On November 18, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported it will be presenting at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6-9 in Orlando, Florida. The Company’s presentations will share new data exploring the clinical and biologic effects of BESREMI ropeginterferon alfa-2b-njft in polycythemia vera (PV).

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"The new data presented at ASH (Free ASH Whitepaper) build on the growing body of evidence showing deep and durable responses with ropeginterferon alfa-2b in PV, including molecular and transcriptomic findings that offer insight into potential mechanisms of disease modification," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. "These results expand the evidence supporting the potential of ropeginterferon alfa-2b-njft to transform outcomes for patients with PV."

Presentation Details

Long-term efficacy and safety of ropeginterferon alfa-2b under its HIDAT regimen for the treatment of polycythemia vera

Abstract: abs25-10438 (2039)
Session Type: Poster
Presenter: Shanshan Suo
Room: OCCC – West Halls B3-B4
Date: Saturday, December 6, 5:30 PM – 7:30 PM EST
Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Transcriptomic signatures associated with deep molecular response to ropeginterferon alfa-2b in polycythemia vera

Abstract: abs25-10525 (2040)
Session Type: Poster
Presenter: Seug Yun Yoon
Room: OCCC – West Halls B3-B4
Date: Saturday, December 6, 5:30 PM – 7:30 PM EST
Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Rapid JAK2 V617F decline predicts response durability: kinetics of JAK2 V617F in ropeginterferon alfa-2b treated polycythemia vera

Abstract: abs25-13127 (3819)
Session Type: Poster
Presenter: Sung-Eun Lee
Room: OCCC – West Halls B3-B4
Date: Sunday, December 7, 6:00 PM – 8:00 PM EST
Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Clinical significance of earlier CHR achievement and long-term CHR maintenance in polycythemia vera patients treated with ropeginterferon alfa-2b

Abstract: abs25-13190 (5598)
Session Type: Poster
Presenter: Sung-Eun Lee
Room: OCCC – West Halls B3-B4
Date: Monday, December 8, 6:00 PM – 8:00 PM EST
Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
About Polycythemia Vera
Polycythemia vera, or PV, is a rare and chronic blood cancer. It’s part of a group of blood cancers called myeloproliferative neoplasms, or MPNs. PV starts in the bone marrow. Normally the body keeps all types of blood cells in a healthy balance, but with PV, the body produces too many red blood cells and may create excess white blood cells and platelets.

About BESREMi (ropeginterferon alfa-2b-njft)
BESREMi is the only FDA-approved treatment indicated for adults with polycythemia vera (PV) that targets the source of the disease. BESREMi is not chemotherapy, it’s an innovative immunotherapy. Ropeginterferon alfa-2b-njft is a preferred first-line cytoreductive therapy option for both low-risk (symptomatic) and high-risk PV in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). National Comprehensive Cancer Network (NCCN)–preferred interventions are based on efficacy, safety, and evidence, and when appropriate, affordability.

BESREMi holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia and is manufactured at the company’s facility in Taichung. PharmaEssentia retains full global intellectual property rights across all indications.

Indication
BESREMi is indicated for the treatment of adults with polycythemia vera.

Important Safety Information

Boxed WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

Contraindications
Existence of or history of severe depression, suicidal ideation, or suicide attempt
Hypersensitivity to interferons or any inactive ingredients
Moderate or severe hepatic impairment
History or presence of active serious or untreated autoimmune disease
History of transplantation and receiving immunosuppressant agents

Warnings and Precautions

Depression and Suicide: Closely monitor patients for any symptoms of psychiatric disorders and, if needed, consider psychiatric consultation and treatment or dosage modifications as listed in the full prescribing information.
Endocrine Toxicity: Do not use BESREMi in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi therapy. Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi.
Cardiovascular Toxicity: Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi therapy. Avoid use of BESREMi in patients with severe or unstable cardiovascular disease or recent stroke or myocardial infarction.
Decreased Peripheral Blood Counts: Monitor complete blood counts at baseline, during titration, and every 3-6 months during the maintenance phase.
Pancreatitis/Colitis/Pulmonary Toxicity: Interrupt BESREMi treatment in patients with possible pancreatitis, colitis, or pulmonary toxicity and evaluate promptly. Consider discontinuation of BESREMi in patients with confirmed pancreatitis or who show signs or symptoms of serious ulcerative or hemorrhagic colitis, or who develop pulmonary infiltrates or pulmonary function impairment.
Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Discontinue BESREMi in patients who develop new or worsening eye disorders.
Hyperlipidemia/Hepatotoxicity/Renal Toxicity: Monitor serum triglycerides, liver enzymes, hepatic function, and serum creatinine at baseline and during therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min. Discontinue BESREMi in patients with persistently marked elevated triglycerides, evidence of hepatic decompensation, or if renal impairment develops during treatment.
Dental and Periodontal Toxicity: Patients should have good oral hygiene and regular dental examinations.
Dermatologic Toxicity: Consider discontinuation of BESREMi if clinically significant dermatologic toxicity occurs.
Driving and Operating Machinery: BESREMi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi affects their abilities. Patients who experience dizziness, somnolence, or hallucination during BESREMi therapy should avoid driving or using machinery.
Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi can cause fetal harm when administered to a pregnant woman. Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi and for at least 8 weeks after the final dose. Advise women not to breastfeed during treatment and for 8 weeks after the final dose.
Adverse Reactions
The most common adverse reactions reported in >40% of patients were influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.

Drug Interactions
Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification. Avoid use with myelosuppressive agents, narcotics, hypnotics, or sedatives, and monitor patients receiving the combination for effects of excessive CNS toxicity.

(Press release, PharmaEssentia, NOV 18, 2025, View Source [SID1234660071])

On November 18, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be attending the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at the Lotte New York Palace in New York, NY.

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(Press release, Personalis, NOV 18, 2025, View Source [SID1234660070])

On November 18, 2025 Kangpu Biopharmaceuticals reported that the company will deliver a poster presentation to highlight the Phase I clinical trial results of epaldeudomide (KPG-818) for the treatment of hematological malignancies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida, USA.

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Poster Title: KPG-818, a Novel Cereblon (CRBN) Modulator, in Patients with Hematological Malignancies: Results of a Phase I, Open-Label, Multiple Ascending Dose Study

Poster Number: 5809

Poster Category: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III

Presenter: Dr. Aaron Rosenberg, MD, UC Davis Comprehensive Cancer Center, California, United States

Presentation Time: 6:00-8:00 PM, December 8 (Local Time)

Location: OCCC – West Halls B3-B4

The study is a multicenter, open-label, multiple ascending dose Phase I clinical trial (NCT04283097) completed in the United States to evaluate the safety, tolerability, pharmacokinetics, along with preliminary efficacy of epaldeudomide in combination with dexamethasone in adults with relapsed/refractory multiple myeloma, or as monotherapy in other selected hematologic malignancies, and to determine the recommended Phase II dose. Epaldeudomide demonstrated favorable pharmacokinetic characteristics, good safety and tolerability, and promising efficacy. The overall response rate in the heavily pre-treated multiple myeloma patients was 50% with a disease control rate (including stable disease) of 94%. No febrile neutropenia of any grade was observed, and no peripheral neuropathy events of any grade was reported.

Epaldeudomide is a novel molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It showed high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. Epaldeudomide possesses remarkable broad-spectrum immunomodulatory effects, anti-angiogenic, and anti-tumor effects.

For more information about the 67th ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source

(Press release, Kangpu Biopharmaceuticals, NOV 18, 2025, View Source [SID1234660069])

On November 18, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported that the ProSense system and cryoprobes for the treatment of malignant or benign tissue of the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions, has been officially registered and approved for distribution by Swissmedic, the Swiss Agency for Therapeutic Products. These indications are the same as those for which ProSense is approved in the European Union.

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"We believe approval in Switzerland adds to the strong regulatory and commercial momentum we’ve generated leading up to and following the FDA’s recent marketing authorization for ProSense in low-risk breast cancer," said Eyal Shamir, IceCure’s Chief Executive Officer. "Gaining access to another important European market enhances our ability to scale adoption and brings us closer to making ProSense a standard-of-care option to surgery for patients globally."

Switzerland is a leader in healthcare innovation and medical technology, providing high-quality healthcare to its citizens in a market-driven compulsory system. According to the KOF Swiss Economic Institute, the total healthcare market in Switzerland is projected to reach $120 billion in 2023, as the country spends 12% of its GDP on healthcare, one of highest in OECD countries.

About ProSense

The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website.

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.

(Press release, IceCure Medical, NOV 18, 2025, View Source [SID1234660068])

On November 18, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of an underwritten public offering of shares of Class A common stock at a price to the public of $101.00 per share. Nuvalent is selling 4,950,496 shares in the offering. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $500.0 million. The offering is expected to close on November 20, 2025, subject to the satisfaction of customary closing conditions.

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In addition, Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (together, the "Selling Stockholders") have granted the underwriters a 30-day option to purchase from the Selling Stockholders up to an additional 742,574 shares of Class A common stock at the public offering price less underwriting discounts and commissions. Nuvalent will not receive any proceeds from the sale of any shares by the Selling Stockholders.

J.P. Morgan, Jefferies, TD Cowen and Cantor are acting as joint book-running managers for the offering.

The shares are being offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus can be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nuvalent, NOV 18, 2025, View Source [SID1234660067])