On January 6, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, and NorthStar Medical Radioisotopes (NorthStar), a leading radiopharmaceutical company, reported an expanded agreement under which Convergent will support its drug development and clinical batch production with dedicated manufacturing suites on NorthStar’s Beloit, Wisconsin campus.

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Co-locating Convergent’s manufacturing at NorthStar establishes an integrated and reliable supply chain for CONV01-α drug product production with Ac-225, relieving supply constraints for alpha-based radiotherapies and supporting Convergent’s ongoing clinical trials through to commercial production.

"The relationship with NorthStar enables us to fully realize the potential of our leading radioantibody program as we demonstrate the advantages of alpha emitters in addressing metastatic castration-resistant prostate cancer (mCRPC) and the significant need for new, safer, and more effective therapies for patients. With secured Ac-225 supply, clinical proof-of-concept, and potential best-in-class efficacy and tolerability, CONV01-α is well-positioned to advance mCRPC treatment," said Convergent CEO and Co-Founder Philip Kantoff, M.D. "Our strategic investment in manufacturing will support late-stage monotherapy studies of CONV01-α, and additional trials to assess CONV01-α in earlier stages of prostate cancer and in combination with other therapeutics."

CONV01-α, Convergent’s lead program for mCRPC and other radiopharmaceuticals in its pipeline, leverage the power and precision of alpha-emitting isotopes. NorthStar recently announced it now produces alpha radioisotopes for therapeutic applications at scale, with Convergent as a key customer for Ac-225. Reliable Ac-225 supply further supports Convergent’s ability to deliver the next generation of alpha-based radiotherapies, building on the precision and tolerability advantages demonstrated in clinical trials to date with CONV01-α.

"We are pleased to expand our partnership with Convergent," said Frank Scholz, President and CEO of NorthStar Medical Radioisotopes, LLC. "This agreement underscores the value of our integrated campus designed to reduce complexity and create a robust, reliable supply chain to deliver patient-ready drugs."

In August 2024, NorthStar and Convergent announced a strategic contract manufacturing services agreement to provide Convergent with Ac-225 for use in CONV01-α and to utilize NorthStar’s new state-of-the-art contract development and manufacturing facility to manufacture CONV01-α for Convergent’s clinical trials and perform research and development activities.

"Having drug product and Ac-225 supply co-located on the NorthStar campus provides a unique advantage for our supply chain, enabling greater efficiencies, flexibility, and cost savings, as we leverage NorthStar’s extensive track record in radiopharmaceutical manufacturing," said Caitlyn Harvey, Head of Manufacturing at Convergent. "Their leadership in producing alpha emitters for radiotherapies ensures critical production capabilities and access to Ac-225 are in place for pivotal studies through commercial launch and beyond."

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of metastatic castration-resistant prostate cancer (mCRPC), uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver Actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, JAN 6, 2026, https://convergentrx.com/convergent-therapeutics-and-northstar-medical-radioisotopes-announce-expanded-partnership-to-support-convergents-late-stage-alpha-emitting-radioantibody-program/ [SID1234661750])

On January 6, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) ("Crinetics"), a pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported the pricing of an underwritten public offering of 7,620,000 shares of its common stock at a price to the public of $45.95 per share. All of the shares to be sold in the offering are to be sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $350 million. In addition, Crinetics has granted the underwriters a 30-day option to purchase up to an additional 1,143,000 shares of common stock. The offering is expected to close on or about January 8, 2026, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the offering, together with its cash, cash equivalents and investment securities, to fund its commercial activities in connection with the launch of PALSONIFY, research and development of its product candidates, other research programs and other general corporate purposes, which may include, among other things, capital expenditures or working capital. Crinetics may also use a portion of the remaining net proceeds, together with its existing cash, cash equivalents and investment securities, to in-license, acquire, or invest in complementary businesses, technologies, products or assets; however, it has no current commitments or obligations to do so.

Leerink Partners, J.P. Morgan, Evercore ISI, Piper Sandler and Cantor are acting as joint bookrunning managers for the offering. Baird is acting as lead manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to this offering has been filed with the SEC, and a final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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

(Press release, Crinetics Pharmaceuticals, JAN 6, 2026, View Source [SID1234661766])

On January 5, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that Nate Fernhoff, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

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The company presentation will take place on Monday, January 12, 2026, at 7:30AM PST at the Westin St. Francis in the Mission Bay Room on the 32nd floor.

(Press release, Orca Bio, JAN 5, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-at-the-44th-annual-j-p-morgan-healthcare-conference [SID1234661719])

On January 5, 2026 Incyte (Nasdaq:INCY) reported positive topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi/Minjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of three to five (3-5) for patients >60 years of age, or age-adjusted IPI (aaIPI) of two to three (2-3) for patients ≤60 years of age.

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The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p-value 0.019), according to Lugano 2014 criteria. The trial also met its key secondary endpoint of event-free survival (EFS) by investigator assessment. No new safety signals were observed.

"The frontMIND study results highlight the potential benefit of combining tafasitamab and lenalidomide with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed DLBCL patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Despite improvement in treatment for patients with DLBCL, outcomes for many high-risk patients are not optimal. We look forward to working with regulatory authorities globally and to providing a new treatment option for patients in the future."

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4,5,6 With about 40% of these patients not responding to initial therapy or relapsing thereafter7,8, there is a high medical need for new, effective therapies.

Based on these positive results, Incyte expects to file a supplemental Biologics License Application (sBLA) for tafasitamab for the first-line treatment of adults with newly diagnosed DLBCL in the first half of 2026. The frontMIND data will be submitted for presentation at an upcoming scientific meeting.

Tafasitamab was approved in combination with lenalidomide by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 and 2021 respectively, for adult patients with relapsed or refractory DLBCL not otherwise specified including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. Additionally, tafasitamab was approved in combination with lenalidomide and rituximab by the FDA in June 2025 for adult patients with relapsed or refractory follicular lymphoma (FL). In November 2025, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the approval of tafasitamab for patients with relapsed or refractory FL.

About frontMIND

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

The study has enrolled approximately 900 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) compared with R-CHOP alone.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).

For more information about the frontMIND trial, please visit View Source

About Tafasitamab (Monjuvi/Minjuvi)

Tafasitamab (Monjuvi/Minjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

(Press release, Incyte, JAN 5, 2026, View Source [SID1234661735])

On January 05, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported regulatory clearances of Investigational New Drug (IND) applications for CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an integrin beta-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.

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The U.S. Food and Drug Administration (FDA) has cleared Crescent’s IND for CR-001, and Crescent’s partner Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") has received IND approval for CR-003 (also known as SKB105) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

"With regulatory clearances for CR-001 and CR-003, we are excited to begin 2026 with strong momentum as we work to deliver next generation therapies for people living with cancer," said Ellie Im, M.D., chief medical officer of Crescent. "We are on track to have four clinical trials initiate across our portfolio in 2026, starting with the ASCEND trial of CR-001 planned for this quarter. Based on its intentional design replicating a clinically validated approach and robust preclinical profile demonstrating cooperative pharmacology and anti-tumor activity, we believe CR-001 has the potential to be a best-in-class therapy and immuno-oncology backbone."

The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naïve and previously treated patients with multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity in first-line and previously treated patients.

In December 2025, Crescent announced a strategic collaboration with Kelun-Biotech for CR-001 and CR-003 (SKB105). Under the terms of the strategic collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China.

About CR-001 (also known as SKB118)

CR-001 (SKB118) is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. ASCEND, a global Phase 1/2 trial of CR-001 in patients with solid tumors, is anticipated to commence in the first quarter of 2026. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with Crescent’s antibody-drug conjugates (ADCs) in development. The first Phase 1/2 ADC combination trial with CR-001 is expected to initiate in the second half of 2026.

About CR-003 (also known as SKB105)

CR-003 (SKB105) is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. CR-003 (SKB105) incorporates proprietary Kthiol irreversible conjugation technology, linking anti-ITGB6 fully human IgG1 monoclonal antibody to a clinically validated cleavable linker. The design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, CR-003 (SKB105) demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.

(Press release, Crescent Biopharma, JAN 5, 2026, View Source [SID1234663675])