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Amgen Nears a Death CrossMany stocks have hit new highs this month, but Amgen isn’t one of them. The biotech may be showing signs of topping out. The main thing jumping off its chart now is the falling 50-day simple moving average (SMA). Current prices have dropped back to the 200-day SMA. If the trend continues, it could produce a “death cross.” Next, why is AMGN’s 50-day SMA falling? The reason can be found on October 8 when a potential heart drug failed to reduce death in a phase 3 trial. Its partner, Cytokinetics , lost more than 40 percent of its value on the news. Third, AMGN’s last peak occurred at almost exactly the same price around $241 where it ended 2019. It’s back in negative territory YTD and at risk of potentially bearish window dressing into December. Fourth, stochastics have been overbought -- even as the stock made a lower high versus early October. Finally, relative strength has been poor in big pharma. Most of the gains in health care lately has been in HMOs, hospitals and medical devices. For an example of the weakness, just look at Pfizer or Gilead Sciences. Even with Covid products, they haven’t been able to advance. Investors should always be wary of stocks falling when the market’s rising because it can foreshadow broader distribution. TradeStation is a pioneer in the trading industry, providing access to stocks, options, futures and cryptocurrencies. See our Overview for more.
NASDAQ:AMGNShort
by TradeStation
Vaccibody / Genentech deal closed #biotechVaccibody announces the closing of the worldwide license and collaboration agreement with Genentech All antitrust contingencies required to close the agreement with Genentech, regarding the development of individualized neoantigen cancer vaccines, have been satisfied Oslo, Norway, November 06, 2020 – Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced the closing of its exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, following expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended. As announced on October 1, 2020, Vaccibody and Genentech have entered into an agreement for the development and commercialization of DNA-based individualized neoantigen vaccines. With the expiration of the HSR Act waiting period, the agreement is now effective and Vaccibody is entitled to receive USD 200 million in initial upfront and near-term payments. Under the terms of the agreement, in addition to the USD 200 million in initial upfront and near-term payments that Vaccibody is entitled to receive, Vaccibody will be eligible to receive up to a further USD 515 million in potential payments and milestones, plus low double-digit tiered royalties on sales of commercialized products arising from the partnership. Through this partnership, Genentech and Vaccibody will progress Vaccibody’s investigational product candidate, VB10.NEO, into clinical trials in the U.S. and in Europe. Following completion of a planned Phase 1b trial, Genentech will have responsibility and bear all costs for clinical, regulatory, manufacturing and commercialization activities. About Vaccibody Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. The Company is using the Vaccibody technology to generate best-in-class therapeutics against cancers and infectious diseases with a high unmet medical need. Vaccibody is developing cutting-edge, targeted DNA vaccines for clinical use, based on a deep understanding of immunological principles. Vaccibody’s vaccines specifically targets antigens to Antigen Presenting Cells (APC), which are essential for inducing rapid, strong and specific immune responses and elicit efficacious clinical responses. By intelligent design, Vaccibody’s vaccines can be tailored to induce the desired immune response profile correlating with protection for each specific disease with any given antigen. Hence, the Vaccibody vaccine platform has the potential to address many disease areas with a high unmet medical need such as cancer and infectious diseases. Vaccibody has collaborations with Roche and Genentech, and Nektar Therapeutics and will pursue further collaborations and strategic partnerships to maximize the value of its technology platform. Vaccibody’s shares are traded on Merkur Market, a trading platform operated and wholly owned by Oslo Børs ASA, the Oslo Stock Exchange. Further information about the Company may be found at www.vaccibody.com
VLong
by savepiginvest
Genmab $GMAB all time high after Q3 earnings beat #biotechNovember 4, 2020; Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2020 Highlights Novartis granted U.S. FDA approval for Kesimpta® (ofatumumab) in relapsing multiple sclerosis Janssen and European Myeloma Network achieved positive topline results from Phase 3 APOLLO study of daratumumab in relapsed or refractory multiple myeloma Janssen was granted U.S. FDA approval for DARZALEX® (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma based on Phase 3 CANDOR study DARZALEX net sales increased 35% compared to the first nine months of 2019 to USD 2,937 million, resulting in royalty income of DKK 2,898 million for the first nine months of 2020 Genmab (GNMSF) commenced binding arbitration of two matters under daratumumab license agreement with Janssen Announcement of plan to transition Arzerra® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S. “Genmab continued to deliver on the promise of improving the lives of patients, with multiple regulatory milestones for Genmab-created products under development by our partners, including the exciting U.S. FDA’s approval of Kesimpta and the 8th U.S. FDA approval for DARZALEX,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “During the first nine months of 2020, with our solid financial footing Genmab has continued its focused investment in advancing its proprietary antibody product pipeline and building its capabilities as we evolve into a fully integrated biotech.” Financial Performance First Nine Months of 2020 Revenue was DKK 8,067 million in the first nine months of 2020 compared to DKK 2,405 million in the first nine months of 2019. The increase of DKK 5,662 million, or 235%, was primarily driven by the upfront payment from AbbVie pursuant to our new collaboration announced in June and higher DARZALEX royalties. Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 2,937 million in the first nine months of 2020 compared to USD 2,168 million in the first nine months of 2019, an increase of USD 769 million, or 35%. Operating expenses were DKK 2,641 million in the first nine months of 2020 compared to DKK 1,943 million in the first nine months of 2019. The increase of DKK 698 million, or 36%, was driven by the advancement of epcoritamab (DuoBody®-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline. Operating income was DKK 5,426 million in the first nine months of 2020 compared to DKK 462 million in the first nine months of 2019. The increase of DKK 4,964 million was driven by higher revenue, which was partly offset by increased operating expenses. Outlook Genmab is maintaining its 2020 financial guidance published on August 20, 2020.
OMXCOP:GMABLong
by savepiginvest
Wedge setup: Pre-R/S #VolatilityWatchI’m sharing this as an impromptu for this upcoming weeks Earnings regarding what stock looks like pre-R/S, being this severely damaged. I look forward to seeing how management goes forward with addressing the company’s current financial state. Technicals : - Stock at bottom of wedge = Bullish, for bounce play, especially “good” on news. - Weekly RSI “oversold” - Trend lines converge into end of November. If we don’t get all news next week, likely test local ceiling/ floor by EOM. Why? : After several offerings and uncertainty due to loan covenant EYPT had made with CRG, Eyepoints stock price has been devastated. (Don’t forget covid). EYPT has upcoming Earnings on November 4th and had previously promised data on anti-vegf treatment “EYPT 1901” by October, 2020. With November and election days away, it is my belief that EYPT management/ BOD are waiting till next week to give news in hopes of catching good news pump from The company update in hopes they can serve Investors a side dish of R/S (Reverse split) to help EYPT meet listing requirements and to set themselves up for their next offering they’ll need - unless the company had some miracle blowout quarter., that is.. Furthermore, with rates as low as they are and as mad as it may sound, we may see them leverage the current low rates to keep cash afloat, as borrowing is currently very cheap. Again, I’m sharing this as an impromptu for this upcoming weeks’ Earnings and * hopeful * news regarding what stock looks like pre-R/S, being this severely damaged, and with supposed upcoming FDA filings. I look forward to seeing how management goes forward with addressing the company’s current financial state and using this data to help future financial decisions. Disclaimer: I am not a financial advisor. This is not a buy/ or sell recommendation it is to be used for educational purposes only.
NASDAQ:EYPTLong
by follow_the_money
Healthcare Critical LevelTechnical Analysis The 200ema has been tested several times, and has worked very well as a mid-term support level. Risk reward ratio is easy to set-up with a 3:1 ratio approximately. Sector & Industry Analysis It is important to note that the industries inside the sector have different performance, which has been very useful to analyze what the market thinks of the risk of healthcare with the election coming up. The following list is the Healthcare Industries with a 6-month performance % move, as well as a some good ETF to follow/trade: Healthcare Technology --> +56% // have not found appropriate ETF. Biotechnology --> +21% // XBI (smaller biotech), IBB (large-cap biotech), ARKG (genomics) Healthcare Equipment --> +19% // IHI Healthcare Providers --> +5.51% // IHF Pharmaceuticals --> -1.3% // IHE
AMEX:XLV
by dorfmanmaster
ALRN Weekend Data CatalystALRN had some weekend news. Will be interesting to see if it can break above a near-two-year resistance level. I didn't show it all the way back to November of 2018 but if you take the chart out further, you can see this level holding as resistance. "Saturday, the company announced new positive clinical data from its ongoing Phase 1b trial. The trial demonstrated clinical proof of concept that treatment with ALRN-6924 prior to second-line topotecan administration resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia. This was in patients with p53-mutated small cell lung cancer. The results were featured in a late-breaking poster presentation entitled, 'Prevention of Chemotherapy-induced Myelosuppression in SCLC Patients Treated with Dual MDM2/MDMX Inhibitor ALRN-6924.'" Original Quote Source: 5 Penny Stocks On Robinhood To Buy Under $2; Are They Too Risky?
NASDAQ:ALRN
by PennyStocks101
Ultimovacs Announces Updated Positive Results from Phase I TrialOslo, 19 October 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today announced five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer. The results confirm achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit. "Ultimovacs has established a growing body of clinical data demonstrating a strong safety and tolerability profile for UV1 and a range of preliminary efficacy signals in several cancer indications, all of which supports the further development of our proprietary cancer vaccine candidate," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up results announced today demonstrate that treatment with UV1 is safe both at the time of administration and throughout the follow-up period of at least 5 years. Non-small cell lung cancer highly expresses telomerase and remains an indication in great need of new treatment options for patients." In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as maintenance treatment. Outcomes of the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the cut-off date of June 2020, every patient in the trial reached at least 60-months of follow-up post treatment with UV1. At the five-years landmark, the Overall Survival (OS) rate was 33% and median Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up period, none of the patients experienced unexpected safety issues related to UV1. Further, none of the patients alive after 5 years have received other immunotherapy after the vaccination with UV1. "At the time of the study initiation, there were no checkpoint inhibitors available for treatment of this patient population. For patients that received a second-line of chemotherapy the expected 5-year survival rate was less than 5 percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our Phase I study is non-randomized and conducted in a small population, it is promising to see that UV1 was safe and well-tolerated and that using UV1 as a maintenance therapy could potentially provide benefit to patients in need of novel approaches." Ultimovacs presented 48-months of follow-up data at the Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting in November of last year.
OSL:ULTILong
by savepiginvest
Unheard gross margins of 95% and a $800B TAM : $GDRXGoodRx is a free-to-use service that allows Americans to find the lowest-cost prescription drugs in their area. The company makes money by receiving a commission for every prescription order filled via its coupons, which are accepted by nearly all 70,000 pharmacies across the country. -Most Downloaded medical app in US with 4.8/5 rating(700,000+ reviews) -Partnership with Kroger -Competing with TDOC with the launch of HeyDoctor - Rising prices of pharmaceuticals and their mission is to lower the cost of healthcare -95% Gross margin (What?!?!). 30% Operating margin. - $75M Free cash flow. - TAM $800 Mn - NPS 86 - 4.6/5 Glassdoor - Founder led Concerns, 1. P/S of 37.1 and 201 PE. Average PE in healthcare is 24. 2. IPO hype(good for trades though) 3. 94% of top line revenue still coming in from prescription stream(concentration risk?) which grew 42% Q1. 4. Regulations 5. International expansion? 6. 4 holders own 60-65% of the company(Both good and bad) TA, 1. Wedge breakout 2. Potential base of Cup. 3. Low volume on Pullback Not a long term position yet. Swing trade. Entry : break of 52 Stop loss : 49 (-7.8%)
NASDAQ:GDRXLong
by ashainp
2
Vaccibody is now public company listed on Euronext MerkurVACCIBODY ENTERS INTO WORLDWIDE LICENSE AND COLLABORATION AGREEMENT WITH GENENTECH, A MEMBER OF THE ROCHE GROUP, TO DEVELOP INDIVIDUALIZED NEOANTIGEN CANCER VACCINES Vaccibody enters into worldwide, exclusive license and collaboration agreement with Genentech to develop VB10.NEO, individualized neoantigen cancer vaccines OCTOBER 1, 2020 VACCIBODY LISTS ON OSLO STOCK EXCHANGE’S MERKUR MARKET Vaccibody Lists on Oslo Stock Exchange’s Merkur Market OCTOBER 7, 2020
V
by savepiginvest
PCI Biotech $PCIB bullish breaching 100EMA coming into Q4* Norwegian Drug Delivery Platform Biotech operating within the Oslo Cancer Cluster * Notoriously volatile norwegian small cap with large amount of stock held by enthusiastic retail investor crowd. * Ongoing research collaboration with AstraZeneca recently concluded, longs betting on partnership deal incoming. * Stock typically rallies ahead of quarterly reports and experiences sell the news events. * Norwegian biotech flying at All Time High valuations after recent Vaccibody partnership with Genentech.
OSL:PCIBLong
by savepiginvest
$OCUL can rise in the next daysContextual immersion trading strategy idea. Ocular Therapeutix, Inc., a biopharmaceutical company, focuses on the formulation, development, and commercialization of therapies for diseases and conditions of the eye using its bioresorbable hydrogel platform technology. The share price rose after the company announced topline phase 1 clinical trial results of OTX-CSI. The demand for shares of the company still looks higher than the supply. These and other conditions can cause a rise in the share price in the next days. So I opened a long position from $11,22; stop-loss — $10,00. Information about take-profits will be later. Do not view this idea as a recommendation for trading or investing. It is published only to introduce my own vision. Always do your own analysis before making deals. When you use any materials, do not rely on blind trust. You should remember that isolated deals do not give systematic profit, so trade/invest using a developed strategy. If you like my content, you can subscribe to the news and receive my fresh ideas. Thanks for being with me!
NASDAQ:OCULLong
by KozakHlib
IBB wave checkLooks like ABC pattern just wrapped up and another wave has already played out as well. EW could be so complicated so we don't know what pattern will be going forward at this point. The RSI bullish divergence was missed though. hats off to those who caught it. Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation. Personally I hold both long term long positions and occasionally short term short position, for disclosure purpose.
NASDAQ:IBB
by hanzhao311
Biotech etf catching up to the Qstested recently pitchfork upper line and bounced off..bullish sign. depending on timeframe but for this one BBC is catching up to the Qs. short term it looks just as over-exteneded as the Qs. trading will get very choppy short term. Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation. Personally I hold both long term long positions and occasionally short term short position, for disclosure purpose.
AMEX:BBC
by hanzhao311
2
MESOBLAST (MSB) - FDA will likely approve Ryoncil (analysis)MSB is developing Ryoncil - an IV stem cell therapy for the treatment of acute graft versus host disease (aGVHD) in paediatrics. aGCHD is a potentially life threatening (up to 70-90% mortality) complication of bone marrow transplants (indicated for leukemia/lymphoma etc). Ryoncil has been accepted by the FDA for priority review with a PDUFA action date of US 30th September (1st Oct in AUS). Why might the FDA approve Ryoncil? Probability wise: - Oncology therapy's have an average 88% probability of being approved once they have been accepted for review (data averaged from results from Wong et al (2018), Thomas et al (2016), Hay et al (2014), and DiMasi et al (2010)). - As part of the review, the FDA requested a recommendation from the Oncologist Drugs Advisory Committee (clinical oncology academics and statisticians) who on Aug 13th voted 9:1 that the available data supports the efficacy of Ryoncil. - Ryoncil has been approved in Japan for the last 5 years with strong yoy growth. Benefit-risk ethics analysis: - There are no FDA approved treatments for aGCHD in pediatrics and no therapies are considered standard of care. - Ryoncil is effective vs placebo (28d survival 64% vs 38%, 100d survival 79% vs 54%). - Adverse Effects of Ryoncil were not statistically different from placebo. In fact unapproved treatments (steroids) carry high risk of toxicity. - aGCHD has a 70-90% mortality rate, there are no FDA approved treatments, Ryoncil appears to be effective, risk of doing harm by approving Ryoncil is low. It seems like the ethical decision is to approve Ryoncil. Why might not the FDA approve Ryoncil? - The FDA prefers double-blinded, placebo-controlled RCT's to show effectiveness. However, due to the high mortality rate of aGCHD, enrolling children into an RCT is clearly not ethical. I'd argue that the single arm study comparing to an external control population is as good as you're gonna get. It also does not need to be blinded as the primary endpoint is mortality. The 9:1 ODAC vote seems to support this. - The study was small (N=14, N=13). It might be reasonable for the FDA to ask for another (potentially larger) study to replicate the results which is a risk. - Quality control concerns. The FDA raised concerns that the way MSB measure the potency of the Ryoncil (CQA's) may not be enough to ensure the clinical effectiveness of the product. I'm no expert in this part but when MSB responded to these concerns in the webcast, they kind of just reiterated the CQA's from their manufacturing were very high but didn't really address the concern that the CQA's might not translate to clinical effectiveness. It might be reasonable for the FDA to ask for more data on this. - Even if more data is requested, Ryoncil can still be provisionally approved. Conclusion: The FDA will likely approve or provisionally approve (with the request of more data) Ryoncil therapy for pediatric aGVHD in the US which will strongly improve the revenue potential of MSB.
ASX:MSBLong
by Sean_Kenworthy