On September 25, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported the pricing of its underwritten public offering of 18,959,914 shares of its Class A common stock at an offering price of $9.23 per share, which is equal to the last reported sale price for Immuneering’s Class A common stock on The Nasdaq Global Market on September 24, 2025 (Press release, Immuneering, SEP 25, 2025, View Source [SID1234656238]). In addition, Immuneering has granted the underwriters a 30-day option to purchase up to an additional 2,843,987 shares of Class A common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds from the public offering are expected to be approximately $175 million, before deducting underwriting discounts and commissions and offering expenses payable by Immuneering, and excluding any exercise of the underwriters’ option to purchase additional shares. In addition, Immuneering announced that Sanofi has agreed to purchase 2,708,559 shares of Immuneering’s Class A common stock, at a purchase price of $9.23 per share, in a separate private placement transaction that is expected to close concurrently with the public offering. All securities in the public offering and private placement will be offered by Immuneering. The public offering and private placement are expected to close concurrently on or about September 26, 2025, subject to customary closing conditions, and the closing of the private placement is contingent upon the closing of the public offering.

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Immuneering intends to use the net proceeds of the public offering and the private placement to advance the preclinical and clinical development of its product candidates and for working capital and other general corporate purposes.

Leerink Partners and Oppenheimer & Co. are acting as the joint bookrunners for the public offering and as placement agents in connection with the private placement.

The public offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by Immuneering with the Securities and Exchange Commission (the "SEC") on August 13, 2025 and declared effective by the SEC on August 20, 2025. A prospectus supplement relating to the offering will be filed with the SEC. Copies of the prospectus supplement relating to the offering, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected], or by visiting the EDGAR database on the SEC’s website at www.sec.gov.

The shares being sold in the Private Placement have not been and will not be registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

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

On September 25, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported that the U.S. Food and Drug Administration (FDA) approved PALSONIFY (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

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"With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved."

The approval is based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which evaluated PALSONIFY’s safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.

Participants also reported significant reductions in signs and symptoms associated with acromegaly as measured by the Acromegaly Symptom Diary (ASD) — an FDA-aligned patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly. Symptoms include headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling. PALSONIFY was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial.

Long-term results from the open-label extension (OLE) phases of both trials were presented at this year’s Endocrine Society’s annual meeting, ENDO 2025, providing further evidence of PALSONIFY’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile. Ninety-one percent of patients from PATHFNDR-1 and 97 percent of completers from PATHFNDR-2 enrolled in the OLE.

"The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity," said Dr. Shlomo Melmed, Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai, "The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly."

"For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track," said Jill Sisco, President of Acromegaly Community. "What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care."

PALSONIFY is expected to be available in the U.S. in early October. Crinetics is ensuring broad access to PALSONIFY by working closely with payers, healthcare providers, and patient advocacy organizations to support those who may benefit from this treatment.

As part of this commitment, Crinetics has launched CrinetiCARE, a comprehensive support program designed to assist people living with acromegaly throughout their treatment journey. CrinetiCARE provides disease and product education, benefit verification, financial assistance resources, and access to dedicated nurse educators who can offer support with treatment onboarding and ongoing adherence. For more information, visit www.CrinetiCARE.com or the PALSONIFY product website Palsonify.com.

A Marketing Authorization Application (MAA) for paltusotine in acromegaly is currently under review for use in the European Union, and the current timeline for the Committee for Medicinal Products and Human Use (CHMP) opinion is the first half of 2026. Crinetics is in partnership with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize paltusotine for acromegaly in Japan.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial. Global enrollment for CAREFNDR is expected throughout 2025.

(Press release, Crinetics Pharmaceuticals, SEP 25, 2025, View Source [SID1234669419])

On September 25, 2025 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported that its enhanced Fast CAR-T product JWCAR239, targeting CD19/CD20, has completed the first patient infusion in its clinical study for relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).

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Targeted CD19 CAR-T cell therapy represents a breakthrough treatment for patients with refractory/relapsed (r/r) B-cell non-Hodgkin lymphoma (B-NHL), demonstrating remarkable short-term efficacy. However, many patients remain unresponsive to initial treatment or experience relapse, with long-term progression-free survival (PFS) rates approximately 40%¹. Common mechanisms of refractory/relapse include antigen escape (e.g., loss of CD19 antigen expression), immunosuppressive microenvironments (e.g., inhibitory TGF-β signaling), and dysregulation of CAR-T cell-mediated cytotoxic pathways (e.g., apoptosis)².

Simultaneously targeting CD19/CD20 and enhancing CAR-T cells’ resistance to immunosuppressive microenvironments and apoptotic signals represent key strategies for overcoming CAR-T resistance. In recent years, dual-targeted CAR-T cells targeting CD19/CD20 and fourth-generation CAR-T cells incorporating various enhancement elements have yielded preliminary safety and efficacy data in lymphoma patients.

Additionally, Fast CAR-T possesses unique characteristics compared to traditional CAR-T in terms of production processes and cellular properties, offering multiple advantages. It is gradually demonstrating promising prospects in the treatment of cancer and autoimmune diseases3.

JWCAR239 is a fast CAR-T cell product derived from patient-specific T cells genetically engineered to target CD19 and CD20. It prevents antigen escape while incorporating two exogenously transduced enhancement elements—dnFas-CD2 and dnTGFβRII—that enhance CAR-T cells’ resistance to apoptosis (via CD58 downregulation) and their ability to counteract immunosuppressive signals in the tumor microenvironment. Its rapid manufacturing process not only significantly shortens production cycles but also yields CAR-T cells with a younger phenotype, preserving a high proportion of youthful Tscm cells. This results in enhanced in vivo expansion and tumor cell killing capacity. Preclinical studies have preliminarily validated its efficacy and safety. This study aims to conduct a preliminary assessment of JWCAR239’s safety and/or efficacy in patients with r/r B-NHL.

(Press release, JW Therapeutics, SEP 25, 2025, View Source [SID1234671258])

On September 25, 2025 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it will present data at a number of upcoming scientific conferences, highlighting key aspects of lead product candidate INO-3107 for RRP (Press release, Inovio, SEP 25, 2025, View Source [SID1234656239]). INOVIO has begun the rolling submission of its Biologics License Application (BLA) for INO-3107, which it anticipates completing in the second half of 2025 with the goal of file acceptance by the U.S. Food and Drug Administration by the end of 2025.

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INOVIO also plans to highlight its next-generation DNA-medicine technology, including presentations on a Phase 1 clinical trial of a DNA-encoded monoclonal antibody (DMAb) product candidate and new preclinical data on DPROTs addressing Hemophilia A.

Presentations on INO-3107 for RRP:

American Academy of Otolaryngology – Head and Neck Surgery Annual Meeting
Indianapolis
Date: October 11-13
Poster Title: DNA Immunotherapy (INO-3107) Demonstrates a Durable Response for Treatment of HPV-6/11 Recurrent Respiratory Papillomatosis

World Vaccine Congress Europe
Amsterdam, NL
Date: October 13
Time: 3:45 PM CEST
Presentation Title: Leveraging the Potential of DNA Immunotherapy: Long-Term Efficacy in HPV-6 & 11 Recurrent Respiratory Papillomatosis

European Society For Medical Oncology Congress
Berlin, DE
Date: October 19
Poster Title: DNA Immunotherapy (INO-3107) in HPV-6 & 11 Recurrent Respiratory Papillomatosis – Long-Term Efficacy

37th Annual International Papillomavirus Society Conference
Bangkok, TH
Date: October 24
Time: 2:40 – 2:55 PM ICT
Presentation Title: Clinical Response to INO-3107 in RRP is Irrespective of Papilloma Microenvironment and Molecular Subtype

Date: October 25
Time: 6:54 – 7:00 PM ICT
E-Poster Title: DNA Immunotherapy (INO-3107) Induces Persistent Immune Responses Resulting in Long-term Efficacy Through Post-Treatment Year 2 for HPV 6&11 RRP

International Society for Vaccines Annual Congress
Stellenbosch, SA
Date: October 30
Time: 10:20 – 10:35 AM SAST
Presentation Title: Immunotherapy, INO-3107, is Well-Tolerated, Effective, and Elicits an Antigen-Specific T-cell Response in Adults with HPV-6 & 11 Recurrent Respiratory Papillomatosis

Presentations on Next-Generation DNA Medicine:

European Society of Gene and Cell Therapy Congress
Seville, ES
Date: October 7-10
Poster Title: Employment of the CELLECTRA in vivo gene delivery platform in a first in human (FIH) DNA encoded monoclonal antibody (DMAb) clinical trial

World Vaccine Congress Europe
Amsterdam, NL
Date: October 16
Time: 1:00 PM CET
Presentation Title: DMAb Technology: Next Generation DNA Medicine Design and Delivery

World Orphan Drug Congress
Amsterdam, NL
Date: October 29
Time: 11:10 AM CET
Presentation Title: DMAb Technology: The Transformational Potential of Next Gen DNA Medicine in Rare Disease

14th World Federation of Hemophilia Global Forum
Montreal, CA
Date: November 14
Time: 1:45 PM EST
Presentation Title: Novel FVIII Secretion Via Non-Viral Vector DNA Medicine Platform

Available abstracts will be shared on INOVIO’s website following presentations.

On September 25, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML) (Press release, Kura Oncology, SEP 25, 2025, View Source [SID1234656240]). Although newly diagnosed patients with NPM1-m AML have high response rates to approved standard of care, relapses are common and survival outcomes are poor. There is currently no approved therapy to specifically target NPM1-m AML. Ziftomenib is currently under priority review by the Food and Drug Administration (FDA) for treatment of R/R NPM1-m AML.

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"Relapsed or refractory NPM1-mutated AML remains very challenging to treat, particularly after venetoclax-based therapy or transplant," said Eunice Wang, M.D., Chief of Leukemia Service, Professor of Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY. "The manuscript describes deep responses, signals of clinical activity across relevant subgroups and a generally manageable tolerability profile, which is important in treatment of late line AML patients where accumulated toxicity can limit treatment options. The benefit-risk profile of ziftomenib is highly encouraging and, if replicated in additional treatment settings, has potential to be transformative for a large population of patients with menin pathway-driven AML."

"Publication in ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology is an important advancement for adult patients with NPM1-m AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "In addition to evidence of monotherapy activity, the safety and tolerability profile of ziftomenib from this trial is encouraging, marked by the absence of clinically meaningful QTc prolongation as well as low rates of both myelosuppression and treatment discontinuation. No clinically meaningful drug-drug interactions were observed, including with commonly used supportive-care medications, which may simplify co-administration in a polypharmacy setting. We continue to conduct studies in earlier line settings and in combination with multiple therapeutic agents in close collaboration with investigators, study teams and our partner Kyowa Kirin."

Summary of the published data
The publication, entitled "Ziftomenib in Relapsed or Refractory NPM1-Mutated AML", includes positive data from 92 adult patients with R/R NPM1-m AML in the phase 2 portion of the clinical trial as of the primary data cutoff date of October 28, 2024.

The KOMET-001 phase 2 trial met its primary endpoint with a complete remission with full or partial hematologic recovery (CR/CRh) rate of 22% (95% CI, 14 to 32; P=0.0058), which was significantly higher than the 12% historical standard-of-care response rate for patients with R/R NPM1-m AML. One additional response of CRh occurred after the primary analysis data cutoff resulting in a cumulative CR/CRh rate of 23% (95% CI, 15 to 33). 61% of evaluable CR/CRh responders were negative for measurable residual disease (MRD). Overall response rate (ORR) was 33% (95% CI, 23 to 43), with a median duration of overall response of 4.6 months (95% CI, 2.8 to 7.4).

Median overall survival (OS) was 6.6 months (95% CI, 3.6 to 8.6). Among ORR responders, median OS was 18.4 months (95% CI, 8.6 to not estimable) vs. 3.5 months (95% CI, 2.7 to 4.2) among non-responders. Two responders received subsequent allogeneic stem cell transplant and both resumed ziftomenib maintenance after transplant. At the time of data cutoff, nine patients (two after transplantation) remained on ziftomenib treatment. Prespecified subgroup analyses showed comparable CR/CRh rates regardless of lines of therapy, prior venetoclax exposure, or presence of co-mutations, including FLT3m or IDH1/2m.

Ziftomenib was well tolerated with a safety profile consistent with previously disclosed data. The most common grade ≥3 treatment-emergent adverse events were febrile neutropenia (26%), anemia (20%), and thrombocytopenia (20%). Differentiation syndrome occurred in 25% of patients (15% grade 3; no grade 4-5) and was manageable with protocol-defined mitigation. Three patients (3%) discontinued treatment because of ziftomenib-related adverse events.

These findings formed part of the data set used for the New Drug Application for ziftomenib as a potential treatment for patients with R/R NPM1-m AML. The FDA target action date is November 30, 2025. There is currently no FDA-approved treatment for patients with R/R NPM1-m AML.

"The publication of the investigational ziftomenib data adds important scientific context for clinicians and patients," said Takeyoshi Yamashita, Ph. D., Executive Vice President and Chief Medical Officer, Kyowa Kirin. "Together with Kura Oncology, we are committed to rigorous, globally coordinated evidence generation to support the benefit-risk profile of menin inhibition across the treatment landscape. Our shared goal is to advance development rapidly and generate the evidence needed to deliver ziftomenib to appropriate patients in need."

The publication is now available on the Journal of Clinical Oncology website and in the Scientific Manuscripts section on Kura’s website.

Ziftomenib is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.