BCRX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• In May 2026, we presented new real-world evidence underscoring the ongoing burden of pediatric HAE, with studies highlighting the significant healthcare and quality-of-life burden associated with HAE in pediatric patients and their caregivers. In addition, on June 12, 2026, we announced that new cli…

• We announced on August 5, 2026 that initial product shipments of ORLADEYO oral pellets to pediatric patients began the week of August 3, marking a new paradigm in the treatment of HAE in pediatrics. In addition, to support the growing scale of ORLADEYO across both adults and pediatrics, we have enga…

• On May 4, 2026, we announced that we entered into a licensing agreement granting an Irish affiliate of Neopharmed Gentili S.p.A. (“Neopharmed”) exclusive rights to commercialize navenibart for HAE in Europe (the “Neopharmed License Agreement”). We received upfront consideration of $70.0 million and …

• On May 6, 2026, we announced that patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart for the prophylaxis of HAE, was on track to be completed by the end of June 2026. On June 29, 2026, we announced that enrollment was completed in June 2026, putting navenibart on track to pot…

• On June 12, 2026, we announced that a post-hoc analysis of the Phase 1b/2 multicenter, dose-ranging, open-label ALPHA-STAR study of navenibart demonstrated that investigational navenibart consistently reduced HAE attack rates across patient subgroups, supporting the ongoing Phase 3 evaluation of nav…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• Pursuant to the Merger, on the Closing Date, we acquired STAR-0310, which is a monoclonal antibody OX40 antagonist that incorporates YTE half-life extension technology for the treatment of atopic dermatitis (“AD”) and potentially other indications. STAR-0310 was designed as a potentially best-in-cla…

• On February 26, 2026, we announced that new positive, interim results from the long‑term, open‑label ALPHA‑SOLAR trial show sustained, robust HAE attack suppression with navenibart administered every three and six months. In addition, we announced on May 6, 2026 that patient enrollment in ALPHA-ORBI…

• On May 4, 2026, we announced that we entered into a licensing agreement granting an Irish affiliate of Neopharmed Gentili S.p.A. (“Neopharmed”) exclusive rights to commercialize navenibart for HAE in Europe. We received upfront consideration of $70.0 million and will be eligible to receive up to $27…

• On May 6, 2026, we announced that we have begun dosing in Part 4 of a Phase 1 trial of BCX17725 for the treatment of Netherton syndrome, which will enroll up to 12 patients for three months.

• In the first quarter of 2026, we ended development of avoralstat, a plasma kallikrein inhibitor for the treatment of diabetic macular edema, to focus our pipeline on rare diseases.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn on our portfolio, changes in the market value due to changes in interest rates and other market factors, as well as the increase or decrease in any re…

• Inflation generally impacts us by potentially increasing our operating expenses, including cost of product sales, clinical trial costs and selling activities. We do not believe that inflation has had a material impact on our business or

• results of operations during the periods for which the condensed consolidated financial statements are presented in this report. Significant adverse changes in inflation could negatively impact our future results of operations.

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn on our portfolio, changes in the market value due to changes in interest rates and other

• market factors, as well as the increase or decrease in any realized gains and losses. Our investment portfolio includes only marketable securities and instruments with active secondary or resale markets to help ensure portfolio liquidity. A hypothetical 100 basis point increase or decrease in intere…

• We do not anticipate that foreign currency transaction gains or losses will be significant at our current level of operations. We have not engaged in foreign currency hedging during the three months ended March 31, 2026; however, we may do so in the future.

• Inflation generally impacts us by potentially increasing our operating expenses, including cost of product sales, clinical trial costs and selling activities. We do not believe that inflation has had a material impact on our business or results of operations during the periods for which the condense…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• Because of the numerous risks and uncertainties associated with developing or acquiring product candidates, launching new products, and their potential for commercialization, we are unable to predict the extent of any potential

• future losses. Even though we have achieved profitability in a given reporting period, we may not be able to sustain or increase profitability on a quarterly or annual basis. For example, as a result of the accounting treatment for the Merger, we recorded a net loss on a U.S. GAAP basis for the quar…

• The anticipated benefits and synergies of the Merger may not be realized, and risks associated with Astria’s business or product candidates could adversely affect our business, financial results and the market price of our common stock.

• The success of the Merger depends, in part, on our ability to integrate Astria into our business and realize the anticipated benefits, cost savings and synergies of the transaction. While we have generally completed the integration of Astria with our business, those benefits may not be realized full…

• Although we conducted due diligence on Astria before completing the Merger, we may not yet be aware of all material risks, liabilities or challenges associated with Astria’s business or product candidates (in particular, navenibart). Unexpected risks may arise, and previously known risks may materia…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• Because of the numerous risks and uncertainties associated with developing or acquiring product candidates, launching new products, and their potential for commercialization, we are unable to predict the extent of any potential future losses. Even though we have achieved profitability in a given rep…

• If the benefits of the Merger do not meet the expectations of investors or securities analysts, the market price of our common stock may decline.

• The market price of our common stock may decline as a result of the Merger if we do not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial analysts or investors or if the effect of the Merger on our financial results is not consistent with the expectati…

• Combining Astria with our business may be more difficult, costly or time consuming than expected and the combined company may fail to realize the anticipated benefits and synergies of the Merger.

• The success of the Merger will depend, in part, on the ability to realize the anticipated benefits, and cost savings from combining our business and Astria’s business. To realize the anticipated benefits and synergies from the Merger, we must successfully integrate and combine our businesses in a ma…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• Until February 26, 2027, or such earlier date upon which all transactions are completed or the plan is terminated

• Until December 31, 2027, or such earlier date upon which all transactions are completed or the plan is terminated

• (1) This trading plan provides for the sale of up to (i) 151,868 shares of common stock underlying stock options and (ii) 64,738 shares of common stock underlying restricted stock units, net of shares withheld to cover taxes.

• (2) This trading plan provides for the sale of up to 800,000 shares of common stock underlying stock options expiring in 2027.