Silence Therapeutics Announces Positive Topline Results from Phase 2 SANRECO
Trial of Divesiran in Polycythemia Vera, Supporting its Potential Best-in-Class Profile

On August 10, 2026 Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, reported positive topline results from the Phase 2 SANRECO trial of divesiran, a first-in-class siRNA, in 48 phlebotomy-dependent patients with polycythemia vera (PV).

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The 36-week, randomized, double-blind, placebo-controlled portion of the Phase 2 trial evaluating divesiran (6 mg/kg) administered subcutaneously (s.c.) every six weeks (Q6W) or every twelve weeks (Q12W) met its primary endpoint and secondary endpoints.

Key findings from the study include:


The primary endpoint was met, with a significantly higher proportion of clinical responders among divesiran-treated patients with PV compared to those who received placebo (88% for divesiran versus 19% for placebo; p<0.0001). The primary endpoint was the proportion of patients achieving a response, which was defined as the absence of phlebotomy and maintenance of hematocrit (HCT) below 45% during weeks 18-36.


Importantly, both divesiran dose groups showed substantial primary endpoint efficacy with response rates of 93.8% and 81.3% for Q6W and Q12W, respectively.


The key secondary endpoint of phlebotomy rate during weeks 0-36 was also met with the mean number of phlebotomies per patient in the divesiran groups significantly reduced compared to placebo (0.2 for divesiran versus 2.1 for placebo; p<0.0001).


Divesiran groups also showed improvements in hematocrit control, iron markers including ferritin, and patient reported outcomes using the MPN-SAF Total Symptom Score (MPN-SAF TSS).


Divesiran was observed to be well tolerated and safety was in line with previous trials. No new safety findings were observed in the trial. Injection site reactions were infrequent and self-limiting. There were two investigator reported grade 1 anemia adverse event cases.

"Across the SANRECO Phase 1/2 program, divesiran has been well tolerated and has consistently delivered durable hematocrit control in phlebotomy-dependent patients with PV, regardless of risk level or disease severity," said Marina Kremyanskaya, MD, PhD, Associate Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai. "These compelling results highlight divesiran’s potential to transform PV management with convenient, infrequent dosing that reliably controls hematocrit and addresses longstanding unmet needs for patients."

"The SANRECO Phase 2 trial delivered our best-case outcome, confirming the impressive results observed in Phase 1 with dosing every six weeks and demonstrating equally robust and durable effects with quarterly dosing," said Curtis Rambaran, MD, Chief Medical Officer at Silence. "These results reinforce divesiran’s potential to become the first and best-in-class siRNA treatment for PV. We look forward to initiating Phase 3 development and bringing divesiran to patients as quickly as possible."

Silence plans to present full results from the Phase 2 SANRECO trial at an upcoming medical congress.

Silence will host a conference call and webcast today, Monday, August 10, 2026 at 8:00 a.m. ET, to discuss the Phase 2 SANRECO topline results.

Investor Conference Call and Webcast Details

Conference call link: View Source

Webcast link: View Source

A replay of the webcast will be available on the Investors section of the Silence website at www.silence-therapeutics.com/events.

SANRECO Phase 2 Study Design

The Phase 2 portion of SANRECO is an ongoing, three-part, global, randomized, placebo-controlled, double-blind study evaluating divesiran in 48 phlebotomy-dependent PV patients. The trial is evaluating the safety and efficacy of divesiran 6 mg/kg administered s.c. Q6W or Q12W in patients with uncontrolled hematocrit who are phlebotomy dependent despite standard of care treatment which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during weeks 18-36, which was defined as the absence of "phlebotomy eligibility." To meet phlebotomy eligibility, patients in the study were required to have hematocrit below 45%. All patients have completed their participation in the placebo-controlled portion of the trial and are now in the 3-year, double-blind and open label extension periods.

About PV

PV is a rare, myeloproliferative neoplasm – a type of blood cancer – characterized by the excessive production of red blood cells, often resulting in elevated hematocrit levels. Elevated hematocrit above 45-percent is associated with a four-times higher rate of death from cardiovascular and thrombotic events. PV is associated with a range of burdensome symptoms including fatigue, cognitive disturbance and pruritus and additionally, longer term can transform to myelofibrosis and Acute Myeloid Leukemia. The aim of treatment is to maintain hematocrit less than 45%, a level that is associated with a reduced incidence of thrombosis and CV-associated death. The current standard of care includes repeated phlebotomies to reduce hematocrit and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and hematocrit.

About Divesiran

Divesiran is Silence’s wholly owned siRNA product candidate developed from its proprietary mRNAi GOLD platform that "silences" TMPRSS6 expressed almost exclusively in the liver. TMPRSS6 is a negative regulator of hepcidin, the body’s master regulator of iron metabolism including its absorption, distribution, and storage. By silencing TMPRSS6 in PV patients, divesiran aims to increase hepcidin production and release by liver hepatocytes, leading to the restriction of iron to the bone marrow and, thus, reducing the excessive production of red blood cells, a process dependent on availability of iron. Divesiran has FDA Fast Track and Orphan Drug designations for PV.

(Press release, Silence Therapeutics, AUG 10, 2026, View Source [SID1234669906])

Replimune Announces Pricing of $150.0 Million Underwritten Offering

On August 10, 2026 Replimune Group, Inc. (Nasdaq: REPL) ("Replimune"), a commercial-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported the pricing of an underwritten offering of 9,701,490 shares of its common stock at an offering price of $12.06 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 2,736,340 shares of its common stock at a purchase price of $12.0599 per pre-funded warrant, which equals the offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses. All of the securities in the offering are to be sold by Replimune. The offering is expected to close on August 11, 2026, subject to the satisfaction of customary closing conditions.

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Leerink Partners, J.P. Morgan, and Cantor are acting as the bookrunning managers for the offering.

The securities are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the Securities and Exchange Commission (the "SEC") on May 23, 2025, as amended by Amendment No. 1 to the Registration Statement on Form S-3 filed with the SEC on November 6, 2025. A prospectus supplement relating to the offering, and the accompanying prospectus, will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement and the accompanying prospectus, when available, may be obtained from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or email: [email protected] and [email protected]; and Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of 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.

(Press release, Replimune, AUG 10, 2026, View Source [SID1234669905])

Corporate presentation

On August 10, 2026 Purple biotech presented its corporate presentation.

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(Presentation, Purple Biotech, AUG 10, 2026, View Source [SID1234669904])

Nkarta Reports Second Quarter 2026 Financial Results and Corporate Highlights

On August 10, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the second quarter ended June 30, 2026.

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"Expanding access to NKX019 in the communities where autoimmune patients already receive care is central to how we’re advancing this program," said Paul J. Hastings, Chief Executive Officer of Nkarta. "This quarter, we continued to enroll patients across all indications in Ntrust-1 and Ntrust-2 at the 4 billion cell dose level. Following our recent agreement with the FDA on outpatient dosing, we have begun administrating NKX019 through our expanding network of community-based sites, with re-dosing available, if needed, to patients in both trials. We look forward to presenting our initial clinical dataset from Ntrust-1 and Ntrust-2 at a medical conference in 2026."

NKX019 Clinical Program Progress and Upcoming Milestones


Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.

Outpatient dosing is underway within our network of community-based sites, broadening patient access beyond those who can travel to academic medical centers.

Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.

Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

Second Quarter 2026 Financial Highlights


Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $243.2 million as of June 30, 2026.

Research and development (R&D) expenses were $29.0 million for the second quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the second quarter of 2026.

General and administrative (G&A) expenses were $14.1 million for the second quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.1 million for the second quarter of 2026.

Net loss was $40.4 million, or $0.54 per basic and diluted share, for the second quarter of 2026. This net loss includes non-cash charges of $11.8 million that consisted primarily of share-based compensation of $1.9 million, depreciation of $2.7 million, and impairment of right-of-use assets, leasehold improvements and other equipment of $8.0 million.

Financial Guidance


Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional participants may be enrolled if needed to refine patient populations for further study.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in both trials may also receive additional cycles, if needed, to restore response or enable a deeper response.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, AUG 10, 2026, View Source [SID1234669903])

INNATE PHARMA ENTERS STRATEGIC PARTNERSHIP WITH SOBI TO LICENSE LACUTAMAB IN T-CELL LYMPHOMA

On August 10, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") and Swedish Orphan Biovitrum AB (publ) (Sobi) reported that they have entered a strategic partnership to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T-cell lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL.

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Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma, supporting a planned accelerated approval filing in Sézary syndrome. The planned TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. Closing of the transaction is subject to closing conditions, including the receipt of transaction related anti-trust clearance.
"We are thrilled to partner with Sobi and enable TELLOMAK-3 initiation, the pivotal next step in advancing lacutamab toward a potential accelerated approval in Sézary syndrome," said Jonathan Dickinson, CEO of Innate Pharma. "Sobi is the ideal partner to help unlock the full potential of lacutamab. Their expertise in rare diseases, proven commercial capabilities and global reach perfectly complement Innate’s expertise in CTCL clinical development. Together, we share the ambition to bring lacutamab to patients globally as quickly as possible."

"This agreement is an important step in strengthening our portfolio and reflects our strategy of partnering with leading innovators to bring differentiated therapies to patients with rare diseases. We look forward to working with Innate Pharma to advance lacutamab and, subject to regulatory approvals, make it available to patients globally," said Guido Oelkers, President and CEO of Sobi.

Transaction details

Under the terms of the agreement, Sobi will pay Innate Pharma USD 75 million, payable on closing. Innate will be eligible to receive up to a further USD 40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales.

About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL). CTCL is a group of rare non-Hodgkin lymphomas that includes Sézary syndrome, a rare and aggressive leukemic form, and mycosis fungoides, the most common subtype in CTCL.

The program has received Fast Track designation from the FDA, PRIME designation from the EMA for Sézary syndrome, Orphan Drug designation in both the U.S. and EU for CTCL, and Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome. The program is advancing toward a pivotal Phase 3 TELLOMAK-3 study, an open-label, multicenter, randomized trial in patients with Sézary syndrome and mycosis fungoides who have failed at least one prior systemic therapy. The study includes a confirmatory cohort in Sézary syndrome intended to support a potential accelerated approval and upon study completion a full approval for Sézary syndrome, and a registrational cohort in mycosis fungoides intended to support full approval, with progression-free survival (PFS) as the primary endpoint.

(Press release, Innate Pharma, AUG 10, 2026, View Source [SID1234669902])