On June 16, 2025 Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DSB2455, its next-generation, CNS-active selective PARP1 inhibitor, for the treatment of patients with brain metastases originating from primary triple-negative breast cancer (TNBC) tumors harboring BRCA1/2 and/or homologous recombination repair (HRR) alterations (Press release, Duke Street Bio, JUN 16, 2025, View Source [SID1234653916]).

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DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic possibilities in hard-to-treat indications. The compound is a next-generation, highly PARP1-selective inhibitor with demonstrated brain penetrance and potent anti-tumour activity in preclinical models of homologous recombination-deficient cancers, including brain metastases.

The Fast Track designation is intended to facilitate the development of new therapies for serious conditions where there is significant unmet medical need. It allows for more frequent interactions with the FDA, eligibility for rolling review of an NDA, and potential consideration for Priority Review or Accelerated Approval.

"Receiving Fast Track designation for DSB2455 represents an important milestone in our mission to develop more targeted and effective therapies for patients with limited treatment options," said Alan Wise, Chief Executive Officer of Duke Street Bio. "Next-generation PARP1-selective inhibitors such as DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use both as monotherapy and in combination with other anti-cancer agents across a range of tumors."

"DSB2455’s ability to achieve therapeutically relevant concentrations in the CNS represents a key differentiator," added Dónal Landers, Chief Medical Officer of Duke Street Bio. "This could offer a new treatment option for patients with secondary HRD brain metastases, where clinical need remains high and current therapeutic choices are limited."

About Fast Track Designation
The FDA’s Fast Track program is designed to accelerate the development and review of new drugs for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Companies granted this designation benefit from more frequent communication with the FDA and eligibility for rolling submissions and other expedited review processes.

On June 16, 2025 Pierre Fabre Laboratories reported the acquisition from Antares Therapeutics, Inc. ("Antares"), a spin-out of Scorpion Therapeutics, Inc., of the worldwide rights for PFL-721 and PFL-241 (formerly known as STX-721 and STX-241, respectively) (Press release, Pfizer, JUN 16, 2025, View Source [SID1234653932]). Under the terms of the agreement, Pierre Fabre Laboratories will expand its previous agreement with Scorpion Therapeutics to hold the global rights for both assets and will be leading the clinical development of both programs.

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PFL-721 is a mutant-specific EGFR exon 20 and HER2 exon 20 inhibitor, soon to transition to dose optimization within a first-in-human trial in NSCLC. PFL-241 is a mutant-specific, brain penetrant, 4th generation EGFR inhibitor, currently in dose escalation in a first-in-human trial, to address C797S resistance mutations in NSCLC patients.

NSCLC is the most common sub-type of lung cancer and various EGFR mutations are the most frequent drivers of NSCLC, occurring in approximately 14-38 percent of tumors, depending on geography.[1], [2], [3]

"With this agreement with Antares, Pierre Fabre Laboratories now own the global rights for all the assets within our R&D portfolio: exarafenib, PFL-002 (formerly VERT-002), PFL-721 and PFL-241. The R&D team is fully engaged and committed to progress the clinical development of these programs, aiming at providing novel and differentiated precision medicines to patient populations with significant unmet needs." said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

On June 16, 2025 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, reported that the company is participating in the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts (Press release, Enveric Biosciences, JUN 16, 2025, View Source [SID1234653917]).

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During the conference, CEO and Director of Enveric, Joseph Tucker, Ph.D., will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and development strategy, recent corporate achievements, and anticipated milestones.

On June 16, 2025 BioDlink reported that its self-developed Bevacizumab Injection (Pusintin) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria (Press release, Tot Biopharm, JUN 16, 2025, View Source [SID1234653933]). This significant milestone accelerates BioDlink’s global expansion efforts, and reaffirms its R&D and commercialization strength in biosimilar—offering a high-value, accessible treatment option for cancer patients worldwide.

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Leveraging synergies with Kexing BioPharm, the global licensee for Pusintin in emerging markets, Pusintin has initiated regulatory filings in 35 countries. The approval in Nigeria not only marks the implementation of its global strategy but also signifies officially opening the door to the African market, bringing more affordable treatment alternatives to Nigerian patients.

ADDRESSING AFRICA’S GROWING HEALTHCARE NEEDS

Africa, with a population exceeding 1.5 billion (World Bank, 2024), faces increasing medical demand. Nigeria, as the "most populous country in Africa" (~220 million people), possesses both massive healthcare challenge and a major growth opportunity. According to the World Health Organization (WHO), Nigeria reports over 120,000 new cancer cases annually, growing at a rate of 5% per year—amid limited access to high-quality therapies. Pusintin’s approval meets this urgent medical need while serves as a model for expansion into other emerging-market.

INTERNATIONALLY RECOGNIZED MANUFACTURING & QUALITY EXCELLENCE

The approval has validated Pusintin’s compliance complies with international standards for R&D, manufacturing, and quality system. BioDlink’s production facilities have already passed GMP inspections in China, Japan, Brazil, Colombia, Egypt, Indonesia, and Argentina and also passed antibody drug and ADC EU QP inspection 4 times in past two years. BioDlink’s global-quality system ensures robust commercial supply, delivering more than 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including European and the U.S. in the past 3 years.

This millstone marks the beginning of BioDlink’s international commercial rollout, injecting new momentum into its revenue diversification strategy and reinforcing its capabilities in global biosimilar commercialization.

BioDlink operates a large-scale, GMP-compliant biologics manufacturing facility, featuring four commercial lines with five drug substance production centers (including non-toxic conjugated drug substance units) and four drug production centers. Its world-class facilities and stringent quality system deliver reliable global supply for monoclonal antibodies (mAbs), bispecific antibodies, XDCs, and other biologics at global standards.

SUSTAINING GLOBAL MOMENTUM

BioDlink will continue collaborating with Kexing BioPharm to accelerate Pusintin’s approval in Southeast Asia and Latin America. Driven by a committed to innovation, quality, and global compliance, BioDlink will continue accelerating its expansion in overseas and emerging markets—bringing life-changing therapies to more patients worldwide.

On June 16, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has closed the third $5 million tranche of the previously announced Standby Equity Purchase Agreement (the "SEPA") with YA II PN, Ltd. ("Yorkville"), an investment fund managed by Yorkville Advisors Global, LP (Press release, FibroBiologics, JUN 16, 2025, View Source [SID1234653918]). The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25 million in the aggregate of its common stock to Yorkville over the course of two years.

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Yorkville agreed to advance to FibroBiologics the first $15 million available under the SEPA in three equal tranches to be evidenced by convertible promissory notes. The first tranche in the amount of $5 million was funded upon entry into the SEPA and the second tranche of $5 million was funded after the filing of a registration statement covering the resale of the shares issuable to Yorkville under the promissory notes. The third tranche of $5 million was funded following the effectiveness of the registration statement and receipt of shareholder approval in satisfaction of certain Nasdaq rules. FibroBiologics can sell an additional $10 million of its common stock to Yorkville, subject to Yorkville’s consent and other conditions, while the convertible promissory notes remain outstanding.

The net proceeds of the financing are expected to be used for general corporate purposes, including funding for research and development programs and supporting the upcoming Phase 1/2 diabetic foot ulcer clinical trial expected to begin in the second half of 2025.

For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected]. For more information on the SEPA, including important terms and conditions, please see FibroBiologics’ filings with the Securities and Exchange Commission, including its Current Reports on Form 8-K filed with the Securities and Exchange Commission from time to time.

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

D. Boral Capital LLC acted as the exclusive placement agent in connection with the SEPA.