Crinetics Pharmaceuticals: Approaching PDUFA Deadline Amid Low Expectations

Crinetics Pharmaceuticals is nearing its PDUFA (Prescription Drug User Fee Act) deadline for its acromegaly drug. Despite previous expectations, the company's stock price has remained relatively stable since its last article. As a finance expert with experience at Bloomberg, I would rate Crinetics as a "Hold" given the low expectations surrounding its upcoming PDUFA deadline.

Title: Crinetics Pharmaceuticals: Low Expectations as PDUFA Deadline Looms

Crinetics Pharmaceuticals (NASDAQ:CRNX) is nearing its Prescription Drug User Fee Act (PDUFA) deadline for its acromegaly drug, PALSONIFY. Despite previous expectations, the company's stock price has remained relatively stable since its last article. As a finance expert with experience at Bloomberg, I would rate Crinetics as a "Hold" given the low expectations surrounding its upcoming PDUFA deadline.

PALSONIFY, previously known as Paltusotine (SST2 agonist), is Crinetics' lead therapy for the treatment and long-term maintenance of acromegaly in adults. The FDA has not yet provided a PDUFA date for PALSONIFY, but it is expected to be approved by September 25, 2025 [1].

Crinetics' stock price has only slightly changed since its last article, dropping by approximately 3% [1]. The company's CEO, Hammad Khan, has noted that the FDA review of PALSONIFY is proceeding as expected, and the team working on the review has not changed, ensuring continuity throughout the critical review period [1].

Acromegaly patients have a full menu of therapeutic options, including injected somatostatin analogs, oral octreotide, pegvisomant, and other approved therapies. If PALSONIFY receives FDA approval, it will be interesting to see whether it can effectively differentiate itself from its competition. Crinetics' market research suggests that health care professionals perceive PALSONIFY as the preferred therapy among newly diagnosed patients due to its rapid reduction of IGF-1 levels and its accelerated titration time frame relative to monthly injectables [1].

However, the preference of physicians is not the controlling factor. Insurance companies can limit coverage for acromegaly patients to the lowest cost choice. Crinetics has noted that formulary placement for PALSONIFY is expected to take at least 6 to 9 months after launch, and acromegaly patients see their endocrinologists relatively infrequently, approximately 2 to 4 times per year. Consequently, Crinetics does not expect a bolus of patients on drug shortly after approval and instead expects adoption to gradually ramp in line with their outreach and engagement initiatives [1].

Crinetics' cash position is strong, with $1.2 billion in cash, cash equivalents, and investments as of June 30, 2025. The company's revised guided 2025 annual cash burn range is between $340 million to $370 million, reflecting greater precision on clinical timeline estimates and prudent measures taken on overhead growth [1].

The valuation of Crinetics is a real stumper. As of September 1, 2025, the market is awarding it a market cap of $2.92 billion. Wall Street analysts see things quite differently, with 10 analysts giving a "Strong Buy" rating, 5 with "Buy", and 2 with "Hold". Their average price target is $69.38 for a 123.88% upside [1].

In conclusion, Crinetics Pharmaceuticals is nearing its PDUFA deadline for PALSONIFY, and the company's stock price has remained relatively stable. Given the low expectations surrounding its upcoming PDUFA deadline and the competitive landscape for acromegaly treatments, I would rate Crinetics as a "Hold".

References

[1] https://seekingalpha.com/article/4818837-crinetics-low-expectations-as-the-pdufa-clock-ticks-to-zero