Biocryst Receives Fast Track Designation For ALK-2 Inhibitor …

(MENAFN- ValueWalk)

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) is a final clinical phase biotech firm focusing on oral drugs for the treatment of rare and serious diseases. The company was founded in 1986 and was first listed on the Nasdaq in 1994. Since listing, BCRX shares have suffered a wild cycle almost every 5 years. The cyclical nature of a clinical stage biotech company presents a variety of investment opportunities for patient investors.

Pre-market on Wednesday 8th June, BioCryst released news that the U.S. Food and Drug Administration (FDA) has issued a Fast Track designation for BCX9250 for the prevention of heterotopic ossification (HO) in patients may fibrodysplasia ossificans progressiva (FOP).

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An FDA Fast Track Assignment is a priority process granted to an organization’s newly developed treatment to expedite the review of the medication needed to treat serious conditions without any current medical solutions. Providing a fast track designation will have benefits that include: more frequent FDA meetings during development, eligibility for expedited approval, priority reviews and rolling reviews that allow section of an application to submit for review rather than wait for a full application to be reviewed.

In addition to this news, earlier in the week Tuesday, another BioCryst product named Orladeyo (berotralstat) was approved for use by regulatory authorities in Switzerland and Canada for patients 12 years of age and older. Orladeyo is an oral administration therapy used to prevent recurrent hereditary angioedema (HAE) attacks in patients.

The releases of these approvals have added support to the share price momentum that has developed since mid-May.

Earlier in May, BioCryst reported first -quarter results with the company posting a broader -than -expected EPS loss of -40 cents compared to forecasts of -36 cents. BCRX generated revenues of $ 49.9 million which is slightly less than the $ 51.5 million forecast from the street. The company finished the quarter with $ 446.8 million and spent $ 71 million on operating costs.

In outlook for the rest of 2022, management expects generate revenues of $ 250 million , following the recent strength of Orladeyo’s launch. The company also guided operating costs of between $ 440-480 million that could be affected more or less depending on the outcome of the BCX9930 program.

Fintel Platform Analysis

BCRX has taken 12th place so far this week and is currently 64th with the most securities held by retail investors on the platform. Retail ownership of BCRX has been declining over the past three months where sales were further boosted in April when BioCryst stopped enrolling for clinical trials of BCX9930.

When comparing retail interest with institutional interest with a longer perspective, it is noticeable that the level of ownership continues to grow over time regardless of price volatility. According to the Fintel platform, BioCryst has 477 institutional owners and shareholders who collectively hold 142.3 million or 76.7% of the total float. In addition, there was significant insider selling in the last quarter.

Sentiment in the options market is bullish as indicated by a put/call ratio of 0.31 . This ratio shows the total number of disclosed placement options on the market and divides it by the number of open call options. The chart provided below shows the historical institutional put/call ratio in the stock over the longer period.

Analyst Comments and Thoughts

Jonathan Wolleben from JMP Securities said the fast-track designation reflects the need for a therapeutic solution for ultra-rate pain that currently has no approved option available on the market. The company wanted the opportunity for ‘9250’ because ALK-2 mutations were found in the vast majority of FOP patients. The company reiterated its ‘market perform’ rating and $ 25 target for the stock.

Ken Cacciatore from Cowen believes only Orladeyo supports the companies ’current price target of $ 25. The company stressed that if the BCX9930 is discontinued, profitability could be earlier and higher than originally expected because it will eliminate an estimated $ 200 million in R&D spending in 2023.

BCRX has a consensus ‘overweight’ rating and an average price target of $ 17.10, indicating a ~ 57% upside to the current price.

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Article by Ben Ward, Fintel

Updated Jun 9, 2022, 4:18 pm


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