Emergent BioSolutions Inc., a life sciences company, provides preparedness and response solutions for accidental, deliberate, and naturally occurring public health threats in the United States. The company offers NARCAN Nasal Spray for the emergency treatment of known or suspected opioid overdose; Vaxchora vaccine for the prevention of cholera; Vivotif vaccine for oral administration for the prevention of typhoid fever; Anthrasil for the treatment of inhalational anthrax; BioThrax, an anthrax vaccine; CYFENDUS for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis; and Raxibacumab injection for the treatment and prophylaxis of inhalational anthrax. It also provides ACAM2000, a smallpox vaccine; CNJ-016 to address complications from smallpox vaccination; TEMBEXA for the treatment of smallpox disease caused by variola virus in adult and pediatric patients; BAT for the treatment of symptomatic botulism; Ebanga for the treatment of Ebola; Reactive Skin Decontamination Lotion Kit to remove or neutralize chemical warfare agents from the skin; Trobigard, a atropine sulfate obidoxime chloride auto-injector. In addition, the company is developing CGRD-001 for the treatment of poisoning by organophosphorus nerve agents or organophosphorus compounds; EBS-LASV to prevent Lassa fever; EBS-MARV to prevent Marburg virus disease; EBS-SUDV to prevent Sudan virus disease; Pan-Ebola mAbs for the treatment of ebola virus; SIAN Antidote for initial treatment of certain or suspected acute cyanide poisoning; UniFlu for immunity against influenza A and B viruses; and WEVEE-VLP for equine encephalitis virus infections. Further, it provides contract development and manufacturing services comprising drug substance and product manufacturing, and packaging, as well as technology transfer, process, and analytical development services. The company was incorporated in 1998 and is headquartered in Gaithersburg, Maryland.

Emergent BioSolutions Inc.

Emergent BioSolutions (EBS) Q4 2024 Earnings Call Transcript

(RTTNews) - Below are the earnings highlights for Emergent BioSolutions Inc (EBS):
Earnings: -$31.3 million in Q4 vs. -$49.5 million in the same period last year. EPS: -$0.58 in Q4 vs. -$0.95 in the same period last year. Excluding items, Emergent BioSolutions Inc reported adjusted earnings of $2.6 million or $0.05 per share for the period.
Revenue: $194.7 million in Q4 vs. $276.6 million in the same period last year.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Emergent BioSolutions Inc Q4 Earnings Summary

Gilead Sciences (GILD) came out with quarterly earnings of $1.90 per share, beating the Zacks Consensus Estimate of $1.67 per share. This compares to earnings of $1.72 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 13.77%. A quarter ago, it was expected that this HIV and hepatitis C drugmaker would post earnings of $1.58 per share when it actually produced earnings of $2.02, delivering a surprise of 27.85%.
Over the last four quarters, the company has surpassed consensus EPS estimates four times.
Gilead, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $7.57 billion for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 7.27%. This compares to year-ago revenues of $7.12 billion. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Gilead shares have added about 3.4% since the beginning of the year versus the S&P 500's gain of 3.1%.
What's Next for Gilead?
While Gilead has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Gilead: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $1.82 on $6.66 billion in revenues for the coming quarter and $7.59 on $28.27 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 26% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Emergent Biosolutions (EBS), another stock in the same industry, has yet to report results for the quarter ended December 2024.
This biopharmaceutical company is expected to post quarterly loss of $0.35 per share in its upcoming report, which represents a year-over-year change of +54.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Emergent Biosolutions' revenues are expected to be $252.61 million, down 8.7% from the year-ago quarter.
Should You Invest in Gilead Sciences, Inc. (GILD)?
Before you invest in Gilead Sciences, Inc. (GILD), want to know the best stocks to buy for the next 30 days? Check out Zacks Investment Research for our free report on the 7 best stocks to buy.
Zacks Investment Research has been committed to providing investors with tools and independent research since 1978. For more than a quarter century, the Zacks Rank stock-rating system has more than doubled the S&P 500 with an average gain of +24.08% per year. (These returns cover a period from January 1, 1988 through May 6, 2024.)
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Emergent Biosolutions Inc. (EBS) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Gilead Sciences (GILD) Tops Q4 Earnings and Revenue Estimates

Bristol Myers Squibb (BMY) came out with quarterly earnings of $1.67 per share, beating the Zacks Consensus Estimate of $1.46 per share. This compares to earnings of $1.70 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 14.38%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.49 per share when it actually produced earnings of $1.80, delivering a surprise of 20.81%.
Over the last four quarters, the company has surpassed consensus EPS estimates four times.
Bristol Myers, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $12.34 billion for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 6.59%. This compares to year-ago revenues of $11.48 billion. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Bristol Myers shares have added about 5.6% since the beginning of the year versus the S&P 500's gain of 3.1%.
What's Next for Bristol Myers?
While Bristol Myers has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Bristol Myers: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $1.66 on $11.32 billion in revenues for the coming quarter and $6.98 on $46.32 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 28% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Another stock from the same industry, Emergent Biosolutions (EBS), has yet to report results for the quarter ended December 2024.
This biopharmaceutical company is expected to post quarterly loss of $0.35 per share in its upcoming report, which represents a year-over-year change of +54.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Emergent Biosolutions' revenues are expected to be $252.61 million, down 8.7% from the year-ago quarter.
Should You Invest in Bristol Myers Squibb Company (BMY)?
Before you invest in Bristol Myers Squibb Company (BMY), want to know the best stocks to buy for the next 30 days? Check out Zacks Investment Research for our free report on the 7 best stocks to buy.
Zacks Investment Research has been committed to providing investors with tools and independent research since 1978. For more than a quarter century, the Zacks Rank stock-rating system has more than doubled the S&P 500 with an average gain of +24.08% per year. (These returns cover a period from January 1, 1988 through May 6, 2024.)
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
Emergent Biosolutions Inc. (EBS) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Bristol Myers Squibb (BMY) Beats Q4 Earnings and Revenue Estimates

An analyst initiated coverage of Emergent BioSolutions (NYSE: EBS) stock as the last trading week of 2024 kicked off, and investors reacted quite positively to the move. On the news, they piled into the stock, ultimately sending it to a nearly 12% gain on the day. That contrasted very favorably to the stumbling S&P 500 (SNPINDEX: ^GSPC), which ended Monday down 1%.
More than an emerging company
Emergent, which benefits from a wider-than-average range of revenue-generating activities, is now being tracked by H.C. Wainwright's Raghuram Selvaraju. He launched his coverage with a buy recommendation at a price target of $15 per share. That is 62% higher than the stock's current level, even after that almost 12% increase.
Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. See the 10 stocks »
According to reports, Selvaraju believes Emergent is well diversified in its offerings, and it is active in several medical segments that have fine potential for growth. He feels the company's Narcan opioid reversal spray will continue to experience heavy demand due to the continuing epidemic of such drugs in the U.S.
The analyst also waxed bullish about the company's vaccines business, pointing out that it has jabs for monkeypox and smallpox. The former has been in the news lately as a possible global healthcare threat.
A stock to consider as we move into 2025
News of Sevaraju's fresh and positive take on Emergent puts a nice cap on the company's 2024. Heading into next year, with various illnesses that might become the next pandemic, it's well positioned to be a frontline soldier in the next worrying healthcare emergency.
Even if that doesn't occur, the analyst's view that Emergent's business is well (and effectively) diversified is accurate. This alone makes the stock worthy of consideration as a buy.
Should you invest $1,000 in Emergent BioSolutions right now?
Before you buy stock in Emergent BioSolutions, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Emergent BioSolutions wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $839,670!*
Stock Advisor provides investors with an easy-to-follow blueprint for success, including guidance on building a portfolio, regular updates from analysts, and two new stock picks each month. The Stock Advisor service has more than quadrupled the return of S&P 500 since 2002*.
See the 10 stocks »
*Stock Advisor returns as of December 30, 2024
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool recommends Emergent BioSolutions. The Motley Fool has a disclosure policy.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Why Emergent BioSolutions Stock Blasted Higher Today

Emergent BioSolutions (EBS) Q3 2024 Earnings Call Transcript

Health care stocks were mixed Wednesday as the Health Care Select Sector SPDR Fund (XLV) was up 0.3% and the iShares Biotechnology ETF (IBB) was down 0.2%.
Emergent Biosolutions (EBS) shares were up 6% in Wednesday's premarket session after saying it received approximately $400 million in orders for its smallpox and mpox vaccine products.
2seventy bio (TSVT) shares rose 2.7% pre-bell after it said Wednesday it would discontinue enrollment for the ongoing phase 3 study of Abecma with lenalidomide maintenance as treatment for newly diagnosed multiple myeloma due to scarce eligible patients for the trial.
Elevai Labs (ELAB) has closed a securities offering for about $8 million in gross proceeds, placement agent Univest Securities said late Tuesday. The company's shares rose 4% pre-bell.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Sector Update: Health Care Stocks Mixed Pre-Bell Wednesday

Below is Validea's guru fundamental report for EMERGENT BIOSOLUTIONS INC (EBS). Of the 22 guru strategies we follow, EBS rates highest using our Shareholder Yield Investor model based on the published strategy of Meb Faber. This strategy looks for companies returning cash to shareholders via dividends, buybacks and debt paydown.
EMERGENT BIOSOLUTIONS INC (EBS) is a small-cap growth stock in the Biotechnology & Drugs industry. The rating using this strategy is 85% based on the firm’s underlying fundamentals and the stock’s valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.
The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.
Detailed Analysis of EMERGENT BIOSOLUTIONS INC
EBS Guru Analysis
EBS Fundamental Analysis
More Information on Meb Faber
Meb Faber Portfolio
About Meb Faber: Meb Faber is the founder of Cambria Investments. His research has covered a wide spectrum of the investment world, including topics like shareholder yield, trend following, global asset allocation and home country bias. His shareholder yield strategy, which is based on his book "Shareholder Yield" and forms the basis for an ETF of the same name, looks for companies that are focused on creating value for shareholders by returning cash to them in the form of dividends, share buybacks and debt paydown. Meb is also the author of 4 other books and numerous white papers on investing related topics.
Additional Research Links
Top Healthcare Stocks
Dividend Aristocrats 2024
Wide Moat Stocks
Recession Proof Stocks
High Insider Ownership Stocks
Factor-Based Stock Portfolios
About Validea: Validea is aninvestment researchservice that follows the published strategies of investment legends. Validea offers both stock analysis and model portfolios based on gurus who have outperformed the market over the long-term, including Warren Buffett, Benjamin Graham, Peter Lynch and Martin Zweig. For more information about Validea, click here
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Validea Detailed Fundamental Analysis - EBS

(RTTNews) - As September unfolds, let us review some of the regulatory news that made headlines last month and look ahead to what this month has in store.
Adaptimmune Therapeutics plc's (ADAP) Tecelra was granted accelerated approval by the FDA on Aug.1, 2024, for the treatment of adults with unresectable or metastatic synovial sarcoma, a rare form of cancer, becoming the first new treatment option for this disease in more than a decade. It also represents the first gene therapy for metastatic synovial sarcoma.
On August 7, the FDA approved Purdue Pharma's Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
Another notable first on the regulatory front is the FDA approval of ARS Pharmaceuticals' (SPRY) neffy, the first nasal spray for the treatment of anaphylaxis, on Aug.9.
To enhance protection against the currently circulating variants and mitigate the serious consequences of COVID-19, the FDA approved updated mRNA COVID-19 vaccines manufactured by Moderna Inc. (MRNA) and Pfizer Inc (PFE) on Aug.22.
Another headline that captured global attention in August was the WHO declaring the Mpox outbreak as a public health emergency of international concern on Aug.14. Emergent BioSolutions Inc.'s (EBS) smallpox vaccine ACAM2000, on Aug.30, received FDA approval for expanded use in the prevention of Mpox disease in high-risk individuals.
Now, let's turn our attention to the biotech stocks that are anticipating FDA decisions in September.
Travere Therapeutics Inc. (TVTX)
The FDA is scheduled to determine whether or not to convert accelerated approval of Travere Therapeutics' Filspari to a traditional approval on September 5, 2024.
Filspari was granted accelerated approval in the U.S. to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression in February 2023. The drug generated net product sales of $27.1 million in the second quarter of 2024, compared to $3.46 million in the year-earlier quarter.
IgA nephropathy, also known as Berger's disease, is a rare progressive kidney disease. It occurs when a protein called immunoglobulin A (IgA), which normally helps fight infections, builds up in the kidneys. This buildup affects the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function over time.
Under a license agreement with Ligand Pharmaceuticals (LGND), Travere remains obligated to make payments to Ligand Pharma upon achievement of certain regulatory and sales milestones.
TVTX closed Friday's trading at $9.47, up 1.18%.
Avadel Pharmaceuticals plc (AVDL)
Avadel Pharma has sought FDA approval to expand the use of its lead drug Lumryz for the treatment of cataplexy or excessive daytime sleepiness (EDS) in the pediatric narcolepsy population. A decision is due on September 7, 2024.
Lumryz, indicated to be taken once at bedtime, received tentative approval from the FDA for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy in July 2022, and final approval last May. The drug was launched in the U.S. on June 5, 2023.
Net product revenue from Lumryz sales was $45.1 million in the second quarter of 2024, compared to $1.5 million in the second quarter of 2023.
AVDL closed Friday's trading at $15.17, up 1.88%.
Iterum Therapeutics plc (ITRM)
An FDA panel is scheduled to review Iterum Therapeutics' resubmitted New Drug Application for oral Sulopenem on September 9, 2024.
Oral Sulopenem is proposed for the treatment of uncomplicated urinary tract infections (uUTI) in adult women. This is the company's second attempt to secure FDA approval for the investigational drug.
The U.S. regulatory agency had declined to approve Oral Sulopenem in July 2021, requiring the company to conduct at least one additional adequate and well-controlled clinical trial. The company addressed the concerns raised by the FDA and resubmitted the New Drug Application for oral Sulopenem in April of this year, which is now under FDA review.
The final FDA decision is expected on October 25, 2024.
ITRM closed Friday's trading at $1.18, up 4.42%.
Roche Holding AG (RHHBY.OB)
The FDA decision on Roche Holding AG's (RHHBY) Ocrevus SC, proposed for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis, is expected on September 13, 2024.
Ocrevus SC is a 10-minute injection, co-formulated with ENHANZE, Halozyme Therapeutics Inc.'s (HALO) proprietary recombinant human hyaluronidase enzyme, rHuPH20. It retains the twice-yearly dosing regimen of Ocrevus IV that was approved in the U.S in 2017 for both relapsing and primary progressive forms of multiple sclerosis.
If approved, Ocrevus SC has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations.
RHHBY.OB closed Friday's trading at $42.33, down 0.05%.
Vanda Pharmaceuticals Inc. (VNDA)
Vanda Pharma's lead drug candidate Tradipitant, proposed for the treatment of symptoms of gastroparesis, is under FDA review, with a decision due on September 18, 2024.
Gastroparesis is a serious medical condition characterized by delayed gastric emptying. This delay in gastric emptying can cause symptoms such as nausea, vomiting, bloating, fullness after meals and abdominal pain, as well as affect a person's social and work life. An estimated 6 million people in the U.S. are affected by gastroparesis, though many of these cases go undiagnosed.
If approved, Tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years.
While the review is still in progress, the FDA recently issued a preliminary notice indicating that there are deficiencies that prevent discussion about labeling.
VNDA closed Friday's trading at $5.29, up 1.34%.
Zevra Therapeutics Inc. (ZVRA)
The FDA decision on Zevra Therapeutics Inc.'s (ZVRA) Arimoclomol, proposed for the treatment of Niemann-Pick disease type C, is expected on September 21, 2024.
Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative disorder caused by mutations in the NPC1 or NPC2 genes, which are responsible for making lysosomal proteins. Patients with NPC experience restrictions in both physical and cognitive abilities, characterized by significant neurological issues affecting speech, thinking, swallowing, walking, and precise movements.
This is the company's second attempt to secure FDA approval for Arimoclomol. The U.S. regulatory agency had declined to approve Arimoclomol in June 2021, requiring the company to submit additional data.
After addressing the concerns raised by the FDA, the company resubmitted the New Drug Application for Arimoclomol in December 2023, and now awaits the agency's final decision.
Meanwhile, on August 2, 2024, an FDA panel, which reviewed the Arimoclomol NDA voted 11-5 recommending its approval.
If approved, Arimoclomol would become the first authorized treatment specifically designed to slow the progression of Niemann-Pick disease type C.
Arimoclomol was initially developed by LadRx Corp. (LADX.OB), and in 2011, it sold the drug rights to Orphazyme A/S (now Zevra Therapeutics) in exchange for milestone payments and royalties. Later in 2023, XOMA Corp. (XOMA) acquired the royalty and milestone rights associated with Arimoclomol from LadRx.
ZVRA closed Friday's trading at $7.65, up 3.52%.
Heron Therapeutics Inc. (HRTX)
Heron Therapeutics' Prior Approval Supplement application for Zynrelef Vial Access Needle is under FDA review, with a decision anticipated on September 23, 2024.
Zynrelef is an extended-release, fixed-dose combination of the local anesthetic Bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) Meloxicam indicated for postoperative pain management. Currently, it is delivered via a single, needle-free application into the surgical site.
If approved, the introduction of the Vial Access Needle (VAN) will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing Zynrelef's withdrawal time from up to three minutes down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of Zynrelef, increase adoption, and improve the preparation process, according to the company.
HRTX closed Friday's trading at $1.93.
Merck & Co., Inc. (MRK)
Merck has sought FDA approval to expand the use of its blockbuster cancer drug Keytruda to include the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma in combination with chemotherapy and a decision is expected on September 25, 2024.
Malignant mesothelioma is a cancer that originates in the linings of specific body areas, such as the chest, abdomen, heart, and testicles. Pleural mesothelioma, which develops in the lining of the lungs, is the most common form of malignant mesothelioma, accounting for about 75% of all cases. Malignant pleural mesothelioma often progresses rapidly, and the five-year survival rate is only 12%.
Keytruda is already approved in the U.S. for several indications, say, melanoma, metastatic, non-small cell lung cancer, Merkel cell carcinoma, renal cell carcinoma, esophageal carcinoma, head and neck cancer, Hodgkin's lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, hepatocellular carcinoma, endometrial cancer, squamous cell carcinoma, hepatocellular carcinoma, breast cancer, and biliary tract tumor.
MRK closed Friday's trading at $118.45, up 0.84%.
Bristol-Myers Squibb Co. (BMY)
The FDA decision on KarXT, an antipsychotic, proposed for the treatment of schizophrenia in adults, is due on September 26, 2024.
KarXT came under Bristol-Myers Squibb's fold, following the acquisition of Karuna Therapeutics early this year for $14 billion. PureTech Health plc (PRTC) is a founder of Karuna and co-inventor of the KarXT program.
KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.
If approved, KarXT will be the first new mechanism in over 50 years for patients living with schizophrenia.
BMY closed Friday's trading at $49.95, up 0.46%.
Regeneron Pharmaceuticals Inc. (REGN)
Regeneron Pharma and Sanofi (SNY) have sought FDA approval for the expanded use of Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease, and a decision is due on September 27, 2024.
Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
The drug is already approved in the U.S. for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.
REGN closed Friday's trading at $1,184.69, up 0.49%.
Sanofi (SNY)
Sanofi's Sarclisa, in combination with a standard-of-care VRd regimen, proposed for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma is under priority review by the FDA, with a decision anticipated on September 27, 2024.
VRd is a three-drug regimen of bortezomib, lenalidomide, and dexamethasone and is the preferred first-line treatment option for patients with newly diagnosed multiple myeloma. (Source: NEJM).
The proposed indication, if approved, would be the third one for Sarclisa. The drug, in combination with pomalidomide and dexamethasone secured FDA approval for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor in March 2020. The following year, i.e., in March 2021, Sarclisa in combination with carfilzomib and dexamethasone was approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
SNY closed Friday's trading at $56.26, down 0.12%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Biotech Stocks Facing FDA Decision In September 2024

(RTTNews) - As biotech companies reprioritize their research and development activities, the sector continues to face layoffs. Unfortunately, this week was no exception. The FDA greenlighted a new vaccine for Mpox, which is the second for this viral infection, amid increasing cases in Africa. Meanwhile, a pharma giant faced a clinical trial setback related to one of its blockbuster drugs as it failed in two late-stage studies.
Let's dive into the details.
Layoffs
BioMarin Pharmaceutical Inc. (BMRN), in a SEC filing dated Aug.28, 2024, revealed that it will implement its plan of reducing its global workforce by approximately 225 employees, with this process expected to be substantially completed by the end of 2024. This decision is driven by the company's organizational restructuring efforts, its updated strategy for its Hemophilia A drug ROCTAVIAN to enhance long-term profitability, and its choice to discontinue the development of BMN 293, a gene therapy for hypertrophic cardiomyopathy. The workforce reduction will result in a one-time pre-tax charge of approximately $30 to $35 million, with a majority of the expense expected to be incurred during the second half of 2024.
BMRN closed Friday's trading at $91.21, down 0.18%.
Repare Therapeutics Inc. (RPTX), on Thursday, announced that it is reducing its overall workforce by approximately 25%, which will primarily affect its preclinical group. The workforce reduction is part of the company's strategic reprioritization of its research and development activities to focus its resources on its clinical oncology pipeline. The company expects to incur total non-recurring cash payments of approximately $1.5 million to $2.0 million in the third quarter of 2024 associated with the workforce reduction and expects to generate annual savings of approximately $15.0 million that will extend its cash runway into the second half of 2026.
RPTX closed Friday's trading at $2.91, down 3.32%.
Roche Holding AG's (RHHBY) subsidiary Genentech is terminating 93 employees at its San Francisco site, with the layoffs set to take effect on Oct.8, 2024. Earlier in August, the company announced its plan to wind down the Cancer Immunology department and consolidate its R&D activities in this area with its molecular oncology programs, with the goal of creating a unified and expanded cancer research initiative.
RHHBY.OB closed Friday's trading at $42.35, up 0.74%.
FDA Approvals and Rejections
Emergent BioSolutions Inc.'s (EBS) smallpox vaccine ACAM2000, received FDA approval, on Thursday, for expanded use in prevention of Mpox disease in high-risk individuals. As the Mpox outbreak continues across Africa and other regions, the company has pledged to donate 50,000 doses of ACAM2000 for potential deployment across impacted countries in Central Africa. ACAM2000 is the second Mpox vaccine to receive FDA approval. Bavarian Nordic's Jynneos, approved in 2019, is the first vaccine to be approved in the U.S for the prevention of Mpox.
EBS closed Friday's trading at $8.31, down 6.73%.
The FDA, on Friday, granted Emergency Use Authorization for Novavax Inc.'s (NVAX) updated version of COVID-19 vaccine to prevent COVID-19 in individuals aged 12 and older. The updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
NVAX closed Friday's trading at $12.38, up 8.60%.
Johnson & Johnson (JNJ), on Thursday, filed for FDA approval of its investigational drug Nipocalimab for the treatment of people living with generalized myasthenia gravis. Nipocalimab came under JNJ's fold following the acquisition of Momenta Pharmaceuticals in 2020 for roughly $6.5 billion in cash. Nipocalimab, if granted FDA nod, would have to compete with Argenx's Vyvgart, which was approved in 2021, and UCB's Rystiggo, approved in 2023.
JNJ closed Friday's trading at $165.86, up 0.99%.
Deal or No Deal
Flagship Pioneering, a venture capital firm, and Quotient Therapeutics, on Wednesday, entered into an agreement to identify potential novel targets for the treatment of cardiovascular and renal diseases under a strategic partnership with Pfizer (PFE). Flagship's strategic partnership with Pfizer was announced in July 2023. Quotient Therapeutics was founded by Flagship Pioneering in 2022. The Quotient agreement is the most recent program initiated under Flagship Pioneering/Pfizer 2023 partnership.
PFE closed Friday's trading at $29.01, up 1.01%.
AstraZeneca plc (AZN) and QIAGEN (QGEN), which entered into collaboration in 2014 to develop diagnostic test for lung cancer patients, announced on Thursday they are expanding their partnership beyond oncology. Under the expanded agreement, QIAGEN will develop and validate a genotyping assay with its QIAstat-Dx syndromic testing platform. The new deal will also enable QIAGEN to develop and commercialize companion diagnostics for AstraZeneca's future therapies being developed to address chronic diseases.
QGEN closed Friday's trading at $45.71, up 0.07%.
Clinical Trials - Breakthroughs and Setbacks
Bristol Myers Squibb (BMY), on Sunday, announced new long-term follow-up results of its heart drug CAMZYOS from EXPLORER-LTE cohort of the MAVA-Long-Term Extension study. Even after up to 3.5 years, CAMZYOS demonstrated consistent and sustained improvements in echocardiographic measures and symptoms, with no new safety signals, in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy. CAMZYOS is the first and only approved cardiac myosin inhibitor that targets the source of symptomatic obstructive hypertrophic cardiomyopathy. The drug received FDA approval in 2022.
BMY closed Friday's trading at $49.95, up 0.46%.
NuCana plc (NCNA), on Thursday, revealed that it is discontinuing its phase II NuTide:323 Study, following pre-planned initial analysis and recommendation from a Steering Committee. In the phase II NuTide:323 trial, NUC-3373 was evaluated in combination with leucovorin, irinotecan (Onivyde), and bevacizumab (Avastin) against the control arm of 5-FU, leucovorin, irinotecan and bevacizumab (FOLFIRI+bev) for the treatment of patients with colorectal cancer in the second line. The pre-planned initial analysis by the Steering Committee has found that the combination of NUC-3373 with leucovorin, irinotecan and bevacizumab was unlikely to achieve the study's primary objective of superior Progression Free Survival (PFS) compared to the control arm.
NCNA closed Friday's trading at $3.66, down 52.65%.
Merck (MRK), on Thursday, announced it is discontinuing two phase III trials of its blockbuster drug Keytruda in non-small cell lung cancer and cutaneous squamous cell carcinoma as a planned interim analysis of the trials revealed disappointing data. The trials that are being terminated are KEYNOTE-867, a phase III trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery, and KEYNOTE-630, a phase III trial evaluating KEYTRUDA for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation.
MRK closed Friday's trading at $118.45, up 0.84%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Emergent BioSolutions Inc.

Sign up and get access to the forecasts, "shares 360" and dividend history