On July 31, 2026 Novartis reported the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC).

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Approval is based on the Phase III PSMAddition trial, which showed Pluvicto reduced the risk of progression or death by 28% (HR 0.72; 95% CI: 0.58–0.90) when combined with standard of care (SoC; ARPI + androgen deprivation therapy [ADT]) compared to SoC alone. At a subsequent updated analysis, the Pluvicto combination further reduced the risk of progression or death by 33% (HR 0.67; 95% CI: 0.55–0.82) with a positive overall survival (OS) trend favoring Pluvicto plus SoC (HR=0.80; 95% CI: 0.63–1.01), as data continue to mature ahead of final OS analysis.

"The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters," said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a Principal Investigator of the study in the US. "Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients."

Pluvicto can now be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. The approval builds on its established use in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer, also known as metastatic castration-resistant prostate cancer (mCRPC).

More than 186,000 men are diagnosed each year with mHSPC globally*1. Despite significant treatment advancements, about a third of patients do not achieve undetectable PSA with ARPI-ADT doublet therapy alone and half will progress to castration-resistant disease within 20 months, highlighting the need for earlier treatment intensification in this disease state2-6. The PSMA biomarker is present in more than 80% of patients with prostate cancer7-11.

"This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention," said Gina Carithers, CEO and President of the Prostate Cancer Foundation. "This milestone redefines prostate cancer care, ensuring that from day one of their metastatic diagnosis, men have a precision option."

The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION. At primary analysis, grade ≥3 adverse events (AEs) were reported in 50.7% of patients who received Pluvicto plus SoC compared to 43.0% receiving SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia. Health-related quality of life was maintained based on longitudinal assessment reflecting patient experience over time, with similar outcomes across arms in PSMAddition.

"Pluvicto is now approved across PSMA-positive metastatic prostate cancer, nearly doubling the number of patients who may benefit from this targeted approach," said Victor Bultó, President, US, Novartis. "Patients with metastatic prostate cancer continue to face significant unmet need, underscoring the importance of introducing precision options earlier in the treatment journey. Backed by nearly a decade of leadership in radioligand therapy and continued investment in science and infrastructure, we are expanding this field and bringing its promise to more patients."

Novartis RLT Patient and Office Support
With five manufacturing sites now operational or under construction in the US, Novartis has established an industry-leading footprint to support its goal of establishing RLT as a fundamental pillar of oncology care. Backed by an integrated end-to-end RLT ecosystem, Novartis can deliver Pluvicto to US treatment sites within 5 days to ensure prompt treatment initiation.

Novartis Patient Support is available to help eligible patients get started on treatment, including help understanding insurance coverage and identifying potential financial assistance options. Patients or providers can speak to a live agent at 1-844-638-7222 or visit View Source

About Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
Pluvicto is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

Pluvicto is the only PSMA-targeted agent approved across metastatic prostate cancer. Novartis is also investigating Pluvicto in oligometastatic prostate cancer (PSMA-DC, NCT05939414).

Radioligand Therapy (RLT) at Novartis
Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation, RLT is designed to deliver treatment directly to target cells anywhere in the body.

As a global leader in this space, Novartis has built integrated capabilities across research, manufacturing, logistics, and patient and provider support to help ensure approved RLTs reach patients reliably and efficiently. Novartis is investigating a broad portfolio of isotopes, ligands, and combination therapies to expand the use of RLT beyond prostate and neuroendocrine tumors.

(Press release, Novartis, JUL 31, 2026, View Source [SID1234669578])

On July 31, 2026 Ratio Therapeutics, Inc. (Ratio), a clinical-stage pharmaceutical company developing best-in-class radiopharmaceuticals for cancer treatment, reported the closing of a $70 million Series C financing.

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The financing included strong participation from existing investors Duquesne Family Office and Bristol Myers Squibb, along with new investors Catalio Capital Management, Eli Lilly and Company, and Wasatch Group.

Proceeds from the financing will fuel Ratio’s next phase of growth. The company expects to use the funding to advance its ongoing ATLAS study evaluating its lead radiotherapeutic asset [Ac-225]RTX-2358 in advanced sarcomas, and to move its next-generation RLT candidate into the clinic. Ratio also plans to expand its discovery pipeline into new, high-value oncology targets, extending its radiopharmaceutical platform beyond its current indications and into additional tumor types with significant unmet need and substantial market potential. In parallel, the company will continue to strengthen its proprietary radiopharmaceutical technology and scale its manufacturing capabilities to support pipeline expansion and future commercial demand.

"This financing reflects the confidence our investors and strategic partners have in the progress we have made to date and the opportunities that lie ahead," said Dr. Jack Hoppin, Chief Executive Officer of Ratio Therapeutics. "As we march the ATLAS trial forward and prepare for our 5th IND filing, these proceeds are instrumental across the development and ultimately the supply of our targeted and PK-optimized radiopharmaceuticals."

"Ratio is a leader in radiopharmaceutical innovation and it has backed up science with execution — hitting clinical milestones, deepening strategic partnerships, and building the manufacturing infrastructure this modality demands," said Sue Meng, Managing Director of Duquesne Family Office. "We’ve tracked that progress closely, and our investment reflects our strong conviction in Ratio’s platform and its potential to change outcomes for patients."

(Press release, Ratio Therapeutics, JUL 31, 2026, View Source [SID1234669579])

On July 31, 2026 Sona Nanotech Inc. (CSE: SONA, OTCQB: SNANF) (the "Company", "Sona") reported that it plans to raise up to $2,400,000 through a private placement financing (the "Financing") of up to 8,000,000 common shares of Sona (each, a "Share") at a price of $0.30 per Share (the "Offering Price"). Insiders and certain other existing shareholders of Sona may also subscribe for Shares under the Financing.

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Sona intends to use the net proceeds of the Financing for advancing studies to support the clinical advancement and continuing research and development work on its Targeted Hyperthermia TherapyTM ("THT") oncology treatment, as well as for general working capital purposes.

Completion of the Financing is subject to the satisfaction of certain conditions as well as the approval of the Canadian Securities Exchange. All securities issued pursuant to the Financing will be subject to a hold-period of four months and a day commencing from the closing date.

(Press release, Sona Nanotech, JUL 31, 2026, View Source [SID1234669580])

On July 31, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the second quarter ended June 30, 2026.

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"In the second quarter of 2026, as previously announced, Werewolf entered into an asset purchase agreement with Jazz Pharmaceuticals Ireland Limited ("Jazz") with respect to the JZP898 program previously licensed to Jazz, and repaid all amounts owed under its loan and security agreement with K2 HealthVentures LLC ("K2"). Together, these transactions, which included a $21.0 million payment to Werewolf, enabled the Company to explore multiple options for the continued development of its INDUKINE and INDUCER platforms and programs," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "In the second half of the year, we expect to provide additional updates on the strategic alternatives process that is being run with assistance from our exclusive financial advisor, Piper Sandler & Co. ("Piper Sandler"), as well as data updates on our clinical trials of WTX-124 and WTX-330."

Financial Results for the Second Quarter of 2026:

•Cash position: As of June 30, 2026, cash and cash equivalents were $22.0 million, compared to $46.5 million as of March 31, 2026. Based on its current operating plan, the Company expects to be able to fund its operations into the second quarter of 2027.
•Collaboration revenue: Collaboration revenue was $21.0 million for the second quarter of 2026, and consists of revenue recognized related the Company’s agreement to sell its JZP898 program to Jazz Pharmaceuticals Ireland Limited. No collaboration revenue was recognized during the second quarter of 2025.
•Research and development expenses: Research and development expenses were $6.2 million for the second quarter of 2026, compared to $13.1 million for the same period in 2025.
•General and administrative expenses: General and administrative expenses were $7.7 million for the second quarter of 2026, compared to $4.4 million for the same period in 2025.
•Net income (loss): Net income was $3.7 million for the second quarter of 2026, compared to a net loss of $18.0 million for the same period in 2025.

(Press release, Werewolf Therapeutics, JUL 31, 2026, View Source [SID1234669581])

On July 31, 2026 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the second quarter of 2026.

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"The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial profile with an improved 2026 operating expense outlook," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs."

Commercial Updates

During the second quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In Brazil, a collaboration was signed with a local manufacturer in support of a supply agreement for COVID vaccines. In the EU, the Company signed a joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA. Moderna also received regulatory approvals in Australia and Mexico for mRESVIA and in Japan and Taiwan for mNEXSPIKE, and its investigational seasonal influenza vaccine, mFLUSIVA, received a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of an August 5 Prescription Drug User Fee Act (PDUFA) goal date in the U.S.

Second Quarter 2026 Financial Results

Revenue: Total revenue for the second quarter of 2026 was $145 million, compared to $142 million in the same period in 2025. Lower COVID vaccine sales in the U.S. and South America were offset by deliveries in the United Kingdom under a long-term strategic government partnership and higher stand-ready manufacturing and collaboration revenue. Revenue was $87 million in the U.S. and $58 million in international markets.

Cost of Sales: Cost of sales for the second quarter of 2026 was $93 million, including $41 million of inventory write-downs, $23 million of unutilized manufacturing capacity costs, and $11 million of third-party royalties. Cost of sales decreased by 22% compared to the same period in 2025, primarily reflecting lower unutilized manufacturing capacity costs resulting from continued manufacturing productivity improvements and operational efficiencies.

Research and Development Expenses: Research and development expenses for the second quarter of 2026 were $651 million, a 7% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development costs following the wind-down of several late-stage programs.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2026 were $216 million, a 6% decrease compared to the same period in 2025. The decrease reflected continued discipline across the organization.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(0.8) billion for the second quarter of 2026, an improvement of $43 million, or 5%, compared to the second quarter of 2025.

Loss Per Share: Loss per share was $(1.97) for the second quarter of 2026, compared to loss per share of $(2.13) for the second quarter of 2025.

Cash Position: Cash, cash equivalents and investments as of June 30, 2026, were $6.9 billion, compared to $7.5 billion as of March 31, 2026. The decrease primarily reflected cash used to fund operations, continued investment in research and development and advancement of the Company’s pipeline. The Company subsequently paid $950 million in July 2026 related to the litigation settlement announced in the first quarter of 2026.

2026 Financial Framework

Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international. Moderna expects approximately 55% of its second half 2026 revenue to be recognized in the third quarter.

Cost of Sales: Cost of sales for 2026 is expected to be approximately $1.7 billion, lowered from approximately $1.8 billion, and including the $0.9 billion non-recurring litigation settlement charge.

Research and Development Expenses: Research and development expenses for 2026 are now anticipated to be approximately $2.9 billion, lowered from approximately $3.0 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion.

Income Taxes: The Company expects its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion.

Cash and Investments: Year-end cash and investments for 2026 are now projected to be $4.7 to $5.2 billion, an improvement of approximately $0.2 billion. This excludes any further drawdowns from the Company’s remaining $0.9 billion available under its credit facility.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Infectious disease vaccines:

Seasonal flu + COVID vaccine: Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. The Company is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus COVID combination vaccine.

Seasonal flu vaccine: The Company’s mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026

Norovirus vaccine: Moderna’s Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. The trial is ongoing and remains blinded as the Company works toward enrolling an additional cohort.

Oncology therapeutics:

Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC announced last quarter.

Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026.

The Company recently presented positive five-year Phase 2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.

mRNA-4359: Moderna’s Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company’s PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026.

Methylmalonic acidemia (MMA) therapeutic: The Company deferred its decision on a pivotal trial for mRNA-3705 until PA registrational data readout.

Moderna Corporate Updates

Appointed Ester Banque to Chief Commercial Officer of Moderna, effective June 15, 2026.

Appointed Michael McDonnell, former Chief Financial Officer of Biogen, to Moderna’s Board of Directors, effective July 8, 2026.

Company Accolades

Moderna was ranked no. 1 by TIME on its list of the World’s Most Impactful Companies.

Key 2026 Investor and Analyst Event Dates

Analyst Day: November 12

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on July 31, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

(Press release, Moderna Therapeutics, JUL 31, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=7044027068145026&symbol=MRNA [SID1234669583])