UPDATED: Cytokinetics is getting its shot at a major PhIII showdown with Bristol Myers after posting positive data for a rare cardio disease. Shares rocket up
John Carroll
Editor & Founder
After losing a whole lot of market confidence in their lead drug, little Cytokinetics is now lining up for a crucial Phase III pivotal challenge for the next cardio drug in the pipeline. And that will put them toe-to-toe against powerhouse rivals at Bristol Myers Squibb, which just 9 months ago put down a $13 billion wager on what will likely be the first drug approved for the same rare cardio condition the biotech is contending for.
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.
Novo CEO Lars Fruergaard Jørgensen on R&D risk, the deal strategy and targets for gender diversity
John Carroll
Editor & Founder
I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.
John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.
SPONSORED
October 11, 2021 06:00 AM EDT
Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?
Brian Abrahams
Co-Head of Biotechnology Research
The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.
RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.
AstraZeneca's MCL-1 cancer drug put on hold after flagging a safety issue — 2 years after Amgen axed rival drug
John Carroll
Editor & Founder
Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca is now flagging safety issues for a rival therapy of the same class.
The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.” There was no further explanation and a spokesperson for AstraZeneca hadn’t followed up with us ahead of our publishing deadline.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 120,100+ biopharma pros reading Endpoints daily — and it's free.
Radius rockets higher as Kelly Martin boasts of a big PhIII success — but the spoils belong to Menarini
John Carroll
Editor & Founder
Radius Health stuck with some fuzzy top-line Phase III results for its oral SERD therapy elacestrant, but investors saw enough to push a rally that sparked a big surge in its share price.
According to researchers, the drug hit both primary endpoints among ER+/HER2- breast cancer patients: beating standard of care on progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations — a key factor in developing resistance. And while some analysts were left wondering about specific data, most of the crowd seemed happy to hear that the drug is now being steered to the FDA.
Some cancer patients now have to find other options as Bristol Myers' Abraxane falls into shortage from manufacturing woes
Zachary Brennan
Senior Editor
When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.
“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.
Renowned Dana-Farber scientist, mentor and biopharma advisor David Livingston has died
John Carroll
Editor & Founder
David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.
One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.
Surgeons successfully attach pig kidney to a human for the first time, using tech from United's Revivicor
Max Gelman
Editor
In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.
Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 120,100+ biopharma pros reading Endpoints daily — and it's free.
FDA shoots down a biotech’s last-stand patient pitch after faulting data
Max Gelman
Editor
Stealth BioTherapeutics appeared unsure its pitch for an ultra-rare disease would be accepted when submitting an NDA in August, and on Wednesday its fears came to pass.
The FDA issued Stealth a refusal to file letter for a candidate looking to treat Barth syndrome, the biotech announced Wednesday morning. It’s a move not entirely unexpected, given Stealth’s own admission earlier this year that the agency didn’t find existing data to support NDA review.
Manufacturing woes for Novavax’s Covid jab badly disrupt plans for rollout to the poor — report
Josh Sullivan
Associate Editor
Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.
The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.
