Curis (CRIS) is taking investors on a wild ride. After rocketing on a promising blood-cancer drug on Wednesday, CRIS stock plummeted Thursday.
The biotech company said its treatment reduced abnormal cells in eight out of nine patients. But it was also met with dose-limiting toxicities, Curis said late Wednesday. In response, CRIS stock tumbled after soaring more than 65% during the regular session.
In morning trading on the stock market today, CRIS stock tanked 16.1% near 13.70.
CRIS Stock Yo-Yos On Cancer News
Curis is testing a treatment for acute myeloid leukemia and myelodysplastic syndromes, two types of blood cancer. The biotech company released some test results early Wednesday ahead of the European Hematology Association 2021 Virtual Congress.
Nine patients could be evaluated as of February. Eight of those patients experienced reductions in abnormal cells known as marrow blasts.
Objectively, four patients responded to the treatment. That included one patient who completely responded. This means doctors couldn't find any evidence of cancer after the treatment. One was determined to be in remission. Two others had complete responses in the bone marrow.
Also bullish for CRIS stock, three patients with genetic mutations achieved complete responses in the bone marrow.
Shares Could Reenter Buy Zone
But late Wednesday, Curis said it updated its dosing regimen in the study. Two patients reported side effects at high doses of the drug.
One experienced a condition called rhabdomyolysis, in which muscle fibers die and release their contents into the blood stream. This can cause kidney failure. The other lost consciousness after the patient's blood pressure fell. Both incidents resolved after the company stopped treatment.
Curis says it's now enrolling patients to receive lower levels of the treatment.
The news Wednesday led to a breakout for CRIS stock. Shares were consolidating with a buy point at 13.10, according to MarketSmith.com. CRIS stock surged well beyond the buy zone and topped a profit-taking zone, defined as 20%-25% above a buy point.
On Thursday, CRIS stock looked to return to the buy zone, which is within 5% of the buy point.
Shares have a best-possible Relative Strength Rating of 99. This puts CRIS stock in the top 1% of all stocks in terms of 12-month performance.
Chicago has released more than 1,000 feral cats onto the streets — hoping to end its long-running ranking as the rat capital of the US.
The “Cats at Work” program came to light after the Windy City was named by pest control company Orkin as the rattiest city for the sixth consecutive year, with the Big Apple third after Los Angeles.
The Tree House Humane Society hopes its program will help replace rats with cats — insisting it is also kind to the felines, which would otherwise face long stays in shelters and often even euthanasia.
“These are feral cats who wouldn’t thrive in a home or shelter environment,” the society insisted of the program, which has run since 2012.
“By placing them in Cats at Work colonies, we’re able to make sure they’re living their best lives,” it said.
While feral, the cats have all been neutered to “create a net positive impact on the small animal population of Chicago,” the society said.
The cats are all vaccinated against diseases like rabies, and will be provided food and water.AP
And rather than just randomly released, they are put into outdoor colonies with a registered caretaker who makes sure there is food, water and shelter, the society said.
“In most cases, the cats are better cared for after placement in the Cats at Work program than they were before,” the society insisted.
The cats are all vaccinated against diseases like rabies, and are far safer than allowing rodents to run rampant, the society said.
The cats will be released into outdoor colonies, rather than being randomly released.Getty Images/iStockphoto
“While feral cats do kill rats, often their pheromones are enough to scare rats away,” it said.
Investing is all about profits, and part of generating profits is knowing when to start the game. The old adage says to buy low and sell high, and while it’s tempting just to discount cliches like that, they’ve passed into common currency because they embody a fundamental truth. Buying low is always a good start in building a portfolio.
The trick, however, is recognizing the right stocks to buy low. Prices fall for a reason, and sometimes that reason is fundamental unsoundness. Fortunately, Wall Streets analysts are busy separating the wheat from the chaff among the market’s low-priced stocks, and some top stock experts have tagged several equities for big gains.
We’ve used the TipRanks database to pull up the data and reviews on three stocks that are priced low now, but may be primed for gains. They’ve been getting positive reviews, and despite their share depreciation, they hold Buy ratings and show upwards of 80% upside potential.
First up, Vapotherm, is a medical device manufacturer, specializing in heated, humidified, high-flow nasal cannulas. These are therapeutic breath aids, designed to deliver oxygenated air directly to the patient’s nose. Heating and humidifying the air reduces the discomfort of delivering dry oxygen.
As can be expected, during a pandemic of a respiratory illness, Vapotherm saw high sales in recent months – but the share price has pulled back since early February. Paradoxically, the two events are related.
First, on the positive side, Vapotherm’s 1Q21 financial results were solid. The company’s revenue, at $32.3 million, was up 69% year-over-year, and worldwide, installations of the Precision Flow base unit was up 73% over the same period. The company’s net loss in the quarter, $5.2 million, was an improvement from the $10.2 million loss in the year-ago quarter.
On the negative side, VAPO shares are down from their early-February peak. The drop is substantial; the stock has fallen 50% from its peak, and is down 34% year-to-date.
The fall in share value reflects concerns that the company’s flagship product is oversold, that customers, fearful of COVID-related respiratory emergencies, bought more units that would be needed in ordinary times. This is the case made by Piper Sandler analyst Jason Bednar.
“Shares have meaningfully underperformed since early February as many investors have questioned utilization dynamics for the bolus of Precision Flow systems that were sold into hospitals last year… We understand the logic here, particularly for those investors with a shorter time horizon, but with much of that concern seemingly already reflected in the stock at current levels we do believe the upside opportunity meaningfully outweighs the risk of further downside,” Bednar noted.
The analyst added, "It’s also our view that investors who wait for utilization trends to bottom out will ultimately miss an initial move higher that could come as HVT 2.0 begins to contribute with a rollout later this year and as market expanding opportunities for HVT 2.0 in 2022 begin to take on a more defined shape (particularly EMS and home-based care)."
To this end, Bednar rates VAPO an Overweight (i.e. Buy), and his $32 price target implies a robust upside of 81% in the year ahead. (To watch Bednar’s track record, click here)
Overall, the unanimous Strong Buy consensus rating on this stock, supported by 4 recent analyst reviews, makes it clear that Bednar is not alone in his bullish view. The average price target here, $39, is even more optimistic, suggesting an upside of ~122% from the current trading price of $17.65. (See VAPO stock analysis on TipRanks)
The next stock we’re looking at, Emergent, is a biopharmaceutical company. The company has multiple products on the market, including a NARCAN nasal spray for use on opioid overdose patients, and vaccines against smallpox, anthrax, and other diseases.
Emergent’s development pipeline includes a pediatric cholera vaccine, Vaxchora, currently in a Phase III trial. Several programs, including an anthrax vaccine candidate, a Chikungunya vaccine, and a seasonal flu shot, have all completed Phase II and are in preparation for Phase III.
One of Emergent’s most important programs is in its Contract Development and Manufacturing service, a service extended to other pharmaceutical companies to manufacture vaccines which they have developed. Under a CDMO plan, Emergent is part of Johnson & Johnson’s manufacturing chain for a COVID-19 vaccine.
That last is a key point. The J&J vaccine has been linked – at least in some reports – to serious adverse events, particularly blood clots in otherwise healthy recipients. That has caused a hold in manufacturing of the vaccine, and consequently a delay in receiving payments from J&J. Which, in turn, impacted the company’s 1Q21 financials, resulting in lower revenues and earnings than expected. Investors are concerned, and the stock has fallen 33% year-to-date.
Despite the setback, Benchmark analyst Robert Wasserman keeps a Buy rating on EBS shares, along with a $120 price target. If correct, the analyst’s objective could deliver one-year returns of 101%. (To watch Wasserman’s track record, click here)
"EBS remains solidly profitable, and even with the lowered expectations for J&N and AZ vaccine contracts, is expected to show solid revenue growth for this year. These shares remain a bargain in our CDMO/bioprocessing group and could offer significant upside for value-oriented investors if circumstances turn around or new business can be garnered in the near-term," Wasserman opined.
Overall, the Street currently has a cautiously optimistic outlook for the stock. The analyst consensus rates EBS a Moderate Buy based on 3 Buys and 2 Holds. Shares are priced at $59.59, and the average price target of $89.67 suggests an upside potential of ~50% for the next 12 months. (See EBS stock analysis at TipRanks)
For the last stock on our list, we’ll stick with the medical industry. Haemonetics produces a range of products for blood and plasma collection and separation, as well as software to run the machines and service agreements for maintenance. In short, Haemonetics is a one-stop shop for blood donation centers and hospital blood banks. Blood products is a $10.5 billion market in the US alone, with plasma accounting for 80% of that, and Haemonetics has made itself an integral part of that business.
Haemonetics had been recovering steadily from a revenue dip at the height of the corona crisis, and its 3Q fiscal 2021 earnings showed a solid results: top line revenue of $240 million and EPS of 62 cents. While the revenue was down 7.3% yoy, EPS was up 6.8%.
Even with that, however, the stock dropped sharply between April 15 and April 20, losing 42% of its value in that short time. The reason was simple. One of Haemonetics’ largest customers, CSL Pharma, announced that it does not plan to renew its contract with HAE. That contract, for supply, use, and maintenance of Haemonetics’ PCS2 plasma collection system, was worth $117 million and made up approximately 12% of the company’s top line. The cancellation comes with a one-time charge of $32 million in other related losses.
Fortunately for HAE, the CSL contract does not expire until June of 2022, giving the company time to plan and prepare.
Covering the stock for JMP Securities, analyst David Turkaly noted: “The advance notice gives HAE some time (~15 months) to prepare for the expiration, and we note that management has consistently strengthened its financial position using levers such as complexity reduction and product optimization to derive significant cost savings, and more of these will likely be employed ahead to help offset the customer loss.”
The analyst continued, "While this disappointing decision could impact HAE's plasma positioning with other fractionators, we continue to believe that giving customers the ability to collect more plasma in less time is a very compelling value proposition - and HAE still has contracts and maintains significant market share with many of the most relevant plasma players."
Accordingly, Turkaly rates HAE an Outperform (i.e. Buy), and sets a $110 price target. This figure implies an upside of 86% from current levels. (To watch Turkaly’s track record, click here)
All in all, HAE has a Moderate Buy consensus rating, based on 7 reviews that break down 5 to 2 in favor the Buys over the Holds. The stock is trading for $59.02 and carries an average price target of $108.67, which suggests ~84% one-year upside. (See HAE stock analysis at TipRanks)
After showing that all types of consumer electronics companies have what it takes to navigate the FDA and enter the medtech market, Bose is officially introducing its long-awaited hearing aid.
The speaker-monger made an early splash with its groundbreaking de novo clearance from the agency in 2018—less than a month after Apple first unveiled its FDA-cleared ECG smartwatch.
Bose’s direct-to-consumer hearing aid is designed to allow users to fit, program and control it on their own, without the typical clinic visits and setups guided by healthcare providers.
Though it carries a full green light from the FDA, Bose’s device is not technically classified as an “over-the-counter” hearing aid, or one allowed to be purchased just anywhere. That would require the agency to set up a new regulatory category that's been in the works since 2017, when Congress directed the FDA to do so.
And though the devices may lack premium features, such as the Bluetooth phone streaming seen in other devices, analysts at Bernstein said the lower price point and initial rollout show that Bose is committed to breaking into the healthcare market.
“With OTC legislation expected at some point soon, they could be a major player in pushing that category given their brand reputation and penetration of consumer electronic channels,” they wrote.
The company plans to sell its hearing aids straight to consumers where it can. It will start later this month in Massachusetts, Montana, North Carolina, South Carolina and Texas before expanding nationwide—though other states’ laws may require in-person sales by a licensed hearing aid dispenser.
The SoundControl device is priced at $850—far less than other hearing aids, which regularly range in the thousands of dollars—and comes with the typical trimmings that accompany consumer electronics, such as a 90-day, risk-free trial.
It also pairs wirelessly with Bose’s smartphone app. People with mild to moderate hearing loss can use the app to adjust the device’s settings without prescriptions or hearing tests, using an at-home setup process that the company says takes less than an hour.
In addition, the app offers complimentary, one-on-one video appointments with Bose staff for assistance. It does not, however, enable direct streaming of music or calls from a connected smartphone.
And while not the same as Bose's line of noise-canceling headphones, the behind-the-ear, non-rechargeable hearing aids are designed to help people focus on specific sounds.
The devices include settings to amplify just the person talking in front of the wearer in a noisy outdoor environment, for example, and presets for opening up the hearing aids to hear quieter sounds from all directions while indoors.
Palisade Bio, Inc. (Nasdaq: PALI), a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational drug LB1148, which has the potential to be the first oral treatment to reduce adhesions following abdominal or pelvic surgery. LB1148 was previously granted Fast Track Designation for the treatment of postoperative GI dysfunction associated with gut hypoperfusion injury in pediatric patients who have undergone congenital heart disease repair surgery inJanuary 2021.
"Fast Track Designation represents another positive step for the clinical development of LB1148 and is a clear recognition of the serious need that exists for patients looking to avoid long-lasting and serious complications from post-surgical adhesions,” said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We look forward to working closely with the FDA to maintain an open dialogue about the clinical path forward with LB1148, not only for the reduction of surgical adhesions indication, but also in the other post-op indications where it is being investigated in the clinic. We believe that by reducing adhesions, LB1148 has the potential to benefit patients, physicians, hospitals, and payers alike."
Exelixis' flagship oncology drug Cabometyx has attracted a pharma partner to take it into a new type of cancer thanks to promising results in a pivotal trial.
In a late-stage trial in patients with a form of thyroid cancer, Cabometyx posted promising results, executives say, prompting French pharma Ipsen to step in and help get the drug across the finish line with global regulators.
Ipsen has exercised its option to collaborate with Exelixis on Cabometyx’s pivotal phase 3 clinical trial, known as COSMIC-311, studying the medicine in patients with radioiodine-resistant differentiated thyroid cancer who have progressed after prior treatment with vascular endothelial growth factor receptor (VEGFR)-targeted therapies.
Ipsen is anteing up in the thyroid cancer use thanks to “promising and clinically meaningful results” in the trial, Howard Mayer, Ipsen's R&D head, said in a statement.
In late December, Exelixis said interim results from COSMIC-311 showed the tyrosine kinase inhibitor reduced the risk of disease progression or death by 78%, meeting its co-primary endpoint of progression-free survival. For the study, investigators enrolled approximately 300 patients at 150 sites globally. Patients received either cabozantinib or placebo once daily.
After the interim results, the FDA awarded the drug a breakthrough therapy designation in February. Now, Exelixis and Ipsen plan to present detailed results from the phase 3 trial at the ASCO Annual Meeting, taking place beginning on June 4. Ipsen will have access to its full set of results, which it will use for potential future regulatory submissions.
The company previously had a partnership with Exelixis to commercialize Cabometyx—authorized in over 50 countries for the treatment of kidney cancer—outside the U.S. and Japan.
Roughly 44,000 new cases of thyroid cancer will be diagnosed in the U.S. this year, Exelixis says. Differentiated thyroid tumors make up most of all thyroid cancers and are usually treated with surgery, followed by treatment with radioiodine.
But roughly 5% to 15% of those tumors are resistant to the treatment, leaving patients with few treatment options to improve life expectancy, Exelixis says.
Aside from its Ipsen collab, Exelis has partnerships on its cancer medicines with Bristol Myers Squibb and Roche.
Earlier this year, the FDA authorized Cabometyx in combination with Bristol Myers Squibb’s Opdivo for the treatment of patients with advanced renal cell carcinoma, setting up a showdown between that combo and the Merck and Pfizer’s cocktail of Keytruda and Inlyta. In previously untreated kidney cancer, the Opdivo-Cabometyx combo slashed the risk of death by 34% compared with Pfizer’s older drug Sutent.
An early cut of the Keynote-522 trial, of Keytruda in neoadjuvant and adjuvant triple-negative breast cancer, was not enough to win the checkpoint blocker FDA approval earlier this year: Merck received a complete response letterin the wake of a negative adcom. But a hit on the study’s co-primary endpoint, announced today, means that the company is heading straight back to regulators for a second shot. An interim analysis found a “statistically significant and clinically meaningful” improvement in event-free survival (EFS), Merck said. At least three previous interim looks had failed to find a statistical showing on this measure, and Merck had tried to win approval largely on the other co-primary, pathological complete response (pCR); despite a statistically very sound readout on pCR, this surrogate measure is considered to provide more questionable evidence of effectiveness than does EFS. The hit on a survival endpoint should put the application on better footing – though it is not inconceivable that the FDA will want to wait for longer cuts of the data, or possibly the final readout. That will depend on the strength of the EFS finding, and for now Merck is keeping that under wraps.
Ongoing trials of Keytruda in perioperative breast cancer settings
