Iterum Therapeutics plc

(RTTNews) - Iterum Therapeutics plc (ITRM) Friday announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.
"We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of Orlynvah. Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians," said Corey Fishman, Iterum's Chief Executive Officer.
"As the first oral penem approved in the U.S., Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders."
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Iterum Therapeutics Gets FDA Approval Of Orlynvah For Treatment Of Urinary Tract Infections

(RTTNews) - September saw several notable "firsts" in the regulatory landscape alongside the approval of four novel drugs in the U.S.
Among these advancements, two new drugs to treat Niemann-Pick Disease, Type C, a rare genetic disease that results in progressive neurological symptoms and organ dysfunction, were approved by the FDA - IntraBio's Aqneursa and Zevra Therapeutics' Miplyffa.
Additionally, the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones, received FDA authorization in the month.
Now, let's turn our attention to the upcoming drug approvals of October.
Biofrontera Inc. (BFRI)
The FDA decision on Biofrontera's request to increase the maximally approved dosage of Ameluz from one to three tubes per treatment is expected on October 4, 2024.
Ameluz, a topical gel, is used in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, a narrowband, red light illumination source, to treat a skin condition called actinic keratosis (warty overgrowths of skin) of mild-to-moderate severity on the face and scalp.
As per the current recommendation, no more than 2 grams of AMELUZ (one tube) should be applied in a single session and the application area should not exceed 20cm2.
Since many patients have actinic keratoses over large surface areas, the ability to treat these pre-cancerous lesions in one office visit will be more convenient for patients and more efficient for their dermatologists with simultaneous use of three tubes, according to the company.
BFRI closed Friday's (Sep.27, 2024) trading at $1.28, up 1.59%.
Zealand Pharma A/S (ZEAL.CO)
Zealand's investigational drug Dasiglucagon, proposed for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism, is under FDA review.
The regulatory review is being conducted in two parts - Part 1 relates to dosing of Dasiglucagon up to three weeks, whereas Part 2 relates to the use beyond three weeks.
The FDA decision on Part I of the New Drug Application for Dasiglucagon is anticipated on October 8, 2024.
For Part 2 of the NDA, the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which the company expects to submit in the second half of 2024.
Bristol Myers Squibb (BMY)
Bristol Myers Squibb's applications seeking approval for neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer are under FDA review, with a decision due on October 8, 2024.
Non-small cell lung cancer is one of the most common types of lung cancer, representing up to 84% of diagnoses. Between 30% to 55% of non-small cell lung cancer patients who undergo surgery are said to experience disease recurrence.
If the proposed indication is approved, the company anticipates that Opdivo will provide a new Opdivo-based treatment option for patients who could benefit from it in the perioperative setting.
In the indication of NSCLC, Opdivo is already approved as a single and combination-based therapy for certain patients.
Melanoma, Metastatic, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Malignant Pleural Mesothelioma, and Gastric Cancer are the other indications for which Opdivo has secured FDA approval.
The drug generated sales of $2.4 billion in the second quarter of 2024, compared to $2.1 billion in the year-ago quarter.
BMY closed Friday's trading at $50.91, up 1.58%.
Amgen (AMGN)
Amgen has sought FDA approval for its drug LUMAKRAS for, yet another indication and a decision is anticipated on October 17, 2024.
The proposed use involves LUMAKRAS in combination with Vectibix, compared to the investigator's choice of therapy, for treating KRAS G12C-mutated metastatic colorectal cancer. Vectibix, also from the stable of Amgen, is an approved drug for colorectal cancer.
LUMAKRAS was granted accelerated approval for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, following at least one prior systemic therapy, in May 2021.
The drug generated sales of $85 million in the second quarter of 2024, compared to $77 million in the year-earlier quarter.
If approved for the expanded indication, LUMAKRAS will need to compete with Bristol Myers Squibb's Krazati, which received accelerated approval for colorectal cancer in June of this year.
AMGN closed Friday's trading at $322.67, up 1.12%.
Camurus (CAMRF.OB)
The FDA will decide whether or not to approve Camurus' Oclaiz, proposed for the treatment of acromegaly, on October 21, 2024.
Acromegaly is a rare, slowly progressive disease, typically caused by a pituitary gland tumor that produces excess growth hormone, leading to elevated levels of insulin-like growth factor 1 (IGF-1). This causes abnormal growth of bones and tissues, resulting in enlarged hands, feet, facial features, and internal organs. Patients may also experience symptoms such as fatigue, joint pain, headaches, visual disturbances, excessive sweating, and tingling sensations.
Oclaiz is a once-monthly, subcutaneous (SC) long-acting depot formulation of the approved somatostatin analogue Octreotide. It is designed to enable easy self-administration, including the option of a pre-filled pen. In clinical trials, Oclaiz demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular Octreotide, according to the company.
CAMRF.OB closed Friday's trading at $61.90, up 6.32%.
Iterum Therapeutics plc (ITRM)
The FDA decision on Iterum Therapeutics' resubmitted New Drug Application for Oral Sulopenem is anticipated on October 25, 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 oral Sulopenem in the proposed indication.
The U.S. regulatory agency 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.
On September 9, 2024, the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met to evaluate the overall benefits and risks of Oral Sulopenem for treating uncomplicated urinary tract infections (uUTI) caused by specific susceptible microorganisms in adult women over 18 and discussed the considerations that would be important for medical providers to know to ensure its appropriate use.
The FDA Committee recognized oral Sulopenem as an important treatment option for certain patients with uUTI.
ITRM closed Friday's trading at $1.05, up 0.96%.
PharmaTher Holdings Ltd. (PHRRF.OB)
PharmaTher Holdings' New Drug Application for Ketamine, which is under FDA review, is assigned a goal date of October 29, 2024.
Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) and has been on the FDA's drug shortage list since February 2018.
Upon approval, the company is expected to launch Ketamine in the U.S., under the brand name Ketarx, in the first quarter of 2025.
PHRRF.OB closed Friday's trading at $0.20, up 5.79%.
Lexicon Pharmaceuticals Inc. (LXRX)
An FDA panel is slated to discuss Lexicon Pharma's drug candidate Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease on October 31, 2024.
Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.
This is Zynquista's second go-around with the U.S. regulatory agency.
The FDA declined to approve Zynquista in March 2019. The company resubmitted its New Drug Application for Zynquista in June of this year and awaits the FDA's final decision, which is due on December 20, 2024.
Zynquista was granted marketing authorization in the European Union in April 2019 as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. However, the European Commission withdrew the drug from the European Union in March 2022 at the request of Guidehouse Germany GmbH, the holder of Zynquista's marketing rights in Europe, which opted not to sell the product for commercial reasons.
LXRX closed Friday's trading at $1.60, up 3.90%.
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 October 2024

(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) - Iterum Therapeutics plc (ITRM) announced it has resubmitted New Drug Application to the FDA for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women. The NDA resubmission includes data from the REASSURE, SURE1, SURE 2 and SURE 3 phase 3 clinical trials.
The company said, provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter the company received from the FDA in July 2021, it expects that the FDA will complete review and take action six months from the date the FDA received the resubmitted NDA.
For More Such Health News, visit rttnews.com.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Iterum Therapeutics Announces Resubmission Of NDA Filing For Oral Sulopenem

The average one-year price target for Iterum Therapeutics (NasdaqCM:ITRM) has been revised to 6.63 / share. This is an increase of 550.00% from the prior estimate of 1.02 dated December 13, 2021.
The price target is an average of many targets provided by analysts. The latest targets range from a low of 6.06 to a high of 7.35 / share. The average price target represents an increase of 391.11% from the latest reported closing price of 1.35 / share.
What is the Fund Sentiment?
There are 14 funds or institutions reporting positions in Iterum Therapeutics. This is an increase of 12 owner(s) or 600.00% in the last quarter. Average portfolio weight of all funds dedicated to ITRM is 0.02%, an increase of 70,293.94%. Total shares owned by institutions increased in the last three months by 371,421.15% to 386K shares.
What are Other Shareholders Doing?
Apollon Financial holds 200K shares representing 1.49% ownership of the company.
New Leaf Venture Partners, L.L.C. holds 97K shares representing 0.72% ownership of the company. No change in the last quarter.
Renaissance Technologies holds 50K shares representing 0.37% ownership of the company. In it's prior filing, the firm reported owning 47K shares, representing an increase of 6.01%. The firm increased its portfolio allocation in ITRM by 134.13% over the last quarter.
Susquehanna International Group, Llp holds 18K shares representing 0.13% ownership of the company. In it's prior filing, the firm reported owning 48K shares, representing a decrease of 171.81%. The firm decreased its portfolio allocation in ITRM by 59.77% over the last quarter.
Royal Bank Of Canada holds 10K shares representing 0.07% ownership of the company.
Fintel is one of the most comprehensive investing research platforms available to individual investors, traders, financial advisors, and small hedge funds.
Our data covers the world, and includes fundamentals, analyst reports, ownership data and fund sentiment, options sentiment, insider trading, options flow, unusual options trades, and much more. Additionally, our exclusive stock picks are powered by advanced, backtested quantitative models for improved profits.
This story originally appeared on Fintel.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Iterum Therapeutics (ITRM) Price Target Increased by 550.00% to 6.63

(RTTNews) - The following are some of the stocks making big moves in Friday's pre-market trading (as of 06.50 A.M. ET).
In the Green
iRobot Corporation (IRBT) is up over 37% at $41.10. MMTec, Inc. (MTC) is up over 24% at $1.22. Fisker Inc. (FSR) is up over 12% at $2.38. Vigil Neuroscience, Inc. (VIGL) is up over 6% at $3.15. Metalla Royalty & Streaming Ltd. (MTA) is up over 6% at $2.99. Iterum Therapeutics plc (ITRM) is up over 6% at $2.21.
In the Red
Reliance Global Group, Inc. (RELI) is down up over 13% at $1.12. Mountain Crest Acquisition Corp. IV (MCAF) is down over 10% at $8.04. Cardio Diagnostics Holdings, Inc. (CDIO) is down over 9% at $1.99. Cuentas Inc. (CUEN) is down over 9% at $1.25. Puyi Inc. (PUYI) is down over 6% at $4.20. Safe and Green Development Corporation (SGD) is down over 6% at $3.60. E-Home Household Service Holdings Limited (EJH) is down over 5% at $4.27. Sibanye Stillwater Limited (SBSW) is down over 5% at $4.26. Agape ATP Corporation (ATPC) is down over 5% at $1.12.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Iterum Therapeutics plc

Sign up and unlock all the capabilities of the AI-screener