Replimune Gets 33% Price Target Bump Ahead Of Upcoming Readouts

 

• BMO Capital Markets raised the price target on Replimune Group Inc 
  REPL+5.32%+ Free Alerts
   to $40 from $30 on a bullish view into upcoming data readouts for lead asset RP1 in melanoma and cutaneous squamous cell carcinoma (CSCC).
• The analyst says robust safety and clinical benefit would give confidence in RP1 in earlier lines of treatment and earlier assets, RP2 and RP3. 
• The analyst expects RP2 updates later this year for the monotherapy and RP2+Opdivo combo. RP3+Opdivo combo initial data is also expected later in 2022.
• RP1 data demonstrates superiority over Amgen Inc’s 
  AMGN-0.26%+ Free Alerts
   Imlygic (approved in 2015 for r/r melanoma, $67M revs 2021), and broader adoption and commercial success are expected.
• Early combo data in CSCC showed 64% ORR, with a CR of 47.1%. This is a meaningful improvement vs. PD1i monotherapy (Libtayo 47% ORR and 4% CR; Keytruda 34% ORR and 4% CR; Opdivo 55% ORR and 0% CR), the analyst says.
• Last year, Replimune obtained a $200 million non-dilutive term loan facility from Hercules Capital Inc 
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  .
• This non-dilutive capital extends the cash runway into 2025.

https://www.benzinga.com/general/biotech/22/10/29272033/replimune-gets-33-price-target-bump-ahead-of-upcoming-readouts-analyst-lists-the-catalysts

'Students flailing' on Adderall shortage

 The Food and Drug Administration on Wednesday confirmed what many Americans had already discovered the hard way: The country is experiencing a nationwide shortage of Adderall, the drug used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.  

The FDA said the shortage of "amphetamine mixed salts" -- the drug behind the brand name -- is driven in large part by manufacturing delays at the largest manufacturer: Israel-based Teva Pharmaceuticals. 

Teva said the problems arose out of labor shortages that have been resolved. However, the shortage persists, and the end isn't imminent: A Teva spokesperson told NBC News that patients should expect "inventory recovery in the coming months" and "intermittent delays through end of year." 

Teva's competitors aren't able to pick up the slack. "Other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers," the FDA said in its public notice. 

The shortage affects the immediate-release variety of the drug. The FDA encouraged patients to work with their health care professionals to explore alternative therapies, including the extended-release version of the medicine.

Dr. Gabrielle Shapiro, a psychiatrist and a professor at the Icahn School of Medicine at Mount Sinai in New York, tells NBC the shortage is taking a real toll, particularly on school-age patients: 

“Parents are panicked. Their children are being sent home from school or told they cannot come back if they are not on their meds. I have high school students that are trying to take their SATs and do their applications for college, and they can’t focus. They can’t get them done.”

Meanwhile, government regulation of the drug -- which can be prone to abuse -- adds more hurdles for those who take it...like Emily Hoffman, who uses multiple pharmacies to find one who has an inventory: 

“The fact that it’s controlled means you can’t ask for the prescription early. I have to call when I’m down to my last pill or two.”

Perhaps driven by Covid lockdown-driven mental health issues and children's difficulty in focusing in disastrous "remote schooling" arrangements imposed by public health officials and teacher unions, use of the drug has soared: Up 16% from 2019 to 2021, to reach 41.2 million prescriptions.

https://www.zerohedge.com/medical/fda-confirms-major-adderall-shortage-wont-end-soon