Spezialisten kommen von Janssen zu Geron die schon dort Imetelstat weiterentwickelt haben, für mich ein super Hinweis, dass Imetelstat eine große Zukunft bei der Leukemiebehandlung haben wird, Janssen spielte ein dreckiges Spiel mit Geron, jetzt hat es Geron selbt in der Hand einen Blockbuster auf den Markt zu bringen:
Geron Expands Senior Leadership of Its Development Team GlobeNewswire?April 18, 2019
MENLO PARK, Calif., April 18, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (GERN) today announced an expansion of its development team?s senior leadership with the addition of three highly experienced professionals for key functional areas. Their oncology and drug development expertise will support Geron?s late-stage clinical development, including the planned opening of the Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes for screening and enrollment by mid-year 2019.
Vice President, Clinical Development ? Faye Feller, M.D.
Prior to Geron, Faye Feller, M.D., was Senior Director, Clinical Leader on the myeloid program at Janssen Research and Development, LLC (Janssen). Prior to that role, Dr. Feller was a physician for multiple clinical trials of late-stage development assets at Janssen, including the IMbark Phase 2 clinical trial of imetelstat, and was responsible for protocol writing, regulatory interactions, medical monitoring, study results interpretation and preparation of abstracts and final study reports. Prior to Janssen, Dr. Feller was an attending physician and instructor in the leukemia department of Memorial Sloan Kettering Cancer Center in New York. Dr. Feller holds a B.A. from New York University and an M.D. from Mount Sinai School of Medicine. She completed her residency in internal medicine at Mount Sinai Hospital and her fellowship in medical oncology at Memorial Sloan Kettering Cancer Center.
As Vice President, Clinical Development, Dr. Feller will provide hematology-oncology medical expertise to the clinical science and operations teams in the execution and monitoring of clinical trials. In addition, she will also act as the primary medical point of contact between Geron and other medically qualified healthcare professionals, including clinical investigators, prescribers, medical professionals at payer organizations and regulatory authorities.
Vice President, Clinical Science and Operations ? Laurie Sherman
Laurie Sherman has more than 20 years of experience in oncology drug development. Prior to joining Geron, Ms. Sherman was Senior Director, Compound Development Team Leader for non-small cell lung cancer (NSCLC) assets at Janssen, where she was responsible for multiple aspects of drug development, including: clinical strategy and execution; chemistry, manufacturing and controls (CMC); toxicology; and clinical pharmacokinetics. Preceding that role, Ms. Sherman held several senior positions in the late-stage team at Janssen, including Senior Director, Myeloid Portfolio Clinical Scientist Leader, where she led development strategy and overall clinical execution of myeloid clinical trials, including the imetelstat clinical trials, IMerge and IMbark. Prior to that role she was Senior Director, Lead Project Scientist on the ibrutinib mantle cell lymphoma program. Ms. Sherman has held various positions with increasing responsibilities across various drugs? product life cycles, from initial Phase 1 clinical trials through late-stage development, including operational leadership for pivotal Phase 3 clinical trials and supporting regulatory filings of New Drug Applications and Marketing Authorization Applications at multiple pharmaceutical companies and organizations, including: GlaxoSmithKline plc; Pfizer Inc.; World Wide Clinical Trials, Inc.; and Affiliated Research Institute. Ms. Sherman has a B.S. in nursing from the University of Washington.
As Vice President, Clinical Science and Operations, Ms. Sherman will provide oversight and management of current and future clinical trials, as well as strategic and technical guidance to and management of the Company?s contract research organization and other vendors supporting clinical operation activities. She will also directly oversee and manage internal operations and personnel involved with clinical operations, clinical science, data management and medical writing functions.
Vice President, Quality ? Denise Grippo
Denise Grippo has more than 18 years of experience in drug development. Prior to joining Geron, Ms. Grippo was Vice President, Quality at Iovance Biotherapeutics, Inc. where she was responsible for developing and executing quality policies and plans to ensure lifecycle management of their early- and late-stage clinical oncology portfolio. In addition to Iovance, Ms. Grippo has held various quality and compliance positions with increasing responsibility and scope at XenoPort, Inc.; Mylan Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Alvogen, Inc.; and Marietta Corporation. Ms. Grippo has an M.S. in clinical chemistry from University of Scranton and a B.A. in biology from Temple University.
3 Cancer Treatment Stocks to Buy in April [Motley Fool] George Budwell, Keith Speights, and Sean Williams, The Motley Fool ,Motley Fool?April 20, 2019
Cancer drug sales are on track to eclipse the $200 billion mark early in the next decade, thanks to an innovation bonanza that's transformed oncology into the fastest-growing segment across the entire pharmaceutical industry. Specifically, a recent report by EvaluatePharma estimated that global cancer drug sales will rise at a blistering compound annual growth rate of 12% over the next five years.
With this double-digit growth trend in mind, we asked three of our Motley Fool contributors which cancer treatment stocks they think are worth buying this month. They picked Geron (NASDAQ: GERN), AbbVie (NYSE: ABBV), and Exelixis (NASDAQ: EXEL). Here's why. Cancerous cells floating in plasma. Cancerous cells floating in plasma.
Image source: Getty Images. A path forward
George Budwell (Geron): Small-cap cancer companies normally aren't even worth considering as investing vehicles. Developing cancer treatments is prohibitively expensive after all. Geron, however, isn't your typical small-cap cancer play.
The brief rundown is that Geron is developing a first-in-class telomerase inhibitor, imetelstat, for patients afflicted with a blood-based malignancy known as lower risk myelodysplastic syndromes (MDS). Per the company's latest update, the drug's pivotal trial for MDS should commence by the middle of this year. So, depending on how quickly enrollment goes, Geron might be able to file for imetelstat's regulatory approval as early as mid-2021.
Why is Geron worth a deeper dive? Imetelstat's MDS indication represents an enormous commercial opportunity for the company. While the entrance of potential competitors like Acceleron Pharma and Celgene's luspatercept has muddied the waters from a commercial standpoint, Geron's management still believes that imetelstat could generate sales in excess of $500 million in the MDS setting. That's a sizable payday for a company with a sub-$340 million cap at the time of writing.
What's the risk? With less than $182 million remaining in cash, Geron is probably going to have to raise capital at some point during imetelstat's late-stage development. The bright side is that Geron's share price has been bolting higher heading into the start of imetelstat's late-stage MDS trial, and this upward trend should continue based on the magnitude of this commercial opportunity. Therefore, risk-tolerant investors might to take a flier on this deeply undervalued cancer stock this month. A growing oncology franchise
Keith Speights (AbbVie): Yes, AbbVie is best known for immunology rather than oncology. That's understandable for a company that claims the world's top-selling drug, Humira, which treats a wide range of autoimmune diseases. But AbbVie is steadily becoming a force to be reckoned with in cancer treatment.
The company's No. 2 product, Imbruvica, is already a major success. AbbVie thinks the drug will generate peak annual sales of around $7 billion in the future. Imbruvica is already more than halfway there, raking in nearly $3.6 billion last year. AbbVie also has a fast-rising star with leukemia drug Venclexta.
When asked at the Cowen Healthcare Conference in March what investors are missing about AbbVie, the company's president, Michael Severino, listed the strength of AbbVie's early-stage pipeline near the top of the list. Several promising cancer drugs are in that early-stage pipeline, and Severino expects solid progress for these drugs in the next few years.
Of course, we have to work immunology into any conversation about AbbVie. Although Humira faces biosimilar competition in Europe, the drug remains strong in the U.S. and will likely continue to dominate for several more years. In the meantime, AbbVie expects approvals this year for two new drugs that could take the baton from Humira: risankizumab and upadacitinib.
AbbVie currently trades at only 8.5 times expected earnings. With a dividend yield north of 5% on top of this bargain valuation, I think AbbVie is a great cancer treatment stock to buy in April. The top value stock among cancer drug developers
Sean Williams (Exelixis): Although big pharma is often viewed as the smartest way for investors to take advantage of novel cancer treatments, my preference among cancer stocks has been the same for years: midcap biotech Exelixis.
Admittedly, Exelixis isn't particularly diversified, which is usually a red flag for pharma and biotech investors. But Exelixis' bread-and-butter drug has delivered multiple label expansions, has additional indication opportunities, and has made Exelixis one of the cheapest growth stocks you can buy in the entire healthcare sector.
Exelixis' Cabometyx was first approved in April 2016, following positive data from the Meteor trial, as a second-line treatment for patients with advanced renal cell carcinoma (RCC). It was the first therapy to deliver a "trifecta" in treating advanced RCC patients. In other words, it provided a statistically significant improvement in objective response rate, progression-free survival, and median overall survival.
In December 2017, following impressive data in the midstage Cabosun study, Cabometyx's label was expanded to include first-line treatment for advanced RCC patients. Rather than trailing Bristol-Myers Squibb's (NYSE: BMY) immunotherapy Opdivo, which it did in second-line RCC, Cabometyx beat Opdivo to the punch in first-line RCC.
And most recently, Cabometyx got the green light from the Food and Drug Administration in patients with previously treated hepatocellular carcinoma (HCC) following strong data in the phase 3 Celestial trial. Both indications (RCC and HCC) may offer more than $1 billion in peak annual sales.
Furthermore, Exelixis is working together with its biggest RCC competitor, Bristol-Myers, on a possible combination therapy in first-line RCC. The CheckMate 9ER trial should read out soon, and if it winds up blowing Pfizer's (NYSE: PFE) Sutent out of the water (Sutent was the standard of care before Cabometyx came along), Exelixis could secure itself a larger share of first-line RCC, even if sharing with Bristol-Myers.
All told, Exelixis is forecast to nearly double sales from $854 million to $1.6 billion between 2018 and 2022, while doubling earnings per share from $1.05 to $2.06 between 2019 and 2022. That's a compound annual sales growth rate of at least 17% and a price earnings-to-growth (PEG) ratio of less than 0.5. For added context, a PEG ratio below 1 is typically considered to undervalued. Exelixis is probably the top value among cancer stocks.
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George Budwell owns shares of AbbVie, Celgene, Geron, and Pfizer. Keith Speights owns shares of AbbVie, Celgene, and Pfizer. Sean Williams owns shares of Celgene and Exelixis. The Motley Fool owns shares of and recommends Celgene and Exelixis. The Motley Fool has a disclosure policy.
warum : 1) Imetelstat offiziell in Phase III 2) Keine Schulden 3) 100% iges Eigentum an Imet und eine Schatztruhe an Patenten. 4) Bestes Bring-to-Market-Team an Ort und Stelle 5) FDA-Fast-Track-Status 6) FDA-Orphan-Drug-Status 7) Die Phase-3-Transformationsstudie von GERN hat eine 90-prozentige Chance auf FDA-Zulassung, da wir über einen Fast-Track- und Orphan-Drug-Status verfügen. 8) GERN hat 162,3 Mio. USD in bar bei der Bank. 9) GERN verfügt über Steuergutschriften in Höhe von über 1 Milliarde US-Dollar. 10) Es hat sich gezeigt, dass GERNs Medikament Imetelstat in Kombination mit dem Medikament Venetolax AML in Tierversuchen heilt. 11) GERN hat einen zweiten Vertrag mit JNJ / Janssen mit Meilensteinzahlungen in Höhe von 75 Mio. USD plus Lizenzgebühren abgeschlossen. 12) GERN auch ein Deal mit BTX
Charttechnische :Tasse und Henkel Formation ?Vielleicht ?