On July 11, 2025 Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, reported the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable (Press release, Nutcracker Therapeutics, JUL 11, 2025, View Source [SID1234654354]).

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As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hindered by the use of bacterial cells in the process, which can be unreliable and introduce contamination that must be removed. The second step of GMP-grade RNA production from the template is impeded by a slow, unreliable, and inefficient process in which only one therapy can be made per GMP suite. Consequently, PCT production is slow, very costly, and does not scale for individualized therapies — a new manufacturing paradigm is needed.

Nutcracker Therapeutic’s NMU-Symphony system, the second generation of its Nutcracker Manufacturing Unit (NMU), brings the fastest, most scalable, and cost-efficient GMP RNA manufacturing platform available today. Fully enclosed and built for speed, it reliably delivers clinical-grade PCTs consistent with just a three-week overall turnaround time, from RNA sequence design to released nanoparticle formulated drug product — cutting traditional timelines in half. By incorporating Elegen’s cell-free GMP-ready DNA template production, the combination of the two platforms will enable an even faster and more scalable synthesis of longer, more complex neo-antigen sequences, while eliminating risks of bioburden and endotoxin contamination.

With a faster, more reliable and lower-cost solution, Elegen and Nutcracker Therapeutics aim to democratize PCTs, making them accessible to more developers and saving critical time for cancer patients, where even days can make a meaningful impact.

"Integrating cell-free DNA with cell-free biochip-based RNA production gives researchers and partners worldwide access to a more reliable, streamlined, and cost-effective platform to rapidly test and advance new therapies," said Matthew Hill, founder and CEO of Elegen. "By eliminating cells from the process, we can accelerate the development and evaluation of new therapeutic modalities, helping patients receive treatment as quickly as possible."

"We’re not just improving our manufacturing process, we’re laying the foundation to democratize PCTs with truly scalable solutions," added Benjamin Eldridge, co-founder and chief technology officer of Nutcracker Therapeutics. "Achieving that vision means giving developers the ability to produce clinical-grade RNA without investing hundreds of millions in infrastructure. This is a key step toward our mission of delivering scalable, low-cost, and rapid formulated RNA manufacturing for individualized therapies."

Elegen’s cell-free ENFINIA DNA with an unparalleled combination of speed, length, accuracy and complexity integrates seamlessly with Nutcracker Therapeutics’ existing RNA-based PCT development process, which leverages artificial intelligence and machine learning technologies through its CodonCracker RNA design software, the NMU-Symphony microfluidics biochip-based system, and ProcessVision technology for real-time performance and quality monitoring. Combined, Elegen and Nutcracker Therapeutic’s technologies enable the efficient, flexible, and GMP-ready production of individualized nanoparticle-formulated RNA therapeutics.

On July 11, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported the pricing of a best-efforts offering of 1,500,000 shares of its common stock (Press release, Cel-Sci, JUL 11, 2025, View Source [SID1234654353]). Each share of common stock is being sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5.7 million. The offering is expected to close on July 14, 2025, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as the sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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 an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 11, 2025 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, reported that the Company signed a financial agreement with the European Investment Bank (EIB) for a new financing facility of up to €37.5 million, on July 11, 2025 (Press release, MEDIAN Technologies, JUL 11, 2025, View Source [SID1234654352]).

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The signature of the financial agreement is in line with previous announcements on January 24, 2025, and April 24, 2025 stating that Median and the EIB were working to conclude an agreement for a new financing facility.

"We welcome the conclusion of our discussions with the European Investment Bank and the signature of the financial agreement", said Fredrik Brag, CEO and Founder of Median Technologies. "We are very honored to belong to the European innovative ecosystem supported by the EIB, and to contribute to the European technological sovereignty. Proceeds from this new EIB financing facility will strengthen our financial independence to negotiate the best possible options for the commercialization of eyonis LCS in U.S. and in Europe."

Financing Facility Structure

The EIB 2025 financing facility could be drawn in three (3) tranches, i.e., €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C).

Median Technologies will request the drawdown of the €19 million Tranche A, as soon as all contractual conditions with respect to such tranche, are satisfied, specifically:

Full issuance of the EIB new Tranche A warrants to the EIB and registration, in accordance with the warrant issuance agreement,
Completion of a share capital increase for an amount at least equal to €16 million (issuance premium included),
Repayment of the first tranche of the previous EIB 2019 loan, for which the maturity has been extended from April to October 2025.
Furthermore, the Company has undertaken to have secured by June 30, 2026, incremental equity financing in a total amount of at least €10 million.

The characteristics of tranche A are:

Maturity of 72 months, and monthly amortization over a period of 36 months after a 36-month grace period,
Annual interest rate of 5%.
The release of the tranche A of €19 million will result in the issuance of warrants which quantity and exercise price will depend on the stock price on the date of issuance. At current trading stock price, and after fulfilment of all drawdown conditions, the total amount of shares resulting from the exercise of the warrants would represent 10% of the share capital.

As stated in the financial agreement, Tranche B and Tranche C disbursements remain at Median’s discretion, subject to certain conditions which are specified in the financial agreement.

Intended use of proceeds

The EIB funds will be to support eyonis Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S and in Europe, and to accelerate the expansion of Median’s proprietary suite of Software as a Medical Device, eyonis, for image-based early cancer diagnosis, notably the scientific and clinical development of eyonis IPN for incidental findings of pulmonary nodules, and eyonis HCC, for primary liver cancer early diagnosis.

eyonis LCS progress status and next steps

Regulatory filings for marketing in U.S. and Europe and marketing authorizations:

On May 14, 2025, Median Technologies announced the filing of an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis LCS.
On July 1, 2025, the Company announced the filing of an application for Class IIb CE marking of eyonis LCS.
Given the usual timelines for regulatory review, the U.S. FDA 510(k) clearance for eyonis LCS is expected around the end of Q3 2025, expected to be followed by commercial launch in the US. Median Technologies expects European marketing authorization for eyonis LCS as soon as Q1 2026.
Commercial launch

Median Technologies is actively engaged in discussions with several leading players in AI- diagnostic and imaging equipment manufacturing, for the commercialization of eyonis LCS. Some of these strategic partnerships are expected to be finalized upon FDA marketing authorization of eyonis LCS.
The Company has finalized its US market access strategy, based on a comprehensive mapping of medical institutions involved in screening procedures, particularly in the United States, eyonis LCS’ first and leading market. This mapping has enabled the identification of health institutions generating the highest volume of lung cancer screening procedures, positioning them as key drivers for the commercial launch of eyonis LCS.
Discussions with U.S. payers will be initiated upon FDA marketing authorization. At this stage, preliminary studies have been conducted to estimate the projected economic benefits of using eyonis LCS in lung cancer screening programs. To date, the Company has developed a detailed mapping of payers in the United States. Furthermore, an initial analysis based on a health economics Markov model simulating lung cancer progression over five years and incorporating the performance of eyonis LCS, demonstrates that eyonis LCS enhances early detection and characterization, reduces unnecessary health procedures, and generates significant cost savings for U.S. payers. The results of this preliminary analysis were presented at ISPOR 2025, the leading global conference for health economics and market access, held this past May. Results from the study are available on Median’s website.
Over the past year, the Median eyonis team has built a very substantial network of early adopters composed of key opinion leaders. The team has conducted numerous visits to leading healthcare institutions and actively participated in major medical conferences organized by medical societies in pulmonology, oncology, and radiology, both in the U.S. and Europe, including the Radiological Society of North America (RSNA), the European Radiology Society (ESR), the American Thoracic Society (ATS), the European Society of Thoracic Imaging (ESTI), the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The Company now enjoys strong recognition of its eyonis LCS technology within the medical community, along with a strong brand image associated with the product. Most of the leading healthcare institutions in contact with Median have expressed interest in participating in future health economics studies, which will be launched following regulatory market approvals.

On July 11, 2025 CEL-SCI Corporation (NYSE American: CVM) reported it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia (Press release, Cel-Sci, JUL 11, 2025, View Source [SID1234654351]). The formal agreement is expected to be signed with the Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market.

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While CEL-SCI has the option of filing for Breakthrough Medicine Designation directly, the Company made a strategic decision to collaborate with its local partner for the regulatory filing and subsequent commercial distribution in Saudi Arabia. In a prior meeting with the SFDA, the Saudi regulatory agency provided guidance and encouragement to seek breakthrough approval for Multikine in head and neck cancer. CEL-SCI and its Saudi pharma partner believe that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA and are now developing a comprehensive commercialization plan. This plan leverages the partner’s deep expertise in the local healthcare market to rapidly take Multikine through regulatory approvals and into distribution.

"We have been directly, and through our representative, First Berlin of Germany and its local Saudi representatives, engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA. These meetings and the support of leaders in the pharmaceutical industry, healthcare and other sectors in Saudi Arabia, are critical ingredients to bringing our cancer drug to market in the Kingdom. Several meetings have also occurred with some of the most important Saudi Arabian funds that have expressed interest in investing in CEL-SCI directly or the venture between CEL-SCI and our Saudi pharma partner," stated CEL-SCI CEO, Geert Kersten.

Martin Bailey, Managing Director and Founder of First Berlin, commented, "We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s short timeline, this is a near term opportunity for local in-country investors to help bring a much-needed cancer treatment to market while also supporting their nation’s health-tech goals."

Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. In the world’s largest head and neck cancer study spanning 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone. The 5-year risk of death was halved from 55% to 27%.

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility include having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:

Target serious debilitating or life-threatening conditions with unmet medical need.
The medicinal product is likely to offer major advantage over methods currently used.
The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
The product is not registered at any regulatory authority at the time of submission of the designation request.

On July 11, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the primary analysis of the Phase 2 RAMP 201 clinical trial was published online in the Journal of Clinical Oncology (JCO) (Press release, Verastem, JUL 11, 2025, View Source [SID1234654350]). The data reported in the publication showed that avutometinib plus defactinib demonstrated a confirmed overall response rate (ORR) of 31% in all patients with recurrent low-grade serous ovarian cancer (LGSOC). The full manuscript, titled "Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201," will also appear in the print publication of JCO.

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"The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., chief medical officer at Verastem Oncology. "The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation."

The Company will submit the RAMP 201 publication and the recent publication of the FRAME study to the National Comprehensive Cancer Network (NCCN) in support of its consideration of inclusion of the KRAS wild-type population evaluated in these trials in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Currently, the combination is listed as an NCCN Category 2A recommendation for the treatment of KRAS-mutated recurrent LGSOC, which is aligned with the FDA-approved indication.

JCO Publication of RAMP 201

The Phase 2 RAMP 201 trial evaluated the safety, tolerability, and efficacy of avutometinib with and without defactinib in patients with recurrent LGSOC who had received a median of three (range one to nine) prior lines of therapy, including chemotherapy, hormonal therapy, bevacizumab, and MEK inhibitors. The publication included the primary analysis of the Phase 2 RAMP 201 trial that showed a confirmed ORR of 31% (34/109) in all 109 evaluable patients, 44% (25/57) in patients with a KRAS mutation, and 17% (9/52) in patients with KRAS wild-type. The median duration of response (DOR) was 31.1 months for all patients, 31.1 months in the KRAS mutant population, and 9.2 months in the KRAS wild-type population. Median progression-free survival (PFS) was 12.9 months for all patients, 22.0 months in the KRAS mutant population, and 12.8 months in the KRAS wild-type population. The majority of patients (82%) had some reduction in target lesions, regardless of KRAS mutation status. The disease control rate (DCR) at 6 or more months was 61% in the total population, 70% in the KRAS-mutated population, and 50% in the KRAS wild-type population.

"Our paper showed that the combination of avutometinib plus defactinib demonstrated clinically meaningful and durable responses in patients with recurrent low-grade serous ovarian cancer. The recent FDA accelerated approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer, which is based on these results, is fantastic news. The fact that a majority of patients had some reduction in target lesions, regardless of KRAS mutation status, underscores the advancement the combination represents in this rare ovarian cancer and its potential to be the new standard of care in recurrent low-grade serous ovarian cancer," said Professor Susana Banerjee, M.B.B.S., M.A., Ph.D., F.R.C.P, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London and Global Lead Principal Investigator of ENGOTov60/GOG3052/NCRI/RAMP201.

The results also demonstrated that the combination is well-tolerated, with a 10% discontinuation rate due to adverse events (AEs). The most common AEs (all grades, grade ≥3) were nausea (67.0%, 2.6%), diarrhea (58.3%, 7.8%), and increased creatine phosphokinase levels (60.0%, 24.3%).

"The publication of the Phase 2 RAMP 201 trial supports our understanding of the role that the combination of avutometinib plus defactinib plays in treating patients with recurrent low-grade serous ovarian cancer. We are excited to continue to build on the findings from the trial and advance the research in this disease with the ongoing international Phase 3 RAMP 301 trial, which is evaluating the combination in patients with and without a KRAS mutation," said Rachel Grisham, M.D., Section Head, Ovarian Cancer at Memorial Sloan Kettering Cancer Center in New York, NY and Global Lead Principal Investigator of GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301.

The RAMP 201 study results were initially presented in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Annual Meeting in October 2024.

About RAMP 201

RAMP 201 (ENGOTov60/GOG3052/NCRI) (NCT04625270) was an adaptive, two-part multicenter, parallel cohort, randomized, open-label Phase 2 registration-directed trial evaluating the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). The first part of the trial (Part A) determined the selection of the go-forward regimen, which was the combination of avutometinib and defactinib versus avutometinib alone, based on overall response rates. The expansion phases of the trial (Parts B and C) evaluated the safety and efficacy of the go-forward regimen of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily. The Part D portion of the trial evaluated a low dose of the combination to inform individualized dose reduction.

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib in combination with defactinib and other agents as a potential treatment for patients with advanced pancreatic cancer (RAMP 205; NCT05669482) and advanced KRAS G12C mutant non-small cell lung cancer (RAMP 203; NCT05074810). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations

Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.