SST001, an α-syn PET tracer from Mabwell’s incubated company SynuSight Biotech, received NMPA approval to initiate a clinical trial

On April 14, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that 18F-FD4 (R&D code: SST001), an α-synuclein (α-syn) targeted PET tracer independently developed by its incubated company SynuSight Biotech, has recently been approved by the National Medical Products Administration (NMPA) to initiate a Phase I clinical trial.

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The clinical trial to be initiated is a non-randomized, open-label study to be conducted at Huashan Hospital, Fudan University and the Affiliated Hospital of Jiangnan University. The study plans to enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease (PD). The primary objectives are to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001, thereby supporting subsequent clinical development.

Abnormal aggregation and deposition of α-syn protein are key pathological features of α-synucleinopathies such as PD and MSA. However, current clinical diagnosis still relies mainly on clinical symptom assessment and indirect functional imaging biomarkers. As an α-syn-specific PET molecular tracer validated through IIT (Investigator-Initiated Trial) studies, SST001 enables in vivo, real‑time, qualitative, and quantitative detection. It is expected to provide more objective and quantifiable imaging evidence for early diagnosis and disease subtyping of PD and MSA, as well as potential imaging support for subject screening and efficacy evaluation in clinical trials of related therapeutic drugs.

According to data from the Global Burden of Disease (GBD) Study 1990–2021, there were approximately 11.8 million PD patients worldwide in 2021, of which Chinese patients accounted for more than 40%. In China, the number of PD patients increased significantly from 651,800 in 1990 to 5.077 million in 2021, driven mainly by population aging. Although MSA is a rare disease, it progresses more rapidly and has a poorer prognosis, with a median survival of only 6 to 10 years, resulting in a significant disease burden.

Previously, SST001, partnering with XingImaging, has received high recognition from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and obtained a research grant of US$3.84 million, which will be specifically used to support its clinical research advancement in the United States. In January this year, SST001 received a Research IND clearance from the U.S. FDA, and clinical studies have been successfully initiated with the first subject dosed. Relevant data are being continuously collected. SST001 has now entered clinical stage in both China and the United States, entering a new phase of global development.

(Press release, Mabwell Biotech, APR 14, 2026, View Source;syn-pet-tracer-from-mabwells-incubated-company-synusight-biotech-received-nmpa-approval-to-initiate-a-clinical-trial-302741808.html [SID1234664366])

Physiomics Awarded New Contract by Numab Therapeutic

On April 14, 2026 Physiomics plc (AIM: PYC), a leading mathematical modelling, data science and biostatistics company supporting the development of new therapeutics and personalised medicine solutions, reported a new contract with its valued and long-standing client, Numab Therapeutics AG ("Numab Therapeutics").

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Numab Therapeutics is a biopharmaceutical company focused on the discovery and development of next-generation multispecific antibody-based therapeutics for inflammation and oncology. Under this new contract, Physiomics will develop a mechanistic pharmacokinetic-pharmacodynamic (PK/PD) modelling framework to support proof-of-concept activities for a new programme within Numab Therapeutics’ oncology pipeline.

Throughout the project, Physiomics will apply quantitative approaches to interpret emerging data, optimise experimental design and development strategy, and inform key go/no-go decision-making. The project is expected to commence in April 2026 and complete in Q3 2026.

This project further strengthens Physiomics’ established collaboration with Numab Therapeutics and highlights the ongoing integration of model-informed approaches to support strategic decision-making across Numab Therapeutics’ pipeline.

Dr Peter Sargent, CEO of Physiomics, commented:

"We are thrilled to extend our collaboration with Numab Therapeutics to provide insights that can support robust proof-of-concept decision-making for this early oncology programme."

(Press release, Physiomics, APR 14, 2026, View Source [SID1234664362])

Medicenna to Present at the 2026 Bloom Burton & Co. Healthcare Investor Conference

On April 14, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer and autoimmune diseases, reported that Dr. Fahar Merchant, President and CEO of Medicenna, will present and participate in one-on-one meetings at the 2026 Bloom Burton & Co. Healthcare Investor Conference, taking place in Toronto on April 21-22, 2026.

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During this investor presentation, the Company will provide a corporate update as well as latest MDNA113 preclinical data from the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). More details are as follows:

Date: Tuesday, April 21, 2026
Time: 3:00 p.m. Eastern Time
Location: Metro Toronto Convention Centre, Toronto
Webcast Link: https://event.summitcast.com/view/7Mc8ivebFGUgA8YD45rSGK/UpbJ5d5vehkPikKiwCUsv6

Webcast and replay information for this event will also be available on the Investor Relations section of Medicenna’s website at ir.medicenna.com. The replay will be available for 90 days.

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from premier Canadian publicly traded and private companies through presentations and private meetings. For more information, please visit: bloomburton.com/conference.

(Press release, Medicenna Therapeutics, APR 14, 2026, View Source [SID1234664359])

Johnson & Johnson reports Q1 2026 results, raises 2026 outlook

On April 14, 2026 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2026. "Johnson & Johnson had a strong start to 2026 and is delivering on its promise for a year of accelerated growth and impact," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "The depth and strength of our portfolio and pipeline is unrivaled and our relentless focus on innovation delivered multiple game-changing approvals this quarter, including ICOTYDE in the U.S. for moderate to severe plaque psoriasis and VARIPULSE Pro in Europe. These advancements have the potential to transform patient outcomes and create sustainable, long-term value for shareholders."
Overall financial results
Q1
($ in Millions, except EPS)
2026
2025
% Change
Reported Sales

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$24,062
$21,893
9.9%
Net Earnings
$5,235
$10,999
-52.4%
EPS (diluted)
$2.14
$4.54
-52.9%

Q1
Non-GAAP* ($ in Millions, except EPS)
2026
2025
% Change
Operational Sales1,2

6.4%
Adjusted Operational Sales1,3

5.3%
Adjusted Net Earnings1,4
$6,614
$6,706
-1.4%
Adjusted EPS (diluted)1,4
$2.70
$2.77
-2.5%
Free Cash Flow5,6
~$1,500
$3,379

Regional sales results
Q1

% Change

($ in Millions)
2026
2025
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$13,330
$12,305
8.3%
8.3
–
6.2
International
10,732
9,588
11.9
3.9
8.0
4.0
Worldwide
$24,062
$21,893
9.9%
6.4
3.5
5.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q1

% Change

($ in Millions)
2026
2025
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$15,426
$13,873
11.2%
7.4
3.8
5.6
MedTech
8,636
8,020
7.7
4.6
3.1
4.7
Worldwide
$24,062
$21,893
9.9%
6.4
3.5
5.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

First-Quarter 2026 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 7.4%*, with net acquisitions and divestitures positively impacting growth by 1.8% primarily due to CAPLYTA. Growth was driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (920) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology.
MedTech
MedTech worldwide operational sales grew 4.6%*, with divestitures negatively impacting growth by 0.1%. Growth was driven primarily by electrophysiology products, Abiomed, and Shockwave in Cardiovascular, as well as trauma in Orthopaedics.

Full-year 2026 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
April 2026
January 2026
Adjusted Operational Sales1,2
Change vs. Prior Year / Mid-point
5.6% – 6.6% / 6.1%
5.4% – 6.4% / 5.9%
Operational Sales2 / Mid-point
Change vs. Prior Year / Mid-point
$99.7B – $100.7B / $100.2B
5.9% – 6.9% / 6.4%
$99.5B – $100.5B / $100.0B
5.7% – 6.7% / 6.2%
Estimated Reported Sales3/ Mid-point
Change vs. Prior Year / Mid-point
$100.3B – $101.3B / $100.8B
6.5% – 7.5% / 7.0%
$100.0B – $101.0B / $100.5B
6.2% – 7.2% / 6.7%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$11.30 – $11.50 / $11.40
4.7% – 6.7% / 5.7%
$11.28 – $11.48 / $11.38
4.5% – 6.5% / 5.5%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$11.45 – $11.65 / $11.55
6.1% – 8.1% / 7.1%
$11.43 – $11.63 / $11.53
5.9% – 7.9% / 6.9%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: April 2026 = $1.17 and January 2026 = $1.17 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast.
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Johnson & Johnson Announces FDA Approval of TECNIS PureSee Intraocular Lens, a Breakthrough Solution for U.S. Cataract Patients
Press Release
Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI plus DARZALEX FASPRO for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
Press Release
Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)
Press Release
Johnson & Johnson seeks FDA approval of IMAAVY (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Press Release
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
Press Release
FDA approves RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
Press Release
DARZALEX FASPRO-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
Press Release

Data Releases
Johnson & Johnson Highlights Favorable 12-Month Interim Results for the VARIPULSE Platform at EHRA 20261
Press Release
Johnson & Johnson Showcases New Clinical Data for TECNIS PureSee IOL at ASCRS 2026 Demonstrating Excellent Contrast Sensitivity and Extended Range of Vision1
Press Release
STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct Size
Press Release
ICOTYDE (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis
Press Release
Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer
Press Release
Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer
Press Release
TREMFYA (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
Press Release
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer
Press Release
Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium
Press Release
Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA (apalutamide) versus darolutamide without docetaxel through 24 months
Press Release

Product Launch
Johnson & Johnson Advances Pulsed Field Ablation Portfolio with the Launch of VARIPULSE Pro in Europe1
Press Release
FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide
Press Release

Other
Johnson & Johnson Expands U.S. Footprint with more than $1 Billion Investment in Next Generation Cell Therapy Manufacturing Facility in Pennsylvania
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

(Press release, Johnson & Johnson, APR 14, 2026, View Source [SID1234664358])

Greenwich LifeSciences Provides Update on Financing Strategy

On April 14, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported additional updates on its financing strategy.

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The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for Q1 2026 exceeded the Company’s Q1 2026 cash burn rate, leading to a Q1 2026 cash balance of approximately $10.5 million as of March 31, 2026. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q1 2026.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, APR 14, 2026, View Source [SID1234664357])