On September 29, 2025 ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, reported the close of over $29 million in additional financing (Press release, ReCode Therapeutics, SEP 29, 2025, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-announces-over-29-million-in-additional-financing-to-advance-genetic-medicines-pipeline-and-provides-corporate-update [SID1234656323]). The company also reported expanded support from the Cystic Fibrosis Foundation (CF Foundation) and a new research collaboration with Praxis Precision Medicines, Inc. (NASDAQ: PRAX).

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"With continued support from organizations like the CF Foundation and our collaboration with Praxis, we are building on our momentum to deliver on the promise of genetic medicines for people living with genetic diseases who currently have limited or no effective treatments," said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer of ReCode Therapeutics.

Key Updates

Over $29 Million Raised in New Financing: ReCode has raised more than $29 million to advance its pipeline of genetic medicines, including investigational therapies for cystic fibrosis (CF). The funding strengthens the company’s financial foundation as it progresses its clinical and preclinical programs.
Expanded Support from the CF Foundation: The CF Foundation, which previously invested $15 million to support the development of and early-stage clinical trials for RCT2100, an inhaled mRNA therapy, is committing an additional $3 million to support the company’s ongoing Phase 2 clinical trial of RCT2100. RCT2100 is designed to provide functional CFTR protein by delivering a correct copy of CFTR mRNA to lung cells, offering potential benefits to all people with CF, including those with rare and nonsense mutations who do not benefit from existing modulator therapies. In total, the Foundation has agreed to invest up to $33 million in ReCode’s mRNA and gene editing research programs. For more information, please visit www.CF-Clinical-Studies.com.
Partnership with Praxis Precision Medicines for ASO Delivery: ReCode has entered into a research collaboration with Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance, to identify a well-tolerated lipid nanoparticle (LNP) formulation that enhances the delivery of antisense oligonucleotides (ASOs) to underexposed brain regions.
ERS and NACFC Attendance: ReCode leadership will attend the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands, from September 27 to October 1, and the North American Cystic Fibrosis Conference (NACFC) in Seattle from October 22 to 25.

On September 29, 2025 Genmab A/S (Nasdaq: GMAB) and Merus N.V. (Nasdaq: MRUS) reported that they have entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus, a clinical-stage biotechnology company with its late-stage breakthrough therapy asset petosemtamab, which is in Phase 3 development, for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion (Press release, Genmab, SEP 29, 2025, View Source [SID1234656300]). The transaction has been unanimously approved by the Boards of Directors of both companies. A wholly owned subsidiary of Genmab ("Purchaser") will commence a tender offer for 100% of Merus’ common shares, which is anticipated to close by early in the first quarter of 2026.

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The proposed acquisition of Merus is expected to meaningfully accelerate Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader. The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Following the closing of the transaction, Genmab will have four proprietary programs expected to drive multiple new drug launches by 2027.

"The proposed acquisition of Merus clearly aligns with our long-term strategy. It has the potential to significantly accelerate our evolution into a global biotechnology leader by providing durable growth for the company well into the next decade," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. "Petosemtamab has the potential to be a transformational therapy for patients living with head and neck cancer. With our proven track record of success, both in clinical development and in commercialization, we are confident that we will be able to unlock the promise of petosemtamab."

"We are excited for the opportunity to join Genmab, a leader in antibody therapeutics, to further develop and bring petosemtamab to patients. Our two companies have a rich history of innovation with multiple approvals in the field of multispecific antibodies. We believe Genmab has the right vision and experience to advance petosemtamab in recurrent/metastatic head and neck cancer and beyond," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "I’m immensely proud of the Merus team who have pioneered our foundational platform technologies to make better medicines and who have demonstrated – with an approved product and a product candidate, petosemtamab, in registrational studies – an ability to deliver on our promise to close in on cancer."

Petosemtamab is an EGFRxLGR5 bispecific antibody with the potential to be both first- and best-in-class in head and neck cancer. It has been granted two Breakthrough Therapy Designations (BTD) by the U.S. Food and Drug Administration (FDA) for first- and second-line plus head and neck cancer indications. Of note, compelling Phase 2 data was presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting showing both an overall response rate and median progression free survival that were substantially higher than standard of care.

Merus is currently running two Phase 3 trials in first- and second/third line head and neck cancer, with topline interim readout of one or both trials anticipated in 2026. Based on Genmab’s experience in late-stage development and excellence in commercial execution, Genmab anticipates the potential for the initial launch of petosemtamab in 2027, subject to clinical results and regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into earlier lines of therapy. Following its initial anticipated approval, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

Details of the Transaction and Financing
Under the transaction agreement, Purchaser, a wholly owned subsidiary of Genmab, will commence a tender offer for all the outstanding common shares of Merus. Following the closing of the tender offer, Merus and Genmab will effect a series of transactions resulting in Genmab owning 100% of the common shares of Merus (or a successor entity). Depending on the structure of the back end transactions, Merus shareholders that do not tender their shares into the tender offer will either receive the same consideration for their common shares as the common shares tendered into the tender offer (subject to applicable withholding taxes) or a fair price for their common shares determined by a Dutch court in statutory buy-out proceedings. The closing of the tender offer is subject to the satisfaction of customary closing conditions for similar transactions, including a minimum acceptance condition of at least 80% of Merus’ common shares (which threshold may be reduced to 75% unilaterally by Genmab if all other closing conditions are satisfied), approval by Merus’ shareholders of resolutions relating to Merus’ post-closing governance and the back end transactions at Merus’ extraordinary shareholders meeting to be held for that purpose, and completion of the relevant works councils consultation processes.

The USD 97.00 per common share purchase price payable in the tender offer represents a premium of approximately 41% over Merus’ closing stock price on September 26, 2025, of USD 68.89 and approximately 44% over Merus’ 30-day volume weighted average price of USD 67.42.

The transaction is not subject to a financing condition. Consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount.

The financing package includes a meaningful portion of prepayable debt, in line with Genmab’s commitment to deleveraging with a target of gross leverage <3x within two years after the closing of the proposed transaction. Today’s news does not impact Genmab’s financial guidance for the full year 2025, last issued on August 7, 2025. Genmab will provide its financial outlook for the full year 2026 in conjunction with its full year 2025 earnings report in February 2026.

PJT Partners and Morgan Stanley & Co. International plc are acting as joint financial advisors to Genmab and A&O Shearman and Kromann Reumert as its legal advisors.

Jefferies LLC is acting as financial advisor to Merus and Latham & Watkins and NautaDutilh as its legal advisors.

Conference Call Details
Genmab will hold a conference call to discuss the transaction today, September 29, 2025 at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT. To join the call please use the following registration link View Source Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN. A live and archived webcast of the calls and relevant slides will be available at View Source

On September 29, 2025 Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported the closing of its previously announced "reasonable best efforts" public offering with participation from existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the Company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering") (Press release, Soligenix, SEP 29, 2025, View Source [SID1234656324]). The warrants have an exercise price of $1.35 per share, are exercisable immediately and will expire five years from the issuance date. The Company received aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other Offering expenses.

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The Company agreed that certain existing May 2023, April 2024 and July 2024 warrants (together, the "Existing Warrants") to purchase an aggregate of 1,162,064 shares of common stock will be amended such that the Existing Warrants will have a reduced exercise price of $1.35 per share and shall expire commensurate with the warrants sold in the Offering.

This funding extends the Company’s cash runway through the end of 2026, providing sufficient funds for anticipated key inflection points. The Company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners acted as the sole placement agent in connection with the Offering.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-290413), previously filed with the Securities and Exchange Commission ("SEC") on September 19, 2025, which became effective on September 25, 2025. This Offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the Offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the Offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 29, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that the US Patent and Trademark Office (USPTO) has notified the Company that a key patent protecting the Company’s best-in-class FAK inhibitor narmafotinib has been allowed in the US (Press release, Amplia Therapeutics, SEP 29, 2025, View Source [SID1234656325]). The patent, titled A salt and crystal form of a FAK Inhibitor, describes the specific chemical form of narmafotinib being utilised in currently ongoing clinical trials.

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The patent allowance precedes a formal ‘Notification of Grant’ of the patent, which is expected in the coming months. The Company has previously announced that this key patent has already been granted in Japan and Europe1, and it has also been granted in Australia, India, Korea, Singapore, and New Zealand. Granting of this patent extends protection of narmafotinib out to a least 2040 in these jurisdictions. Protection in other regions is under review by the respective patent offices.

This patent describes a stable, manufacturable form of narmafotinib that provides improved drug levels upon dosing. Importantly, it is this specific form of the drug that is being developed clinically by the Company, including in the current ACCENT and AMPLICITY trials in advanced pancreatic cancer.

Amplia’s CEO and Managing Director Dr Chris Burns comments: "We continue to build a patent portfolio around narmafotinib to ensure the Company’s key intellectual property is protected and thus commercially valuable, for as long as possible."

On September 29, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported subgroup analyses focused on the radiation regimen from the Company’s positive phase 3 clinical trial of CAN-2409 (aglatimagene besadenovec) in patients with intermediate-to-high-risk localized prostate cancer at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Candel Therapeutics, SEP 29, 2025, View Source [SID1234656327]).

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Current standard-of-care radiation therapy for intermediate-to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately ~30% of patients experience disease recurrence within 10 years.

The Company has previously presented data from a randomized phase 3 clinical trial of CAN-2409 plus valacyclovir vs. placebo added to standard of care radiotherapy with curative intent in patients with localized prostate cancer. The press release is posted on the investor relations section of our website, available here. The randomized, double-blind, placebo-controlled, multicenter phase 3 trial (NCT01436968) enrolled 745 patients with intermediate-to-high-risk localized prostate cancer randomized 2:1 to either CAN-2409 plus valacyclovir in combination with standard of care or standard of care alone, with experimental treatment administered before and during radiation therapy. The trial achieved its primary endpoint with a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and demonstrated a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046). At two years, pathological complete response rates were 80.4% as compared to 63.6% observed in the control arm (p=0.0015).

This study represents the first potential advancement in localized, non-metastatic prostate cancer in more than 20 years. The Company today released additional information from its subgroup analysis of the phase 3 data showing that CAN-2409’s activity was independent of the radiation modality used in the trial.

Key Highlights from ASTRO 2025 Presentation:

CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated EBRT (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131)
Demonstrated safety and compatibility across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients) showing similar tolerability profiles
Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and control arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively
"These additional analyses suggest that the efficacy of CAN-2409 is independent of the modality of radiation used. Most importantly, the activity of CAN-2409 was maintained with moderate hypofractionated radiation, which is more convenient for patients," said Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study.

Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel said, "These new insights presented at ASTRO further support the broad therapeutic potential of CAN-2409 in localized prostate cancer treated with curative intent. Previously, we have shown the benefit of CAN-2409 compared to placebo in patients treated with standard of care radiotherapy, independent of the use of short-term androgen deprivation therapy. The consistency of benefit, across radiation therapy modalities, supports the therapy’s potential as the first major advancement in localized prostate cancer treatment in over 20 years. Our regulatory strategy remains on track with Biologics License Application submission expected in the fourth quarter of 2026."

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.