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Tag: ORPH

  • Commencement of Restructuring: Orphazyme A/S (ORPH) Stock Tumbling Aftermarket.

    Commencement of Restructuring: Orphazyme A/S (ORPH) Stock Tumbling Aftermarket.

    Orphazyme A/S (ORPH) is a global late clinical-stage biotherapeutics business engaged in the development of arimoclomol for patients with Niemann-Pick disease type C.

    The price of ORPH stock during the regular trading of March 10, 2022, was $1.26 with a gain of 5.88%. At the last of the aftermarket, the company’s stock nose-dived by 36.5%.

    ORPH: Events and Happenings

    On March 10, 2022, ORPH reported about the decision made by the company’s BoDs following the receiving of the adverse Trend Vote and because of its financial situation to file a petition for its intra-court restructuring. The company will also reduce up to 50% of its international employees.

    On February 23, 2022, ORPH updated on the review of the Marketing Authorisation Application for arimoclomol by the European Medicines Agency’s Committee for Medicinal Products. The company was informed of a negative trend vote on the MAA for arimoclomol in NPC.

    On February 18, 2022, ORPH announced the issuance of shares from February 11-17, 2022 due to the use of its US At-the-Market Offering Platform with Cowen and Company, LLC. A total of 360,000 ordinary shares each of DKK 1, represented by ADSs, had been issued and sold by Cowen at a market price in agreement with the company’s Articles of Association. On February 11, 2022, ORPH informed the press about the protocol and projected timelines for its FDA’s resubmission for NDA for arimoclomol.

    ORPH: Key Financials

    On August 31, 2021, ORPH released its interim financial statement for the first half of 2021 ended June 30, 2021. Some of the significant updates are as follows.

    Revenue

    Net revenues in H1 2021 were DKK 13.1 million compared to no revenues reported in the same period of 2020.

    EPS

    Net loss basic and diluted per share during H1 2021 was DKK 463.7 million or DKK 13.27 in comparison to DKK 251.4 million or DKK 9.77 in the same period of 2020. The company noted a considerable increase in its losses over the year.

    Conclusion

    ORPH stock was hit hard in the pandemic as its stock price dropped considerably by 90% in the last year. Currently, its stock plunged in Thursday’s aftermarket trading as the company announced the beginning of its intra-court restructuring procedures.

  • Update on Regulatory Review of Arimoclomol in EU: Orphazyme A/S (ORPH) Nosedives Pre-Market

    On February 23, Orphazyme A/S (ORPH) provided an update on the review of the Marketing Authorization Application (MAA) for arimoclomol in the European Union. With a tendency towards denial of the approval, the stock nosedived in the pre-market on Wednesday.

    The stock remained bullish with a mild gain of 1.51% during the regular trading session on Wednesday. After fluctuating between $1.97 and $2.12, ORPH closed the regular session at $2.02. The day witnessed a below-average volume of 586.47K shares. Following the negative update, the stock plunged down by 20.79% in the pre-market. Hence, ORPH stock was trading at a value of $1.60 per share in the pre-market session on Thursday. Thus, the stock marked its new 52-week low against the previous $1.82.

    The biopharmaceutical company, Orphazyme A/S has a market capitalization of $69.77 million. Its 34.95 million outstanding shares stand at a year-to-date loss of 16.18%.

    ORPH’s Arimoclomol Update

    Arimoclomol is the company’s investigational product candidate. Currently, it is under MAA review for Niemann-Pick disease type C (NPC) in the EU. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is reviewing the product. The review process is expected to convene by the end of March 2022.

    On February 17, an ad-hoc expert group meeting was held regarding the review process which encouraged the company. But on February 23, CHMP notified the company of a negative trend vote after an Oral Explanation. Therefore, the trend vote indicates that CHMP would probably not approve arimoclomol.

    As a result, the company is now evaluating its alternatives and options based on the recent update and its financial situation.

    Recent Developments

    On February 18, the company announced the issuance of new shares from February 11 to 17, 2022 under its U.S. At-the-Market Offering Program. The company has commenced the program with Cowen and Company, LLC. The company issued 360,000 ordinary shares on February 11, 2022. The new shares are expected to enter trading and official listing on Nasdaq Copenhagen by the end of this month.

    ORPH’s Upcoming 2021 Earnings

    The company will be posting its audited financial results for fiscal 2021 on March 15, 2022.

    Recently, on January 18, the company updates its financial outlook for 2021 based on a preliminary review.

    For fiscal 2021, ORPH expects net revenues between DKK 35 and 37 million, while the previous guidance was DKK 30-40 million.

    Moreover, the operating loss is expected to be DKK 630-640 million against DKK 670-700 million.

  • Arimoclomol NDA Resubmission Plan Updates: Orphazyme A/S (ORPH) Surges Premarket

    Arimoclomol NDA Resubmission Plan Updates: Orphazyme A/S (ORPH) Surges Premarket

    On February 11, Orphazyme A/S (ORPH) provided updates regarding its NDA resubmission for arimoclomol for Niemann-Pick Disease Type-C NPC). Consequently, the stock surged in the premarket on Friday.

    In the previous trading session, the stock suffered a loss of 1.45% at its closing price of $2.04. Following the announcement, the stock was trading at $2.31 per share in the premarket, at the last check. Hence, the stock had increased by 13.24% in the premarket, at the time of writing on Friday.

    The biopharmaceutical company, Orphazyme A/S has a market capitalization of $71.43 million. Currently, its 34.95 million outstanding shares stand at a year-to-date loss of 15.35%. ORPH stock had lost a value of 83.48% in the past year.

    ORPH’s NDA Resubmission Updates

    Previously, the company had submitted an NDA application for its investigational product candidate, arimoclomol for NPC. In response to the submission, FDA sent a Complete Response Letter to the company.

    In October 2021, the company had a Type A meeting with the Food and Drug Administration. In line with the recommendations during the meeting, ORPH plans to request a Type C Meeting. The purpose of the meeting is the discussion of the additional data along with certain items of the previous Complete Response Letter. Presently, the request for the Type C Meeting is expected in the second quarter of 2022. Therefore, based on the discussions and outcomes of the meeting ORPH hopes to resubmit the NDA during the second half of 2022.

    Recent Presentations

    On February 07, the company announced its participation in the 18th Annual WORLDSymposiumTM Scientific Meeting. The meeting was set to take place from February 07 to February 11, 2022. Marc Patterson, M.D. and Nikolaj Petersen, Ph.D. presented new non-clinical data on arimiclomol during the event.

    ORPH’s Executive Management Changes

    On January 31, the company announced certain changes to its executive management. The company’s CEO Christophe Bourdon will be resigning from ORPH. Mr. Bourdon will take on the role of Pharma A/S’s chief executive officer following his resignation.

    Furthermore, the company’s chief financial officer, Anders Vadsholt will be taking on the role of the new CEO, effective April 1, 2022.

    Conclusion

    In conclusion, investors seem happy with the company’s developments in the NDA resubmission timeline and updates. The good news resulted in the stock rising in the premarket. Even though the small volume in the before-hours session calls for higher volatility in the session, the stock so far seems to be on the right path.

  • Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) stock prices skyrocketed by a monumental 71.24% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$17.21 early on in the trading day.

    Meme Stock Phenomenon

    The meme stock phenomenon continues to dominate the stock exchange, with a slew of stocks being targeted for a coordinated pump by the Reddit-driven retail investors. Underdogs with a high short interests find themselves fortuitously bolstered as the community of investors continues to target companies without a logical basis for their support. In the absence of recent news or any fundamental developments, companies sometimes on the brisk of collapse find themselves renewed by the sweeping meme stock craze.

    About ORPH

    OPRH is a late-stage biopharmaceutical company that specializes in the pioneering of a heat-shock protein response, which it uses to treat neurodegenerative orphan diseases. As such, OPRH aims to develop and commercialize novel therapeutics based on the amplification of heat-shock proteins. The company’s leading drug candidate is arimoclomol.

    Arimoclomol Development

    Arimoclomol is currently in clinical development targeted at four orphan diseases: Niemann-Pick disease Type C (NPC), Amyotrophic Lateral Sclerosis (ALS), Inclusion Body Myositis (IBM) and Gaucher disease. The company is based out of Denmark, with shares of its common stock listed on the Nasdaq as an American Depositary Receipt. With some operations based on the U.S, most of the company’s operations are focused in Europe.

    Future Outlook for ORPH

    Armed with the fortuitous surge in the value of their equity, ORPH is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.