BioCryst Pharmaceuticals Inc - BCRX STOCK NEWS

BioCryst Pharmaceuticals (BCRX) has announced that Health Canada and Swissmedic have accepted the submission for ORLADEYO (berotralstat) for reviewing its potential to prevent recurrent attacks in patients with hereditary angioedema (HAE) aged 12 and older. This marks a significant milestone in the company's efforts to provide a targeted oral therapy for HAE patients, as no such therapies currently exist in these regions. CEO Jon Stonehouse emphasizes that approval could introduce an essential treatment option for patients and physicians in Canada and Switzerland.

BioCryst Pharmaceuticals (BCRX) has withdrawn its proposed public offering due to unfavorable market conditions. The company expressed confidence in its strong balance sheet, reporting $222.8 million in liquid assets as of June 30, 2021. With continued revenue growth from ORLADEYO®, BioCryst anticipates a cash runway extending into 2023 and the ability to leverage an additional $75 million from its credit facility. The firm remains focused on developing treatments for rare diseases while maintaining a strong financial position to support its ongoing projects.

BioCryst Pharmaceuticals (BCRX) announced a public offering to sell $200 million of its common stock and pre-funded warrants. The underwriters will have a 30-day option to purchase an additional 15% of the offering. Proceeds will support general corporate purposes, including development of ORLADEYO and BCX9930 for rare diseases, among other pipeline projects. The offering is contingent on market conditions and follows an effective shelf registration statement with the SEC.

BioCryst Pharmaceuticals reported $50.0 million in revenue for Q2 2021, up from $2.9 million a year earlier. The company's ORLADEYO (berotralstat) generated $28.5 million in net revenue, driven by a strong launch and increased patient access. Financial results included a $15 million milestone payment from a Japanese partner, while R&D expenses rose to $52.9 million. Despite growing revenues, the company reported a net loss of $43.2 million and does not provide detailed guidance for 2021. Cash and investments totaled $222.8 million.

BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options for 12 new employees, totaling 222,500 shares. The options were issued on July 30, 2021, with an exercise price of $16.12, equal to the closing stock price on that date. Options will vest in equal annual installments over four years, contingent on the employees' continued service. This action follows Nasdaq Listing Rule 5635(c)(4), aimed at enhancing employee incentives and aligning their interests with shareholders.

BioCryst Pharmaceuticals (BCRX) has appointed Vincent Milano, a leader in hereditary angioedema (HAE) and rare diseases, to its board of directors. Milano brings extensive experience from his tenure as CEO of Idera Pharmaceuticals and ViroPharma, where he successfully launched the HAE treatment, Cinryze. His appointment is expected to enhance BioCryst's strategic direction, especially in commercializing its oral HAE treatment, ORLADEYO, and advancing its pipeline products, including BCX9930. The company focuses on developing innovative therapies for rare diseases.

BioCryst Pharmaceuticals (BCRX) will report its Q2 2021 financial results on August 5, 2021. The conference call at 8:30 a.m. ET will provide insights into the company's performance and future outlook. BioCryst is known for its development of oral medicines for rare diseases, including ORLADEYO for HAE prevention. The company also has ongoing projects like BCX9930 for complement-mediated diseases and galidesivir for Marburg virus treatment, showcasing a strong commitment to addressing significant medical needs.

BioCryst Pharmaceuticals (BCRX) announces pivotal trials REDEEM-1 and REDEEM-2 for its oral Factor D inhibitor, BCX9930, targeting paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 will compare BCX9930 monotherapy to C5 inhibitors, while REDEEM-2 will evaluate BCX9930 against placebo in treatment-naïve patients. Primary endpoint: change in hemoglobin over 12-24 weeks. Both trials begin patient enrollment in H2 2021. Previous trials showed BCX9930 increased hemoglobin by 3.2 g/dL and was well-tolerated. FDA granted Fast Track and Orphan Drug Designation for BCX9930.

BioCryst Pharmaceuticals (BCRX) announced significant findings from the APeX-2 trial for ORLADEYO (berotralstat), demonstrating an 80% average reduction in monthly hereditary angioedema (HAE) attacks. The treatment was well-tolerated, with 81% of patients completing the trial. Additional presentations at the EAACI Congress revealed a 78-85% reduction in the use of on-demand medications for patients with significant attack rate reductions. Long-term data underscores the drug's efficacy and safety, crucial for patient demand as therapy shifts from injectables to oral solutions.