On a relative basis, biotech and pharmaceutical indexes outperformed the S&P 500 by 18% and 10%, respectively, in the past three recessions, according to SVB Leerink analyst Geoffrey Porges.
Gilead Sciences’ antiviral drug remdesivir showed “quite good news,” according to White House health advisor Dr. Anthony Fauci. Assistant Professor in Department of Health Policy and Management at the Harvard Global Health Institute Dr. Tom Tsai joins Yahoo Finance’s Seana Smith to discuss the latest developments.
Shares of Navidea Biopharmaceuticals Inc. more than doubled in very active premarket trading Friday, after the company provided upbeat data on an ongoing phase 2 trial of its treatment for rheumatoid arthritis. Trading volume topped 5.2 million shares about an hour before the open, compared with the full-day average of about 217,000 shares. The stock soared 145% ahead of the open, putting it on track to open at the highest regular-session price seen since April 2019. The company said late Thursday that preliminary results of a second interim analysis of its NAV3-31 Phase 2B study further corroborates its hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA), and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The stock has rallied 13.4% over the past three months through Thursday, while the iShares Nasdaq Biotechnology ETF has gained 7.6% and the S&P 500 has lost 11.7%.
Biotech funds have rallied within striking distance of multi-year resistance and could break out in coming weeks.
Technically speaking, the U.S. benchmarks’ grinding-higher recovery attempt remains in play, writes Michael Ashbaugh, though amid increasingly uneven price action.
It has been almost three months since the coronavirus-driven volatility hit the global economy, and the market continues to rapidly move into both the green and the red. Yet, since its March 16 low, the S&P 500 has come a long way, rising nearly 18%. Wall Street pros remind investors that one area of the market has performed significantly better than the S&P 500: the biotech sector. As a result, names inhabiting this space have found themselves under the Street’s microscope.Having said that, there is something to consider when making these investment decisions. Biotech stocks are especially volatile due to the characteristics of the industry itself. For these companies, there are only a few key indicators like study results or regulatory approvals to determine whether or not sustainable revenues are on the horizon. As a result, a favorable outcome can act as a catalyst that sends shares flying out of the ballpark. For this reason, risk-tolerant investors flock to these stocks. However, biotech stocks are famous for being risky as the opposite also holds true.This makes it difficult to separate the biotechs with massive growth prospects from those poised to strike out. Don’t worry, Wall Street analysts can lend a hand with that.During our search for compelling biotech stocks, we turned to the analysts for help. Using TipRanks’ database, we found exactly what we were looking for: three Buy-rated biotech stocks trading for under $4 with massive upside potential. We are talking returns of at least 50% over the next months.Osmotica Pharmaceuticals (OSMT)Osmotica Pharmaceuticals boasts a diverse product portfolio that addresses needs in the specialty neurology and women's healthcare space, with it also developing non-promoted complex formulations of generic drugs. Following a strong quarter in which it held up well despite COVID-19's impact, at $3.86 apiece, several members of the Street think now is the time to snap up shares.Weighing in for RBC Capital, analyst Randall Stanicky tells investors he is optimistic ahead of the July 16 PDUFA date for its lead candidate, RVL-1201 (blepharoptosis). The company still plans on launching the product right after the PDUFA, with pricing expected to be in the $75-$100 range. It should be noted that COVID-19 has forced OSMT to scale down the launch and the initial sales force. That being said, the company has a new plan. The launch will instead be more “controlled” and kick off with a core group of KOLs and other eye care professionals, with it ramping up after more states and practices reopen.Stanicky fully supports this approach, noting that the strategy “makes sense." “The U.S. is unlikely to have returned to normal by mid-summer, which is reason enough for caution. And importantly, OSMT has a diversified book of business (and liquidity) that reduces the urgency to launch. We might also add that a ‘soft’ launch keeps the door open to a potential U.S. therapeutic partnership, adding further optionality,” the analyst explained.As for the aesthetics opportunity, the approach is very similar. Stanicky points out that while OSMT has a few potential partners lined up, it isn’t in a rush to finalize the decision. “Either way, we think there could be strong demand for RVL-1201 from aesthetics providers as a complementary offering to facial toxins/fillers (and as a way to help make up for lost revenue due to COVID-19). OSMT also expressed interest in adding additional eye care or aesthetics offerings to leverage its commercial infrastructure, while potentially divesting non-core assets (eg. Women's Health),” the analyst commented.If that wasn’t enough, Stanicky cites the Ontinua ER (arbaclofen) NDA re-submission, which is slated for June, as well as the potential for both U.S. and international partnerships for RVL as possibly representing additional catalysts for shares.Taking all of this into consideration, Stanicky reiterates an Outperform (i.e. Buy) rating on OSMT stock, along with a $10 price target. Should this target be met, a twelve-month gain of 159% could be in store.Turning now to the rest of the Street, other analysts also like what they’re seeing. 3 Buys and a single Hold have been assigned in the last three months, making the consensus rating a Strong Buy. While less aggressive than Stanicky’s, the $8 average price target still leaves room for 107% upside potential. (See Osmotica stock analysis on TipRanks)Iterum Therapeutics (ITRM)With at least two million people infected with bacteria that’s resistant to antibiotics every year in the U.S., Iterum Therapeutics develops differentiated anti-infectives to combat these multi-drug resistant (MDR) pathogens. As the data readouts for its SURE 1/2 trial are expected any day now, the analyst community is telling investors to pull the trigger before its $3.45 share price goes up.Previously, ITRM landed in some hot water after announcing at the end of March that the data release would be pushed back until early in the second quarter. However, RBC Capital analyst Gregory Renza believes the delay is “unsurprising given the quick development of COVID-19 and how the company has been framing their progress and study wrap-up over this month.”"Today's update mirrors our recent conversation with management as active COVID-19 assessments have been underway where, given enrollment had already wrapped, the impact was initially viewed as minimal, but the coronavirus has affected the process of final data staging by a few weeks - we consider it as reasonable given the various restrictions under the macro-environment," Renza added.After the data is released, management stated it doesn’t foresee any delays for the NDA filing, given that the manufacturing sites were approved by the FDA before COVID-19 and the clinical module could be prepared after the SURE trial readouts. Offering further explanation, Renza said “If positive, ITRM believes that they could make a swift transition into the next phase of development, and believes that the current supply of sulopenem would be sufficient for the first year of launch.”It should come as no surprise, then, that Renza has high hopes for this biotech. To this end, he kept both an Outperform call and $8 price target on the stock. This target conveys the five-star analyst’s confidence in ITRM’s ability to soar 132% in the next year. (To watch Renza’s track record, click here)Do other analysts agree with Renza? As it turns out, they do. With 100% Street support, or 3 Buy ratings to be exact, the message is clear: ITRM is a Strong Buy. In addition, the $8 average price target matches Renza’s. (See Iterum stock analysis on TipRanks)Verastem, Inc. (VSTM)Focused on developing small molecule drugs that inhibit critical signaling pathways that promote cancer cell survival and tumor growth, Verastem believes its approach could potentially help stomp out cancer. With clinical and regulatory updates slated for late 2020, some analysts think that its $1.76 share price represents a compelling entry point.On April 27, VSTM presented the most updated results from the ongoing investigator-sponsored Phase 1 study of VS-6766, which was formerly known as CH5126766, in combination with defactinib for the treatment of KRAS mutant solid tumors. The company acquired the candidate, a RAF/MEK dual inhibitor, back in January from Chugai Pharmaceuticals. As the asset could overcome key resistance mechanisms seen with traditional MEK inhibitors such as Mekinist, it’s no wonder Wall Street focus has locked in on this biotech.Among the bulls is H.C. Wainwright analyst Sean Lee. He argues that the most encouraging outcomes were seen in eight patients with low-grade serous ovarian cancer (LGSOC). Four demonstrated a response to the therapy and all eight patients achieved disease control. Additionally, the therapy generated a response from 67% of the participants with KRAS mutant tumors, with three of the four responding patients having previously failed MEK inhibitor therapy. Not to mention the dose exhibited a strong safety profile and was well-tolerated.Expounding on this, Lee stated, “Considering that LGSOC is an orphan indication with less than 1,000 patients diagnosed in the U.S. each year and has no specific approved therapy, we believe that these results are highly relevant and could lead to an accelerated path to approval. According to management, the company plans to meet with the FDA in 1H20 to discuss the path forward, and we believe the company could initiate a registrational study in LGSOC in late-2020.”That being said, when it comes to VS-6766's use in KRAS mutant non-small cell lung cancer (NSCLC), the results varied much more across the board. The response rate was significantly lower than what is produced by KRAS inhibitors from its peers, but Lee highlights the fact that these agents only target patients with the G12C mutant form.“Conversely, VS-6766 plus defactinib targets all KRAS mutations, and initial results suggest that the combination may be particularly effective in treating G12V and G12D mutants. Therefore, while these early results in NSCLC may appear well short of expectations, we note that the number of treated patients so far remain very small and that targeting underserved patient populations could allow Verastem carve out a niche in the KRAS NSCLC market,” Lee explained.As the company is also set to enroll additional patients with G12V and G12D mutant NSCLC and pancreatic cancer, with it potentially releasing the results by the end of 2020, the deal is sealed for Lee. The analyst reiterated both his Buy recommendation and $2.75 price target, implying 56% upside potential from current levels. (To watch Lee’s track record, click here)Looking at the consensus breakdown, VSTM has received 2 Buys and 1 Hold over the last three months. As a result, the biotech earns a Moderate Buy consensus rating. At $4.50, the average price target puts the upside potential at 156%, which flies past Lee’s forecast. (See Verastem stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Shares of Geron Corp. plunged 26% in premarket trading Friday, after the biopharmaceutical company's large public offering of stock priced at a 34% discount. The stock offering comes about a week after the stock surged to a near 2-year high after the company announced "very encouraging durability data" regarding its cancer treatment imetelstat. On Friday, the company said its offering of 107.05 million common shares priced at $1.30, after the stock closed Thursday at $1.96. The offering represented about 53% of the shares outstanding. The company also offered pre-funded warrants to buy 8.34 million shares, together with warrants to buy 57.69 million shares. The company said it plans to use the proceeds from the offerings to fund its ongoing IMerge Phase 3 trial in lower risk myelodysplastic syndromes to top-line results, its planned Phase 3 clinical trial in refractory myelofibrosis to complete patient enrollment, and for working capital and general corporate purposes. The stock has run up 44.1% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF has gained 9.9% and the S&P 500 has lost 8.7%.
Yahoo Finance's Seana Smith and ETF Trends CIO and Director Dave Nadig discuss the outlook on biotech ETFs as optimism grows over results for coronavirus treatments.
Technically speaking, the major U.S. benchmarks are back on the defensive, pressured amid plunging crude-oil prices, writes Michael Ashbaugh.
JP Morgan Private Bank Head of Cross-Asset Thematic Strategy Anastasia Amoroso joins Yahoo Finance’s Seana Smith to discuss the latest market action as more states move to reopen their economies in the wake of the coronavirus.
University of Alabama at Birmingham School of Public Health Epidemiologist Suzanne Judd, Ph.D. joins Yahoo Finance’s Seana Smith to discuss the latest coronavirus developments, as a new CBS poll reveals 70% of people think curbing the spread of the coronavirus should be the top U.S. priority right now.
There will be a big shift in the economy, helping the likes of biotechnology and semiconductor stocks.
Professor of Medicine at Yale and Director of The Yale New Haven Hospital Center for Outcomes Research and Evaluation Dr. Harlan Krumholz joins Yahoo Finance’s Seana Smith to discuss Moderna’s recent headway in an early-stage coronavirus vaccine trial.
Will markets go up or down as we move toward summer? No one knows for sure, but one metric to watch is activity among short sellers — investors who believe a particular security will decline in value.
Biotechnology-themed exchange-traded funds surged higher late Monday morning as investors rewarded pharmaceutical companies that looked likely to profit from treatments for COVID-19. The SPDR S&P Biotech ETF was up 3.1%, and the iShares NASDAQ Biotechnology ETF gained more than 2%. Two funds with the most exposure to the company making headlines in the morning, Moderna Inc. , jumped even higher: the Loncar Cancer Immunotherapy ETF , with a 13% allocation to Moderna, was 4.8% higher, and the iShares Genomics Immunology and Healthcare ETF was 5% higher. In the year to date, XBI has gained 11.7%, compared with a 8.8% decline for the S&P 500 in that period.
Telehealth companies enabling individuals to see physicians without stepping foot into a physical doctor’s office are having their moment, as the coronavirus pandemic confines individuals and would-be patients across the country largely to their homes.
Nasdaq Stock Exchange President Nelson Griggs joins Yahoo Finance’s Seana Smith to discuss market operations amid the coronavirus and the outlook on IPOs.
Dr. Leana Wen, Emergency Physician and Visiting Professor at George Washington University School of Public Health, joins Yahoo Finance’s Seana Smith to discuss the outlook on a timeline for a coronavirus vaccine as more states begin to reopen their economies.
Take your eye off the ball, and you might have just missed a home run. Veteran players of the stock picking game know that biotechs are capable of delivering a win at what feels like the drop of a hat. How do they do it?It comes down to the nature of the industry itself. Unlike names in other sectors, biotech companies rely on only a few key indicators like study results or regulatory approvals to determine whether or not sustainable revenues are on the horizon. As a result, a favorable outcome can act as a catalyst that sends shares flying out of the ballpark. For this reason, risk-tolerant investors flock to these stocks. However, biotech stocks are famous for being risky as the opposite also holds true.This makes it difficult to separate the biotechs with massive growth prospects from those poised to strike out. Don’t worry, Wall Street analysts can lend a hand with that.Turning to Wedbush analyst Liana Moussatos for guidance, we wanted to check out some of her recent picks in the biotech space to see if she could steer us towards any game-changers. After running the tickers through TipRanks’ database, we found out that three recently scored Buy ratings from the rest of the Street and sport triple-digit upside potential. Liquidia Technologies, Inc. (LQDA)By leveraging its innovative PRINT technology, Liquidia wants to enhance the clinical profile of approved active pharmaceutical ingredients (APIs). Following its recent data readout, several analysts think this biotech is a long-term winner.On April 30, the company published the final data set from the pivotal Phase 3 INSPIRE trial for its lead candidate, LIQ861, as a presentation on the International Society for Heart & Lung Transplantation virtual education platform (ISHLTv). The therapy is a dry powder formulation of inhaled treprostinil (reference drug TYVASO), and was designed for the treatment of Pulmonary Arterial Hypertension (PAH).Based on the trial’s final analysis, the data was consistent with earlier results, with the asset exhibiting a robust safety profile in 121 patients. It should be noted that 113, or 93% of these patients, completed two months of treatment.Calling LIQ861 “potentially best-in-class", Moussatos points out that it was evaluated across doses ranging from 26.5 mcg to 159 mcg, and no drug-related serious adverse events (SAEs) were witnessed. The implications? LQDA is progressing right on track, with the therapy’s PDUFA date in PAH slated for November 24, 2020.Moussatos commented, “The NDA package included positive results from three clinical studies that highlight safety, tolerability and pharmacokinetics (PK) of LIQ861. Based on positive safety and efficacy data, we anticipate approval for LIQ861/PAH as highly likely and project potential U.S. approval on or before the November 24, 2020 PDUFA date, commercial U.S. launch in May 2021, and gross annual U.S. sales reaching over $660 million in 2027.” Along with her Outperform call, Moussatos left a $41 price target on this biotech stock. This implies shares could skyrocket 606% in the next twelve months. Like Moussatos, other analysts take a bullish approach when it comes to LQDA. With 100% Street support, the message is clear: the stock is a Strong Buy. At $37, the average price target puts the upside potential at 537%. (See Liquidia stock analysis on TipRanks)ObsEva SA (OBSV)Moving on to an entirely different segment of the biotech space, ObsEva develops treatments for women’s reproductive health, including Linzagolix for endometriosis and uterine fibroids (UF), and OBE022 for the prevention of premature labor. While shares have climbed 27% higher in the last month, Wedbush believes its growth story is nowhere near its conclusion.With management stating that COVID-19 won’t delay the Phase 3 trials for Linzagolix in UF, PRIMROSE 1 and PRIMROSE 2, Moussatos tells investors that OBSV is “on-track to report Linzagolix/UF primary endpoint results following 24 weeks of treatment from the PRIMROSE 1 trial and the 52 weeks of treatment results from the PRIMROSE 2 trial.”In both of these trials, the company wants to demonstrate that both a 100mg once daily dose of Linzagolix without hormonal add-back therapy (ABT) and a 200mg once daily dose with ABT are effective and safe. It should also be noted that the primary endpoint of the PRIMROSE trials is response rate, which will be determined by the reduction in heavy menstrual bleeding (HMB) due to UF.Speaking to the probability of success, Moussatos points out that in December 2019, the company published strong top-line data from the PRIMROSE 2 study, with the therapy meeting the 24-week primary endpoint, menstrual blood loss of less than 80 mL and equal to or greater than a 50% decrease from the baseline. It also exhibited a 93.9% responder rate for 200 mg with ABT and a 56.7% responder rate for 100 mg without ABT. Not to mention it met multiple important secondary endpoints including a drop in pain.As a result, Moussatos thinks that the primary endpoint readout for the PRIMROSE 1 study will most likely be positive. She added, “ObsEva plans to submit an MAA and NDA for UF by year end 2020 and first half of 2021, respectively. Of note, ObsEva is engaged in discussion with commercial partners for Linzagolix and we anticipate a potential announcement in 2020. We project gross annual sales of more than $800 million in 2026 for UF.”Based on all of the above, Moussatos left an Outperform rating on OBSV shares along with a $30 price target, which leaves room for a whopping 949% potential twelve-month gain.Turning now to the rest of the Street, other analysts are in agreement. Only Buy ratings, 3 to be exact, have been received in the last three months, so the biotech stock gets a Strong Buy consensus rating. Should the $23.67 average price target be met, shares could soar 728% in the next year. (See ObsEva stock analysis on TipRanks)Catabasis Pharmaceuticals (CATB)Last up to bat, we have Catabasis Pharmaceuticals, which focuses on developing treatments for rare diseases. Even though it has already posted an impressive 49% one-month gain, if you ask Wedbush, there’s still plenty of fuel left in the tank.For Moussatos, the key value driver is CATB’s lead asset, edasalonexent, a first-in-class oral NF-kB inhibitor for the treatment of Duchenne Muscular Dystrophy (DMD). Management revealed on April 17 that it would be conducting a series of presentations on Phase 3 PolarisDMD baseline characteristics and edasalonexent compliance at the 2020 Muscular Dystrophy Association Virtual Poster Session. After this, the analyst believes top-line results from the global Phase 3 PolarisDMD trial, which are slated for release in Q4 2020, will serve as a major catalyst for shares. Not to mention positive data could open the door for a potential NDA submission in the first half of 2021.Looking at the trial specifically, the patients enrolled in Phase 3 PolarisDMD exhibited similar baseline characteristics to the participants in the Phase 2 MoveDMD study. This is important because during Phase 2, treatment with edasalonexent was well tolerated and demonstrated optimal growth patterns.On top of this, edasalonexent soft-gel capsules did not reduce compliance, which landed at 98%. Also noteworthy, in both Phase 2 MoveDMD and Phase 3 PolarisDMD, patients could swallow soft-gel capsules.All of this prompted Moussatos to comment, “Based on robust Phase 2 safety and efficacy data, we anticipate positive results from PolarisDMD trial in Q4 2020. The Company also initiated an open-label extension trial (GalaxyDMD) designed to provide long-term safety results to support the NDA filing.”As Moussatos estimates CATB’s cash runway will last until Q3 2021 and that gross edasalonexent sales will exceed $500 million in 2025, it’s no wonder she is optimistic. To this end, the analyst reiterated an Outperform rating and $15 price target, suggesting 152% upside potential.Judging by the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Only one other review was published recently, but it was also bullish. Therefore, CATB earns a Moderate Buy consensus rating. The $37.50 average price target is more aggressive than Moussatos’ and implies 530% upside potential. (See Catabasis stock analysis on TipRanks) To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Shares of Bluebird Bio Inc. fell 2.9% in premarket trading Monday, after the gene therapy company said it was proposing a public offering of $400 million worth of common stock. Based on Friday's stock closing price of $56.66, the offering could be for about 7.06 million shares, or about 12.7% of the current shares outstanding. All of the shares would be sold by the company. The stock has dropped 35.8% over the past three months through Friday, while the iShares Nasdaq Biotechnology ETF has gained 7.9% and the S&P 500 has lost 15.0%.