BioCryst Pharmaceuticals Goes Ahead with FDA Marketing Application

BioCryst Pharmaceuticals (BCRX) reported that the FDA has accepted its marketing application for review. The application pertains to its drug candidate Berotralstat designed to prevent hereditary angioedema attacks. The PDUFA date for the drug has been set at December 3, 2020. According to the NDA filing acceptance letter issued by the FDA, the agency is not planning to hold any advisory committee meeting for discussing the NDA.

Earlier this month, the company had submitted a new drug application for Berotralstat with the Japanese Pharmaceuticals and Medical Devices Agency. Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial said, “The data from APeX-J and the berotralstat clinical program are very exciting for HAE patients in Japan. Based on the clinical benefit observed in patients in APeX-J, I expect many patients in Japan will want to use this new treatment, once it becomes available.” The company is looking forward to receive the verdict during the latter half of this year.

BioCryst Pharmaceuticals is engaged in discovering and developing oral small molecule medicines for treating rare diseases. The pharma company has strong pipeline with several drug candidates under process. The prominent ones include Berotralstat which is an oral treatment for hereditary angioedema and BCX 9930 which is an oral Factor D inhibitor for treating complement mediated diseases. Apart from these, the company is also working on BCX9250, which is an oral ALK-2 inhibitor for treatment of Fibrodysplasia Ossificans Progressiva and BCX4430 (galidesivir), a broad-spectrum antiviral for hemorrhagic fevers.

Currently, the pharma company has only one approved product which is Rapivab, a viral neuraminidase inhibitor for the treatment of influenza. The product has been approved in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union.

BioCryst Pharmaceuticals stock has shown choppy performance in the market. Mid-2019, the stock dipped sharply despite posting positive results for its Phase 3 study APeX-2. The trial was designed to evaluate oral BCX7353, which is a selective inhibitor of plasma kallikrein for preventing hereditary angioedema attacks. The trial met its primary endpoint related to the rate of investigator-confirmed angioedema attacks over 24 weeks of study drug administration.

Both the dose levels of 110mg and 150mg met the primary endpoints where the former dosage reduced the HAE attack rate by 30 percent compared to placebo and the latter reduced the attack rate by 44 percent. BCX7353 has the potential of being the first oral treatment option for HAE.

However, the stock is expected to show some positive moves as the company plans to report its fourth quarter and full year results on March 5, 2020. The company expects its net operating cash use to be in the range of $105 to $130 million. The operating expenses for the year will likely be in the range of $120 and $145 million.

For its third quarter, the company had reported its revenue at $1.8 million, up from $1.5 million it had reported for the corresponding quarter of the previous year. Its research and development expenses for the third quarter stood at $25.1 million, up from $22 million it had spent during the third quarter of the previous year. Its net loss for the quarter was reported at $37.6 million.

Co-Diagnostics Files Application for CE Mark for Coronavirus Test

Co-Diagnostics (CODX) reported that it has completed the process of application for gaining CE Mark certification for its Logix Smart COVID 19 Test. The technical file has been presented to the European Community for registration purpose. It is expected that the Test platform will be available in the markets which accept a CE marking as valid regulatory approval. The test is expected to be out in the markets by the end of this month as an in vitro diagnostic kit.

Dwight Egan, CEO of Co-Diagnostics, said, “We are pleased to announce this milestone, which comes after weeks of hard work by our team at Co-Diagnostics to develop a high-performance diagnostic to help prevent the spread of the new strain of coronavirus.” The test kit is claimed to have several benefits over regular tests. The company claims that its patented CoPrimer molecules are better capable of reducing the risk of false positive results in comparison to other polymerase chain reaction technologies. Further, the test also provides for enhanced multiplexing which helps in identifying different targets simultaneously as the company works towards making the test kit to identify other mutations of COVID 19 and strains of coronavirus.

The test kit is based on CoPrimer technology and works by detecting the presence of RNA of the novel strain of coronavirus. Its real time RT PCR kit which focuses on conserved regions in the virus genome. The company has included a description of the test to support conformance to the CE marking standards in the application submitted for the approval purpose. It is expected that the registration process will likely be completed by the end of this month. The sales process will likely start soon after the approval obtained.

Co-Diagnostics is a molecular diagnostics company and focuses on developing and marketing novel diagnostics technologies. In the past 12 months, the company stock has gained over 250 percent in the market.

Allergan Sued by Emsculpt’s BTL Industries

Allergan (AGN) has been hit by a lawsuit filed by privately held BTL Industries. The lawsuit pertains to the company’s body contouring treatment CoolTone and holds Allergan responsible for its “deceptive” advertising. BTL has its Emsculpt product in the market in direct competition with CoolTone. The company is seeking cash compensation from Allergan including all profits derived from its “wrongful acts.” Allergan and BTL have been embroiled in previous legal altercations as well.

BTL is also seeking a moratorium on the company’s claim that CoolTone has 50 percent more magnetic intensity than its “competitor device”. It is also disputing the implication that magnetic intensity is a direct measure of efficiency. Filip Donner, Director of BTL Industries said, “Long before bringing their product to the market, Allergan knowingly made false, deceptive, and misleading descriptions of fact concerning the nature, characteristics, and qualities of the EMSCULPT device as compared to their product.” Earlier, BTL had slapped another lawsuit against Allergan claiming that the company had infringed its patents.

CoolTone was approved by the FDA in July, 2019 and is designed to tone and strengthen muscles. The device uses magnetic muscle stimulation for this purpose, which involves sending electromagnetic waves into muscles for causing involuntary contractions. The FDA approval pertains to the use of device for toning muscles in three body areas which are thighs, butt and abs.

Allergan is currently in the process of finalizing its takeover by AbbVie. The deal has been widely opposed by regulators and other stakeholders. The acquisition will likely result in the halt of development of Allergan’s drug candidate brazikumab. The deal has been valued at $63 billion and is expected to help AbbVie diversify its portfolio.

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