On February 20, 2026 AstraZeneca reported that Calquence (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting and published in The New England Journal of Medicine.1,2

CLL is the most common type of leukaemia in adults.3 An estimated 18,500 people were treated for CLL in the 1st-line setting in the US in 2024.4

Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the AMPLIFY trial, said: "The continuous regimens frequently used to treat chronic lymphocytic leukaemia often come with side effects that may become burdensome to patients over time. The US approval of the Calquence combination offers patients an all-oral, 14-month, fixed-duration treatment option that is highly effective and well-tolerated, and gives physicians greater flexibility to tailor treatment plans for individual patient needs and goals."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia. This Calquence combination has the potential to meaningfully change 1st-line chronic lymphocytic leukaemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers."

Gwen Nichols, MD, Chief Medical Officer of Blood Cancer United, formerly The Leukemia & Lymphoma Society, said: "Managing an incurable blood cancer that progresses slowly can often feel indefinite and overwhelming. We welcome new treatment options that may ease the burden, restore a sense of control and offer renewed hope for those navigating life with chronic lymphocytic leukaemia."

Results from the AMPLIFY Phase III trial showed 77% of patients treated with Calquence plus venetoclax were progression free at three years, versus 67% of patients treated with standard-of-care chemotherapy (investigator’s choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab).2 Median progression-free survival (PFS) was not reached versus 47.6 months for chemoimmunotherapy.2 Further, Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (based on hazard ratio 0.65; 95% confidence interval 0.49-0.87; p=0.0038).2

Calquence plus venetoclax is approved in the European Union, Canada, UK and several other countries, and regulatory applications for the regimen based on the AMPLIFY results are currently under review in additional countries.

The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.

Notes

Chronic lymphocytic leukaemia (CLL)
CLL is the most prevalent type of leukaemia in adults, with an estimated 40,000 people being treated for CLL in the first line in the US, UK, France, Germany, Spain, Italy, Japan and China in 2024.4 Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.5 In CLL, there is an accumulation of abnormal lymphocytes within the blood, bone marrow and lymph nodes. As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets.3 This could result in infection, anaemia and bleeding. B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

AMPLIFY
AMPLIFY is a randomised, global, multi-centre, open-label Phase III trial evaluating the efficacy and safety of Calquence in combination with venetoclax, with or without obinutuzumab, compared to investigator’s choice of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in adult patients with previously untreated CLL without del(17p) or TP53 mutation.6 Patients were randomised 1:1:1 to receive either Calquence plus venetoclax, or Calquence plus venetoclax with obinutuzumab for a fixed duration, or standard-of-care chemoimmunotherapy.6 Both the Calquence containing arms were administered for a fixed duration of 14 cycles (each 28 days), and the standard-of-care chemoimmunotherapy was administered for 6 cycles.6

The primary endpoint is PFS in the Calquence and venetoclax arm as assessed by an Independent Review Committee, and PFS is a key secondary endpoint in the Calquence plus venetoclax with obinutuzumab arm.7 Other key secondary endpoints include overall survival (OS) and undetectable measurable residual disease.6 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.6

The AMPLIFY trial enrolled patients from 2019 to 2021, continuing through the COVID-19 pandemic.6

Calquence
Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US, Japan and China, and approved for CLL in Europe and many other countries. Calquence is also approved as a fixed-duration treatment for the treatment of adult patients with previously untreated CLL in combination with venetoclax in the US, and in combination with venetoclax, with or without obinutuzumab, in Europe, Canada, the U.K. and several other countries. Calquence is also approved for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) in the US, Europe, Japan and other countries. It is also approved for the treatment of adult patients with MCL who have received at least one prior therapy in China and several other countries.

As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

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(Press release, AstraZeneca, FEB 20, 2026, View Source [SID1234662814])

On February 19, 2026 etherna, a leading provider of cutting-edge mRNA and lipid nanoparticle (LNP) technology across the biotech and pharma industry, reported that one of its key collaborators, Almirall (www.almirall.com), a leading medical dermatology company, nominated LAD116 as a novel therapy targeting non-melanoma skin cancer for further development in IND enabling studies. LAD116 is based on etherna’s intratumoral mRNA/LNP platform for therapies intended to generate a potent immune response directly within the tumor microenvironment. The collaboration with Almirall on this potential new therapy will now focus on manufacturing and producing GMP-grade material for IND enabling studies and intended Phase I clinical trials.

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Bernard Sagaert, CEO, etherna, added:
"This collaboration is a perfect example of what can be achieved when teams are fully aligned and driven to succeed. The combined efforts of both companies to discover and advance an mRNA-LNP based therapy to preclinical candidate nomination, on time and on budget, has been outstanding. We are extremely happy to continue to support Almirall as they advance this promising approach for non-melanoma skin cancer patients."

Karl Ziegelbauer, Chief Scientific Officer, Almirall, commented:

"Almirall is committed to advancing innovation in medical dermatology to address significant unmet medical needs. We are very excited to advance this innovative intratumoral approach to potentially treat patients with non-melanoma skin cancer and we are delighted to see rapid progress of our collaboration with etherna based on their mRNA and LNP capabilities."

(Press release, eTheRNA, FEB 19, 2026, View Source [SID1234662910])

On February 19, 2026 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by December 18, 2026. Giredestrant plus everolimus could be the first and only oral selective estrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase (CDK)4/6 inhibitor setting.

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"The clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population."

The filing acceptance is based on the Phase III evERA Breast Cancer study results, which showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. In the ESR1-mutated population, the median progression-free survival (PFS) was 9.99 months compared with 5.45 months in the giredestrant and comparator arm, respectively (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p-value=<0.0001). In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p-value=<0.0001).

Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00, p-value=0.0473) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02, p-value=0.0566). Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines. No unexpected safety findings were observed, including no photopsia.

Data from evERA are being used to support filing submissions to other global health authorities.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes. Oral combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signaling pathways while helping to minimize the impact of treatment on people’s lives without the need for injections.

evERA was the first positive Phase III readout for giredestrant, followed by lidERA Breast Cancer in the early-stage setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer. In the coming weeks, Genentech will submit the giredestrant Phase III lidERA data in early-stage breast cancer to the FDA. The persevERA readout in first-line ER-positive breast cancer is expected in the first half of this year, which will provide further evidence for giredestrant in the ER-positive breast cancer treatment paradigm.

Our extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the evERA Breast Cancer study

evERA Breast Cancer [NCT05306340] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomization to the time when the disease progresses or a patient dies from any cause. The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.

About giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, FEB 19, 2026, View Source [SID1234662821])

On February 19, 2026, Moleculin Biotech, Inc. (the "Company") entered into warrant exercise inducement offer letters (each, an "Inducement Letter") with holders of certain existing warrants (the "Holders") to purchase up to 2,122,652 shares of Company common stock with an exercise price of $3.90 per share (the "Existing Warrants").

Pursuant to the Inducement Letter, the Holders agreed to exercise the Existing Warrants, and the Company agreed to issue the Holders new warrants to purchase up to a number of shares of Company common stock equal to 300% of the number of shares of Company common stock underlying the exercised Existing Warrants, comprised of new Series H warrants to purchase up to 6,367,956 shares of Company common stock (the "Inducement Warrants" and the shares of Company common stock underlying the Inducement Warrants, the "Inducement Warrant Shares") with an exercise term of five years from the initial exercise date.

The issuance and/or resale of the shares of Company common stock underlying the Existing Warrants have been registered pursuant to effective registration statements on Form S-1 (File No. 333-287727) and Form S-3 (File No. 333-290418). The Company anticipates receiving aggregate gross proceeds of up to approximately $8.3 million from the exercise of the Existing Warrants before deducting fees and other expenses payable by it.

Each Inducement Warrant has an initial exercise price per share equal to the lesser of (i) $3.90, and (ii) the lowest volume weighted average price of the Company common stock on any trading day during the five trading day period immediately following the public announcement of the Company entering into the Inducement Letters with the Holders, will be exercisable upon the receipt of shareholder approval of the issuance of the Inducement Warrant Shares, and may be exercised for a period of five years from such approval. If while the Inducement Warrants are outstanding, the Company issues or sells, or is deemed to have issued or sold, any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the Inducement Warrants in effect immediately prior to such issuance or sale or deemed issuance or sale, then immediately after such issuance or sale or deemed issuance or sale, the exercise price of the Inducement Warrants then in effect will be reduced to an amount equal to the new issuance price, subject to a floor price of $0.962.

The Inducement Warrants may only be exercised on a cashless basis if there is no registration statement registering, or the prospectus contained therein is not available for, the resale of the shares of common stock underlying the Inducement Warrants by the Holders. The Holders of an Inducement Warrant may not exercise any such warrants to the extent that such exercise would result in the number of shares of common stock beneficially owned by such Holders and its affiliates exceeding 4.99% or 9.99% (at the election of the Holders) of the total number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the Holders’ election not to exceed 9.99% (the "Beneficial Ownership Limitation"). In the event of certain fundamental transactions (as defined in the Inducement Warrants), the Holders of the Inducement Warrants will have the right to receive the Black Scholes value of the Inducement Warrants calculated pursuant to a formula set forth in the Inducement Warrants, payable either in cash or in the same type or form of consideration that is being offered and being paid to the Holders of common stock.

The Company agreed to file a registration statement on Form S-3 (or other appropriate form, including Form S-1, if it is not then Form S-3 eligible) providing for the resale of the Inducement Warrant Shares issuable upon the exercise of the Inducement Warrants (the "Resale Registration Statement"), on or before March 31, 2026, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC by April 30, 2026 and to keep the Resale Registration Statement effective at all times until no Holders of the Inducement Warrants own any Inducement Warrant Shares.

Roth Capital Partners, LLC served as financial advisor for the transaction and received as compensation for such services a fee of 7.0% of the gross proceeds the Company received from the warrant inducement of the Existing Warrants and reimbursement of $50,000 in legal fees.

The representations, warranties and covenants contained in the Inducement Letter were made solely for the benefit of the parties to the Inducement Letter. In addition, such representations, warranties and covenants: (i) are intended as a way of allocating the risk between the parties to such agreements and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Inducement Letter is filed with this report only to provide investors with information regarding the terms of transaction, and not to provide investors with any other factual information regarding the Company. Information concerning the subject matter of the representations and warranties may change after the date of the Inducement Letter, which subsequent information may or may not be fully reflected in public disclosures.

The forms of the Inducement Warrant and Inducement Letter are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K. The foregoing summaries of the terms of these documents are subject to, and qualified in their entirety by, such documents, which are incorporated herein by reference.

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(Filing, Moleculin, FEB 19, 2026, View Source [SID1234662819])

On February 19, 2026 Havah Therapeutics, a clinical-stage biopharmaceutical company pioneering androgen receptor (AR) agonist therapies for hormone receptor positive breast cancer, reported that Professor Stephen Birrell MD, PhD, will deliver a presentation titled "HAV-088: Bending Evolution to the Will of Medicine" at the upcoming RiseUp for Breast Cancer and Women’s Health Conference in San Francisco.

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Key highlights of the presentation include:

A translational framework for "endocrine steering" of hormonally active breast tissue using HAV-088, an androgen receptor (AR) agonist
An overview of Havah’s prospectively registered pilot, randomized controlled trial comparing HAV-088 with tamoxifen in high-risk premenopausal women with dense breasts and marked MRI background parenchymal enhancement (BPE)
An integrated evidence chain linking drug exposure, spatial tissue biology, intracrine hormone metabolism, and imaging biomarkers
Details for the presentation are as follows:

RiseUp For Breast Cancer and Women’s Health Conference
February 19-21, 2026
Hotel Nikko, San Francisco, CA

Presentation Title: HAV-088: Bending Evolution to the Will of Medicine
Presenter: Professor Stephen Birrell, MD, PhD
Date/Time: Friday, February 20, 12:10 Pacific Time

(Press release, HavaH Therapeutics, FEB 19, 2026, View Source [SID1234662811])