Upcoming FDA event : IOVA, ALVO, NERV, EYEN, VNDA, MIRM, JNJ, MDGL

 The provided information outlines upcoming events and FDA decisions related to various pharmaceutical companies and their respective drugs. Here's a summary:

1. Ipsen SA (IPSEY):

   • Drug: Onivyde (sNDA)
   • Event Date: 02/13/2024
   • FDA Decision: Pending
   • Purpose: Decision on Onivyde plus NALIRIFOX regimen for expanded use in first-line treatment for metastatic pancreatic ductal adenocarcinoma.

2. Iovance Biotherapeutics, Inc. (IOVA):

   • Drug: Lifileucel (BLA)
   • Event Date: 02/24/2024
   • FDA Decision: Pending
   • Purpose: Decision on Lifileucel for patients with advanced melanoma.

3. Alvotech (ALVO):

   • Drug: AVT02 (Resubmitted BLA)
   • Event Date: 02/24/2024
   • FDA Decision: Pending
   • Purpose: Decision on AVT02, an interchangeable biosimilar candidate to Humira.

4. Minerva Neurosciences Inc (NERV):

   • Drug: Roluperidone (NDA)
   • Event Date: 02/26/2024
   • FDA Decision: Pending
   • Purpose: Decision on Roluperidone for the treatment of negative symptoms in schizophrenia.

5. EYENOVIA, INC. (EYEN):

   • Drug: APP13007 (NDA)
   • Event Date: 03/04/2024
   • FDA Decision: Pending
   • Purpose: Decision on APP13007 for the treatment of inflammation and pain following ocular surgery.

6. VANDA PHARMACEUTICALS (VNDA):

   • Drug: HETLIOZ (sNDA)
   • Event Date: 03/04/2024
   • FDA Decision: Pending
   • Purpose: Decision on the expanded use of HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation.

7. Viatris Inc. (VTRS):

   • Drug: GA Depot 40 mg (NDA)
   • Event Date: 03/08/2024
   • FDA Decision: Pending
   • Purpose: Decision on GA Depot for Relapsing Forms of Multiple Sclerosis.

8. Mirum Pharmaceuticals Inc. (MIRM):

   • Drug: LIVMARLI (sNDA)
   • Event Date: 03/13/2024
   • FDA Decision: Pending
   • Purpose: Decision on the expanded use of LIVMARLI in progressive familial intrahepatic cholestasis.

9. Johnson & Johnson (JNJ):

   • Drug: CARVYKTI (sBLA)
   • Event Date: 03/14/2024
   • FDA Panel Review: Pending
   • Purpose: FDA panel to review CARVYKTI for expanded use in treating adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

10. MADRIGAL PHARMACEUTICALS, INC. (MDGL):

• Drug: Resmetirom (NDA)
• Event Date: 03/14/2024
• FDA Decision: Pending
• Purpose: Decision on Resmetirom for the treatment of adult patients with NASH with liver fibrosis.

Please note that the information provided is based on the events and decisions mentioned, and you may want to follow up with official sources or financial experts for the latest updates and analysis.

Earning watchlist for Febraury 12 and 13th: VNO, HPP, INMD, GFS, Z, DNUT, LYFT, UPST

As the financial world gears up for the upcoming earnings season, investors are keenly observing various stocks to gauge their performance and potential market impact. Let's delve into the earnings predictions and recent trends of a diverse set of stocks:

1. VNO (Vornado Realty Trust) - Market Cap: $5.03B

   • Volatility: 3.72%
   • Earnings: Feb 12/a
   • Price: $26.45
   • Change: +0.15%

   Vornado Realty Trust, a player in the real estate sector, is set to release earnings on February 12. The moderate volatility and a slight positive change in stock price indicate a cautiously optimistic sentiment in anticipation of the earnings report.

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3. HPP (Hudson Pacific Properties) - Market Cap: $1.08B

   • Volatility: 3.97%
   • Earnings: Feb 12/a
   • Price: $7.69
   • Change: 0.00%

   Hudson Pacific Properties, another real estate contender, displays a relatively stable stock performance ahead of its earnings announcement on February 12. Investors are awaiting insights into the company's financial health and future outlook.

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5. INMD (InMode Ltd.) - Market Cap: $2.16B

   • Volatility: 3.77%
   • Earnings: Feb 13/b
   • Price: $25.96
   • Change: +2.37%

   InMode Ltd., operating in the aesthetics industry, is projected to announce earnings on February 13. The stock's positive change indicates a potential market confidence in the company's performance.

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7. GFS (G4S plc) - Market Cap: $30.95B

   • Volatility: 3.65%
   • Earnings: Feb 13/b
   • Price: $55.94
   • Change: +2.12%

   G4S plc, a multinational security services company, is scheduled to report earnings on February 13. The stock's positive change suggests investor optimism surrounding the upcoming financial results.

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9. DNUT (Krispy Kreme) - Market Cap: $2.29B

   • Volatility: 2.14%
   • Earnings: Feb 13/b
   • Price: $13.56
   • Change: +0.30%

   Krispy Kreme, renowned for its sweet treats, is expected to share its financial results on February 13. The slight positive change in stock price indicates a measured anticipation of the upcoming earnings report.

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11. Z (Zillow Group) - Market Cap: $12.84B

    • Volatility: 3.14%
    • Earnings: Feb 13/a
    • Price: $54.95
    • Change: -2.36%

    Zillow Group, a major player in online real estate, faced a negative change ahead of its February 13 earnings release. The dip suggests a degree of uncertainty or caution among investors.

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13. LYFT (Lyft Inc.) - Market Cap: $5.12B

    • Volatility: 5.39%
    • Earnings: Feb 13/a
    • Price: $13.03
    • Change: +1.96%

    Lyft Inc., a prominent ride-sharing platform, is set to unveil its earnings on February 13. The positive change in stock price indicates a potential optimism or positive sentiment leading up to the earnings report.

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15. UPST (Upstart Holdings) - Market Cap: $2.88B

    • Volatility: 6.69%
    • Earnings: Feb 13/a
    • Price: $33.90
    • Change: -1.19%

    Upstart Holdings, operating in the AI lending space, is expected to announce earnings on February 13. The relatively high volatility suggests that investors are anticipating significant movements based on the upcoming financial results.

As investors eagerly await these earnings reports, the stock market is likely to experience fluctuations, driven by the revealed financial performances and the subsequent market reactions. It's crucial for investors to stay vigilant, considering both the earnings data and broader market trends, to make informed decisions during this crucial period.