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Tag: PRVB

  • Provention Bio Inc. (PRVB) Might be a Good Choice as Market Sinks but with High-Reward comes High-Risk

    While Monday proved a sigh of relief in the stock market, 2022 has been a very tough year so far due to geopolitical and economic instability. While Nasdaq Composite is squarely in the bear market territory, the S&P 500 also briefly joined it on Friday. The tech-heavy composite has fallen by nearly 29% year to date and S&P 500 extended losses to 20.6% from its January high before making a comeback on Monday. The recovery on Monday as a result of the Biden government’s indication of easing tariffs on Chinese goods imposed by the prior administration. While the index might have saved itself from the official bear market territory, its year-to-date decline of over 17% still highlights the increasing dark economic outlook. This downfall is fueled by slowing economic and earnings growth, geopolitical turmoil, rising inflation, and the subsequent interest rate hike and monetary tightening by the Fed.

    Times like the current while instigating a wider sell-off in the market also force investors to stay away from anything that comes with risks. But times like these are also a great opportunity to make some profits by wisely and thoroughly choosing the kinds of risks one can take. A wider downfall in stock markets brings forth good entry points for stocks worth taking the risk at a beaten-down price. One such stock, that has been beaten down but comes with a high reward is Provention Bio Inc. (PRVB). But then again with high reward comes high risk.

    Down nearly 30% in 2022, the stock has suffered a decline of over 60% in the past twelve months. PRVB was in the green at the close of the latest trading session on Monday, May 23, at a price of $4.00 in the after hours. Let’s have a look at the rewards and risks associated with the biotechnology stock.

    PRVB’s Pipeline Developments

    The biotechnology company is working on developing therapies that delay the onset of various autoimmune diseases. Its lead product candidate is teplizumab which targets type 1 diabetes (T1D). The clinical study of the candidate demonstrated its ability to delay the onset of the clinical disease and insulin dependence in the patients for about three years. However, due to some manufacturing issues, the medicine was not approved by the FDA despite the hugely positive results. The FDA did not dispute the safety and efficacy of teplizumab in T1D. Fortunately, the company resubmitted the application for the drug in the first quarter of 2022 after addressing the raised issues.

    The FDA has assigned a user-free goal date of August 17, 2022, by which an answer will be given to PRVB. Moreover, the company recently held an investor event on May 19, regarding the potential commercial launch of teplizumab in the second half of this year. Following the FDA’s response later this year, PRVB shares could soar high on positive news or plunge further on another regulatory roadblock.

    In addition to the lead candidate, the company’s pipeline also includes PRV-3272 which is a potential therapy for preventing systematic lupus erythematosus (SLE). In case of approval, the programs would bring exponential value to PRVB. Approval of teplizumab would result in peak sales of $800-$1.2 billion and the probability of success lies around 80%.

    Financial Highlights

    Source: LaPorte

    In its latest earnings for the first quarter of 2022, the company posted a net loss of 35 cents a share against the expected 45 per share. With a quarterly earnings surprise of 22.22%, the company shrunk its loss from 52 cents per share in Q1 2021. The total net loss for the quarter was $22.0 million against the comparable $32.4 million. The decline in net loss came from a decrease in R&D expenses and an income tax benefit in Q1 2022.

    However, the company’s revenue missed the consensus estimate by 20.87% in Q1 2022. The revenues were $0.58 million for the March quarter under its License Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. Comparatively, there were no revenues in the year-ago period. Moreover, the company also gained $1.5 million in research, development, and manufacturing funding from Huadong, recorded in deferred revenue.

    At the end of the quarter, the company’s cash, cash equivalents, and marketable securities totaled $113.4 million. The management expected the cash balance to be enough for runway into Q1 2023.

    With the ongoing preparation for the potential FDA approval of teplizumab in Q3 2022, PRVB is expecting cash-based operating expenses of $29-$33 million in Q2 2022. Analysts are expecting a loss of 49 cents per share on revenue of $0.87 million in the ongoing quarter.

    PRVB stock Rating

    In early February of this year, PRVN was given a strong buy rating when the company announced its intention for resubmitting the teplizumab application. However, with the continued blows from the wider market instability and the goal date of August 17th, it was downgraded to a hold.

    As of last week, the consensus recommendation for the stock is a “Buy” from nine research forms with two analysts giving it a “Hold” rating. Furthermore, the stock has an average 12-month price target of $16.25.

    Conclusion

    Market dips, like the present due to the wider geopolitical and economic instability, bring forth numerous opportunities to buy meaningful stocks at pennies for their value. PRVB with a great potential near-term success for its lead candidate is one such stock that might give great profits. There are certain risks associated with the stock due to the upcoming FDA decision regarding its lead candidate but the upside is bright with an 80% chance of success.

  • Provention Bio, Inc. (PRVB) stock is moving up by 22.06% in after hours – Why is this happening?

    Provention Bio, Inc. (PRVB) stock is moving up by 22.06% in after hours – Why is this happening?

    Provention Bio, Inc. (PRVB) experienced an increase of 22.06% in aftermarket following the announcement of Resubmitting Biologics License Application for Clinical Type 1 Diabetes. However, the last trading session concluded at $3.4 with a decrease of 6.59%.

    Resubmitting Biologics License Application – What’s up?

    On 27th January 2022, PRVB announced that it has resubmitted the teplizumab Biologics License Application (BLA) for the control of clinical type 1 diabetes. In the BLA resubmission, the Company will present a hybrid 14-day treatment plan to alleviate the FDA’s comparability concerns. This will be based on the Company and FDA’s agreed-upon PK modeling and the Company’s experience with various dosages and regimens evaluated in earlier clinical studies. According to an agreement reached with the FDA at a Type A meeting conducted in August last year, the BLA resubmission will contain responses to the CRL’s Chemical, Manufacturing, and Controls (CMC) and quality control concerns. In the first quarter, PRVB expects to be able to resubmit the BLA.

    Now what?

    PRVB is ecstatic to be working on resubmitting the teplizumab BLA, which will move the firm one step closer to its goal of giving teplizumab to family members at risk of developing end-stage, insulin-dependent type 1 diabetes while taking into account the FDA’s feedback.

    Furthermore, the company appreciates the FDA’s Breakthrough Therapy Designation team’s high level of participation and assistance during this regulatory review process (BTD).

    Not only that, but the company plans to resubmit the BLA as quickly as possible, assisting the FDA with its review and decision. The team continues to prepare PRVB for a future launch of teplizumab with carefully controlled spending and planning.

    Initiation of the Phase 2a PREVAIL-2 Study of PRV-3279 – Latest News

    PRVB stated on 20th January 2022 that Phase 2a PREVAIL-2 study of PRV-3279 has been started. PRV-3279 combines two important immune protein targets to change their interactions in a smart way. Moreover, CD32B is a natural activator of B cells and CD79B is part of the B cell receptor. Arthritis and Clinical Immunology Program has led global efforts to produce more interpretable trials. The use of a B cell gene profile to stratify and pre-define subsets in PREVAIL-2 helps to identify patients who will benefit from PRV-3279 treatment in the future.

    What’s Next?

    PRV-3279 has an elegant mode of action which is to intercept and ameliorate the pathophysiology of lupus. In addition, PRVB believes that PRV-3279 allows for fast suppression of active B cells while sparing non-activated B cells from depletion. Last but not the least, PREVAIL-2 data is expected to be available in the first half of 2024.

  • 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.

  • Provention Bio Inc. (PRVB) stock plunged in the after-hours trading session: here’s why

    Provention Bio Inc. (PRVB) stock had recently traded at $6.03 at the time of writing which is a -38.06% downward movement in the after-market trading session. PRVB stock dropped -2.36% which closed Thursday’s session at $9.73. The stock volume was 1.56 million shares which was higher than the average daily volume of 0.93 million shares within the past 50 days. In the past 12 months, the PRVB shares have moved up by 16.03%, however, in the past six months and past 3 months, it lost -31.97% and -44.02%. In the past week, the shares went down by -7.24%. Furthermore, PRVB has a current market of $568.73 million and its outstanding shares total 56.63 million.

    The recent pattern of downward movement in after-hours trading has come adjacent with the announcement made by PRVB stock stating the FDA has found deficiencies for Teplizumab’s application approval.

    Insight on Provention Bio’s background

    Provention Bio Inc. (PRVB) is a biopharmaceutical company that specifically focuses on the development of investigational therapies. The focus on investigative therapies is to tackle in an innovative and effective way to treat the diseases which can be debilitating and can also cause life-threatening immune-mediated diseases.

    PRVB stock’s Pipeline Projects

    Provention Bio Inc (PRVB) has many projects in its pipeline which include additional clinical-stage product candidates specifically for celiac and lupus treatment as well as other autoimmune diseases. These are candidates that have shown the proof of concept and proof of mechanism for the pre-clinical or clinical studies.

    Announcement of FDA’s update on Biologic License Application of Teplizumab

    Provention Bio Inc (PRVB) announced on 8th April 2021 that it received a notification from the Food and Drug Administration that mentioned finding deficiencies on the subject of post-marketing requirements for the review of the ongoing Biologic License Application process of teplizumab.

    Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb). It is used to delay or prevent the onset of type 1 diabetes (T1D) in at-risk individuals. Multiple clinical studies with up to 1000 subjects have proven the efficacy of the drug for T1D by preserving beta-cell function – which is responsible for the body’s insulin production. Subsequently, the clinical trials also showed teplizumab to make the patients less reliant on external insulin. The FDA had accorded teplizumab with Breakthrough Therapy Designation to expedite the review of the drug.

    Outlook of PRVB stock

    However, despite the downturn of the stock, market sentiment may change drastically given Provention Bio Inc.’s optimism regarding the application of teplizumab. The CEO Ashleigh Palmer remained headstrong and confident about the review and is adamant on fulfilling the further data requirements of FDA. A conference call has been scheduled by the firm to discuss the recent developments and an audio webcast will also be available on the Company’s website afterwards. Moreover, the FDA has also stated that notification does not communicate the final decision – indicating towards a possible positive outcome. The Food and Drug Administration authority has also shown willingness to discuss the additional data requirements along with the ongoing review. The fulfilment of the additional requirements will be the deciding factor in FDA’s final decision regarding teplizumab’s BLA.