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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Starting TIGIT things done: Arcus, Iteos, others forge ahead

May 17, 2021
By Randy Osborne
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players.
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Adicet of data to the heap; Allogene, Celyad also among allogeneic T-cell players

May 14, 2021
By Randy Osborne
Allogeneic chimeric antigen receptor T cell (AlloCAR T) specialist Allogene Therapeutics Inc.’s promise of data readouts at this year’s American Society of Clinical Oncology meeting, along with the virtual CD19 forum slated by the company for May 19, whetted investor thirst in the space.
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Blood vessels

Split vote at adcom for avacopan; FDA not Hy on Chemocentryx trial setup

May 6, 2021
By Randy Osborne
The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”
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Stock merger illustration

Amryt rocks the Chiasma, no clash over synergies in stock deal

May 5, 2021
By Randy Osborne
As investors await an MAA submission to the EMA for U.S.-approved Mycapssa (octreotide) in acromegaly, Chiasma Inc. disclosed its plan to merge with Amryt plc in an all-stock deal, thereby gaining a global commercial presence. Terms call for the exchange of each Chiasma share for 0.396 American depositary share of Amryt. The latter closed May 4 at $12.95, so the deal values Chiasma at $5.13 per share, an 81% premium over the previous day’s ending price, noted Piper Sandler analyst Edward Tenthoff. The stock (NASDAQ:CHMA) rose $1.14, or 40%, to finish at $3.98.
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Avacopan scanned, Chemocentryx in briefing docs’ penalty box

May 4, 2021
By Randy Osborne
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
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T2D or not T2D: Astrazeneca’s Farxiga gets yes answer to CKD question as class grows

May 3, 2021
By Randy Osborne
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral  SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression. 
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Drug vials

Fixes to Bayview plant Emergent soon? FY21 guidance clipped

April 30, 2021
By Randy Osborne
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
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Person scratching arm

Cara jacking up efforts in pruritis, oral Korsuva drives on to phase III

April 29, 2021
By Randy Osborne
Despite stock-denting phase II data with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis (AD), Cara Therapeutics Inc. CEO Derek Chalmers said the outcome “prioritizes moving forward. We got what we needed from the phase II trial,” which identified the patients most sensitive to the drug, nailed down a dose spectrum, and equipped the company to power a registrational effort, he said.
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Brain with handshake and cityscape

Biovie resistance futile to insulin as Neurmedix’s next-generation AD approach

April 28, 2021
By Randy Osborne
Biovie Inc. Chairman Terren Peizer said Neurmedix Inc. “had been offered a better deal in the shorter term,” but the contract signed by the two firms – which installs entrepreneur Cuong Do the new CEO of Biovie, replacing Peizer – made more sense to both parties. Santa Monica, Calif.-based Biovie is taking over the assets of Neurmedix Inc., of San Diego, bringing aboard phase III-ready NE-3107, an oral small-molecule therapy designed to inhibit insulin resistance in Alzheimer’s disease (AD).
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Eye drops

Aldeyra’s AC data Invigorate shares; DED shred within RASP grasp?

April 27, 2021
By Randy Osborne
Lexington, Mass.-based Aldeyra Therapeutics Inc.’s phase III win in the study called Invigorate with reproxalap for allergic conjunctivitis (AC) restarted speculation about odds of the drug, a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species (RASP), to treat dry eye disease (DED). “I do think there is potential read-through,” CEO Todd Brady said, especially with regard to the redness endpoint. A six-week safety study necessary before going to the FDA has not yet started, he told investors during a conference call. “That will require some discussions with the FDA, but I do not think, given the length of the trial, the safety study would impair our guidance of potentially filing NDAs by the end of this year.”
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