105.30 +0.33 (0.31%)
Pre-Market: 5:00AM EDT
|Bid||105.21 x 1300|
|Ask||106.82 x 2900|
|Day's Range||104.83 - 106.32|
|52 Week Range||89.01 - 122.97|
|PE Ratio (TTM)||N/A|
|Beta (3Y Monthly)||1.39|
|Expense Ratio (net)||0.47%|
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.
Biotech stocks went about in a steady manner this week amid a slew of big pharma and biotech earnings announcements, a handful of FDA approvals and a few clinical trial readouts. Lexicon Pharmaceuticals, ...
U.S. equities slipped lower on Thursday as investors continued to digest a heavy flow of earnings reports. There have been some disappointment as well surrounding a lack of specifics from European Central Bank President Mario Draghi, who has been jawboning fresh stimulus but hasn't yet actually taken action.Some weakness in key industrial and technology stocks has weighed on sentiment. Now, biotech stocks are coming under pressure as well. The Nasdaq Biotechnology ETF (NASDAQ:IBB) is falling away from its 200-day moving average, falling down what looks like the right shoulder of a head-and-shoulders reversal pattern going back to 2017. * 7 Oversold Stocks To Buy Right Now Here are four biotech stocks helping lead the decline:InvestorPlace - Stock Market News, Stock Advice & Trading Tips Biotech Stocks: Vertex Pharmaceuticals (VRTX)Shares of Vertex Pharmaceuticals (NASDAQ:VRTX) stock, which focuses on cystic fibrosis treatments, are falling away from their 50-day and 200-day moving averages to return to the April-June trading range. This marks the latest test of uptrend channel support going back to late 2017. Coverage of this biotech stock was recently resumed at Citigroup, which assigned a buy rating and a $205 price target.The company will next report results on July 31 after the close. Analysts are looking for earnings of $1.08 per share on revenues of $886.3 million. When the company last reported on April 30, earnings of $1.14 beat estimates by 13 cents per share on a 34.3% rise in revenues. Regeneron Pharmaceuticals (REGN)Shares of Regeneron Pharmaceuticals (NASDAQ:REGN), maker of treatments including EYLEA for wet age-related macular degeneration, have fallen back below their 50-day moving average and look set for a test of vital support near its early 2018 lows around $290. This marks the bottom of a trading range going all the way back to 2014, so a breakdown would open the door to a major reversal of the gains posted between 2010 and 2015 that resulted in a 23x rally. * 7 Stocks to Sell This Summer Earnings Season The company will next report results on Aug. 6 before the bell. Analysts are looking for earnings of $5.44 per share on revenues of $1.8 billion. When the company last reported on May 7, earnings of $4.45 missed estimates by $1.07 per share on a 13.3% rise in revenues. Alexion Pharmaceuticals (ALXN)Shares of Alexion Pharmaceuticals (NASDAQ:ALXN), which makes various medications including a treatment for genetic blood disorders, are falling away from their 200-day moving average to threaten a decline below its late May low near $115. This marks nearly a 20% decline from its April high.The company reported better-than-expected results on Wednesday, with earnings of $2.64 per share beating estimates by 30 cents. Forward guidance was raised as well. Yet it appears the whisper number was higher, as investors sold on the report. The company will next report results on Oct. 23 before the market. Incyte (INCY)Shares of Incyte (NASDAQ:INCY) stock, which is a maker of various cancer treatments among other drugs, is falling away from double-top resistance near the $90-a-share threshold and is once again threatening a decline below its 200-day moving average. Shares enjoyed a lift last month on the premium purchase of Array BioPharma (NASDAQ:ARRY), maker of treatment for certain BRAF-mutant cancers, by Pfizer (NYSE:PFE). * 10 Stocks to Buy From This Superstar Fund The company will next report results on July 30 before the bell. Analysts are looking for earnings of 49 cents per share on revenues of $496.6 million. When the company last reported on April 30, earnings of 62 cents per share beat estimates by 21 cents on a 30.2% rise in revenues.As of this writing, William Roth did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Oversold Stocks To Buy Right Now * 7 Stocks to Buy Upgraded by Wall Street * 7 Marijuana Stocks With Critical Levels to Watch The post 4 Biotech Stocks Sliding Lower appeared first on InvestorPlace.
Shares of Capricor Therapeutics Inc. nearly doubled (up 93%) in very active premarket trading Monday, after the biotechnology company announced upbeat results from a trial for its treatment (CAP-1002) of Duchenne muscular dystrophy. Trading volume was about 1.7 million shares ahead of the open, compared with the full-day average of about 56,500 shares. "I am incredibly pleased with the outcome of the interim analysis as it has demonstrated the biologic activity of CAP-1002 that has resulted in changes of clinically relevant outcomes including the upper limb, the hand and diaphragmatic function," said Craig McDonald, the principal investigator for the trial. The stock has lost 42.6% over the past three months through Friday, while the iShares Nasdaq Biotechnology ETF has slipped 4.5% and the S&P 500 has gained 3.7%.
Biotechnology stocks and sector-related exchange traded funds stood out on Tuesday after a U.S. District Court overruled President Donald Trump’s wishes to require drugmakers list prices on television ...
Late Monday, a U.S. District Court overturned President Trump's requirement that pharmaceutical companies and biotech stocks list the prices of their medicines in TV ads.
Shares of Altimmune Inc. soared 14% in premarket trading Tuesday, after the biopharmaceutical company announced a deal to buy Spitfire Pharma Inc., which is developing a treatment for non-alcoholic steatohepatitis, known as NASH. Altimmune will make an upfront payment of $5 million to Spitfire shareholders, who will also be eligible to receive an additional $8 million in regulatory and clinical milestones and up to $80 million in sales-based milestones. The deal is expected to close in July. Spitfire's NASH product candidate SP-1373 will be renamed ALT-801. "Compelling preclinical data generated by Spitfire suggests that ALT-801 could reverse obesity, a primary cause of NASH, thereby reducing excess liver fat, inflammation and fibrosis associated with the disease," said Altimmune Chief Executive Vipin Garg. Altimmune's stock has tumbled 21.1% over the past three months through Monday, while the iShares Nasdaq Biotechnology ETF has lost 4.3% and the S&P 500 has gained 3.4%.
Shares of Tyme Technologies Inc. shot up 31% in active morning trading Friday, after the biotechnology company provided upbeat updated data from its phase 2 study of SM-88 for the treatment of pancreatic cancer. Trading volume swelled to 4.1 million shares, or already more than six-times the full-day average. The company said before the open that data from the study of SM-88 as an oral monotherapy showed that median overall survival of patients was 6.4 months, which compares favorably to historical trials which showed survival of 2.0 to 2.5 months. "We believe that these outcomes further justify advancing the development of SM-88," said Chief Medical Officer Giuseppe Del Priore. "We are increasingly encouraged that SM-88 has the potential to be a new treatment approach for late-stage pancreatic patients." Despite Friday's rally, the stock was still down 57% year to date, while the iShares Nasdaq Biotechnology ETF has gained 14% and the S&P 500 has advanced 19%.
Shares of Unum Therapeutics Inc. tumbled 19% toward a record low in premarket trading Wednesday, after the Food and Drug Administration placed a "clinical hold" on the phase 1 trial of its cancer treatment ACTR087. The company said late Tuesday that the clinical hold was initiated after the biopharmaceutical company submitted a safety report regarding one patient in the trial experienced serious adverse events. Unum said it will work with the FDA to further review the events, and plans to report data from the trial at the end of the year. Analyst Peter Lawson at SunTrust Robinson Humphrey slashed his stock price target to $6 from $10, while keeping his rating at buy as the new target is more than triple current premarket prices. Lawson said that after speaking with management, he noted that the ACTR087 program was already de-prioritized in November. The stock has plunged 50% year to date through Tuesday, while the iShares Nasdaq Biotechnology ETF has gained 14% and the S&P 500 has advanced 19%.
Incyte Corp. said Tuesday it will receive an upfront payment of $17.5 million as part of a license agreement with Zai Lab Ltd. for the development and commercialization of Incyte's cancer treatment INCMGA0012 in China. Under terms of the agreement, Incyte is eligible to receive up to an additional $60 million in milestone payments, as well as tiered royalty payments from the "low to mid-twenties." In return, Zai Lab will have exclusive rights to commercialize INCMGA0012 in China, Hong Kong, Macau and Taiwan. Incyte and Zai Lab shares were still inactive in the premarket. Over the past three months, Incyte shares have lost 1.5% and Zai Lab's stock has climbed 19.4%, while the iShares Nasdaq Biotechnology ETF has slipped 2.7% and the S&P 500 has gained 3.4%.
Adaptive Biotechnologies Corp. increased the number of shares it will sell in its initial public offering, and the expecting pricing range increased as well, according to a filing with the Securities and Exchange Commission on Wednesday. The company is now offering 15 million shares, up from 12.5 million shares disclosed last week, while the expected pricing range is now $18 to $19 a share, up from $15 to $17 a share. The developer of immune-system derived disease treatments is now looking to raise $285 million, and be valued at up to $2.30 billion, before underwriters exercise any options to buy up to an additional 2.25 million shares. The upsized IPO comes at a time that the Renaissance IPO ETF has gained 2.0% over the past three months, the iShares Nasdaq Biotechnology ETF has slipped 2.9% and the S&P 500 has advanced 3.9%.
Recent news from a leading gene therapy company highlights the risks, but the charts suggest ample room to the upside for biotech stocks.
The often politically sensitive healthcare sector displayed that sensitivity in positive fashion Wednesday as a variety of exchange-traded funds (ETFs) tracking the sector surged on news that Senate Republicans are close to unveiling new healthcare legislation. On Wednesday, 15 ETFs hit all-time highs, and eight of those were healthcare funds.
Shares of ContraVir Pharmaceuticals Inc. rocketed 69% in active premarket trading Friday, to bounce off the previous session's record low close, after the biopharmaceutical company said it received "positive feedback" from the U.S. Food and Drug Administration in response to its pre-Investigational New Drug (pre-IND) meeting. Trading volume ballooned to over 760,000 shares, compared with the full-day average of about 1 million shares. The pre-IND meeting was with respect to the development of CRV431 for the treatment of liver disease arising from non-alcoholic steatohepatitis (NASH). The company said the feedback supports an IND submission for CRV431. "This IND submission for NASH will be in addition to our current existing IND for hepatitis B virus treatment," Chief Executive Robert Foster said. The stock has plunged 78% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF has gained 13% and the S&P 500 has advanced 18%.
Adaptive Biotechnologies Corp. set terms for its initial public offering Monday, in which the developer of immune-system derived disease treatments is expected to raise up to $212.5 million and be valued at about $2.01 billion. The Seattle-based company is offering 12.5 million shares in the IPO, which is expected to price between $15 and $17 a share. If the underwriters, led by Goldman Sachs, J.P. Morgan and BofA Merrill Lynch, exercise all options to buy 1.875 million additional shares, the company could raise up to $244.4 million and be valued at up to $2.05 billion. The stock is expected to list on the Nasdaq under the ticker symbol "ADPT." The underwriters are led by Goldman Sachs, Citigroup and Wells Fargo Securities. After the IPO, the company will have about 118.5 million shares outstanding. The company recorded a net loss of $46.3 million on revenue of $55.7 million in 2018, after a loss of $42.5 million on $38.4 million in revenue in 2017. The company is looking to go public at a time that the iShares Nasdaq Biotechnology ETF has gained 10% year to date and the S&P 500 has advanced 15%.
Karuna Therapeutics Inc. set terms Monday for its initial public offering, in which the biopharmaceutical company developing treatments for neuropsychiatric conditions is expected to raise up to $74.4 million and be valued at about $363.3 million. The company is offering 4.375 million shares in the IPO, which is expected to price between $15 and $17 a share. The stock is expected to list on the Nasdaq under the ticker symbol "KRTX." The company said some existing shareholders and directors have expressed interest in buying up to a combined $30 million of shares at the IPO price. The underwriters are led by Goldman Sachs, Citigroup and Wells Fargo Securities. After the IPO, the company will have about 21.4 million shares outstanding. The company recorded a net loss of $17.5 million on no revenue in 2018, after a loss of $6.0 million on no revenue a year ago. The company is looking to go public at a time that the iShares Nasdaq Biotechnology ETF has lost 7.2% over the past three months, while the Renaissance IPO ETF has gained 3.2% and the S&P 500 has gained 2.5%.
Morphic Holding Inc. set terms of its initial public offering, in which the Waltham, Mass.-based biopharmaceutical company focused on developing treatments for chronic diseases looks to raise up to $80 million. The company said it is offering 5 million shares, with the IPO expected to price between $14 and $16 a share, which would give Morphic an initial market capitalization of up to $457.5 million. The company expects the stock to list on the Nasdaq under the ticker symbol "MORF." The lead underwriters are Jefferies, Cowen, BMO Capital Markets and Wells Fargo Securities. Morphic recorded a net loss of $23.8 million on total collaboration revenue of $3.4 million in 2018, after a loss of $16.9 million on no revenue in 2017. The company is looking to go public at a time the Renaissance IPO ETF has edged up 2.3% over the past three months, the iShares Nasdaq Biotechnology ETF has lost 8.1% and the S&P 500 has gained 2.7%.
Shares of Kura Oncology Inc. soared 27% toward a record high in premarket trading Friday, after the biopharmaceutical company announced a phase 2 trial of its lymphoma treatment achieved its primary efficacy endpoint. The stock was on track to open above its March 2, 2018 record close of $23.40. The company said the results of the trial demonstrated "ongoing anti-tumor activity and a manageable safety profile" in advanced patients with angioimmunoblastic T-cell lymphoma (AITL), as well as non-AITL relapsed or refractory peripheral T-cell lymphoma (PTCL). "We believe these data support the potential to register tipifarnib in both the AITL and PTCL-NOS patient populations, and we look forward to seeking regulatory feedback on next steps for this program," said Chief Executive Troy Wilson. The stock has run up 32% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF has gained 8% and the S&P 500 has advanced 15%.
Shares of Provention Bio Inc. surged 4.5% in premarket trade Thursday, after the biopharmaceutical company said it has terminated its planned public stock offering, citing current market conditions. The stock had more than tripled (up 217%) on Monday, after the company reported positive results from a study of its diabetes treatment. The stock then fell 13% on Tuesday, and 1.7% on Wednesday, after Provention looked to take advantage of the rally by proposing a public offering of 5.5 million common shares, which represented about 14.7% of the shares outstanding. On Thursday, the company said it decided not to sell shares after determining that "current market conditions are not conducive for an offering on terms that would be in the best interests of the company's shareholders." The stock has run up nearly 7-fold (up 569.5%) year to date through Wednesday, while the iShares Nasdaq Biotechnology ETF has gained 7.2% and the S&P 500 has advanced 14.9%.
Investment banker Barclays announced it has initiated coverage of 20 U.S. specialty pharmaceuticals stocks.But which 20 stocks within this sector are we talking about today? They include generic drugs companies Mylan (MYL), which Barclays rates Overweight (i.e. 'buy') and Teva Pharmaceutical Industries (TEVA), which the analyst rates Underweight (i.e. 'sell'), as well as: * Amneal Pharmaceuticals (AMRX) * Endo International (ENDP) * Reddy's Laboratories (RDY) * and Mallinckrodt plc (MNK)Each of which is rated Equal weight (i.e. 'hold').Within the animal health sector (i.e. veterinary medicine), Barclays initiates coverage with Overweight ratings on Zoetis (ZTS) and Kindred Biosciences (KIN), but gives Phibro Animal Health Corporation (PAHC) an Underweight rating.Among developmental and commercial stage companies "with unique products & segments," Barclays has two 'sells' -- Allergan (AGN) and Evolus (EOLS) -- and one hold: Ligand Pharmaceuticals (LGND). As for Barclays' 'buy' ratings, it rates the following companies Overweight ratings: * AMAG Pharmaceuticals (AMAG) * Jazz Pharmaceuticals (JAZZ) * Osmotica Pharmaceuticals (OSMT) * Coherus BioSciences (CHRS) * Pacira BioSciences (PCRX) * Revance Therapeutics (RVNC) * Bausch Health Companies (BHC) * and Foamix Pharmaceuticals (FOMX)Today, we really only have time to glance at just one of these stocks: Rehovot, Israel-based Foamix.Foamix is a late clinical-stage specialty pharmaceutical company focusing on foam-based medications for the treatment of acne and rosacea. Foamix stands out in this report primarily by virtue of the extremely high hopes Barclays' has for it, namely, valued at just $2.53 per share today, Barclays believes that within a year, Foamix stock will be selling for $10 -- a four-bagger in just one year.Why is Barclays so optimistic? As the analyst explains, Foamix is on the cusp of becoming a "commercial stage company" -- i.e. a company with actual revenue from sales, a rarity in small drugs stocks -- thanks to its topical Minocycline product for acne and rosacea. Designated "FMX-101" for acne treatment and "FMX-103" for rosacea, both these foam-based products "combine [the] proven efficacy of minocycline with a more tolerable side effect profile" says Barclays. From $3 million in annual revenue today, the banker predicts Foamix could do as much as $272 million in annual sales by 2025E.Considering that the entire company has a market cap of barely half that number -- $138 million -- today, Foamix at least seems to have earned its place on Barclays' list.Foamix has a few upcoming catalysts that could send its shares surging higher: * There is a scheduled PDUFA for FMX-101 on October 20, 2019. This is a key event for Foamix, as FMX-101 is its lead product in acne. * Foamix anticipates filing an NDA in mid-2019 for FMX-103 in moderate-to-severe papulopustular rosacea. * FCD-105 Phase II study initiation in mid-2019: FCD-105 is another pipeline product being evaluated in patients with acne and is a foam-based combination of minocycline and adapalene."We value Foamix on a DCF basis, assuming an 11.5% discount rate and a 3% terminal growth. We include risk adjusted pipeline values for both FMX-101 (90% probability of success) and FMX-103 (70% probability of success). We also assume base uptake of FMX-101, reaching 2025 risk-adj. sales of ~$200mm. This scenario yields a value of ~$10/share and serves as the basis for our price target," Barclays noted.Read more: Foamix (FOMX): A Beaten-Down Biotech Stock That Looks Like a Bargain Now More recent articles from Smarter Analyst: * Deutsche Bank: 3 Stocks With Over 30% Upside Potential * 3 “Strong Buy” Stocks Poised to Soar in the Next 12 Months * Analysts Go Gaga Over Nvidia (NVDA) Stock * Why You Should Keep Tesla (TSLA) and W.W. Grainger (GWW) Stocks on Your Sell List
Personalis Inc. disclosed Friday terms of its initial public offering, in which the cancer genomics company could raise up to $106.7 million, and be valued at up to about $456 million. The company said it was offering 6,666,667 shares in the IPO, which is expected to price between $14 and $16 a share, and will have about 28.5 million shares outstanding after the offering. Personalis plans to use the IPO proceeds for the expansion of research and development, infrastructure, facilities, headcount, marketing spend and other capital expenditures. The stock is expected to list on the Nasdaq exchange under the ticker symbol "PSNL." The lead underwriters of the IPO are Morgan Stanley, BofA Merrill Lynch and Cowen. The company recorded a 2018 net loss of $19.9 million on revenue of $37.8 million, after a loss of $23.6 million on revenue of $9.4 million in 2017. Personalis is looking to go public at a time the iShares Nasdaq Biotechnology ETF has lost 6.4% over the past three months, while the both the Renaissance IPO ETF and the S&P 500 have gained 3.4%.