On August 10, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported the publication of a manuscript in Blood, the flagship journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), detailing the discovery and preclinical development of ziftomenib, a potent and selective menin inhibitor approved by the U.S. Food and Drug Administration in 2025 for adult patients with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML).

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The publication describes the scientific foundation underlying ziftomenib’s development, including its differentiated binding profile, potent and selective inhibition of the menin-KMT2A interaction, activity across multiple genetically defined leukemia models, and activity against certain treatment-emergent MEN1 mutations associated with resistance to other menin inhibitors.

"The publication in Blood captures the remarkable scientific journey that led to ziftomenib, from identifying the menin-KMT2A interaction as a compelling therapeutic target to designing a potent and selective inhibitor with the properties needed for clinical development," said Francis Burrows, Ph.D., Chief Scientific Officer of Kura Oncology. "The findings also provide important insight into the molecular properties that distinguish ziftomenib and supported its advancement from discovery through clinical development."

Researchers from the University of Michigan pioneered the discovery of small molecules that target the interaction between menin and KMT2A, which plays an important role in leukemias with genetic changes such as NPM1 mutations and KMT2A rearrangements. A collaboration between the University of Michigan and Kura Oncology, initiated in 2014, ultimately led to the development of ziftomenib, a menin inhibitor that Kura Oncology subsequently advanced through clinical development and FDA approval.

Study findings in preclinical leukemia models
As reported in Blood, across KMT2A-rearranged, NPM1-mutated and NUP98-rearranged leukemia models, ziftomenib demonstrated potent on-target activity, including suppression of key KMT2A-regulated genes such as MEIS1 and HOXA9, induction of differentiation, and reduced leukemia cell viability.

Ziftomenib also was shown to induce leukemia regression and extended survival in multiple xenograft and patient-derived xenograft models, including durable responses observed after treatment discontinuation in a patient-derived model.

The research further evaluated ziftomenib against treatment-emergent MEN1 mutations associated with resistance to menin inhibition. Researchers found that ziftomenib retained activity against certain resistance-associated menin mutations while other menin inhibitors did not, providing additional insight into ziftomenib’s differentiated binding profile and the molecular determinants of resistance. Clinical studies have shown a low frequency of treatment-emergent MEN1 resistance mutation with ziftomenib; in KOMET-001, MEN1-M3271 emerged in only 1 of 29 evaluable patients.i

"Ziftomenib represents the culmination of years of discovery, development, and dedication from an extraordinary team of scientists, clinicians, and colleagues who share a common goal: making a meaningful difference for patients," said Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This publication provides important scientific validation of the properties that enabled ziftomenib to advance from an early discovery program to an approved medicine for adult patients with relapsed or refractory NPM1-mutated AML. More importantly, these findings reinforce our conviction in ziftomenib’s potential as a foundational therapy across the AML treatment continuum as we continue to pursue combination strategies with established standards of care and development across molecularly defined patient populations."

Kura continues to advance ziftomenib as a potential foundational therapy across the AML treatment continuum by combining it with multiple standards of care in molecularly defined patient populations. These efforts are designed to build upon ziftomenib’s established activity in NPM1-mutated AML and expand its potential benefit to additional patients with menin-dependent acute leukemias, which represent up to 50% of eligible patients.

About Ziftomenib
Ziftomenib (marketed as KOMZIFTI in the U.S.) is a once-daily, oral menin inhibitor approved by the U.S. Food and Drug Administration for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib is being studied across the AML treatment continuum, including in combination studies in newly diagnosed and relapsed or refractory NPM1-mutated AML, KMT2A-rearranged AML, and FLT3-mutated AML. Ziftomenib is also being explored in additional oncology indications, including advanced gastrointestinal stromal tumors.

(Press release, Kura Oncology, AUG 10, 2026, View Source [SID1234669910])

On August 10, 2026 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2026, and provided an overview of recent operational highlights.

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"We are pleased with the execution of TONMYA’s launch, including nearly tripling net sales and achieving growth across our key metrics in the second quarter," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "We are seeing TONMYA’s value resonate among healthcare providers and patients as the first FDA-approved treatment for fibromyalgia in 15 years. It is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use. We are now beginning to see coverage translate into broader patient access following the execution of agreements with commercial payers, managed Medicare, and Medicaid. Our newly expanded sales force is expected to deploy in the field by September. We believe we are well positioned to reach more of our target prescribers and support the treatment of more patients with TONMYA."

Dr. Lederman continued, "We are also progressing our clinical development pipeline priorities. We enrolled the first patient in HORIZON, our potentially pivotal Phase 2 study of TNX-102 SL in MDD. For Lyme prevention, we expect to start enrollment in the first quarter of 2027 in a Phase 2 adaptive field study after we reached alignment with FDA on the development path for TNX-4800, an investigational long-acting borreliacidal human monoclonal antibody targeting OspA on Borrelia burgdorferi."

Commercial Updates
TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults; commercially launched on November 17, 2025

Performance Across Key Metrics

In the second quarter of 2026, key metrics include:
12,592 total prescriptions, increasing 100% quarter-over-quarter. This includes bridge prescriptions that are facilitated through the Company’s digital pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
New patient prescriptions increased 36% quarter-over-quarter.
Refills increased 207% quarter-over-quarter.
Payer Access and Coverage

The Company is prioritizing ongoing engagement with commercial payers, managed Medicare, and Medicaid to increase access:
Tonix announced commercial payer agreements with two leading GPOs in May and June 2026, providing access to a combined approximate 52 million lives (29% of the total commercial lives in the U.S.).
Currently, total coverage for TONMYA across commercial, managed Medicare, and Medicaid channels represents approximately 136 million covered lives (~43% of the approximately 314 million covered lives in the U.S.).
When the managed Medicare payer coverage agreement goes into effect on January 1, 2027, it will add approximately nine million Medicare lives (16% of the approximately 55 million Medicare lives in the U.S.). Total coverage will then reach approximately 145 million covered lives (~46% of the 314 million covered lives in the U.S.).
TONMYA is covered under Medicaid in most states, representing approximately 75 million lives.
Commercial Execution

Following these coverage milestones and encouraging trends across launch key performance indicators, Tonix is implementing its strategy to expand the TONMYA sales force. The Company expects to deploy 50 new sales representatives in the field by September 2026, bringing the full sales force to approximately 150 people.
In parallel, the Company is advancing marketing activities to enhance understanding of fibromyalgia and product awareness among patients and healthcare providers, as well as non-commercial medical affairs initiatives.
In the second quarter of 2026, Tonix presented data highlighting TONMYA at the European Alliance of Associations for Rheumatology (EULAR) 2026, 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and Professional Society for Health and Outcomes Research (ISPOR 2026) Annual Meeting, as well as published a manuscript in the peer-reviewed journal, Clinical Pharmacology in Drug Development.
Key Product Pipeline Candidates: Recent Highlights

Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD

In June 2026, Tonix enrolled the first patient in HORIZON, a potentially pivotal, 6-week, randomized, double-blind, placebo-controlled Phase 2 study of TNX-102 SL 5.6 mg as a first-line monotherapy in adults with MDD. Approximately 360 patients are expected to enroll at approximately 30 U.S. sites, with the primary endpoint of change from baseline in MADRS (Montgomery-Asberg Depression Rating Scale) total score at Week 6. TNX-102 SL targets disturbed sleep through antagonism at four neuronal receptors, an approach mechanistically distinct from currently available antidepressants.
TNX-102 SL: in Phase 2 development for acute stress disorder (ASD) and acute stress reaction (ASR)

The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) study is being conducted by the University of North Carolina under an investigator-initiated IND. Topline data is expected to be reported mid-2027.
TNX-1300 (double-mutant cocaine esterase) for cocaine intoxication; Phase 2 program has Breakthrough Therapy designation from the FDA, with no products on the market for this indication

The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2 study has been completed).
Infectious Disease Pipeline
TNX-4800 (anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the U.S., for which no FDA-approved vaccines or prophylactics are available

The Company received final minutes from a Type C meeting held with the FDA in early third quarter of 2026. The adaptive Phase 2 field study is expected to start in the first quarter of 2027 pending final FDA review and agreement on the study protocol.
The study will be a randomized, double-blind, placebo-controlled field study, with the primary efficacy endpoint of protection through six months, and a key secondary efficacy endpoint of protection through three months. Adults aged 18 and older from U.S. Lyme-endemic areas who engage in activities that increase their risk of deer tick bites will be randomized to receive placebo or two doses of TNX-4800: 450 mg subcutaneous (SC) dose at Day 1, and a second dose of 450 mg SC dose three months later at Day 85.
In April 2026, Tonix presented Phase 1 data and announced plans for an adaptive Phase 2 field study of TNX-4800 at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University.
The Company expects to deliver investigational product to the Phase 2 clinical study sites in the first quarter of 2027.
TNX-801 (recombinant horsepox virus): an attenuated, minimally replicative, live virus vaccine candidate in pre-clinical development for the prevention of smallpox and mpox
In July 2026, Tonix announced a new paper in the Journal of Virology describing new murine models for investigating mpox pathogenesis. TNX-801 is expected to enter a Phase 1 study in mid-2027 pending FDA clearance of the Investigational New Drug (IND) application.
TNX-4200 (broad-spectrum antiviral targeting CD45) for the prevention or treatment of high-lethality infections to improve the medical readiness of military personnel in biological threat environments

The ongoing TNX-4200 program is supported by an up to $34 million contract over five years from the Department of Defense’s Defense Threat Reduction Agency (DTRA). In the second quarter, the project began its next project phase.
Immunology Pipeline
TNX-1500 (dimeric Fc-modified anti-CD40L, humanized mAb): Phase 2-ready third-generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune diseases

In July 2026, the World Health Organization (WHO) included mosdaprubart as the proposed International Nonproprietary Name (pINN) for TNX-1500, pending publication as a recommended INN.
In May 2026, Tonix announced the publication of Phase 1 clinical data for TNX-1500 in the Journal of Clinical Immunology that support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection.
A Phase 2, open-label, investigator-initiated study in adult kidney transplant patients at Massachusetts General Hospital (MGH) is expected to initiate in the second half of 2026 pending FDA clearance of MGH’s IND application. The study is expected to enroll five adult kidney transplant recipients.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug and Rare Pediatric Disease designation that could potentially make Tonix eligible for a Priority Review Voucher upon approval

Tonix plans to initiate a Phase 2, randomized, double-blind, placebo-controlled study in children and adolescents with Prader-Willi syndrome in the second half of 2027.
Immuno-oncology Pipeline
TNX-1700 (TFF2-albumin fusion protein): in preclinical development for gastric and colorectal cancer

In June 2026, Tonix presented preclinical data at the Ninth JCA-AACR Special Joint Conference on Novel Therapies and Diagnostics in Upper Digestive and Head and Neck Cancers demonstrating TNX-1700 normalizes myelopoiesis and enhances anti-PD-1 therapy in gastric cancer.
Financial: Recent Highlights
Tonix had approximately $176.2 million of cash and cash equivalents as of June 30, 2026, compared to approximately $207.6 million as of December 31, 2025. Net cash used in operating activities was approximately $84.6 million for the six months ended June 30, 2026, compared to $31.4 million for the same period in 2025.

Subsequent to quarter-end, the Company raised $3.7 million in proceeds under its At-the-Market facility.

The Company believes that its cash resources as of June 30, 2026, together with the net proceeds that it raised from equity offerings in the third quarter of 2026 to date, will meet its planned operating and capital expenditure requirements into early second quarter of 2027.

As of August 7, 2026, the Company had 17,151,024 shares of common stock outstanding.

Second Quarter 2026 Financial Results
Net product revenue for the second quarter 2026 was approximately $13.5 million, compared to $2.0 million for the same period in 2025, and consisted of combined net sales of TONMYA, Zembrace SymTouch, and Tosymra. Net revenue from sales of TONMYA for the second quarter was approximately $11.0 million. Net revenue from sales of Zembrace SymTouch and Tosymra was approximately $2.5 million, compared to $2.0 million for the same quarter in 2025. Cost of sales for the second quarter 2026 was approximately $0.7 million, compared to $3.3 million for the same period in 2025. The decrease in the cost of sales is predominantly driven by a change in product mix and a write-off related to the migraine products in 2025.

Research and development expenses for the second quarter 2026 were approximately $19.4 million, compared to $10.8 million for the same period in 2025. The increase of $8.6 million was primarily attributable to higher manufacturing and clinical trial costs associated with advancing the Company’s prioritized pipeline programs, as well as increased employee-related costs reflecting expanded headcount.

Selling, general, and administrative expenses for the second quarter 2026 were approximately $36.0 million, compared to $16.2 million for the same period in 2025. The increase of $19.8 million was primarily attributable to sales and marketing investment supporting the commercial launch of TONMYA and the Company’s migraine products, together with increased employee-related and professional expenses.

Net loss available to common stockholders was $40.6 million, or $2.44 per basic and diluted share, for the second quarter 2026, compared to net loss available to common stockholders of $28.3 million, or $3.86 per basic and diluted share, for the same period in 2025. The basic and diluted weighted average common shares outstanding for the second quarter 2026 was 16,635,254 compared to 7,327,257 shares for the same period in 2025.

Conference Call and Webcast Information
The Company will host a conference call and webcast to report second quarter 2026 financial results and operational highlights on Monday, August 10, 2026, at 8:30 a.m. ET.

To listen to the conference call, register at this link. To view the webcast, register at this link.
A replay will be available under "IR Events" in the Investors section of the Company’s website at View Source

(Press release, TONIX Pharmaceuticals, AUG 10, 2026, View Source [SID1234669907])

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])

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])

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

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