1. Scrip
  2. >>Business
  3. >>Stock Watch

Stock Watch: Digging Holes And Clutching At Straws In Biotech R&D

Tenacity Is Not Always A Virtue

 
• By Andy Smith

Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.

Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

It was once suggested to me by an investor in resources that investing in biotech is very similar to investing in mining. No matter how good the geological survey (or clinical trial protocol), you may still end up with a worthless hole in the ground. Furthermore, when faced with challenges, biotechs tend to be tenacious – or, in the spirit of the gold rush, keep on digging until the money runs out.

The early August complete response letter (CRL) for ACADIA Pharmaceuticals Inc.’s supplementary new drug application (sNDA) to expand its only approved drug Nuplazid (pimavanserin) from Parkinson’s disease psychosis (PDP) to the much larger Alzheimer’s disease psychosis (ADP) indication resulted in Acadia’s CEO being “disappointed with this outcome

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Stock Watch

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By Andy Smith

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

Stock Watch: Market Optimism Outshines Q1 Currency And Tariff Woes

 
• By Andy Smith

The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.

Stock Watch: Sanofi, Merck Open Windows Into Geopolitical Risks

 
• By Andy Smith

First-quarter results season featured tariff talk but without any full-year quantitation. As tariffs and foreign exchange movements bump up against capped drug prices, profitability could suffer.

Stock Watch: Dollar Weakness, Tariffs, Biosimilars In J&J’s Q1 Mix

 
• By Andy Smith

Announcing increased full-year earnings guidance and another dividend increase, Johnson & Johnson’s stock price weakened, outweighed by concerns about the replacement of Stelara revenues and possible drug import tariffs.

More from Business

Merck KGaA Braces For Volatility But Does Not Expect Europe To Budge On Pricing

 
• By Andrew McConaghie

Shares are hit as German conglomerate lowers revenue forecast.

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.