In two midphase tests, GB001 failed in chronic rhinosinusitis, missing its primary and secondary endpoints, leading Gossamer Bio to scrap plans to develop GB001 in chronic rhinosinusitis. Gossamer Bio’s GB001 has failed in two midphase trials in asthma and chronic rhinosinusitis. Why Gossamer Bio Stock Is Swinging Wildly Today ... is a DP2 antagonist like fevipiprant. However, on December 16, 2019, Novartis announced it was terminating the development of its similar DP2 antagonist drug for asthma after it failed a pair of phase 3 clinical trials. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SAN DIEGO--(BUSINESS WIRE)--Nov. 10, 2020-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the third quarter of 2020 and provided a corporate update. After the company snuck news of the failure of the project’s first pivotal trials into its third-quarter earnings today, the main question now is what it means for Gossamer Bio’s lead asset, GB001, which also hits DP2. “Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma,” the biotech said in a short note in its financials. In the LEDA study, the primary endpoint, which was not met, was asthma worsening. The signs of efficacy have persuaded Gossamer Bio to look past the primary endpoint failure and forge ahead with further development of GB001. The failure that rocked the company last October was for GB001, an oral DP2 antagonist for eosinophilic asthma. Gossamer Bio has fresh data from two midphase clinical trials of the oral antagonist of the DP2 pathway. Shares in Gossamer Bio fell almost 30% in response to the data. However, Gossamer Bio pointed to numeric reductions in the odds of asthma worsening versus placebo of 32% to 35% across the three GB001 arms as evidence that the drug may work. The content in this report or email is not provided to any individual with a view toward their individual circumstances. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. No communication by our employees to you should be deemed as personalized financial advice. Gossamer’s IPO materials and public statements misled the market about its GB001 drug and its related clinical trials and studies. None of the trials succeeded, leading Novartis to halt development of the asset. GB001 was statistically no better than placebo at stopping those outcomes. Gossamer Bio has been unraveling over the past year, hit hard by a failure for its leading drug program and the axing of its CEO Sheila Gujrathi, M.D., soon after. It seems that path will require a partner or remain dead on arrival, though it still has some faith the drug can go the distance. Gossamer Bio funded its attack on the target by raising a major $276 million in an IPO in 2019, but it failed to move the needle. The biotech also tracked a statistically significant improvement in time to asthma worsening in the low- and high-dose GB001 cohorts and performed a post hoc analysis that linked the drug to lower odds of suffering three or more forms of asthma worsening. The two midphase failures add to the case against DP2 inhibitors. A secondary measure that looked at the annualized severe exacerbation rate—an expected phase 3 endpoint—also found no statistical benefit to taking GB001 over placebo. The biotech did not say whether it was in active conversation with a company, and its future is now in the balance. The failures come months after Novartis dumped rival DP2 inhibitor fevipiprant in response to a clutch of phase 3 flops. Gossamer Bio is plotting a move into phase 3 in asthma despite a second phase 2a trial in patients with chronic rhinosinusitis also failing. That trial missed its primary and secondary endpoints, leading Gossamer Bio to scrap plans to develop GB001 in chronic rhinosinusitis. John Carroll Editor & Founder. GB001 is Oral DP2 antagonist at Phase 2b stage for the treatment of moderate-to-severe eosinophilic asthma. San Diego-based Gossamer Bio (GOSS) is a clinical stage biopharma with four pipeline candidates in development that currently target seven indications. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. biotech-today.com is a wholly-owned subsidiary of Maynard Communication Limited. Nothing in this publication should be considered as personalized financial advice. Biotech Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. Neither trial was a success. These glimmers persuaded the biotech to look past the primary endpoint failure and forge ahead with further development of GB001, though now this comes with provisos. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Last year, Novartis reported data from four phase 3 trials of its DP2 drug fevipiprant in different groups of asthma patients. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. The failure that rocked the company last October was for GB001, an oral DP2 antagonist for eosinophilic asthma. The failures come months after Novartis dumped rival DP2 inhibitor fevipiprant in response to a clutch of phase 3 flops.. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Gossamer Bio has been unraveling over the past year, hit hard by a failure for its leading drug program and the axing of its CEO Sheila Gujrathi, M.D., soon after. After 24 weeks of daily dosing, patients in the GB001 arms performed no better on a measurement of asthma worsening than their peers in the placebo cohort. (Gossamer Bio) Gossamer Bio’s GB001 has failed in two midphase trials in asthma and chronic rhinosinusitis. Yet, none of… GB001 was statistically no better than placebo at stopping those outcomes. The company plans … Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of … No communication by our employees to you should be deemed as personalized financial advice. Avrobio plans head-to-head Fabrazyme trial after FDA changes path to market, Stock-market investors should brace for a weaker dollar, says Goldman Sachs, Investors betting defensive stock market plays will win as they sold tech, financials, Next Windows 10 update nearing completion as it gets its official name, Vaccine Breakthroughs Stemming from 2020 Crisis Could Treat MORE Than Just Covid-19, Creating Major Opportunity for Investors, QuestCap Inc. – The Social Impact Investment Company Targeting Pandemic Response Technologies and Therapies. At the end of last year, Gossamer had $512.6 million in the bank. At issue is fevipiprant’s failure in the severe asthma setting of its Luster clinical programme, measuring exacerbations at one year. But while this is a positive, it will not be going it alone. After 24 weeks of daily dosing, patients in the GB001 arms performed no better on a measurement of asthma worsening than their peers in the placebo cohort. The promise of DP2 inhibition has attracted companies including Amgen, AstraZeneca and Novartis. Sheila Gujrathi (Gossamer Bio) ... take another beating as its lead drug fails 2 key clinical studies, highlighting harsh reviews for DP2. The company was founded in 2015 and completed its IPO in February 2019. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. The content in this report or email is not provided to any individual with a view toward their individual circumstances. The promise of DP2 inhibition has attracted some Big Pharma names over the years, yet none of those heavyweight drug developers were able to build on evidence that activation of the prostaglandin receptor drives allergy and inflammation and go on to create efficacious therapies. More on this story. Gossamer Bio, Inc. (NASDAQ:GOSS) Q4 2020 Earnings Conference Call February 25, 2021 8:30 AM ET Company Participants. Gossamer Bio, Inc. (Nasdaq: GOSS), ... GB001 is a potent and highly selective oral antagonist of the DP2 pathway, a potentially important modulator of the … Investigation of Gossamer Bio, Inc. You Have Legal Options Gossamer Bio, Inc. (GOSS) Accused of Misleading Shareholders On February 8, 2019, Gossamer held its IPO offering approximately 17.25 million shares at $16.00 per share and raising $256 million in proceeds. Please consult a licensed financial advisor before making any investment decision. A secondary measure that looked at the annualized severe exacerbation rate—an expected phase 3 endpoint—also found no statistical benefit to taking GB001 over placebo. Please consult a licensed financial advisor before making any investment decision. “We believe these data provide important information for designing a well-powered phase 3 program for GB001 in severe asthma. Participants were classed as worsening if their peak expiratory flow, FEV1, rescue medication use or scores on an asthma control questionnaire deteriorated by a certain amount, or if they suffered the occurrence of severe asthma exacerbations. We are not licensed under securities laws to address your particular financial situation. Wij willen hier een beschrijving geven, maar de site die u nu bekijkt staat dit niet toe. Neither trial was a success. “Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner,” it added. Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of … Nothing in this publication should be considered as personalized financial advice. The promise of DP2 inhibition has attracted companies including Amgen, AstraZeneca and Novartis. Gossamer Bio has fresh data from two midphase clinical trials of the oral antagonist of the DP2 pathway. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program,” Gossamer Bio CEO Sheila Gujrathi, M.D., said in a statement. Now, Gossamer Bio’s GB001 has joined the list of DP2 drugs to fail in clinical trials. Gossamer Bio’s GB001 has failed in two midphase trials in asthma and chronic rhinosinusitis. The promise of DP2 inhibition has attracted companies including Amgen, AstraZeneca and Novartis. That's a lot of science words. Investors at first assumed that Novartis' failure could mean that Gossamer's drug is likely to flop as well. Gossamer Bio Investigated by Block & Leviton; ... Novartis announced that it was terminating the development of its DP2 antagonist for asthma after it failed a … Gossamer Bio (GOSS) – Speculative Biotech For Asthma Trial. Gossamer Bio funded its attack on the target by raising $276 million in an IPO last year. Gossamer Bio with DP2 antagonist - GB001. The lead drug candidate of Gossamer Bio is GB001, an antagonist of prostaglandin D2 receptor 2 (DP2) proteins. Novartis announced on December 16, 2019, that it was terminating development of its DP2 antagonist for asthma based on two failed phase 3 clinical trials. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Gossamer Bio, Inc., on behalf of wholly-owned subsidiaries of the organization, is committed to making investigational products available to seriously ill patients who have exhausted other available treatment options and are not eligible to participate on an active clinical trial testing a Gossamer Bio, Inc. investigational product. Always consult a licensed investment professional before making any investment decision. The promise… While all information is believed to be reliable, it is not guaranteed by us to be accurate. Californian company Gossamer Bio lost more than a third of its market value in Tuesday morning’s trading. The stock was already trading at around half the price it commanded before the second set of Novartis’ failed phase 3 clinical trials dampened expectations for GB001. ... Gossamer shares plummet after latest DP2 drug setback 13-10-2020 Print. A month later, in November 2020, Gujrathi was axed, succeeded by Faheem Hasnain, who was rehired as its chief to try and find a way through. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Article Sanofi strengthens case for Dupixent in children with asthma. Yet, none of those heavyweight drug developers were able to build on evidence that activation of the prostaglandin receptor drives allergy and inflammation and go on to create efficacious therapies. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Always consult a licensed investment professional before making any investment decision. The larger of the two clinical trials randomized 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma to receive one of three doses of GB001 or placebo on top of standard of care. Gossamer Bio also tracked a statistically significant improvement in time to asthma worsening in the low and high dose GB001 cohorts and performed a post hoc analysis that linked the drug to lower odds of suffering three or more forms of asthma worsening. Avrobio plans head-to-head Fabrazyme trial after FDA changes path to market, Stock-market investors should brace for a weaker dollar, says Goldman Sachs, Investors betting defensive stock market plays will win as they sold tech, financials, Next Windows 10 update nearing completion as it gets its official name, QuestCap Inc. – The Social Impact Investment Company Targeting Pandemic Response Technologies and Therapies, Here’s an example of why you should have Biotech stocks in your portfolio. Now, Gossamer Bio’s GB001 has joined the list of DP2 drugs to fail in clinical trials. Gossamer Bio announced today that its two studies examining GB001 – the Phase IIb LEDA trial in eosinophilic asthma and Phase II TITAN trial in chronic rhinosinusitis – failed to meet their primary endpoints.. Like fevipiprant, Gossamer’s lead asset, GB001, is a DP2 inhibitor targeting asthma. The writing was, in some ways, already on the wall, given its failuresF months after Novartis dumped rival DP2 inhibitor fevipiprant in response to a clutch of phase 3 flops, with similar flops for Amgen and AstraZeneca in the past. Today’s discontinuation of Novartis’s fevipiprant blows a hole in the investment thesis behind Gossamer Bio. This is because in that data set, Gossamer pointed to numeric reductions in the odds of asthma worsening versus placebo of 32% to 35% across the three GB001 arms as evidence that the drug may work. Participants were classed as worsening if their peak expiratory flow, FEV1, rescue medication use or scores on an asthma control questionnaire deteriorated by a certain amount, or if they suffered the occurrence of severe asthma exacerbations. It was a similar outcome in asthma, where the larger of the two clinical trials randomized 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma to receive one of three doses of GB001 or placebo on top of standard of care. Gossamer’s leading product is its GB001 drug, which is a DP2 antagonist drug for the treatment of asthma. Gossamer now has a focus on several early- to mid-stage drugs targeting pulmonary arterial hypertension and ulcerative colitis, seralutinib (GB002) and GB004, respectively, with top-line data expected next year, as well as an early cancer asset in GB1275, an oral CD11b modulator. Faheem Hasnain - Co-Founder, CEO, & Chairman . Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Its shares dragged down more than 5% on its financial report. Novartis’s DP2 inhibitor fevipiprant had always looked like a long shot in asthma. Gossamer Bio funded its attack on the target by raising $276 million in an IPO last year. We are not licensed under securities laws to address your particular financial situation. Bryan Giraudo - CFO . Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Fevipiprant joined DP2 drugs once in development at Amgen, AstraZeneca and Boehringer Ingelheim on the scrapheap. Gossamer Bio is developing GB001, a DP2 antagonist that's in a Phase 2b study for moderate to severe eosinophilic asthma. The failures come months after Novartis dumped rival DP2 inhibitor fevipiprant in response to a clutch of phase 3 flops. Gossamer Bio CEO Sheila Gujrathi, M.D. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. 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