On August 20, 2025 Agilent Technologies Inc. (NYSE: A) reported that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer (Press release, Agilent, AUG 20, 2025, View Source [SID1234655417]). This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

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The mismatch repair (MMR) pathway corrects DNA replication errors to maintain genomic stability1. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency, leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition2.

MMR IHC Panel pharmDx (Dako Omnis) is an immunohistochemical (IHC) panel specifically developed and validated to detect the loss of function of any of the four MMR proteins in formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue. Agilent’s panel is the only FDA-approved companion diagnostic IHC panel to diagnose colorectal cancer patients eligible for treatment with Opdivo alone or in combination with Yervoy.

"This approval marks an important step forward in the ongoing effort to improve colorectal cancer care," stated Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. "Our new CDx product offers healthcare providers an additional tool to identify mismatch repair deficiency in patients, complementing existing options and enhancing the ability to tailor immunotherapy treatments. By providing more choices, we aim to support better tumor control and potentially improve progression-free survival, ultimately contributing to patient care and well-being."

Agilent partnered with Bristol Myers Squibb to develop the MMR IHC Panel pharmDx (Dako Omnis). This highlights the collaborative efforts between Agilent and Bristol Myers Squibb in developing and gaining approval for diagnostic assays that aid in selecting patients for specific treatments.

Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb Company.

On August 20, 2025 Larkspur Biosciences, a company pioneering a new wave in cancer therapy that destroys tumors by targeting cancer cell fitness, reported the discovery of LRK-4189, a first-in-class degrader of the lipid kinase PIP4K2C for the treatment of microsatellite stable (MSS) colorectal cancer (CRC) and other solid tumors (Press release, Larkspur Biosciences, AUG 20, 2025, View Source [SID1234655402]). The announcement was made at a presentation Larkspur was invited to give at the prestigious MEDI First Time Disclosures: Breakthroughs on New Medicines session at ACS Fall 2025, a meeting of the American Chemical Society in Washington, DC.

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Cancer cells maintain their fitness by developing survival adaptations that foster escape from intrinsic and extrinsic mechanisms of cell death in conditions of stress. Phosphatidylinositol 5-phosphate 4-kinase, type II, gamma (PIP4K2C) is a lipid kinase associated with poor outcomes in a range of cancers including CRC and breast cancers. PIP4K2C is co-opted by cancer cells to increase their fitness by evading immune surveillance and adapting to stress.

"Genetic studies have long highlighted PIP4K2C as a key player in cancer stress adaptation, but its extremely low kinase activity made it resistant to conventional inhibition approaches," said Catherine Sabatos-Peyton, PhD, CEO of Larkspur Biosciences. "With our novel degrader, LRK-4189, we’ve finally unlocked this critical pathway. By reducing cancer cell fitness, triggering intrinsic apoptosis, and engaging the immune system to clear residual tumor cells, LRK-4189 has the potential to overcome the limitations of earlier therapies. We’re excited to advance this promising therapy to the clinic later this year."

According to the American Cancer Society, in the United States, approximately 150,000 cases of CRC are diagnosed annually, with MSS CRC accounting for about 85% of all CRC cases.

About LRK-4189

LRK-4189 is an orally bioavailable, selective degrader of PIP4K2C with subnanomolar potency in primary human cells.
LRK-4189-mediated degradation of PIP4K2C leads to intrinsic cancer cell death and activates interferon signaling, triggering multiple killing mechanisms in difficult-to-treat MSS CRC cells.
In vivo, LRK-4189 demonstrates dose dependent PKPD with single agent efficacy in multiple models of CRC and synergy with first-line standard of care chemotherapy.
In primary human CRC patient-derived spheroids, 50% of patient samples respond to LRK-4189 with a preferential response in MSS CRC, which compares favorably to benchmark cetuximab in the same platform (35%). Cetuximab may be either a first- or second-line treatment in people with RAS wild type CRC.
LRK-4189 has completed IND-enabling studies and expects to initiate a Phase 1 clinical trial in Q4 2025.

On August 20, 2025 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company ("Mural"), and XOMA Royalty Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator ("XOMA Royalty"), reported they have entered into a definitive agreement pursuant to which XRA 5 Corp., a newly formed company wholly owned by XOMA Royalty ("Sub"), has agreed to acquire the entire issued and to be issued share capital of Mural for cash (the "Acquisition") subject to the satisfaction of the closing conditions set out in Appendix I of this Announcement (the "Conditions"), including approval by Mural Shareholders (Press release, Mural Oncology, AUG 20, 2025, View Source [SID1234655403]). Following a strategic review process, the Mural board of directors (the "Mural Board") determined the acquisition and cash offer by XOMA Royalty is in the best interests of all Mural Shareholders and has approved the Acquisition. The Acquisition has also been approved by the boards of directors of XOMA Royalty and Sub.

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Under the terms of the Acquisition and subject to certain conditions, at closing, each Mural Shareholder (i) would receive a base cash price of $2.035 per share (the "Base Price Per Share") and (ii) may receive an additional cash amount per share of up to $0.205 (the "Additional Price Per Share") which would be calculated on the basis of the amount by which Mural’s Closing Net Cash on the Closing Net Cash Date exceeds its Estimated Closing Net Cash (the "Excess Cash") as set out in more detail below and in accordance with the provisions of the transaction agreement entered into between Mural, Sub and XOMA Royalty in respect of the Acquisition (the "Transaction Agreement"), as appended at Appendix IV of this Announcement.

The Base Price Per Share has been calculated on the basis of Mural having approximately $36.2 million in Closing Net Cash on the Closing Net Cash Date (the "Estimated Closing Net Cash"), and would be payable to Mural Shareholders on closing of the Acquisition regardless of the actual quantum of Mural’s Closing Net Cash on the Closing Net Cash Date. The Additional Price Per Share is intended to return any Excess Cash to Mural Shareholders. As a result, the Additional Price Per Share would only be payable to Mural Shareholders on closing of the Acquisition if Mural’s Closing Net Cash on the Closing Net Cash Date exceeds the Estimated Closing Net Cash. There is no certainty that Mural’s Closing Net Cash on the Closing Net Cash Date will exceed the Estimated Closing Net Cash and, if Mural’s Closing Net Cash does not the exceed Estimated Closing Net Cash, the amount of the Additional Price Per Share will be zero and each Mural Shareholder would receive only the Base Price Per Share.

The Additional Price Per Share is subject to a cap of a maximum amount of $0.205 per share.

The Acquisition, excluding any amount that may be payable in respect of the Additional Price Per Share, values the entire issued and to be issued share capital of Mural at approximately $36.2 million.

Excluding any Additional Price Per Share which may be payable as described above, the Acquisition represents a:

premium of approximately 13.1% to Mural’s closing share price of $1.80 on August 19, 2025, being the Business Day immediately before the date on which this Announcement has been released; and
premium of approximately 97.6% to Mural’s undisturbed closing share price of $1.03 on April 14, 2025 (being the last Business Day prior to the announcement of the commencement of the strategic review by the Mural Board on April 15, 2025).
Capitalised terms used in this Announcement and not otherwise defined have the meaning given to them in Appendix I.

Commenting on the Acquisition, Caroline Loew, Ph.D., Chief Executive Officer of Mural, said:

‘The Transaction Agreement with XOMA Royalty announced today is the result of a thorough and wide-ranging strategic review process, conducted with the support of our legal and financial advisors. We believe that this transaction, which is supported by our Board, achieves the goal of this strategic review process, which was to maximize shareholder value.’

Commenting on the Acquisition, Owen Hughes, Chief Executive Officer of XOMA Royalty, said:

‘XOMA Royalty looks forward to working with Mural to close the transaction as soon as possible.’

The Mural Directors, who hold Mural Shares representing, in aggregate, approximately 0.42% of Mural’s outstanding ordinary shares, Mural RSUs representing, in aggregate, approximately 1.27% of Mural’s outstanding ordinary shares and options to acquire Mural Shares representing, in aggregate, approximately 4.32% of Mural’s outstanding ordinary shares have entered into irrevocable undertakings to vote in favor of the Acquisition. All outstanding options to acquire Mural Shares held by the Mural Directors have a strike price above the maximum Consideration payable pursuant to the Acquisition and will be cancelled without the right to receive any Consideration in accordance with the terms of the Transaction Agreement.

Having taken into account the relevant factors, applicable risks and alternatives available to Mural, the Mural Board, which has been so advised by Lucid Capital Markets, LLC ("Lucid"), as financial adviser and Rule 3 adviser to Mural, as to the financial terms of the Acquisition, considers the terms of the Acquisition as set out in this Announcement to be fair and reasonable. Accordingly, the Mural Board intends to recommend that Mural Shareholders vote in favor of the Acquisition.

It is intended that the Acquisition will be implemented by means of a High Court sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act (or, if Sub elects, subject to the terms of the Transaction Agreement, compliance with the Irish Takeover Rules and with the consent of the Irish Takeover Panel, a Takeover Offer). The Acquisition is expected to close by the end of 2025, subject to the satisfaction of the Conditions, which include (i) the approval by Mural Shareholders of the Scheme Meeting Resolution and the Required EGM Resolutions; and (ii) the sanction of the Scheme by the High Court.

The Scheme Document, which will contain, among other things, further information about the Acquisition, notices convening the Scheme Meeting and the Extraordinary General Meeting (the "EGM"), the expected timetable for completion of the Acquisition and action to be taken by Mural Shareholders, will be published as soon as practicable following this Announcement. The Scheme Document will be included within the Proxy Statement to be filed by Mural with the U.S. Securities and Exchange Commission (the "SEC") and sent to Mural shareholders as of the record date(s) to be established for voting at the Scheme Meeting and EGM in respect of the Acquisition.

On August 19, 2025 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of September (Press release, Incyte, AUG 19, 2025, View Source [SID1234655386]):

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Cantor Global Healthcare Conference on Wednesday, September 3, 2025 at 8:00 am (EDT)
Well Fargo Healthcare Conference on Thursday, September 4, 2025 at 8:45 am (EDT)
Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025 at 10:00 am (EDT)
The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On August 19, 2025 iBio, Inc. (Nasdaq: IBIO), an AI-driven innovator of precision antibody therapies, reported the pricing of an underwritten public offering (the "offering") of (i) pre-funded warrants to purchase 71,540,000 shares of iBio’s common stock (the "pre-funded warrants"), and (ii) accompanying Series G warrants representing the right to purchase (the "Series G warrants") (a) 35,770,000 shares of iBio’s common stock, or pre-funded warrants in lieu thereof, and (b) Series H warrants representing the right to purchase 35,770,000 shares of iBio’s common stock, or pre-funded warrants in lieu thereof (the "Series H warrants") (Press release, iBioPharma, AUG 19, 2025, View Source [SID1234655372]). The combined public offering price of one pre-funded warrant and one Series G warrant to purchase (1) one-half of a share of common stock, or a pre-funded warrant in lieu thereof, and (2) one Series H warrant to purchase one-half of a share of our common stock, or a pre-funded warrant in lieu thereof, which are being sold together but are immediately separable, is $0.699. The offering is expected to close on or about August 22, 2025, subject to satisfaction of customary closing conditions. All of the securities are being offered by iBio.

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The pre-funded warrants will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. The Series G warrants and Series H warrants will each be exercisable from their date of issuance and will have an exercise price equal to $0.70 per share of iBio’s common stock (or $0.699 per pre-funded warrant) and in the case of the Series G warrants, the accompanying Series H warrant. The Series G warrants will expire on the date that is the earlier of (i) 30 trading days following iBio’s public announcement, via a press release on a nationally recognized news wire or the filing of a Current Report on Form 8-K with the Securities and Exchange Commission (the "SEC"), that an Investigational New Drug Application ("IND") filed with the U.S. Food and Drug Administration, a Clinical Trial Notification filed with the applicable foreign governmental body in Australia, a Clinical Trial Application filed with the European Medicines Agency, or an equivalent submission filed with a foreign governmental body to initiate a clinical trial in any other foreign jurisdiction has been accepted or has otherwise gone into effect, as applicable (such public filing or announcement, the "Trial Initiation Milestone") and (ii) five years from the date of issuance. In addition, each Series G warrant will immediately expire in proportion to the extent that the corresponding pre-funded warrant held by a holder is exercised prior to the occurrence of the Trial Initiation Milestone (solely to the extent the proportion of the unexercised portion of the Series G warrant relative to the originally issued Series G warrant is greater than the proportion of the unexercised portion of the pre-funded warrant relative to the originally issued pre-funded warrant). When issued upon exercise of the Series G warrants, the Series H warrants will expire on the four-year anniversary of the closing date of this offering.

The estimated gross proceeds from the offering are expected to be approximately $50 million before deducting underwriting discounts and commissions and offering expenses. The pre-funded warrants and Series G warrants (and the Series H warrants upon exercise of the Series G warrants) may be exercised for cash or, in certain circumstances at the holder’s discretion, on a net exercise or "cashless" basis. If all of the Series G warrants sold in this offering and all of the Series H warrants underlying the Series G warrants were to be exercised in cash at their exercise price, we would receive additional gross proceeds of approximately $50 million, before deducting expenses and fees.

iBio intends to use the net proceeds received from the offering to advance its preclinical cardiometabolic programs, including IBIO-610, the myostatin and activin A bispecific, and IBIO-600 programs, through key development milestones, as well as to continue to progress its other preclinical pipeline assets, and the balance, if any, to fund iBio’s working capital requirements and for other general corporate purposes.

Leerink Partners acted as the lead bookrunner for the offering. LifeSci Capital and Oppenheimer & Co. acted as bookrunning managers. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as a financial advisor to iBio.

The offering is being made by iBio pursuant to a shelf registration statement on Form S-3 (File No. 333- 280680), as amended (the "registration statement"), initially filed with the SEC on July 3, 2024 and, which became effective on August 6, 2024. The offering is being made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may be obtained by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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.