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Gossamer Bio (GOSS) Sees Strong Analyst Confidence Amid Seralutinib Progress and Upcoming PROSERA Data
Yahoo Finance· 2025-12-21 12:31
With strong 1-year returns and upside potential, Gossamer Bio, Inc. (NASDAQ:GOSS) secures a spot on our list of the 12 best multibagger stocks to buy heading into 2026. Gossamer Bio (GOSS) Sees Strong Analyst Confidence Amid Seralutinib Progress and Upcoming PROSERA Data Amid the company’s continued efforts to advance seralutinib across two late-stage pulmonary hypertension programs, analyst confidence in Gossamer Bio, Inc. (NASDAQ:GOSS) remains high. By the end of Q3 2025, Gossamer Bio, Inc. (NASDAQ:GO ...
Gossamer Bio to Participate in Upcoming Investor Conferences
Businesswire· 2025-11-07 12:31
Core Insights - Gossamer Bio, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing seralutinib for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3][5][6] Upcoming Investor Conferences - Gossamer Bio will participate in the UBS Global Healthcare Conference on November 10, with a format of 1x1 meetings in Palm Beach, FL [2] - The company will also attend the Guggenheim Securities Healthcare Innovation Conference on November 11, featuring a presentation and 1x1 meetings in Boston, MA [2] Company Overview - Gossamer Bio aims to be an industry leader in enhancing the lives of patients suffering from pulmonary hypertension [3]
Gossamer Bio (NasdaqGS:GOSS) Conference Transcript
2025-10-23 20:42
Summary of Conference Call for Gossamer Bio and Regen BioPharma Gossamer Bio (NasdaqGS:GOSS) Industry Overview - Gossamer Bio is a late-stage biopharmaceutical company focused on pulmonary hypertension (PH) [1] - The company is preparing for significant developments in the $7 billion pulmonary arterial hypertension (PAH) market [2] Key Points - **Phase 3 Study Readout**: The company expects to announce top-line data from the ProSera phase 3 study in PAH in February next year, which is anticipated to be a major catalyst for the stock [2][3] - **Regulatory Process**: Positive data from the ProSera study will initiate the regulatory process for drug approval in the U.S. and globally with partners at Chiesi [3] - **Expansion into PAH-ILD**: Gossamer plans to start a phase 3 study for pulmonary hypertension associated with interstitial lung disease (PAH-ILD), a market potentially two to three times larger than PAH, with minimal competition [3][4] - **Market Potential**: The combined market for PAH and PAH-ILD could exceed $20 billion [4] - **Patient Population Strategy**: The company has implemented an enrichment strategy to ensure a sicker patient population for the ProSera study, enhancing the probability of success [5][6] - **Seralutinib's Competitive Edge**: Seralutinib is positioned as a best-in-class treatment with superior safety and efficacy compared to current market leaders, potentially becoming the preferred therapy after existing treatments [10][11] - **Acquisition of Respira Therapeutics**: The acquisition of Respira Therapeutics and its investigational inhaled therapy RT-234 is expected to complement seralutinib, providing a fast-acting treatment option for PAH patients [12][13] - **Reimbursement Landscape**: Gossamer believes that seralutinib's safety profile will favorably position it for reimbursement compared to competitors facing significant side effect management costs [14][16] Regen BioPharma, Inc. (OTC: RGBP) Industry Overview - Regen BioPharma operates in the biotech sector focusing on immune-oncology and autoimmune diseases [21] Key Points - **Orphan Drug Status**: The company is in discussions with the FDA regarding orphan drug status, with a response expected within 90 days [24][32] - **Funding for Clinical Trials**: Regen has raised approximately $95,000 towards the goal of $105,000 needed to initiate clinical phase 1 trials [25][29] - **Market Activity**: The company has observed good trading volume and liquidity, which is encouraging for potential investors [25][29] - **Focus on Clinical Phase 1**: The primary goal is to commence clinical phase 1 trials, which is seen as a significant milestone for the company [30][32] - **Investor Engagement**: There is ongoing interest from potential investors, with a focus on maintaining the Regulation A offering within a limited group to avoid price dilution [34] Additional Insights - **Patents and Future Developments**: The company is currently prioritizing clinical phase 1 over new patent applications, with plans to patent findings from the trials [36][37] - **Future Presentations**: Upcoming presentations are expected to provide more detailed information and updates on the company's progress [38]
3 Biotech Stocks That Could More Than Triple if Their Trials Succeed
Yahoo Finance· 2025-10-11 16:00
Core Viewpoint - Astria Therapeutics is positioned as a promising investment opportunity with a consensus rating of "Strong Buy" from analysts, indicating significant potential upside in its stock price over the next year [1][15]. Financial Performance - In Q2, Astria reported a net loss of $33.1 million, or $0.57 per share, with R&D expenses rising to $25.9 million due to costs associated with navenibart's Phase 3 trial [2]. - The company ended Q2 with cash, cash equivalents, and short-term investments totaling $259.2 million, which is expected to support operations through 2028 [2]. Product Development - Astria's lead program, navenibart, is a monoclonal antibody currently in Phase 3 clinical trials for hereditary angioedema (HAE) [3]. - Top-line results from the ALPHA-ORBIT Phase 3 trial are anticipated in early 2027, with collaboration established with Kaken Pharmaceutical for development in Japan [3]. Industry Context - The biotech sector is characterized by high-risk, high-reward dynamics, particularly in clinical trials, which can significantly impact stock valuations [4]. - The overall consensus for Astria stock reflects strong analyst confidence, with an average price target of $29.89 suggesting a potential upside of 253.7% from current levels [1].
Respira Therapeutics Enters into Agreement with Gossamer Bio (Gossamer) Granting Gossamer Option to Acquire Respira from Samsara BioCapital
Prnewswire· 2025-09-25 11:41
Core Viewpoint - Respira Therapeutics has entered into an agreement with Gossamer Bio, granting Gossamer an option to acquire Respira, aimed at accelerating the development of RT234, a first-in-class inhalation therapy for pulmonary hypertension (PH) [1][3]. Company Overview - Respira Therapeutics is a clinical-stage biopharmaceutical company focused on developing RT234 (vardenafil inhalation powder) as a self-administered, as-needed therapy for rapid relief of exertional symptoms in pulmonary hypertension patients [5]. - RT234 utilizes proprietary dry-powder formulation and inhaler technologies to maximize drug delivery to the deep lung [5]. Product Development - RT234 is designed to provide rapid, on-demand relief for symptoms such as breathlessness, which are prevalent among PH patients and often disrupt daily life [5]. - The therapy is positioned to be used alongside existing chronic treatments, representing a novel approach in the management of PH [5]. Clinical Data - In two completed open-label Phase 2 studies involving 56 PAH patients, RT234 showed rapid and clinically meaningful improvements in hemodynamic and functional measures, including reduced pulmonary vascular resistance and increased exercise capacity [6]. - The therapy has demonstrated a favorable safety and tolerability profile to date [6]. Transaction Details - Under the option agreement, Gossamer is issuing 2.5 million shares of common stock upon signing, with an additional 1.5 million shares to be issued upon exercising the acquisition option [3]. - The agreement includes success-based milestone payments and royalties on potential net sales of RT234 [3]. Strategic Collaboration - The collaboration aims to leverage Gossamer's established late-stage product development platform to advance RT234 into late-stage clinical development [3][7]. - Both companies share a commitment to improving the lives of patients living with pulmonary hypertension [2][7].
Gossamer Bio Enters into Option Agreement to Acquire Respira Therapeutics and Its Lead Candidate, RT234, an Inhaled, On‑Demand Vardenafil for Pulmonary Hypertension
Businesswire· 2025-09-25 11:31
Core Insights - Gossamer Bio, Inc. has announced an option agreement to acquire Respira Therapeutics and its lead product candidate RT234, which is an investigational inhaled vardenafil dry powder [1] Company Overview - Gossamer Bio is a late-stage clinical biopharmaceutical company focused on developing and commercializing seralutinib for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1] Product Development - The acquisition of Respira Therapeutics will enhance Gossamer Bio's portfolio, particularly in the area of pulmonary hypertension treatments [1]
Gossamer Bio Announces Presentations at the European Respiratory Society (ERS) Congress 2025
Businesswire· 2025-09-22 11:31
Core Insights - Gossamer Bio, Inc. is focused on developing and commercializing seralutinib for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1] Group 1 - Five scientific presentations related to seralutinib will be showcased at the European Respiratory Society (ERS) Congress 2025 [1]
H.C. Wainwright Asserts Buy Stance on Gossamer Bio Inc. (GOSS) on Pulmonary Arterial Hypertension Drug Prospects
Yahoo Finance· 2025-09-11 17:15
Group 1 - Gossamer Bio Inc. (NASDAQ:GOSS) has shown strong momentum, rallying by more than 100% year to date, and has received a 'Buy' rating from H.C. Wainwright with a $10 price target [1][2] - The positive outlook from H.C. Wainwright is based on anticipated key clinical data for the investigational drug seralutinib, aimed at treating pulmonary arterial hypertension, expected early next year [2][3] - Data from the Phase 2 TORREY trial indicated sustained hemodynamic and functional improvements through 72 weeks, including reduced pulmonary vascular resistance and improved six-minute walk distance among patients [3] Group 2 - Gossamer Bio Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for rare diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [4]
Gossamer Bio stock upgraded at UBS (GOSS:NASDAQ)
Seeking Alpha· 2025-09-10 14:04
Group 1 - Gossamer Bio's shares increased after UBS upgraded the stock from Neutral to Buy, indicating a positive outlook for the company [2] - The upgrade is based on an "underappreciated" late-stage data catalyst related to Gossamer Bio's lead asset, seralutinib [2] - This upgrade comes at a strategic time for the company, suggesting potential for growth and investor interest [2]
Gossamer Bio (GOSS) 2025 Conference Transcript
2025-09-03 14:12
Summary of Gossamer Bio Conference Call Company Overview - **Company**: Gossamer Bio - **Focus**: Transitioning from an R&D-based organization to a commercialization-focused company, particularly for the drug seralutinib targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [4][42] Key Points and Arguments Transition to Commercialization - Gossamer Bio is building commercial infrastructure in preparation for the launch of seralutinib, expected in the first half of 2027 [4][42] - The company is focusing on brand development, patient service infrastructure, market access plans, and engagement with payers and key opinion leaders (KOLs) [4][42] Clinical Trials and Data - The ProSera study for seralutinib in PAH is set to disclose primary endpoint data in February 2026, with expectations for detailed secondary endpoint data [6][7] - The company aims to enroll the first patient in the Serenata study for PH-ILD by the end of 2023, with robust enrollment anticipated in the first half of 2026 [5][42] Patient Population and Study Design - The ProSera study has a well-defined patient population, enriched for those likely to show improvement at week 24, which is expected to enhance the likelihood of a successful outcome [9][11] - The study design includes rigorous quality assurance and quality control measures, with Gossamer employees visiting all 191 sites multiple times [10][11] Efficacy and Safety Expectations - A clinically meaningful improvement in the six-minute walk test is expected to be between 20 to 25 meters, with statistical significance anticipated around 17 to 18 meters [16][18] - Gossamer Bio believes that seralutinib will demonstrate a better safety profile compared to other therapies, particularly in light of adverse events associated with competitors like sotatercept [31][32] Market Positioning and Strategy - Seralutinib is positioned as a potential first-line therapy for both functional class two and three patients, with expectations for earlier initiation in treatment regimens [13][24] - The company anticipates that seralutinib could be used in combination with other therapies, including sotatercept, although data on this combination will be limited due to low enrollment [26][28] Regulatory and Commercial Pathway - The filing timeline for seralutinib is projected for July 2026, with a potential commercial approval by March 2027 [38][39] - Gossamer Bio is already engaging with payers to discuss the drug's profile and data, indicating a proactive approach to market access [40][41] Future Development Plans - Beyond seralutinib, Gossamer Bio is exploring opportunities in other areas such as idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) [46][48] Additional Important Insights - The company has a partnership with Chiesi Group for commercialization outside the U.S., while retaining control over U.S. sales [41] - Gossamer Bio's approach to patient engagement and infrastructure development is seen as a long-term strategy to build a sustainable presence in the pulmonary hypertension market [46][48]