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Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

On April 1, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.

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"We are excited to complete our PEAK NDA submission which marks a significant step toward bringing a new therapy to patients with second-line GIST," said Andrew Robbins, President and Chief Executive Officer. "Based on the strength of the PEAK data, we believe the bezuclastinib combination has the potential to meaningfully change the treatment landscape for these patients. We are grateful to the patients, investigators, and study teams who made this possible."

Pivotal data from PEAK, a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with GIST who have received prior treatment with imatinib, were reported in November 2025. As disclosed in the top-line results, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. Data for overall survival remains immature.

At the time of data cutoff, based on the number of ongoing patients receiving treatment on the bezuclastinib combination arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. The NDA submission with bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) also remains on track for the first half of 2026.

Bezuclastinib – Expanded Access Program
Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on March 30, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of March 30, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 21,100 shares of Cogent common stock and (ii) 15,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, APR 1, 2026, View Source [SID1234664121])

Calidi Biotherapeutics to Present New Data on Its Differentiated Approach to In Situ T-Cell Engagers Including a New Candidate Targeting TROP-2 at the AACR Annual Meeting in April 2026

On April 1, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will demonstrate new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment (TME).

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 SA, a known T and NK-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the AACR (Free AACR Whitepaper) meeting will showcase RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail may overcome these historical limitations.

The Company is developing a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"We continue to advance the RedTail platform through our lead asset, CLD-401, and now through our work with T-cell engagers," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads in a targeted fashion to distal sites of disease through systemic administration."

"The data we will present at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics likes cytokines and T-cell engagers and profoundly alter the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The ability of the RedTail platform to induce high levels of expression of its genetic payloads only at the tumor can potentially overcome many of the limitations currently seen with cytokine and T-cell engager therapies."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 1, 2026, View Source [SID1234664120])

Adagene Reports Full Year 2025 Financial Results and Provides Corporate Update

On April 1, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2025 and provided corporate updates.

"Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "The 10 mg/kg data reported at ASCO (Free ASCO Whitepaper) have now matured into the classic long survival tail of CTLA-4 inhibition. By significantly mitigating severe toxicities, patients remain on therapy longer, allowing CTLA-4-mediated intratumoral Treg depletion, alongside PD-1-mediated reinvigoration and CTLA-4-mediated priming of effector T cells, to drive durable disease control. Importantly, these data provide a clear, de-risked read-through to the 20 mg/kg dose, which already shows an encouraging 29% ORR with median duration of response not yet reached.

"Supported by Fast Track Designation and FDA alignment under Project Optimus, we are on track to finalize the optimal combination dose regimen for a potential MSS colorectal cancer registrational trial. The expanded therapeutic window also helps to establish muzastotug as a foundational combination backbone. At AACR (Free AACR Whitepaper), we will showcase this potential with data from triplet regimens—combining with fruquintinib in 3L+ MSS CRC, alongside results from the Morpheus Liver study evaluating a triplet of muzastotug, atezolizumab, and bevacizumab versus atezolizumab and bevacizumab alone in first-line HCC. These readouts underscore our ability to safely unlock deeper responses in hard-to-treat tumors."

2026 OBJECTIVES & CASH RUNWAY INTO EARLY 2028

· Data update from the ongoing Phase 1b/2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts

· Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

· Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

· Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

· Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

· Establish additional collaboration/licensing agreements.

With cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, Company expects a cash runway extending into early 2028.

PIPELINE HIGHLIGHTS

AMERICAN ASSOCIATION FOR CANCER RESEARCH 2026 PRESENTATIONS

The following abstracts have been selected for presentation at AACR (Free AACR Whitepaper) 2026:

1) Title: Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer

This poster will provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

2) Title: Results from the phase 1b/2 Morpheus Liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm

This poster will share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of liver cancer.

3) Title: Preclinical characterization of XB404, a masked anti-ROR1/2 antibody-drug conjugate

Partner Exelixis will present preclinical data from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects.

ONGOING COLLABORATIONS

· Sanofi: Invested up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with Sanofi’s SAR445877 (PD-1 x IL-15 fusion protein) in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody discovery program.

· Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.

· Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

· ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

· Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$74.5 million as of December 31, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.1 million as of December 31, 2025 from US$ 18.2 million as of December 31, 2024. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

Net Revenue:

Net revenue was US$7.7 million for the year ended December 31, 2025, compared to US$0.1 million in 2024. The increase of approximately 7,333% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi, ConjugateBio and Third Arc Bio, respectively.

Research and Development (R&D) Expenses:

R&D expenses were US$22.0 million for the year ended December 31, 2025, compared to US$28.8 million in 2024. The decrease of approximately 23% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.1 million for the year ended December 31, 2025, compared to US$7.3 million in 2024. The decrease was mainly a result of cost-control measures.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$17.6 million for the year ended December 31, 2025, compared to US$33.4 million in 2024.

Ordinary Shares Outstanding:

As of December 31, 2025, there were 59,231,993 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

ADG126- Phase 1b/2 data:

· As presented at ASCO (Free ASCO Whitepaper) 2025, muzastotug showed 29% (6/21) confirmed overall response rate (ORR) in the combined 20 mg/kg dose cohorts.

· Among 41 patients in the combined 10mg/kg dose cohorts, median overall survival (mOS) was 19.4 months with a 17.8-month median follow-up, which compares favorably to 11-12 month mOS from fruquintinib Phase 3 trials in the same population1

· Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 27% in the 20 mg/kg cohorts, which were generally transient and manageable.

· Updated data demonstrate the durability of response and further support the optimized therapeutic index profile of muzastotug, which overcomes well-known dose-limiting toxicities of other CTLA-4 inhibitors at 10-20-fold higher doses2, to provide potentially improved efficacy.

· Randomized Phase 2 trial enrollment ongoing, with results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

(Press release, Adagene, APR 1, 2026, View Source [SID1234664119])

BioInvent International AB publishes Annual Report 2025

On March 31, 2026 BioInvent reported annual report 2025.

(Presentation, BioInvent, MAR 31, 2026, https://www.bioinvent.com/sites/bioinvent/files/pr/20260331-2fe033aa-39f5-4c8c-acf3-4f188cfc6620-1.pdf?ts=1774950435 [SID1234669186])

Biogen to Acquire Apellis, Enhancing the Company’s Growth Portfolio in Immunology and Rare Disease, Bolstering Growth Outlook and Accelerating Expansion into Nephrology

On March 31, 2026 Biogen Inc. (Nasdaq: BIIB) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) reported the companies have entered into a definitive agreement under which Biogen has agreed to acquire all outstanding shares of Apellis for $41.00 per share in cash at closing, or approximately $5.6 billion. Apellis stockholders will also receive a nontransferable CVR for each Apellis share held, entitling the holder to receive two payments of $2 per share each, contingent on certain annual global net sales thresholds being met for SYFOVRE.

The addition of Apellis, a leader in advancing treatments for serious, complement-driven diseases, is expected to enhance Biogen’s short- and long-term revenue growth profile by adding two commercialized differentiated immunology and rare disease medicines to its growth portfolio. EMPAVELI and SYFOVRE add immediate sales revenue to Biogen, having achieved combined net sales of $689 million in 2025, which is expected to grow at a rate in the mid-to-high teens at least through 2028.

EMPAVELI is FDA-approved in rare immune-mediated kidney diseases (C3G and primary IC-MPGN) and in PNH and SYFOVRE is FDA-approved in geographic atrophy secondary to age related macular degeneration, an immune-mediated retinal disease. Apellis brings an established U.S. sales infrastructure and capabilities, including in nephrology, that Biogen believes will accelerate and strengthen Biogen’s commercial readiness for felzartamab, which is currently in Phase 3 studies for three kidney diseases with the first trial readout expected in the first half of 2027. Upon closing, Biogen expects a significant proportion of Apellis employees to join the company. Biogen will continue to work with Sobi, which retains commercial rights to EMPAVELI (Aspaveli in the EU) outside the U.S.

"Consistent with our strategy, this acquisition immediately advances Biogen’s ongoing transformation. The addition of Apellis expands our growth portfolio in immunology and rare disease with two approved, best-in-class medicines that complement our existing portfolio and bolsters our near-and long-term growth potential," said Christopher A. Viehbacher, Biogen’s President and Chief Executive Officer. "We look forward to welcoming Apellis employees to Biogen. We believe our combined capabilities and experience will allow us to maximize the potential of SYFOVRE and EMPAVELI, while Apellis’ talent, expertise and field capabilities will further strengthen Biogen, deepening the foundation for our growing nephrology franchise with felzartamab and serving many more patients with immune-mediated retinal disease."

"I am incredibly proud of the Apellis team and what we have achieved, including bringing two transformational medicines – SYFOVRE and EMPAVELI – to patients and building an innovative pipeline leveraging our deep expertise in complement science," said Cedric Francois, M.D., Ph.D., co-founder and Chief Executive Officer of Apellis. "With Biogen’s extensive experience with immunology and rare disease, we believe this transaction will accelerate our impact and enable us to reach more patients. This transaction represents a compelling outcome for our shareholders and a strong validation of our strategy, scientific innovation, and execution."

Two differentiated, complement therapies to enhance Biogen’s growth portfolio and expand Biogen’s nephrology capabilities

EMPAVELI (pegcetacoplan) is a targeted complement component 3 (C3) therapy designed to regulate excessive activation of the complement cascade, a part of the body’s immune system. EMPAVELI has been approved with a broad label for adults and adolescents with C3 glomerulopathy (C3G) or primary IC-MPGN (primary immune-complex membranoproliferative glomerulonephritis) that also includes data on patients with post-transplant C3G disease recurrence. In the Phase 3 VALIANT study, EMPAVELI demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits (as measured by C3 staining by biopsy), compared to placebo.

Positive results were seen in adolescent and adult patients with C3G and primary IC-MPGN and in C3G patients with post-transplant disease recurrence.
EMPAVELI is the only FDA-approved treatment for pediatric patients (12+ years) with C3G and the only FDA-approved treatment for patients with post-transplant C3G disease recurrence.
EMPAVELI is also the first and only FDA-approved treatment for both adult and pediatric (12+ years) populations in primary IC-MPGN.
EMPAVELI/Aspaveli is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally.

SYFOVRE (pegcetacoplan injection) is an approved therapy for geographic atrophy (GA) secondary to age-related macular degeneration. By targeting C3, SYFOVRE has been shown to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE was approved based on positive results from the Phase 3 OAKS and DERBY studies at 24 months, which included a broad and representative patient population.

In these studies, SYFOVRE reduced the rate of geographic atrophy (GA) lesion growth compared to sham treatment.
The treatment demonstrated increasing effects over time, with the greatest benefit — up to 36% reduction in lesion growth with monthly treatment in the DERBY study — occurring between months 18 and 24.
In November 2025, Apellis presented a post-hoc analysis of its five-year long-term efficacy data from the GALE open-label extension study, showing SYFOVRE delayed GA lesion progression by approximately 1.5 years in patients with nonsubfoveal GA when compared to sham/projected sham.
SYFOVRE is approved in the United States and Australia.
Apellis has completed a clinical trial for a SYFOVRE prefilled syringe (PFS) and plans to submit its application for FDA approval in the first half of 2026.

Transaction brings significant opportunity for value creation
Upon closing of the transaction, expected in the second quarter of 2026, the addition of Apellis is expected to add commercial products to Biogen that together recorded $689 million in revenue in 2025, and which are expected to grow at a rate in the mid-to-high teens at least through 2028.

This transaction is expected to strengthen Biogen’s revenue and EPS growth potential and is expected to be increasingly accretive to Biogen’s Non-GAAP diluted EPS starting in 2027. Importantly, the transaction is expected to meaningfully increase Biogen’s non-GAAP EPS compounded annual growth rate (CAGR) through the end of the decade. Biogen expects to finance the acquisition with a combination of cash and borrowings and believes it can fully de-lever by the end of 2027, allowing it to maintain financial flexibility for future investments.

Biogen plans to update full year 2026 guidance when it reports earnings for the first quarter of 2026.

Transaction and financial details
Under the terms of the agreement, Biogen will commence a tender offer to acquire all of the outstanding shares of Apellis common stock for $41 per share in cash at closing (representing an 86% premium to the 90-day volume-weighted average stock price and a 35% premium to the 52-week high stock price) and a non-transferable CVR per share. Each CVR represents the right to receive a cash payment of $2 per share if SYFOVRE achieves $1.5 billion in annual global net sales in any calendar year between 2027 and 2030, a right to receive an additional cash payment of $2 per share if SYFOVRE achieves $2 billion in annual global net sales in any of these calendar years, and, if these thresholds are not met and no CVR payment is due for any of these years, but if SYFOVRE achieves $2 billion in annual global net sales in the 2031 calendar year, a cash payment of $4 per share. Upon the successful completion of the tender offer, Biogen will acquire all remaining Apellis shares that are not tendered into the tender offer through a second-step merger at the same consideration.

The transaction, which was approved by the boards of directors of both companies, is subject to successful completion of the tender offer, customary closing conditions, and the receipt of necessary regulatory approvals.

Conference Call Details
Biogen will host an investor call on March 31, at 8:30 a.m. ET. The conference call will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

Advisors
Lazard acted as sole financial advisor and Cravath, Swaine & Moore LLP and Arnold & Porter acted as legal advisors to Biogen. Evercore acted as sole financial advisor and Wachtell, Lipton, Rosen & Katz and WilmerHale acted as legal advisors to Apellis.

(Press release, Apellis Pharmaceuticals, MAR 31, 2026, View Source [SID1234668984])