|Bid||0.00 x 1200|
|Ask||17.80 x 3100|
|Day's Range||16.63 - 17.18|
|52 Week Range||11.78 - 23.91|
|Beta (3Y Monthly)||0.63|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||31.71|
Amarin Corporation plc (AMRN), a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present a general company update at the Cantor Global Healthcare Conference on Thursday, October 3, 2019, from 10:05-10:35 a.m. Eastern Time in New York City. Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates.
Millions of Patients on Statins with Elevated Triglycerides Are at Risk of Cardiovascular Events, Such as Heart Attack, Stroke or Death Icosapent Ethyl Recognized as Only.
Most biotech stocks have been under pressure recently, but as we approach the end of the year, many analysts are quite bullish as to what is next for these stocks.While the biotech industry carries substantial risk based on the fact that any negative event such as disappointing results from a clinical study can trigger a drop in share prices, analysts argue that a few stocks in this space are set to heal the market flu ahead of their upcoming FDA advisory committee (AdCom) meetings.During an AdCom, both the company and agency will give presentations, with patients often getting a chance to speak as well. A vote will then take place to decide if a drug gets an approval recommendation. This recommendation can help determine whether or not a drug receives final FDA approval, with a positive AdCom outcome acting as a catalyst that can cause shares to skyrocket.We wanted to take a closer look at 3 biotech stocks poised to soar ahead of their upcoming FDA AdCom meetings. Each boasts almost 100% upside potential as well as significant support from the Street with a “Strong Buy” analyst consensus, based on TipRanks’ Stock Screener.With that in mind, let’s dive in:Aimmune Stock Is Looking for a TurnaroundAimmune Therapeutics (AIMT) develops treatments to help protect people with food allergies by potentially reducing the risk of allergic reactions, thus making accidental exposures to allergens less dangerous.Going into its September 13 AdCom for its primary drug AR101, the company’s long-term growth narrative appears healthy. As Food Allergy Research & Education states that 32 million Americans have food allergies, including 5.6 million children under age 18, there’s a large market available for AIMT.While shares are down 18% year-to-date, the panel is expected to put AIMT back on an upward trajectory assuming all goes according to plan.AIMT is on track in terms of its timeline. A regulatory decision for AR101 should be announced in January 2020 but could come before. This means that the company would be able to launch the drug at the beginning of Q4 2019.Adding to the good news, AIMT’s management stated that it would be initiating its P2 AR201 trial for egg allergies. Investors could also get an update regarding its AR301 program for walnut allergies by the end of 2019.5-star Piper Jaffray Christopher Raymond commented: “With all eyes ahead to September, we continue to like the setup and remain buyer.” As a result, he reiterated his Buy rating and $60 price target. Raymond’s price target demonstrates his confidence in AIMT’s potential to surge 207% over the next twelve months. (To watch Raymond’s track record, click here)“As investors are well aware, the AR101 AdCom is scheduled for Sept 13th, an event that we think could help reverse the stock’s downward trend if things go well. With this in mind, we’ve looked beyond the compelling data package and instead focused on factors affecting how the meeting may go, digging deeper on APAC panelists’ views on OIT, and becoming more comfortable that FDA understands that allergen immunotherapies cause allergic reactions during patient desensitization (per sublingual immunotherapy commentary). Though the small minority of (vocal) naysayers might continue to debate the risk/reward of OIT, we feel very comfortable that FDA understands this point well,” Raymond wrote.Wall Street is on the same page. AIMT boasts a ‘Strong Buy’ analyst consensus as well as a $51 average price target, suggesting 158% upside potential. (See AIMT’s price targets and analyst ratings on TipRanks)Agile Therapeutics Shares Can Soar ~250%Agile Therapeutics (AGRX) is working to fulfill the unmet healthcare needs of women globally. Its current product candidates were developed to provide a contraceptive method for women that don’t want to commit to a longer-acting method or take a daily pill.With the U.S. contraceptive market expected to grow from $7.6 billion in 2017 to reach $11.6 billion by 2025 according to a Grand View Research report, AGRX stands to reap the benefits.The FDA announced at the end of June that an AdCom would take place for lead candidate Twirla, its once-weekly transdermal low-dose combination hormonal contraceptive (CHC) patch, on October 30. This news had investors excited as the AdCom will fall closely before AGRX’s November 16 Prescription Drug User Fee Act (PDUFA), the date that the FDA will reveal is if it has approved the treatment. Some have interpreted this timing to mean that the FDA may already have draft labeling ready.4-star H.C. Wainwright analyst, Oren Livnat, argues that the FDA wants to “tease out labeling issues regarding lower CHC efficacy in obese subjects, an issue that has long been ripe for discussion”. However, he thinks the Twirla SECURE Phase 3 trial was “the most robust CHC trial ever”, especially regarding AGRX’s inclusion of a significant number of obese patients.“We can’t predict the final labeling, if approved, but we maintain our current projection of $300M peak sales with just 2.6% market share, or approximately 50% of transdermal share,” he explained.Based on all of the above factors, the four-star analyst reiterated his Buy rating and $4 price target, implying 251% upside. (To watch Livnat’s track record, click here)Livnat is not the only fan of this healthcare company on Wall Street, as TipRanks analytics exhibit AGRX as a Strong Buy. Based on 4 analysts polled in the last 3 months, all 4 rate Agile stock a Buy. The 12-month average price target stands at $3.50, marking a 207% upside from where the stock is currently trading. (See AGRX’s price targets and analyst ratings on TipRanks)Amarin Has What It Takes to Score Crucial FDA approvalAmarin’s (AMRN) primary drug, Vascepa, is a purified fish oil derivative and has already been approved by the FDA as an EPA treatment to lower triglycerides without increasing bad cholesterol levels.Investors were not as happy to hear that the FDA would be holding an AdCom for Vascepa on November 14. The AdCom is related to its pending supplemental new drug application (sNDA) for expansion of Vascepa labeling based on its ability to reduce the risk of major adverse cardiovascular events from the REDUCE-IT study. Management stated that the AdCom meeting will most likely extend the original PDUFA date from September 28 to the end of December.That being said, the American Heart Association (AHA) published an update on August 20 to its 2002 scientific statement for omega-3 fatty acids for reducing triglycerides in patients with hypertriglyceridemia, with the update working in Vascepa’s favor. While this wasn’t a formal change to guidelines, it is a step in the right direction.The points from the AHA update noted that a wealth of evidence including epidemiological and genetic studies suggest the treatment of triglycerides is valid method to reduce cardiovascular disease. The AHA also highlighted the fact that over-the-counter fish oil agents should not be used for pharmacological treatment for patients, which bodes well for AMRN.Despite some negative investor sentiment, Jeffries’ Michael Yee remains confident in AMRN’s long-term growth narrative. “Scripts continue to grow every week despite no label change and we think 2020 numbers are too low. In our view, we think the totality of AMRN’s data support approval,” he explained.As a result, the four-star analyst reiterated his Buy rating and $30 price target. He believes share prices could gain 86% over the next twelve months. (To watch Yee’s track record, click here)The Street appears to mirror Yee’s sentiment. With 7 Buy ratings and no Holds or Sells assigned in the last three months, AMRN has a ‘Strong Buy’ analyst consensus. Its $32 average price target suggests 96% upside potential. (See AMRN’s price targets and analyst ratings on TipRanks) More recent articles from Smarter Analyst: * Is 33% Upside Good Enough to Risk Buying Fitbit (FIT) Stock? Deutsche Bank Doesn't Think So * Deutsche Bank Remains Sidelined on AMD Stock; Here's Why * Antitrust Investigation Is Not a Major Threat to Alphabet (GOOGL) Stock, Says Top Analyst * Tesla's (TSLA) Gigafactory Is Impressive, But Its Stock Isn't, Says RBC Capital
Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have updated their Clinical Practice Guidelines for the Management of Dyslipidaemias. This 2019 update incorporates findings from the REDUCE-IT™1,2 cardiovascular outcomes study and includes the recommendation that icosapent ethyl, 2g twice a day, should be considered for patients with cardiovascular disease who have triglyceride levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of cardiovascular events, such as heart attack, stroke or death.3 This new recommendation incorporates icosapent ethyl specifically.
Amarin Corporation plc (AMRN), a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present a general company update at the H.C. Wainwright 21st Annual Global Investment Conference on Monday, September 9, 2019, from 8:45-9:10 a.m. Eastern Time in New York City. Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates.
Multiple Papers and Presentations Highlight REDUCE-IT and Vascepa®Potential Mechanisms of Action of Vascepa Becoming Better Understood American Heart Association References.
If there is one biotech with massive potential right now, it’s Amarin (AMRN), say top analysts. This is the Ireland-based biotech pioneering a fish oil revelation. We can see from TipRanks that the stock currently scores seven back-to-back buy ratings- hence its ‘Strong Buy’ Street consensus. And what’s more the $32 price target indicates compelling upside potential of 108%.Indeed, both Jefferies analyst Michael Yee and Roth Capital’s Yasmeen Rahimi recently published bullish calls on the stock:So what’s driving this wave of extremely positive sentiment? Let’s take a closer look now: Vascepa- big FDA decision lies ahead As you may well know, Amarin’s Vascepa drug- a purified fish oil derivative- is the first and only prescription EPA treatment approved by the FDA to lower very high triglycerides (without raising bad cholesterol). And now Vascepa is also on the cusp of another exciting- and potentially extremely lucrative- development. Amarin has submitted a supplemental new drug application (sNDA) to The US Food and Drug Administration (FDA) regarding Vascepa’s ability to reduce the risk of major adverse cardiovascular events based on the landmark REDUCE-IT study."We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the United States" commented CEO John Thero on May 29. In REDUCE-IT, Vascepa achieved the primary endpoint with a 25% relative risk reduction compared to placebo in the first occurrence of a major adverse cardiovascular event (MACE) in the intent-to-treat population. Indeed, the company has just announced that the FDA will hold an advisory committee meeting in mid-November to discuss this application. According to Amarin it is likely that the advisory committee meeting will extend the original Prescription Drug User Fee Act (PDUFA) date by about 3 months, from September 28 to late December. This is the date on which the FDA will reveal is if it has approved Vascepa for this additional indication- which could see a major spike in share price if all goes to plan. Positive AHA UpdateAhead of this key date, Jefferies analyst Michael Yee reiterated his AMRN buy rating with a $30 price target (97% upside potential). Although investors were disappointed by the suggested PDUFA delay, Yee noted a new, and encouraging, development for the company. In short, the AHA (American Heart Association) issued an updated science advisory report for use of omega-3 fatty acids (fish oils) for management of hypertriglyceridemia.The update stated that prescription n-3 fatty acids (which include Vascepa, a pure EPA product) “are clinically useful for reducing triglycerides, after any underlying causes are addressed and diet and lifestyle strategies are implemented, either as monotherapy or as an adjunct to other triglyceride-lowering therapies.” Notably, the advisory does appear to endorse using omega-3 fatty acids in people with triglycerides 200 and up, which is broader than the current labels recommending use to lower triglycerides 500 and up.Following the news, Yee commented: "Although this is not a formal guideline update, we note AHA has historically been slow to update guidelines (took long time for PCSK9). Scripts continue to grow every week despite no label change and we think 2020 numbers are too low; we are positive but fully acknowledge investors remain nervous into a panel presumably in Nov."Similarly, post-AHA update Roth Capital’s Yasmeen Rahimi also reiterated her AMRN buy rating. That came with a slightly higher price target of $31 (104% upside potential). She didn’t hold back when she told investors: "this strong validation for Vascepa's TG reduction gives a sneak peek of the favorable cardiologists' view (3/8 voting docs are cardios) ahead of Nov. AdCom, and sets the stage for Vascepa to capture even greater market share". So watch this space. Find analysts’ favorite stocks with the Top Analysts’ Stocks tool
BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 21, 2019 -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on the commercialization and development of.
Take a look at the Biotechnology ETF (NASDAQ:IBB) and investors will notice how badly the sector is underperforming. Though it is up by around 9% year-to-date, the S&P 500 (NYSE:SPY) is up by 15.6% while the Nasdaq (NASDAQ:QQQ) is up by 20%. Government scrutiny over drug pricing and the high-cost structure of the healthcare system in the U.S. is hurting biotech stocks, too.Company-specific news is also weighing on specific biotechnology stocks. Those are the ones investors should watch. But as disappointing developments send such stocks lower, which ones should investors buy or sell? Volatility is increasing in markets and is triggered by an inverted yield curve and trade tensions between the U.S. and China. This creates wider price movements for biotech stocks, opening up better entry and exit points for investors. * 10 Undervalued Stocks With Breakout Potential What are the nine biotech stocks to watch amid the uncertainties ahead?InvestorPlace - Stock Market News, Stock Advice & Trading Tips Regeneron Pharmaceuticals (REGN)Source: Shutterstock Regeneron Pharmaceuticals (NASDAQ:REGN) started 2019 on a positive note when shares rose steadily and topped $440 by March. Since then, however, even a strong quarterly earnings report, posted on Aug 6, has failed to move the stock higher.Regeneron reported non-GAAP earnings per share of $6.02. GAAP EPS was $1.68 after revenue grew 19.9% Y/Y to $1.93 billion. Market share for EYLEA grew to 71% of net product sales. And Regeneron has a plan to develop Eylea's position in diabetic retinopathy. It is educating physicians and patients with the drug as a first-line anti-VEGF treatment.Sales of Dupixent, which treats patients suffering from Type 2 inflammatory diseases -- atopic dermatitis, asthma, and now chronic rhinosinusitis with nasal polyposis - grew 151% Y/Y. Net sales in Q2 was $557 million. Total prescriptions grew 30% sequentially, driven by the growth in approved indications. Its approval for treating atopic dermatitis for adolescents will ensure the drug's continued growth.Non-GAAP R&D expenses rose to $589 million, up from $470M Y/Y. Continued investments in its research platform and pipeline will pay off if the company's history is an indication.This report shows that Regeneron stock has substantial upside potential from here. If Dupixent sales continue growing in the 150% range, Regeneron stock trading at 12-times forward earnings is too low. Amarin (AMRN)Source: Shutterstock Amarin (NASDAQ:AMRN) was up over 30% year to-date -- until August 8. Then ARMN stock fell 23% after-hours when the FDA pushed back an advisory committee date for it's drug Vascepa.So markets will have to wait for the review and discussion of Amarin's supplemental marketing application seeking a cardiovascular benefit claim for Vascepa. But even without the label expansion, Vascepa's projected revenue is $400 million annualized. In Q2 2019, net total revenue was $100.8 million. Increased Vascepa prescription volume from prior and new prescribers lifted sales.The company also has plans to double its number of sales reps to 800 by October. This will allow them to expand the number of targeted healthcare professionals from ~50,000 to up to 80,000. Performing more sales calls to prescribers, assisting physicians in the familiarization with Vascepa, and a direct to consumer campaign will support product growth. And despite the FDA setback, Amarin raised its 2019 full-year revenue guidance to $380 million to $420 million. For the current Q3 period, the Vascepa normalized TRx will exceed 700,000. * 10 Mid-Cap Dividend Stocks to Buy Now On the balance sheet, Amarin has $661 million in cash and cash equivalents, lifted from a $440 million equity offering in July 2019. Since it will not need to sell more shares in the near future, investors only need to worry about the FDA decision next. Arena Pharmaceuticals (ARNA)Source: Shutterstock Arena Pharmaceuticals dipped to below $52.50 in the days following its earnings report posted on Aug. 8. The company reported an EPS GAAP loss of $1.24 as revenue fell 74.$ Y/Y to $1.02 million. Profits and revenue growth are not expected from Arena in the near future. It is still in the development stage. And although it has a promising pipeline cautious investors may want to avoid the stock for now.In the second quarter, the company highlighted its key clinical and regulatory goals. It started two trials: the etrasimod Phase 3 ELEVATE UC 52 trial and the olorinab Phase 2 CAPTIVATE trial. Etrasimod is an oral, once-daily selective sphingosine-1-phosphate (S1P) receptor modulator. The drug treats multiple immune and inflammatory diseases, such as ulcerative colitis. The Elevate UC 52 trial has a 12-week induction period followed by 40 weeks of maintenance. Arena started the trial in June. The Elevate UC 12 is also a 12-week trial that will be started at a later date.Arena spent $51.2 million in R&D in the second quarter, while SG&A totaled $18.4 million. The net loss was $1.24 a share, or $61.4 million. With cash and cash equivalents of over $1.2 billion, investors need not worry about the company issuing shares to raise cash in the near-term. CRISPR Therapeutics (CRSP)Source: Shutterstock Gene editing is a very hot area and CRISPR (NASDAQ:CRSP) stock's uptrend reflects that. CRISPR's mandate is to create transformative gene-based medicines for serious diseases. The company advanced CRISPR in the clinic with CTX001 in beta-thalassemia and sickle cell disease. The gene-edited allogeneic cell therapies -- CTX110, CTX120, and CTX131 -- are considered the next-generation immune-oncology platform. The company's solution enables regenerative medicine through the CRISPR/Cas9-edited allogeneic stem cells.CRISPR has a deep pipeline of programs, with most of them still in the research phase. Still, it has three programs in the clinical phase. After it completes enrollment, investors will have plenty of clinical data to interpret in the years ahead. Patients with Sickle Cell Disease (SCD) and beta-Thalassemia, both of which are a hemoglobinopathy, suffer from anemia, pain, and even early death. By editing the gene, the company aims to mimic variants of naturally occurring hereditary persistence of fetal hemoglobin.The first step of the clinical trial, following enrollment of 45 adult patients, is to assess the safety and efficacy of CTX001. Mice studies suggest it may achieve 80% allelic editing, over 90% of cells modified, and over 30% HbF. * Major Headlines Mean Opportunities for Smart Investors CRISPR is in a hot area of gene editing and if it can treat patients successfully, the value of the company will soar. United Therapeutics (UTHR)Source: Shutterstock United Therapeutics (NASDAQ:UTHR) stock enjoyed the $110 - $120 range up until March. Then the company's declining revenue growth in Q4/2018 began scaring off investors. But by the second quarter, performance improved. The company reported non-GAAP EPS of $3.63, $0.89 higher than consensus. GAAP EPS was $4.66. United Therapeutics reported revenue of $373.6 million, falling 16% from last year.Its prostacyclin product franchise (Remodulin, Tyvaso, and Orenitram), is being used by patients to treat pulmonary arterial hypertension. The company is advancing the drug delivery systems and has late-stage clinical programs in cardiopulmonary diseases. The company's management is set on tripling its business over the next few years. This is possible with a dozen products in its pipeline and many FDA-approved product platforms. It has three new Remodulin products in the pipeline, and after these products gain FDA approval, United's sales could triple.In the COPD and interstitial lung disease space, the company awaits for approval for Tyvaso. And new indications for Uptravi, which treats pulmonary hypertension, will also drive sales higher.In the near-term, generic competition for Remodulin is moderating in the U.S. and in the EU. And as new products come online, markets will realize UTHR stock at a forward P/E of 9.5 times is too low. Exelixis (EXEL)Source: Shutterstock Exelixis (NASDAQ:EXEL) posted Q2 results on July 31. Its non-GAAP EPS was $0.29, while GAAP EPS was $0.25, down 11% from last year. Cabometyx is its best-in-class TKI driving its growth. Revenue rose 29.1% Y/Y to $240.3 million. $46.6 million of that revenue came from collaboration. This included a $20 million milestone from Daiichi Sankyo for the commercial launch of Minnebro tablets for the treatment of hypertension.The company ended the quarter with cash and cash equivalents of $1.16 billion.Exelixis forecast COGS (cost of goods sold) to be between 4% and 5% of net product revenues. R&D expenses will be between $330 million and $350 million. SG&A will be between $220 million - $240 million.Exelixis has four ongoing pivotal trials. It initiated three Phase 3 studies since late 2018 and early 2019. The company is now actively enrolling patients worldwide. Management is optimistic with positive data from its ongoing pivotal trials in first-line RCC and first-line HCC refractory DTC. Investors also believe the company's strong prospects, although EXEL stock trades at a P/E of just 10.6 times.Exelixis increased expenses in the second quarter, with R&D spending up 93%. These efforts will pay off as the company wins more indications for Cabometyx. The drug is the number one prescribed for TKI in RCC. * 10 Undervalued Stocks With Breakout Potential In the near term, strong efficacy data and overall survival benefit numbers will drive demand for Cabometyx higher. Nektar Therapeutics (NKTR)Source: Shutterstock On Aug 9, Nektar Therapeutics (NASDAQ:NKTR) revealed a "softening in response rates" in its Phase 1/2 PIVOT-02 study. This evaluated NKTR-214 with Bristol-Myers Squibb's (NYSE:BMY) Opdivo. The problem is that two of its earliest production patches of bempeg were different than the other 20 batches produced. This would explain the outlier variances as more clinical data matured and became available.As a result of this discovery, Nektar developed a comprehensive control strategy to limit variances in raw materials. But it also means it may build new IP around the product using new assays and control strategies.On its conference call, the company said Bristol-Myers is still committed to the bempeg development program:They remain very committed to the bempeg development program, particularly in light of the recent breakthrough designation in melanoma and the tremendous opportunity for both companies. They are highly committed to the ongoing registrational trials in first-line melanoma, first-line urothelial cancer, and first-line renal cell carcinoma, as well as our new expansion cohort of second-line non-small cell lung cancer patients in PIVOT.NKTR shares may not rebound for a while until it reports updated data from its studies. Novo Nordisk (NVO)Source: Shutterstock Novo Nordisk (NYSE:NVO) is firing on all cylinders after reporting revenue growth of 9.6% Y/Y. Its diabetes and obesity reported combined sales growth of 10% and 6% and constant exchange rates. The company's product pipeline grew after it had a handful of product approvals and filings since May. For example, in Japan, it filed its semaglutide for treating Type II diabetes.For 2019, Novo forecast operating profit growth in the range of 4% to 6%.Novo's diabetes drug is a revenue growth driver. As the global diabetes market leadership rose to 28.3%. its insulin volume market share increased. Additionally, market share grew after Novo launched Ozempic in 18 European markets. In the U.S., Opempic's launch led to a stabilization in the TRx market share at around 45%.Sales of Saxenda, which is a weight-loss drug, increased 56% in the first half of 2019. Novo Nordisk's market share is 50%. And now that it has been launched in 43 countries, the company will invest in market development activities to drive sales.Although Novo stock is trading at close to its 52-week high, this is justified by the higher sales forecast. Investment opportunities and R&D activities starting in the second half of the year will ensure that the company maintains its pace of growth.Disclosure: As of this writing, the author did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Cheap Dividend Stocks to Load Up On * The 10 Biggest Losers from Q2 Earnings * 5 Dependable Dividend Stocks to Buy The post 8 Biotech Stocks to Watch After the Q2 Earnings Season appeared first on InvestorPlace.
2019 has been a good year for the stock market. Year-to-date, both the S&P 500 and the Nasdaq are up 15% and 19%, respectively. From an economic perspective, the unemployment levels and interest rates have remained low, which helped boost share prices. That being said, the market isn’t immune to the recent dramas that have unfolded. The ongoing trade war with China and weak global growth have raised red flags among investors that a recession could be on the way, with those fears causing widespread volatility.However, analysts are telling investors not to panic. Wall Street analysts believe that healthcare stocks still represent compelling investment opportunities amid economic uncertainty.Using TipRanks powerful stock screener, we set out to pinpoint three stocks that command the support of the Street. You can customize the screener settings to match your investment strategy. In this case, we selected filters for healthcare stocks with a “strong buy” consensus ratings. We also specifically select stocks with big upside potential from the current share price. This is based on the upside potential from the current share price to the average analyst price target.Now let’s delve into these three top healthcare stocks and see if they really have what it takes to fight off the market flu: Novavax Inc. (NVAX)The first healthcare company on our list develops vaccines that target respiratory syncytial virus (RSV), seasonal influenza and Ebola virus (EBOV).Novavax has riled up Wall Street last week with enticing Phase III ResVax trial results. The data presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) on August 12 showed that the company's ResVax vaccine was able to protect infants one year after birth from all causes of pneumonia, including RSV associated pneumonia. It also highlighted the fact that protecting infants from the RSV infection can protect infants from contracting an infection from other microbes.Investors have more reasons to be excited about the vaccine maker. On August 5, NVAX reached an agreement with the FDA on its Phase 3 trial design for Nanoflu, its seasonal influenza vaccine for adults 65 years and older. The company also partnered with Catalent Biologics (CTLT) back in June, allowing CTLT to expand its gene therapy footprint with the acquisition of Novavax’s manufacturing assets and capabilities.B.Riley FBR analyst George Zavoico remains bullish on NVAX with a Buy rating, and his $35 price target, which seems like wishful thinking, may get another boost: “Based on these new results and other recent events, we place our price target for Novavax under review as we update our financial model of the company.” (To watch Zavoico's track record, click here)"We do not believe these new, positive results will lead the FDA to reconsider its decision to require another Phase III trial of ResVax by maternal immunization before considering a BLA filing. While we still forecast that the European Medicines Agency (EMA) is likely to agree with the FDA on this point, we would not be surprised if, due partly to these new results, the EMA may decide to allow Novavax to file a marketing authorization application (MAA) for ResVax while also requiring a post-marketing efficacy trial to confirm the results. A decision is expected this fall," Zavoico opined.All in all, the rest of the Street mirrors the analysts’ bullish sentiment. NVAX has a ‘Strong Buy’ analyst consensus and a $29.88 average price target, implying ~281% upside potential from current levels. (See NVAX’s price targets and analyst ratings on TipRanks) Amarin Corporation (AMRN)It’s no secret that Wall Street analysts like Amarin stock. It has a ‘Strong Buy’ analyst consensus and a ~$32 average price target, suggesting over 100% upside potential from current levels. (See AMRN’s price targets and analyst ratings on TipRanks)Investors were caught by surprise recently after Amarin announced the FDA’s notice of plans to hold an advisory committee (AdCom) on the sNDA for its Vascepa drug.4-star Roth Capital analyst Yasmeen Rahimi argues that the AdCom might work in AMRN’s favor.While the news comes as a shock given how close AMRN is to its September 28 priority-review PDUFA for Vascepa, management stated in May that they believed an AdCom was likely as they are seeking a Vascepa label extension. As such, the AdCom gives AMRN a platform to defend its label extension as well as highlight Vascepa’s ability to reduce cardiovascular related events and deaths, its superior safety and its support from the medical community.“AdCom allows for Vascepa discussion in a public forum, increasing awareness and transparency on key issues, and puts all this info just a click away for potential future Vascepa-prescribers to find and digest,” Rahimi opined, as she reiterates her Buy rating and $31 price target on Amarin stock."In totality, we believe AMRN is primed to make a strong case to the FDA and can turn this AdCom into a highlight reel of the CV benefits Vascepa offers patients," the analyst concluded. (To watch Rahimi's track record, click here) Zynerba Pharmaceuticals (ZYNE)Zynerba develops innovative therapies to treat Fragile X syndrome (FXS), Autism Spectrum Disorder (ASD), 22q and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).Investment firm Canaccord Genuity has hosted Zynerba at its annual growth conference the day after its second quarter earnings release in which the company altered some timelines for its data readouts. Lead analyst Sumant Kulkarni believes the company is still cautiously optimistic regarding its Zygel (cannabidiol gel) in Fragile X syndrome (FXS). While its Zygel trial enrollment continues, the company hasn’t provided an end date for enrollment. ZYNE does remain confident that Zygel use in DEE treatment can deliver an adequate dose of CBD via the transdermal route.The analyst points out that an Epidiolex CBD solution for Lennox-Gastaut/Dravet syndromesits has already been released by its competitor, GW Pharmaceuticals (GWPH). Not to mention GWPH’s market cap is $5 billion versus ZYNE’s $250 million. However, Kulkarni argues that this disparity represents a unique buying opportunity.Based on all of the above factors, Kulkarni reiterates his Buy rating and $18 price target on ZYNE stock, which implies about 60% upside from current levels.Kulkarni is certainly not the first analyst with an optimistic outlook for the biotech firm, as TipRanks analytics showcasing ZYNE stock as a Strong Buy. With an average price target of $22, analysts are predicting an upside of nearly 100%. In total, the stock has received 4 'buy' ratings in the last three months. (See ZYNE’s price targets and analyst ratings on TipRanks)
Wall Street loves growth stocks -- and for good reason. In 2018, according to Bank of America, "growth" oriented mutual funds outperformed "value" mutual funds by a factor of 59 to 32. And yet, as it turns out, sometimes Wall Street can't pass up the prospect of a good bargain either.Luckily for investors in Amarin (AMRN), their stock is a little bit of both -- a stock with the potential for high sales growth, and a stock currently trading at a depressed price.Last week we told you about Stifel Nicolaus analyst Derek Archila, and how a recent blow to Amarin's stock price had only increased his love for the stock. Amarin, as you will recall, had just received unexpected news from the Food and Drug Administration. Despite all indications to the contrary, the FDA had elected to set up an Advisory Committee to review results from Amarin's recent "REDUCE-IT" study of Vascepa's suitability for reducing "borderline" to "high" levels of triglycerides in patients at risk of cardiovascular disease.Amarin's stock price immediately tumbled more than 17% in response to the news, and has continued falling -- now down about 20% from its value before the news broke. In Archila's view, though, this made the stock only more attractive -- and as it turns out, Archila isn't the only analyst thinking along these lines.Yesterday, analyst Ami Fadia at investment banker SVB Leerink published yet another note of support for Amarin stock, rating the stock "outperform" with a $25 price target. And once again, Amarin's stock price was a big draw. Thanks to the and "-20% stock reaction," Fadia believes there's now the potential for a positive decision on Amarin's supplemental New Drug Application for Vascepa to "drive >20% upside to the stock." (To watch Fadia's track record, click here)Why does Fadia think Vascepa will be approved?As the analyst explains, "the most likely reason for the AdCom [being called] is to review the impact of the mineral oil placebo to the 25% relative risk reduction (RRR) demonstrated in the REDUCE-IT study." This has been a point of some contention -- whether using mineral oil for the control group resulted in inflated "risk reductions" (relative to the control group) in the group of patients treated with Vascepa.But Fadia doesn't think this will be a big issue. For one thing, the FDA was well aware of Amarin's intention to "treat" control patients with mineral oil rather than some other inert substance, yet never raised any objection to this during the study itself. For another, while it sounds like the control group may have had somewhat elevated risk, making the group treated with Vascepa look somewhat better by comparison, Fadia doesn't think the elevated risk cancels out more than perhaps five percentage points of Vascepa's 25-point reduction in risk.So in a nutshell, whether or not mineral oil skewed the results, there was a pretty clear and convincing reduction in risk from treatment with Vascepa in any case. For this reason, Fadia believes Vascepa will eventually win the FDA's approval, perhaps as early as December.And here's the best part: Once that happens, an expanded "label" permitting Vascepa to be used to treat triglyceride levels below 500 mg/dL could increase the total addressable market for the drug from about 600,000 patients per year to 10 million, "leading to peak US sales >$4B" per year.In the nearer term, Fadia is predicting 2019 sales for Amarin will leap nearly 75% over 2018 levels, to $399.7 million, then jump a further 60% in 2020 -- pretty impressive near-term growth en route to that $4 billion-a-year prediction. Moreover, the analyst expects to see Amarin turn at least pro forma-profitable in 2020, a nice contrast to the $0.33 per diluted share Amarin lost last year.After 15 straight years of losing money, it looks like things could finally be turning around for Amarin.All in all, Wall Street’s analysts have been nothing but bullish on Amarin stock over the past three months. Out of 7 analysts, all 7 are bullish on the stock. With a return potential of about 115%, the stock's consensus target price stands at $31.17. (See AMRN's price targets and analyst ratings on TipRanks)
Amarin's stock jumped after SVB Leerink upped its rating on the biotech's stock to outperform, saying a recent double-digit decline offers a buying opportunity.
One week ago, Stifel analyst Derek Archila reiterated his "buy" rating on anti-cholesterol drugmaker Amarin (AMRN). He did this partly because he liked how Amarin's Q2 earnings report showed sales soaring, and losses lessening -- but also because he thought it unlikely the Food and Drug Administration would empanel an Advisory Committee to review Amarin's supplemental New Drug Application for expanded usage of "Vascepa," thus speeding the "sNDA" towards approval.Last Thursday, Amarin announced that the FDA will be holding an AdCom after all, "tentatively scheduled for November 14, 2019, to review the data from Amarin's "REDUCE-IT cardiovascular outcomes study" and recommend whether the FDA should approve the expanded usage of Vascepa to treat "borderline" to "high" levels of triglycerides in the bloodstream. (I.e. levels from ranging from 151 mg/dL to 499 mg/dL).Because of the late date of the AdCom, Amarin warned that it now "does not expect the FDA to take action on the sNDA by the previously announced September 28, 2019" deadline. Instead, it expects the deadline for approval under the Prescription Drug User Fee Act to be pushed back to "late December" -- postponing by three months the date at which Amarin might expect to begin booking new revenues under the expanded usage.Because of that, Amarin stock plunged more nearly 17% in Friday trading, another 6% today, and at least one law firm filed a shareholders' class action lawsuit against Amarin, implying the company did something shady when it advised investors last week that "it was unlikely that the FDA would proceed with an advisory panel review."Therein, says Archila, lies an opportunity.Although frustrated by the FDA's decision, so at odds with his own guess, Archila urged investors to take advantage of Amarin's newly discounted stock price and buy some Amarin stock. The analyst reiterates a Buy rating on AMRN with a $26 price target, which implies nearly 90% upside from current levels. (To watch Archila's track record, click here)His reasoning: "It's difficult to say why the FDA has chosen to convene an adcom this late in the game." Regardless, "our research and checks ... underlie our confidence that Vascepa's dataset will stand up to the scrutiny of a panel." But even more than that:Under one possible scenario, Archila mused, it's possible the FDA might offer Amarin the option of labeling Vascepa for use "for cardiovascular risk reduction regardless of triglyceride levels" -- in other words, permitting the drug to be used by patients no matter how low, or how high, their triglycerides might be. No restrictions at all!Such a labeling (if it's in fact on the table) would obviously be good news for Amarin. As Archila explains, it "would increase the commercial opportunity for the drug," meaning more sales and more profits for Amarin.So as a pure question of risk and reward, Archila now believes the odds favor investing in Amarin.All in all, AMRN has one of the best ratings by the Street. TipRanks reveals that the stock has a Strong Buy analyst consensus rating with 6 back-to-back buy ratings in the last three months. Meanwhile the average analyst price target of $32.67 suggests the stock has upside potential of nearly 135% from the current share price for the next 12 months. (See AMRN's price targets and analyst ratings on TipRanks)
There are roughly 4,700 stocks on U.S. exchanges with a market capitalization over $50 million. Of that group, 94 -- almost exactly 2% of the total -- have been the best stocks in the market over the past year, gaining more than 100% over that period.From a sector standpoint, there aren't a lot of surprises in the group. The three best stocks over the past twelve months all are biotechnology plays -- a sector that often provides either huge gains or huge losses. Small-cap tech, another high-risk, high-reward category, provides another chunk of winners, including stocks like Digital Turbine (NASDAQ:APPS) and GlobalSCAPE (NYSE:GSB), both of which have tripled in 2019 alone. * 10 Internet Stocks Getting Hammered The obvious question is how these stocks will perform going forward. In some cases, 100%+ gains are a sign of a company significantly outperforming expectations. In others -- particularly in what remains a bull market -- that kind of upside suggests a stock that may have outrun its fundamentals. These 10 stocks all have posted big gains over the past year, but some may head in a very different direction over the next twelve months.InvestorPlace - Stock Market News, Stock Advice & Trading Tips What You Can Expect From the Best Stocks of 2018 Today: Shopify (SHOP)Source: Shutterstock 1-Year Performance: +140%The gains in Shopify (NYSE:SHOP) stock have been truly impressive. No stock in the market has added more value over the last 12 months than SHOP stock. Shopify's market capitalization has risen by nearly $23 billion over that period. To put that figure into perspective, those gains are equal to the entire market capitalization of United Airlines (NASDAQ:UAL).What makes the rise even more impressive is that all of the gains have come just in 2019. But at this point, there's an obvious question as to whether the gains can continue. SHOP stock trades at a staggering 18x next year's revenue estimates, and roughly 350x 2020 consensus earnings-per-share. This week, InvestorPlace contributor Josh Enomoto argued that it was time to take profits in SHOP -- it's difficult to disagree with that sentiment.That said, there's little reason to see the gains suddenly ending. New plans to provide fulfillment for online sellers add another potential profit stream for Shopify. More broadly, investors who have seen growth stocks as "too expensive" in this market generally have missed out on big gains. (Indeed, I made precisely that case on SHOP stock earlier this year; that argument looks close to silly in retrospect.)It does seem like at some point SHOP stock at least needs to slow down, given valuation multiples that are the highest in the market among stocks its size. But nothing has stopped Shopify stock yet, which might mean it can continue to defy gravity for some time to come. Axsome Therapeutics (AXSM)Source: Shutterstock 1-Year Performance: +876%Even including nano-caps, no stock in the market, on a percentage basis, has outperformed Axsome Therapeutics (NASDAQ:AXSM). AXSM stock has gained a stunning 876% over the past year and it has risen 783% in 2019 alone.These types of gains aren't completely unprecedented in the biotechnology space, where stocks can rise by several hundred percent -- or lose most of their value -- on a single trial result. And Axsome's flagship compound, AXS-05, has real potential. The drug has entered Phase III trials for treatment of major depressive disorder, agitation in Alzheimer's and smoking cessation. * 7 Marijuana Stocks With Critical Levels to Watch With a market cap still under $1 billion, AXSM stock could run higher if trials further validate the company's core product. Compounds elsewhere in the pipeline aim to treat migraines and narcolepsy, among other disorders. But as biotech investors know all too well, it takes only one piece of bad news for big gains to reverse in a hurry. Amarin Corporation (AMRN)Source: Shutterstock 1-Year Performance: +481%The good news for Amarin Corporation (NASDAQ:AMRN) is that its stock is up 481% over the past 12 months. The bad news might be that its stock is down 15% over the past 10 months.Indeed, all of the stock's gains came in a short burst last September. A successful clinical trial of the company's Vascepa, a prescription Omega-3, led AMRN to better than quadruple in a single day. The stock kept rising, gaining 579% in just nine sessions.Since then, however, some of the old skepticism toward Amarin has returned. After all, bears argue, Vascepa simply is derived from fish oil, which in theory means it can be easily replicated.But Wall Street, at least, sees it very differently. The average target price of $33 suggests nearly 100% upside from current levels. It very well could be that, once again, skeptics toward AMRN are going to miss out on big gains. Coca-Cola Consolidated (COKE)Source: Shutterstock 1-Year Performance: +114%It's not entirely clear why Coca-Cola Consolidated (NASDAQ:COKE) has gained so significantly over the last year. The company is a bottler for Coca-Cola (NYSE:KO), which is hardly the type of business model to see 100%+ gains over a short period of time.Coca-Cola Consolidated has posted decent results so far this year, but they've hardly been spectacular. First-half physical case volume rose just 0.3% year-over-year. Gross profit dollars did increase 8%. But this is a stock now trading at 39x the sole analyst estimate for next year. That seems like a huge multiple for a business that is posting single-digit growth. * 10 Stocks to Buy on the Trade War Dip There is a theory that COKE stock has risen because some smaller investors -- potentially those using the Robinhood app -- are mistaking COKE for KO. Whatever the cause, it does seem like COKE has run too far. But even if that's the case, it's not clear when the stock will pull back, or how far it might have to fall. Match Group (MTCH)Source: Shutterstock 1-Year Performance: +115%Last May, shares of Match Group (NASDAQ:MTCH) fell 22% in a single session. The decline didn't come from anything Match itself had done. Rather, Facebook (NASDAQ:FB) had announced its entry into the dating space and investors fled MTCH stock as a result.Those investors that sold Match Group stock would regret it. Since that selloff, MTCH stock has nearly tripled. It has gained 115% over the past year, with its $15 billion gain in market value second only to Shopify.The gains may not be over. MTCH gained 24% on Wednesday after a blowout quarter. The user base for Tinder continues to soar, with subscribers rising 39% year-over-year in the second quarter. Match is dominating online dating -- a market that should only grow in the U.S. and, more importantly, overseas.To be sure, MTCH stock isn't cheap at these levels. It trades at 46x 2020 EPS estimates, even though those estimates are likely to rise after the company forecast stronger growth in the second half of 2019. But, in this market, online plays that dominate their space get big multiples (see Etsy (NASDAQ:ETSY), for instance). And betting against MTCH has proven to be foolhardy so far. Workiva (WK)Source: Workvia1-Year Performance: +145%One of the more difficult aspects of this bull market is that investors have had to figure out how to value stocks whose earnings are negative. Data play Workiva (NYSE:WK) is one of those stocks. The company is guiding for an adjusted operating loss in 2019 -- yet WK stock gained 13% on Wednesday after updating that outlook.To be sure, data preparation and collection has been a hot space. Salesforce (NYSE:CRM) paid $15.7 billion for Tableau Software earlier this year. Smaller data prep play Datawatch was taken out by Altair Engineering (NASDAQ:ALTR) late last year. More broadly, investors clearly have been willing to pay up for growth in recent years. * 7 Stocks to Buy to Ride the Vegan Wave That said, there is a case that the gains in Workiva stock have gone a bit too far. WK now trades, even backing out cash, at over 9x revenue. Growth is solid, but at a guided 19% this year not quite spectacular. At the very least, it does look like the easy money has been made. The Trade Desk (TTD)Source: Shutterstock 1-Year Performance: +189%So-called "adtech stocks" like The Trade Desk (NASDAQ:TTD) hadn't been very good investments until recently. Rocket Fuel went closed its first day of trading at $55 and sold itself for less than $3 to Sizmek. The combined company wound up selling its assets for just $36 million.YuMe went public at $9 -- and sold for less than $2. Marin Software (NASDAQ:MRIN) is down 98% from its highs.But for the winners, including The Trade Desk, the news has become notably better of late. While leaders like Facebook and Alphabet (NASDAQ:GOOG, NASDAQ:GOOGL) took up most online advertising growth, other providers are starting to flex their muscles. So-called "programmatic" marketplaces like the one run by TTD are seeing greater adoption as a result.TTD isn't alone in soaring. The Rubicon Project (NASDAQ:RUBI), after losing 90% of its value, has risen 400% from early 2018 lows -- and roughly matched TTD's performance over the past year.For TTD, valuation does look a bit stretched: The stock trades at 70x next year's EPS estimates. And it's worth wondering what happens if the online advertising space sees another soft patch, as it did just a few years ago. This seems like a story that sounds better on paper -- online advertising growth should continue for years going forward -- than in practice. The market may grow, but the history of that market shows that third-party providers don't always benefit. Cronos Group (CRON)Source: Shutterstock 1-Year Performance: +145%Cannabis stocks like Cronos Group (NASDAQ:CRON) have mostly pulled back in the past few months. And so performance over the past twelve months generally doesn't look all that impressive.CRON stock, too, has pulled back, dropping almost 40% from March highs. But even with that weaker trading of late, the stock still has gained 145% over the past year, and is up 1,000% from 2017 levels.The question with CRON, as it is for much of the sector, is whether valuation remains stretched even after the pullback. The Canadian market looks somewhat disappointing. Legalization elsewhere is moving slower than hoped. And as I wrote last month, Cronos is taking its time as the market develops, which suggests investors should do the same. * 5G Stocks With 10X Potential That said, marijuana companies still have a massive potential opportunity worldwide. And it's possible the weakness of late, in retrospect, will look like a buying opportunity. But patience might be a virtue when it comes to Cronos Group stock. MongoDB (MDB)Source: Shutterstock 1-Year Performance: +142%High-growth software plays are trading at nosebleed valuations. But even in that context, MongoDB (NASDAQ:MDB) is one of the most expensive stocks out there. MDB stock trades at well over 20x 2019 revenue.Of late, however, the rally has stalled out somewhat. MDB has pulled back 23% from highs reached after fiscal Q1 earnings in June. Recently, InvestorPlace contributor Luke Lango argued that the weakness was a buying opportunity, and given the company's explosive growth, there's a case he's right. Revenue increased 78% year-over-year in the fiscal first quarter, and increased adoption of the company's platform should keep growth sizzling for some time to come.That said, this remains a company valued at $8 billion, with negative earnings. And in a suddenly jittery market, it's not hard to wonder if a better price might be on offer. Investors so far have been rewarded for shrugging off valuation concerns. But as with so many software plays, the question is for how long that will last. Roku (ROKU)Source: Shutterstock 1-Year Performance: +158%The 12-month gains in Roku (NASDAQ:ROKU) are reasonably impressive. YTD performance, however, has been even better. ROKU stock now has nearly quadrupled so far this year, easily reversing a steep decline in last year's fourth quarter, and then some.Here, too, the question is whether the gains have to end at some point. Roku's growth is impressive. Q2 earnings look like a blowout. Its importance to the streaming media ecosystem at a time of cord-cutting is obvious. But its valuation, as I wrote in June, is even steeper than headline numbers suggest.After all, about one-third of this year's revenue will come from the sale of Roku players. Gross margins in that business are in the single-digits, meaning hardware sales are likely unprofitable. Back out that revenue, and ROKU stock trades at over 20 times its guidance for platform (i.e., digital), revenue.That figure, in the context of the overall market, doesn't sound that high. Of course, that raises the question of whether the market simply has pushed growth stocks like ROKU and MDB too far. But that worry aside, Roku still gets minimal revenue from Netflix (NASDAQ:NFLX) and Alphabet unit YouTube -- two of the biggest companies in streaming. And so the argument that Roku is a natural beneficiary of cord-cutting seems thinner than some investors might think. * 7 Winning High-Yield Dividend Stocks With Payouts Over 5% It may be that streaming offerings from Disney (NYSE:DIS), Comcast (NASDAQ:CMCSA) and AT&T (NYSE:T) will accelerate revenue growth, as those media companies fight for consumer attention. Roku could be an acquisition target at some point. Those potential catalysts are part of all the good news that surrounds Roku. The question after nearly 300% gains in seven-plus months is whether even those catalysts are priced in.As of this writing, Vince Martin did not hold a position in any of the aforementioned securities … though he wishes he did. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 8 Dividend Aristocrat Stocks to Buy Now No Matter What * 7 Stocks to Buy to Ride the Vegan Wave * 4 Safe Stocks to Buy Amid Trade War Turbulence The post How the 10 Best Stocks From Last Year Hold Up Today appeared first on InvestorPlace.
(Bloomberg Opinion) -- The drug industry is rarely dull, but this week took things to another level.Things kicked off Tuesday with the Food and Drug Administration’s unusual revelation that Novartis AG had delayed disclosing manipulated data related to early animal tests of its $2.1 billion gene therapy Zolgensma. While the drug is still considered safe, the lapse sparked a decline in Novartis shares. A couple of days later, a wild Thursday afternoon created broader biotech turmoil. Amarin Corp.’s stock plunged after it revealed an unexpected delay in the FDA review of new data for its fish oil-derived heart drug Vascepa. Nektar Therapeutics followed by disclosing a manufacturing issue for its key cancer drug that may have impacted trial results. Its shares tanked more than 30% Friday.Investing in biotechnology can be a tricky business. Stock buyers typically focus on clinical-trial readouts or shifts in drug pricing and health policy, but a whole host of other things can go wrong. Good management and transparency can make things smoother. In the case of this week’s stumbles, spin from company leaders made things worse. Novartis’s reputation still suffers from an earlier effort to seemingly buy White House access via former Trump fixer Michael Cohen. That should have encouraged the company to err on the side of transparency when it discovered this data issue in March, and let regulators and the public know as soon as possible. Instead, Novartis decided to complete a rather slow internal investigation and didn’t inform the FDA until after the drug was approved two months later.The data in question came from a test in mice that is no longer in use. Patient safety wasn’t affected, and the drug will rightfully stay on the market. But the FDA relies on drugmakers to provide clean data, especially for drugs like Zolgensma that are on an accelerated path to approval. Breaking that trust is a big deal for a company of this size, and the FDA was understandably livid about the way this was handled. CEO Vas Narasimhan held a conference call and analyst Q&A after the issue became public, but spent much of it defensively downplaying the problem. He didn’t do nearly enough to fix his relationship with the agency or boost investor trust. The problem escalated on Friday after a group of Senators wrote a letter to the FDA blasting Novartis and urging action. Amarin’s issue wasn’t withholding information from the FDA, but putting words in its mouth. The company said late last month that it believed it was unlikely that the FDA would choose to convene an expert panel to review Vascepa’s ability to cut the risk of heart attacks and strokes. That wasn’t entirely unreasonable as the FDA’s target date for marketing approval on Amarin’s new data was less than two months away. But the FDA sets those dates and can change them. Amarin disclosed Thursday that the agency wants to convene a panel in November after all. That will likely delay approval until at least December. The panel may go swimmingly, and this may be only a minor delay. But investor expectations would have been better calibrated if Amarin hadn’t publicly made risky assumptions. Nektar’s situation is the strangest of all. On its second-quarter conference call Thursday, management revealed that the company was curious about why some patients weren’t responding as well to its cancer drug bempegaldesleukin. After examining early drug lots used in trials, it found variations in two batches. Nektar said it’s rebuilding its quality-control strategy as a result, which is a good idea; its decision to try to spin a flub that may have harmed patients into an upside case for its medicine wasn’t. The company spent a chunk of its second-quarter call elaborating a confusing post-hoc analysis of the impact of different drug batches. As you might imagine, the way they sliced the data suggests that its drug might have looked more promising if it weren’t for those bad batches. The analysis split already small trials into even smaller new subgroups, which makes the data difficult to interpret. Only a new trial will give investors data they can actually trust. In short, Nektar’s attempt at clarification only muddied the waters. When confronted with bad news or uncertainty, the desire to spin it is natural. Drugmakers would be wise to resist that urge. When the truth comes out, it just makes the backlash bigger. To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Beth Williams at email@example.comThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
Amarin shares are plunging after the biotech company revealed the FDA will proceed with a review of its heart drug. This coming as Nektar Therapeutics is sliding after it disclosed a quality control issue with a key cancer therapy. Yahoo Finance's Jared Blikre joins Akiko Fujita on 'The Ticker' to discuss.