Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIO), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech, Inc. (Nasdaq: FBIO) is a biopharmaceutical company that regularly issues news about its portfolio of prescription pharmaceutical products and development programs. Its press releases cover updates from Fortress itself and from majority-owned and partner companies that it has founded or supports, providing investors with a consolidated view of activity across oncology, dermatology and rare disease assets.
Recent announcements highlight regulatory milestones, clinical progress and transaction-driven events. Fortress and its majority-owned subsidiary Cyprium Therapeutics have reported U.S. Food and Drug Administration (FDA) approval of ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients, noting that it is the first and only FDA-approved treatment for Menkes disease in the United States. Earlier updates described FDA acceptance of the resubmission of the New Drug Application for CUTX-101 and the transfer of development and commercialization responsibilities to Sentynl Therapeutics, with Cyprium eligible for royalties and milestone payments.
News related to Journey Medical Corporation, which was founded by Fortress, includes financial results driven by net revenues from dermatology products and the commercial launch of Emrosi (DFD-29) for inflammatory lesions of rosacea in adults. Releases also present clinical data, such as pooled Phase 3 analyses demonstrating Emrosi’s efficacy versus comparators, and discuss payer access and prescription trends.
Additional Fortress news items describe monetization events and pipeline updates, such as the acquisition of Checkpoint Therapeutics by Sun Pharma, the sale of dotinurad rights to Crystalys Therapeutics with associated equity and royalty interests, and the initiation of Phase 3 trials of dotinurad for gout by Crystalys. Investors following FBIO news can use this page to review these types of announcements, track regulatory interactions, and monitor how Fortress’ subsidiaries and partners contribute to the overall portfolio.
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company specializing in FDA-approved dermatological treatments, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Claude Maraoui, President and CEO, will present a corporate overview available for on-demand viewing starting September 9, 2024, at 7:00 a.m. ET.
The company will also engage in one-on-one meetings during the conference. Investors can access a replay of the presentation on Journey Medical's website for approximately 30 days after the event, providing an opportunity to gain insights into the company's strategies and performance in the dermatological pharmaceutical market.
Checkpoint Therapeutics (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. James Oliviero, the company's President and CEO, will deliver a corporate overview on September 10, 2024, at 10:00 a.m. ET.
The presentation will be accessible via webcast on Checkpoint's investor relations website for approximately 30 days following the event. Additionally, the company will engage in both in-person and virtual one-on-one meetings during the conference, providing an opportunity for investors to gain deeper insights into Checkpoint's operations and strategies.
Fortress Biotech (Nasdaq: FBIO) reported Q2 2024 financial results and corporate highlights. Key points include:
1. FDA acceptance of NDA for DFD-29 (rosacea treatment) with PDUFA date of November 4, 2024.
2. FDA acceptance of BLA resubmission for cosibelimab (cSCC treatment) with PDUFA date of December 28, 2024.
3. Q2 2024 product revenue of $14.9 million, up 15% from Q1 2024.
4. Cash position of $76.2 million as of June 30, 2024.
5. Net loss of $(13.3) million, or $(0.73) per share for Q2 2024.
6. R&D expenses decreased to $12.7 million in Q2 2024 from $32.1 million in Q2 2023.
7. New loan agreement with Oaktree Capital Management, resulting in a net $15 million debt reduction.
Journey Medical (Nasdaq: DERM) reported financial results for Q2 2024. Key highlights include:
- Total revenues of $14.9 million, a 14% increase from Q1 2024
- Net loss reduced by $5.0 million to $3.4 million or $(0.17) per share
- Positive Adjusted EBITDA of $0.3 million
- Cash and cash equivalents of $23.9 million as of June 30, 2024
The company's New Drug Application for DFD-29 to treat rosacea is under FDA review with a PDUFA goal date of November 4, 2024. Journey Medical appointed Joseph M. Benesch as CFO and Michael C. Pearce to its Board of Directors. The company remains on track to deliver its 2024 financial guidance.
Checkpoint Therapeutics (Nasdaq: CKPT) reported Q2 2024 financial results and corporate updates. Key highlights include:
1. FDA accepted resubmission of BLA for cosibelimab in cSCC with PDUFA date of December 28, 2024.
2. Collaboration announced to explore cosibelimab with GC Cell's Immuncell-LC.
3. Completed registered direct offering for $12.0 million in gross proceeds.
Financial results:
- Cash position: $5.0 million as of June 30, 2024
- R&D expenses: $4.5 million, down from $13.9 million in Q2 2023
- G&A expenses: $2.2 million, slightly down from $2.3 million in Q2 2023
- Net loss: $6.7 million ($0.18 per share), improved from $16.5 million ($1.05 per share) in Q2 2023
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company focusing on FDA-approved dermatological treatments, has announced it will release its second quarter 2024 financial results on August 12, 2024, after U.S. market close. The company will host a conference call and audio webcast at 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Interested parties can join the call by dialing 1-866-777-2509 (domestic) or 1-412-317-5413 (international). Participants can also register online to receive a dial-in number. A live audio webcast will be available on the company's website and will remain accessible for approximately 30 days after the call.
Fortress Biotech (Nasdaq: FBIO) has entered into a new loan agreement with Oaktree Capital Management for up to $50 million, receiving an initial $35 million tranche. This arrangement allows Fortress to repay its prior $50 million loan due in August 2025 and extends the maturity to July 2027. The new loan has a 30-month interest-only period with an interest rate of 3-month SOFR plus 7.625%.
The company expects this agreement to provide financial flexibility for long-term expansion, asset acquisition, and execution of its commercial business and late-stage pipeline. Fortress anticipates up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing by 2025. This strategic partnership with Oaktree supports Fortress' ability to develop innovative assets addressing areas of high unmet medical need.
Checkpoint Therapeutics (Nasdaq: CKPT) announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 antibody, for treating advanced cutaneous squamous cell carcinoma (cSCC). The FDA set a PDUFA goal date of December 28, 2024. This resubmission addresses the complete response letter (CRL) issued in December 2023, which only cited issues with the third-party contract manufacturing organization. Notably, the CRL did not raise concerns about the clinical data package, safety, or labeling for cosibelimab's approvability. Checkpoint's CEO expressed satisfaction with the FDA's acceptance and looks forward to potentially delivering cosibelimab's unique dual mechanism of action to cSCC patients.
GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody, with GC Cell's Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy. The partnership will initially focus on in vitro combination studies to evaluate synergistic effects on cancer cell destruction.
The anticipated synergy leverages cosibelimab's antibody-dependent cellular cytotoxicity (ADCC) mechanism and Immuncell-LC's CIK T cell response. Positive preliminary data could lead to future in vivo research and clinical studies. Both companies' CEOs expressed optimism about the collaboration's potential to set new standards in immuno-oncology and possibly result in commercial licensing or joint development opportunities.
Journey Medical (Nasdaq: DERM) has appointed Michael C. Pearce to its Board of Directors, effective July 9, 2024. Pearce, an experienced principal investor and advisor in the healthcare sector, has an extensive background, including roles at EP Group, Evening Post Industries (EPI), and as Chairman of Range Therapeutics. His appointment comes as Journey Medical approaches the potential FDA approval of DFD-29, a promising treatment for rosacea, in November 2024. Pearce's strategic, business, and financial expertise is expected to bring significant value to Journey Medical's leadership as it continues to pursue its corporate goals.