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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Moderna COVID-19 vaccine

CDC, FDA take action on COVID-19 boosters

Nov. 19, 2021
By Randy Osborne
The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot. 
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Stem cells

Jasper Therapeutics delivers findings that could refresh HSCT space

Nov. 19, 2021
By Randy Osborne
New conditioning agents for hematopoietic stem cell transplant (HSCT) are in the works at a handful of companies, with Jasper Therapeutics Inc. ushering through the pipeline a candidate viewed by some on Wall Street as especially promising.
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Vials, syringes, pills and masks

Feds show EPIC-PEP for Pfizer’s Paxlovid in COVID-19; gusto garners near-$5.3B contract

Nov. 18, 2021
By Randy Osborne
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
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Kidneys

Interim peek finds phase II Mission accomplished by Kezar in LN

Nov. 16, 2021
By Randy Osborne
Kezar Life Sciences Inc. shares (NASDAQ:KZR) rose 37%, or $3.18, to close Nov. 16 at $11.59 on interim results from the phase II part of the study called Mission, testing KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).
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STATute of limitations? Time running out for ‘undruggable’ SH2 as Recludix bags $60M series A

Nov. 15, 2021
By Randy Osborne
Recludix Pharma Inc. launched with a $60 million series A round to target Src homology 2 (SH2) domains, and the new money will get the San Diego-based firm to reach the IND-enabling stage, CEO Nancy Whiting told BioWorld.
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Oncorus line: SITC hosts good phase I show, curtain falls on stock

Nov. 12, 2021
By Randy Osborne
Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities.
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IPO puzzle pieces

In the Vaxxinity of success: $78M IPO prices low but stock trades high

Nov. 11, 2021
By Randy Osborne
Vaxxinity Inc. priced its IPO below the targeted range, selling 6 million shares (NASDAQ:VAXX) at $13 each for proceeds of $78 million, but came out of the gate impressively, closing at $16.55, up $3.55, or 27%, after reaching $22.77 during the day.
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Early data in PD lift spirits of Yumanity and others, but stock price depressed

Nov. 10, 2021
By Randy Osborne
Yumanity Therapeutics Inc. CEO Richard Peters said his firm is “in the driver’s seat” with regard to partnering options or going it alone, after YTX-7739 hit the primary endpoints in a phase Ib Parkinson’s disease (PD) study. Wall Street seemed less than certain about the success, knocking shares (NASDAQ: YMTX) down $2.83, or 33.4%, to close at $5.65.
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Psilocybin drug trips on side effects in TRD as Compass nails phase IIb endpoint

Nov. 9, 2021
By Randy Osborne
Compass Pathways plc rolled out favorable top-line findings from the largest randomized, controlled, double-blind psilocybin therapy study ever completed, showing that COMP-360 at 25 mg yielded a highly statistically significant and clinically relevant reduction in symptom severity after three weeks in patients with treatment-resistant depression (TRD) .
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Kidney illustration

Follow your BlyS, or not? Chinook, Vera findings in IgAN compared

Nov. 8, 2021
By Randy Osborne
Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other.
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View All Articles by Randy Osborne

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