Imviva Biotech to Present Clinical Data from Ongoing Phase 1/2 Study of CTA313 at the American Society of Gene & Cell Therapy’s Annual Meeting

On April 29, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that it will present clinical data from its ongoing open-label Phase 1/2 study of CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy, at the American Society of Gene & Cell Therapy’s Annual Meeting (ASGCT 2026). The conference is taking place May 11-15, 2026, in Boston, Massachusetts. The study evaluates CTA313 in patients with systemic lupus erythematosus (SLE).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ben Capoccia, Director of Translational Medicine and Clinical Research at Imviva Biotech, will present results from a study of SLE patients treated with a single administration of CTA313, demonstrating rapid and profound B-cell depletion, followed by an immunologic profile consistent with an immune-reset mechanism.

Presentation details:

Title: CTA313, CD19/BCMA dual targeted allo-CAR-T ANS cell, Induces Deep B-Cell depletion, Supporting an Immune-Reset Mechanism for Durable Remission in Autoantibody-Mediated Diseases

Session Title: Engineering high-performance CAR T cells to overcome resistance and improve potency

Session Type: Oral Abstract Sessions

Session Location: Thomas Michael Menino Convention & Exhibition Center, MCEC Room 258ABC (Level 2)

Presentation Date & Time: Tuesday, May 12, 8:30 AM – 8:45 AM ET

Abstract Number: 425

Presentation ID: 28

Abstracts are currently available to the public at: View Source

For more information, visit www.imvivabio.com.

About CTA313

CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva’s proprietary ANSWER inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy.

(Press release, Imviva Biotech, APR 29, 2026, View Source [SID1234664926])

Sandoz reports strong biosimilars growth in Q1 2026; full-year 2026 guidance confirmed

On April 29, 2026 Sandoz (SIX: SDZ/OTCQX: SDZNY), the global leader in affordable medicines, reported its net-sales performance for the first quarter of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q1 2026

%

Q1 2025

Change

USD m

Net sales

USD m

USD %

CC %1,2,3

Net sales

2,756

100%

2,480

11%

3%

Biosimilars

853

31%

671

27%

18%

Generics

1,903

69%

1,809

5%

-3%

Europe

1,556

57%

1,372

13%

2%

International

609

22%

590

3%

-2%

North America

591

21%

518

14%

12%

Performance in line with Company expectations. Overall net sales up by 3% at CC, and by 5% when excluding effect of adverse dynamics in anti-infective B2B business4. Impact of dynamics in year concentrated in first quarter, with remaining effects dissipating thereafter

Biosimilar net sales up by 18% at CC, with generics net sales declining by 3% at CC. Underlying generics net sales declined by 1% at CC when excluding aforementioned anti-infective B2B impact

North America net sales up by 12% at CC, reflecting exceptional biosimilars performance. Europe net sales up by 2% at CC with biosimilars net sales up by double digit. Excluding anti-infective B2B impact, Europe net sales up by 4% at CC. Exceptional International biosimilar net sales, with region’s generics result impacted by active portfolio rationalisation and phasing of sales, as well as anti-infective B2B effect

Announcement of strategic partnership with Samsung Bioepis, covering up to five biosimilar assets

Full-year 2026 guidance confirmed

Richard Saynor, Chief Executive Officer of Sandoz, commented: "The performance in the first quarter illustrates the underlying strengths of Sandoz. I was delighted by the exceptional growth in North America and International across biosimilars, supported by new launches and excellence in execution. We produced sales growth in line with our expectations, and the fundamentals of the 2026 roadmap are strong. We are happy to confirm our full-year guidance today.

"As we look further out, I’m excited by the overwhelming scale of the opportunities ahead. We’ll complete the construction of our biosimilar hub soon; we’re rapidly expanding the biosimilar pipeline; regulatory streamlining is an important tailwind, and a very significant number of losses of exclusivity are approaching. More than 20,000 Sandoz colleagues are ready to capitalise on these opportunities and deliver even more for patients and shareholders."

BUSINESS HIGHLIGHTS

In March 2026, Sandoz and Samsung Bioepis entered a strategic partnership covering up to five biosimilar assets, with the first being a proposed vedolizumab biosimilar. The agreement expands the Sandoz biosimilar pipeline to up to 32 assets

In the period, the Company focused its biosimilar development, manufacturing and supply activities under newly appointed Armin Metzger. This will drive faster decision making, greater vertical integration and improved launch readiness across the expanding biosimilars pipeline. There are no changes to the Company’s financial-reporting structure

The European Medicines Agency (EMA) recently confirmed that, for well‑characterised biological medicines, a robust analytical comparability package, combined with comparative pharmacokinetic data, may be sufficient to demonstrate biosimilarity, and comparative clinical efficacy and safety studies are not necessarily required. The EMA commented, "this tailored clinical approach is expected to be applicable for the majority of biosimilar candidates"

In March 2026, the US FDA expanded the label for Enzeevu (aflibercept) to include macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema, along with the previously approved indication of neovascular (wet) age-related macular degeneration. This significantly broadened the treatable patient population and supports a planned Q4 2026 US launch

In the period, the European Commission granted marketing authorisation for Ranluspec (ranibizumab) across all reference indications, reinforcing the Company’s ophthalmology franchise and paving the way for an expected H2 2026 European launch

In April2026, following a Commerce Department investigation, the US government confirmed that generic and biosimilar medicines "should not be subject to section 232 tariffs at this time"

During the period, the Company announced the issuance of a CHF 275 million bond with a six-year maturity and a CHF 275 million bond with a 10-year maturity, for the refinancing of maturing debt and other general corporate purposes. Sandoz is on track to extend its average debt maturity to six to seven years

FULL-YEAR 2026 GUIDANCE

The Company continues to anticipate strong net-sales growth and further core EBITDA-margin expansion this year. As a result, the Company confirms its guidance for 2026:

Net sales to grow at CC by a mid-to-high single-digit percentage

Core EBITDA-margin expansion of around 100 basis points
No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low-to-mid single-digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation.

(Press release, Sandoz, APR 29, 2026, View Source [SID1234664867])

AB Science announces the successful completion of a EUR 3.2 million private placement

On April 29, 2026 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported the successful completion of a capital increase of a total gross amount of EUR 3.2 million subscribed by a limited number of investors (the "Private Placement").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Private Placement is not subject to a prospectus requiring an approval from the French Financial Market Authority (Autorité des Marchés Financiers – the "AMF").

Use of proceeds

The Company intends to use the net proceeds of the Private Placement to finance its ongoing activities, with a focus on the clinical development of the AB8939 program.

This transaction strengthens the Company’s cash position and enables it to cover its financing needs beyond the next 12 months.

Terms and conditions of the Private Placement

The Private Placement, for a total amount of EUR 3.2 million (including share issue premium), was carried out through the issuance, without preferential subscription rights and without a priority subscription period, of 3,412,768 new ordinary shares of the Company (the "New Shares"), each with one share warrant attached (a "BSA" and, together with the New Share to which it is attached, an "ABSA"). Two BSA entitle their holder to subscribe to one new ordinary share of the Company at a price of EUR 1,30 per ordinary share. The issuance of the ABSA was conducted through a share capital increase with cancellation of shareholders’ preferential subscription rights for the benefit of investors within the category of persons defined by the 16th resolution of the Combined General Meeting of the Company’s shareholders of June 30, 2025 (the "General Meeting"), in accordance with article L. 225-138 of the French commercial code (the "Private Placement").

The issue of the ABSAs, representing approximately 4.67% of the Company’s share capital, on a non-diluted basis, before completion of the Private Placement, and 4.46% of the Company’s share capital, on a non-diluted basis, after completion of the Private Placement, was decided on April 28, 2026 by the Chief Executive Officer, pursuant to the delegation of competence granted to him by the board of directors dated April 23, 2026, pursuant to the delegation of competence granted to it under the 16th resolution of the General Meeting.

The issue price of one ABSA is EUR 0.94 (including share issue premium), representing a facial discount of 19.80% (i.e. EUR 0.232) to the volume-weighted average price of the AB Science shares on the regulated market of Euronext Paris ("Euronext Paris") over the three trading days preceding the setting of such issue price, i.e. April 24 to 28, 2026, i.e. EUR 1.1720 (the "3-day VWAP").

The issue price of an ABSA, including the theoretical value of the BSA attached to it (as described below, together with the issue price of the new ordinary share issued upon exercise of two BSA) represents a total 17.53% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 16th resolution.

Terms and conditions of the BSA

One BSA is attached to each New Share.

Two BSA entitle their holder to subscribe to one new ordinary share of the Company at a price of EUR 1.30 per ordinary share.

The BSAs may be exercised at any time within 48 months of their issuance. In the event all BSAs are exercised, a total number of 1,706,384 additional ordinary shares of the Company will be issued, representing additional total proceeds of approximately EUR 2.2 million.

The theoretical value of each BSA, assuming a volatility of 29.622%1 and based on closing price as of April 28, 2026, is equal to EUR 0.1402 using Black & Scholes model.

The BSAs will be immediately detached (détachés) from the New Shares upon issuance and will not be listed.

Impact of the Private Placement on the Company’s shareholding

Following the issuance of the ABSAs, the Company’s total share capital will be EUR 765,389.12 (and EUR 782,452.96 in the event of exercise of all BSAs). It will be comprised of 69,776,233 ordinary shares (and of 71,482,617 ordinary shares in the event of exercise of all BSAs) with a par value of EUR 0.01. There will be no change on the number of preferred shares.

To the Company’s knowledge, immediately prior to completion of the Private Placement and after completion of the Private Placement, the breakdown of the Company’s share capital is as follows:

Shareholders

Before the capital increase After the capital increase (before exercising the BSA) After the capital increase and exercise of the BSA
Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2)
A. Moussy 7 345 396 10,04% 16,02% 7 345 396 9,60% 15,46% 7 345 396 9,39% 15,20%
AMY SAS (3) 12 273 000 16,78% 12,95% 12 273 000 16,03% 12,50% 12 273 000 15,69% 12,29%
Subtotal concert A. Moussy 19 618 396 26,83% 28,97% 19 618 396 25,63% 27,96% 19 618 396 25,07% 27,49%
Other investors members of the concert 2 453 682 3,36% 5,40% 2 453 682 3,21% 5,21% 2 453 682 3,14% 5,12%
Actions in the pact 1 123 902 1,54% 4,00% 1 123 902 1,47% 3,86% 1 123 902 1,44% 3,79%
Actions outside the pact 1 329 780 1,82% 1,40% 1 329 780 1,74% 1,35% 1 329 780 1,70% 1,33%
Total concert 22 072 078 30,18% 34,37% 22 072 078 28,84% 33,18% 22 072 078 28,21% 32,61%
Other investors above 5% 6 888 610 9,42% 8,51% 6 888 610 9,00% 8,21% 6 888 610 8,80% 8,07%
Other investors 44 165 456 60,40% 57,12% 47 578 224 62,16% 58,61% 49 284 608 62,99% 59,32%
Total 73 126 144 100,00% 100,00% 76 538 912 100,00% 100,00% 78 245 296 100,00% 100,00%
(1) All classes of shares are affected. The number of ordinary shares amounts to 66,663,465 before the Private Placement, 69,776,233 after the Private Placement (but before exercise of the BSAs), and 71,482,617 after the Private Placement and exercise of the BSAs.
(2) The diluted basis takes into account the exercise of all instruments giving access to the capital, the definitive allocation of all free shares and the conversion of all preferred shares into ordinary shares (aiming for the highest theoretical dilution).
(3) AMY SAS is a company controlled by A. Moussy.

On the basis of the share capital of the Company immediately after completion of the Private Placement, the interest of a shareholder who held 1.00% of the Company’s share capital prior to the above-mentioned capital increase and who did not subscribe to it now stands at 0.9554% on a non-diluted basis and 0.7449% on a diluted basis.

Admission to trading of the New Shares

The New Shares are expected to be admitted to trading on the regulated market of Euronext Paris on May 5, 2026.

The New Shares will be subject to the provisions of the Company’s by-laws and will be assimilated to existing shares upon final completion of the Private Placement. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

The BSAs will not be admitted to trading on any market.

The new ordinary shares issued upon exercise of the BSAs will be, when issued, subject to the provisions of the Company’s by-laws and will be assimilated to existing shares. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

Lock-up commitments

The Company has signed a lock-up commitment (to the benefit of the investors) pursuant to which it has agreed to a lock-up period of 45 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

The directors and officers of the Company have signed a lock-up commitment (to the benefit of the investors) pursuant to which they have agreed to a lock-up period of 90 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

Financial Intermediaries

Maxim Group LLC acted as the sole placement agent in connection with the Private Placement.

Indicative timetable

April 23, 2026 Decisions of the Board of Directors deciding the principle of the Private Placement.
April 28, 2026 Decisions of the Chief Executive Officer setting the terms and conditions of the Private Placement (including the subscription price of the ABSAs and the gross amount of the Private Placement).
April 29, 2026 Publication of this press release.

May 4, 2026 Settlement-delivery of the ABSAs – Detachment of the BSA

May 5, 2026 Start of trading of the New Shares on Euronext Paris.
Risk factors

AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows:

The existing shareholders who do not participate in the Private Placement will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the BSA, as well as in the event of new securities transactions.

The volatility and liquidity of AB Science shares could fluctuate significantly. The market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued in the context of the Private Placement. The sale of Company shares may occur on the secondary market, after the Private Placement, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Due to its unique mode of action, the Company believed that masitinib can be developed in a wide range of diseases, including oncology, inflammatory diseases, and certain central nervous system diseases. In oncology, through its immunotherapy activity, masitinib may have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain inflammatory and central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.

(Press release, AB Science, APR 29, 2026, View Source [SID1234664890])

European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe

On April 29, 2026 Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) reported the European Commission (EC) has granted marketing authorization for POHERDY (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union," said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 "Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines."3,4

"Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon," said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system."

In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).5

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6

About POHERDY (pertuzumab) in the E.U.

Early breast cancer

Poherdy is indicated for use in combination with trastuzumab and chemotherapy in:

the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
Metastatic breast cancer

Poherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

For more information please visit: Poherdy | European Medicines Agency (EMA)

(Press release, Shanghai Henlius Biotech, APR 29, 2026, View Source [SID1234664910])

Oncoinvent presents corporate update in live webcast

On April 29, 2026 Oncoinvent ASA (ONCIN), a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported a live webcast at 8:00 AM CET today, Wednesday, 29 April 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presenters: CEO Øystein Soug, CFO Ramzi Amri
Time: 8:00am CET
Webcast link: View Source
Highlights:

Recruited and randomized 37 patients (accumulated, ITT*) into the ovarian Phase 2 trial
Secured new patent expanding protection for Radspherin
Published positive final data from Phase 1 trial of Radspherin to treat ovarian cancer
Journal: Gynecologic Oncology
Conference: ESGO European Gynaecological Oncology Congress 2026
Appointed Dr Ramzi Amri as CFO
The presentation material and the recording of the webcast will be made available at www.oncoinvent.com.

Oncoinvent reports its financial results on a half-yearly basis, complemented by quarterly business updates to keep stakeholders informed and ensure ongoing transparency.

(Press release, Oncoinvent, APR 29, 2026, https://www.oncoinvent.com/press-release/oncoinvent-presents-corporate-update-in-live-webcast/ [SID1234664868])