Orphazyme A/S

Orphazyme A/S is a biopharmaceutical company, which engages in the development of treatment for patients living with life-threatening and debilitating rare diseases. It provides Arimoclomol program and molecular entities program. The company was founded by Anders Morkeberg Hinsby, Marja Jaattela, Martin Rahbek Kornum, and Thomas Kirkegaard Jensen in 2009 and is headquartered in Copenhagen, Denmark.

Strategic Partners A/S is a biopharmaceutical company, which engages in the research and development of treatments for rare diseases. It provides Arimoclomol program and molecular entities program. The company was founded by Anders Morkeberg Hinsby, Marja Jaattela, Martin Rahbek Kornum, and Thomas Kirkegaard Jensen in 2009 and is headquartered in Copenhagen, Denmark.

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Orphazyme A/S (NASDAQ: ORPH) plans an approximate two-thirds reduction in its global workforce due to a restructuring, aiming to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C (NPC). The company further said it remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. after being hit by a Complete Response Letter from the FDA last week.

Orphazyme To Cut Two-Third Workforce Under Restructuring; Reaffirms FY21 Outlook

Orphazyme A/SCompany announcement        No. 21/2021Company Registration No. 32266355

Orphazyme presents 36-month data supporting durable response to arimoclomol during Parseghian Scientific Conference for NPC Research

Copenhagen – June 28, 2021 – Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C (NPC). The resulting cost savings include an approximate two thirds reduction in our global workforce. Orphazyme remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. following receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on June 17, 2021.

Orphazyme announces restructuring to focus resources on supporting a path forward for arimoclomol in NPC

Goldman Sachs upped its stake in the drugmaker -- but only briefly.

Why Orphazyme Stock Skyrocketed 24.6% Today

Today's massive upward move in ORPH stock appears to be the result of a disclosed stake in the company of more than 5% from Goldman Sachs. The post ORPH Stock: Why Orphazyme Is Gaining Today Despite FDA Disappointment appeared first on InvestorPlace.

ORPH Stock: Why Orphazyme Is Gaining Today Despite FDA Disappointment

The bank held a greater than 5% stake on June 16, before dropping below that threshold the next day.

Goldman Sachs bought into the meteoric rise of a Danish biotech stock that became a meme last week - then sold

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Entera Bio Ltd. (NASDAQ: ENTX), Orphazyme A/S (NASDAQ: ORPH) and Bellerophon Therapeutics, Inc. (NASDAQ: BLPH) are among the biggest biopharma movers Wednesday.

Why Entera Bio, Orphazyme, Bellerophon Are Moving Today

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ORPH stock, a play on Niemann-Pick disease, generated big headlines for its even bigger price action. But you want to do some serious due diligence before gambling on this biotech stock.

Assess Biotech Landscape Hazards Before Trading Orphazyme Stock

Here's what many investors missed during this biotech stock's recent run-up.

This Is How You Could Have Anticipated Orphazyme's Implosion

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (OTCQB: CYTR) ("CytRx"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ: ORPH) ("Orphazyme") announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treat

CytRx Notes Orphazyme's Regulatory Update from the FDA on Arimoclomol for Niemann-Pick Disease Type C

The FDA didn't deliver the approval decision investors were expecting.

Here's Why Orphazyme Stock Is Imploding Today

Orphazyme A S ADR (NASDAQ:ORPH) shares are trading lower by 42% at $8.41 Friday morning after the company announced it received a Complete Response Letter from the FDA for its treatment for Niemann-Pick Disease Type C and also cut its FY2021 outlook. See Also: Orphazyme Wild Party At Risk As FDA Rejects Its Rare Neurodegenerative Disease Drug

ORPH Stock Price Falls Over 40%: Why It Happened

The shares of Orphazyme A S ADR (NASDAQ:ORPH) are dramatically lower this morning, slammed by news that the Food and Drug Administration (FDA) rejected the firm's experimental genetic disorder drug candidate, arimoclomol.

ORPH Falls From Speculative Surge After FDA Rejection

ORPH stock is taking a plunge on Friday after the FDA told Orphazyme it needed more data on its lead drug candidate. The post ORPH Stock: The FDA News That Has Orphazyme Plunging Today appeared first on InvestorPlace.

ORPH Stock: The FDA News That Has Orphazyme Plunging Today

Shares of Orphazyme A/S plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it received a "Complete Response Letter" (CRL) from the U.S. Food and Drug Administration regarding its treatment for Niemann-Pick disease type C (NPC). The CRL said additional qualitative and quantitative evidence was needed to substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and the swallow domain, as well as additional data to confirm evidence beyond the single Phase 2/3 trial supporting the benefit-risk assessment of the New Drug Application (NDA).

Orphazyme stock plunges after receiving CRL from FDA after review of NPC treatment

Orphazyme A/S (NASDAQ: ORPH) shares, which have been extremely volatile of late, could come under pressure Friday following a regulatory setback. What Happened:  Denmark-based Orphazyme said its new drug application, seeking approval for arimoclomol as a treatment option for Niemann-Pick disease type C (NPC), was turned down with a complete response letter.

Orphazyme Wild Party At Risk As FDA Rejects Its Rare Neurodegenerative Disease Drug

The stock price of Orphazyme A S ADR (NASDAQ: ORPH) fell by over 55% pre-market. This is why it happened.

ORPH Stock Price Falls Over 55% Pre-Market: Why It Happened

(Reuters) -Orphazyme slashed its financial forecasts on Friday after U.S. health regulators rejected its key drug candidate, sending shares in Denmark's first so-called meme stock tumbling 75% in early trading.

Danish 'meme stock' Orphazyme plunges after drug setback

Orphazyme A/SCompany announcement        No. 16/2021Inside informationCompany Registration No. 32266355

Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C

A sign there could be a buyout offer on the table sent this volatile biotech stock through the roof today.

Here's Why Orphazyme Shares Rocketed Higher on Wednesday

The stock price of Orphazyme A S (NASDAQ: ORPH) increased by over 80% today. This is why it happened.

ORPH Stock Price Increases Over 80%: Why It Happened

Up nearly 90% today, meme stock Orphazyme is trading at sky high volume just one day ahead of an FDA review for its key drug candidate. The post ORPH Stock: What to Know as Orphazyme Pops Again Ahead of June 17 Catalyst appeared first on InvestorPlace.

ORPH Stock: What to Know as Orphazyme Pops Again Ahead of June 17 Catalyst

After sobering down in the past three sessions, shares of Danish biopharma Orphazyme A/S (NASDAQ: ORPH) have taken off yet again. The Curious Case of The ‘Orphazyme Rally:' Orphazyme became the latest muse of retail traders, who pushed the stock to an all-time intra-day high of $77.77 last Thursday.

News for Orphazyme A/S Stock (ORPH)