On September 10, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported the closing of its previously announced registered direct offering and concurrent private placement of an aggregate of 5,142,858 shares of common stock and unregistered warrants to purchase up to an aggregate of 5,142,858 shares of common stock (Press release, Citius Oncology, SEP 10, 2025, View Source [SID1234655928]). The combined effective offering price for each share of common stock and accompanying warrant was $1.75. The warrants have an exercise price of $1.84 per share, will be exercisable six months from the date of issuance, and will expire on the five and one-half year anniversary from the date of issuance.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement were approximately $9.0 million before deducting placement agent fees and other offering expenses payable by the Company.

Maxim Group LLC acted as the sole placement agent in connection with the offering.

The shares of common stock described above were offered pursuant to a registration statement on Form S-3 (File No. 333-289979), which was filed with the U.S. Securities and Exchange Commission ("SEC") on September 2, 2025, and was declared effective by the SEC on September 4, 2025. The offering of shares of common stock was made only by means of a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock has been filed with the SEC. Electronic copies of the prospectus relating to this offering, may also be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, Attention: Syndicate Department, by telephone at (212) 895-3745 or by email at [email protected]. The warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

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

On September 10, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, reported it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi) (Press release, Hoth Therapeutics, SEP 10, 2025, View Source [SID1234655927]).

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The submission marks a major regulatory inflection point for Hoth, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments. Pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple U.S. sites.

CEO Commentary

"We are very pleased with the timely CTA submission to the EMA, a pivotal step in advancing our international development of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Skin toxicities from EGFRi therapies remain an urgent, unmet medical need, and with no FDA or EMA-approved treatment available, advancing HT-001 in Europe represents a powerful opportunity to improve patient quality of life and drive meaningful value creation for shareholders."

Next Catalysts on Horizon

EMA Decision Expected in Coming Months covering initial sites across three EU countries.
Broader EU Expansion underway, with additional sites targeted to accelerate patient enrollment.
U.S. Phase 2a Trial Progressing – evaluating efficacy, safety, and tolerability of HT-001.

On September 10, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported key clinical updates from its daraxonrasib Phase 1 clinical trials (Press release, Revolution Medicines, SEP 10, 2025, View Source [SID1234655926]). The data, to be presented during an investor webcast today at 5:00 p.m. Eastern Time (ET), will focus on new daraxonrasib data in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), including long-term follow-up data in second line patients and initial monotherapy and chemotherapy-combination data in first line patients.

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"Patients living with pancreatic cancer have an urgent need for more effective and durable treatment options, and we are pursuing a bold vision to establish new global standards of care across treatment lines for this devastating disease," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Daraxonrasib’s pioneering mechanism of action covering RAS cancer driver mutations broadly, and highly encouraging new clinical findings released today, together provide strong evidence of its potential to serve these patients. The promising clinical profile observed in investigational studies to date in both previously treated and treatment-naïve patients with pancreatic cancer compels initiation of our planned registrational study evaluating daraxonrasib as monotherapy and in combination with chemotherapy in the first line metastatic setting."

Daraxonrasib Monotherapy: Long-term Follow-Up in 2L Metastatic PDAC
As of a June 30, 2025 cutoff date, patients with second line and beyond (2L+) metastatic PDAC treated with daraxonrasib 300 mg daily (QD) were evaluated for long-term follow-up on key safety and efficacy endpoints.

Safety: In 2L+ patients with RAS mutant PDAC (n=83), daraxonrasib 300 mg QD was generally well tolerated with a safety profile consistent with previously reported data. No new safety signals were identified.
Efficacy: Daraxonrasib at 300 mg QD demonstrated compelling antitumor activity and durability, with the following results for patients with second line (2L) RAS mutant PDAC with a RAS G12X mutation (n=26) or any RAS mutation (n=38), respectively:
The confirmed objective response rate (ORR) per RECIST v1.1 was 35% and 29%.
The disease control rate (DCR) was 92% and 95%.
The median progression-free survival (PFS) was 8.5 months (95% confidence interval (CI), 6.7 – 10.5) and 8.1 months (95% CI, 5.9 – 10.1).
The median overall survival (OS) was 13.1 (95% CI, 10.9 – NE) and 15.6 months (95% CI, 10.9 – NE).
Median follow-up was 16.7 months.
RASolute 302, the ongoing Phase 3 registrational trial of daraxonrasib monotherapy as a 2L treatment for metastatic PDAC, remains on track to complete global enrollment this year to enable an expected data readout in 2026.
Daraxonrasib Monotherapy: Initial Results in 1L Metastatic PDAC
As of a July 28, 2025 cutoff date, patients with treatment-naïve RAS-mutant PDAC treated with daraxonrasib 300 mg QD monotherapy were evaluated on key safety and antitumor activity endpoints.

Safety: In patients treated in this cohort (n=40), the safety profile observed for daraxonrasib monotherapy as a first line (1L) treatment was generally consistent with the reported safety findings for daraxonrasib in the 2L setting. The mean dose intensity was 85%.
Efficacy: In patients who met the definition of 1L metastatic PDAC and had sufficient follow-up (n=38), the ORR was 47% and the DCR was 89%, with a median follow-up of 9.3 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
Daraxonrasib plus Gemcitabine nab-Paclitaxel (GnP) Combination: Initial Results in 1L Metastatic PDAC

The combination of daraxonrasib plus chemotherapy is designed to sustain continuous suppression of RAS signaling by maintaining sufficient dose intensity for daraxonrasib, to leverage the antitumor contribution of chemotherapy and to achieve a safety profile that is competitive against standard chemotherapy.

For the combination, the company selected daraxonrasib 200 mg QD plus the standard dose of GnP given on a Days 1 and 15 schedule.

As of a July 28, 2025 data cutoff date, patients with 1L metastatic PDAC treated with the combination of daraxonrasib plus GnP were evaluated on key safety and antitumor activity endpoints.

Safety: In patients with RAS mutations (n=40), daraxonrasib plus GnP was generally well tolerated. The safety profile observed for the combination regimen was consistent with the sum of the known safety findings of each respective agent, and no new safety signals emerged. The mean dose intensity was 81%.
Efficacy: In patients who had sufficient follow-up (n=31), the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
These encouraging clinical results support the company’s plans to initiate RASolute 303, a global, randomized Phase 3 trial in patients with 1L metastatic PDAC, in the fourth quarter of 2025. The three-arm trial will evaluate daraxonrasib monotherapy and the combination of daraxonrasib plus GnP, each compared to a control arm with GnP treatment.

Investor Webcast

Revolution Medicines management will host an investor webcast today, September 10, at 5:00 p.m. ET (2:00 p.m. PT) to discuss these updates. To participate in the live webcast, participants may register at View Source A live webcast of the call will be available on the website at View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases2. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations3. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%4.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

On September 10, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that the Examining Division of the European Patent Office has issued an intention to grant a European Patent for Application No. 20168234.1, titled ‘Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer’ (Press release, Purple Biotech, SEP 10, 2025, View Source [SID1234655925]).

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This application, if granted, is expected to provide broad protection for NT219 combinations with leading immunotherapies, such as anti-PD-1, PD-L1, CTLA-4, and CD20 antibodies, which are designed to enhance responsiveness in resistant cancers. It further covers combinations of NT219 with MEK inhibitors that may expand treatment sensitivity for resistant tumors. Finally, the application includes claims for combinations of NT219 with selected chemotherapies or targeted agents to address cancers that develop resistance driven by KRAS amplification or mutation. The patent term, excluding extensions, runs through 2036.

"NT219 covalently binds to Insulin Receptor Substrate (IRS1/2), leads to IRS1/2 degradation, and blocks STAT3; both targets are key drivers of drug resistance and tumor immune evasion. We believe that combining NT219 with leading immunotherapies could represent a significant opportunity to thwart cancer’s natural ability to develop resistance mechanisms," said Gil Efron, CEO of Purple Biotech. "A Phase 2 study in squamous cell carcinoma of the head and neck (SCCHN) was initiated, evaluating NT219 in combination with either pembrolizumab as proof of concept for the combination with immunotherapy, or in combination with cetuximab where we observed activity in a Phase 1 study."

A comprehensive preclinical package supports the Phase 2 clinical study, demonstrated the synergistic activity of NT219 with immunotherapy in suppressing refractory tumors across multiple indications, showing conversion of the tumor microenvironment from immunosuppressive to immunoreactive (as reported at AACR (Free AACR Whitepaper) 2023 and AACR (Free AACR Whitepaper) 2025).

On September 10, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients (Press release, Karyopharm, SEP 10, 2025, View Source [SID1234655924]).

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"We are excited to announce that we have completed enrollment of our Phase 3 SENTRY trial and look forward to sharing top-line data from this pivotal trial in March 2026," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Selinexor plus ruxolitinib has the potential to be the first combination therapy approved for the treatment of myelofibrosis, depending on the outcome of the data. By combining selinexor with the current standard of care, we believe we have the potential to redefine the way people living with myelofibrosis are treated."

"I am grateful for the patients, their families and caregivers, the investigators and their clinical trial staff, as well as the extraordinary efforts of the Karyopharm team and our external partners for their help in successfully achieving this important milestone," said Reshma Rangwala, MD, PhD, Chief Medical Officer and Head of Research of Karyopharm. "This trial is advancing our understanding of the treatment of myelofibrosis and the potential role that XPO1 inhibition may play in this disease. People living with myelofibrosis deserve new treatment options and everyone involved in SENTRY is making an important contribution towards our common goal of providing additional options to patients with this disease."

"We are encouraged by the work that Karyopharm is doing in myelofibrosis and eagerly await data from the Phase 3 SENTRY trial," said Kapila Viges, Chief Executive Officer of MPN Research Foundation. "The myelofibrosis community is in need of new, more effective therapies that can help a greater number of patients beyond what is available with currently approved options. Efforts to develop new therapies bring hope to the myelofibrosis community and open the potential for patients to have more treatment options. For patients, options matter."

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L. Patients are randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume response rate ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline. The Phase 3 trial enrolled 353 patients.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia.2 Anemia and transfusion dependence are strongly correlated with poor prognosis and shortened survival.3

1. Clarivate/DRG (2023)
2. Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).
3. Pardanani, A., & Tefferi, A. (2011). Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica, 96(1), 8–10.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).

For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.