Galapagos Receives Transparency Notifications from Bank of America

Galapagos Receives Transparency Notifications from Bank of America




Galapagos Receives Transparency Notifications from Bank of America

Mechelen, Belgium; November 26, 2025, 07:30 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received transparency notifications from Bank of America.

Pursuant to Belgian transparency legislation1, Galapagos received transparency notifications on November 18 and November 19, 2025, from Bank of America Corporation indicating that it positively crossed the threshold of 5% of Galapagos’ voting rights on November 12, 2025 following an acquisition of Galapagos’ voting rights and equivalent financial instruments, and then subsequently fell below this threshold on November 14, 2025 following the disposal of such instruments.

On November 14, 2025, the Bank of America Corporation (taking into account the holding of its affiliates) owned 103,534 voting rights and 2,159,259 equivalent financial instruments, representing together 3.43% of Galapagos’ currently outstanding 65,897,071 shares, versus 168,924 voting rights and 3,295,951 equivalent financial instruments, representing together 5.26%, in the previous notification.

Summary of the transactions:

Date on which the threshold was crossed Date of notification Direct voting rights after the transaction Equivalent financial instruments after the transaction Total
November 12, 2025 November 18, 2025 0.26% 5.00% 5.26%
November 14, 2025 November 19, 2025 0.16% 3.28% 3.43%

Content of the notifications from Bank of America Corporation:
The notification dated November 19, 2025 contains the following information:

  • Date of notification: November 19, 2025
  • Date on which the threshold is crossed: November 14, 2025
  • Threshold of voting rights crossed downwards (in %): 5%
  • Notification by: Bank of America Corporation
  • Denominator: 65,897,071
  • Reason for the notification: Acquisition or disposal of financial instruments that are treated as voting securities
  • Notified details:
A) Voting Rights Previous notification After the transaction
  # of voting rights # of voting rights % of voting rights
Holder of voting rights   Linked to securities Not linked to securities Linked to securities Not linked to securities
Bank of America Corporation 0 0   0.00%  
Bank of America, National Association 12,568 12,476   0.02%  
Merrill Lynch International 65,070 66,430   0.10%  
Managed Account Advisors LLC 3 3   0.00%  
BofA Securities, Inc. 76,700 10,042   0.02%  
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
14,462 14,462   0.02%  
U.S. Trust Company of Delaware 121 121   0.00%  
Subtotal 168,924 103,534   0.16%  
  TOTAL 103,534 0 0.16% 0.00%

B) Equivalent financial instruments   After the transaction
Holder of equivalent financial instruments Type of financial instrument Expiration date Exercise period or date # of voting rights that may be acquired if the instrument is exercised % of voting rights Settlement
Merrill Lynch International Right to Recall     195,533 0.30% physical
BofA Securities, Inc. Rights of Use     1,796,975 2.73% physical
Merrill Lynch International Rights of Use     8,679 0.01% physical
Merrill Lynch International Physical Call Option 19/06/2026   100,000 0.15% physical
Bank of America, National Association Swaps 15/10/2027   27 0.00% cash
Bank of America, National Association Swaps 15/06/2026   12,500 0.02% cash
Merrill Lynch International Swaps 30/04/2026   18,790 0.03% cash
Merrill Lynch International Swaps 02/07/2026   717 0.00% cash
Merrill Lynch International Swaps 15/10/2027   27 0.00% cash
Merrill Lynch International Swaps 01/11/2027   162 0.00% cash
Merrill Lynch International Swaps 15/06/2026   12,500 0.02% cash
Merrill Lynch International Swaps 30/01/2026   169 0.00% cash
Merrill Lynch International Swaps 17/11/2025   12,521 0.02% cash
Merrill Lynch International Swaps 28/08/2026   659 0.00% cash
  TOTAL     2,159,259 3.28%  

TOTAL (A&B) # of voting rights % of voting rights
  2,262,793 3.43%

The chain of control has been described at the end of the notification (section 11) and can be found here.

The notification dated November 18, 2025 contains the following information:

  • Date of notification: November 18, 2025
  • Date on which the threshold is crossed: November 12, 2025
  • Threshold of voting rights crossed upwards (in %): 5%
  • Notification by: Bank of America Corporation
  • Denominator: 65,897,071
  • Reason for the notification: Acquisition or disposal of voting securities or voting rights and acquisition or disposal of financial instruments that are treated as voting securities
  • Notified details:
A) Voting Rights Previous notification After the transaction
  # of voting rights # of voting rights % of voting rights
Holder of voting rights   Linked to securities Not linked to securities Linked to securities Not linked to securities
Bank of America Corporation   0 0 0.00% 0.00%
Bank of America, National Association   12,568 0 0.02% 0.00%
Merrill Lynch International   65,070 0 0.10% 0.00%
Managed Account Advisors LLC   3 0 0.00% 0.00%
BofA Securities, Inc.   76,700 0 0.12% 0.00%
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
  14,462 0 0.02% 0.00%
U.S. Trust Company of Delaware   121 0 0.00% 0.00%
Subtotal   168,924   0.26%  
  TOTAL 168,924 0 0.26% 0.00%

B) Equivalent financial instruments   After the transaction
Holder of equivalent financial instruments Type of financial instrument Expiration date Exercise period or date # of voting rights that may be acquired if the instrument is exercised % of voting rights Settlement
Merrill Lynch International Right to Recall     196,491 0.30% physical
BofA Securities, Inc. Rights of Use     2,936,452 4.46% physical
Merrill Lynch International Rights of Use     4,089 0.01% physical
Merrill Lynch International Physical Call Option 19/06/2026   100,000 0.15% physical
Merrill Lynch International Swaps 30/04/2026   19,220 0.03% cash
Bank of America, National Association Swaps 15/06/2026   12,500 0.02% cash
Merrill Lynch International Swaps 02/07/2026   744 0.00% cash
Merrill Lynch International Swaps 15/06/2026   12,500 0.02% cash
Merrill Lynch International Swaps 30/01/2026   1,434 0.00% cash
Merrill Lynch International Swaps 17/11/2025   12,521 0.02% cash
  TOTAL     3,295,951 5.00%  

TOTAL (A&B) # of voting rights % of voting rights
  3,364,875 5.26%

The chain of control has been described at the end of the notification (section 11) and can be found here.

For further information, contact Galapagos:
Investor Relations
Glenn Schulman

+1 412 522 6239
ir@glpg.com

Corporate Communications
Marieke Vermeersch
+32 479 490 603

media@glpg.com

Visit us at www.glpg.com or follow us on LinkedIn or X.


1 Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market and regarding miscellaneous provisions, as amended from time to time.

Attachments

Valneva Announces Positive Final Phase 2 Results for Lyme Disease Vaccine Candidate

Valneva Announces Positive Final Phase 2 Results for Lyme Disease Vaccine Candidate




Valneva Announces Positive Final Phase 2 Results for Lyme Disease Vaccine Candidate

  • Antibody levels remained well above baseline across all six serotypes and age groups sixth month after third yearly booster dose
  • No safety concerns observed in any age group by an independent Data Monitoring Committee (DMC)
  • Results confirm benefits of a yearly vaccination prior to each Lyme season

Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from Phase 2 study, VLA15-221, of Lyme disease vaccine candidate, VLA15. The results showed strong anamnestic immune response and favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the anticipated benefits of a yearly vaccination prior to each Lyme season. Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by Pfizer.

There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest in clinical development, with all vaccinations completed in the pivotal VALOR Phase 3 trial1. The Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year2, and 132,000 cases are reported annually in Europe3. Subject to positive Phase 3 data, Pfizer aims to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These final Phase 2 data are consistent with those reported previously4,5 and confirm the potential benefits of booster doses across all evaluated age groups. Lyme disease continues to expand geographically and remains a pressing unmet medical need affecting communities across the Northern Hemisphere. Each set of positive results moves us closer to the possibility of making this vaccine available to adults, adolescents and children living in Lyme-endemic areas.”

As observed in previous VLA15 clinical studies, an additional dose immediately boosted the antibody levels which then undergo a gradual decline over time but remained well above baseline in all study groups, confirming their persistence at month 48, six months after vaccination at month 42. The study compared two dosing schedules and overall, antibody levels remained higher with the three-dose primary vaccination schedule compared to the two-dose schedule. Geometric mean fold rise (GMFRs) compared to baseline ranged from 9.5-fold for Serotype 1 (ST1) to 15.6-fold for Serotype 2 (ST2) across all age groups in the three-dose Month 0-2-6 primary vaccination schedule. The highest GMFRs were reported in the 5 to 11 years old age group, with GMFR levels ranging from 15.5-fold (ST1) to 28.5-fold (ST2).

These results further validate the use of the three-dose vaccination schedule and a yearly booster dose, already included in the Phase 3 protocols.

The safety and tolerability profile of VLA15 six months after the third booster dose was similar to the profile observed after previous booster doses. No safety concerns were observed by the independent DMC in any vaccination or age group.

About VLA15

There are currently no approved human vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.

About Clinical Study VLA15-221

VLA15-221 was a randomized, observer-blind, placebo-controlled Phase 2 study. It was the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old). 560 healthy participants received either VLA15 in two immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=181]) or placebo (month 0-2-6 [N=189]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in two previous Phase 2 studies. The main safety and immunogenicity readout (primary endpoint) was performed one month after completion of the primary series vaccination schedule. All eligible subjects received yearly booster doses of VLA15 or placebo at Months 18, 30 and 42. Antibody persistence was followed up to six months post third annual booster. VLA15 was tested as an alum-adjuvanted formulation and administered intramuscularly. The study was conducted at U.S. sites located in areas where Lyme disease is endemic and enrolled both volunteers with a prior infection with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve volunteers.

About Lyme Disease

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of infected Ixodes ticks6. It is considered the most common vector-borne illness in the Northern Hemisphere7,8. While the true incidence of Lyme disease is unknown, the Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 132,000 cases are reported annually in Europe. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint paints) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system9,10. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens11.

About Valneva SE

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced tetravalent Shigella vaccine candidate as well as vaccine candidates against other global public health threats.

Valneva Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, and financial guidance including projected product sales, total revenue and total R&D investments. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Valneva Media and Investor Relations Contacts

Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
 Joshua Drumm, Ph.D
VP Global Investor Relations
M +1 917 815 4520
joshua.drumm@valneva.com

References


1 Second-Quarter 2025 Earnings Conference Call Prepared Remarks August 5, 2025: https://s206.q4cdn.com/795948973/files/doc_financials/2025/q2/Q2-2025-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf

2 Lyme Disease Surveillance and Data | Lyme Disease | CDC
3 Lyme Borreliosis Incidence Across Europe, 2015-2023: A Surveillance-Based Review and Analysis – PubMed
4https://valneva.com/press-release/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster-results-for-lyme-disease-vaccine-candidate/
5https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-booster-results-for-lyme-disease-vaccine-candidate/
6 Stanek, et al. Lyme Borreliosis. 2012. The Lancet 379:461–4737 Burn L, et al. Incidence of Lyme Borreliosis in Europe from National Surveillance Systems (2005–2020). 2023. Vector Borne and Zoonotic Diseases. 23(4):156–171.
8Kugeler KJ, et al. Estimating the frequency of Lyme disease diagnoses—United States, 2010-2018. 2021. Emergency Infectious Disease. 27(2).
9 Centers for Disease Control and Prevention. Lyme disease. Signs and Symptoms. Available from: https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed September 2022.
10 Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature Reviews Disease Primers. 2016;2:16090.
11 Centers for Disease Control and Prevention. Understanding Lyme and Other Tickborne Diseases. May 2022. Available from: https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html. Accessed April 2024.

 

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Kuros Biosciences to present at the Piper Sandler 37th Annual Healthcare Conference

Kuros Biosciences to present at the Piper Sandler 37th Annual Healthcare Conference




Kuros Biosciences to present at the Piper Sandler 37th Annual Healthcare Conference

Kuros Biosciences to present at the Piper Sandler 37th Annual Healthcare Conference

Schlieren (Zürich), Switzerland, November 26, 2025 – Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, will present at the Piper Sandler 37th Annual Healthcare Conference, taking place December 2–4, 2025 at The Lotte New York Palace in New York City.

The Company’s presentation will highlight continued commercial momentum, clinical advancement across the MagnetOs portfolio, and ongoing expansion in new indications and the global market. Kuros will also provide insights into its path to sustainable profitability and operational leverage through the transformation of its business model, supported by recent investments in operational infrastructure designed to secure long-term growth.

A live webcast of the presentation will be available on the Piper Sandler conference website for 30 days following the event: https://statusproconf.com/Agenda/event/2091    

Presentation Details
     Event: Piper Sandler 37th Annual Healthcare Conference
     Presenter: Chris Fair, CEO, Kuros Biosciences
     Format: Company Presentation
     Date: Wednesday, December 3, 2025
     Location: The Lotte New York Palace, New York, NY

For more information about the conference, please visit Piper Sandler’s website at: https://www.pipersandler.com/

For further information, please contact:

Alexandre Müller Daniel Geiger
Investor Relations Chief Financial Officer
Tel +41 43 268 32 31 Tel +41 44 733 47 41
IR@kurosbio.com daniel.geiger@kurosbio.com

        

About MagnetOs
Growing bone with MagnetOsTM gives surgeons confidence where it matters most – delivering predictable fusion outcomes.1 In a Level I human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate of autograft (79% vs. 47%) in posterolateral fusions (PLFs).1 Among active smokers – who made up 1 in 5 patients – the fusion difference between MagnetOs and autograft was even more dramatic.*1,2 MagnetOs grows bone on its own thanks to NeedleGripTM – a proprietary submicron surface technology that harnesses the immune system to stimulate bone growth, without added cells or growth factors.§4-6 Ready-to-use, easy to mold, and reliably staying put, MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures.7-12

Indications Statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across five continents. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

* 19 of initial 100 patients were active smokers.
Radiographic fusion data of the smoker subgroup were not statistically analyzed as a subgroup and were not included in the peer-reviewed publication of the study.
Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com. 
§ MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft. 
MagnetOs must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix must be hydrated with BMA & mixed with autograft in posterolateral spine & intervertebral disc space. MagnetOs Granules must be hydrated with blood in the intervertebral disc space.

  1. Stempels, et al. Spine. 2024;49(19):1323-1331.
  2. Van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024.
  3. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.
  4. Van Dijk, et al. eCM. 2021;41:756-73.
  5. Van Dijk, et al. J Immunol Regen Med. 2023;19:100070.
  6. Duan, et al. eCM. 2019; 37:60-73.
  7. Instructions for Use (IFU) MagnetOs Granules.
  8. Instructions for Use (IFU) MagnetOs Putty.
  9. Instructions for Use (IFU) MagnetOs Easypack Putty.
  10. Instructions for Use (IFU) MagnetOs Flex Matrix.
  11. Instructions for Use (IFU) MagnetOs MIS.
  12. Data on file. MagnetOs Putty and MagnetOs Easypack Putty

Attachment

Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia




Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

–  Prescription Drug User Fee Act (PDUFA) goal date extended by three months to February 28, 2026

COPENHAGEN, Denmark, Nov. 25, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.

“We have responded to all outstanding requests from the FDA, including the request for a revised protocol for the post-marketing study, which we received as the lone item for discussion at our late-cycle meeting,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “We are committed to working diligently with the FDA to finalize elements of the post-marketing requirement, with the goal of bringing this innovative therapy to patients in the U.S. as soon as possible.”

About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the PDUFA target action date; (ii) Ascendis’ commitment to work with the FDA to finalize elements of the post-marketing requirement for TransCon CNP; (iii) Ascendis’ goal of bringing TransCon CNP to patients in the U.S. as soon as possible; (iv) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients; and (v) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; and the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © November 2025 Ascendis Pharma A/S.

Investor Contacts:   Media Contact:
Chad Fugere   Melinda Baker
Ascendis Pharma   Ascendis Pharma
ir@ascendispharma.com   media@ascendispharma.com
     
Patti Bank    
ICR Healthcare    
+1 (415) 513-1284    
patti.bank@icrhealthcare.com    

KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)

KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)




KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)

KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States

SAN DIEGO and TOKYO, Nov. 25, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced KOMZIFTI™ (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, has been included in the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 2A recommended treatment option for adults with relapsed/refractory AML with NPM1 mutation.

KOMZIFTI received full approval by the U.S. Food and Drug Administration on November 13, 2025, for the treatment of adults with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The approval was supported by data from the KOMET-001 clinical trial, including a 21.4% CR/CRh rate and median duration of CR/CRh response of 5 months.1,2 KOMZIFTI is now commercially available to prescribers in the U.S. and is available for purchase from a limited network of specialty pharmacies and distributors.

“The addition of KOMZIFTI to the NCCN Guidelines® in Oncology underscores the potential impact of KOMZIFTI for patients with R/R NPM1-mutated AML and supports our commitment to ensuring that patients have access to this important treatment option,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “NPM1-mutated disease carries a substantial risk of relapse and historically poor outcomes in the relapsed or refractory setting. We are pleased to have received inclusion in the NCCN guidelines so rapidly after FDA approval and are committed to making KOMZIFTI available to patients in the United States.”

About KOMZIFTI™
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

KOMZIFTI is in development for the front-line treatment of AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients earlier in their disease course.

IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION

Boxed WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome

KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.

In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A-rearranged AML.

In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.

Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.

QTc Interval Prolongation

KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R/R AML with an NPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.

Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).

Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%).

Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%).

DRUG INTERACTIONS

Drug interactions may occur when KOMZIFTI is concomitantly used with:

  • Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions.
  • Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.
  • Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time.
    • Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist.
    • Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid.
  • Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI.

Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose.

Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.

Please see full Prescribing Information, including Boxed WARNING.

About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™, the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

About Kyowa Kirin
Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.

Kura Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the potential impact of KOMZIFTI for patients with R/R NPM1-mutated AML and Kura’s ability to provide patients with access to KOMZIFTI. Factors that may cause actual results to differ materially include the risk that KOMZIFTI may have unintended side effects; risks associated with market competition, market acceptance and commercialization of KOMZIFTI; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contacts

Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

Kyowa Kirin Contacts

Investors:
Ryohei Kawai
ir@kyowakirin.com

Media, Global:
Nobuyuki Manita
media@kyowakirin.com

References:

1. KOMZIFTI (ziftomenib). Prescribing Information. San Diego, CA: Kura Oncology, Inc.; 2025.
2. Wang et al. J Clin Oncol 43, 3381-3390 (2025).

BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis

BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis




BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis

The Company continues working with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial

An independent Data Monitoring Committee (DMC) completed a safety review following adverse events identified in the BX004 Phase 2b trial and recommended that the study continue with revised dosing

Following the DMC review, the study protocol will be updated, and topline results are now expected in Q2 2026

NESS ZIONA, Israel, Nov. 25, 2025 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the Company’s Phase 2b trial of BX004 in patients with cystic fibrosis. The Company is working with the third-party manufacturer to address recent FDA follow up information requests in order to lift the FDA’s clinical hold with respect to the trial. In parallel, an independent DMC has completed a safety review of the BX004 Phase 2b clinical trial.

BiomX recently received additional follow-up questions from the FDA related to the third-party nebulizer device used for BX004 administration. The Company is working closely with the device manufacturer to assemble the remaining additional information requested by the Agency. BiomX considers the outstanding items readily addressable to resolve the outstanding questions raised by the FDA while maintaining a productive and ongoing dialogue with the Agency. The Company expects enrollment in the U.S. to resume once this process is complete.

Separately, an independent DMC has conducted a safety review of the BX004 Phase 2b clinical trial. The review included participants who experienced adverse events, and following its evaluation, the DMC recommended that the study continue with an adjusted dosing regimen. In accordance with the recommendations, BiomX is updating the trial protocol, and pending availability of financial resources and other factors, topline results are now expected in the second quarter of 2026.

“We are encouraged by the DMC’s conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented. We remain committed to advancing a potential treatment for the unmet need of Pseudomonas aeruginosa (P. aeruginosa) infections in patients with cystic fibrosis,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We are working closely with our device manufacturer to provide the FDA with the remaining clarifications and remain confident in the path forward for BX004. We look forward to reporting topline results in the second quarter of 2026.”

About BX004
BX004 is a fixed multi-phage cocktail designed to target P. aeruginosa, a major contributor to morbidity and mortality in people with cystic fibrosis. In February 2023, BiomX announced positive Part 1 Phase 1b/2a results demonstrating safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden versus placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%). Pending resolution of the FDA clinical hold on U.S. enrollment, and availability of funding resources, BiomX is expects to enroll up to approximately 60 patients in a randomized, double blind, placebo-controlled, multi-center Phase 2b trial evaluating lung function, bacterial load, and quality-of-life measures over an 8-week treatment period. BX004 has received Fast Track and Orphan Drug Designations from the U.S. FDA.

About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.

Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX refers to  the possibility that the data BiomX provides will allow the FDA to lift the clinical hold, sufficiency of financial resources,  resumption of patient enrollment and timing thereof, the expected timing for topline results and the potential impact of the adjustment to the dosing regimen on the BX004 Phase 2b trial, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA, and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.

Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com

BioAge Labs to Present at Piper Sandler 37th Annual Healthcare Conference

BioAge Labs to Present at Piper Sandler 37th Annual Healthcare Conference




BioAge Labs to Present at Piper Sandler 37th Annual Healthcare Conference

EMERYVILLE, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) — BioAge Labs, Inc. (NASDAQ: BIOA) (“BioAge”, “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company will present at the Piper Sandler 37th Annual Healthcare Conference taking place in New York, NY on December 2-4, 2025.

Kristen Fortney, PhD, CEO and co-founder, and Dov Goldstein, MD, CFO, are scheduled to participate in a fireside chat on Thursday, December 4 from 1:30 – 1:55 PM ET, and will participate in one-on-one meetings. To access the live webcast of the presentation, register here.

Replays of the webcast will be available in the investor section of the Company’s website at https://ir.bioagelabs.com/, and will be archived for 30 days following the presentations.

About BioAge Labs, Inc.

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company’s lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for obesity and cardiovascular risk factors. A Phase 1 SAD/MAD trial of BGE-102 is underway, with initial SAD data anticipated by end of year. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.

Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Dov Goldstein, ir@bioagelabs.com
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com

Bright Minds Biosciences to Present at Piper Sandler 37th Annual Healthcare Conference and 2025 AES Annual Meeting

Bright Minds Biosciences to Present at Piper Sandler 37th Annual Healthcare Conference and 2025 AES Annual Meeting




Bright Minds Biosciences to Present at Piper Sandler 37th Annual Healthcare Conference and 2025 AES Annual Meeting

NEW YORK, Nov. 25, 2025 (GLOBE NEWSWIRE) — Bright Minds Biosciences, Inc. (“Bright Minds,” “BMB” or the “Company”) (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, today announced that the Company will participate in the following upcoming events:

  EVENT: Piper Sandler 37th Annual Healthcare Conference
  DATE:  Wednesday, December 3, 2025
  TIME: 11:30am ET
     
  EVENT: 2025 American Epilepsy Society Annual Meeting – Scientific Exhibit Session
  DATE: Sunday, December 7, 2025
  TIME: 2pm – 5pm ET
     

About Bright Minds Biosciences

Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients’ lives.

Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry.

Contact Information

Investor Relations
Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com

Century Therapeutics to Participate in Piper Sandler 37th Annual Healthcare Conference

Century Therapeutics to Participate in Piper Sandler 37th Annual Healthcare Conference




Century Therapeutics to Participate in Piper Sandler 37th Annual Healthcare Conference

PHILADELPHIA, Nov. 25, 2025 (GLOBE NEWSWIRE) — Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced that the company will participate in the Piper Sandler 37th Annual Healthcare Conference in New York, NY, as follows:

  • Chad Cowan, Ph.D., Chief Scientific Officer of Century Therapeutics, will participate in the “State of the Art in Cell Therapy” panel discussion at 12:00 p.m. ET on Tuesday, December 2, 2025.
  • Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics, and Dr. Cowan will participate in a webcasted fireside chat at 10:00 a.m. ET on Wednesday, December 3, 2025.

A live webcast of the fireside chat will be available on the Investors page of Century’s website at www.centurytx.com. An archived replay of the webcast will be available for at least 30 days.

About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.

For More Information:

Century Therapeutics
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com

JPA Health
Sarah McCabe
smccabe@jpa.com

Este Surgery Announces Advanced DHI Hair Transplant Technology in Turkey’s Medical Tourism Sector

Este Surgery Announces Advanced DHI Hair Transplant Technology in Turkey’s Medical Tourism Sector




Este Surgery Announces Advanced DHI Hair Transplant Technology in Turkey’s Medical Tourism Sector

Turkey Raises the Bar in Medical Tourism with Advanced DHI Hair Transplant Technology

Istanbul, Nov. 25, 2025 (GLOBE NEWSWIRE) — Turkey’s growing share of the global medical tourism market has led to significant advancements in surgical techniques. According to Este Surgery, a leading hair transplant clinic in Turkey, DHI protocols are being used to improve patient comfort and procedural success, leading to enhanced service quality and increased international demand in the sector.

Este Surgery Announces Advanced DHI Hair Transplant Technology in Turkey's Medical Tourism Sector

Dr. Alp Aslan, the founder of Este Surgery and a specialist in plastic, reconstructive, and aesthetic surgery

Industry data shows a steady upward trend in Turkey’s medical tourism revenues over the past five years, fueled by an increasing number of high-value surgical procedures. Rising global demand for non-invasive techniques has significantly increased the popularity of the DHI method, which is known for offering faster recovery times than traditional approaches.

Integration of Sapphire DHI in DHI Hair Transplant Processes

Recent clinical developments demonstrate the use of implantation pens (also known as Choi pens) paired with sapphire blades during the canal-opening phase. This method, referred to in medical literature as Sapphire DHI (S-DHI), aims to improve the efficacy of the standard DHI procedure.

Medical Infrastructure Requirements for the “Best Hair Transplant in Turkey”

Industry experts emphasize that international patients seeking the best hair transplant in Turkey should have their procedures performed in sterile hospital environments by expert surgeons. Surgical success depends not only on technical equipment, but also on the medical setting in which operations are conducted.

While Turkey has many providers, Este Surgery stands out with its “physician-led” operational model. Unlike commercial clinics that rely heavily on technicians, the center prioritizes direct surgeon involvement. Este Surgery leverages over 20 years of plastic and reconstructive surgery experience to minimize complications and maximize aesthetic results.

Dr. Alp Aslan, the founder of Este Surgery and a specialist in plastic, reconstructive, and aesthetic surgery, shared his evaluation of the clinic’s practices and the impact of the DHI method.

“At Este Surgery, we conduct all our processes within a fully equipped hospital infrastructure that complies with international accreditation standards. However, technology is only as good as the hands that use it. In a market saturated with high-volume operations, our competitive edge lies in our refusal to compromise medical ethics for speed. We treat hair restoration as a form of microsurgical art that requires a plastic surgeon’s perspective, not just a procedure.”

DHI technology helps us minimize the amount of time that grafts spend outside the body, thereby preserving follicle viability. Specifically, using smooth-surfaced sapphire blades instead of metal slits in our protocols reduces tissue trauma and bleeding risks. Our combination of advanced technology and decades of surgical experience ensures results that align naturally with our patients’ anatomy, setting a higher standard for safety and aesthetics.

Dr. Aslan is a proud representative of Turkey’s medical expertise on the global stage as a member of the International Society of Hair Restoration Surgery (ISHRS) and the European Society of Hair Restoration Surgery (ESHRS).

Bridging Distances: Free Online Consultation and Assessment

Este Surgery recognizes the logistical challenges faced by international patients and offers a comprehensive, complimentary online consultation service. Prospective patients can submit photographs through the clinic’s secure digital platform for a preliminary medical evaluation, eliminating the need to travel. This pre-surgical assessment allows the medical team to design a personalized treatment plan, determine the patient’s suitability for the S-DHI technique, and provide transparent graft estimation. This enables patients to make informed decisions before arriving in Istanbul.

 

About Este Surgery

Founded by Dr. Alp Aslan, a member of the ISHRS and ESHRS, Este Surgery is an international medical center based in Istanbul that specializes in plastic surgery and advanced hair transplant techniques. The clinic provides high-standard medical services to thousands of patients every year by combining innovative techniques such as S-DHI and Sapphire DHI with personalized treatment protocols.

Este Surgery Announces Advanced DHI Hair Transplant Technology in Turkey's Medical Tourism Sector

Dr. Alp Aslan, the founder of Este Surgery and a specialist in plastic, reconstructive, and aesthetic surgery

Press inquiries

Este Surgery
https://www.estesurgery.com
Este Surgery Press Office
burakcelep@gmedya.com
+90530 975 5310
Turkey, Fulya Mahallesi, Büyükdere Cd. Torun Center A Blok 212 numara. No:74, A Blok 212, 34394 Şişli/İstanbul