AngioDynamics Reaffirms Fiscal Year 2022 Guidance

Fiscal 2022 Third Quarter Highlights

• Net sales of $74.0 million increased 3.9% compared to the prior-year quarter

• Med Tech grew 28.6% and Med Device declined 2.8% year over year

• Gross margin of 52.2% declined 190 basis points year over year

• GAAP loss per share of $0.13 and adjusted earnings per share of $0.03

• Subsequent to quarter end:

• the Company enrolled the first patients in its PRESERVE study for the use of NanoKnife in prostate;

• the Company received FDA approval for its AlphaVac F18 thrombectomy system; and

• the Company received FDA approval for its IDE study for the use of AlphaVac F18 to treat pulmonary embolism

• https://finance.yahoo.com/news/angiodynamics-reports-fiscal-2022-third-110000276.html

HTG Expands Features of Proprietary HTG EdgeSeq Technology

 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, announced that it has improved the sample preparation protocol for its miRNA Whole Transcriptome Assay (miRNA WTA) so that it is now harmonized with the HTG Transcriptome Panel (HTP).

The harmonized protocol is designed to enable customers to process a single sample with HTG’s nearly 20,000 gene mRNA and 2,000+ miRNA transcriptome panels using a single sample lysate. Validated for use with several commonly used sample types, including formalin fixed paraffin embedded (FFPE) tissue, PAXgene, and RNA extracted from FFPE or freshly frozen tissue, this approach is intended to allow customers to save time with better sample and workflow efficiency while generating more comprehensive expression data.

“Harmonization of our mRNA and miRNA workflows should facilitate the generation of more robust multiomic mRNA and miRNA expression analysis while furthering the value proposition of our HTG EdgeSeq technology as a tissue-preserving gene expression profiling (GEP) technology,” said Dr. Marian Navratil, HTG’s Senior Vice President of Research and Development. “Prior to completion of this harmonization, separate tissue sections and sample preparation processes were needed to analyze the full transcriptome. With this innovation, only a single tissue section and just one lysis method are typically expected to be required to release all the RNA needed for downstream testing without any confounding factors that could interfere with expression data.”

“We believe HTG now offers the only solution enabling extraction-free full transcriptomic profiling, both mRNA and miRNA, from a single tissue section,” said Byron Lawson, HTG’s Senior Vice President and Chief Commercial Officer. “Alternate GEP technologies typically require a minimum of 4-8 tissue sections, and often 12 or more sections for RNA extraction, as well as separate library preparation methods for RNA size selection for mRNA and miRNA processing. Our technology offers customers a streamlined workflow, with more efficient turnaround times and simplified bioinformatics. We are very optimistic that these advantages will encourage customers to interrogate mRNA using our HTP and miRNA using our miRNA WTA, while allowing them to retain precious samples for use in other analysis.”

https://finance.yahoo.com/news/htg-expands-features-proprietary-htg-200500802.html

IMAC Holdings Completes Walmart Pilot Program

 IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or the “Company”), today announces the successful completion of its pilot program for The Back Space retail chiropractic concept located in select Walmart stores. As a result, the Company is committed to tripling its store count with at least 20 additional locations over the next twelve months with a further goal of adding significantly more stores over the next three years. The Company expects the new stores to be a combination of corporate and The Back Company franchise locations to address market demand.

“We are excited to guide our prospective franchisees with the experience gained during our ten-store pilot program. During the pilot, we learned that our price point resonates well with consumers and a potential price increase could yield increased revenue without diminishing the consistent desire for care,” said Dr. Ben Lerner, Chief Operating Officer of IMAC. “Similar models by competitors have proven an increased demand for spinal health that this fragmented industry has yet to meet. We believe our location inside Walmart stores and the foot traffic therein provides a significant competitive advantage.”

The Back Space’s retail healthcare centers specialize in chiropractic adjustments and percussion tool therapies for soft tissue recovery, muscle relaxation and spinal wellness. Services are offered on a walk-in and appointment basis, priced at $25 per treatment, with memberships available for $65 per month that are valid at any The Back Space location.

“The initial interest from franchisees has been strong using only our internal marketing efforts. As such, we do not expect that it will be necessary to engage brokers to sell franchises in the foreseeable future which will allow us to retain a greater portion of the franchise fee to support our franchisee’s development efforts. The feedback has consistently referenced our lower initial investment requirements compared to other chiropractic franchisors,” said Jeff Ervin, Chief Executive Officer of IMAC. “We believe this helps expand our brand at an accelerated pace as compared to solely opening corporate owned storefronts.”

https://finance.yahoo.com/news/imac-holdings-completes-walmart-pilot-124700132.html

Minerva Neurosciences Update on FDAs Meeting with FDA, Next Steps for NDA

 Minerva Neurosciences, Inc.,  (NASDAQ: NERV), a clinical-stage biopharmaceutical company developing therapies to treat central nervous system (CNS) disorders, announced today that it has received the official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration (FDA) held on March 2, 2022, regarding development of roluperidone for the treatment of negative symptoms in schizophrenia.

The primary purpose of the meeting was for Minerva to seek the FDA’s agreement on the use of roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia in the subgroup of patients with moderate to severe negative symptoms and stable positive symptoms.

Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences said, “Both the patient and medical communities recognize the need for a radical new treatment to address the negative symptoms of schizophrenia. Presently, there is no approved treatment for negative symptoms in the United States. I believe roluperidone has the potential to transform the lives of people who are unable to participate in and enjoy everyday activities due to their negative symptoms. We are mindful of our responsibility to patients and would particularly like to thank Dr. Tiffany Farchione, Director, Division of Psychiatry and Dr. Billy Dunn, Director, Office of Neuroscience, and their colleagues for their support at the Type C meeting. We are committed to working with the Division and continuing an open dialogue in preparation for a potential NDA submission for roluperidone in the summer, subject to guidance from the Division.”

The Division agreed that there is an unmet need for negative symptom treatments and restated its position following the November 2020 Type C meeting in which they indicated a marketing application was highly unlikely to be filed. The Division also stated at the November 2020 meeting that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this novel indication. The Division acknowledged at the time that the studies appear to show promising signals and encouraged Minerva to continue the drug development program for this indication. Since the Type C meeting in November 2020, Minerva has completed the Open-label extension of the Phase 3 study and has continued to develop roluperidone as a monotherapy specifically for the treatment of negative symptoms of schizophrenia in the subgroup of patients with moderate to severe negative symptoms and stable positive symptoms.

At the recent meeting, Minerva and the Division discussed roluperidone’s use as a monotherapy for negative symptoms and the Division advised that several important and substantial concerns remain including:

• the applicability of the results of the Phase 2b study (conducted in Europe) to the US population. Minerva presented data in the briefing document sent to the Division in advance of the meeting showing comparable baseline data and efficacy across both US and ex-US patients in the Phase 3 study.
• the proposed use of post hoc analyses for the primary endpoint results of the Phase 3 study. The Division added that even with the exclusion of one trial site that Minerva believes to be subject to potential data integrity issues, the overall study remains negative. For the Phase 3 study to be positive, where the truncated Hochberg procedure was used to control the overall Type I error, both roluperidone doses must be statistically significant versus placebo, which was not the case for the 32 mg dose. Minerva confirmed in post-meeting follow-up that the exclusion of one site had been prespecified in the SAP submitted to the Division in May 2020 before the unblinding of the double-blind data. Excluding the trial site with data integrity issues resulted in a nominal p-value of 0.044 on the primary endpoint for the 64 mg dose. In the Phase 2b study the 64 mg and the 32 mg doses of roluperidone achieved statistical significance versus placebo.

The Division sought reassurance that Minerva could reliably identify patients who do not need antipsychotics and how to evaluate the stability of those patients, and potential recurrence of positive symptoms of those patients, what would be considered a significant change in symptoms, how much time patients should be monitored to evaluate whether positive symptoms will recur, and what should be done if positive symptoms recur. Minerva informed the Division that it believes this patient population can be readily identified by clinicians, that this patient population presents commonly in clinical practice, that there is an unmet need for treatments for these patients and that Minerva expects that the population could be clearly characterized in product labelling.

The Division pointed out that prescribers are likely to use roluperidone in a way that differs significantly from the intended monotherapy use, noting that at this time, there are no data to show that roluperidone does not interfere with the safety or efficacy of antipsychotic medications. Minerva stated that it believes that findings from the completed Phase 2b (MIN101-C03) and Phase 3 (MIN101-C07) studies, (in which roluperidone was administered in monotherapy without concomitant use of antipsychotic medications), demonstrate continued stability of positive symptoms in patients over time. Minerva stated that the relapse rate in these trials was less than 15% of the treated population compared to relapse rates of more than 25%¹ in other trials in which patients were treated with antipsychotics. Following the meeting, Minerva submitted additional data to the Division from the Phase 2b and Phase 3 studies demonstrating that roluperidone does not interfere with the efficacy of antipsychotics in patients who suffered relapse and withdrew from the studies.

The Division confirmed that results from the pivotal bridging Bioequivalence study appear to be adequate for a future acceptable NDA submission but advised that final confirmation of this would be a matter of review and also acknowledged that Minerva’s initial pediatric study plan (iPSP) dated November 28, 2017, remains in force.

Minerva continues to believe that it has conducted two adequate and well controlled studies for the intended indication, and that the data from these studies are sufficient to support a marketing application. Minerva views the concerns raised regarding the data from the Phase 2b and Phase 3 studies as those that FDA would ordinarily consider during its review of an NDA.

At the end of the meeting, the Division suggested that there may be a way to address its concerns, whether the completed studies provide substantial evidence that negative symptoms are responsive to roluperidone, concurrently with the questions about positive symptoms and coadministration with antipsychotic medication through the acquisition of additional data. The Division advised that collection of additional data could begin in parallel with Minerva’s preparations for a potential marketing application and need not be deferred until a determination about submission or filing of the application has been made.

https://www.biospace.com/article/minerva-neurosciences-provides-update-from-type-c-meeting-with-fda-and-next-steps-in-preparation-for-submission-of-a-new-drug-application-nda-for-roluperidone-for-the-treatment-of-negative-symptoms-in-schizophrenia/

Jazz Howls at Immuno-Oncology Success with Werewolf Alliance

 Jazz Pharmaceuticals continues to advance its efforts toward becoming a leading oncology company via a key licensing deal with Werewolf Therapeutics for WTX-613, an engineered IFN⍺2b cytokine pro-drug, which is currently in preclinical development. The deal marks the first immuno-oncology program for Jazz Pharma.

Rob Iannone, global head of research and development at Jazz, expressed excitement about the potential of the Werewolf cancer asset. At the American Society of Hematology meeting last year, Werewolf presented compelling proof-of-concept data that showed how a surrogate WTX-613 molecule demonstrated anti-tumor activity, he said. Those WTX-613 molecules were also well-tolerated, according to Werewolf’s own announcement.

WTX-613 was created leveraging Werewolf's proprietary PREDATOR protein engineering technology. Type 1 interferon signal transduction by IFNα agonism is a clinically validated mechanism of action. Jazz noted in its announcement that IFNα has been shown to “work synergistically in combination with other proven therapies,” which includes immune checkpoint inhibitors, targeted therapies and chemotherapy. Because of this synergy, the company believes WTX-613 has applications across a wide range of cancer types, combination regimens and lines of therapy. Jazz anticipates seeking approval from the U.S. Food and Drug Administration for in-human studies next year.

Additionally, Iannone said the company believes that WTX-613 has the potential to minimize the toxicity currently associated with systemic IFNα therapy, something that has plagued developmental assets across the oncology space. WTX-613 is designed to specifically activate within the tumor microenvironment where it can then stimulate IFNα receptors on cancer-fighting immune effector cells.

"We are excited about the potential of WTX-613,” Iannone said in a statement. “This transaction underscores our commitment to enhancing our pipeline to deliver novel oncology therapies to patients, and also provides us with an opportunity to expand into immuno-oncology.”

Daniel Hicklin, president and chief executive officer of Werewolf Therapeutics, echoed Iannone’s thoughts on WTX-613. He expressed excitement about the partnership with Jazz, noting that the collaboration will drive WTX-613 into the clinic, while giving his company more space to advance their lead programs, WTX-124 and WTX-330, through expected Investigational New Drug application filings later this year.

Under terms of the deal, Werewolf will receive an upfront payment of $15 million. As WTX-613 progresses through the clinic, the value of the licensing deal could grow to $1.26 billion. If commercialized, Werewolf would then be eligible for royalties as well.

Jazz’s momentum into oncology continues following the 2021 approval of Rylaze, a new leukemia drug aimed at patients who have developed hypersensitivity to E. coli-derived asparaginase, an enzyme that is a common component of the chemotherapy regimen used with leukemia patients.

Last month, the company enrolled the first patient in its EMERGE 201 study, which will assess Zepzecala (lurbinectedin) as a monotherapy in various solid tumors. Zepzecala was approved in 2020 under the accelerated approval program for small cell lung cancer. Jazz hopes that Zepzecala, an alkylating drug that binds guanine residues within DNA, will prove to be safe and effective in different solid tumor types, including urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and homologous recombination deficient tumors

At the American Association of Cancer Research (AACR) meeting this week, Jazz will present data from the pan-RAF inhibitor JZP815 development program that will form the basis of an IND application later this year.

Iannone said the company will continue to identify and advance promising treatments and novel combinations in order to deliver at least five additional novel therapies to patients by the end of the decade as part of the company’s Vision 2025, which was announced earlier this year. Under this new image, Jazz Pharmaceuticals sees itself as a company that has expertise in neuroscience, which includes sleep and movement disorders, as well as oncology.

https://www.biospace.com/article/jazz-howls-at-immuno-oncology-success-with-werewolf-deal-worth-potential-1-26b/

Acadia To Seek First-Ever FDA Approval in Rett Syndrome

 Shares in Acadia Pharmaceuticals rose 5.71% to $27.22 per share at the close of NASDAQ Wednesday on positive late-stage data from the study of an investigational treatment for Rett syndrome.

The company presented an update on its Phase III LAVENDER study of trofinetide for Rett syndrome at the American Academy of Neurology's annual meeting in Seattle. The trial, which involved around 6,000 female participants, demonstrated statistically significant results highlighting the drug's effectiveness and safety.

Participants were observed in a double-blind, randomized, placebo-controlled procedure and results were measured using physician and caregiver metrics such as the Rett Syndrome Behavior Questionnaire and the Clinical Global Impression-Improvement assessment. The girls and young women were also evaluated using the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist - Social Composite Score.

"The consistent efficacy across primary and key secondary endpoints in the Lavender study demonstrates the potential of trofinetide to treat Rett syndrome. We want to thank the patients, their caregivers, study site personnel, physicians and everyone who participated in the Lavender study for their contribution to making this milestone a reality," said Kathie Bishop, Ph.D., Acadia's senior vice president and chief scientific offer, in an earlier statement.

Rett syndrome is a rare and debilitating neurological disease that targets mostly females following normal development in the first six months of life. It is often misdiagnosed as cerebral palsy, autism or non-specific development delay. It is caused by mutations in the MECP2 gene and happens in one of every 10,000 to 15,000 female births worldwide. There are 6,000 to 9,000 patients diagnosed with the disease in the country, which is characterized by brain function problems.

The U.S. Food and Drug Administration has not approved any treatment for Rett syndrome as of this writing, so the good news around trofinetide is incredibly encouraging. Trofinetide is a synthetic analog of the amino-terminal tripeptide of IGF-1 and can reduce neuroinflammation and support synaptic function. Having IGF-1 in the brain is critical to normal development and proper disease and injury response.

The FDA has already given trofinetide Fast Track Status and Orphan Drug Designation for Rett Syndrome. The drug also has a Rare Pediatric Disease designation. Acadia intends to submit a New Drug Application by the middle of 2022.

"In a severe disorder like Rett syndrome that has no approved therapies and where all of our interventions are purely symptomatic, it's very exciting to be at a point where a phase 3 trial shows benefit," study investigator Jeffrey L. Neul, M.D., Ph.D., director of the Vanderbilt Kennedy Center and professor of pediatrics, Vanderbilt University Medical Center told Medscape Medical News.

Acadia is progressing trofinetide after signing an exclusive license agreement with Neuren Pharmaceuticals to develop and commercialize the drug for Rett syndrome and other possible indications in North America in 2008. 

https://www.biospace.com/article/acadia-shares-rise-on-positive-late-stage-data-on-rett-syndrome-treatment-preps-for-nda/

Your dog’s kisses may contain a superbug that could kill you

 Newsflash: Dog butts are teeming with nasty germs.

So the innocent, thumbless creature does its best to clean using its tongue and teeth — from the same wet snout that loves giving you kisses.

Now a new study is urging dog owners to stop allowing their dogs to lick them — and to even wash their hands after petting a pooch — as their slobber may be a source of antibiotic-resistant superbugs.

A joint team of researchers from the UK Royal Veterinary College and the University of Lisbon focused on a super strain of E.coli found in human and animal fecal samples from 41 homes in Portugal and 45 in Great Britain.

Close to 14% of dogs (14 out of 85) turned up the superbug, making theirs the largest share of infected poo.

Before we turn our noses up at our pooches, though, the results also suggested that us bipeds aren’t much cleaner, with about 13% of human samples (15 out of 114) showing the powerful E.coli — so we might not wanna go licking each other either.

Meanwhile, it was the not-so-humble cat that was recorded as the most sanitary, with only 5% (one out of 18) showing the superbug.

Harmful bacteria have evolved to withstand our most powerful drugs and have been anticipated as one of the biggest global threats to public health of our time. Scientists have already identified drug-resistant strains of several commonly known bugs, including salmonella, tuberculosis, streptococcus, staphylococcus and so-called “super” gonorrhea, to name a few. Those are added to the more than 2.8 million drug-resistant infections — 35,000 of them fatal — that occur every year in the US, according to the most recent data from the Centers for Disease Control.

“Even before COVID, antibiotic resistance was one of the biggest threats to public health,” said lead study author Dr. Juliana Menezes, whose findings are being presented at the European Congress of Clinical Microbiology & Infectious Diseases in Lisbon later this month. “It can make conditions like pneumonia, sepsis, urinary tract and wound infections untreatable.”

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Researchers can’t be sure who — human or beast — is to blame for the spread, so they’re asking pet parents to be vigilant with their pups and refrain from wet kisses or “eating from the owner’s plate,” Menezes told the Telegraph.

However, Menezes noted that E.coli is found in the gut and, thus, in feces. As such, she stressed that “good hygiene practices on the part of owners would help to reduce sharing, such as washing hands after collecting dog waste, or even after petting them.”

https://nypost.com/2022/04/06/your-dogs-kisses-could-contain-deadly-superbug-study-says/