TLDR
- FDA approved Crinetics’ PALSONIFY (paltusotine) as first oral daily treatment for acromegaly
- Drug priced at $290,000 per year, higher than existing injectable treatments
- Morgan Stanley raised price target to $77 from $65, maintaining Overweight rating
- Multiple analysts upgraded targets following approval, citing broad label and unmet need
- Stock surged 26.66% on approval news despite year-to-date losses of 30.38%
Crinetics Pharmaceuticals shares jumped 26.66% Thursday following FDA approval of PALSONIFY, the company’s oral treatment for acromegaly. The approval marks a major milestone for the biotech company, which has struggled this year with shares down 30.38% year-to-date.
PALSONIFY represents the first once-daily oral treatment option for acromegaly patients. The drug offers an alternative to current injectable therapies that dominate the market.
The FDA granted the treatment a broad label for acromegaly patients. This wide approval allows the drug to address various patient segments within the acromegaly population.
Crinetics set the wholesale acquisition cost at $290,000 annually. This pricing exceeds current standard injectable treatments in the market.
The premium pricing reflects the drug’s differentiated profile as an oral option. Patients currently rely on injectable treatments that require more complex administration.
Analyst Response and Price Target Updates
Morgan Stanley led the analyst upgrade wave by raising its price target to $77 from $65. The investment bank maintained its Overweight rating on the stock.
The firm cited the higher-than-expected list price and broad label as key factors. Morgan Stanley expects a measured launch ramp rather than immediate sales surge.
Jones Trading boosted its target from $65 to $85 while maintaining a Buy rating. H.C. Wainwright set an $81 price target, emphasizing the drug’s unique market position.
Cantor Fitzgerald maintained an Overweight rating with a $90 target. The firm updated its financial model to reflect the premium pricing structure.
Stifel reiterated its Buy rating with a $58 target. The firm highlighted the drug’s clean label that aligns with post-surgery care standards.
Market Position and Treatment Landscape
PALSONIFY addresses what analysts call an unmet need in acromegaly treatment. Current therapies require injection administration, creating patient compliance challenges.
The oral format could improve patient adherence compared to injectable options. This convenience factor may drive adoption across different patient segments.
Oppenheimer noted the approval as a major milestone for acromegaly treatment options. The firm maintained its Outperform rating following the FDA decision.
Crinetics currently holds a market cap of $3.31 billion. The company’s average trading volume stands at 1.07 million shares.
The stock trades with a technical Buy signal despite year-to-date declines. Thursday’s surge brought renewed investor interest to the biotech name.
Analysts expect a gradual market uptake for PALSONIFY rather than immediate adoption. The measured launch approach reflects typical patterns for specialty pharmaceutical products.
The approval positions Crinetics to compete in the established acromegaly market. The company now holds the only oral daily treatment option available to patients and physicians.
Morgan Stanley’s price target increase represents an 18.5% jump from its previous forecast. The new target sits within the analyst range of $35 to $143 per share.
