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Michael Gibney

Michael Gibney is a freelance writer with more than a decade covering the biotech, pharmaceutical and healthcare industries. Most recently he served as senior writer and editor at PharmaVoice.

Light in a room through the open door; The choice between the three variants; Version with the left door; Eps10
Rare diseases
BridgeBio gears up for rare muscular dystrophy launch with FDA approval in sight
If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would be the first therapy for limb-girdle muscular dystrophy. The FDA has an action date of Nov. 27.
November 2, 2026
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6 min read
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Michael Gibney
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Pancreatic cancer
EMSO 2026: Incyte a ‘firm contender’ in G12D pancreatic cancer race as early candidate shines
In a Phase 1 study, treatment with Incyte’s KRAS G12D inhibitor in combination with standard-of-care chemotherapy elicited an 89% confirmed objective response rate in patients with a type of pancreatic ductal adenocarcinoma, leading analysts to draw comparisons with Revolution Medicines’ zoldonrasib.
October 27, 2026
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3 min read
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Michael Gibney
Rett syndrome
Neurogene, Taysha near finish line in ‘two-horse race’ for first Rett syndrome gene therapy
As both Taysha Gene Therapies and Neurogene warm up for an important year of readouts, the Rett syndrome community is hopeful of seeing a therapy that can truly change the disease’s path.
October 26, 2026
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6 min read
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Michael Gibney
Intricate vector illustration of vibrant cancer cells on a blue grid, highlighting microscopic detail.
Immuno-oncology
ESMO 2026: Marengo’s bispecific antibody shrinks 8 tumor types in Phase 2
Invikafusp alfa, a first-in-class dual T cell agonist, showed an objective response in various types of cancer, particularly among patients who did not respond to previous checkpoint inhibitor therapy.
October 23, 2026
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3 min read
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Michael Gibney
An eye and DNA
Immunology and inflammation
Roivant’s TYK2/JAK inhibitor reduces need for steroids in inflammatory eye disease
Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”
October 22, 2026
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3 min read
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Michael Gibney
Glowing neon blue and purple arrows surge upward, representing the high-speed nature of increasing market value in Finance concepts, with business graphic features jagged paths moving upward, illustrating a powerful and increasing growth trajectory.
Drug Development
Veradermics’ minoxidil pill improves hair coverage in men in Phase 3
In the wake of a successful IPO and strong stock growth throughout the year, Veradermics now has late-stage data to support a regulatory package for its hair loss pill.
October 19, 2026
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3 min read
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Michael Gibney
Chain of arrows blocks. Consistency and focus. Concept of conformism, vertical of power. Unchanging course of development. Moving forward. Education and skill growth. Building a solid strategy.
FDA
FDA’s latest rare disease framework seeks to prioritize consistency in flexibility
Following several recent initiatives, the FDA’s newest rare disease framework sets out to standardize the agency’s approach to scientific evidence and bring rare disease therapies to patients faster.
October 15, 2026
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4 min read
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Michael Gibney
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Obesity
Roche expands obesity R&D footprint with Rona deal worth $1B+
Roche has gained access to a genetic obesity approach from China’s Rona Therapeutics for up to $100 million in upfront and near-term payments.
October 13, 2026
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2 min read
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Michael Gibney
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Cancer
RevMed’s Rasonque gets a subtype data asterisk, but analysts remain bullish
Data released by the FDA show that Revolution Medicine’s newly approved pancreatic cancer drug underperformed in a large subgroup of patients, but analysts say the biotech still has a clear winner.
October 12, 2026
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3 min read
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Michael Gibney
Orientation, Businessman opens the door to welcome new employees
Pipeline
Roivant, the ‘inveterate drug hunters’, enters commercial era with Lisraya
CEO Matt Gline is juggling Roivant Sciences’ first solo drug launch and several maturing programs as the hub-and-spoke company sets its sights on a massive turning point into commercial viability.
October 5, 2026
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6 min read
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Michael Gibney
Light in a room through the open door; The choice between the three variants; Version with the left door; Eps10
Approvals
FDA nod for Mirum’s Atebrioz makes 3 options for ultra-rare bone disease
The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved Pasatru and Ipsen’s Sohonos.
September 28, 2026
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6 min read
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Michael Gibney
Targeting cancer as oncology drugs and oncologist symbol for preventing malignant tumor growth disease as a symbol for pharmaceutical science and immunology or fighting human cancers.
Cancer
Citing Replimune approval, experts say localized cancer meds could redefine care
Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but challenges remain before the method becomes a mainstay in treatment.
September 21, 2026
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4 min read
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Michael Gibney
Bridging the gap connect the path to success together, teamwork or partnership, collaboration or cooperation for winning challenge, businessman connect jigsaw puzzle as the bridge to connect the gap.
Deals
Novo notches up to $1.4B pact with Orbis to develop oral macrocycle cardiometabolic drugs
The multi-drug partnership with Orbis Medicines—which Novo Holdings has backed since the biotech’s seed rounds—is focused on cardiometabolic targets, but the technology at the center of the deal could deliver oral weight loss candidates. Obesity rival Eli Lilly has also helped fund Orbis.
September 17, 2026
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2 min read
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Michael Gibney
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Psychedelics
Stakeholders urge FDA to define data, treatment standards as psychedelic drugs near market
Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
September 15, 2026
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5 min read
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Michael Gibney
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Psychedelics
Psychedelic therapies ride wave of public favor into FDA hearing
Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.
September 14, 2026
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3 min read
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Michael Gibney