On January 9, 2026 AnaptysBio presented its corporate presentation.

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(Presentation, AnaptysBio, JAN 9, 2026, View Source [SID1234661887])

On January 9, 2026 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 44th Annual J.P. Morgan Healthcare Conference, January 12-14, 2026, in San Francisco.

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Valneva’s CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming catalysts from its clinical development pipeline, including the pivotal data readout for its Lyme disease vaccine in the first half of this year, as well as the Company’s commercial portfolio of vaccines.
To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can contact Valneva’s investor relations department at [email protected].

(Press release, Valneva, JAN 9, 2026, View Source [SID1234661904])

On January 9, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported a business and strategic roadmap update, including planned 2026 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update on Monday, January 12, during the 44th Annual J.P. Morgan Healthcare Conference.

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"With our proven TransCon technology platform, strong R&D capabilities, and a maturing commercial infrastructure and financial profile, Ascendis is rapidly transforming into a leading global biopharma company," said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. "Over the next year, this inflection will be driven by further global penetration and commercial expansion, a third potential TransCon product approval with blockbuster potential, and an advancing R&D pipeline of highly differentiated internal and external TransCon product candidates, all of which create the foundation for sustainable long-term growth."

Selected Key Updates and Milestones

TransCon PTH
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH fourth-quarter 2025 and full-year 2025 unaudited preliminary revenue expected to be ~€187 million and ~€477 million, respectively.
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.
Confirmed product profile for once-weekly TransCon PTH targeting patients receiving stable YORVIPATH doses.
Ongoing label expansion trials through PaTHway60 (adults) and PaTHway Adolescent.
TransCon hGH
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA fourth-quarter 2025 and full year 2025 unaudited preliminary revenue expected to be ~€53 million and ~€206 million, respectively.
Received first label expansion in July 2025 with U.S. Food & Drug Administration (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).
TransCon CNP
(navepegritide)
In the U.S., PDUFA 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.

TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)

On January 8, 2026, announced Week 52 topline results from Phase 2 COACH Trial, which demonstrated improvements in annualized growth velocity (AGV) 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 arm span, and a safety profile consistent with those observed for monotherapies of TransCon CNP and TransCon hGH.
In Q4 2025, Ascendis submitted a protocol and held an end of Phase 2 meeting with the FDA regarding a Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia.
Week 78 COACH data update anticipated in second quarter of 2026.
Planned new trials to support TransCon CNP + TransCon hGH treatment in additional indications, such as hypochondroplasia.

TransCon IL-2 β/γ
(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

Novo Nordisk A/S
Ongoing multi-product collaboration with Novo Nordisk for TransCon technology-based therapies in obesity and metabolic diseases.
Lead program TransCon semaglutide remains on track to enter the clinic as anticipated.
Eyconis, Inc.
Ascendis has granted Eyconis exclusive rights to develop and commercialize TransCon ophthalmology products globally and holds a 41% equity position in the company.
Lead program TransCon aVEGF (EYC-0305) in development for wet AMD and other retinal diseases anticipated to enter the clinic in 2026.
VISEN Pharmaceuticals
Ascendis has granted VISEN Pharmaceuticals exclusive rights to develop and commercialize TransCon hGH, TransCon PTH, and TransCon CNP in Greater China and maintains a 39% ownership interest in the public company.
Biologic License Application (BLA) for TransCon hGH (lonapegsomatropin) as a potential treatment for pediatric growth hormone deficiency (PGHD) was accepted by China’s National Medical Products Administration (NMPA) in March 2024, with an approval decision anticipated in the first quarter of 2026.
Teijin Limited
Ascendis has granted Teijin Limited an exclusive license agreement for the further development and commercialization of TransCon hGH, TransCon PTH, and TransCon CNP for rare endocrinology diseases in Japan.
In August 2025, YORVIPATH received MAA approval from Japan’s Ministry of Health, Labour, and Welfare.

Financial Update

Unaudited preliminary estimate of 2025 financial results:
Total full-year 2025 product revenue of ~€683 million:
YORVIPATH full-year 2025 revenue of ~€477 million
SKYTROFA full-year 2025 revenue of ~€206 million
Total full-year 2025 revenue of ~€720 million
Full-year 2025 gross margin expected to be ~87%
Total full-year 2025 operating expenses of ~€762 million
December 31, 2025 unaudited preliminary cash balance of ~€616 million
Expect operating cash flow of ~€500 million in 2026, based on current plans, exchange rates and excluding any contribution from TransCon CNP
Planned $120 million share repurchase program in 2026

Share Repurchase Program
The Board of Directors of Ascendis has authorized a $120 million Share Repurchase Program. Purchases under the Share Repurchase Program may be made from time to time through a variety of methods, which may include open-market purchases, privately negotiated transactions, or other methods permitted under applicable securities laws. The timing and amount of any repurchases pursuant to the Share Repurchase Program will be determined based on market conditions, share price and other factors. The Share Repurchase Program does not require Ascendis to repurchase any specific number of shares, and may be modified, suspended or terminated at any time without notice.

Presentation at J.P. Morgan Healthcare Conference on Monday, January 12
A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at View Source The presentation will begin at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time. A webcast replay will be available for 30 days.

The Company’s slides from the J.P. Morgan presentation will be available on the same Investors & News website at View Source

(Press release, Ascendis Pharma, JAN 9, 2026, View Source [SID1234661888])

On January 9, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company has entered into a $60 million equity line of credit (ELOC) agreement with Yorkville Advisors Global, LP, strengthening the Company’s financial flexibility as it continues to advance its clinical and preclinical pipeline of multispecific anti-cancer agents that are differentiated by design.

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The facility provides Aptevo with access to capital, allowing the Company to raise funds incrementally, at its discretion, and under market-based conditions. Further, an ELOC offers affordable capital financing with minimal fees and no warrants. Proceeds from the ELOC will be used to support ongoing clinical development, advance preclinical programs, and fund general corporate purposes.

"This agreement offers added flexibility and control over how and when we access capital," said Daphne Taylor, Chief Financial Officer at Aptevo. "Importantly, the fully leveraged facility plus cash on hand is sufficient to fund us for three years, into 2029. During this time, we plan to continue generating clinical data and advancing differentiated assets across the portfolio focusing on execution and value creation."

The ELOC complements Aptevo’s existing capital resources and is designed to support the Company’s disciplined approach to balance sheet management, while preserving optionality around future strategic and growth decisions.

Under the terms of the agreement, Aptevo has the right, but not the obligation, to sell shares to the counterparty from time to time, subject to customary conditions and limitations. The Company is not required to draw on the facility and retains full discretion over its use.

Aptevo’s portfolio includes five CD3-engaging assets anchored by mipletamig, a first-in-class CD123 x CD3 bispecific currently being evaluated in RAINIER, a Phase 1b/2 trial for frontline AML. In total, mipletamig has been evaluated in more than 100 patients across three trials, where mipletamig has consistently demonstrated high remission rates and a favorable safety and tolerability profile, with no observed events of cytokine release syndrome in frontline patients treated to date.

Building on this clinical validation, Aptevo has built a portfolio of tumor-directed CD3 programs, including bispecific candidates APVO442 (PSMA × CD3) for prostate cancer and APVO455 (Nectin-4 × CD3) for solid tumors, as well as trispecific candidates APVO451 and APVO452. All incorporate the Company’s proprietary application and unique use of the CRIS-7-derived CD3 binding domain, designed to enable tumor-focused immune activation with the potential for meaningful antitumor activity while also prioritizing safety and tolerability.

(Press release, Aptevo Therapeutics, JAN 9, 2026, View Source [SID1234661905])

On January 9, 2026 Biolexis Therapeutics, a clinical-stage biotechnology company pioneering an all-oral infrastructure for metabolic disease, reported it will present at the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026 at 9:00am PST.

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The presentation will spotlight Biolexis’ differentiated strategy to overcome the maintenance, side effect, scalability, and access crises with existing market therapies for weight loss. To solve these issues, Biolexis has two clinical-stage programs:

• BLX-7006 — A first-in-human oral small-molecule allosteric GLP-1 receptor agonist based on a new chemical scaffold that is not an orforglipron or danuglipron analog like other existing market solutions. Phase 1 data demonstrates a clean safety profile and predictable once-daily pharmacokinetics, and the asset is now advancing to Phase 2

• BLX-0871 — A first-in-class γ3 isoform-selective AMPK activator designed to preserve lean muscle mass and metabolic durability, entering Phase 1 in January 2026

BLX-7006: Redefining GLP-1 Access

BLX-7006 binds a distinct allosteric pocket on the GLP-1 receptor, enabling cooperative activation while reducing receptor desensitization—a key limitation of peptide-based therapies. As a small molecule, BLX-7006 offers transformative advantages: oral administration without fasting requirements, no cold-chain logistics, and a fundamentally lower cost-of-goods structure enabling global-scale deployment.

BLX-0871: Solving the Muscle Loss Problem

Current GLP-1 therapies produce significant weight loss, but up to 40% of lost mass is lean muscle, driving metabolic adaptation and weight regain. BLX-0871 selectively activates γ3-containing AMPK complexes enriched in skeletal muscle, engaging exercise-associated metabolic pathways while sparing cardiac isoforms. The result: preserved lean mass, enhanced glucose uptake, and sustained metabolic rate.

The All-Oral Combination Advantage

Biolexis is developing the only all-oral dual-mechanism combination currently in clinical development. By pairing GLP-1-mediated appetite suppression with muscle-selective AMPK activation, the company aims to deliver what injectable monotherapies cannot: durable weight loss with preserved muscle mass and metabolic function.

"The GLP-1 revolution has proven we can treat obesity—but injectable peptides alone won’t get us to a billion patients," said David J. Bearss, PhD, Co-founder and Chairman of Biolexis Therapeutics. "Our all-oral platform isn’t an incremental improvement—it’s infrastructure for global scale. And by adding muscle-selective AMPK activation, we’re not just helping patients lose weight, we’re helping them keep it off. That’s the durability breakthrough the field has been waiting for."

Conference Availability

Biolexis management will be available throughout the conference for meetings with pharmaceutical companies, institutional investors, and strategic partners to discuss Phase 2 clinical plans, combination development strategy, and partnership opportunities.

(Press release, Biolexis Therapeutics, JAN 9, 2026, View Source [SID1234661889])