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Food and Drug Administration

10:08 a.m. Dec. 6, 2019 - By Jaimy Lee
Alzheimer’s expert says more clinical trials are needed for controversial Biogen drug “The bottom line is we need more data to evaluate the effectiveness,” Dr. Howard Fillit said.An Alzheimer’s disease expert said Biogen “absolutely” needs to conduct a third clinical trial for aducanumab, its now controversial and recently resurrected Alzheimer’s disease drug candidate.
6:19 a.m. Dec. 6, 2019 - Barrons.com
Risks of Biogen Alzheimer’s Drug Are Clear, but Its Benefits Are Still Unproven, Says Raymond James The stock rose after company scientists presented a new analysis of Alzheimer’s drug tests that management thinks will convince regulators that the treatment works.
11:06 a.m. Dec. 5, 2019 - Barrons.com
Biogen Is Up After an Alzheimer-Drug Presentation Biogen doesn’t seem to have answered all the questions around its Alzheimer’s disease drug aducanumab, at a scientific conference presentation on Thursday, but it was enough for investors.
9:19 a.m. Dec. 5, 2019 - By Jaimy Lee
Biogen stock climbs as investors shrug off analyst skepticism about Alzheimer’s drug New Biogen data on Alzheimer’s therapy is panned by analysts. The stock promptly falls—then recoversShares of Biogen rose 4.5% in afternoon trading in response to new data that indicates its recently resurrected experimental Alzheimer’s disease treatment can reduce cognitive decline.
7:22 a.m. Dec. 5, 2019 - By Jaimy Lee
Biogen shares rise on Alzheimer's candidate dataShares of Biogen are up 3% after it released additional data about its recently resurrected Alzheimer's disease drug candidate. A fresh take on data from two Phase 3 trials for aducanumab showed that patients in the Emerge trial who received a high dose of the therapy reported reduced clinical decline, meeting the trial's first and secondary endpoints. The Engage trial did not report a reduction in clinical decline. The biotechnology company had that it would scrap trials for aducanumab after a futility analysis indicated that the drug would not meet the studies' primary endpoints. The stock sunk to its lowest point, $216.71, in 2019 the day after that announcement. But then in a surprise move, Biogen it would seek Food and Drug Administration approval for aducanumab early next year following discussions with the regulator using a larger dataset than what was used in the futility analysis. Biogen shares have fallen about 3% year-to-date, compared to the S&P 500 , which is up about 24%.
9:13 a.m. Dec. 4, 2019 - Barrons.com
J&J Says FDA Was Wrong About Asbestos In Baby Powder Shares of the pharmaceutical giant rose after the company said extensive tests had found no asbestos in the bottle of baby powder in which the Food and Drug Administration found asbestos in October. Johnson & Johnson stock has risen 1.5%.
5:38 a.m. Dec. 4, 2019 - By Jaimy Lee
Omeros stock gains on transplant drug dataShares of Omeros Corp. rallied 7% in morning trading on positive data for narsoplimab, its experimental therapy for a complication that can occur for patients undergoing stem cell transplants. Half of the patients who underwent treatment with narsoplimab in a trial met the Food and Drug Administration's response criteria. "The data from this trial form the efficacy basis of the application" to the FDA, Omeros CEO Gregory Demopulos said in a news release. Narsoplimab has been granted orphan drug and breakthrough therapy designations. Omeros stock has gained 40% year-to-date. The S&P 500 , in comparison, is up 24%.
3:37 a.m. Dec. 4, 2019 - By Jaimy Lee
Lannett shares rally on insulin biosimilar trial resultsShares of Lannett Company Inc. rallied 11% in premarket trading after it said a clinical trial for its experimental long-acting insulin biosimilar met the primary endpoints. Lannett and HEC Group are developing a biosimilar version of Sanofi's Lantus, which has long been the French drugmaker's top-selling drug. Mylan and Biocon are also expected to bring a Lantus biosimilar to market in 2020, although the U.S. application process has slowed since the Food and Drug Administration sent two complete response letters with corrective actions. Lannett's stock has jumped 78% year-to-date, compared to the S&P 500 , which is up 24%.
6:11 a.m. Dec. 3, 2019 - By Jaimy Lee
Astellas’ $3 billion gene therapy deal steadies investors after stalled Roche acquisition Analysts are now predicting the return of gene therapy M&A. Astellas Pharma Inc.’s $3 billion acquisition of Audentes Therapeutics is a strong indicator that the pharmaceutical industry’s march into gene therapy development isn’t going to slow down in 2020.
8:56 a.m. Dec. 2, 2019 - By Jaimy Lee
Biogen's shares drop on critical view of Alzheimer's dataBiogen shares fell 2.6% after an analyst scoffed at the possibility of a Food and Drug Administration approval for the company's experimental Alzheimer's disease treatment. "There are so many reasons we think aducanumab is getting rejected, our word count restrictions don't allow us to put them all here," Baird analyst Brian Skorney wrote in a Dec. 2 note. Skorney's primary argument is that he believes data from the most recent clinical trial doesn't make for a compelling case to take to the FDA. Earlier this year, Biogen's stock to a three-year low after the company said it would stop trials for the therapy, prompting Mizuho analyst Salim Syed "aducanumab is dead, and we'd argue so is the beta-amyloid hypothesis." But then in October Biogen announced plans to pursue FDA approval following discussions with the regulator. The biopharmaceutical company has said it will release additional clinical trial information about aducanumab on Dec. 5. Separately, shares of Cortexyme Inc. , which is also developing an Alzheimer's treatment, jumped in morning trading, by 20%. Shares of Biogen have fallen about 3% year-to-date, compared to the S&P 500 , which has gained about 24%.
7:35 a.m. Dec. 2, 2019 - By Jaimy Lee
Therapix shares fall as it moves forward with cannabinoid drugShares of Therapix Biosciences fell 5% in morning trading after the Israeli drugmaker said it would continue to test its experimental cannabinoid-based therapy as an autism treatment. The study, in Israel, will evaluate the safety and efficacy of THX-210 compared to cannabidiol (CBD) oil. Therapix plans to first seek approval in Israel; a submission to the Food and Drug Administration is expected to follow after 2020, interim CEO Ascher Shmulewitz said in an email. GW Pharmaceuticals markets the only FDA-approved cannabis-based medication, a treatment for children with two rare forms of epilepsy. The regulator last week on CBD, saying that there is limited data about the safety of CBD and that the available data it does have points to "real risks that need to be considered before taking CBD for any reason." Therapix stock has fallen 53% year-to-date. The S&P 500 has gained 24% so far this year.
5:58 a.m. Dec. 2, 2019 - Barrons.com
Biogen’s Alzheimer’s Drug Won’t Get Approved, Analyst Says Baird analyst Brian Skorney seems to have spent Thanksgiving weekend sharpening a pin. On Monday morning, he stuck it into Biogen.
4:54 a.m. Dec. 2, 2019 - By Meera Jagannathan
64 million Americans have tried CBD and now the FDA says it could cause liver damage ‘Hopefully it stands up — because otherwise, we’re kind of all owed an explanation for why this was pushed on us’‘Hopefully it stands up — because otherwise, we’re kind of all owed an explanation for why this was pushed on us.’
3:57 a.m. Dec. 2, 2019 - Barrons.com
Merck Stock Gains as FDA Accelerates Review of New Keytruda Indication The pharmaceutical company said that the U.S. Food and Drug Administration is likely to decide in January whether to allow the blockbuster drug to be used to treat a form of bladder cancer.
2:58 a.m. Dec. 2, 2019 - By Ciara Linnane
UPDATE: Lexicon Pharmaceuticals stock slides 31% after FDA denies appeal of decision relating to diabetes drugLexicon Pharmaceuticals Inc. shares slid 31% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has denied its appeal of a decision relating to a diabetes treatment. The Woodlands, Texas-based company said the FDA denied its appeal of a Complete Response Letter relating to its new drug application for sotagliflozin in type 1 diabetes. The company said it would appeal the decision and will hold a conference call at 8.00 a.m. Eastern. The FDA issued the Complete Response Letter, a ruling that means it cannot accept a NDA in its present form, back in February. Lexicon shares have fallen 47% in 2019, while the S&P 500 has gained 25%.
2:43 a.m. Dec. 2, 2019 - By Max A. Cherney
‘CBD has the potential to harm you,’ FDA warns consumers ‘Number of questions regarding CBD’s safety and there are real risks that need to be considered,’ official says as pot stocks fall in after-hours tradingThe U.S. Food and Drug Administration updated its stance on CBD late Monday, saying that the cannabis derivative may have the potential to harm people.
5:18 a.m. Nov. 30, 2019 - By Ciara Linnane
Cannabis stocks rocked as FDA warning undermines case for CBD investments Canadian companies were planning to use CBD acquisitions to access the much bigger U.S. marketCannabis stocks were slammed anew on Tuesday, after the U.S. Food and Drug Administration issued new guidance on CBD that included a stark warning that it can cause liver injury and other damage to the human body.
4:38 a.m. Nov. 30, 2019 - By Philip van Doorn
Weekend reads: A turning point for the cannabis industry Also, estate planning, stock-market timing and where (and how) to live as you grow olderAlso, estate planning, stock-market timing and where (and how) to live as you grow older.
1:25 p.m. Nov. 29, 2019 - Barrons.com
4 Stocks to Unload Before the Year-End Tax-Selling Rush It’s time to comb through your portfolio and decide what to do with the year’s losers. Parting with these laggards could save you more disappointment later.
8:42 a.m. Nov. 29, 2019 - Barrons.com
Don’t Write Off Energy Stocks Yet Four cheap energy stocks for investors to consider, on the expectation that the increasingly unpopular sector will emerge from a decadelong slump. Plus: a bet on three drugs formerly in Celgene’s pipeline.
6:34 a.m. Nov. 29, 2019 - By Quentin Fottrell
Another health warning for e-cigarette users — that has nothing to do with lung disease New research on vaping will be presented at an annual medical conference in Philadelphia from Nov. 16 to Nov. 18New research on vaping will be presented at an annual medical conference in Philadelphia from Nov. 16 to Nov. 18.
2:20 a.m. Nov. 29, 2019 - By Ciara Linnane
Cannabis stocks boosted by expectations of a spike in spending on weed over holiday weekend Aurora Cannabis is opening a store in North America’s biggest mall and Canopy is prepping THC and CBD drinksCannabis stocks rose Wednesday to recover some of their prior-day losses, boosted by expectations for a steep rise in spending on cannabis over the Thanksgiving period, one of the busier shopping periods of the year.
2:30 a.m. Nov. 28, 2019 - Barrons.com
The 3 Best-Performing Health Care Stocks of 2019 So Far Stocks to be thankful for.
2:00 a.m. Nov. 28, 2019 - Barrons.com
The 3 Worst-Performing Health Care Stocks of 2019 So Far These stocks sit in the basement of the S&P 500 Health Care sector.
9:54 a.m. Nov. 27, 2019 - By C. Michael White
Importing cheaper drugs from Canada isn’t the miracle cure for high U.S. prices First, the most expensive drugs wouldn’t be covered under the Trump administration’s plan to allow some importsStart with that the most expensive drugs wouldn’t be covered under the Trump administration’s plan to allow some imports.
6:02 a.m. Nov. 27, 2019 - Associated Press
Tory Prime Minister Johnson has held secret talks with U.S. about privatizing National Health Service, Labour rival claims ‘We have now got evidence that under Boris Johnson the NHS is on the table and will be up for sale’: Jeremy CorbynThe Conservative prime minister, claims Labour Party leader Jeremy Corbyn, has held secret trade talks with the Trump administration in the U.S.
2:23 a.m. Nov. 27, 2019 - By Jaimy Lee
Drug maker ChemoCentryx shares rocket on blockbuster potential in rare autoimmune disease Analysts say they expect blockbuster sales from the drug if it is approved by the FDAA set of conclusive findings from a late-stage clinical trial testing ChemoCentryx Inc.’s experimental vasculitis treatment surprised company executives and investors, who now say they are bullish on the sales and pipeline potential of avacopan.
8:07 a.m. Nov. 26, 2019 - Barrons.com
CBD Stocks Tumble After FDA Warning “CBD is supposed to be the smoother regulatory path in the U.S.,” one analyst says. “This hiccup will cast doubts around THC policy.”
8:07 a.m. Nov. 26, 2019 - Barrons.com
‘CBD Has the Potential to Harm You,’ FDA Warns Consumers Number of questions regarding CBD’s safety and there are real risks that need to be considered,’ official says as pot stocks fall in after-hours trading
6:09 a.m. Nov. 26, 2019 - By Nigam Arora
Here’s how investors should think about the FDA’s warning on CBD Money flows are mostly negative or neutral in marijuana stocks, and the Food and Drug Administration’s warning is creating an overhangMoney flows are mostly negative or neutral in marijuana stocks, and the Food and Drug Administration’s warning is creating an overhang.
3:53 a.m. Nov. 26, 2019 - By Jaimy Lee
Global Blood Therapeutics stock is up on sickle cell therapy approvalShares of Global Blood Therapeutics jumped 11% in premarket trading following the announcement Monday evening that the Food and Drug Administration had approved Oxbryta, its sickle cell disease treatment. It's the second sickle cell drug approved by the FDA this month. Novartis's Adakveo was approved by the regular on Nov. 15. The monthly wholesale acquisition cost for Adakveo is between $7,071 and $9,428; for Oxbryta, it's $10,417 per month. SunTrust Robinson Humphrey analysts forecast $69 million in sales of Oxbryta in 2020 and raised their price target to $110 from $100. Global Blood Therapeutics' stock has rallied 46% year-to-date, while the S&P 500 is up 25%.
1:39 p.m. Nov. 25, 2019 - By Max A. Cherney
FDA updates stance on CBD, pot stocks dipThe U.S. Food and Drug Administration said late Monday that it cannot conclude that cannabidiol, or CBD, is generally recognized as safe among experts for its use in human or animal food. Weed stocks dipped in the extended session, with Tilray Inc. falling nearly 1%, and Aurora Cannabis Inc. falling 0.4%. Canopy Growth Corp. stock was up 0.3% and Cronos Group Inc. was flat. As a part of the announcement, the FDA said it had warned 15 companies around the U.S. that they were illegally selling products containing CBD, a nonintoxicating cannabinoid found in the cannabis plant. The revised consumer update issued late Monday discusses safety concerns around CBD use and potential liver injury, as well as side effects such as drowsiness, gastrointestinal distress, and changes in mood. The FDA said it plans to continue to issue updates as it learns more about CBD. The revised consumer update included the warning that it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. The ETFMG Alternative Harvest ETF , which tracks a basket of weed and consumer packaged goods stocks, gained 0.1% in the extended session.
10:16 a.m. Nov. 25, 2019 - By Jaimy Lee
Adamis shares tumble after letter from FDAShares of Adamis Pharmceuticals Corp. fell 52% in trading on Monday after the Food and Drug Administration rejected its application for Zimhi, a naloxone product aimed at treating opioid overdose. The company said the regulator's complete response letter (CRL) questioned chemistry, manufacturing and controls, and not the experimental treatment's safety or efficacy. "The comments and recommendations stated in the CRL are manageable," Adamis president and CEO Dennis Carol said in a news release. The company plans to resubmit its application once those issues have been addressed. Adamis shares have fallen 73% year-to-date. The S&P 500 is up nearly 25%.
8:04 a.m. Nov. 25, 2019 - Barrons.com
Bristol-Myers Play on 3 Drugs Is a Good Bet, Analyst Says Mizuho analyst Salim Syed began coverage of new contigent-value rights issued by Bristol-Myers Squibb with a Buy rating and a price target of $3.14, a substantial premium to the current price.
5:27 a.m. Nov. 25, 2019 - Barrons.com
Novartis’s Deal for Medicines Company Is Good News for 2 More Stocks The $9.7 billion acquisition of The Medicines Company that Novartis announced Sunday is good news for other companies pursuing the same technology, Jefferies analyst Maury Raycroft says.
3:56 a.m. Nov. 25, 2019 - By Jaimy Lee
Aquestive shares jump on FDA approvalShares of Aquestive Therapeutics Inc. jumped 20% in premarket trading on the news that the Food and Drug Administration on Friday approved Exservan Oral Film as a treatment for amyotrophic lateral sclerosis (ALS), an orphan disease that affects about 30,000 people in the U.S. The newly approved therapy is in the form of a film placed on the tongue that dissolves, making it easier for ALS patients who have trouble swallowing to receive a dose of Rilutek, the only FDA-approved treatment for ALS patients. The company has not yet established a commercial partner in the U.S. but said it is in discussions with "potential licensees." Aquestive received an orphan-drug designation from the FDA for the therapy in 2018. Aquestive's shares are up 2% year-to-date, while the S&P 500 has risen 24%.
3:37 a.m. Nov. 25, 2019 - Barrons.com
Novartis to Buy The Medicines Company for $9.7 Billion Shares of The Medicines Company were up nearly 23% on Monday after Novartis said Sunday that it had agreed to buy the single-drug, clinical-stage biotech company for $85 per share.
3:24 a.m. Nov. 25, 2019 - Barrons.com
5 Drugs in Pfizer’s Pipeline That Could Turn the Stock Around While much of the focus has been on the breast cancer drug Ibrance, there are other new drugs worth watching.
10:41 a.m. Nov. 23, 2019 - Barrons.com
Pfizer’s New Strategy Makes It Worth Another Look Whether building or buying, Pfizer needs to come up with a handful of drugs that can refill its pipeline. Its stock depends on it.
4:58 a.m. Nov. 23, 2019 - By Jaimy Lee
Five things you should know about Stephen Hahn, Trump’s nominee to head FDA Dr. Hahn currently runs the MD Anderson Cancer Center.Dr. Stephen Hahn, President Donald Trump’s nominee for commissioner of the Food and Drug Administration, on Wednesday told members of Congress he believes “aggressive action” is needed on vaping yet declined to say whether he supports a flavor ban.
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