On June 27, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Press release, Schrodinger, JUN 27, 2025, View Source [SID1234654163]).

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

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

                  Schedule Your 30 min Free Demo!

"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."

"We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients," said Margaret Dugan, chief medical officer at Schrödinger. "We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year."

The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenström macroglobulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data.

About SGR-1505
SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders.

SGR-1505 was designed using Schrödinger’s computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019).

On June 26, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and Nusano, a physics company transforming the production of radioisotopes, reported the signing of a multi-year supply agreement in which Nusano will provide Cellectar with iodine-125 (I-125) and actinium-225 (Ac-225) for its clinical studies and future commercial needs (Press release, Nusano, JUN 26, 2025, View Source [SID1234654137]).

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

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

                  Schedule Your 30 min Free Demo!

"Securing a reliable supply of both iodine-125 and actinium-225 is a critical milestone in advancing our targeted radiotherapy programs," said James Caruso, chief executive officer of Cellectar. "This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer. We look forward to partnering with Nusano to support our mutual vision to deliver new radiotherapeutics to patients in critical need of novel treatment options. I-125 and Ac-225 will be produced at Nusano’s next-generation radioisotope production facility in Utah. This production platform enables the creation of rare and hard-to-produce medical radioisotopes in quantities needed for commercial-stage therapeutics and diagnostics."

"The power and flexibility of the Nusano production platform is designed to solve the critical supply chain challenges and enable innovation across multiple industries," said Chris Lowe, chief executive officer of Nusano. "We’re proud to support Cellectar with critical isotope supplies so they can advance their product pipeline and create new, personalized cancer treatments."

On June 26, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer (Press release, Phio Pharmaceuticals, JUN 26, 2025, View Source [SID1234654138]). Phio reported that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

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

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

                  Schedule Your 30 min Free Demo!

Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported.

Pathology results related to the efficacy of PH-762 in the fourth cohort will be forthcoming.

"We are encouraged by the continuing safety profile of PH-762 having now progressed through four escalating dose concentrations, and we anticipate that IT administration of the highest dose concentration of PH-762 in cohort 5 will result in a similar safety profile," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma.

Pathological response at Day 36 (planned tumor excision) in the previous three cohorts demonstrated complete response (100% tumor clearance) in 4 of 9 patients with cSCC. One cSCC patient had a near complete response (>90% clearance) and one cSCC patient had a partial response (>50% clearance). The other three patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients exhibited clinical progression of disease. Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection.

Phio expects to complete enrollment in the expected final cohort in this trial in the third quarter of 2025.

"The continuing favorable safety profile of PH-762 through the fourth cohort provides promise of a well-tolerated treatment for skin cancer," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

On June 26, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported the closing of its underwritten public offering of 9,147,727 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,193,181 shares, at a price to the public of $44.00 per share (Press release, Cidara Therapeutics, JUN 26, 2025, View Source [SID1234654141]). The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, were $402.5 million. All of the shares in the offering were sold by Cidara.

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

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

                  Schedule Your 30 min Free Demo!

J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor acted as joint book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

On June 26, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that it intends to offer and sell $85.0 million of shares of its common stock in an underwritten public offering (Press release, CorMedix, JUN 26, 2025, View Source [SID1234654157]). All of the shares to be sold in the offering will be offered by CorMedix. In addition, CorMedix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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

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

                  Schedule Your 30 min Free Demo!

RBC Capital Markets is acting as sole bookrunner for the offering.

CorMedix intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions, joint ventures or collaborations, involving companies, products or assets that complement CorMedix’s business.

The securities described above are being offered by CorMedix pursuant to a shelf registration statement on Form S-3 which was initially filed by CorMedix with the Securities and Exchange Commission (the "SEC") May 6, 2024, and was declared effective by the SEC on May 22, 2024.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering, as well as copies of the final prospectus supplement, when available, may be obtained from RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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. Any offer or sale will be made only by means of CorMedix’s prospectus supplement and prospectus forming part of the effective registration statement relating to these securities.