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Today’s Big News

Oct 25, 2024

Septerna's $288M IPO is another sign of the market warming to biotech investment

GenSight enters final weeks of cash runway as revenue stream edges out of reach

AbbVie makes Richter richer, paying $25M to form discovery pact with Vraylar originator

Arcus' new HIF-2a data in kidney cancer hint at potential edge over Merck's Welireg, analysts say

Monopar retrieves Wilson disease candidate from AstraZeneca's scrap heap

Poseida's HAE therapy edits gene in primate livers and reduces kallikrein protein levels in mice, company says

GSK embarks on Pennsylvania manufacturing expansion worth up to $800M, creating 200 new jobs

Chutes & Ladders—Jade carves out exec team with Chinook vets

Featured

Septerna's $288M IPO is another sign of the market warming to biotech investment

By Kevin Dunleavy

South San Francisco-based Septerna has scored with an upsized initial public offering of $288 million, which far exceeded the $157.9 million the company said it expected to generate in an SEC filing early this week. Trading for “SEPN” began on Friday.

GenSight enters final weeks of cash runway as revenue stream edges out of reach

By Nick Paul Taylor

GenSight Biologics is weeks away from running out of money. Again. The biotech only has enough cash to fund operations into mid-November and, with a revenue stream set to start later than planned, needs bridge financing to survive.

AbbVie makes Richter richer, paying $25M to form discovery pact with Vraylar originator

By Nick Paul Taylor

AbbVie has returned to the source of its antipsychotic powerhouse Vraylar in search of another blockbuster, paying $25 million upfront to form a new drug discovery pact with Gedeon Richter.

The sudden progress in rare kidney disease is built on years of dedication

Arcus' new HIF-2a data in kidney cancer hint at potential edge over Merck's Welireg, analysts say

By Fraiser Kansteiner

In the phase 1/1b ARC-20 study of Arcus’ candidate casdatifan in metastatic clear cell renal cell carcinoma, the biotech’s HIF-2a inhibitor achieved a confirmed overall response rate (ORR) of 25%. Analysts at Evercore ISI were optimistic about Arcus’ data and the candidate's prospects against an approved rival.

Real-World Data Meets Clinical Trial Design: Optimizing Protocols and Site Selection

Monopar retrieves Wilson disease candidate from AstraZeneca's scrap heap

By Kevin Dunleavy

Monopar Therapeutics is recovering a drug from the scrap heap of AstraZeneca’s rare disease pipeline. It licensed ALXN-1840, a candidate for the treatment of Wilson disease that was previously considered promising enough that Alexion, now an AZ subsidiary, paid $855 million to acquire it six years ago.

Poseida's HAE therapy edits gene in primate livers and reduces kallikrein protein levels in mice, company says

By Darren Incorvaia

Poseida Therapeutics’ gene therapy for hereditary angioedema reduced kallikrein protein activity in a mouse model of the disease and edited a gene in the livers of nonhuman primates, the company said in an Oct. 24 release.

GSK embarks on Pennsylvania manufacturing expansion worth up to $800M, creating 200 new jobs

By Fraiser Kansteiner

In its biggest U.S. manufacturing investment yet, GSK is spending up to $800 million to double the size and capacity of its site in Marietta, Pennsylvania. The upgraded manufacturing campus will be equipped to crank out commercial drugs and vaccines plus medicines for clinical trials.

Chutes & Ladders—Jade carves out exec team with Chinook vets

By Darren Incorvaia,Zoey Becker

Shiny new Jade Biosciences has selected its CEO in Tom Frohlich, who co-founded Chinook Therapeutics and served as chief operating operator until it was bought out by Novartis last year. Jade’s new chief medical officer Hetal Kocinsky, M.D., also comes from Chinook, as does the company’s newly appointed board chairman Eric Dobmeier, formally Chinook’s CEO.

Fierce Pharma Asia—Astellas' first-in-class FDA nod; Otsuka's IgAN win; Samsung Bio's $1.2B contract

By Angus Liu

Astellas' first-in-class CLDN18.2 drug Vyloy has cleared the FDA. After a positive phase 3 readout, Otsuka is targeting an accelerated approval filing for a kidney disease candidate. Samsung Biologics has signed its largest contract from a single customer to date. And more.

The pulse of the medtech industry

By Ayla Ellison,Conor Hale

This week on "The Top Line," Fierce Medtech's Conor Hale dives into EY's 18th annual Pulse of the MedTech Industry report and chats with EY's John Babbitt about the team's findings and the pace of M&A, venture capital funding and recent IPOs.

Baxter International to restart highest-throughput IV solutions manufacturing line next week

By Heather Landi

Baxter International said Thursday it anticipates restarting its highest-throughput IV solutions manufacturing line within the next week.

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Resources

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Is That Heart Attack Really an Adverse Event?

Discover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results.

Planning for success in cell-based manufacturing

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Presented by: Thermo Fisher Scientific

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Decoding the data

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Sponsored by: PHC Corporation of North America

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Strategies to Optimize Expression Challenges of Multi-chain and Bispecific Antibodies

Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects.

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.

Presented by: Blue Matter

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