Strategic Signals Weekly

Arvinas, Inc. announced FDA approval for VEPPANU (vepdegestrant) for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, following at least one line of endocrine-based therapy. This marks the first FDA-approved PROteolysis Targeting Chimera (PROTAC) protein degrader. The approval, received ahead of the PDUFA date, triggered a $50.0 million development milestone payment from its collaborator, Pfizer Inc.

Drug: VEPPANU (vepdegestrant) · Indication: ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following at least one line of endocrine-based therapy

Celcuity Inc. announced positive topline results from the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant, with or without palbociclib, in patients with HR+/HER2- PIK3CA mutant locally advanced or metastatic breast cancer. The primary efficacy analysis demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib and fulvestrant. The company intends to submit these data as a supplemental New Drug Application (sNDA) to the FDA and present them at the 2026 ASCO Annual Meeting.

Drug: gedatolisib · Indication: hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA mutant locally advanced or metastatic breast cancer (ABC), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor

Genprex, Inc. announced that the Israel Patent Office granted a patent for Reqorsa® Gene Therapy (quaratusugene ozeplasmid) for use in combination with PD-1 antibodies for cancer treatment. This expands Genprex's intellectual property portfolio globally, building on existing patents in major markets. Reqorsa is initially being developed for lung cancer, with preclinical studies showing complementarity with targeted drugs and immunotherapies.

Passage Bio, Inc. announced a workforce restructuring plan on April 28, 2026, as part of its ongoing review of strategic alternatives to maximize shareholder value. The plan involves reducing its workforce by approximately 75% to decrease operating expenses. The company expects to incur approximately $3.3 million in severance and exit costs, primarily in the second quarter of 2026.

Genprex announced positive preclinical data for its diabetes gene therapy candidate, GPX-002 (Pdx1/MafA gene therapy), to be presented at the 2026 ASGCT Annual Meeting. The data demonstrated that GPX-002 reversed hyperglycemia in Type 2 diabetic mouse models by enhancing beta-cell function and maturation. This compelling evidence suggests the technical translatability of the approach for long-term glycemic control in T2D.

Arvinas, Inc. announced FDA approval for VEPPANU (vepdegestrant) for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, following at least one line of endocrine-based therapy. This marks the first FDA-approved PROteolysis Targeting Chimera (PROTAC) protein degrader. The approval, received ahead of the PDUFA date, triggered a $50.0 million development milestone payment from its collaborator, Pfizer Inc.

Drug: VEPPANU (vepdegestrant) · Indication: ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following at least one line of endocrine-based therapy · Partner: Pfizer Inc.

Avalo Therapeutics, Inc. amended its merger agreement with AlmataBio, Inc. to restructure a contingent $15 million milestone payment. Avalo will pay $2.25 million immediately and has a 90-day option to pay an additional $5.125 million to fully satisfy the milestone, which was originally tied to the first patient dosed in a Phase 3 trial. If the option is not exercised, Avalo will pay $12.75 million upon the milestone event.

Partner: AlmataBio, Inc.

Fulcrum Therapeutics, Inc. provided notice to CAMP4 Therapeutics Corp. to terminate their License Agreement, effective in accordance with its terms. The agreement, dated July 5, 2023, granted Fulcrum exclusive worldwide rights to CAMP4's Diamond-Blackfan anemia program, including small molecule compounds. Fulcrum had made an undisclosed upfront payment, and CAMP4 was eligible for up to $70 million in potential milestone payments and royalties.

Indication: Diamond-Blackfan anemia · Partner: CAMP4 Therapeutics Corp.

Cue Biopharma entered into an exclusive global (excluding Greater China) license agreement with Ascendant Health Sciences Ltd. for Ascendant-221 (formerly UB-221), an anti-IgE monoclonal antibody. Cue Biopharma will pay an upfront fee of $15.0 million, up to $676.5 million in potential development, regulatory, and commercial milestones, and tiered royalties on net sales.

Shuttle Pharmaceuticals Holdings, Inc. entered into a Merger Agreement to acquire United Dogecoin Inc. through its wholly-owned subsidiary, Merger Sub. The transaction will result in United Dogecoin Inc. becoming a direct wholly-owned subsidiary of Shuttle, with its existing stock converted into Series B-1 convertible preferred stock and potential pre-funded warrants of Shuttle. Shuttle also committed to conducting a private placement offering of at least $10 million post-closing.

Senseonics Holdings, Inc. announced a public offering of 8 million shares and 8 million pre-funded warrants, expecting net proceeds of approximately $74.7 million, or up to $86 million if the underwriters' option is fully exercised. Concurrently, the company provided preliminary Q1 2026 financials, reporting approximately $11.7 million in revenue and a net loss between $31 million and $33 million. Additionally, Senseonics is negotiating an amendment to its loan facility with Hercules Capital to increase borrowing capacity by $40 million to $140 million.

Quest Diagnostics Incorporated announced the pricing of a public offering of $500 million aggregate principal amount of 5.000% senior notes due 2036. The company intends to use the net proceeds for general corporate purposes, including potentially repaying its $500 million 3.45% Senior Notes maturing in June 2026. The offering is expected to close on May 6, 2026.

Senti Biosciences Holdings, Inc. entered into a Securities Purchase Agreement with an accredited investor affiliated with Celadon Partners SPV 24 for a private placement of up to $40.0 million in Senior Secured Convertible Notes. The initial tranche of $10.0 million is subject to closing conditions, with an additional $30.0 million contingent on Celadon's election and the execution of a potential CVR transaction. Proceeds will be used for general corporate purposes and to advance CMC and clinical trials for their product candidate, SENTI-202.