Key Outcomes:
- Nerandomilast (Boehringer) – FIBRONEER studies met the primary endpoint (slowed FVC decline); pooled analysis showed 59% reduction in death risk vs. placebo, but the key secondary composite endpoint was missed
- Evategrel/CG-0255 (CureGene) – First patient dosed in US pivotal trial vs. clopidogrel; prior data show fast onset (<15 min IV/<30 min oral), high potency at ~1% clopidogrel dose, and low bleeding risk
- Zervimesine/CT1812 (Cognition Tx) – FDA aligned on P3 design for DLB psychosis; P2 SHIMMER showed ~89% slower progression of hallucinations/delusions
- SRD-002 (Medera) – DMC found no safety concerns in P1/2 HFpEF gene therapy trial; Cohort A showed improved NYHA class, KCCQ, and PCWP; Cohort B data are due Q4 2026
- Bemnifosbuvir/Ruzasvir (Atea) – Enrollment completed (~880 patients) in P3 HCV trial; topline data expected YE 2026
- Nexviazyme (Sanofi) – P3 Baby-COMET met the primary endpoint (ventilation-free survival) and all secondary endpoints in infantile-onset Pompe disease; well tolerated; US label expansion planned for H2 2026
- HLX43 + Serplulimab (Henlius) – Received Australian regulatory approval to start P2 neoadjuvant NSCLC trial
- ODM-212 (Orion Pharma) – Received EU Orphan Drug Designation for mesothelioma (adds to existing US ODD)
- WAYRILZ/Rilzabrutinib (Sanofi) – Approved in Japan for chronic/persistent ITP based on P3 LUNA 3 (met primary & secondary endpoints)
- MaaT013 (MaaT Pharma) – CHMP issued negative opinion (insufficient efficacy attribution); company seeking re-examination, and a second opinion is expected Sep 2026
- Enhertu (AstraZeneca) – EC approved as EU’s first tumor-agnostic HER2-directed ADC, based on pooled P2 DESTINY trials across multiple tumor types
- Protillion-Merck – AI-biologics collaboration; up to $510M in milestones
- Antengene-K2 Therapeutics – Licensing deal for ATG-106 (bispecific TCE); ~$20M upfront, up to $960.5M in milestones
- BioArctic-Lilly – Brain-penetrant neuro therapy collab; $30M upfront, up to $770M in milestones
- AbbVie-Apogee Therapeutics – $10.9B acquisition (immunology/respiratory assets: zumilokibart, APG273); expected to close Q3 2026
- Frontier Health – Raised $12.8M (total $16M) for AI healthcare admin platform, NHS-focused
June 18, 2026
Long-Term Modeling Highlights Potential Survival Benefit of Nerandomilast in IPF and PPF
Boehringer Ingelheim presented long-term survival modelling for nerandomilast, its oral preferential PDE4B inhibitor, at ATS and EULAR 2026, showing predicted multi-year survival gains in fibrotic lung disease. Data from the P3 FIBRONEER studies, FIBRONEER-IPF and FIBRONEER-ILD indicate that nerandomilast 18 mg monotx. could extend median survival.
Results:
Both studies met their primary endpoint of slowed FVC decline at wk 52, and a pooled analysis showed a nominally significant 59% reduction in risk of death with nerandomilast 18 mg monotherapy vs pbo, though the key secondary composite endpoint (time to first acute exacerbation/hospitalization for respiratory cause/death) was not met. Company and clinical investigators emphasized that tolerability enabling sustained treatment could translate these modeled benefits into meaningful additional time for patients.
Source: Boehringer Ingelheim PR Jun 18, 2026
June 20, 2026
CureGene Doses First Patient in U.S. Pivotal Trial of Evategrel
CureGene Pharmaceutical dosed the first patient in the U.S. pivotal trial of Evategrel (CG-0255), the lead candidate from its proprietary A-proX Prodrug Platform. The novel P2Y12 inhibitor, being developed in both IV and oral formulations, is being evaluated against clopidogrel in patients with ACS, recent MI, ischemic stroke, and PAD to support a future U.S. NDA submission. Previous studies showed Evategrel achieves peak antiplatelet effects in under 15 min IV and under 30 min orally, while demonstrating high potency at approximately 1% of the standard clopidogrel dose and a favourable safety profile with low bleeding risk and minimal drug-drug interactions. The drug has also received clinical trial approval in China, where a P2 ischemic stroke study is expected to begin soon. Its parallel development in the U.S. and China aims to support simultaneous NDA filings and accelerate global access to a potentially faster, safer, and more effective antiplatelet therapy for cardiovascular and cerebrovascular diseases.
Source: PR Newswire PR Jun 20, 2026
June 24, 2026
FDA Supports Cognition Therapeutics’ P3 Development Plan for Zervimesine in DLB Psychosis
Cognition Therapeutics has received FDA meeting minutes confirming alignment on key aspects of its pivotal P3 program evaluating zervimesine (CT1812) for psychosis associated with dementia with Lewy bodies (DLB), with the registrational trial expected to begin in mid-2027. The FDA agreed that DLB-associated psychosis (hallucinations and delusions) is an acceptable approvable outcome and supported the use of the Neuropsychiatric Inventory (NPI) as the primary endpoint, with final analytical and statistical plans to be determined jointly. The P3 study will enroll patients with DLB experiencing hallucinations and delusions, including those receiving stable off-label antipsychotics, and randomize them to QD oral zervimesine 100 mg vs placebo for 9 mos. These plans are supported by positive P2 COG1201 SHIMMER results, in which zervimesine slowed the progression of hallucinations and delusions by approximately 89%, supporting its advancement into registrational development. The company will also present additional P2 analyses of zervimesine’s effects on NPI hallucination and delusion scores at the AAIC in Jul’26. Separately, zervimesine is being evaluated in the ongoing P2 START study in patients with MCI and early Alzheimer’s disease.
Source: Cognition PR Jun 24, 2026
June 25, 2026
Medera Reports Positive DMC Review for SRD-002 HFpEF Gene Therapy, Cohort B Data Expected in Q4 2026
Medera reported that the independent DMC completed its planned safety review of the ongoing P1/2 MUSIC-HFpEF study of SRD-002, an AAV-based gene therapy designed to restore SERCA2a expression for the treatment of heart failure with preserved ejection fraction (HFpEF). The DMC identified no safety concerns and recommended that the trial continue as planned without modifications, results presented at AHA’25. Cohort A patients demonstrated improvements in NYHA functional class, KCCQ scores, & hemodynamic parameters, including pulmonary capillary wedge pressure (PCWP) at rest and during exercise a key physiological marker of HFpEF. The study is evaluating the safety, tolerability, and preliminary efficacy of SRD-002. Medera expects to report 12-mos data from Cohort B in Q4 2026, further advancing the clinical development of its lead HFpEF gene therapy program.
Source: GlobeNewswire PR Jun 25, 2026
June 25, 2026
Atea Completes Enrolment in P3 C-FORWARD Study of Bemnifosbuvir/Ruzasvir for Chronic HCV
Atea has completed enrolment in its global P3 C-FORWARD study of bemnifosbuvir/ruzasvir vs sofosbuvir/velpatasvir for HCV, with topline data expected around YE’26. More than 880 treatment-naïve chronic HCV patients have been enrolled across ~120 sites in 17 countries outside North America, making C-FORWARD, together with the North American C-BEYOND study, the first global P3 head-to-head direct-acting antiviral (DAA) program in HCV.
Parameter:
The primary endpoint is HCV RNA below the lower limit of quantitation at 24 weeks from treatment start, capturing SVR12 in both arms on a per‑protocol basis. Atea positions BEM/RZR as a potentially BIC regimen with shorter treatment duration, low drug-drug interaction risk and no food effect, aiming to improve the SoC in the context of a persistent global HCV burden of ~50M chronically infected patients and ongoing gaps between diagnosis and cure rates. The company reiterates that C‑BEYOND topline data (US/Canada) remain on track for mid‑2026, and highlights its broader antiviral pipeline, including planned mid‑2026 clinical development initiation of AT‑587 for hepatitis E, while noting the usual forward‑looking statement caveats around development timelines and outcomes.
Source: GlobeNewswire PR Jun 25, 2026
June 30, 2026
Sanofi’s Nexviazyme Meets All Endpoints in P3 Baby-COMET Study in Infantile-Onset Pompe Disease
Sanofi released positive results from the P3 Baby-COMET study of Nexviazyme (avalglucosidase alfa) to treat-naïve infants (≤6 mos of age) with infantile-onset Pompe disease (IOPD). The study met its primary endpoint, with participants remaining alive and free of invasive ventilation at 52 wks, and achieved all secondary endpoints, including invasive ventilation-free survival at 12 and 18 mos of age, as well as numerical improvements in cardiac function (left ventricular mass Z-score), motor function (Alberta Infant Motor Scale), and disease burden (urinary glucose tetrasaccharide). Nexviazyme was well tolerated, with no serious treatment-related adverse events, deaths, or treatment discontinuations, and a safety profile consistent with previous studies. The results will be presented at the 19th International Congress on Neuromuscular Diseases on Jul 8, 2026, and will support a US regulatory submission for a label expansion to include IOPD in H2 2026. Nexviazyme is currently approved in the US for late-onset Pompe disease (LOPD) in patients aged ≥1 year and in Europe (as Nexviadyme) for both LOPD and IOPD, while its use in IOPD remains investigational in the US.
Source: Sanofi PR Jun 30, 2026
June 17, 2026
Henlius Secures Australian Approval for P2 Study of HLX43 in the Combination with Serplulimab for Resectable NSCLC
Shanghai Henlius reported that approval from Australia’s Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA) for the P2 HLX43-NSCLC203 study of HLX43 + serplulimab as neoadjuvant therapy for patients with resectable NSCLC. The study is designed to assess whether combining an ADC with an immune checkpoint inhibitor can enhance anti-tumor activity and help reduce the risk of recurrence and metastasis in early- and mid-stage disease. Prior study for HLX43 alone, which was evaluated in a 205-patient was presented at ASCO’26, demonstrated encouraging anti-tumor activity and a manageable safety profile in previously treated NSCLC patients, regardless of histology or PD-L1 expression. In parallel, Henlius is advancing HLX43 through the global P2 HLX43-NSCLC201 study in advanced NSCLC and the international P2/3 HLX43-NSCLC302 study in advanced sqNSCLC. Serplulimab is currently approved in 50 markets worldwide across multiple lung cancer indications, while its global P3 study in LS-SCLC has completed patient enrolment. Henlius is also strengthening its lung cancer portfolio with assets including bevacizumab biosimilar (HLX04), pimurutamab, the tetraspecific T-cell engager HLX3901, and the bispecific ADC HLX48.
Source: Henlius PR Jun 17, 2026
June 23, 2026
Orion Pharma Secures EU ODD for Pan-TEAD Inhibitor ODM-212
Orion Pharma’s oral pan‑TEAD inhibitor ODM‑212 has been granted ODD by the EC for the treatment of malignant mesothelioma, following a positive recommendation from EMA’s COMP, and complementing its previously granted US FDA ODD for mesothelioma. ODM‑212 targets the Hippo signalling pathway by inhibiting TEAD transcription factors and disrupting YAP‑TEAD interactions, and is being investigated in the global P2 TEADES study in patients with malignant pleural mesothelioma, epithelioid hemangioendothelioma and other solid tumours with Hippo pathway alterations who have progressed after standard therapy.
Source: GlobeNewswire PR Jun 23, 2026
June 23, 2026
Japan Approves Sanofi’s WAYRILZ for Persistent or Chronic ITP
Sanofi’s WAYRILZ (rilzabrutinib), a novel oral reversible BTKi, has received marketing and manufacturing authorization in Japan for the treatment of persistent or chronic immune thrombocytopenia (ITP) in patients who have inadequate response or tolerability to other therapies, with the approval based on the P3 LUNA 3 study showing rapid, durable platelet responses, faster onset and longer DoR vs PBO, as well as meaningful improvements in disease‑related QoL. In LUNA 3, WAYRILZ met primary and secondary endpoints.
Result:
Safety Profile:
Most common AEs: diarrhea, nausea, headache, abdominal pain, COVID‑19.
Additional Information:
Wayrilz was developed with TAILORED COVALENCY technology for selective BTK inhibition, is now approved for ITP in the US, EU, UAE, UK, and Japan, and is being further investigated in other rare immune‑mediated diseases (IgG4‑related disease, warm autoimmune hemolytic anemia, and sickle cell disease), for which it also holds ODD in Japan but is not yet approved.
Source: GlobeNewswire PR Jun 23, 2026
June 26, 2026
MaaT Pharma Requests Re-Examination After CHMP Rejects MaaT013 Conditional MAA
MaaT Pharma reported that the EMA’s CHMP issued a negative opinion on the conditional MAA for MaaT013 (Xervyteg) to treat adult patients with acute graft-versus-host disease (aGvHD) with gastrointestinal involvement refractory to prior lines of therapy, confirming the negative trend communicated in May 2026. The company plans to request a re-examination of the opinion and seek a Scientific Advisory Group (SAG) hearing with haematology experts, with a second CHMP opinion expected during the Sep 14-17, 2026 session. The CHMP concluded that the current evidence, primarily from the single-arm P3 ARES study, did not sufficiently attribute the observed efficacy and safety to MaaT013 because of the use of concomitant therapies in aGvHD patients. Despite the setback, MaaT Pharma remains confident in MaaT013’s clinical profile, citing supportive evidence from the P3 ARES study, the CHRONOS real-world study, and its Early Access Program (EAP), which has treated more than 300 patients across 13 countries since 2019. The company also confirmed that the re-examination process will not affect the ongoing EAP, and eligible patients will continue to have access to MaaT013.
Source: MaaT Pharma PR Jun 26, 2026
June 29, 2026
EC Approves Enhertu as EU’s First Tumour-Agnostic HER2-Directed ADC
The EC has approved Enhertu (trastuzumab deruxtecan) as the first tumour-agnostic HER2-directed therapy and ADC in the EU for adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory treatment options. The approval is based on pooled efficacy and safety data from the P2 DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 studies, which demonstrated durable and clinically meaningful responses across multiple HER2-positive tumour types, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and colorectal cancers, supporting a biomarker-driven, tumour-agnostic treatment approach regardless of the cancer’s site of origin. This approval addresses a significant unmet need for patients with advanced HER2-positive solid tumours who have limited treatment options and further expands Enhertu’s global portfolio of HER2-targeted indications.
Efficacy Result:
Source: AstraZeneca PR Jun 29, 2026
June 16, 2026
Protillion and Merck Partner to Develop AI-Engineered Multi-Target Biologics
Protillion Biosciences has entered into a multi-target drug discovery and licensing collaboration with Merck to develop new biologic therapies using its AI-enabled protein engineering platform. The partnership will combine Protillion’s Prot-MaP technology, which generates large-scale protein datasets to improve AI-based drug design, with Merck’s expertise in biologics development. Protillion will receive an undisclosed upfront payment and is eligible for up to $510M in research, development, and commercial milestone payments tied to the successful advancement of multiple therapies. The collaboration will focus on identifying and optimizing biologics with advanced properties, such as multi-target specificity and pH-dependent activity.
Source: Protillion Biosciences PR Jun 16, 2026
June 21, 2026
K2 Therapeutics Secures Rights to Antengene’s ATG-106 and Additional TCE Candidate
Antengene entered into an exclusive licensing agreement with K2 Therapeutics, a biotech company established by MPM BioImpact, granting global rights outside Greater China to ATG-106, a preclinical CDH6×CD3 bispecific T-cell engager (TCE) for targets CDH6 for solid tumors such as ovarian and renal cancers with limited expression in normal tissues. The companies also entered an option agreement that could provide K2 with rights to an undisclosed preclinical bispecific TCE candidate. Both programs are based on Antengene’s proprietary AnTenGager platform, which is designed to improve the safety and tolerability of TCEs by enabling antigen-dependent T-cell activation while maintaining potent anti-tumor activity. Antengene will receive approximately $20M in upfront, a minority equity stake and near-term consideration for the ATG-106 and could receive a similar amount if the option is exercised for the undisclosed preclinical bispecific TCE candidate. The company is also eligible for up to $960.5M in development, regulatory, and commercial milestone payments, plus tiered royalties for ATG-106 and could receive a similar amount if the option is exercised for the undisclosed preclinical bispecific TCE candidate.
Source: PR Newswire PR Jun 21, 2026
June 22, 2026
BioArctic and Lilly Partner to Develop Brain-Penetrant Neurodegeneration Therapy
BioArctic and Eli Lilly have entered a research and collaboration agreement to develop a potential treatment for neurodegenerative diseases by combining Lilly’s undisclosed drug candidate with BioArctic’s BrainTransporter platform. BioArctic will receive a $30M upfront payment and is eligible for up to $770M in development, regulatory, and commercial milestones, plus tiered mid-single-digit royalties on worldwide sales. BioArctic will generate the new drug candidate by integrating its BrainTransporter platform which is designed to enhance drug delivery across the blood-brain barrier via the transferrin receptor with a Lilly molecule, while Lilly will assume responsibility for global development and commercialization. This is the fourth partnership for the BrainTransporter program and further supports its potential to enhance drug delivery, effectiveness, safety, and dosing convenience for neurological therapies.
Source: BioArctic PR Jun 22, 2026
June 22, 2026
AbbVie Announces $10.9B Acquisition of Apogee Therapeutics, Adding Next-Generation Immunology Assets
AbbVie has entered into a definitive agreement to acquire Apogee Therapeutics for $135.11 per share in cash, valuing the company at approximately $10.9B. The acquisition, unanimously approved by both companies’ boards, strengthens AbbVie’s immunology portfolio and expands its respiratory pipeline with Apogee’s clinical-stage assets targeting inflammatory and immunological diseases, including atopic dermatitis (AD) and asthma. The transaction is expected to close in Q3’26, subject to Apogee shareholder and regulatory approvals, and is expected to be accretive to AbbVie’s adjusted diluted EPS beginning in 2032. The acquisition was finalized on Jun 19, 2026, and publicly announced on Jun 22, 2026. This includes zumilokibart (APG777), a SC, half-life extended anti-IL-13 mAb being developed for AD, and APG273, a combination of zumilokibart and APG333 (an anti-TSLP, half-life extended mAb) being developed for asthma. In a P2 study of zumilokibart demonstrated clinically meaningful efficacy, with approximately two-thirds of patients achieving significant skin clearance at 16 wks., alongside notable improvements in itch reduction and disease control. Another P2 Longer-term data support convenient quarterly or twice-yearly maintenance dosing, with a favourable safety profile consistent with its class and potential for additional inflammatory indications. P1 data showed that APG333 has a long half-life and sustained suppression of type 2 inflammatory biomarkers for up to 6 mos, while positive interim P1b asthma data for zumilokibart support the potential of the APG273 combination with quarterly or twice-yearly dosing. The acquisition is expected to create substantial long-term shareholder value with mega-blockbuster peak sales potential across Apogee’s pipeline.
Source: AbbVie PR Jun 22, 2026
June 19, 2026
Frontier Health Raises $12.8M to Expand AI-Powered Healthcare Administration Platform
Frontier Health, an AI-native patient pathway and clinical admin software developer, secured $12.8M in an Atomico-led round with participation from firstminute capital and XYZ Venture Capital. Along with its total sum of $16M, Frontier Health plans to strengthen automation of data orchestration, improve software integration to all NHS networks, and expand both engineering and customer success teams. Healthcare teams can use their software to streamline both hospital workflow and patient tracking, automate follow-ups for diagnostic tests, and identify delays in coordination for improved patient outcomes and reduced waiting times, along with other features. Their software has also been integrated and used in multiple clinical environments.
Source: FinSMEs PR Jun 19, 2026
Thank you for your attention! For any queries, contact us at bd@octavusconsulting.com
Babli Singh is a Senior Analyst with strong analytical skills and a deep understanding of the biopharmaceutical and healthcare industries. She specializes in monitoring emerging trends and distilling complex information into concise, insightful summaries that deliver clear value and actionable intelligence for a global professional audience.
