Alkermes to Present at the Stifel 2026 Virtual CNS Forum

On March 10, 2026 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Stifel 2026 Virtual CNS Forum on Tuesday, March 17, 2026 at 8:30 a.m. ET (12:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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(Press release, Alkermes, MAR 10, 2026, View Source [SID1234663407])

Mipletamig Delivers Compelling 86% Clinical Benefit Rate and No CRS as Evaluable AML Patient Data increases by Nearly 50%

On March 10, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported new interim data for mipletamig in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are either elderly or unfit for intensive chemotherapy. In data from two trials, the combination has demonstrated robust clinical activity, delivering an 86% clinical benefit rate (CR/CRi/PR*)with zero patients experiencing the common symptom of cytokine release syndrome (CRS). These data support an emerging efficacy profile coupled with differentiated patient safety and tolerability that is additive to the current AML standard-of-care therapy.

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"The emerging mipletamig data in frontline AML are highly encouraging and highlight the differentiated profile we believe is needed to advance treatment in frontline AML," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "In this study we are observing strong remission rates in a growing number of evaluable patients together with a consistently favorable safety and tolerability profile, including the absence of cytokine release syndrome. Achieving meaningful clinical activity while maintaining this level of safety and tolerability is essential in the frontline AML setting, where therapies must be compatible with established regimens. These results reinforce our belief that mipletamig can be successfully combined with venetoclax and azacitidine, with the potential to enhance outcomes for older and/or unfit AML patients who continue to face poor prognosis and limited treatment options."

Huebner continued, "Importantly, four of the patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population."

Data Highlights Include:

Among the evaluable frontline patient population treated to date (N=28), including 24 patients from the RAINIER trial and 4 patients from the completed dose expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated:

100% of frontline patients have remained free of cytokine release syndrome (CRS)

86% clinical benefit rate

79% achieved CR or CRi

61% achieved CR

55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses

35% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail

Collectively, these data demonstrate mipletamig’s potential to meaningfully enhance frontline AML treatment in older and/or unfit patients, by improving efficacy outcomes without materially increasing toxicity.

"Our frontline data show that mipletamig has the potential to play a meaningful role in the future frontline AML treatment," said Marvin White, President and Chief Executive Officer of Aptevo Therapeutics. "From the outset, our objective has been to develop an AML drug capable of integrating into the current standard-of-care and improving outcomes for patients who continue to face poor prognoses. The data reported reinforces our conviction that mipletamig may represent a differentiated approach with the potential to complement existing frontline therapies in a practical and impactful way. As enrollment continues, we remain focused on advancing our RAINIER trial and generating the data needed to support mipletamig’s long-term role in AML treatment."

*(Clinical Benefit Rate: CR = complete remission; CRi = complete remission with incomplete blood marker recovery; PR = partial remission.)

Consistent Safety and Tolerability Profile Maintained Across Patients Treated to Date

In frontline patients treated to date, no cytokine release syndrome (CRS) has been observed. Together with strong efficacy outcomes, this outcome underscores mipletamig’s safety and combinability, potentially offering a superior treatment in the future. This safety profile is particularly important in frontline AML, where tolerability and combinability are essential for treating older patients and/or those with comorbidities.

About the RAINIER Trial

RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts.

About Mipletamig

Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date.

(Press release, Aptevo Therapeutics, MAR 10, 2026, View Source [SID1234663424])

Alligator Bioscience strengthens intellectual property protection for bispecific antibody platform

On March 10, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the United States Patent and Trademark Office (USPTO) has granted a patent covering Alligator’s proprietary bispecific antibody format. The granted patent provides protection for the structural design of tetravalent bispecific antibodies capable of dual antigen binding.

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The patent covers a versatile antibody architecture designed to enable stable and efficient assembly of bispecific antibodies, including configurations targeting immune modulators and tumor-associated antigens. This platform is intended to support the development of next-generation immunotherapies across a range of oncology indications and combination strategies.

The bispecific antibody format covered by the patent underpins multiple programs within Alligator’s research platform and has already demonstrated external validation. In September 2025, Alligator entered into an evaluation and option agreement covering the RUBY antibody format, highlighting the commercial and strategic interest in Alligator’s antibody engineering capabilities.

"This patent grant strengthens the intellectual property foundation around our bispecific antibody platform and highlights the value of our technology beyond mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience. "It supports our strategy to build long-term value through our innovative antibody formats, both within our own pipeline and through partnerships, as exemplified by the RUBY agreement."

(Press release, Alligator Bioscience, MAR 10, 2026, View Source [SID1234663408])

Agenus Triggers First $20M Contingent Payment Under Zydus Life Sciences Collaboration to Support BOT+BAL Manufacturing Needs

On March 10, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that it has triggered the first $20 million contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences Ltd.

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The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls (CMC) and production activities related to botensilimab (BOT) and balstilimab (BAL). These activities will allow Zydus to perform the initiation of its commercial supply of Agenus’ lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization.

This milestone marks the first operational activities between Agenus and Zylidac Bio LLC, the U.S.-based biologics manufacturing subsidiary of Zydus Life Sciences.

"This milestone reflects our commitment to progressing BOT and BAL to regulatory approval readiness, and to support our ongoing clinical development and paid compassionate access program needs," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "As reimbursed access continues in France under the AAC framework and named patient programs expand in permitted countries and enrollment advances in the global BATTMAN Phase 3 trial, it is essential that we proactively align manufacturing capacity with anticipated demand. Our partnership with Zydus enables us to scale thoughtfully while maintaining capital discipline."

Agenus currently maintains sufficient cGMP clinical-grade BOT and BAL drug product inventory to support the ongoing BATTMAN Phase 3 trial, the ANSM-authorized French access program (AAC) program, paid named patient programs in select countries where permitted, and ongoing investigator-sponsored trials. The newly initiated manufacturing activities are designed to supplement existing supply and position the company to meet expanding demand across paid compassionate access, development and potential future commercial settings.

Under the collaboration agreement, up to $50 million in contingent payments may be triggered by BOT and BAL production orders. The $20 million payment announced today is contractually allocated specifically for production and CMC-related activities. This structure enables Agenus to execute critical manufacturing work in support of its development and access programs without additional capital expenditures impacting its cash position.

The strategic collaboration between Agenus and Zydus, originally announced in June 2025 and closed in January 2026, provides Agenus with long-term U.S.-based biologics manufacturing capacity to support BOT+BAL’s global development and potential commercialization.

(Press release, Agenus, MAR 10, 2026, View Source [SID1234663425])

Lyell Immunopharma Announces Closing of Additional $50 Million Tranche of Equity Private Placement and Appointment of Smital Shah as Chief Financial and Business Officer

On March 9, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported it has closed the sale of an additional $50 million of shares of its common stock to investors from its July 2025 equity private placement of up to $100 million, following achievement of a clinical milestone within its PiNACLE pivotal trial evaluating rondecabtagene autoleucel (ronde-cel) in patients with relapsed/refractory large B-cell lymphoma (LBCL) in the third- or later-line setting. The Company also announced the appointment of Smital Shah as its Chief Financial and Business Officer, effective March 9, 2026.

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"Smital’s deep expertise in navigating complex financial landscapes and her proven track record of strategic leadership in the biotechnology industry make her the ideal partner to guide Lyell’s financial strategy as we enter a transformative year of execution," said Lynn Seely, M.D., President and CEO of Lyell. "The attainment of the second $50 million tranche of the private placement is evidence of Lyell’s continued advancement toward significant value inflection points. Smital’s insights will be invaluable in ensuring we remain well-capitalized and operationally disciplined to deliver on our mission of bringing next-generation cell therapies to patients with cancer."

Closing of Additional $50 Million Equity Private Placement Following Achievement of Clinical Milestone for Ronde-cel
Under the terms of the securities purchase agreement for the July 2025 equity private placement of up to $100 million, and following the initial closing of $50 million, Lyell held the right to require investors to purchase an additional $50 million of common stock upon the achievement of a clinical milestone for ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy in pivotal clinical development for patients with LBCL. Following the successful achievement of this clinical milestone, Lyell exercised this right and the investors purchased these shares from Lyell at a purchase price per share of $25.61, resulting in gross proceeds of approximately $50 million, bringing the total equity private placement proceeds to approximately $100 million. With the closing of this additional tranche, Lyell expects its cash, cash equivalents and marketable securities to be sufficient to meet working capital and capital expenditure needs into the second quarter of 2027.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued to them in the financing.

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

Smital Shah Appointed Chief Financial and Business Officer
Ms. Shah joins Lyell with over two decades of extensive leadership experience spanning corporate finance, capital markets and strategic operations within the biopharmaceutical industry. Most recently, she operated as an independent Chief Financial Officer and Chief Business Officer consultant, providing strategic guidance to multiple life sciences organizations. From 2014 to 2022, Ms. Shah served as the Chief Business and Financial Officer at ProQR Therapeutics (Nasdaq: PRQR) where she was responsible for directing all business functions, including finance, communications, commercial strategy, business development and legal.

Prior to her tenure at ProQR, Ms. Shah managed multi-billion-dollar debt, cash and investment portfolios at Gilead Sciences, Inc. She developed financial expertise through her tenure as an investment banker at Leerink Partners and J.P. Morgan, where she focused on capital raising and complex strategic transactions across the biotechnology sector. She began her career in various research and development roles at Johnson & Johnson.

Ms. Shah served on the Board of Directors of Pliant Therapeutics until June 2025 and as a Board Member and Chair of the Audit Committee at Graphite Bio until its merger with LENZ Therapeutics in 2024. She holds a B.S. in Chemical Engineering from the University of Mumbai, an M.S. in Chemical Engineering from Virginia Tech, as well as an M.B.A. in Finance from the University of California, Berkeley, Haas School of Business.

(Press release, Lyell Immunopharma, MAR 9, 2026, View Source [SID1234663367])