For biotektosser
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Takker for indlægget MM, jeg ligger også meget tungt lastet i Biotec
Jeg bruger TipsRanks som primære søge "maskine" men de dækker kun US selskaber.
Her på Proinvestor kommer der også tit guldkorn:Jeg have netop solgt mine Hansa Bio aktier med lille gevinst men så kom der et langt indlæg her og jeg købte Hansa igen baseret på det indlæg. Godt jeg gjorde det, har et plus på over 80% nu.
Har også AVXL (meget tungt lastet, stor risiko men gevinsten kan blive enorm hvis det de har gang i lykkes).
SRNE er jeg også tungt lastet i, de har mange ting kørende, udover Covid. -
Hej rasmusdus,
De er førende indenfor Alzheimer og Parkinsons + Rett syndrom.
Du kan se firmaet her:
Anavex Life Sciences | Advancing Therapies for Alzheimer’s and Parkinson's Disease
Anavex Life Sciences (Nasdaq: AVXL) is a biopharmaceutical leader advancing targeted CNS therapies through innovative therapeutic discovery and development.
Anavex Life Sciences (www.anavex.com)
Hvis de kommer igennem med det de arbejder på snakker vi om milliarder af $.
Husk på at Bio-tek er risikabelt og det er ikke en anbefaling og på engen risiko.Det var skribent Tasso1 der ledende mig på sporet, han har lavet en meget meget lang tråd om AVXL som du boer læse.
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Biotektosser update
Måske er nogen af jer gået ind i en af aktierne fra min liste, eller overvejer det. Her lige lidt om hvad der er sket siden mit indlæg. Jeg vil kun omtale dem som er kommet med nyheder af betydning.
Anavex springer jeg over, idet der kører en tråd kun om den, med vidende Tasso som primus motor.
CATB. Catabasis floppede i sit fase 3 i Duchenne. Som jeg skrev har de en meget tynd pipeline, så den har jeg solgt med et tab på 80%. Her er kunne planen så være at finde andre aktier som har gang i den indikation. Der er et stor potentiale for dem som rammer rigtigt.
BDSI. Alt kører som planlagt, de har penge i kassen. Ja de har endda så mange at de nu vil købe aktier tilbage. Det har jeg faktisk aldrig oplevet i en US aktie. Denne aktie vil bare stige stille og roligt er min vurdering.
BioDelivery Sciences Announces $25 Million Share Repurchase Program
RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that its Board of Directors has authorized the repurchase of up to $25 million of the Company’s shares of common stock. “This share repurchase program reflects our confidence in the long-term outlook for the Company, including our ability to generate strong cash flow,” said Jeff Bailey, Chief Executive Officer of BioDelivery Sciences International. “Importantly, we remain focused on balancing our disciplined approach to capital allocation against growth opportunities available to BDSI, including continuing to invest in the organic growth of our portfolio along with pursuing strategic acquisitions that will continue to drive long-term shareholder value.”The Company expects to make repurchases at the discretion of management from time to time in the open market, depending on market conditions, or through privately negotiated transactions. The timing and amount of any shares purchased on the open market will be determined based on the Company's evaluation of market conditions, share price and other factors. The Company plans to utilize existing cash on hand to fund the share repurchase program.ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation.CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTSThis press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the Company’s ability to repurchase shares and to generate cash flow) may differ from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.© 2020 BioDelivery Sciences International, Inc. All rights reserved.Contact:Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
Yahoo Finance (finance.yahoo.com)
BioDelivery Sciences Announces $25 Million Share Repurchase Program
RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with ...
finance.yahoo.comSNGX. Firmaet kom for ikke længe siden med gode nyheder fra fase 3 i CTCL. De er ved at klargøre New Drug Application til FDA, samt finde en partner til medicinen.
De bruger meget partner modellen som strategi, hvorfor det kan tage længere tid for deres successer at ramme markedet. Aktien reagerede ikke meget på den gode nyhed, måske fordi markedet afventer resultaterne fra fase 3 i Oral Mucositis. Jeg ser stadig deres vaccine platform som en uopdaget diamant. Dette program kommer dog ikke videre uden penge udefra.SNGX: Cycle 3 Data for SGX301 Phase 3 Trial in CTCL Shows Continued Positive Effects…
By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update Cycle 3 Data Shows Continued Efficacy for SGX301 in Phase 3 CTCL Trial On October 22, 2020, Soligenix, Inc. (NASDAQ:SNGX) announced data from Cycle 3 of the Phase 3 FLASH clinical trial of SGX301 in cutaneous T cell lymphoma (CTCL) shows continued efficacy for the product along with being safe and well tolerated.
Yahoo Finance (finance.yahoo.com)
SNGX: Cycle 3 Data for SGX301 Phase 3 Trial in CTCL Shows Continued Positive Effects...
The important takeaways for investors are that SGX301 is a safe and well tolerated CTCL treatment that shows positive effects in a relatively short period of time and has increasing efficacy with ...
finance.yahoo.comARAV. Kom med denne gode nyhed i forgårs. De får penge i kassen her og nu, samt milestones. Partner overtager alle udviklingsomkostninger, selvom de beholder rettighederne
i resten af verden, herunder det største marked USA. Denne slags aftaler er i mine øjne af det gode, i biotek skal der altid skaffes penge.Aravive and 3D Medicines Announce Strategic Collaboration to Develop and Commercialize AVB-500 in Greater China
Aravive to Receive $12 Million Signing Payment, up to an Additional $207 Million in Future Milestone Payments plus Tiered Royalties 3D Medicines to Lead Clinical Development and Commercialization of AVB-500 in Greater ChinaHOUSTON and SHANGHAI, China, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, and 3D Medicines Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, today announced a collaboration and exclusive license agreement for the development and commercialization of AVB-500 across all oncology indications in mainland China, Hong Kong, Macau, and Taiwan (Greater China).AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and is also evaluating AVB-500 in clear cell renal cell carcinoma.“We believe 3D Medicines is an excellent partner for the development and potential commercialization of AVB-500 in China,” said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. “3D Medicines has built a pipeline with both innovative biological and small-molecule anti-tumor drugs and a professional team with global development, registration and commercialization capabilities. Following promising results from our Phase 1b trial of AVB-500 in platinum resistant ovarian cancer, we are excited to partner with 3D Medicines to potentially bring AVB-500 to patients in China, expanding AVB-500 clinical indications and broadening our geographic reach.”Under the terms of the agreement, Aravive will receive a signing payment of $12 million and be eligible to receive up to $207 million in development and commercial milestone payments with the potential for near term milestone payments of $6 million. In addition, 3D Medicines will pay Aravive tiered royalties ranging from the low double digits to mid-teens as a percentage of annual net sales of AVB-500 in Greater China. 3D Medicines will be responsible for all costs associated with development and commercialization activities for AVB-500 in Greater China. Aravive will retain all rights to AVB-500 in the rest of the world and will continue to be responsible for the development and commercialization of AVB-500 in the United States and other geographies.“We are very pleased to enter into this exclusive collaboration with Aravive,” said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. “We believe that AVB-500, used in combination with existing standard of care therapeutics or Envafolimab, an innovative subcutaneous PD-L1 antibody to be launched in China soon, could alter the treatment paradigm across various tumor types. We are committed to working closely with Aravive to further advance the development of AVB-500 and bring this important potential therapy to patients living with cancer in China.”BFC Group, Ltd. acted as advisors to Aravive, Inc.About AVB-500 AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.About 3D Medicines 3D Medicines, Inc. is a biopharmaceutical company at the stage of late clinical development and early commercialization. With the concept “Help people with cancer live longer and better,” aiming for the future long-term survival of tumor patients, 3D Medicines focuses on the development of differentiated next-generation immuno-oncology drugs, to help cancer patients live longer with better quality of life. 3D Medicines has built a pipeline with both innovative biological and small-molecule anti-tumor drugs, and a professional team with global development, registration and commercialization capabilities. For more information, please visit www.3d-medicines.com.About Aravive Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive recently successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and selected 15 mg/kg as the dose for the pivotal trial. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company also intends to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. For more information, please visit www.aravive.com.Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended), express or implied, such statements regarding 3D Medicines being an excellent partner for the development and potential commercialization of AVB-500 in China, potentially bringing AVB-500 to patients in China, with the goal of improving the cancer treatment landscape across various tumor types, the Company receiving up to $207 million in development and commercial milestone payments under the terms of the agreement, AVB-500, used in combination with existing standard of care therapeutics, being able to alter the treatment paradigm across various tumor types, and the Company initiating a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: whether the collaboration will be successful and result in any development and commercial milestone payments or royalty payments under the terms of the agreement, the ability to bring AVB-500 to patients in China and improve the cancer treatment landscape across various tumor types, , our ability to establish that AVB-500, used in combination with existing standard of care therapeutics, is able to alter the treatment paradigm across various tumor types, our ability to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma as scheduled later this year, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional oncology indications, the Company's dependence upon AVB-500, AVB-500's ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; the Company's reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.Contacts: Media: Sheryl Seapy, W2O [email protected] (213) 262-9390Investors: Luke Heagle, W2O [email protected] (910) 726-1372
Yahoo Finance (finance.yahoo.com)
Aravive and 3D Medicines Announce Strategic Collaboration to Develop and Commercialize AVB-500 in Greater China
AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in ...
finance.yahoo.comFPRX. De kom efter luk igår med denne nyhed, som i eftermarkedet har givet en stigning på 350% under stor omsætning. Det er et fase 2 som nu er afsluttet
men fortsætter de gode takter i fase 3 er der åbnet for et kæmpe marked i andre kræftformer.Zai Lab Partner Five Prime Therapeutics Announces Bemarituzumab Plus Chemotherapy Demonstrates Significant Progression-Free and Overall Survival Benefit Compared to Placebo Plus Chemotherapy in Front-Line Advanced Gastric or Gastroesophageal Junction Cancer
* All three efficacy endpoints in the global Phase 2 FIGHT trial met pre-specified statistical significance • Median progression-free survival (PFS) improved from 7.4 months in the placebo arm to 9.5 months in the bemarituzumab arm. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073 • Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027 • Overall response rate (ORR) improved by 13% (p=0.106) * Bemarituzumab is a potential first-in-class therapeutic antibody targeting FGFR2b+ tumors found in approximately 30 percent of HER2- gastric cancers worldwide * Trial results support FGFR2b as a novel target for the third most common cause of cancer mortality worldwide and highlight development opportunities in other tumors that overexpress FGFR2b SHANGHAI and SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited’s (NASDAQ: ZLAB; HKEX: 9688) partner Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 2 FIGHT trial. The trial compared bemarituzumab (FPA144), a potential first-in-class targeted therapy, in combination with mFOLFOX6 chemotherapy to placebo in combination with mFOLFOX6 in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), HER2-negative front-line advanced gastric or gastroesophageal junction (GEJ) cancer.All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance in the bemarituzumab arm compared to the placebo arm. The Phase 2 FIGHT trial results validate the importance of the novel target FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide. The incidence of all-grade adverse events was comparable in the treatment and control arms of the study (100% vs. 98.7%, respectively), as were serious adverse events (31.6% vs. 36.4%) and deaths due to adverse events (6.6% vs. 5.2%). Adverse events ≥ Grade 3 were reported more frequently in the treatment arm (82.9% vs. 74.0%). Corneal and stomatitis adverse events were reported more frequently in the bemarituzumab arm. No adverse events of retinal detachment or hyperphosphatemia were reported in the bemarituzumab arm. More patients discontinued bemarituzumab (34.2%) compared to placebo (5.2%) due to an adverse event.“These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade,” said Helen Collins, M.D., Five Prime’s Executive Vice President and Chief Medical Officer. “Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance bemarituzumab, the first and only investigational treatment for patients with FGFR2b+ tumors, to the next phase of development. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide.”Five Prime will complete a full evaluation of the available FIGHT Phase 2 data and work with investigators to share the results at an upcoming medical conference.“We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies,” said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research Support at the Jonsson Comprehensive Cancer Center. “This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab’s potential benefit is an important and exciting development.”Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This finding points to additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.About the FIGHT TrialThe FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.Patients’ tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States. Today’s announcement contains the initial top-line results from the primary analysis based on a prespecified number of events.About FGFR2bThe fibroblast growth factor (FGF) / fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with HER2- gastroesophageal cancers overexpress FGFR2b.1About Bemarituzumab Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China. About Gastric Cancer and GEJ CancerGastric cancer, also known as stomach cancer, is the third most common cause of cancer death and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 In countries where routine screening is not readily available, up to 90 percent of patients are diagnosed with advanced disease that is inoperable.3 For HER2- patients, front-line therapy available today is the same systemic chemotherapy available since the 1990s.3,4Gastric cancer is the second most common cancer type (679,100 new cases in 2015) and the second leading cause of death (498,000 deaths in 2015) in China. Both gastric cancer and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a five-year survival of only 35.9%.About Zai LabZai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious diseases and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China’s pharmaceutical market and address unmet medical needs, Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab’s vision is to become a fully integrated global biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.About Five Prime TherapeuticsFive Prime Therapeutics, Inc. discovers and develops innovative protein therapeutics to improve the lives of patients with serious diseases. Five Prime’s product candidates have innovative mechanisms of action and address patient populations in need of better therapies. The company focuses on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime’s product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit www.fiveprime.com. Zai Lab Forward-Looking StatementsThis press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding business strategy, plans and objectives for future operations. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to obtain additional future funding, (2) Zai Lab’s results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s drug candidates, (4) Zai Lab’s ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. References1\. Data on file. Five Prime Therapeutics; 2020.2\. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.214923\. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub44\. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach1Source: Five Prime Therapeutics, Inc.For more information, please contact: Billy Cho, CFO +86 137 6151 2501 [email protected]: Ryo Imai / Robert Flamm, Ph.D. Burns McClellan, on behalf of Zai Lab 212-213-0006 ext. 315 / 364 [email protected] / [email protected]: Pete Rahmer / Mike Zanoni Endurance Advisors, on behalf of Zai Lab 415-515-9763 / 610-442-8570 [email protected] / [email protected] Lab Limited
Yahoo Finance (finance.yahoo.com)
Zai Lab Partner Five Prime Therapeutics Announces Bemarituzumab Plus Chemotherapy Demonstrates Significant Progression-Free and Overall Survival Benefit Compared to Placebo Plus Chemotherapy in Front-Line Advanced Gastric or Gastroesophageal Junction Cancer
- All three efficacy endpoints in the global Phase 2 FIGHT trial met pre-specified statistical significance • Median progression-free survival (PFS) improved from 7.4 months in the placebo arm ...
finance.yahoo.com
VH
MM - All three efficacy endpoints in the global Phase 2 FIGHT trial met pre-specified statistical significance • Median progression-free survival (PFS) improved from 7.4 months in the placebo arm ...
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Mht. Duchenne kandidat. Det er mit indtryk at det selskab, der har stærkest fokus på DMD og er tættest på en godkendelse er Sarepta (SRPT). En anden kandidat (som jeg selv har) er Capricor (CAPR).
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2/3 dele FPRX byttet ud med CAPR (tak for tip), CWBR og GHTX. Sarepta er langt fremme, flere skud i bøssen, men der er lang vej ned hvis det fejler. Derfor valgte jeg CAPR
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Hej MM.
Idag er der en henvisning til et nyt interview med CAPR's CEO til magasinet Lifeextension. (se link)
Sådanne interviews lyder jo altid helt fantastiske og skal derfor nok også tages med alle mulige forbehold. Jeg har dog selv bemærket, at der blandt DMD patient familier er meget store forventninger til deres HOPE studier. Men, men, ....
How To Treat Degenerative Diseases With Exosomes
Dr. Linda Marban, CEO of Capricor Therapeutics, describes how regenerative factors called exosomes have therapeutic capabilities and may help you achieve a healthy longevity.
(www.lifeextension.com)
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Thorkild1
Her link til update fra dem: http://irdirect.net/prviewer/release_only/id/4528616I linket læser jeg følgende afsnit:
The Company continues the development of our late-stage clinical asset, CAP-1002, for the treatment of advanced stages of DMD, and is currently in discussions with potential partners for this program. The FDA has continued to encourage us to conduct a Phase III study, however at this time, Capricor continues to work with FDA to explore alternative pathways forward.Måske er der mulighed for at de kan springe fase 3 over. Chancen er nok mindre, men den er der dog. Min tolkning: Hvis FDA godtager de foreliggende resulater som gode nok, ja så mangler de kun en partner. Nå, vi må se
God weekend
MM -
Hej MM.
Jeg ved, du ligesom jeg selv har satset lidt på selskaber, der har fokus på at udvikle behandling af sjældne sygdomme. RETT, DMD og ALS, etc.Mht. ALS skulle du prøve at tage et kig på BCLI. De kommer med resultater af et større fase 3 double blind forsøg med 200 patienter sidst i november.
Skal man tolke selskabets seneste forretningsaktiviteter (indgåelse af produktionsaftale med partner etc.) så tyder det på, at selskabet selv tror på gode resultater. Men vi ved jo også at den slags forsøg også bliver en skuffelse. Det er IKKE en anbefaling. Disclaimer. Jeg har selv aktien sammen med AKRO, AVXL, CAPR, AUPH og SRNE.
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Det er desværre den slags forsøgsresultater, man må kalkulere med, når man investerer i biotech selskaber. Kursen bliver helt sikkert mere end halveret i dag. Måske -75%
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Biotektosser/Soligenix
I går købte ledelsen op i aktien, et meget stærkt signal at sende, nu her lige før vi får fase 3 resultater fra OM.
CMO 40000 stk, CFO 40000 stk, CEO 60000 stk, CSO 70000 stk. Alle aktier er købt til markedsvilkår, i 2,34.Spændende. Ved gode resultater forventer jeg at den manglende indprisning af godkendelsen i CTCL vil komme oveni stigningen.
VH
MM
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