On September 2, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will participate at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Quince Therapeutics, SEP 2, 2025, View Source [SID1234655657]). Access to the company’s presentation will be available on Friday, September 5, 2025 beginning at 7:00 a.m. Eastern Time.

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A webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On September 2, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it will participate in the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Intensity Therapeutics, SEP 2, 2025, https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-to-participate-in-fireside-chat-at-the-hc-wainwright-27th-annual-global-investment-conference-302543127.html [SID1234655672]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

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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

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Lewis H. Bender, President and CEO of Intensity Therapeutics will participate in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director, Senior Healthcare Analyst at H.C. Wainwright. The fireside chat will be available on demand beginning Friday, September 5 at 7:00am ET for registered investors of the conference. To request a one-on-one meeting with Mr. Bender, and to register for the conference, click below: View Source

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On September 2, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported it has completed the sale of its China subsidiary to AstraZeneca for a total consideration of approximately $220 million, consisting of $85 million in enterprise value and approximately $135 million in net cash held in China (Press release, FibroGen, SEP 2, 2025, View Source [SID1234655640]).

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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

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"We are thrilled to announce the completion of the sale of FibroGen China to AstraZeneca and are thankful to the teams who worked relentlessly to bring this to a successful close. This transformative transaction substantially strengthens our financial position, and extends our cash runway into 2028, through important clinical milestones," said Thane Wettig, Chief Executive Officer of FibroGen. "With a rejuvenated capital structure, we are on track to commence the Phase 2 monotherapy trial of FG-3246 in mCRPC imminently as well as submit the Phase 3 protocol for roxadustat in anemia associated with lower-risk MDS in the fourth quarter of 2025. Additionally, I would like to express my personal gratitude to our FibroGen China colleagues for their unwavering commitment to the success of roxadustat and to AstraZeneca for being an excellent partner over the past 10 years in China."

The completion of the sale follows the fulfilment of all closing conditions. At closing, FibroGen repaid its term loan facility to investment funds managed by Morgan Stanley Tactical Value for approximately $81 million. The successful completion of the sale extends the Company’s cash runway into 2028.

FibroGen maintains its rights to roxadustat in the U.S. and in all markets not licensed to Astellas (other than China and South Korea). Following a positive meeting with the U.S. Food and Drug Administration (FDA), the Company intends to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in the fourth quarter of 2025.

In addition, FibroGen continues to advance the clinical development of its lead asset FG-3246, and its companion diagnostic FG-3180, and is on track to initiate the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC in the third quarter of 2025.

BofA Securities, Inc. acted as exclusive financial advisor and Ropes & Gray LLP acted as primary legal advisor to FibroGen on this transaction.

On September 2, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma (Press release, Replimune, SEP 2, 2025, View Source [SID1234655658]).

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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

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The Company submitted a briefing book to the FDA addressing the points from the CRL, highlighting prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components. The briefing book also includes an additional analysis of data from the BLA and addresses comments about the phase 3 confirmatory trial design.

"We are eager to engage in a productive discussion with the FDA to reach a swift resolution for the accelerated approval of RP1 in advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "The melanoma community, including leading physicians and patient advocacy groups have emphasized the urgent need for access to RP1 based on the strength of the data and limited effective treatment options for this population. We remain steadfastly committed to patient access while we work with the FDA to secure regulatory approval for RP1, however, without accelerated approval based on the current application, continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable."

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On September 2, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it will participate in the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Intensity Therapeutics, SEP 2, 2025, https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-to-participate-in-fireside-chat-at-the-hc-wainwright-27th-annual-global-investment-conference-302543127.html [SID1234655672]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

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!

Lewis H. Bender, President and CEO of Intensity Therapeutics will participate in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director, Senior Healthcare Analyst at H.C. Wainwright. The fireside chat will be available on demand beginning Friday, September 5 at 7:00am ET for registered investors of the conference. To request a one-on-one meeting with Mr. Bender, and to register for the conference, click below: View Source

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.