On February 20, 2026 Cerus Corporation (Nasdaq: CERS) reported that members of the Company’s management are scheduled to present at the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, 2026, at 10:30 a.m. EST.

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A live webcast of the fireside chat will be accessible through the Investor Relations page of the Cerus website at View Source A replay will be available for 90 days after the event.

(Press release, Cerus, FEB 20, 2026, View Source [SID1234662816])

On February 20, 2026 Exact Sciences Corporation (NASDAQ: EXAS) ("Exact Sciences"), a leading provider of cancer screening and diagnostic tests, reported that its stockholders voted to approve the proposed acquisition of Exact Sciences by Abbott (NYSE: ABT) at the special meeting of stockholders held earlier today.

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At the special meeting, preliminary results showed that more than 99% of the votes cast, representing approximately 67% of the total outstanding shares of Exact Sciences common stock as of the January 9, 2026 record date for the special meeting, were voted in favor of the transaction. Final voting results from the special meeting will be reported by Exact Sciences in a Current Report on Form 8‑K filed with the U.S. Securities and Exchange Commission (the "SEC").

Subject to the satisfaction or waiver of the remaining conditions to closing, the transaction is expected to close before the end of the second calendar quarter of 2026. Under the terms of the definitive agreement with Abbott, upon completion of the transaction, Exact Sciences’ stockholders will be entitled to receive $105.00 in cash, without interest and subject to any applicable withholding taxes, for each share of Exact Sciences common stock they owned as of immediately before the completion of the transaction.

(Press release, Exact Sciences, FEB 20, 2026, View Source [SID1234662817])

On February 20, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported new real world data supporting potential use of PEDMARK (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026.

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Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review.

"Head and neck cancer is one of the most common cancers globally,i underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity," said Maria A. Velez, M.D., M.S., coauthor of the study and clinical instructor in the Division of Hematology/Oncology at UCLA Health.

"Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment," said Leslie Worona, FNP-BC, OCN, coauthor of the study and oncology nurse practitioner at Mount Sinai Hospital. "The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK use in additional patient populations and tumor types such as HNC."

PEDMARK was shown to be well tolerated, with only isolated, self-limited infusion events and no grade 3 or 4 toxicities.

"These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK beyond those studied in our pivotal clinical program," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss."

The study’s primary endpoint evaluated feasibility, defined by timing adherence (≥6 hours) and operational metrics, including administration setting (home vs. clinic infusion) and chair time for infusion-center dosing. Secondary endpoints included infusion-related events, need for antiemetic escalation, and completion of on-treatment and post-treatment audiology assessments.

PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.ii

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyiii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iv Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.v,vi While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vii,viii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.ixx

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, FEB 20, 2026, View Source [SID1234662818])

On February 20, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration ("FDA"). Following the FDA’s standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.

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"Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer."

(Press release, PDS Biotechnology, FEB 20, 2026, View Source [SID1234662820])

On February 19, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

"As we close out 2025 and begin an exciting new year at Insmed, I am energized by the significant opportunities ahead to serve patients with serious diseases," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Our U.S. commercial launch of BRINSUPRI continues to exceed our expectations, and we are proud to provide this medicine to patients who previously had no approved treatment for their disease. Throughout 2026, we will continue to bring BRINSUPRI to patients with bronchiectasis, expand our Phase 3 clinical programs for TPIP, and advance our early-stage pipeline, fueling the research engine that we hope will power the next wave of potentially life-transforming therapies for patients."

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Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

BRINSUPRI

•
Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

•
In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

•
Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom (UK) and Japan in 2026.

•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

•
Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

•
ARIKAYCE global revenue grew 19% in 2025 compared to 2024, reflecting year-over-year growth across all geographic regions and exceeding the upper end of 2025 guidance of $420 to $430 million.

•
In March or April of 2026, the Company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.

•
Pending positive topline data from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

•
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation (ODD) to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH). Insmed plans to initiate a Phase 3 study of TPIP (treprostinil palmitil inhalation powder) in patients with PAH in the first half of 2026.

•
Insmed is actively enrolling patients in the PALM-ILD trial, a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

•
In January 2026, Insmed presented four abstracts from across its TPIP program at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin.

•
The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026.

•
The Company anticipates initiating additional Phase 3 studies of TPIP in patients with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

INS1148

•
In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248).

2

•
The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease (ILD) and moderate to severe asthma.

Immunology & Inflammation

Brensocatib

•
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.

INS1033

•
Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial IND filing expected in 2026.

Neuro & Other Rare

INS1201

•
Insmed continues to enroll the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

•
In January 2026, the Company dosed the first patient in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

INS1203

•
Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

3
Fourth-Quarter and Full-Year 2025 Financial Results

The following table summarizes fourth-quarter and full-year 2025 and 2024 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
73.4

$
67.8

8
%

$
280.3

$
254.8

10
%
International

45.9

36.7

25
%

153.5

108.9

41
%
Total

$
119.2

$
104.4

14
%

$
433.8

$
363.7

19
%
BRINSUPRI

U.S.

$
144.6

$
–

N/A

$
172.7

$
–

N/A

International

–

–

N/A

–

–

N/A

Total

$
144.6

$
–

N/A

$
172.7

$
–

N/A

Total Revenues

U.S.

$
218.0

$
67.8

222
%

$
453.0

$
254.8

78
%
International

45.9

36.7

25
%

153.5

108.9

41
%
Total

$
263.8

$
104.4

153
%

$
606.4

$
363.7

67
%

•
Cost of product revenues (excluding amortization of intangibles) was $44.2 million for the fourth quarter of 2025, compared to $26.2 million for the fourth quarter of 2024. For full-year 2025, cost of product revenues (excluding amortization of intangibles) was $122.9 million compared to $85.7 million for full-year 2024. The increase in cost of product revenues in the fourth quarter of 2025 and full-year 2025 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI, following BRINSUPRI’s U.S. commercial launch in August 2025. Cost of product revenues as a percentage of revenues decreased in the fourth quarter of 2025 and full-year 2025 due to sales of BRINSUPRI, which has a lower manufacturing cost than ARIKAYCE.

•
Research and development (R&D) expenses were $254.9 million for the fourth quarter of 2025, compared to $179.7 million for the fourth quarter of 2024. For full-year 2025, R&D expenses were $771.1 million compared to $598.4 million for full-year 2024. The increase in R&D expenses for fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, increases in manufacturing expense, and the acquisition of INS1148.

•
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2025 were $212.5 million, compared to $142.5 million for the fourth quarter of 2024. For full-year 2025, SG&A expenses were $701.2 million, compared to $461.1 million for full-year 2024. The increase in SG&A expenses for the fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, and an increase in professional fees and other external expenses, both driven by commercial and commercial readiness activities for BRINSUPRI.

•
For the fourth quarter of 2025, Insmed reported a net loss of $328.5 million, or $1.54 per share, compared to a net loss of $235.5 million, or $1.32 per share, for the fourth quarter of 2024. For full-year 2025, Insmed reported a net loss of $1,276.8 million, or $6.42 per share, compared to a net loss of $913.8 million, or $5.57 per share, for full-year 2024.

Balance Sheet, Financial Guidance, and Planned Investments

•
As of December 31, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion.

•
The Company anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

•
Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

4

•
The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.

•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

•
The Company plans to continue to invest in the following key activities in 2026:

(i)
commercialization and expansion of BRINSUPRI and ARIKAYCE;

(ii)
preparation of regulatory submissions for full approval for ARIKAYCE in the U.S. and label expansion to include all patients with a MAC lung infection in the U.S. and Japan, pending positive topline results from the Phase 3 ENCORE trial;

(iii)
advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;

(iv)
advancement of clinical development programs for INS1148 in ILD and moderate to severe asthma;

(v)
advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for INS1203 in Stargardt disease;

(vi)
advancement of IND-enabling activities for INS1033 in RA and IBD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, February 19, 2026, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through February 26, 2026, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, FEB 19, 2026, View Source [SID1234662785])