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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Handshake with DNA, molecules

Protein work Generates interest, and how; potential $1.9B-plus Amgen tie-up

Jan. 6, 2022
By Randy Osborne
A potential $1.9 billion-plus deal with Amgen Inc. in hand, Generate Biomedicines Inc. CEO Michael Nally said his firm’s approach “can take a couple of years off traditional complex protein design” by way of combining in silico work with wet lab capabilities. The pact brought $50 million up front for Cambridge, Mass.-based Generate, with the bigger money possible on the back end plus royalties on any resulting products.
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Lupus, pneumonitis mar Annexon phase II data with C1q blocker in HD

Jan. 5, 2022
By Randy Osborne
Annexon Inc. deemed promising – as did analysts – the interim phase II data with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD), but the safety profile took Wall Street aback, and shares (NASDAQ:ANNX) sank $3.75, or 34%, to close at $7.26.
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Dueling dual bids in MM as big pharma teams with Ayala, Springworks

Jan. 4, 2022
By Randy Osborne
Recent word that Johnson & Johnson submitted the BLA for teclistamab may have reminded Wall Street that a combo-therapy face-off is in progress between the big pharma firm – with partner Springworks Therapeutics Inc. – and Novartis AG, paired with Ayala Therapeutics Inc.
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Clinical data illustration

Ligase embrace in BTK: Nurix depicts promising future with new approach

Dec. 31, 2021
By Randy Osborne
Nurix Therapeutics Inc.’s Dec. 12 disclosure that the U.K. Medicines & Healthcare products Regulatory Agency granted to clearance for the company to kick off a phase I study with Bruton tyrosine kinase (BTK) inhibitor NX-5948 pumped more juice into the space, which has been consistently intriguing since the first drug in the class was approved about eight years ago by the FDA. The San Francisco-based firm will start an experiment in patients with relapsed and refractory B-cell malignancies at clinical sites in the U.K., with dosing of the first subject expected in the first half of 2022.
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Ikena to enter phase I as new research feeds hungry Hippo space

Dec. 29, 2021
By Randy Osborne
Ikena Oncology Inc.’s plan to launch the first-in-human phase I study with IK-930, a transcriptional enhanced associate domain inhibitor targeting the Hippo pathway in cancer, brought new attention to the Hippo space. The FDA accepted Ikena’s IND application early last month. Now, work with other candidates is picking up steam at a handful of companies pursuing early stage prospects.
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Woman using eyedrops

Aldeyra’s reproxalap not DED yet as Palatin prospect reaches phase III

Dec. 28, 2021
By Randy Osborne
With the memory of Dec. 20’s stock-denting, top-line phase III fizzle by Aldeyra Therapeutics Inc. in dry eye disease (DED) still fresh, Palatin Technologies Inc. is launching a late-stage effort in the same indication. Aldeyra offered data from the Tranquility trial with reproxalap – a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species, known as RASP, formulated as an ophthalmic solution – that showed a miss on the primary endpoint of ocular redness.
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FDA Approved stamp

Wall Street faithful as Novartis’ two-timing Leqvio enters LDL-C fray

Dec. 27, 2021
By Randy Osborne
Novartis AG’s FDA go-ahead for Leqvio (inclisiran), the first and only small interfering RNA therapy to lower LDL-C, “should come as a relief, given fears that the pandemic could again limit FDA's ability to conduct manufacturing-site inspections,” Jefferies analyst Peter Welford said. PCSK9-targeting Leqvio’s Dec. 22 approval, which came slightly ahead of the Jan. 1, 2022, PDUFA date, landed after a complete response letter about a year ago, citing unresolved facility inspection-related conditions. The drug is dosed twice per year, unlike competitors in the space.
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Stomach and esophagus

Egads, EGIDs: Wall Street bids Allakos adios on two trial blowups

Dec. 22, 2021
By Randy Osborne
Discouraging news from two trials with lirentelimab slammed shares of Allakos Inc. (NASDAQ:ALLK), which ended the day at $8.55, down $75.84, or almost 90%. The Redwood City, Calif.-based firm reported data from Enigma 2, a phase III study in patients with biopsy-confirmed eosinophilic gastritis and/or eosinophilic duodenitis, and Kryptos, a phase II/III experiment in biopsy-confirmed eosinophilic esophagitis. Both experiments met their histologic co-primary endpoints but fell short of statistical significance on patient-reported symptomatic co-primary goals.
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Handshake dollar sign

Masked mandate: Sanofi authorizes $1B-plus buyout of TCE specialist Amunix

Dec. 21, 2021
By Randy Osborne
Sanofi SA is paying about $1 billion up front and pledging as much as $225 million in development milestone payments to acquire Amunix Pharmaceuticals Inc. in an arrangement that brings aboard several immuno-oncology platforms. South San Francisco-based Amunix’s lead candidate is the clinic-bound, masked T-cell engager (TCE) AMX-818, which targets HER2-expressing solid tumors. The candidate emerged from the company’s XPAT technology, designed with the longstanding XTEN and centered on a protein polymer in a strategy similar to pegylation, except with a polypeptide. XPAT stands for XTENylated, protease-activated TCEs.
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Eye illustration

Opregen pedigree passes Roche muster, draws $670M deal in dry AMD

Dec. 20, 2021
By Randy Osborne
What one analyst called “fantastic external validation but, even more importantly, great for the cell therapy and regenerative medicine space” arrived in the form of Lineage Cell Therapeutics Inc.’s potential $670 million deal with Roche Holding AG. With its subsidiary, Cell Cure Neurosciences Ltd., Lineage signed an exclusive worldwide collaboration and license pact with Roche and its Genentech arm.
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View All Articles by Randy Osborne

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