STOCKS TELEGRAPH

Tag: diabetes

  • Provention Bio, Inc. (PRVB) Stock Undergoes Minor Volatility Ahead of PDUFA Meeting

    Provention Bio, Inc. (PRVB) stock prices were down by a marginal 1.19% as of the market closing on July 1st, 2021, bringing the price per share down to USD$8.33 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 3%, bringing it up to USD$8.58.

    EMDAC Approval

    May 27th, 2021 saw the company announce that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S Food and Drug Administration voted in favor of teplizumab. With 10 affirmations and 7 negations, the question asked was whether the data presented showed the treatment to have benefits that outweighed the risks in support of approval to delay clinical type 1 diabetes mellitus.

    TN-10 Study

    Safety and efficacy data from the pivotal TN-10 Study guided the EMDAC decision, which showed a single 14-day course of the treatment to have deferred insulin-dependent, clinical-stage disease. Stage 2 type 1 diabetes was delayed by a median of at least 2 years in presymptomatic patients as compared to the placebo. With early stage TID patients constituting a significant unmet need, the Committee Members evaluated the pros and cons of the clinical data.

    FDA Designations

    Teplizumab was granted Breakthrough Therapy designation by the FDA and a priority review designation for the Biologics License Application. The Prescription Drug User Fee Act (PDUFA) has been scheduled for July 2nd, 2021. Having been previously disclosed, the treatment’s Pharmacokinetic comparability was not a topic of discussion for the Advisory Committee meeting. PRVB maintains that the FDA’s insistence on PK comparability considerations is likely to delay potential BLA approval timelines.

    Scope of Teplizumab

    With over 1.6 million Americans being affected by TID, the autoimmune disease that results from beta cell destruction has a significant scope. TID is typically diagnosed in childhood or young adulthood, but TID onset can occur at any age after symptoms appear in the absence of sufficient insulin production. TID typically reduces life expectancy by more than a decade, with the average reduction being 16 years in people diagnosed before the age of 10.

    Future Outlook for PRVB

    With the PDUFA taking place later today, the company is hopeful for a positive outcome and additional opportunities to continue its trajectory of success. Investors are hopeful that PRVB will be able to see its trial candidates through to commercialization and proliferation of the large unaddressed TID market.

  • Nemaura Medical Inc. (NMRD) Stock Poised to Recover as Global Immunization Efforts Accelerate

    Nemaura Medical Inc. (NMRD) Stock Poised to Recover as Global Immunization Efforts Accelerate

    Nemaura Medical Inc. (NMRD) stock prices were down by 5.20% as of the market closing on June 17th, 2021, bringing the price per share down to USD$10.57 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 1.89%, bringing it up to USD$10.77.

    GBA Review of sugarBEAT

    May 6th, 2021 saw the company announce the progress made with its attempt to achieve reimbursement for its sugarBEAT device from the German regulatory authority (GBA). After an initial review, the governing authority determined that there was no need for a GBA review of sugarBEAT. Instead, the device will be send directly to the National Association of Statutory Health Insurance Funds for a listing on the durable medical catalog.

    Penetrating German Market

    Currently, NMRD is completing the application for this listing, which will be significantly expedited in the absence of the need for a GBA review. The company continues to concentrate its efforts towards facilitating the commercial availability of its sugarBEAT device, with penetration of the German market marking a significant milestone for the company. To this end, the company continues to actively negotiate to identify the most suitable partner to take on the responsibility of marketing and distributing the product and program in such a crucial market.

    Huge Purchase Order

    May 5th, 2021 saw the company announce the receipt of a purchase order for 5000 of its sugarBEAT transmitters, as well as 200,000 of its sugarBEAT sensors. The order came through its U.K licensee, DB Ethitronix Ltd., with an additional rolling monthly purchase order expected. This rolling order will span a period of 24 months and will see the sale of 15000 transmitters and 2.1 million sensors. Included in the agreement will be an option to increase these volumes should there be an excess of demand.

    sugarBEAT Reception

    This order is a testament to the positive feedback garnered by the soft launch of the sugarBEAT CGM device in the U.K., by DB Ethitronix. The licensee has set up a subscription services for diabetes management that is built on sugarBEAT technology. Feedback from users has been overwhelmingly positive, largely due to the fact that it is the only daily-wear CGM on the market that affords users the flexibility to monitor their glucose levels at their own pace, resulting in lower expenses.

    Future Outlook for NMRD

    Despite trending down consistently for several days, NMRD is poised to capitalize on its recent uptrend, which it will hope to maintain as it returns to its previous trajectory of success. Current and potential ivnestors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Senseonics Holdings Inc (SENS) Stock Continue Upward Trend Following Results of PROMISE Study and Continued Meme Stock Craze

    Senseonics Holdings Inc (SENS) Stock Continue Upward Trend Following Results of PROMISE Study and Continued Meme Stock Craze

    Senseonics Holdings Inc (SENS) stock prices were up by a significant 10.77% as of the market closing on June 11th, 2021, bringing the price per share up to USD$4.01 at the end of the trading day. After-hours trading saw the stock continue to climb by 5.24%, bringing it up to USD$4.22.

    SENS Gains Traction on Reddit

    The recent wave of the meme stock crazy running rampant through the stock market worked in SENS’s favor. With the surge in activity regarding the stock on Reddit, the combination of high short interest and positive fundamental developments made SENS a prime target for the consort of retail investors. SENS consolidated the confidence of both existing and prospective investors with Q1 2021 reports jumping to USD$2.85 million, up from the USD$36,000 reported in the prior-year quarter.

    PROMISE Study

    The company’s stock price saw a surge that it has since maintained following the announcement on June 4th, 2021 by SENS of the results of their PROMISE study. The study was designed to evaluate the safety and accuracy of the next-gen Eversense CGM System for up to 180 days with reduced calibrations.

    Presenting Results

    The findings were presented at the University of Colorado, Denver as an oral presentation at the 14th Annual ATTD Meeting, The presentation showcased results from both the primary sensor and a secondary sensor with modified chemistry in a subset of study participants. The secondary sensor is referred to as the SBA sensor.

    Scope of CGM

    With the essential value of CGM for patients with diabetes, especially the demographic requiring insulin, SENS posits that it is imperative that more patients be enabled to utilize CGM. To this end, there needs to be a greater variety of choice in product features that leads to increases accessibility. With the accuracy profile demonstrated by Eversense in the PROMISE study, the role of long-term implantable CGM system is validated in its capacity to help people manage their glucose levels.

    Key Results of PROMISE Study

    The results reported an overall mean absolute relative difference (MARD) against reference value of 9.1% for the primary sensor, spanning 49,000 paired points. The secondary SBA sensor reported a MARD of 8.5%, spanning 12,000 paired points. The confirmed hypoglycemic alert detection rate was 93% for the primary sensor and 94% for the SBA sensor.

    Future Outlook for SENS

    Armed with both the promising results of the PROMISE study and the surge in value of its equity from Reddit-driven retail investors, SENS is poised to capitalize on the opportunities presented to it. The company is keen to use this momentum to establish a continued trajectory of success. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.