On September 30, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "we" or "us" or "IMMX"), a global leader in relapsed/refractory AL Amyloidosis, reported the closing of its previously announced underwritten registered offering of 11,363,637 shares of its common stock at a public offering price of $11.00 per share. The net proceeds to Immix from the offering, after deducting the underwriting discounts, commissions and other offering expenses, were approximately $117.1 million.

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Immix intends to use the net proceeds from this offering to fund NXC-201 development, working capital and general corporate purposes.

J.P. Morgan acted as the sole book-running manager for the offering. The offering included participation from leading U.S. biotechnology institutional investors and mutual funds.

The shares of common stock described above were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-292665), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 9, 2026, and declared effective on January 22, 2026. A prospectus supplement and accompanying prospectus describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus related to this offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected] and [email protected].

This press release shall not constitute an offer to sell or the 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.

(Press release, Immix Biopharma, SEP 30, 2026, View Source [SID1234671182])

On September 30, 2026 Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, reported that REVTORPYK (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK was approved in combination with palbociclib and fulvestrant ("REVTORPYK triplet") and in combination with fulvestrant ("REVTORPYK doublet"), by the U.S. Food and Drug Administration ("FDA") on July 14, 2026.

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"Our experienced commercial and medical affairs teams have been laying the groundwork for a successful launch with healthcare providers, payers, and patient advocacy partners since REVTORPYK was approved," said Brian Sullivan, CEO and co-founder of Celcuity. "Now that REVTORPYK is commercially available, we are focused on working with physicians to bring this new treatment option to patients living with HR+/HER2- advanced breast cancer."

As part of its commitment to patient access, Celcuity has launched the REVTORPYK Support Services program to provide financial assistance and treatment enrollment resources for physicians and eligible patients. The program offers support with insurance coverage, including access and reimbursement; and facilitates access to financial assistance, including Copay Assistance and Patient Assistance Programs. For more information, healthcare providers can visit www.revtorpykhcp.com or contact REVTORPYK Support Services at 877-4-CELCUITY (877-423-5284).

"There is an urgent need for new and differentiated treatment options for patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer in the second-line setting," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "REVTORPYK demonstrated unprecedented clinical benefit in the pivotal VIKTORIA-1 study, and we believe, provides an important new therapeutic option to address this need. We are excited now to make this new therapy available to physicians and their patients."

Celcuity submitted a supplemental New Drug Application to the FDA in August for REVTORPYK to treat patients with HR+/HER2-, PIK3CA mutated, advanced breast cancer based on the results of Study 2 of the VIKTORIA-1 trial. If approved, physicians would have the option to prescribe REVTORPYK for patients with advanced breast cancer regardless of their PIK3CA tumor status.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

About REVTORPYK (gedatolisib)

REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.3,4,5

REVTORPYK is in development for the first-line treatment of HR+/HER2- ABC and for the second-line treatment of metastatic castration-resistant prostate cancer.

Indication Statement

REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. 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 REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS

REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

USE IN SPECIFIC POPULATION

Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products.

Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility.

Please see full Prescribing Information, including Patient Information, for REVTORPYK.

(Press release, Celcuity, SEP 30, 2026, View Source [SID1234671181])

On September 30, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported an update that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

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"We are grateful to the Agency for their continued guidance and engagement with our partner, PFP, and us," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We will continue to support PFP as it prepares for the review process and anticipate providing a revised anticipated PDUFA date as it becomes available."

PFP, with Atara’s support, has resubmitted the BLA based on the feedback received from the Type A meeting held in April. The resubmission includes an updated data package with additional patients, plus longer follow up from the ongoing, pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT). The resubmission also includes additional supplemental data from the expanded access programs, a separate clinical study, and commercial experience in Europe.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales.

(Press release, Atara Biotherapeutics, SEP 30, 2026, View Source [SID1234671179])

On September 30, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the release of a new installment of its CEO Corner series featuring Chief Executive Officer Thomas K. Equels discussing how Ampligen (rintatolimod) could fit into the evolving treatment landscape for pancreatic cancer.

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In the CEO Corner, Equels discusses recent advances in pancreatic cancer treatment and why AIM believes Ampligen’s distinct immune-modulating approach warrants continued investigation. Rather than directly targeting a cancer-driving pathway, Ampligen has the potential to induce a broad-spectrum therapeutic effect that amplifies a patient’s innate immune response, creating the potential for a complementary role alongside or following therapies that act through different mechanisms.

The segment also highlights observations from a Dutch Named Patient Program ("NPP") in which patients with radiologically stable pancreatic cancer after FOLFIRINOX received Ampligen as a maintenance treatment. In an exploratory analysis of 39 patients with a neutrophil-to-lymphocyte ratio ("NLR") below 4.5, median overall survival was 34.8 months, measured from the start of FOLFIRINOX. This encouraging observation supports further investigation of Ampligen following chemotherapy.

Advances with FOLFIRINOX and daraxonrasib highlight the evolving treatment landscape in pancreatic cancer. The following chart summarizes the median overall survival results from the selected patients from NPP program as well as data from the separate clinical trials of FOLFIRINOX in metastatic pancreatic cancer and a daraxonrasib clinical trial of RAS G12 mutation patients with previously treated metastatic pancreatic cancer.

However, differences in patient selection, disease stage, treatment setting, and the timing of survival measurement prevent direct comparisons between the NPP findings and survival results from trials of these therapies. These findings provide a rationale for randomized studies to determine whether adding Ampligen after chemotherapy improves outcomes. Further research is also needed to establish whether NLR can identify patients more likely to benefit specifically from Ampligen, rather than patients with a generally more favorable prognosis.

"Pancreatic cancer continues to present an urgent need for better treatment strategies, even as important new therapies emerge," said Equels. "Ampligen approaches the disease differently through its potential to activate the innate immune response. We believe the powerful overall survival signal seen in the Named Patient Program, together with the clinical and biomarker data being generated through DURIPANC, will provide a compelling rationale to continue evaluating Ampligen’s potential role in pancreatic cancer. Ultimately, our goal is to get drug approval, which will be based on overall survival, in all probability focused on patients with neutrophil-to-lymphocyte ratios below 4.5."

AIM is continuing to investigate Ampligen through the ongoing Phase 2 DURIPANC study evaluating Ampligen in combination with AstraZeneca’s durvalumab in metastatic pancreatic cancer. The study’s primary endpoint is Clinical Benefit Rate at 24 weeks following initiation of combination therapy, with topline results anticipated in the first quarter of 2027. The study is also evaluating progression-free survival, overall survival and immune profiling, with overall survival analysis expected to begin in 2027.

AIM anticipates topline results from DURIPANC in the first quarter of 2027, followed by its analysis of overall survival – the gold standard for drug approval – commencing in Q3 2027. If supported by the clinical and biomarker data, the Company believes the study could help define the parameters of a potential follow-up pivotal Phase 3 program and provide positive clarity around where Ampligen fits within an evolving pancreatic cancer treatment landscape.

(Press release, AIM ImmunoTech, SEP 30, 2026, View Source [SID1234671178])

On September 30, 2026 Hummingbird Bioscience ("Hummingbird") a biotherapeutics company discovering and developing transformative medicines for diseases with significant unmet need, reported that HMBD-001 has advanced into Phase II clinical development and that the first patient in the Phase II clinical study of HMBD-001-103 has been dosed.

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HMBD-001 is a differentiated anti-HER3 monoclonal antibody engineered with Hummingbird Bioscience’s Rational Antibody Discovery (RAD) platform, a core part of the AI Molecular Medicine (AIMM) platform. Phase II of the HMBD-001-103 clinical study is recruiting patients with advanced squamous cell cancers (NCT05910827) across multiple countries, including China, Australia, Moldova and Singapore. An Investigational New Drug (IND) application for HMBD-001 has been approved by the U.S. Food and Drug Administration (FDA).

Recommended doses for expansion (RDEs) for HMBD-001 in combination with the EGFR inhibitor cetuximab (marketed by Merck KGaA, Darmstadt, Germany as ERBITUX globally, except for the U.S. and Canada) were identified, with advancement into Phase II supported by clinical safety, tolerability, and preliminary efficacy observed to date. Merck KGaA, Darmstadt, Germany will continue to supply cetuximab for the Hummingbird Bioscience-sponsored study under a clinical trial collaboration and supply agreement, and both parties retain all commercial rights to the respective compounds.

The advancement of HMBD-001 provides important clinical-stage validation of Hummingbird Bioscience’s AIMM platform, demonstrating the application of AI across the drug-development continuum: from understanding disease biology and designing differentiated therapeutics to informing clinical development strategy and identifying patients most likely to benefit.

"Advancing HMBD-001 into Phase II is an important milestone for the program and for Hummingbird’s AI-first approach to drug development," said Piers Ingram, PhD, Chief Executive Officer of Hummingbird Bioscience. "From designing HMBD-001 to identifying the disease settings and combination strategy where its differentiated mechanism may have the greatest impact, our AIMM platform has helped shape the program at multiple stages. We look forward to further evaluating the potential of HMBD-001."

Hummingbird Bioscience’s AIMM platform contributed to HMBD-001’s drug design and clinical development strategy. In drug design, the RAD platform identified a functionally critical epitope at the HER3 dimerization interface and engineered HMBD-001 to directly block HER3 heterodimerization with EGFR or HER2. This differentiated mechanism enables HMBD-001 to inhibit both ligand-dependent and ligand-independent HER3 activation to block oncogenic signaling. AIMM also informed the clinical development strategy for HMBD-001. Hummingbird Bioscience’s proprietary AI Reasoning Engine (AIRE) enabled rapid identification of squamous cell carcinomas as tumor types enriched for HER3 dependency, and therefore particularly vulnerable to HER3/EGFR inhibition. These findings supported prioritizing squamous cancers as an indication and informed the trial design combining HMBD-001 with cetuximab, while accounting for potential resistance mechanisms against this combination therapy.

"Genetic alterations commonly observed in squamous cell carcinomas can contribute to aberrant HER3 and EGFR signaling, which drive tumor cell proliferation and survival. Hummingbird’s AI-driven analyses identified a dependency on HER3/EGFR signaling in squamous cancers, providing a strong biological rationale for simultaneously targeting both pathways," said Kon Yew Kwek, BM BCh, DPhil, Chief Medical Officer of Hummingbird Bioscience. "Following the encouraging clinical activity that we have seen, we will continue using our AIMM platform to help enrich our patient population, so that we can optimally deliver a chemo-free treatment to patients suffering from advanced squamous cancers and who will most likely benefit from HMBD-001 plus cetuximab."

The advancement of HMBD-001 in clinical development reflects Hummingbird Bioscience’s AI-first approach to drug discovery and development, which has recently received growing external recognition. Selected from over 600 global applicants, Hummingbird Bioscience won the Asia Pacific Trailblazer Award at the Nebius AI Discovery Awards. The company was also named one of three finalists in the Fierce AI Innovation Awards in the Preclinical Development category, selected as a finalist for the Scrip Awards in the Best Use of AI in Drug Discovery & Preclinical Development category, and honored on the NextGen Tech 30 list by Granite Asia.

About HMBD-001

HMBD-001 is a novel, potentially best-in-class clinical-stage IgG1 antibody designed to target HER3, discovered and developed with Hummingbird Bioscience’s proprietary technologies. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and -independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR. In preclinical models evaluating HMBD-001, superior affinity and more potent tumor growth inhibition compared to existing anti-HER3 antibodies were observed. Additionally, combining HMBD-001 with EGFR inhibition further improved anti-tumor activity in squamous non-small cell lung cancer models. HMBD-001 is currently in Phase II multi-regional clinical trials for advanced squamous cell cancers (NCT05910827).

(Press release, Hummingbird Bioscience, SEP 30, 2026, View Source [SID1234671176])