PolyPidPYPD
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FDA accepted NDA with Priority Review, shortening timeline and triggering milestone payment.
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Azurity PharmaceuticalsPrivate▲ Positive
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Milestone payment triggered, but Azurity is the commercialization partner, not the subject.
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Ultragenyx Wins FDA Approval for FAYUVI, First Sanfilippo Type A Treatment
Ultragenyx Pharmaceutical received full U.S. FDA approval in September 2026 for FAYUVI, also known as UX111, the first-ever treatment for pediatric patients with Sanfilippo syndrome Type A, a previously untreated ultra-rare and fatal neurodegenerative disease. The approval came with a Priority Review Voucher and expands Ultragenyx's commercial gene therapy portfolio and U.S. manufacturing footprint. The FAYUVI clearance follows the accelerated FDA approval of GENGLYCOS, also known as DTX401, for GSDIa in August 2026, giving the company two new gene therapies approved within weeks, each generating its own Priority Review Voucher. Ultragenyx's investment narrative projects $1.2 billion in revenue and $43.8 million in earnings by 2029, with a $27.00 fair value estimate implying 86% upside to the current price. The company's biggest immediate risk remains high cash burn and potential dilution if launches underperform or costs do not come down, with adoption, reimbursement and scaling of the new therapies shaping whether it can move closer to its 2027 profitability goal.
BioMarin Reports Positive Phase 3 VOXZOGO Hypochondroplasia Data and Files sNDA
BioMarin Pharmaceutical reported positive Phase 3 CANOPY-HCH-3 results for VOXZOGO in children with hypochondroplasia and submitted a supplemental FDA application to expand the drug's use, while also adding Bristol Myers Squibb research leader Robert Plenge, M.D., Ph.D., to its Board and Science and Technology Committee. The late-stage data cover an indication with no approved treatments, and the company said the combination of the results and the board appointment underscores its focus on deepening its rare disease franchise and scientific oversight. BioMarin's narrative projects $5.0 billion revenue and $1.3 billion earnings by 2029, requiring 14.0% yearly revenue growth and about a $1.2 billion earnings increase from $73.0 million today, with a $91.42 fair value cited, a 43% upside to its current price. More pessimistic analysts warn that heavy reliance on a few rare disease drugs and uncertainty around future indications could leave BioMarin short of pre-news expectations of about US$4.7 billion in revenue and roughly US$509.5 million in earnings by 2029.
ChemoMetec Posts Record DKK511 Million Revenue, Guides FY26/27 to DKK545-575 Million
ChemoMetec reported record revenue of DKK511 million for its Q4 2026 fiscal year, up 3% year over year and 7% at constant exchange rates, with EBITDA rising 9% to DKK281 million and the EBITDA margin expanding to 55% from 52.1%. Instrument revenue grew 13% on the strength of XM products including NC-203, whose revenue jumped to DKK68.1 million from DKK27.7 million a year earlier, while the life science business, representing 95% of group revenue, grew 6% to approximately DKK485 million. Consumables revenue fell 4% on the US federal government shutdown in fall 2025, US and Canada revenue slipped 6% in reported terms, and the animal semen, beer and milk business dropped 32% amid a continued market exit. The company repurchased 105,000 shares at year-end for about DKK39 million and roughly 206,600 shares, or 1.2% of share capital, as of the call date, and ended with a cash position of approximately DKK290 million and equity of approximately DKK725 million. For FY2026/27, ChemoMetec guided revenue to DKK545 million to DKK575 million, implying roughly 7% to 13% growth, EBITDA to DKK300 million to DKK330 million, and CapEx to approximately DKK120 million, with CEO Martin Behrens saying the outlook excludes any contribution from the Roche, Tecan and Hamilton collaborations and from delayed XM orders.