What's Going On With Moleculin

 

• Moleculin Biotech Inc 
  MBRX-8.34%+ Free Alerts
   announced that preclinical data regarding its next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2023.
• The poster outlined results from the analysis of the pharmacokinetics of two formulations of Annamycin, liposome formulated drug product (L-ANN) and free Annamycin (ANN), in the liver in comparison with doxorubicin (DOX) and to determine its tumoricidal potential in a hepatocellular carcinoma (HCC) model in situ and experimental models of liver metastasis.
• ANN exhibited significantly higher accumulation in the liver parenchyma when compared to DOX (6-fold higher AUC values).
• Researchers observed clear inhibition of the subcutaneous tumor growth after systemic (IV) administration of L-ANN.
• Increased liver uptake of the drug directly affected the drug's activity in vivo. 
• An encouraging activity of L-ANN was observed in orthotopic models. Significant inhibition of the tumor growth and extension of the survival of L-ANN-treated mice vs. vehicle-receiving animals was observed.
• L-ANN treatment resulted in an increase in survival in the CT26 colon cancer experimental metastasis animal model. 
• A significant delay in tumor progression was also observed in the pancreatic cancer liver metastasis model in a separate experiment.
• MBRX shares have been volatile in trading, up 31% at one point before the circuit breaker halt.

https://www.benzinga.com/general/biotech/23/04/31865856/whats-going-on-with-moleculin-biotech-stock-today

SAB Biotherapeutics Gets FDA Breakthrough Therapy Status On Influenza Treatment

 

• Earlier today, SAB Biotherapeutics Inc's 
  SABS+41.6%+ Free Alerts
   SAB-176, an investigational therapy for post-exposure prophylaxis for influenza, received FDA Breakthrough Therapy Designation soon after securing FDA Fast Track Status for the candidate.
• Last Friday, SAB Biotherapeutics' 2022 10-K was released. The analyst says it has no impact on the company; unfortunately, this does not warrant any further investor focus.
• 4Q22 EPS was ($0.19), compared to HC Wainwright's estimate of ($0.04). 
• The analyst says that the FDA is aligned with the company's manufacturing approach, which could address multiple strains of influenza annually. 
• In December 2021, the company announced that SAB-176 met the primary endpoint of statistically significant reductions in viral load compared to the placebo.
• SAB expects SAB-176 to be treated like a vaccine with annual changes to its targets and readily available for each flu season. 
• It forecasts a 2027 launch for SAB-176 with sales of $12.5 million that year and $290 million in 2030.
• HC Wainwright reiterates its Buy rating with a price target of $4.
• Chardan writes that SAB-176 is most likely to proceed with a partner. The analyst reiterates a Buy rating with a price target of $3.
• The analyst notes that SAB-195 is the company's top priority preclinical pipeline candidate for two infection indications.
• Preclinical data indicate that SAB-195 can neutralize both C. diff. bacteria and multiple strains of toxins. The company is conducting IND-enabling activities, with IND filing expected in 1Q24

https://www.benzinga.com/analyst-ratings/analyst-color/23/04/31865108/sab-biotherapeutics-gets-fda-breakthrough-therapy-status-on-influenza-treatment-can

Alkermes Plans Separation of Oncology Business

 Alkermes plc (Nasdaq: ALKS) today announced that it has submitted a confidential draft Form 10 registration statement to the United States Securities and Exchange Commission in connection with the previously announced planned separation of the company's oncology business into an independent, publicly-traded company (Oncology Co.). The company continues to expect to complete the separation in the second half of 2023.

As announced in November 2022, Alkermes' Board of Directors (the Board) unanimously approved the exploration of separating the company's neuroscience business and oncology business. The planned separation is part of a strategic process commenced by the Board to unlock shareholder value through a sharpened strategic focus, simplified capital allocation decision-making, and distinctive investment profiles for each business.

The planned separation would allow Alkermes to maintain its focus on researching, developing and commercializing therapies for people living with complex neurological conditions and is expected to accelerate and enhance the profitability of the remaining neuroscience business. Oncology Co. would focus on the discovery and development of cancer therapies, including continued development of nemvaleukin alfa, which is currently in potential registration-enabling studies in two tumor types.  In addition to the submission of the draft Form 10 registration statement, Alkermes continues to make progress on other elements of the planned separation and will disclose further details regarding Oncology Co. at a future date.

Completion of the planned separation is subject to various customary conditions, including final approval of the Board. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

https://finance.yahoo.com/news/alkermes-announces-submission-confidential-draft-110000823.html

Madrigal Gets Breakthrough Tag for NASH therapy

 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that resmetirom has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with NASH with liver fibrosis. The Company also announced that the outcomes portion of the Phase 3 MAESTRO-NASH biopsy trial has completed enrollment.

https://finance.yahoo.com/news/madrigal-receives-breakthrough-therapy-designation-120000288.html

Ardelyx Resubmits New Drug Application for CKD therapy

 Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of XPHOZAH (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy. An Acknowledgement of Receipt letter from the FDA, confirming the resubmission is complete, is expected in mid-May. We expect that the letter will include the classification of the resubmission and the review goal date.

The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY), as well as two additional Phase 4 open-label clinical trials (OPTIMIZE and NORMALIZE).

https://finance.yahoo.com/news/ardelyx-resubmits-drug-application-u-120000723.html

Precision to Present Duchenne Research at American Society of Gene & Cell Therapy

 Presentation to Highlight Preclinical Development Progress of PBGENE-DMD Program for Potential Treatment of Duchenne Muscular Dystrophy

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced that a late-breaking abstract featuring preclinical data from its PBGENE-DMD program for the potential treatment of Duchenne muscular dystrophy (DMD), was selected for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting being held May 16-20, 2023 in Los Angeles, CA.

"ARCUS nucleases have been shown to be exceptionally versatile for complex gene editing approaches, including large gene excisions. The goal of the PBGENE-DMD program is to utilize a pair of ARCUS nucleases, delivered by a single AAV, that are designed to excise an approximately 500,000 base pair mutation "hot spot" region from the dystrophin gene in order to make a variant of the dystrophin protein that is functionally competent," said Jeff Smith, Chief Research Officer of Precision BioSciences. "We look forward to the upcoming ASGCT presentation highlighting new data from Precision’s DMD gene editing program."

The abstract will be publicly accessible through the ASGCT website at https://annualmeeting.asgct.org/abstracts beginning on May 2, 2023.

https://finance.yahoo.com/news/precision-biosciences-announces-breaking-abstract-120000107.html

Viemed to Acquire Tennessee Based Home Medical Products

 Viemed Healthcare, Inc. (the “Company” or “Viemed”) (NASDAQ:VMD and TSX:VMD.TO), a national leader in respiratory care and technology-enabled home medical equipment services, announced that it has entered into a definitive agreement to acquire Tennessee based Home Medical Products, Inc. (“HMP”), a large regional provider of respiratory focused home medical solutions.

“We are incredibly excited to complement our strong history of organic growth by combining great teams through accretive transactions” said Viemed Chief Executive Officer Casey Hoyt. “The purchase of HMP will launch our acquisition growth initiatives with a stellar organization that has an extraordinary reputation with patients, payors, and physicians. Above all, the team at HMP shares our same driving passion for innovative patient-focused care.”

Home Medical Products, Inc. was founded in September 2004 seeking to offer residents of local communities quality solutions for medical equipment in the home – solutions that would help people live life better. HMP has expanded its programs and services to partner more effectively with physicians, hospitals, and other healthcare partners in order to facilitate quality care plans for patients in their homes that lead to innovative solutions and improved health outcomes. The organization currently manages numerous medical equipment offices throughout Tennessee and in Alabama and Mississippi. Founder David Steele, Chief Executive Officer Jason Shiflet, and the HMP team are expected to join Viemed upon the completion of the transaction.

https://finance.yahoo.com/news/viemed-accelerates-growth-acquisition-tennessee-130000223.html