On February 11, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With a continued focus on making a meaningful difference for patients, we believe Ascendis is entering a steep growth phase as we transform into a leading global biopharma company," said Jan Mikkelsen, President and CEO of Ascendis Pharma. "With strong execution and the power of our TransCon platform, we are positioned to generate approximately €500 million in operating cash flow in 2026 while aspiring to deliver at least €5 billion in global annual product revenue by 2030. At the same time, we are advancing a growing pipeline of highly differentiated programs to deliver durable, long-term growth."

Select 2025 Highlights & Anticipated 2026 Milestones

TransCon PTH
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the fourth quarter of 2025 totaled €187 million and €477 million for the full year 2025, as previously announced.
More than 5,300 unique U.S. patient enrollments, with nearly 2,400 unique prescribing healthcare providers at year end.
Outside the U.S., now available commercially or through named patient programs in more than 30 countries, with full commercial launches anticipated in 10 additional countries by year end 2026.
Presented pooled analysis of 3-year data from PaTHway and PaTH Forward trials at the American Society of Nephrology (ASN) Kidney Week 2025, reinforcing that treatment with TransCon PTH led to rapid and sustained improvements in kidney function in adults with hypoparathyroidism.
Ongoing label expansion trials through PaTHway60 (adults) and PaTHway Adolescent.
Confirmed product profile for once-weekly TransCon PTH, targeting patients who have been transitioned from conventional therapy to YORVIPATH and have achieved a stable daily dose.
TransCon CNP
(navepegritide, FDA NDA and EMA MAA filed)
In the U.S., PDUFA action goal date of February 28, 2026 for pediatric achondroplasia.
Submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) in October 2025, with a regulatory decision on potential use in pediatric achondroplasia anticipated in the fourth quarter of 2026.
Label expansion trial in infants with achondroplasia, reACHin, remains ongoing with enrollment completion anticipated later this year.
TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)
Announced Week 52 topline results from Phase 2 COACH Trial, which demonstrated improvements in annualized growth velocity across both TransCon CNP treatment-naïve and TransCon CNP-treated children that exceeded the 97th percentile of average stature children, along with improvements in body proportionality and in arm span, and a safety profile consistent with those observed for monotherapies of TransCon CNP and TransCon hGH on January 8, 2026.
Held a successful end of Phase 2 meeting with the U.S. Food & Drug Administration (FDA) and Scientific Advice meeting in the EU regarding a Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia in the fourth quarter of 2025.
Week 78 COACH data update anticipated in second quarter of 2026.
Planned new trials to support TransCon CNP + TransCon hGH treatment in additional indications.
TransCon hGH
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the fourth quarter of 2025 totaled €53 million and €206 million for the full year 2025, as previously announced.
Received first label expansion in July 2025 with FDA approval for adult growth hormone deficiency (GHD).
Initiated Phase 3 basket trial for additional indications: idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA).
Oncology Program
(onvapegleukin alfa)
Expect to report median overall survival (OS) data for a cohort of 70 patients with late-line platinum-resistant ovarian cancer (PROC) from the IL-Believe Trial of TransCon IL-2 β/γ + weekly paclitaxel in the second quarter of this year.
Strategic Collaborations & Investments
Ongoing multi-product collaboration with Novo Nordisk for TransCon technology-based therapies in obesity and metabolic diseases, with the lead program, TransCon Semaglutide, on track to enter the clinic as anticipated.
Eyconis lead program, TransCon aVEGF (EYC-0305), in development for wet AMD and other retinal diseases anticipated to enter the clinic in 2026.
On January 26, 2026, VISEN Pharmaceuticals announced that China’s National Medical Products Administration approved its biologics license application for lonapegsomatropin (TransCon hGH) in China for the treatment of pediatric growth hormone deficiency (PGHD).
In November 2025, Teijin Limited announced that YORVIPATH is commercially available for prescription in Japan.
Financial Update
For the fourth quarter of 2025, operating profit was €10 million and cash flow from operating activities was €73 million, primarily driven by continued growth of YORVIPATH revenue globally.
Initiating previously announced $120 million share repurchase program in 2026.
As of December 31, 2025, our cash balance was €616 million, an increase of €77 million compared to €539 million as of September 30, 2025.

Fourth Quarter and Full-Year 2025 Financial Results
Total revenue for the fourth quarter of 2025 was €248 million, compared to €174 million during the same period for 2024. The increase was primarily attributable to the continued growth of YORVIPATH global product revenue, partially offset by the recognition of a $100 million upfront payment in 2024 that did not recur in 2025.

Total revenue for 2025 was €720 million compared to €364 million in 2024. The increase was primarily attributable to the continued growth of YORVIPATH partially offset by recognition of a $100 million upfront payment in 2024 that did not recur in 2025. Non-product revenue was €37 million in 2025, compared to €138 million in 2024.

Total Revenue
(In EUR’000s) Three Months Ended
December 31,
Twelve Months Ended
December 31,
2025 2024 2025 2024
Revenue
Commercial products 240,092 72,130 683,572 225,728
Services and clinical supply 4,780 5,933 18,008 15,570
Licenses 2,628 95,853 5,630 122,343
Milestones — — 12,922 —
Total revenue 247,500 173,916 720,132 363,641

Commercial Products Revenue
(In EUR’000s) Three Months Ended
December 31, Twelve Months Ended
December 31,
2025 2024 2025 2024
Revenue from commercial products
YORVIPATH 186,677 13,584 477,412 28,727
SKYTROFA 53,415 58,546 206,160 197,001
Total revenue from commercial products 240,092 72,130 683,572 225,728

Research and development (R&D) expenses for the fourth quarter of 2025 were €78 million, compared to €79 million during the same period in 2024. R&D expenses for 2025 were €304 million compared to €307 million in 2024. The lower R&D expenses were driven by the completion of clinical trials and development activities within our Endocrinology Rare Disease pipeline partially offset by reversal (income) of prior period write-downs related to YORVIPATH pre-launch inventory.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2025 were €136 million, compared to €80 million during the same period in 2024. SG&A expenses for 2025 were €458 million compared to €291 million in 2024. Higher SG&A expenses were primarily due to the continued impact from global commercial expansion, including global launch activities for YORVIPATH.

Total operating expenses for the fourth quarter of 2025 were €214 million compared to €160 million during the same period in 2024. Total operating expenses for 2025 were €761 million compared to €598 million in 2024.

Net finance expenses were €38 million in the fourth quarter compared to €33 million in the same period in 2024. Net finance expenses for 2025 were €93 million compared to €74 million in 2024. The full year net finance expense increase was driven primarily by non-cash items.

For the fourth quarter of 2025, Ascendis Pharma reported a net loss of €34 million, or €0.55 per share (basic and diluted) compared to a net loss of €38 million, or €0.64 per share (basic and diluted) for the same period in 2024. For the full year 2025, Ascendis Pharma reported a net loss of €228 million, or €3.76 per share (basic and diluted) compared to a net loss of €378 million, or €6.53 per share (basic and diluted) in 2024.

As of December 31, 2025, Ascendis Pharma had cash and cash equivalents totaling €616 million compared to €560 million as of December 31, 2024. As of December 31, 2025, Ascendis Pharma had 61,977,408 ordinary shares outstanding, including 597,096 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its fourth quarter and full year 2025 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.

(Press release, Ascendis Pharma, FEB 11, 2026, View Source [SID1234662595])

On February 11, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, reported that Abizer Gaslightwala, CEO of Akari Therapeutics, participated in a Virtual Investor "What This Means" interview focused on the Company’s expanding ADC pipeline and intellectual property strategy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the segment, Mr. Gaslightwala discussed Akari’s recently announced patent filing and the introduction of AKTX-102, the Company’s second ADC pipeline candidate targeting CEACAM5-expressing solid tumors. The discussion highlighted how this milestone underscores the scalability of Akari’s PH1-powered ADC platform and its ability to generate multiple differentiated therapeutic programs.

Mr. Gaslightwala also addressed Akari’s differentiated approach to CEACAM5 through its novel antibody construct combined with the PH1 spliceosome-modulating payload, as well as the Company’s execution priorities as its lead program, AKTX-101, advances toward IND and CTA submission and first-in-human studies. In addition, the segment explored the strategic importance of Akari’s growing patent estate in supporting long-term value creation and potential partnering opportunities.

The Virtual Investor "What This Means" segment featuring Akari Therapeutics is now available here.

(Press release, Akari Therapeutics, FEB 11, 2026, View Source [SID1234662591])

On February 11, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of its lead product, Ampligen (rintatolimod), for the treatment of late-stage pancreatic cancer – a lethal and unmet global health problem – reported that it has commenced its previously disclosed rights offering (the "Rights Offering").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the Rights Offering, the Company is distributing to all holders of record of the Company’s common stock, par value $0.001 per share ("Common Stock"), and to holders of certain options and warrants that have the right to participate in the Rights Offering (the "Participating Securities"), as of 5:00 p.m., Eastern Time, on February 10, 2026 (the "Record Date"), at no charge, non-transferable subscription rights (the "Subscription Rights") to purchase up to an aggregate of 12,000 units ("Units") at a subscription price of $1,000 per whole Unit.

Each holder of the Company’s Common Stock or Participating Securities will receive one Subscription Right for every share of Common Stock (including each share of Common Stock issuable upon conversion of Participating Securities) owned on the Record Date. Each Subscription Right will entitle its holder to purchase one Unit, each Unit consisting of one share of Series G Convertible Preferred Stock (the "Preferred Stock"), and 1,666 warrants to purchase Common Stock (the "Warrants") at a subscription price of $1,000 per Unit. Each share of Preferred Stock will be convertible, at the option of the holder at any time, into 833 shares of Common Stock, which is equal to the quotient of the stated value of the Preferred Stock ($1,000) divided by the conversion price ($1.20 per share). Each Warrant will be exercisable for one share of Common Stock at an exercise price of $1.20 per share from the date of issuance through its expiration five years from the date of issuance. No fractional Subscription Rights are being distributed and no fractional Units will be issued upon the exercise of any Subscription Rights in the Rights Offering. Stockholders must exercise Subscription Rights for at least one whole Unit to participate in the Rights Offering. The Subscription Rights will expire if they are not exercised by 5:00 p.m., Eastern Time, on February 27, 2025, the expected expiration date of the Rights Offering. The Company may extend the period for exercising the Subscription Rights. Subscription Rights which are not exercised by the expiration date of the Rights Offering will expire and will have no value.

Assuming the Rights Offering is fully subscribed, the Company expects to receive aggregate gross proceeds of $12 million. Holders who fully exercise their basic Subscription Rights will be entitled to subscribe for additional Units that remain unsubscribed as a result of any unexercised basic Subscription Rights. If over-subscription privilege requests exceed the remaining Units available, the remaining Units will be allocated pro-rata among holders who over-subscribe based on the number of Common Stock held by all holders exercising the privilege.

The subscription period for the Rights Offering commenced on February 11, 2026 and will end at 5:00 p.m., Eastern Time, on February 27, 2026, unless extended by the Company (the "Subscription Period"). The Subscription Rights are non-transferable and will only be exercisable during the Subscription Period. Once holders have exercised their Subscription Rights, such exercise may not be revoked, canceled, or changed, even if holders subsequently learn information about the Company or its business, financial position, results of operations or cash flows that is material or adverse or that the holders otherwise consider to be unfavorable. The Company may cancel, modify or amend the Rights Offering at any time and for any reason prior to the expiration of the Subscription Period.

The Company has engaged Maxim Group LLC as dealer-manager for the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via e-mail at [email protected] or telephone at +1 (212) 895-3745.

The Rights Offering is being made pursuant to the Company’s registration statement on Form S-1 (File No. 333-292085) (as amended, the "Registration Statement"), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 10, 2026. The Rights Offering is being made only by means of a prospectus, copies of which will be delivered to holders of the Company’s Common Stock as of 5:00 p.m., Eastern Time, on the Record Date and can be accessed through the SEC’s website at www.sec.gov. Questions about the Rights Offering or requests for a copy of the prospectus related to the Rights Offering may be directed to the Information Agent, Broadridge Corporate Issuer Solutions, LLC, at (855) 793-5068 or via e-mail at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy any Subscription Rights, Common Stock, Warrants, Units or any other securities, nor will there be any offer, solicitation or sale of any Subscription Rights, Common Stock, Warrants, Units or any other securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of such state or jurisdiction. This press release is not an offering and an offering can only be made by the prospectus and any prospectus supplements for the Rights Offering, which should be read carefully before making an investment decision.

The Company has not made and will not make any recommendation to stockholders regarding the exercise of Subscription Rights. The Company’s stockholders as of 5:00 p.m., Eastern Time, on the Record Date should make an independent investment decision about whether to exercise their Subscription Rights based on their own assessment of the Company’s business, financial condition, prospects for the future and the terms of the Rights Offering.

(Press release, AIM ImmunoTech, FEB 11, 2026, View Source [SID1234662590])

On February 11, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues.

Dr Chris Burns, CEO of Amplia, commented: "These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enrol the ongoing study as efficiently as possible. We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities."

The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.

(Press release, Amplia Therapeutics, FEB 11, 2026, View Source [SID1234662577])

On February 10, 2026 Fina Biotech reported that the European Patent Office (EPO) has granted patent number EP2951315 to protect a ´NON-INVASIVE DIAGNOSTIC METHOD FOR DIAGNOSING BLADDER CANCER´ (NICHTINVASIVES DIAGNOSEVERFAHREN ZUR DIAGNOSE VON BLASENKREBS-
PROCÉDÉ DE DIAGNOSTIC NON INVASIF POUR DIAGNOSTIQUER LE CANCER DE LA VESSIE). The patent has been validated in Germany, France and UK and will be in force until January 31st, 2034.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The object of this patent relates to a non-invasive bladder cancer diagnosis method based on the detection and quantification in spontaneous urine of the gene expression of certain genes and/or combinations thereof acting as genetic markers of said disease. Likewise, the use of said genes as bladder cancer diagnosis genetic markers is an object of the present invention, developed by Fina Biotech in collaboration Dr. Antonio Alcaraz and his team at the Hospital Clinic de Barcelona (Spain). Another object of the patent also relates to a bladder cancer diagnosis kit based on the use of several combinations of said genes that have proven to be useful to non-invasively diagnose bladder cancer.

This new patent strengthens the intellectual property portfolio of Fina Biotech and confirms the company strategic commitment in developing non-invasive diagnostic tools useful for patients, doctors and healthcare providers.

(Press release, Fina Biotech, FEB 10, 2026, View Source [SID1234662711])