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Successful drug approvals by the FDA and innovations in the treatment of cancer could provide relevant stocks a boost.
Bristol-Myers Squibb Company
Seattle Genetics, Inc.
Exact Sciences Corporation
Blueprint Medicines Corporation
Inovio Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
Merrimack Pharmaceuticals, Inc.
Foundation Medicine, Inc.
INSYS Therapeutics, Inc.
Inovio Pharmaceuticals (NASDAQ: INO) has been grabbing a lot of headlines over the past few weeks, mostly thanks to its involvement in the race to find a vaccine for COVID-19. The company claimed to have come up with its potential vaccine, INO-4800, in a mere three hours after Chinese researchers publicly published the genetic sequence of the SARS-CoV-2 virus that causes COVID-19. Inovio initiated a phase 1 clinical trial for this vaccine in early April.
Seattle Genetics (NASDAQ: SGEN) shares rose 48.7% in the first half, according to data provided by S&P Global Market Intelligence, after the company gained U.S. regulatory approval for its second drug in less than six months. The U.S. Food and Drug Administration in April approved Tukysa for patients with metastatic HER2-positive breast cancer after approving Padcev in December for locally advanced or metastatic urothelial cancer. Urothelial cancer is the most common form of bladder cancer, and according to Grand View Research, the global drug market for the disease is growing at a 22.9% compound annual growth rate and is set to reach $3.6 billion by 2023.
The path to a COVID-19 vaccine has started to come into view this week, following the stock-moving disclosures of preliminary clinical data for two candidates and a rigorous new regulatory road map from the Food and Drug Administration.
We at Insider Monkey have gone over 821 13F filings that hedge funds and prominent investors are required to file by the SEC The 13F filings show the funds' and investors' portfolio positions as of March 31st, near the height of the coronavirus market crash. We are almost done with the second quarter. Investors decided […]
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that, effective on July 1, 2020, the Compensation Committee of Blueprint Medicines' Board of Directors granted non-qualified stock options to purchase an aggregate of 30,778 shares of its common stock and an aggregate of 15,388 restricted stock units (RSUs) to 13 new employees under Blueprint Medicines' 2020 Inducement Plan.
Blueprint Medicines (BPMC) files an NDA to the FDA for pralsetinib to treat patients with advanced/metastatic RET mutant medullary thyroid cancer and RET fusion-positive thyroid cancers. Stock up.
Shares of Inovio Pharmaceuticals (NASDAQ: INO) were bouncing back on Thursday after being clobbered earlier this week. The biotech stock still has a long way to go to make up its lost ground. Inovio's shares were down 37% this week as of the close on Wednesday.
These companies are fighting disease and improving our standard of care.
Spectrum Pharma (SPPI) saw a big move last session, as its shares jumped more than 9% on the day, amid huge volumes.
If you only looked at stock performance, you might conclude that Inovio Pharmaceuticals (NASDAQ: INO) is a better coronavirus stock than Moderna (NASDAQ: MRNA). While Moderna's share price has more than tripled so far in 2020, Inovio stock has skyrocketed more than 700%. There's a strong case to be made that Moderna is actually the better pick of these two coronavirus-focused biotech stocks.
Drugs acquired in takeover accounted for greater than 70% of company sales in first quarter. More medications are poised for approval this year Continue reading...
Shares of Inovio Pharmaceuticals Inc. declined 15.3% in trading on Wednesday after Maxim Group downgraded the stock to hold from buy. Inovio, which is developing a COVID-19 vaccine, had announced some limited, clinical data about how the candidate performed in a Phase 1 trial on Tuesday. Maxim analysts said it appears that the COVID-19 "opportunity" is already baked into the valuation as shares of Inovio have soared 593.0% year-to-date. "In our opinion, the success of INO-4800 is priced into the shares," they wrote in a note to investors on Wednesday. The company's stock hit a record high of $31.69 on Monday, the day before it released the positive, yet limited data about its vaccine candidate. Inovio said that the full trial data will be published in a peer-reviewed medical journal. The stock then tumbled after it shared the data on Tuesday, closing at $26.95. The S&P 500 is down 4.0% year-to-date.
The frantic global search for a vaccine or therapy for the coronavirus has sent the valuations of previously small cap biotechs to unimagined heights over a short period of time. There can’t be many better examples for the phenomenon than Inovio Pharmaceuticals (INO). Investors have cheered the progress of its COVID-19 DNA vaccine candidate INO-4800 by sending shares on a mightily impressive run – the stock is up by 505% since the turn of the year (even after today's 25% sell off).The massive gains, the richly valued $3.2 billion market cap and a track record that – while promising – has yet to yield any significant results have prompted a rethink at investment firm H.C. Wainwright.“We believe the risk/reward ratio for Inovio has increased significantly as many open questions remain,” said firm analyst Ram Selvaraju, “Including the strength and duration of neutralizing antibodies and T cell responses that may be generated in human trials and the effective protection the vaccine may demonstrate in animal challenge studies.” “As a reminder,” concluded the 5-star analyst, “There is no approved human vaccine for any type of coronavirus, while no DNA vaccines have been approved for human use yet.”INO-4800 is currently in a Phase 1 trial with interim data expected any day now. A Phase 2/3 trial of INO-4800 is also planned to go ahead this summer. The company will need to demonstrate why its DNA based approach is “superior.” Proof Inovio can run the gamut from market authorization, to maintaining enough supply to pricing the vaccine reasonably while also driving profit, will also be required. Lastly, Selveraju says, Inovio’s offering will need to show “evidence that the immunity afforded by vaccination lasts sufficiently to have a significant impact on the spread of the coronavirus pandemic.”As these questions remain to be answered, Selvaraju slashed his rating on INO from Buy to Neutral, while removing his price target. (To watch Selvaraju’s track record, click here)Selveraju’s view is partially echoed by his colleagues across the Street, with 5 analysts saying Hold, and 3 suggesting Buy. Yet, the average price target of $26.50 implies 31% upside from current levels. (See Inovio stock-price forecast on TipRanks)To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Bristol Myers (BMY) could produce exceptional returns because of its solid growth attributes.
Pfizer (PFE) on Wednesday announced early positive results for the first phase of its coronavirus vaccine trial, sparking hopes that an effective treatment can help turn the tide amid an implacable surge in new infections.
The Food and Drug Administration’s new guidance document for developers of Covid-19 vaccines doesn’t spell out a timeline. SVB Leerink analyst Geoffrey Porges says the guidelines point firmly toward no vaccine being made available until next year.
Geron Corporation (GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company’s application for orphan drug designation of its first-in-class telomerase inhibitor, imetelstat, as a potential treatment for myelodysplastic syndromes (MDS). The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July.
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers. Pralsetinib is an investigational, once-daily precision therapy designed to potently and selectively inhibit RET fusions and mutations, including predicted resistance mutations.
Treatments for peanut allergy and Parkinson's disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business, a Reuters review of filings and interviews with executives show. The Food and Drug Administration (FDA) has approved more than 30 new medicines since January, but at least five drugmakers including Bristol Myers Squibb, Sanofi , Neurocrine Biosciences, Endo Pharmaceuticals and Aimmune have changed their launch plans.
Inovio Pharmaceuticals Inc (NASDAQ: INO) reported Tuesday interim Phase 1 readout for INO-4800, its DNA vaccine candidate against the novel coronavirus.The Inovio Analyst: Piper Sandler analyst Christopher Raymond maintained a Neutral rating and $8 price target for Inovio.The Inovio Thesis: There wasn't a ton of detail at this point from the readout except that 94% or 34 of the 36 patients, demonstrating an "overall immunological" response at week 6, with a benign safety profile, Raymond said in a note. This appeared consistent with preclinical data published in May.Raymond, however, said he would like to see data on neutralizing antibody production and T cell response generation separately and broken out by dose before drawing too many conclusions.Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.The analyst expressed satisfaction with the safety data reported by Inovio."While initial human immunogenicity data is a necessary first step toward a viable COVID-19 vaccine, at this stage it's difficult (if not impossible) to determine which development candidate(s) will fare best in large-scale clinical trials," Raymond wrote in the note.An equally important consideration is scalability.The analyst is concerned over Inovio's dispute with its longtime manufacturing partner VGXI.Investor hopes for INO-4800 to emerge as a viable vaccine candidate to address the current COVID-19 pandemic could prove unrealistic, barring clarity on the manufacturing scalability front, the analyst said.Inovio Price Action: Inovio shares tumbled 14.9% to $26.95.Latest Ratings for INO DateFirmActionFromTo Jun 2020HC Wainwright & Co.DowngradesBuyNeutral Jun 2020Cantor FitzgeraldMaintainsOverweight Jun 2020StifelDowngradesBuyHold View More Analyst Ratings for INO View the Latest Analyst Ratings See more from Benzinga * Inovio Analyst Downgrades COVID-19 Vaccine Developer, Says Risk Higher After Rally * The Week Ahead In Biotech (June 28- July 4): Pending Clinical Readouts In Focus During A Short Holiday Week(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Shares of biotech company Inovio Pharmaceuticals (INO) fell sharply on Tuesday after announcing updates to its Covid-19 vaccine candidate, INO-4800.
A Benchmark Research analyst expects that the Food and Drug Administration will allow Inovio Pharmaceuticals Inc.'s COVID-19 vaccine candidate to move to a Phase 2/3 study. Benchmark's Aydin Huseynov noted that while the Phase 1 efficacy data provided by Inovio before the market opened on Tuesday morning was "insufficient to make a judgment call about the future utility of the vaccine," he is still encouraged by the news. He reiterated a buy rating. The company's stock was down 23.7% in trading on Tuesday. Since the start of the year, Inovio's stock has soared 628.3%, while the S&P 500 is down 5.5%.
The coronavirus pandemic is “not even close to being over,” according to the head of the World Health Organization, and the worst is still to come, in what was a grim assessment of the state of affairs some six months after the first cases were reported in China.
The Food and Drug Administration (FDA) issued new rules on Tuesday for the companies developing COVID-19 vaccines. "While the FDA is committed to help expedite this work, we will not cut corners in our decision making, and we're making clear in our guidance what are the data that we need, that should be submitted, to meet our regulatory standards of approval," FDA commissioner Dr. Stephen Hahn said Tuesday during a Senate committee hearing. The guidance states that the primary efficacy endpoint in a placebo-controlled efficacy clinical trial should be at least 50%, meaning the vaccine needs "to reduce the risk of disease caused by COVID-19 by 50%" when compared to the placebo, according to Brad Loncar, a longtime biotech investor and CEO of Loncar Investments. There are a number of drugmakers developing COVID-19 vaccine candidates including AstraZeneca and the University of Oxford, Inovio Pharmaceuticals Inc. , and Moderna Inc. , two of which (Inovio and Moderna) have disclosed preliminary data from their Phase 1 trials. A return to economic normalcy has largely been tied to the arrival of vaccines that can prevent infections from the coronavirus. "There is no guarantee...that we will have a safe and effective vaccine, but we are cautiously optimistic," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, testified during the same hearing.