Principal Clinical Data Lead

CEO Innovation policy update 10.29.26. Oct 29, 2026 MassBio CEO & President Kendalle Burlin O'Connell originally posted this update to LinkedIn: MassBio Back on the Hill: Its team was in Washington on Wednesday for meetings with the offices of Sens. Ed Markey and Elizabeth Warren and Reps. Katherine Clark and Lori Trahan, along with Rep. Morgan Griffith (R-Va.), and the Republican Study Committee. Its message was that small and emerging biotechs, which make up most of its membership and are where America's next medicines start, need funding, speed, and certainty from Washington. MassBio asked Congress to fund NIH at no less than FY2026's $48.7 billion, keep opposing OMB's proposal to let political appointees decide which science gets funded, reauthorize PDUFA on time with FDA staffing that keeps pace, and pair sound protections against China with incentives that keep U.S. companies competitive. That evening, MassBio was proud to be a sponsor of the FNIH Celebration of Science, where Cambridge-based Biogen was among this year's Charles A. Sanders, MD, Partnership Award recipients. Treasury Releases Proposed COINS Act Regulations: Last week, the Treasury Department released proposed regulations implementing the Comprehensive Outbound Investment National Security (COINS) Act, including sweeping new restrictions on U.S. investment in Chinese biotechnology. The proposal would cover a broad range of technologies, including drug development, genetic sequencing, and biomanufacturing, and could prohibit certain equity investments, financing arrangements, and joint ventures. Traditional licensing agreements generally remain outside the scope of the proposed restrictions. MassBio is reviewing the proposal closely and intends to submit comments emphasizing the importance of protecting national security without undermining U.S. biotech competitiveness or limiting opportunities to bring promising discoveries into the American drug development pipeline. MassBio welcome perspectives from member companies on potential implications for their businesses ahead of the December 7 comment deadline. Auchincloss and Griffith Unveil Bipartisan Clinical Trials Legislation: Reps. Jake Auchincloss (D-Mass.) and Morgan Griffith (R-Va.) introduced the Faster Clinical Trials Act, a bipartisan proposal aimed at reducing barriers that slow clinical research in the United States. The legislation would establish a new Center for Clinical Trial Innovation at FDA, expand clinical trial networks into community healthcare settings, streamline review of lower-risk Phase 1 trials, and encourage greater use of AI and alternative testing methods. It would also strengthen FDA's Rare Disease Innovation Hub and address common causes of clinical holds. For Massachusetts' emerging biotechs, the proposal represents a potentially significant step toward making clinical trials faster, more predictable, and easier to conduct domestically, and MassBio looks forward to working with Representatives Auchincloss and Griffith in the months ahead. FDA and CMS Announce New Steps to Advance Gene Therapies: On Tuesday, HHS announced two initiatives aimed at accelerating development and improving access to cell and gene therapies. FDA issued draft guidance establishing a more flexible approval framework for individualized genome-editing treatments, allowing multiple patient-specific variations to be covered under a single application and potentially reducing the need for additional clinical trials. Separately, CMS announced plans to expand its Cell and Gene Therapy Access Model beyond sickle cell disease, allowing more manufacturers to participate in negotiated, outcomes-based Medicaid payment arrangements. Together, the initiatives could provide greater regulatory clarity for developers of personalized therapies while addressing longstanding challenges around patient access and reimbursement. FDA Expedited IND Pilot Application Deadline Approaches: FDA's Expedited Investigational New Drug (IND) Pilot Program closes applications tomorrow, October 30. Part of Operation TrialBlazer, the pilot is designed to accelerate first-in-human clinical trials by pairing drug sponsors with qualified research institutions that can provide early regulatory and scientific support. Selected participants will be able to submit components of their IND applications on a rolling basis, potentially identifying and resolving issues earlier in development. FDA expects to select eight to ten sponsor-institution partnerships for the initial cohort. The pilot is particularly relevant to smaller biotechs seeking to reduce development timelines and navigate FDA requirements with limited internal regulatory resources. FDA Seeks Input on Rare Disease Regulatory Reform: FDA convened a public meeting Wednesday to gather stakeholder feedback on its new Rare Disease Framework Initiative. The effort seeks to establish a more flexible, disease-specific approach to regulatory review, recognizing the challenges of generating traditional clinical evidence in small patient populations. FDA is particularly interested in improving the consistency of regulatory expectations, earlier engagement with sponsors and patients, and more tailored manufacturing requirements. Public comments are being accepted through December 11.

Biogen reported 11% total revenue growth in the third quarter of 2026, boosted by its Appellis acquisition, which management says has integrated faster than expected. The growth portfolio now makes up about 63% of core pharmaceutical revenue. The company recorded $284 million in acquired IPR&D and milestone charges, mainly tied to the Baceira acquisition, which cut non-GAAP diluted earnings per share by about $1.70. It repaid $400 million of Appellis-related term loans and plans to repay the remaining $1.4 billion by the end of 2027. Biogen expects $250 million in run-rate synergies from Appellis by the end of 2027, and says 2026 dilution will be lower than first projected. Phase 3 results for systemic lupus erythematosus are due in the first half of December.

Biogen (NASDAQ: BIIB) revenue climbs 11% but deal charges push it to a GAAP loss. What happened. Biogen Inc. (NASDAQ: BIIB) reported third-quarter 2026 revenue of $2.8 billion, up 11% from a year earlier, but swung to a GAAP loss. The company blames the loss mainly on deal charges. It still raised the floor of its 2026 earnings guidance. GAAP diluted EPS was $(0.14), against $3.17 in the third quarter of 2025. The charges include $284 million of acquired in-process R&D, upfront and milestone expense, mostly for the acquisition of RayThera Inc. A year earlier the figure was $2 million. Net loss attributable to Biogen was $20.6 million, compared with net income of $466.5 million. Discover more Stock trading guide Share market analysis Financial news subscription Non-GAAP diluted EPS was $2.62, down from $4.81. That measure still includes the same acquired R&D expense. For 2026, Biogen now expects non-GAAP diluted EPS of $12.20 to $13.00, up from $12.00 to $13.00. It cited ongoing business strength and favorable dilution from the Apellis acquisition. Key numbers. Where the growth came from. The Growth Portfolio brought in $1.26 billion, up 49% and 63% of Core Pharmaceutical revenue. It includes the first full quarter of products acquired with Apellis, a deal that closed in May 2026. CEO Christopher A. Viehbacher said the results show Biogen "has returned to growth." Syfovre sales were $191 million, up 27%, and Empaveli grew 92%. Prior-period figures for both come from Apellis' own third-quarter 2025 10-Q. Established products also gained. Spinraza sold $461 million, up 23%. Biogen says conversion to a high-dose regimen continues to beat its expectations in all launched markets. Skyclarys rose 34% to $178 million on U.S. and international demand and favorable U.S. inventory dynamics. Eisai recorded global Leqembi in-market sales of $202 million, up 67%. Mature lines shrank. Multiple sclerosis revenue fell 13% to $919 million. Vumerity dropped 11% to $192 million, which Biogen says was hurt mainly by U.S. formulary dynamics. Biosimilars revenue fell 16% to $166 million. How much of the gain was acquired. Total revenue rose $269.4 million from the year-earlier quarter. Specialized immunology, which holds only Syfovre and Empaveli, brought in $242.8 million. By OptimistFi's calculation, that is 90.1% of the increase. Everything else combined added $26.6 million. Rare disease revenue rose 27% and the rest of the Growth Portfolio gained. The small remainder reflects the multiple sclerosis and biosimilars declines offsetting those gains. What pushed GAAP into a loss. GAAP R&D expense rose to $574 million from $436 million. Biogen cites higher clinical trial spending on felzartamab, salanersen and litifilimab, Apellis operating expenses, and less R&D funding from Royalty Pharma. GAAP SG&A rose to $752 million from $595 million. Biogen points to Apellis operations and higher spending on product launches. Cost of sales carried $194.8 million of amortization from the fair-value step-up of acquired inventory, tied to the Reata and Apellis acquisitions. That was up from $60.0 million. Restructuring charges were $66.5 million, up from $7.4 million. The GAAP effective tax rate was negative 128.5%. Biogen blames mainly the non-deductible acquired R&D charge on the RayThera stock acquisition. The non-GAAP rate was 20.0%. Why it matters. OptimistFi has argued that Biogen's value depends on new therapies growing fast enough to offset pressure on mature products. This quarter fits that view. Growth Portfolio revenue rose 49% while multiple sclerosis revenue fell 13%. The report strengthens the case, though most of the lift was bought rather than built. Cash generation stayed positive but weakened. Free cash flow was $600.4 million, down 51.0% from $1.23 billion in the third quarter of 2025. Operating cash flow was about $641 million. Cash and cash equivalents were $1.3 billion at Sept. 30, against $3.01 billion at Dec. 31, 2025. Net debt was $6.4 billion. Biogen expects full-year revenue to rise by a mid-single digit percentage, driven by the Growth Portfolio. It expects combined non-GAAP R&D and SG&A expense of about $4.95 billion. The guidance assumes $3.20 per share of acquired R&D charges, up from $3.00 in the July guidance. The caveats are plain. Guidance leaves out other future acquired R&D charges, acquisitions, pending and future litigation and healthcare reform. Biogen says these are hard to predict. What's next. Biogen expects top-line data from the TOPAZ-1 and TOPAZ-2 Phase 3 studies of litifilimab in SLE in the first half of December 2026. Positive results would add to the pipeline needed to offset the multiple sclerosis decline. A miss would leave growth resting on acquired products. Further Phase 3 readouts are expected for litifilimab in CLE and felzartamab in antibody mediated rejection in the first half of 2027. Zorevunersen in Dravet syndrome is expected in the third quarter of 2027. From optimistfi perps. Sources. * Biogen Reports Third Quarter 2026 Results (SEC 8-K, Exhibit 99.1) - Earnings press release dated Oct. 28, 2026, with income statement, balance sheet, non-GAAP reconciliations, guidance and pipeline timing. * SEC filing Browse every company OptimistFi covers at optimistfi.com/stocks, or read the latest evidence-first research. Originally published on OptimistFi, evidence-first equity research. More at optimistfi.com.