CEL-SCI: Fabulous Story Stock Works To Pass Muster With FDA (NYSE:CVM)

Kharchenko_irina7/iStock via Getty Images I am a long-term follower and chronicler of CEL-SCI (NYSE:CVM). My initial CEL-SCI article was 08/2019’s CEL-SCI: A Risky Bet. My most recent was 07/2023’s “Cel-Sci: Would-Be Cancer Giant Taking Baby Steps”. In this article I evaluate its investment prospects based up on its latest investor communications. These include: 10/25/2023 –…

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Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One

Shidlovski Writing about Alnylam Pharmaceuticals (NASDAQ:ALNY) a month ago, ahead of a panel meeting on the company’s application to market Onpattro for cardiomyopathy from transthyretin-mediated amyloidosis (or ATTR-CM), I said I expected to see pointed questions about the efficacy metrics that Alnylam used for its APOLLO-B study and 10% to 20% downside risk if the…

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Alnylam: Upcoming FDA Meeting Could Create Some Volatility (NASDAQ:ALNY)

Surendra Sharma/iStock via Getty Images I can’t complain too much about the performance of Alnylam Pharmaceuticals (NASDAQ:ALNY) operationally or in stock market terms since my last update on this biotech. The company has continued to deliver positive data from significant clinical programs as well as basically on-target commercial performance. With that, the shares have outperformed…

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Olympus: Experiencing Slower Growth, Cost Overruns And FDA Scrutiny (OCPNF)

romaset/iStock via Getty Images Investment thesis Olympus (OTCPK:OCPNF) is experiencing slower-than-anticipated growth and is experiencing reputational risk with the FDA over the manufacturing of its core endoscope business. We have concerns over the quality of management and believe the upcoming growth trajectory is lower than current consensus forecasts. We rate the shares as a Sell….

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Alvotech: FDA Overhang Remains, Remaining Constructive, Initiate Hold (NASDAQ:ALVO)

Matteo Colombo Investment briefing The biosimilars drug market is forecast to expand at a geometric growth rate of ~18% from 2023—2028, garnishing immense capital inflows along the way. Alvotech (NASDAQ:ALVO) is firmly positioned within the biosimilars value chain and has the potential to unlock compelling value should it successfully convert its pipeline assets. To date,…

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