On June 9, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered an agreement to acquire Nuvalent, Inc. ("Nuvalent") (NASDAQ: NUVL) a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion. The acquisition is consistent with GSK’s strategy of acquiring assets that have validated targets and meaningfully address efficacy and/or tolerability limitations of existing standard-of-care therapies. It includes three products in lung cancer in a single transaction.

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Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage, potential best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for treatment of NSCLC. Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations* and are in review with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib. Subject to FDA approval, they are expected to launch in 2026 and have multi-blockbuster potential. The third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in phase I trials for HER2-altered NSCLC. The acquisition also includes Nuvalent’s preclinical portfolio of multiple programmes, built from their proven precision medicine capabilities and clinical insights from industry-leading physician-scientists.

Luke Miels, Chief Executive Officer, GSK said: "Today’s acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap. The two lead products are potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer.

The acquisition provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III clinical development."

Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting show potential best-in-class profiles for zidesamtinib and neladalkib.1,2 Both assets aim for longer effective treatment with better quality of life through high target-selectivity, durable treatment response, improved tolerability, enhanced blood-brain barrier penetration for tumour spread, and broader coverage of ALK and ROS1 mutations, potentially addressing efficacy and/or tolerability limitations of existing therapies. ROS1- and ALK-altered NSCLC primarily affect non-smoking adults aged 40-50, a uniquely defined and engaged patient population. There is substantive treatment experience with zidesamtinib and neladalkib already through their clinical development and patient assistance programmes.3,4

James Porter, PhD, Chief Executive Officer, Nuvalent, said: "Since our founding, we have leveraged our deep expertise in chemistry and structure-based drug design to develop a portfolio of novel, potentially best-in-class kinase inhibitors. Our close collaboration with leading physician-scientists and patient advocates has driven remarkable enrolment, accelerating development and building confidence in the clinical profile of these drugs. We’re excited that GSK has recognised the significant value these programmes can offer patients and shares our vision for practice-changing innovation. GSK’s proven track record, infrastructure, and expertise will support the successful commercialisation of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline."

Financial considerations
Under the terms of the merger agreement, GSK will commence a tender offer to acquire all of Nuvalent’s outstanding shares of Class A and Class B common stock at a purchase price of $124 per share in cash within 10 business days. The aggregate equity value of the transaction is estimated to be $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is estimated to be $9.4 billion (£7.1 billion). The expected purchase price of $124 per share represents a 40% premium to the last closing price and a 26% premium to the 30 calendar day Volume-Weighted Average Price (VWAP).

There is no change to GSK’s 2026 full-year guidance range of 7-9% core operating profit and core EPS growth. The acquisition is expected to contribute to revenue growth from 2027, be incremental to the Group’s existing ambition for sales of >£40 billion by 2031 and to strengthen core operating profit through the dolutegravir loss of exclusivity period (2028-2030). We expect accretion to core operating profit in 2027 and core EPS in 2029 inclusive of synergies and reprioritisation. Assuming the transaction closes in Q3 2026, we expect low single-digit percentage dilution to core EPS for the current year, FY 2027 and FY 2028.

The transaction will be funded primarily from new and existing debt facilities plus cash, with no impact expected to GSK’s credit rating. GSK will maintain a strong investment grade credit profile and retains balance sheet capacity for further accretive business development.

GSK remains committed to its 70p expected dividend for 2026 and to its progressive dividend policy thereafter.

The transaction is subject to customary closing conditions, including the tender of a majority of Nuvalent’s outstanding shares of Class A common stock in the tender offer and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act in the US. Promptly following the closing of the tender offer, GSK expects to acquire any remaining shares of Nuvalent through a second-step merger under Delaware law at the same price per share.

GSK will account for the transaction as a business combination. GSK will also assume Nuvalent’s existing revenue-sharing arrangements of low-single-digit royalties payable to Royalty Pharma and Deerfield.

Advisors
Leerink Partners LLC and Citigroup Inc. are acting as financial advisors and Davis Polk & Wardwell LLP and Slaughter and May are serving as legal counsel to GSK in connection with the transaction. Centerview Partners LLC is serving as financial advisor and Ropes & Gray LLP is serving as legal counsel to Nuvalent. Jefferies LLC also provided financial advice to Nuvalent. Sidley Austin LLP is corporate counsel to Nuvalent.

About NSCLC
NSCLC is the most common form of lung cancer and is often characterised by specific genetic alterations, such as those in ALK, ROS1, or HER2. It can often metastasise (i.e. spread) to the central nervous system. It primarily affects working-age individuals. Current treatments are associated with mutation resistance and side effects, including metabolic and neurologic events, that can adversely impact patients’ quality of life.

(Press release, GlaxoSmithKline, JUN 9, 2026, View Source [SID1234666507])

On June 9, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported that it has entered into definitive agreements for a registered direct offering and concurrent private placement priced at-the-market under NYSE American rules for gross proceeds of approximately $2.65 million, before deducting placement agent commissions and other offering expenses.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

The offering is expected to close on or about June 10, 2026, subject to the satisfaction of customary closing conditions.

In the registered direct offering, the Company will issue and sell 2,554,119 shares of common stock, par value $0.001, at a purchase price of $0.5189 per share (the "Registered Shares"). In addition, in a concurrent private placement, the Company will issue and sell an aggregate of 2,554,119 unregistered shares of Common Stock (or pre-funded warrants in lieu thereof) (the "Unregistered Shares") at the per share purchase price and unregistered Class J warrants (the "Class J Warrants") to purchase up to 10,216,476 shares of Common Stock. The Class J Warrants will have an exercise price of $0.5189 per share, will be exercisable subject to stockholder approval and will expire five (5) years from the initial exercise date.

The Company intends to use the net proceeds from the offering for (i) the manufacture of clinical drug supply, (ii) the Company’s current clinical trial activities, (iii) the Company’s planned Phase 3 clinical trial activities, and (iv) working capital purposes.

The Registered Shares (or common stock equivalents in lieu thereof) are being offered and sold pursuant to a prospectus supplement to be filed with the Securities and Exchange Commission ("SEC") in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-286319), which was declared effective by the SEC on July 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus which are a part of the effective registration statement. The Unregistered Shares and Class J Warrants will be issued in a concurrent private placement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the prospectus supplement and the accompanying prospectus may be obtained from Ladenburg Thalmann & Co. Inc., 640 Fifth Avenue, 4th Floor, New York, NY 10019, by phone at (212) 409-2000, or by email at [email protected]. The private placement of the Unregistered Shares, the Class J Warrants and the shares underlying the Class J Warrants offered to the institutional investors will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold 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.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities 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, AIM ImmunoTech, JUN 9, 2026, View Source [SID1234666506])

On June 8, 2026, IDEAYA Biosciences, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Jefferies LLC, TD Securities (USA) LLC, UBS Securities LLC and Cantor Fitzgerald & Co., as representatives (the "Representatives") of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 5,555,556 shares (the "Shares") of its common stock, par value $0.0001 per share ("Common Stock"), and, in lieu of Common Stock to certain investors, pre-funded warrants (the "Pre-Funded Warrants") to purchase 5,555,576 shares of Common Stock (the "Warrant Shares") to the Underwriters (the "Offering"). The price to the public in the Offering is $27.00 per Share and $26.9999 per Pre-Funded Warrant, which is the price per share at which the Shares are being sold to the public in the Offering, minus the $0.0001 exercise price per Pre-Funded Warrant. Each Pre-Funded Warrant will be exercisable from the date of issuance until fully exercised, subject to an ownership limitation. Pursuant to the Underwriting Agreement, the Underwriters have agreed to purchase the Shares from the Company at a price of $25.38 per Share and the Pre-Funded Warrants from the Company at a price of $25.3799 per Pre-Funded Warrant. In addition, under the terms of the Underwriting Agreement, the Company granted the Underwriters the option, for 30 days, to purchase up to 1,666,669 additional shares of Common Stock at the public offering price, less underwriting discounts and commissions (the "Underwriters’ Option").

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The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s automatically effective shelf registration statement on Form S-3 (Registration No. 333-295560).

Pursuant to the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities. The Company and the Company’s directors and executive officers also agreed not to sell or transfer any Common Stock without first obtaining the written consent of the Representatives on behalf of the Underwriters, subject to certain exceptions as described in the prospectus supplement, for 60 days after the date of the Prospectus, as defined in the Underwriting Agreement.

On June 10, 2026, the Offering closed and the Company completed the sale and issuance of an aggregate of 7,222,225 shares of Common Stock, including the exercise in full of the Underwriters’ Option, and Pre-Funded Warrants to purchase 5,555,576 Warrant Shares. The Company received net proceeds of approximately $323.6 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by the Company.

A copy of the Underwriting Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing descriptions of the Underwriting Agreement and lock-up arrangements do not purport to be complete and are qualified in their entirety by reference to such exhibit.

A copy of the form of Pre-Funded Warrant is attached as Exhibit 4.1 hereto and is incorporated herein by reference. The foregoing descriptions of the Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to such exhibit.

(Filing, Ideaya Biosciences, JUN 8, 2026, View Source [SID1234666537])

On June 8, 2026 Incyte (Nasdaq:INCY) reported it has entered into a definitive agreement to acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC, for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones, for total potential consideration of up to $2.0 billion subject to customary closing adjustments. The proposed acquisition would add VGA039, a novel monoclonal antibody, to Incyte’s hematology portfolio.

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Vega Therapeutics’ lead candidate, VGA039, modulates Protein S to improve hemostasis, potentially improving the body’s ability to control bleeding in numerous bleeding disorders. VGA039 is in Phase 3 pivotal development for patients with von Willebrand disease (VWD), the most common inherited bleeding disorder. It has the potential to be the first subcutaneous prophylactic therapy with a convenient dosing regimen for patients with VWD who currently require frequent intravenous infusions.

"VGA039 fits directly into our strategy of building a top-tier growth company for the future," said Bill Meury, Chief Executive Officer of Incyte. "It is a first-in-class, Phase 3 asset with compelling early data, a manageable development path and the potential to become an important new growth driver in one of our core therapeutic areas – hematology. The transaction has all of the attributes we look for in business development opportunities."

Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1 The disease is characterized by excessive bleeding that can vary in severity and frequency and may significantly affect quality of life. Current prophylactic treatment options include factor replacement therapies that often require 2 to 3 intravenous infusions each week.2

"This milestone reflects our team’s deep commitment to innovation and underscores our strategy to develop first-in-class and best-in-class therapies for serious conditions with high unmet need," said Adam Rosenthal, Ph.D., Founder and Chief Executive Officer of Star Therapeutics. "VGA039 will be advanced by Incyte, a global biopharmaceutical leader with deep expertise in hematology and a significant commercial track record. I am immensely proud of the Star Therapeutics team and our work toward making a difference for patients with von Willebrand disease."

VGA039 has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.

The transaction has been approved by both Incyte’s and Star Therapeutics’ Boards of Directors. Under the terms of the stock purchase agreement, Incyte will acquire all the outstanding shares of Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is an equity acquisition and is expected to close in the third quarter of 2026, pending Hart-Scott-Rodino review resulting in an expected R&D charge of approximately $1.25 billion, that will be included in third quarter and full year 2026 GAAP and non-GAAP results.

Lazard is acting as financial advisor to Incyte and Goodwin Procter LLP is serving as its legal counsel. Evercore and Morgan Stanley are acting as financial advisors to Star Therapeutics, and Fenwick & West LLP is serving as its legal counsel.

Incyte Conference Call and Webcast
Incyte will host a conference call and webcast on Monday, June 8, 2026, at 8:00 a.m. ET to discuss the acquisition.

To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13761011. If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay, you will need the conference identification number, 13761011.

The live and archived webcast will be available via the Events and Presentations tab of the Investor section of Incyte.com.

About VGA039
VGA039 is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. VGA039 has the potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with all types of von Willebrand disease (VWD). As a subcutaneously self-administered investigational antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to meaningfully improve convenience and quality of life for patients.

VGA039 has received Fast Track, orphan drug, rare pediatric disease and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into a Phase 3 study (NCT07115004), VIVID-6, a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD.

About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.

(Press release, Star Therapeutics, JUN 8, 2026, View Source [SID1234666508])

On June 8, 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 an update on the safety profile of LYL273 in its ongoing U.S. Phase 1 clinical trial in patients with relapsed or refractory metastatic colorectal cancer (mCRC), and announced the Phase 1 trial has been amended to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment.

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LYL273 is a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. A 50% overall response rate across Dose Levels 1 and 2 has been previously reported (data cutoff date of October 28, 2025) in third- or later-line (3L+) relapsed or refractory mCRC patients in the U.S. Phase 1 clinical trial. The FDA has granted LYL273 Fast Track designation for the treatment of mCRC.

"The substantial reduction of Grade 2 or higher diarrhea or colitis, and absence of Grade 3 or higher CRS and ICANS in patients treated under our gastrointestinal prophylaxis and standardized safety management plan suggest we can manage the safety profile of LYL273 in patients with relapsed or refractory metastatic colorectal cancer," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "We are continuing to move forward to selection of the recommended Phase 2 dose and are on track for an End-of-Phase 1 meeting with the FDA by the end of the year."

Updated Safety Data from U.S. Phase 1 Clinical Trial Evaluating LYL273 in Patients with Relapsed or Refractory Third- or Later-Line mCRC

Nineteen patients have been enrolled in the U.S. Phase 1 clinical trial across Dose Levels 1 and 2 (1 and 2 x 106 CAR+ cells/kg) as of the data cutoff date of May 5, 2026. Ten of these patients were enrolled under the new gastrointestinal (GI) prophylaxis regimen including infliximab, vedolizumab and budesonide, along with a standardized safety management plan. Notably, the GI prophylaxis and standardized safety management plan reduced Grade > 2 diarrhea or colitis from 55% to 10% in patients without (N = 9) and with (N = 10) GI prophylaxis, respectively. These ten patients did not experience Grade ≥ 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). No additional adverse events of interest have been identified. There was no difference observed in GCC-CAR+ cell expansion either in terms of maximum cell expansion or area under the curve in those patients who received GI prophylaxis and those who did not.

Dose escalation continues in the U.S. Phase 1 clinical trial; the maximum tolerated dose has not been determined.

Phase 1 Clinical Trial Amended to Phase 1/2 Design

The U.S. Phase 1 clinical trial evaluating LYL273 in relapsed or refractory 3L+ mCRC has been amended to a Phase 1/2 design (CARABINER). The amended design enables seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose has been determined, subject to discussions with the U.S. Food and Drug Administration (FDA). New centers are being added to the trial in preparation for initiating the dose expansion portion of the Phase 1/2 trial.

The Phase 1 portion of the clinical trial includes four dose-escalation cohorts at Dose Levels 1 through 4 (1, 2, 3, 4 x 106 CAR+ cells/kg). Each dose-escalation cohort is designed to include three or six patients, with up to twenty-four patients across the four dose-escalation cohorts.

In addition to the existing 3L+ cohorts, the amendment adds new cohorts, including a second-line cohort and a cohort evaluating a combination strategy with radiotherapy. Up to sixty patients are expected to be enrolled across the new cohorts. The Phase 2 portion will expand enrollment at the recommended Phase 2 dose in an open-label, single-arm cohort.

Upcoming LYL273 Milestones

In the second half of 2026, additional Phase 1 clinical data, including clinical outcomes, and an End-of-Phase 1 meeting with the FDA are expected.

(Press release, Lyell Immunopharma, JUN 8, 2026, View Source [SID1234666501])