Assertio and Garda Mutually Agree to Postpone Commencement of Tender Offer

On May 5, 2026 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), reported that it has reached a mutual agreement with Garda Therapeutics, Inc. ("Garda") to postpone the commencement of the previously announced tender offer to acquire all outstanding shares of Assertio to May 8, 2026.

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As previously announced on May 4, 2026, Assertio has entered into an amended and restated merger agreement (the "Garda Agreement") to be acquired by Garda for $21.80 per share in cash, or total cash consideration of $153.2 million. The Company expects to file a Schedule 14D-9 in connection with the tender offer on May 8, 2026. In addition, Assertio will postpone the commencement of the previously announced tender offer for all outstanding Convertible Senior Notes until May 8, 2026.

(Press release, Assertio Holdings, MAY 5, 2026, View Source [SID1234665152])

ImmunityBio to Present New Comparative Data, Scientific Advances in Non-Muscle Invasive Bladder Cancer CIS and an Update on BCG Naïve Registrational Trial at American Urological Association Annual Meeting

On May 5, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported it will present new treatment comparison results evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.

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These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.

Dr. Soon-Shiong will be presenting on "The Role of IL15 in the Urological Setting" where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer.

"At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting."

Oral Presentations

The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer
Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT, The Square, Learning Lab, Hall B, Walter E. Washington Convention Center
Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am – 9:00 am EDT, Room 206, Walter E. Washington Convention Center
Poster Presentation

An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT, Room 146A, Walter E. Washington Convention Center
ImmunityBio Product Theater Presentation

Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.

The Role of IL15 in the Urological Setting
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT, Product Theater booth 2701, Walter E. Washington Convention Center
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAY 5, 2026, View Source [SID1234665118])

Veracyte Announces First Quarter 2026 Financial Results

On May 5, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the first quarter ended March 31, 2026.

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"We had a strong start to the year, with Decipher and Afirma volume growth surpassing expectations and exceeding our profitability targets," said Marc Stapley, Veracyte’s CEO. "Our growing clinical evidence continues to set us apart, and this quarter strengthened it even further. We believe we are approaching an inflection point with the upcoming launches of Prosigna LDT and TrueMRD, two of the most significant new products in our history, creating meaningful opportunities for market expansion in Breast, Bladder and other cancers, alongside continued growth in our Prostate and Thyroid businesses."

Key Financial Highlights

For the three-month period ended March 31, 2026, as compared to the same period in 2025:

Increased total revenue by 21% to $139.1 million and testing revenue by 26% to $135.1 million, driven by Decipher growth of 30% to $86.5 million and Afirma growth of 21% to $46.4 million.
Increased total volume by 17% to 47,615 tests and testing volume by 19% to 45,248 tests, driven by Decipher growth of 24% to approximately 28,000 tests and Afirma growth of 12% to approximately 17,200 tests.
Recorded GAAP net income of $28.7 million, or 20.6% of revenue, and delivered adjusted EBITDA of $42.8 million, or 30.8% of revenue.
Generated $35.2 million of cash from operations to end the quarter with $439.1 million of cash, cash equivalents, and short-term investments as of March 31, 2026.
Key Business Highlights

Advanced the evidence pipeline for Decipher with enrollment completed for GUIDANCE and G-MAJOR phase III trials.
Announced data published in European Urology Oncology showing Decipher’s ability to stratify risk among patients undergoing active surveillance.
Announced more than 15 studies featuring Decipher Prostate and Decipher Bladder will be presented at the AUA Annual Meeting next week, including the expanding impact of Decipher Prostate in studies using real-world data.
Strengthened the leadership team with the appointments of Kevin Haas as Chief Development and Technology Officer and Tracy Ward as Chief Human Resources Officer.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

First Quarter 2026 Financial Results

Total revenue for the first quarter of 2026 was $139.1 million, an increase of 21% compared to $114.5 million reported in the first quarter of 2025. Testing revenue was $135.1 million, an increase of 26% compared to $107.3 million in the first quarter of 2025, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.7 million, an increase of 3% compared to $3.6 million in the first quarter of 2025. Biopharmaceutical and other revenue was $0.3 million, an expected decrease compared to $3.6 million in the first quarter of 2025 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the first quarter of 2026 was 73%, compared to 69% in the first quarter of 2025. Non-GAAP gross margin was 76%, compared to 72% in the first quarter of 2025.

Operating expenses were $78.5 million for the first quarter of 2026 compared to $76.6 million in the first quarter of 2025. Non-GAAP operating expenses grew 7% to $64.6 million compared to $60.5 million in the first quarter of 2025.

Net income for the first quarter of 2026 was $28.7 million, an improvement of 307% compared to the first quarter of 2025. Diluted net earnings per common share was $0.35, an improvement of $0.26 compared to the first quarter of 2025. Non-GAAP diluted net earnings per common share was $0.52, an increase of $0.21 compared to the first quarter of 2025. Net cash provided by operating activities in the first three months of 2026 was $35.2 million, an improvement of $29.9 million compared to the same period in 2025.

Adjusted EBITDA for the first quarter of 2026 was $42.8 million, an improvement of 73% compared to the first quarter of 2025, representing 30.8% of revenue compared to 21.6% of revenue in the same period in 2025.

2026 Financial Outlook

The company is raising 2026 total revenue guidance to $582 million to $592 million, or 13% to 14% growth, from prior guidance of $570 to $582 million, or 10% to 13% growth. The company is also raising testing revenue guidance to $570 million to $580 million, or 16% to 18% growth, excluding the contribution from new tests.

Additionally, the company is raising guidance for adjusted EBITDA margin to greater than 26%, from approximately 25% prior.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA margin to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering via the following link: View Source

(Press release, Veracyte, MAY 5, 2026, View Source [SID1234665134])

Aura Biosciences Announces Closing of $299 Million Public Offering Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On May 5, 2026 Aura Biosciences, Inc. ("Aura") (Nasdaq: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported the closing of its previously announced underwritten public offering. In the offering, Aura sold (i) 46,099,650 shares of common stock, which includes 6,508,650 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering, and (ii) in lieu of common stock to certain investors, pre-funded warrants to purchase an aggregate of up to 3,800,000 shares of its common stock at an exercise price of $0.00001 per pre-funded warrant. The shares of common stock were sold at a public offering price of $6.00 per share and the pre-funded warrants were sold at a public offering price of $5.99999 per share. The gross proceeds to Aura from the offering were approximately $299.4 million, before deducting underwriting discounts and commissions and other offering expenses. All of the securities sold in the offering were offered by Aura.

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Leerink Partners, TD Cowen and Evercore ISI acted as joint bookrunning managers for the offering. LifeSci Capital also acted as a bookrunning manager in the offering. Citizens Capital Markets acted as a co-manager for the offering.

The offering was made pursuant to the Company’s registration statement on Form S-3 (No. 333-278253), which was previously filed with the Securities and Exchange Commission (the "SEC") on March 27, 2024 and declared effective by the SEC on April 5, 2024, and a related registration statement on Form S-3MEF (File No. 333-295515) effective as of May 4, 2026 and filed with the SEC pursuant to Rule 462(b) under the Securities Act of 1933, as amended (collectively, the "Registration Statement"), and a final prospectus supplement related to and describing the terms of the offering described above was filed with the SEC on May 5, 2026 and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Aura Biosciences, MAY 5, 2026, View Source [SID1234665153])

Alligator Bioscience AB reports financial results for the period 1 January – 31 March 2026 and provides a business update

On May 5, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported its interim results for the first quarter of 2026 and provided a business update.

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"During the first quarter of 2026, we continued to execute against our strategic priorities in a challenging biotech environment. We strengthened the clinical and translational foundation of mitazalimab through new data presentations, while maintaining clear focus on advancing the program toward late‑stage development under disciplined strategic and financial conditions. In parallel, HLX22 progress in our external portfolio, supports additional long‑term value potential without development cost exposure for Alligator."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Additional data dissemination: Updated and final outcomes data from the OPTIMIZE 1 study were presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2026, further strengthening the clinical and translational foundation of the program.
Continued scientific visibility: New data from an investigator initiated trial evaluating mitazalimab were accepted for presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2026, providing additional insight into the antibody’s mechanism of action and tumor directed immune activation.
Technology

Strengthened intellectual property position: Alligator strengthened the intellectual property protection for its bispecific antibody technology RUBY, reinforcing the scientific and commercial foundation for future pipeline development and partnering opportunities.
HLX22

Progress in partnered development: The first patient was dosed in Henlius’ Phase 2/3 study of HLX22 in recurrent breast cancer, marking an additional step in the late stage development of the program.
Company / Financial position

Capital structure updates following the rights issue: Alligator announced the outcome of the exercise of warrants of series TO 14, resulting in gross proceeds of approximately 19 MSEK and changes in the number of shares and votes, as well as related directed issues to guarantors and Fenja Capital, in accordance with previously communicated terms. Alligator’s management further announced their intention to subscribe pro rata in the TO 14 warrant program, aligning management interests with those of shareholders.
Nomination Committee proposal ahead of the AGM: The Nomination Committee presented its proposal for the Board of Directors ahead of the Annual General Meeting, including the nomination of two new Board members.
FINANCIAL SUMMARY FOR Q1 2026
The financial summaries for the quarterly periods ending 31 March 2026 and 31 March 2025 are presented below.

All amounts in MSEK,
unless specified January – March 2026 January – March 2025
Net sales - -
Operating profit/loss -17.8 -43.7
Profit/loss for the period 1.4 -8.3
Cash flow for the period -29.1 -34.6
Cash and cash equivalents 33.0 28.9
Earnings per share before and after dilution*, SEK 0.0 -1.1
* Adjusted for reverse share split in 2025.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Tuesday, 5 May 2026, at 1 p.m. CEST/ 7 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

(Press release, Alligator Bioscience, MAY 5, 2026, View Source [SID1234665102])