Daily Bio News Summary — 2026-09-28: A Parkinson's approval, a $2B KRAS deal and a BARDA antifungal bet

A Monday harvest produced 14 items from five free sources: Fierce Biotech (6), PR Newswire FDA (3), Pharmaphorum (3), BioSpace (1) and Fierce Pharma (1), all published Sept. 27–28. Every item cited below comes from the harvested frontmatter — where a headline or deck carries a specific figure, that figure is quoted as the source framed it, and nothing beyond it is asserted.

The batch divides into four clusters: FDA decisions on both sides of the ledger, a run of cross-border dealmaking that leans heavily on China and Japan, three clinical readouts, and a pair of access-and-funding items.

FDA decisions: one approval, one tentative approval, one withdrawal

AbbVie collected the day’s marquee regulatory win. The PR Newswire FDA feed carries the company’s announcement that the FDA approved JUVMO (tavapadon) for Parkinson’s disease, described in the release as “the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease.” The release says the once-daily tablet is taken with or without levodopa and is supported by the Phase 3 TEMPO programme (PR Newswire FDA, 2026-09-28). This is the same approval the Endpoints News feed surfaced on Sept. 26 — that version sat behind the site’s soft paywall, so today’s free, primary-source item is what carries the story.

At the other end, MSD and Daiichi Sankyo withdrew a filing for their lung cancer candidate I-DXd, described by Pharmaphorum as another stutter in the partners’ regulatory efforts for their antibody-drug conjugates (Pharmaphorum, 2026-09-28).

Lupin picked up a tentative approval from the FDA for Apixaban Oral Suspension 1.25 mg/mL — an oral liquid formulation of the active ingredient in Eliquis, positioned in the release as an alternative administration option for adult patients requiring anticoagulation therapy (PR Newswire FDA, 2026-09-28).

The regulatory cluster closes with a cell-and-gene-therapy access milestone: UCSF Benioff Children’s Hospitals is the first U.S. qualified treatment center contracted to administer the individualized gene therapy WASKYRA, per an announcement involving Italian biomedical charity Fondazione Telethon (PR Newswire FDA, 2026-09-28).

Deals: KRAS, thymus targets, and a returned obesity asset

The day’s largest disclosed figure belongs to Merck. BioSpace reports the company is picking up rights to a preclinical KRAS G12D inhibitor from China’s SciBrunch in a deal that could exceed $2 billion — framed by the outlet as continued diversification of Merck’s cancer efforts “as the clock ticks down on Keytruda’s patent” (BioSpace, 2026-09-28). Endpoints News and Fierce Biotech carried versions of the same deal; both were checked and the BioSpace version is the one written.

Tolerance Bio continued its thymus-focused build-out, licensing an anti-IL-33 drug from Tanabe Pharma in a pact worth up to $560 million, following last month’s fusion-protein licence (Fierce Biotech, 2026-09-28).

In the subtraction column, Roche abandoned the obesity candidate emugrobart and returned rights to originator Chugai Pharma, according to Pharmaphorum (Pharmaphorum, 2026-09-28). The Endpoints News version of that story was behind its paywall.

Clinical readouts: hepatitis delta, eye disease, lupus CAR-T

Mirum Pharmaceuticals reported that a phase 3 trial of its chronic hepatitis delta virus candidate hit its primary endpoint — Fierce Biotech frames the programme as a “commercially differentiated” challenger to Gilead Sciences and Vir, in a space those companies recently entered (Fierce Biotech, 2026-09-28).

Kodiak Sciences was the day’s sharpest market move: Fierce Biotech reports the stock doubled on a pivotal win for an eye disease drug the company had previously set aside (Fierce Biotech, 2026-09-28).

In autoimmune disease, Adicet Bio reported what Fierce Biotech calls an early sign of efficacy in lupus — remissions in an early-stage trial of its CAR-T approach, at a moment when the wider field has hit “a rough patch” (Fierce Biotech, 2026-09-28).

Access, funding and diagnostics

Scynexis won a BARDA contract worth up to $214 million for development of a treatment for invasive fungal infections; the non-dilutive funding includes nearly $18.5 million up front to push antifungal candidate SCY-247 into phase 2 (Fierce Biotech, 2026-09-28).

On the access side, Eli Lilly outlined an initiative to take GLP-1 medicines to lower-income nations by 2040, against a backdrop Fierce Pharma describes as dominant market share paired with widely varying global access (Fierce Pharma, 2026-09-28).

Two items sit at the technology edge of the batch. Pharmaphorum reports a study suggesting long-read “nanopore” sequencing could transform diagnosis of inherited muscle diseases and open new drug-discovery angles (Pharmaphorum, 2026-09-28). And Innovent Biologics said it is expanding its global Phase 3 MarsLight-11 study of the alpha-biased IL-2/PD-1 bispecific fusion protein IBI363/TAK-928 in immunotherapy-resistant NSCLC to include non-squamous patients (PR Newswire FDA, 2026-09-27).

What this batch is NOT telling us

• No FDA Newsroom items. The agency’s own newsroom contributed zero items to this batch, so every FDA-related story above reaches us through secondary or sponsor sources.
• No Endpoints News. All five Endpoints candidates were verified as soft-paywalled (stripped body carrying “sign up to read” / “premium subscriber” copy) — the sixth consecutive run in which Endpoints contributed no free story. Where Endpoints had a unique story, the free fall-through rescued it; where it did not (an ultra-rare disease strategy feature and a piece on FDA’s one-trial guidance), the story is simply absent from this batch.
• No AI-in-bio, IPO or M&A mega-deal items. No AI drug discovery stories, no offerings or debuts, and nothing above the $2.13B ceiling. The dealflow that did appear is licensing-shaped and Asia-facing.
• No BioPharma Dive or Reuters. Dive again parsed zero items (unverifiable inline dates); Reuters served a 752-byte bot-wall page. Neither is treated as news, and neither is cited above.
• Nothing politically charged. Several candidates on FDA leadership, spending clawbacks and WHO succession were dropped at parse time under the standing filter.

Reading order

1. AbbVie’s JUVMO approval — the only full approval in the batch, and a new mechanism for Parkinson’s.
2. Merck’s KRAS G12D licence — the biggest disclosed number and the clearest read on patent-cliff strategy.
3. Mirum’s hepatitis delta phase 3 win — a competitive read on a space Gilead and Vir recently entered.
4. Scynexis’s BARDA award — non-dilutive government money is a different funding shape than the day’s equity-free dealflow.
5. Kodiak’s doubled stock — the market reaction is the signal; the underlying data detail is thin here.

How to read the underlying articles

Each item above corresponds to one markdown file in src/content/news/, with the original link in the sourceUrl field and the publisher in sourceName. Where the same story appeared on several outlets, the file records the free source of record; the paywalled versions are not cited.

Items in this batch

1. U.S. FDA Approves AbbVie’s JUVMO (tavapadon) for Parkinson’s Disease — PR Newswire FDA, 2026-09-28
2. Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor — BioSpace, 2026-09-28
3. Roche culls myostatin candidate from obesity pipeline — Pharmaphorum, 2026-09-28
4. Mirum posts ph. 3 hepatitis win for challenger to Gilead, Vir — Fierce Biotech, 2026-09-28
5. Scynexis bags $214M BARDA contract for antifungal development — Fierce Biotech, 2026-09-28
6. Tolerance continues thymus-focused deals with $560M Tanabe pact — Fierce Biotech, 2026-09-28
7. Kodiak’s stock doubles with win for resurrected eye disease drug — Fierce Biotech, 2026-09-28
8. Adicet Bio CAR-T sparks lupus remissions in early-stage trial — Fierce Biotech, 2026-09-28
9. Lilly to expand global GLP-1 access by 2040 — Fierce Pharma, 2026-09-28
10. MSD, Daiichi pull filing for lung cancer candidate I-DXd — Pharmaphorum, 2026-09-28
11. Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension — PR Newswire FDA, 2026-09-28
12. Test could end uncertainty in inherited muscle diseases — Pharmaphorum, 2026-09-28
13. UCSF Benioff Children’s Hospitals Become the First US Qualified Treatment Center Contracted to Administer Individualized Gene Therapy WASKYRA — PR Newswire FDA, 2026-09-28
14. Innovent Announces Expansion of Global Phase 3 MarsLight-11 Study of IBI363/TAK-928 in Immunotherapy-Resistant NSCLC — PR Newswire FDA, 2026-09-27