Arcellx: CART-ddBCMA Phase 1 Trial in Patients with Relapsed or Refractory Multiple Myeloma

 -- Abstract released today is from a June 2, 2023 data cut --

-- Median duration of response, progression free survival, and overall survival rate not reached with median follow-up after CART-ddBCMA infusion of 22 months --

-- A more recent data cut will be shared during the oral presentation with a median follow-up of 26.5 months --

-- Company to host a live webcast event with an expert panel of clinicians --

Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 11, 2023 at 8 p.m. PT. The event will be accessible from Arcellx's website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

https://www.prnewswire.com/news-releases/arcellx-announces-oral-presentation-for-its-cart-ddbcma-phase-1-trial-in-patients-with-relapsed-or-refractory-multiple-myeloma-at-the-65th-ash-annual-meeting-and-exposition-301975098.html

DarioHealth revenue craters

 

• Third quarter total revenue of $3.52 million compared to $6.6 million in the third quarter of 2022, impacted mainly by lower commercial strategic partners revenues in the quarter of $209,000 as compared to $3.1 million in Q3 2022. 
• Third quarter 2023 commercial B2B2C revenues from monthly recurring revenues derived from employers and health plans is up 19.3% over third quarter 2022; nine months YTD up 57% over comparable period in 2022.
• Aetna on track to launch its Dario powered behavioral health platform in the first quarter of 2024, with multiple employers already committed to the platform.
• Expanded our relationship with Aetna behavioral health to replace an existing vendor and add more than $1 million annual recurring revenues beginning in the first quarter of 2024.
• Expanded our relationship with an existing regional plan from our hypertension solution to now also include diabetes.
• Anticipate adding 15 new customers to Dario's platform in the first quarter of 2024.
• Announced a new agreement with PlanSource, a leading provider of cloud-based benefits administration and engagement technology, to offer Dario's full suite of digital health solutions to more than five million consumers.
• Introduced a new GLP-1 Behavioral Change Program to help members realize the transformational power of GLP-1s and other anti-obesity medications while also helping Dario's customers gain better insights on the impact of these medications across their populations.
• Cash and cash equivalents balance as of the end of the third quarter of 2023 of $44 million.
• Company to host investor conference call and webcast at 8:30 a.m. ET today.

Conference Call Details: Thursday, November 2, 8:30am ET

Dial-in: 1-888-886-7786 (domestic) or 1-416-764-8658 (international)

Call me™: https://connectnow1.accutel.com/EventMeet/control?u=1https://connectnow1.accutel.com/EventMeet/control?u=1

Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. This link will be made active 15 minutes prior to scheduled start time.

Conference title: DarioHealth Corp. – Third Quarter 2023 Results Call

Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1634656&tp_key=1861f55312

Participants are asked to dial-in approximately 10 minutes prior to the start of the event. A replay of the call will be available approximately two hours after completion through Saturday, December 2, 2023. To listen to the replay, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and use replay passcode 68054211.

https://www.prnewswire.com/news-releases/dariohealth-reports-third-quarter-2023-financial-and-operating-results-301975468.html

Acurx Pharmaceuticals Stock Is Plummeting After Biotech Publishes Phase 2 Results

 Acurx Pharmaceuticals Inc ACXP shares are trading lower after the company released efficacy results from a Phase 2 trial.

The company, which had $9.1 million in cash and no debt in June, previously decided to terminate the Phase 2b vancomycin-controlled trial segment early. Aggregate blinded data showed a high observed clinical cure rate with no emerging safety concerns. 

Acurx also decided that the clinical cure rate for ibezapolstat, to treat C. difficile Infection (CDI), was projected to be at least 90% pooled across the open-label Phase 2a and the blinded Phase 2b segments with no safety concerns noted. 

Other factors, including the cost and the challenging enrollment due to the COVID-19 pandemic, also influenced the decision.

The Phase 2b trial was originally designed to be a non-inferiority (NI) trial and was later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (IDMC). 

The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population.

Three patients each experienced one mild adverse event assessed by the blinded investigator to be drug-related. 

All three events were gastrointestinal in nature and resolved without treatment. 

"Ultimately the marketplace will determine the antibiotic of choice for front-line treatment of CDI," CEO David Luci said. "But, in our view, as we plan to enter Phase 3 pivotal clinical trials, ibezapolstat appears to have the properties for ultimate competitive advantage including high clinical cure rates, low recurrent infection, minimal microbiome disruption and manufacturing efficiencies to allow competitive pricing."

https://www.benzinga.com/general/biotech/23/11/35566510/acurx-pharmaceuticals-stock-is-plummeting-after-biotech-publishes-phase-2-results

Panbela: Data on: Inhibition of Polyamine Biosynthesis Preserves β Cell Function in Type 1 Diabetes

 

• A Phase 1 clinical study showed that DFMO treatment may provide metabolic benefits to preserve β cell function and health in T1D.

https://www.globenewswire.com/news-release/2023/11/02/2772286/37414/en/Panbela-Announces-Publication-of-Preclinical-and-Clinical-Data-Titled-Inhibition-of-Polyamine-Biosynthesis-Preserves-%CE%B2-Cell-Function-in-Type-1-Diabetes.html

Alpine: Initial Data on Povetacicept in Autoimmune Glomerulonephritis

  Low-dose povetacicept (80 mg administered once every four weeks) was well tolerated during subcutaneous administration and reduced UPCR by greater than 50% in IgA nephropathy --

-- Higher dose povetacicept (240 mg) administered once every four weeks currently being explored --

-- Based on this data Alpine will now seek to begin a pivotal phase 3 IgAN study in the second half of 2024 --

-- Company to host virtual investor call and webcast today at 4:30 pm ET with James Tumlin, M.D. and Jonathan Barratt, Ph.D., FRCP --

Investor Conference Call and Webcast Information

Date/Time: Thursday, November 2, 2023, at 4:30 pm – 5:30 pm ET

Alpine will host a conference call and webcast to discuss the data update from ASN as well as provide a corporate update. Members of the Alpine executive team will be joined by James Tumlin, M.D., Professor of Medicine at Emory University School of Medicine, Founder and Chief Executive Officer of NephroNet Clinical Trials Consortium, and Jonathan Barratt, Ph.D., FRCP, the Mayer Professor of Renal Medicine at the University of Leicester.

The link to the webcast is available in the investor relations section of the Company’s website at https://ir.alpineimmunesciences.com/events and a replay will be available on the Company's website for 90 days following the live event.

https://www.businesswire.com/news/home/20231102047423/en/Figure

Peloton's Turnaround Plan Falters As Anti-Obesity Drug Craze Soars

 Let's begin with this. 

Shares of Peloton Interactive Inc. tumbled in pre-market trading following a drop in revenue and ongoing difficulties in maintaining its subscriber base during the last quarter. It appears Chief Executive Barry McCarthy's turnaround plan is faltering as America's anti-obesity craze, courtesy of GLP-1-based weight loss drugs such as Wegovy and Mounjaro made by Novo Nordisk and Eli Lilly, is an easier weight loss solution than hoping on an overpriced bike with a giant iPad while being yelled at by an instructor for a 20 minute HIIT workout.

Peloton provided a sales forecast for the second quarter, ending in December, to be between $715 million and $750 million. The midpoint of that range is about an 8% decline from the $769.8 million analysts had predicted

Second Quarter Forecast

• Sees revenue $715 million to $750 million, estimate $769.8 million (Bloomberg Consensus)
• Sees adjusted Ebitda loss $70 million to $90 million, estimate loss $46.8 million
• Sees connected fitness subscribers 2.97 million to 2.98 million, estimate 3.03 million
• Sees gross margin 40%

For the first quarter, Peloton posted a 3.4% drop in revenue, mainly driven by lower sales of its fitness products. The fitness equipment company said its bike rental business, which accounted for 33% of bike orders last quarter, saw promising growth. 

Peloton ended the quarter with 2.96 million paid connected fitness subscribers, missing the 2.98 million estimate. 

First Quarter Results

• Revenue $595.5 million, -3.4% y/y, estimate $590.7 million
• Connected fitness revenue $180.6 million, -12% y/y, estimate $170.8 million 
• Subscription revenue $415.0 million, +0.7% y/y, estimate $419.5 million
• Connected fitness subscribers 2.96 million, estimate 2.98 million
• Paid digital subscribers 763,000, estimate 759,627
• Adjusted Ebitda $9.1 million vs. loss $33.4 million y/y, estimate loss $15.2 million
• Negative cash flow from operations $79.2 million, -61% y/y, estimate negative $54 million 

Shares of Peloton fell 7% in premarket trading - near a record low. 

Goldman's GLP-1 Obesity drug basket vs. Peloton 

Chief Executive said, "The bad news is we were less successful at engaging and retaining free users and converting them to paying memberships than we expected." 

Not explained, but certainly, we can assume that GLP-1-based weight loss drugs have disrupted Peloton's turnaround plan. 

In the third quarter, Novo Nordisk reported a surge in demand for its blockbuster obesity drug Wegovy. 

While Peloton sales fell in the prior quarter, Wegovy sales soared to nearly 10 billion kroner ($896,385,000). About 95% of the sales of Wegovy are in the US as the company struggles to keep up with demand.

Novo CEO Lars Fruergaard Jorgensen said as many as 50 million Americans could need access to the obesity drug right now. 

This shift in consumer preference for quick weight loss may have presented new challenges to Peloton's turnaround story. 

https://www.zerohedge.com/markets/pelotons-turnaround-plan-falters-anti-obesity-drug-craze-soars

Novo Nordisk: obesity drugs priority over century-old focus on insulin

 Novo Nordisk said on Thursday treating obesity with its weight-loss drug Wegovy as a precursor to type 2 diabetes was a priority for the company, continuing the Danish drugmaker's shift away from its century-long focus on insulin.

The company on Thursday reported record sales and operating profits for the third quarter driven by demand for Wegovy, even as the company cautioned shortages will continue in the short to medium term.

Wegovy sales totalled 9.6 billion Danish crowns ($1.36 billion) between July and September, 28% higher than the previous quarter and up eight-fold from the same period last year.

Insulin sales stood at 11.3 billion Danish crowns, almost unchanged from the previous quarter and down 12% from a year before, continuing a years-long trend. A drop in the U.S. was driven by lower realised prices and declining volume.

On a media call after the results announcement, Novo CEO Lars Fruergaard Jorgensen noted the company's 100-year history in diabetes, as one of the first companies to bring insulin to market.

Over the years type 2 diabetes has become the "dominating focus", he said, with many people who develop that type of diabetes suffering from weight issues.

Over time, he said, broader use of Wegovy could lead to fewer people with type 2 diabetes needing to take insulin, which he said would be a "very positive outcome" for society.

Novo's diabetes drug Ozempic and Wegovy are from the class called GLP-1 receptor agonists, and both contain the active ingredient semaglutide, originally developed to help control blood sugar in patients with diabetes.

Ozempic is approved for treatment of type 2 diabetes, while Wegovy is approved for weight loss.

Doctors have told Reuters that patients taking GLP-1s require less insulin. Analysts say that could over time further diminish insulin sales.

Jorgensen also referred to other health problems associated with obesity, such as heart disease, and mentioned the company's large study released in August that showed Wegovy had a clear cardiovascular benefit.

He said the company would continue to pursue other uses for Wegovy, and whether semaglutide could be used in combination with other agents to treat Alzheimer's due to its anti-inflammatory properties.

https://finance.yahoo.com/news/novo-nordisk-obesity-drugs-priority-103101203.html