the selection and engineering of more potent TIL populations capable of durable tumor targeting and generating long-term immune memory, reducing the risk of cancer recurrence.

"This collaboration reflects what progress in immunotherapy really looks like—bringing together partners, data, and discovery to tackle resistance head-on," said Alicia Zhou, PhD, CEO of CRI. "By understanding why some immune cells persist while others fail, Dr. Madi’s work moves us closer to making personalized cell therapies like TILs more reliable, more durable, and more transformative for patients with melanoma."

Melanoma is the deadliest form of skin cancer. In the U.S. alone, over 100,000 new cases are diagnosed each year, and advanced melanoma can be resistant to standard treatments. Because it can spread quickly and evade therapies, developing new, effective treatments is critical to improve survival and offer hope to patients and their families worldwide.

Dr. Asaf Madi earned his Ph.D. in computational immunology at Tel Aviv University in collaboration with the Weizmann Institute of Science, studying B cell and T cell repertoires. He then completed a postdoctoral fellowship at Harvard Medical School and the Broad Institute, focusing on T-cell differentiation and cancer immunology. Dr. Madi then returned to Tel Aviv University, where he is now an Associate Professor in the Department of Pathology, leading a team that drives the development of novel anti-cancer therapies.

(Press release, Cancer Research Institute, JAN 22, 2026, View Source [SID1234662175])

New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer

On January 21, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported The New England Journal of Medicine (NEJM) published the full results from the positive Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). ASCENT-04 successfully met its primary endpoint of progression-free survival (PFS) with a 35% (HR: 0.65; p<0.001) reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) versus standard of care Keytruda plus chemotherapy (n=222). Median PFS with Trodelvy plus Keytruda was 11.2 months versus 7.8 months when Keytruda was given in combination with chemotherapy.

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"Metastatic TNBC patients often show rapid progression and poor outcomes after current first-line therapies, illustrating the urgent need for new and more efficacious treatment options," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "These results represent important progress toward our goal of delivering Trodelvy to patients in earlier lines of breast cancer treatment, with potential to become a backbone therapy for all frontline metastatic TNBC patients in need of innovative therapeutics."

"Patients with PD-L1+ metastatic triple-negative breast cancer continue to face limited options in the first-line setting," said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and Principal Investigator of the ASCENT-04 study. "As such, these very promising data with the novel combination of sacituzumab govitecan and pembrolizumab in frontline metastatic TNBC represent a meaningful step forward in establishing a potential new standard of care for this challenging disease."

The NEJM publication of the ASCENT-04 results follow a data presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Congress, as well a simultaneous presentation at the 2025 European Society for Medical Oncology Congress and publication in NEJM of primary results from the ASCENT-03 trial of Trodelvy monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors. Gilead has submitted supplemental applications for both indications to the U.S. Food and Drug Administration and European Medicines Agency.

The safety profile of Trodelvy plus Keytruda in ASCENT-04 was consistent with the known safety profile of each agent. No new safety signals were identified with the combination, and the combination did not exacerbate the safety profile of either therapy. The most frequent (≥10% of patients) grade ≥3 treatment-emergent adverse events with Trodelvy plus Keytruda were neutropenia (43%) and diarrhea (10%), and with Keytruda plus chemotherapy were neutropenia (45%), anemia (16%) and thrombocytopenia (14%). Fewer patients discontinued treatment due to adverse events on the Trodelvy plus Keytruda arm than with Keytruda plus chemotherapy (12% vs. 31%).

Healthcare professionals have well-established experience with Trodelvy, with more than 60,000 breast cancer patients treated across 50+ countries over the past five years. It remains the only Trop-2-directed antibody-drug conjugate (ADC) to demonstrate meaningful survival benefits in both 2L+ metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. With ASCENT, TROPiCS-02, ASCENT-03 and ASCENT-04, Trodelvy is also the only ADC with four positive Phase 3 trials in HER2- mBC (IHC 0, IHC 1+, or IHC 2+/ISH–).

The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Triple-Negative Breast Cancer with PD-L1+ Tumors

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

Despite progress in treatment, first-line metastatic TNBC has seen limited new approvals in recent years for tumors that express PD-L1+, and additional options are urgently needed. Despite recent advances, over 50% of patients do not receive treatment beyond first-line, reinforcing the urgent need for new options to help improve patient outcomes. Breast cancers expressing PD-L1 are overall more aggressive and associated with reduced survival time.

About the ASCENT-04/KEYNOTE-D19 Study

In 2021, Gilead entered a collaboration with Merck & Co. to investigate Trodelvy in combination with Keytruda in the Phase 3 trial, ASCENT-04/KEYNOTE-D19. The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy in combination with Keytruda compared with treatment of chemotherapy plus Keytruda in patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The study enrolled 443 patients across multiple study sites.

Patients were randomized in a 1:1 ratio to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus Keytruda (200 mg intravenously on Day 1 of a 21-day cycle) or chemotherapy plus Keytruda. The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Treatment continued until blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Patients randomized to chemotherapy were allowed to cross over and receive Trodelvy upon disease progression as part of the study.

The primary endpoint of the study is progression-free survival (PFS) as determined by BICR using RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety.

More information about ASCENT-04/KEYNOTE-D19 is available at ClinicalTrials.gov: NCT05382286.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

INDICATIONS

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
IMPORTANT SAFETY INFORMATION

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, JAN 21, 2026, View Source [SID1234662139])

Corvus Pharmaceuticals Announces Pricing of Upsized Public Offering of Common Stock

On January 21, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the pricing of an upsized underwritten public offering of 7,900,677 shares of its common stock at a price to the public of $22.15 per share. Gross proceeds from the underwritten public offering before deducting underwriting discounts and commissions and estimated offering expenses are expected to be approximately $175.0 million. All of the shares of common stock are being offered by Corvus. In addition, Corvus has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,185,101 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Corvus currently expects to use the net proceeds from this offering for working capital and general corporate purposes, which may include capital expenditures and research and development, including for its Phase 3 T cell lymphoma, and Phase 2 atopic dermatitis, hidradenitis suppurativa and asthma clinical trials, sales and marketing and administrative expenses.

The offering is expected to close on or about January 23, 2026, subject to satisfaction of customary closing conditions.

Jefferies and Goldman Sachs & Co. LLC are acting as lead book-running managers for the offering. Mizuho is acting as bookrunner for the offering. Ladenburg Thalmann & Co. Inc. is acting as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-281318) relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission ("SEC") on August 15, 2024 and a related registration statement that was filed with the SEC on January 21, 2026 pursuant to Rule 462(b) under the Securities Act of 1933 (and became automatically effective upon filing). The offering of these securities is being made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statements. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 1-877-821-7388, or by email at [email protected]; and Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526, or by email at [email protected].

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

(Press release, Corvus Pharmaceuticals, JAN 21, 2026, View Source [SID1234662140])