On January 13, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin, bringing the total number of Annamycin treated subjects reviewed by its independent expert to 90. Data from the most recently completed clinical trials’ subjects were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of certain data, the independent expert concluded that there was no evidence of cardiotoxicity. This data is across five clinical trials treating acute myeloid leukemia (AML) and soft tissue sarcoma (STS) with Annamycin as a monotherapy and in combination with cytarabine and across multiple sites in the United States (US) and the European Union (EU). Most of these subjects were treated above the recommended lifetime maximum for other anthracyclines.

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The data made available to the expert included, but was not limited to, data from serial 12-lead ECGs, transthoracic echocardiography with centralized global longitudinal strain (GLS) analysis, and cardiac biomarker (troponins I and T) concentration measurements by a central lab using validated assays. Cardiac health biomarkers such as blood troponin levels are considered an indicator of potential long-term heart damage.

"As we closely approach almost 100 subjects that have received Annamycin (also known by the name "naxtarubicin") which have been reviewed by our expert, we continue to be encouraged by the potential of Annamycin. This additional independent report of additional datasets provides further validation of the absence of cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Annamycin continues to demonstrate an absence of cardiotoxicity, even in subjects who have received far more than the lifetime maximum cumulative anthracycline exposure established by the US Food and Drug Administration (FDA). In fact, 65 of the 90 subjects evaluated have been taken over the FDA’s lifetime maximum of 550 mg/m2 and with one of them being taken over 6500 mg/m2. Our growing body of positive data for Annamycin continues to bolster our confidence in our belief that Annamycin is truly a ‘next generation’ anthracycline, especially in light of the growing efficacy data that we have previously reported in the treatment of AML and STS. We remain focused on advancing our Annamycin development programs and ultimately, addressing the medical unmet needs of people with difficult to treat cancers."

"It is important to understand that nearly half of all cancers and 60% of childhood cancers are currently treated with cardiotoxic anthracyclines that result in permanent damage to the heart. To quote one study: ‘Some commonly used cancer drugs, such as the anthracyclines, are known to be cardiotoxic. Left undetected and untreated, this cardiotoxicity is progressive and persistent and can lead to cardiomyopathy, clinical heart failure, the need for a heart transplant, or death. In fact, 30 years after diagnosis, the number of cardiac-related deaths among survivors exceeds the number caused by cancer recurrence (emphasis added).’ We believe Annamycin has the potential to become the first ever non-cardiotoxic anthracycline. Coupled with its observed ability in a wide range of tumor animal models to avoid cross-resistance with existing anthracyclines and to demonstrate equal or greater efficacy, we believe the market opportunity for Annamycin is potentially enormous. We are looking forward to adding to this dataset and completing long-term cardiac follow-up with active subjects in our current trials."

(Press release, Moleculin, JAN 13, 2026, https://moleculin.com/moleculin-reports-independent-assessment-confirms-no-cardiotoxicity-of-annamycin-in-90-subjects/ [SID1234662017])

On January 13, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported an update on the Company’s 2026 strategic priorities and clinical development progress. These updates will be discussed as part of the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 3:00 p.m. PT / 6:00 p.m. ET.

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"Since our founding, we have intentionally built Zai Lab as a dual-engine company – combining a commercially profitable and scaling China business with a global innovation engine that is now reaching a pivotal inflection point," said Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "With Zoci now in Phase 3 and multiple global programs advancing behind it, we are entering our next phase with a highly efficient, globally integrated R&D platform, a strong balance sheet, and the capabilities to execute at scale."

"Our regional business is built around a portfolio of high-impact, first- and best-in-class medicines that are driving durable, multi-year growth," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "This engine provides a strong and growing financial foundation to support our long-term strategic priorities. At the same time, our dual-gateway model and partner-of-choice position enable us to consistently access high-quality innovation and advance those assets efficiently on a global stage."

Zai Lab’s Dual-Engine Strategy

Zai Lab’s differentiated dual-engine model is designed to drive both near-term performance and long-term global value creation. The Company’s commercially profitable and scaling China business provides a strong financial foundation to invest in global innovation. Its fully integrated cross-border R&D platform enables faster, more capital-efficient development of high-quality assets, as demonstrated by Zoci’s rapid advancement from first-in-human studies to global pivotal trials. Together, these two engines uniquely position Zai Lab to build a globally competitive biopharmaceutical company.

Advancing Differentiated Global Programs Across Oncology and Immunology

Zocilurtatug Pelitecan (Zoci or ZL-1310)

Zoci, the Company’s lead global asset and a potential first- and best-in-class DLL3-targeting ADC, is expected to be in three registrational studies by the end of 2026:

2L/3L SCLC (small cell lung cancer): Data demonstrated a 68% overall response rate (ORR) with a favorable safety profile, including low rates of Grade 3+ adverse events and no treatment-related discontinuations at 1.6 mg/kg. A registrational Phase 3 study has been initiated.
1L SCLC: An ongoing Phase 1 combination study with PD-L1 ± chemotherapy is expected to inform the design of a Phase 3 study anticipated to initiate by year-end. A novel combination Phase 1 study is expected to initiate in the first half of 2026.
NEC (neuroendocrine carcinoma): A Phase 1 study is ongoing, with results expected in the first half of 2026. A registration-enabling study is expected to initiate in the second half of 2026.
Other Global Oncology Assets

ZL-6201: A novel LRRC15-targeting ADC designed to disrupt the tumor microenvironment by targeting tumor-associated fibroblasts (TAF), enabling potential for broad applicability across multiple solid tumors (sarcoma, breast cancer, NSCLC). Global Phase 1 initiation is expected in 1Q 2026.
ZL-1222: A next-generation PD-1/IL-12 immunocytokine that has demonstrated strong anti-tumor activity in preclinical models, including in PD-1-sensitive and resistant settings, with an improved systemic safety profile. IND-enabling studies are expected to complete this year.
ZL-1311: A next-generation T-cell engager (TCE) targeting MUC17, a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. The program represents Zai Lab’s first globally owned TCE and strategically expands our immuno-oncology portfolio while leveraging our established expertise in GI cancers. ZL-1311 is expected to enter global clinical development this year.
Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year.

ZL-1503: A Novel Dual-Targeting Approach for Atopic Dermatitis (AD)

ZL-1503 is a first-in-class bispecific antibody dual-targeting IL-13 and IL-31R designed to provide rapid itch relief and broad disease control.

The Company anticipates reporting First-in-Human (FIH) data from healthy volunteers in the second half of 2026, paving the way for Phase 2 development in AD patients.
Key Near-Term Regional Launches to Drive Steady Growth

Today, Zai Lab has eight commercial products in China, forming a diversified and durable commercial portfolio. COBENFY is expected to launch in the first half of 2026 through a focused, high-impact commercial strategy, emphasizing physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Additional near-term launches, including povetacicept and VRDN-003, are expected to add further layers of growth to the regional business. As China’s regulatory and market access environment continues to evolve, Zai Lab is well positioned to deliver long-term growth.

Catalyst-Rich 2026: Granular Milestones to De-Risk Pipeline and Drive Value

2026 is expected to be a defining year for Zai Lab, with multiple high-impact milestones across its global pipeline. Key catalysts include the continued execution of Zoci’s pivotal program, the advancement of multiple novel oncology and immunology assets into the clinic, several anticipated IND filings, and data readouts designed to further validate the Company’s integrated R&D platform. On the regional front, the expected launch of COBENFY and continued growth of existing product franchises are expected to further strengthen the Company’s financial foundation. Together, these milestones are expected to continue to de-risk the pipeline, accelerate value inflection points, and support Zai Lab’s next phase of global growth.

(Press release, Zai Laboratory, JAN 13, 2026, View Source [SID1234662032])

On January 13, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), reported updated timelines on its ongoing clinical trials in advanced cancer and adult NF1-PN patients.

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Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN (NCT06961565):

Pasithea has completed enrollment of 12 patients through the first 4 dose cohorts (4, 8, 12 and 18 mg tablets) in Part A of the study.

The Company plans to present data in the second half of 2026, including available efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas. The planned data release is also expected to include safety, tolerability and pharmacokinetic (PK) data.
Ongoing Phase 1 clinical trial in advanced cancer patients (NCT06299839):

Pasithea expects to present longer-term follow-up data from patients in Cohort 4 (15mg capsule) through Cohort 8 (45mg capsule) in the second quarter of 2026.
"2025 was a pivotal year for Pasithea, highlighted by early evidence of a differentiated safety and tolerability profile and initial signals of clinical activity in our first-in-human dose escalation advanced cancer study of PAS-004, our potentially best-in-class macrocyclic MEK inhibitor," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "In November 2025, we announced encouraging results in patients previously treated with a MEK inhibitor, including a partial response and an initial disease control rate of 71.4% among efficacy evaluable patients with BRAF-mutated tumors and met our planned milestone of providing initial NF1-relevant data through the presentation of pharmacokinetic results in the first two cohorts of our NF1 study. We believe these findings from our advanced cancer study support the development of PAS-004 for the treatment of NF1-PN patients. Additionally, in December 2025, we successfully raised $60 million in gross proceeds through a public offering, enabling us to advance PAS-004 through several key milestones and support operations through at least the first half of 2028. We remain steadfast in our mission to deliver safe, tolerable and effective therapies to patients with significant unmet need, especially in indications requiring chronic dosing."

(Press release, Pasithea Therapeutics, JAN 13, 2026, View Source [SID1234662018])

On January 13, 2026 ESTEVE and TerSera Therapeutics LLC reported that they have entered into an agreement in which ESTEVE will acquire TerSera’s Infusion Specialty Therapies Business Unit (IST). This strategic acquisition enables ESTEVE to expand its U.S. presence, with two highly specialized on-market assets and a dedicated team of sales, marketing and medical professionals.

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TerSera’s IST business unit includes two specialty medications, Prialt (ziconotide intrathecal infusion) and Quzyttir (cetirizine hydrochloride injection). Prialt is the only FDA-approved, non-opioid agent indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.1 Prialt is currently marketed in Europe by ESTEVE.2 Quzyttir is the first and only injectable second-generation H1 antihistamine approved by the FDA for the treatment of acute urticaria in adults and children six months of age and older.3

With this transaction, ESTEVE will obtain worldwide rights for Quzyttir in all territories (except for China) and consolidates its rights for Prialt worldwide.

Staffan Schüberg, ESTEVE’s Chief Executive Officer stated: "We are excited to welcome the Infusion Specialty Therapies Business Unit and look forward to welcoming TerSera’s talented team to ESTEVE. This acquisition perfectly aligns with our strategic vision of providing highly specialized solutions where there is a significant unmet medical need. By adding Quzyttir to our portfolio and expanding to the US market with Prialt, we not only strengthen our expertise in highly specialized therapies but also accelerate our expansion in the United States—the world’s largest pharmaceutical market."

"ESTEVE has been our long-term partner for Prialt in Europe. Their expertise and core areas of focus make them the ideal future owner for IST," said Edward Donovan, Chief Executive Officer of TerSera. "We believe this transaction provides an excellent home for Prialt and Quzyttir to continue the strong momentum we have established with these medicines, while we sharpen our focus on our core therapeutic areas of oncology and rare disease."

This deal reinforces ESTEVE’s growth in the United States, a growth that began with the acquisition in 2024 of a business specialized in rare and ultra-rare diseases in the areas of endocrinology and onco-endocrinology. ESTEVE’s highly specialized portfolio has been further strengthened by the subsequent expansion in 2025: licensing-in for Ex US a biologic product used to treat children and adolescents from 2 to 18 years-old who suffer from severe primary insulin-like growth factor 1 deficiency4; an adjuvant treatment being investigated in the U.S. and considered standard of care outside of the U.S. where it is approved for high-grade resectable non-metastatic osteosarcoma in patients aged between 2 and 30 years5 ; and a medicine that is used in adults and children above 5 years of age to treat aggressive and symptomatic medullary thyroid cancer.6

The current transaction is expected to close in the first quarter of 2026, subject to regulatory clearances.

Perella Weinberg Partners are the financial advisor to ESTEVE on this transaction, and Arnold & Porter are serving as legal counsel. Leerink Partners acted as the lead financial advisor to TerSera, and Kirkland & Ellis LLP is serving as legal counsel.

About PRIALT (Ziconotide Intrathecal Infusion)

PRIALT is a non-opioid intrathecal analgesic indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. Derived from a marine snail peptide, ziconotide acts as a selective N-type calcium channel blocker, interrupting pain signal transmission in the spinal cord. Ziconotide is administered via continuous intrathecal infusion and is not associated with the risk of addiction or respiratory depression commonly seen with opioid therapies.1

IMPORTANT SAFETY INFORMATION

WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS

PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.

Contraindications

PRIALT is contraindicated in patients with:

A known hypersensitivity to ziconotide or any of its formulation components.
Any other concomitant treatment or medical condition that would render intrathecal administration hazardous, such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF).
A pre-existing history of psychosis.
Warnings and Precautions

Cognitive and Neuropsychiatric Adverse Reactions

Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients frequently for cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.

In clinical trials, 12% of patients reported hallucinations; other acute psychiatric events included paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%).

Patients with pretreatment psychiatric disorders may be at increased risk. Management of psychiatric complications may need to include discontinuation of PRIALT, treatment with psychotherapeutic agents and/or short-term hospitalization.

In clinical trials, cognitive adverse reactions included confusion (33%), memory impairment (22%), speech disorder (14%), aphasia (12%), thinking abnormal (8%), and amnesia (1%). Cognitive impairment may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop, but other contributing causes must also be considered. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation. The elderly (≥65 years) are at higher risk for confusion. Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects.

Meningitis and Other Infections

Meningitis can occur due to inadvertent contamination of the microinfusion device and other means. In clinical trials, the rate of meningitis was 3% (40 cases) in the PRIALT group using either internal or external microinfusion devices and 1% (1 case) with placebo. In patients with external microinfusion devices and catheters, meningitis occurred in 38 out of 41 patients (93%), 37 of whom received PRIALT and one who received placebo. Patients, caregivers, and healthcare providers must be particularly vigilant for the signs and symptoms of meningitis including, but not limited to, fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.

Strict aseptic procedures must be used during the preparation of the PRIALT solution and refilling of the microinfusion device.

Reduced Level of Consciousness

In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, and other etiologies (e.g., meningitis) must be considered.

Elevation of Creatine Kinase

In clinical trials, serum creatine kinase (CK) levels above the upper limit of normal (ULN) were reported in 40% of patients, with 11% of patients having CK levels >3 times ULN. Incidences were higher during the first 2 months of treatment. Serum CK should be monitored periodically. In the setting of new neuromuscular symptoms, evaluate patients, obtain CK measurements, and if symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.

Withdrawal From Opiates

PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates. To avoid withdrawal syndrome when opiate withdrawal is necessary, do not abruptly reduce or withdraw opioid medications.

Driving and Operating Machinery

Use of PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥25%) in clinical trials (n=1254 PRIALT-treated patients) were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.

Indication

PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or [email protected].

Please see PRIALT Full Prescribing Information, including BOXED Warning.

About QUZYTTIR (Cetirizine Hydrochloride Injection)

QUZYTTIR is a second-generation intravenous antihistamine indicated for the treatment of acute urticaria in adults and children six months of age and older. As a selective H1 receptor antagonist, cetirizine works by blocking histamine activity, helping to rapidly relieve symptoms of allergic reactions. QUZYTTIR is administered via intravenous infusion and offers fast onset of action with less sedation compared to first-generation antihistamines.2

IMPORTANT SAFETY INFORMATION

Contraindications

Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.

Warnings and Precautions

The occurrence of somnolence/sedation has been reported in some patients. Advise patients to exercise due caution when driving or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.

Adverse Reactions

The most common adverse reactions (incidence <1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The most common adverse reactions (incidence ≥2%) with chronic dosing of oral cetirizine hydrochloride in adults are somnolence, fatigue, dry mouth, pharyngitis and dizziness. Adverse reactions observed in pediatric patients with chronic use of oral cetirizine hydrochloride are headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting.

Indication and Usage

QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or [email protected].

Please see QUZYTTIR Full Prescribing Information.

(Press release, Esteve, JAN 13, 2026, View Source [SID1234662033])

On January 13, 2026 Immunofoco, a clinical-stage biotechnology company advancing innovative CAR-T cell therapies for solid tumors, reported clinical data from its Phase I/IIa study of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, in patients with advanced gastric cancer and gastroesophageal junction cancer (GC/GEJ). The data were presented as a poster (Abstract No. 398) at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2026).

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The study is a multicenter, open-label, dose-escalation Phase I/IIa trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ who had failed at least two prior lines of systemic therapy. The results presented at ASCO (Free ASCO Whitepaper) GI 2026 focus on the GC/GEJ cohort.

As of the data cutoff on August 8, 2025, 16 patients had received a single infusion of IMC002 and were included in the safety analysis, with 15 patients evaluable for efficacy. IMC002 demonstrated a favorable and manageable safety profile, with no dose-limiting toxicities observed during the dose-escalation phase. Cytokine release syndrome (CRS) occurred in all patients but was limited to Grade 1 or 2, and no Grade ≥3 CRS, ICANS, or treatment-related deaths were reported.

In evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7% (10/15). Survival data were immature at the time of analysis, with a median progression-free survival (mPFS) of 7.0 months (95% CI: 3.9, NA) and a median overall survival (OS) of 10.3 months (95% CI: 6.1, NA).

Notably, one patient in the 2.5×10⁸ CAR-T cell dose cohort achieved a complete response (CR) and has remained tumor-free for 60 weeks, demonstrating antitumor activity following IMC002 treatment in a heavily pretreated setting.

Further analyses indicated that IMC002 provided clinically meaningful PFS benefits in third-line and later-line GC/GEJ patients, comparing favorably with historical outcomes reported for this population. Together with its well-tolerated safety profile, these findings support the continued clinical development of IMC002 and its potential evaluation in earlier-line treatment settings.

"IMC002 demonstrated a controllable safety profile and encouraging antitumor activity in patients with advanced gastric and gastroesophageal junction cancers, including those who had failed multiple prior lines of therapy," said Professor Jianming Xu, corresponding author of the study and Professor at the First Medical Center of the Chinese PLA General Hospital. "Of particular clinical significance, one patient achieved a complete response lasting for more than one year. These findings provide important clinical evidence supporting the application of CLDN18.2-targeted CAR-T therapy in solid tumors, and the favorable safety profile also opens the possibility for future exploration in earlier-line settings and strategies aimed at long-term clinical benefit."

IMC002 is a novel CLDN18.2-targeted CAR-T cell therapy incorporating a highly specific VHH domain, designed to enhance tumor targeting while maintaining a favorable safety profile in solid tumors. Based on the encouraging results from this Phase I/IIa study, a Phase III randomized controlled trial of IMC002 in late-line GC/GEJ patients has been initiated.

The presentation at ASCO (Free ASCO Whitepaper) GI 2026 highlights Immunofoco’s continued progress in advancing CAR-T cell therapies for solid tumors and underscores the therapeutic potential of CLDN18.2-targeted approaches in addressing significant unmet medical needs in advanced gastrointestinal cancers.

(Press release, Immunofoco, JAN 13, 2026, View Source;highlighting-a-durable-complete-response-beyond-one-year-and-a-66-7-orr-in-advanced-gcgej-302659498.html [SID1234661990])