On November 18, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported its plans to commence a public offering, subject to market and other conditions, to issue and sell shares of its common stock, or for certain investors that so choose, in lieu of shares of common stock, pre-funded warrants to purchase shares of its common stock. All of the securities are being offered by Olema.

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In connection with the proposed offering, Olema expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock Olema is offering plus the shares of common stock underlying the pre-funded warrants. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

TD Cowen is acting as book-running manager for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the "SEC") on January 6, 2025 and declared effective on January 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected].

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

(Press release, Olema Oncology, NOV 18, 2025, View Source [SID1234660056])

On November 18, 2025 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that it will participate in the following investor conferences:

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Piper Sandler 37th Annual Healthcare Conference (New York, NY)
Date: Tuesday, December 2
Time: 8:30-8:55 AM ET
Format: Fireside Chat
Webcast: https://bit.ly/44af19l (live webcast and replay available for 90 days after the event)

Oppenheimer Movers in Rare Disease Summit (New York, NY)
Date: Thursday, December 11
Time: 12:05-12:25 PM ET
Format: Panel – Elevator Pitches from Rare Disease Companies with Key Near-Term, Potentially Stock-Moving Catalysts

Members of INOVIO’s management team will also be conducting one-on-one meetings with investors during these conferences.

(Press release, Inovio, NOV 18, 2025, View Source [SID1234660055])

On November 18, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the United States Patent and Trademark Office (USTPO) has granted Genprex a patent that covers the use of the Company’s lead drug candidate, Reqorsa Gene Therapy in combination with PD-L1 antibodies, such as Tecentriq, through 2037.

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"We continue to build protection around our lead drug candidate, REQORSA, and this new patent provides the necessary technology protection applicable to our Acclaim-3 clinical trial in small cell lung cancer," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "In the Acclaim-3 clinical trial, we are combining REQORSA with Tecentriq, a PD-L1 antibody, and this patent secures exclusivity for this drug combination for the treatment of cancer, preventing would-be competitors from making, using or selling this drug combination."

Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would also be applicable to Genprex’s Acclaim-3 clinical trial.

PD-L1 antibodies are a type of targeted immunotherapy that block the activity of PD-L1 immune checkpoint proteins present on the surface of cells.

About Acclaim-3

Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.

The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026. The Acclaim-3 clinical trial is supported by U.S. Food and Drug Administration (FDA) Fast Track Designation and Orphan Drug Designation.

(Press release, Genprex, NOV 18, 2025, View Source [SID1234660054])

On November 18, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it and its wholly owned subsidiary Genmab Finance LLC ("Genmab Finance") have priced their previously announced offering of $1.5 billion of 6.250% senior secured notes due 2032 (the "Secured Notes") and $1.0 billion of 7.250% senior unsecured notes due 2033 (the "Unsecured Notes," and together with the Secured Notes, the "Notes"). The issue price of the Notes is 100.000%. The offering is expected to close on December 3, 2025, subject to the satisfaction of customary closing conditions.

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Genmab also announced that it has completed the previously announced syndication of the new $2.0 billion senior secured term loan "B" facility, which term loan "B" facility is in addition to the $1.0 billion senior secured term loan "A" facility and $500 million senior secured revolving credit facility (collectively, the "New Credit Facilities") that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the "Acquisition") of Merus N.V. ("Merus").

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, Genmab, NOV 18, 2025, View Source [SID1234660053])

On November 18, 2025 Genmab A/S (Nasdaq: GMAB) reported that EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 study that evaluated fixed duration EPKINLY + R2 compared to standard of care R2.i

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In the study, treatment with fixed duration EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13-0.33, p<0.0001) compared to R2. Median progression-free survival (PFS) was not reached (NR) among patients treated with EPKINLY + R2 (95% CI: 21.9-NR) compared to 11.2 months for patients treated with R2 (95% CI: 10.5-NR). Among patients who were treated with EPKINLY + R2, 89% responded to treatment (n=216/243, 95% CI: 84-93, p<0.0001) and 74% achieved a complete response (CR) (n=181/243, 95% CI: 69-80). This is compared to a 74% overall response rate (n=181/245, 95% CI: 68-79) and 43% CR rate among patients treated with R2 (n=106/245, 95% CI: 37-50).i The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors.

The safety profile of EPKINLY + R2 in the EPCORE FL-1 study was generally consistent with the known safety profiles of the individual regimens (epcoritamab and R2). The most common (≥ 20%) adverse reactions in patients who received EPKINLY + R2 were rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, cytokine release syndrome (CRS), pneumonia, COVID-19, and fever. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) were decreased neutrophil count, lymphocyte count, and platelets. CRS occurred in 24% of patients at the recommended 3 step-up dosing schedule, and was primarily low grade (19% Grade 1, 5% Grade 2). A single event of immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in one patient, grade 1 (0.8%). The prescribing information has a Boxed Warning for serious or fatal CRS and ICANS. Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity. Please see additional Important Safety Information below.i

"Recurrent follicular lymphoma can be an incurable, complex, and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey," said Lorenzo Falchi, M.D., Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center. "The results shown with EPKINLY + R2 in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R2 alone. These data, delivered by a regimen that’s chemotherapy-free and can be administered in the outpatient setting, suggest that EPKINLY + R2 could potentially become a new standard of care."

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that impacts approximately 15,000 new patients per year in the U.S..ii,iii The disease is considered incurable with current standard of care therapies.iv Patients with FL often relapse, and in some cases, the disease can transform into a more aggressive form of NHL called diffuse large B-cell lymphoma (DLBCL).v

"Today’s milestone marks meaningful progress for people living with follicular lymphoma. With a bispecific-based therapy that can be administered in a variety of medical settings, patients have the possibility of accessing this treatment at sites of care closer to where they live," said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation.

EPKINLY + R2 was previously granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R FL. This designation is granted to investigational medicines for serious or life-threatening diseases in cases where preliminary clinical evidence shows that the therapy may provide substantial improvements over available therapies.

"The FDA approval of EPKINLY + R2 is an important advancement for patients with follicular lymphoma, enabling treatment at initial recurrence when more effective intervention is needed," said Judith Klimovsky, M.D., Executive Vice President & Chief Development Officer, Genmab. "This milestone also underscores EPKINLY’s potential as the core therapy for B-cell malignancies, demonstrating benefit in combination and earlier disease, and building on its established role as a single agent option in later lines of treatment."

In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R/R FL following two or more lines of systemic therapy. With the results from the confirmatory Phase 3 EPCORE FL-1 study, the FDA has also converted the accelerated approval into a full approval.

Data from the Phase 3 EPCORE FL-1 study will be presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December.

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR).

EPKINLY (epcoritamab-bysp) U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with:

certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments.
EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.
follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab
follicular lymphoma (FL) that has come back or that did not respond after receiving 2 or more treatments.
It is not known if EPKINLY is safe and effective in children.

Important Warnings—EPKINLY can cause serious side effects, including:

Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

People with follicular lymphoma (FL) may need to be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets.

The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

Helping Patients Access Care
Genmab strives to positively impact patients’ lives, and we’re committed to helping ensure our medicines reach the people who need them. We understand the impact that cancer can have, and so we empower patients and their care partners to take ownership of their treatment journey, offering support every step of the way. MyNavCare Patient Support by Genmab offers resources and services, from financial information to ongoing support, to help eligible patients access their Genmab medication and navigate their treatment journey. MyNavCare is available now to patients who have been prescribed EPKINLY. Patients, care partners, and healthcare providers interested in learning more about MyNavCare can visit www.MyNavCare.com or call 1-866-NAV-CAR1 (1-866-628-2271).

About Follicular Lymphoma (FL)
Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases and is diagnosed in approximately 15,000 people in the U.S. every year.ii,iii FL is considered incurable with current standard of care therapies.iv Patients often relapse, and with each relapse the remission and time to next treatment shorten.vi Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.v

About EPKINLY (epcoritamab-bysp)
EPKINLY (epcoritamab-bysp) is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii

Epcoritamab (approved under the brand name EPKINLY in countries including the U.S. and Japan, and as TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercialization responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four additional ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice immunochemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, NOV 18, 2025, View Source [SID1234660052])