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Signatera™ MRD Test Predicted Overall Survival Benefit from Chemotherapy in Resected Metastatic Colorectal Cancer

On July 6, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the publication of new data in JAMA Oncology, evaluating the utility of Signatera, its personalized molecular residual disease (MRD) test, in patients with resected colorectal liver metastases (CRLM). The data was also presented as an oral presentation at the 2026 European Society for Medical Oncology Gastrointestinal (ESMO GI) Congress.

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The liver is the most common site of distant metastasis in colorectal cancer, and CRLM is a major cause of cancer-related mortality.1,2 In patients where curative-intent surgery is possible, the benefit of adjuvant chemotherapy (ACT) has been a point of debate and uncertainty.3 MRD status has previously been shown to predict a disease free survival (DFS) benefit from ACT, but not an overall survival (OS) benefit. This is the first dataset in a large cohort to show MRD test prediction of OS from ACT in this population.

The JAMA paper included 298 patients from the GALAXY trial, the prospective, observational arm of CIRCULATE-Japan. Outcomes were evaluated according to MRD status and whether patients received ACT, with a median follow-up of 43 months. Key findings included:

Signatera identified patients who derive a significant survival benefit from ACT. Among MRD-positive patients who underwent surgery without neoadjuvant chemotherapy, ACT was associated with improved DFS and OS compared to observation (OS: adjusted HR, 0.27; P=0.03; 48-month OS, 65.3% vs. 32.9%; DFS: adjusted HR, 0.07; P<0.0001). MRD-negative patients had favorable outcomes, with no observed survival benefit from ACT.
Post-surgical MRD status was strongly prognostic. MRD positivity 2–10 weeks after surgery was associated with significantly worse DFS and OS, including those who received neoadjuvant chemotherapy before surgery (DFS: HR, 4.82; P<0.0001; OS: HR, 9.43; P<0.001), and those who did not (DFS: HR, 4.14; P<0.0001; OS: HR, 9.13; P<0.0001).
"For patients with colorectal liver metastases, the benefit of ACT after curative-intent surgery has remained uncertain," said Kozo Kataoka, M.D., Ph.D., division of lower GI, department of gastroenterological surgery, Hyogo Medical University, and senior author of the study. "Importantly, this is the largest analysis to show that post-surgical MRD status may help identify which patients benefit from ACT in patients who underwent upfront surgery."

"This analysis adds important overall survival data in resected colorectal liver metastases, a setting where clinicians have historically had limited tools to determine who is most likely to benefit from ACT," said Adham Jurdi, M.D., senior medical director of oncology at Natera. "It further reinforces how Signatera can help tailor treatment to each patient."

(Press release, Natera, JUL 6, 2026, View Source [SID1234669083])

Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe

On July 6, 2026 Shilpa Medicare Limited reported that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe.

Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity.

Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product development and serve as exclusive long-term commercial manufacturer and supplier for Europe. Shilpa will receive development and regulatory milestone payments, and supply revenue over life of partnership.

"Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals," said Vishnukant Bhutada, Managing Director, Shilpa Medicare. "It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale."

"We are pleased to add yet another product to our strategic partnership with Shilpa," said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma. "This agreement strengthens our operations in hospital segment in Continental Europe, and reflects progress of implementation of our division’s strategy to give everybody an access to affordable quality medicines."

(Press release, Orion, JUL 6, 2026, View Source [SID1234669082])

Vertex to Acquire Crinetics Pharmaceuticals

On July 6, 2026 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases, reported that the companies have entered into a definitive agreement under which Vertex will acquire Crinetics for $85.00 per share in cash, for a total equity value of approximately $10.0 billion, or approximately $8.8 billion net of estimated cash acquired. The transaction was unanimously approved by both the Vertex and Crinetics Boards of Directors and is anticipated to close in the third quarter of 2026.

Crinetics’ marketed medicine, PALSONIFY (paltusotine), received approval from the U.S. Food and Drug Administration (FDA) in September 2025. PALSONIFY was recently approved by the European Medicines Agency (EMA) and is under review by other global regulatory bodies. It is the first and only once-daily oral therapy for adults with acromegaly, a rare and debilitating condition caused by a pituitary tumor that secretes excess growth hormone, which affects an estimated 20,000 diagnosed people in the U.S. PALSONIFY leads to rapid disease control and normalization of key disease markers in both treatment-experienced and untreated populations. Since launch, PALSONIFY has demonstrated promising early commercial momentum, supported by strong demand across all patient segments, prescribing activity expansion, and growing reimbursement coverage, all of which reinforce its potential to redefine the treatment paradigm in acromegaly.

Crinetics’ most advanced pipeline candidate, atumelnant, is a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist currently in Phase 3 development for congenital adrenal hyperplasia (CAH). Classic CAH, the most severe form of the disease, with 17,000 addressable patients in the U.S., is a rare, chronic genetic condition affecting the adrenal glands that has significant unmet medical need. Among other features, CAH is characterized by impaired cortisol synthesis and, in most cases, excess androgen production, both of which contribute to a range of serious health consequences. In Phase 2 studies, patients taking atumelnant were able to achieve near normalization of excess androgen levels on physiologic replacement doses of glucocorticoids. This unique therapeutic profile positions atumelnant to become the leading medical therapy for people struggling with CAH. Atumelnant was generally well tolerated with no treatment-related severe or serious adverse events to date.

"Crinetics is an excellent strategic fit for Vertex, with its focus on serious diseases in specialty markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines that could deliver transformative benefit to patients," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. "We believe Vertex can build on the strong momentum of the PALSONIFY launch by applying our experience in commercializing medicines for rare genetic diseases. We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids."

Dr. Kewalramani continued, "We look forward to working with the talented Crinetics team to rapidly advance their pipeline of medicines for patients living with serious, rare endocrine disorders. Together, these potential blockbuster assets build on our core CF business, ongoing launches and internal innovation portfolio, adding to our growth outlook and driving value for patients and shareholders."

"Nearly 18 years ago, we founded Crinetics with a clear goal of transforming the lives of patients living with endocrine-related diseases. Today marks a historic milestone as we embark on this next chapter with Vertex," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics Pharmaceuticals. "This partnership is anchored by a mutual commitment to science and a shared vision for delivering innovative treatments to patient communities that have long been underserved. Vertex’s global infrastructure and commercial footprint will serve to amplify the reach of our science and allow us to maximize the impact of PALSONIFY, atumelnant and our pipeline. I want to extend my deepest gratitude for the relentless dedication, brilliance and passion of our extraordinary employees, who have worked tirelessly to bring our scientific vision to life, as well as the clinical partners and patient communities who have championed our mission from the very beginning."

Financial Benefits

The transaction is expected to contribute immediately to Vertex’s revenue growth via the ongoing launch of PALSONIFY, which has blockbuster potential in acromegaly. Longer term, atumelnant has the potential to be a multi-billion-dollar opportunity in CAH, with additional upside from its potential in Cushing’s syndrome. At peak, these assets have the potential to deliver more than $5 billion in combined annual revenue, which will further Vertex’s goal of delivering sustained double-digit revenue growth, in addition to industry leading operating margins. The transaction is expected to become accretive to non-GAAP operating income in 2029.

Transaction Terms and Financing

Under the terms of the merger agreement, Vertex will acquire all outstanding shares of Crinetics common stock for $85 per share in cash for a total equity value of approximately $10.0 billion or $8.8 billion net of estimated cash acquired. Vertex expects to finance the acquisition using a combination of cash on hand and debt, supported by $4.5 billion of fully committed bridge financing from Bank of America, N.A. and Morgan Stanley Senior Funding, Inc.

The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including receipt of regulatory approvals and approval by Crinetics shareholders.

Advisors

Morgan Stanley & Co. LLC and Lazard are acting as financial advisors to Vertex, and Kirkland & Ellis LLP is serving as legal counsel to Vertex. J.P. Morgan Securities LLC and Leerink Partners LLC are acting as financial advisors to Crinetics, and Paul, Weiss, Rifkind, Wharton & Garrison LLP and Morrison Foerster LLP are legal counsel to Crinetics.

Vertex Conference Call and Webcast

Vertex will host a conference call and webcast at 4:30 pm ET today, July 6, 2026. To access the call, please dial (833)-630-2124 (U.S.) or +1 (412)-317-0651 (International) and reference the "Vertex Pharmaceuticals Conference Call."

The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website in the "Investors" section.

(Press release, Vertex Pharmaceuticals, JUL 6, 2026, View Source [SID1234669081])

Anixa Biosciences and Moffitt Cancer Center Advance Ovarian Cancer CAR-T Clinical Trial to Highest Dose Level to Date

On July 6, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the first patient has been treated in the fifth cohort of its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center ("Moffitt").

The Phase 1 study is evaluating a novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels.

The patient received a dose of 1×10⁷/kg CAR-positive cells following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed across any cohort up to and including the dose level of 3×106/kg CAR-T cells, the prior dose tested.

As of the date of this release, five patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17, and 13 months post-treatment, respectively. The Company believes these outcomes are notable in a highly pre-treated, recurrent ovarian cancer population that has progressed after multiple prior lines of therapy and limited treatment options and poor prognosis.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Advancing to the fifth cohort and highest dose level while observing no dose-limiting toxicities across the study to date is a meaningful milestone for the program. Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes. While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that five patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter weeks. These are precisely the kinds of signals we hoped to see at this stage. We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as enrollment progresses."

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, JUL 6, 2026, View Source [SID1234669080])

Nuvation Bio Inc. Announces Full Exercise of Greenshoe Option in $287.5 Million Convertible Senior Notes Offering

On July 6, 2026 Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the underwriters have exercised in full their over-allotment option (the "Greenshoe Exercise") to purchase an additional $37.5 million aggregate principal amount of its 0.75% Convertible Senior Notes due 2032 (the "Notes"). The aggregate principal amount of Notes sold in the offering was $287.5 million, inclusive of the $37.5 million aggregate principal amount of Notes issued pursuant to the Greenshoe Exercise.

On July 1, 2026, in connection with the Greenshoe Exercise, Nuvation Bio entered into additional capped call transactions with a cap price of $10.4580, which represents a premium of 80.0% over the last reported sale price of the Class A common stock on the New York Stock Exchange on June 25, 2026, and is subject to certain adjustments under the terms of the capped call transactions.

The Notes were offered and sold in a public offering pursuant to a registration statement on Form S-3 (File No. 333-285621) filed with the Securities and Exchange Commission, which automatically became effective on March 6, 2025.

Nuvation Bio estimates that the net proceeds from the offering, inclusive of the Notes issued pursuant to the Greenshoe Exercise, will be approximately $277.6 million, after deducting the underwriting discounts and commissions and the estimated offering expenses payable by Nuvation Bio. Nuvation Bio used the net proceeds from the Greenshoe Exercise to pay the approximately $2.2 million cost of the additional capped call transactions described above and expects to use the remaining net proceeds from the Greenshoe Exercise for general corporate purposes, which may include working capital, operating expenses, capital expenditures and general and administrative expenses.

(Press release, Nuvation Bio, JUL 6, 2026, View Source [SID1234669079])