Jacob Plieth
@JacobPlieth
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Journalist @ ApexOnco. The Wolverine Of Biotech / Mr ASH. Once had a blue tick. Interested in: oncology. Not interested in: what stock you bought today.
London, UK
Joined October 2012
Nerd alert! What do the latest proposed INNs tell us about $MGNX $AZN $BNTX $GSK $IVBXF and other ADCs? Via @ApexOnco -> H/t @raffcolo.
www.oncologypipeline.com
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Another bombshell, via Evercore: founder of Lanova is married to the founder of $IMAB (did I hear that right?).
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Fascinating Evercore ISI webinar going on right now about disconnect between value of Sino deal and what $MRK owes Lanova on the PD-1 x VEGF. In summary: 40% of $588m MRK up front, and 25% of the $300m tech transfer, actually went to Genscript (!) $LEGN.
Hong Kong-listed Sino Biopharma (CTTQ’s holding company) announced that it will acquire a 95.09% stake in 🇨🇳LaNova Medicines for approximately USD 500 million. Combined with the 4.91% stake it previously acquired during LaNova’s Series C financing, LaNova will become a wholly.
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It would be nice if investors, doctors & patients somehow didn't have to wait 7 years for this kind of stuff to be disclosed, but then that would breach confidentiality, and the wheels of capitalism would fall off $GSK
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Fresh Padzur intervention sees FDA's odac strike down Blenrep. 23 July Pdufa date, tic toc! .Via @ApexOnco -> $GSK.
www.oncologypipeline.com
A surprising no to both multiple myeloma uses puts the ball in the FDA's court.
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Risk-adjusted NPV calculation didn’t justify the costs. But remember, folks, IT'S ABOUT THE BOYS!. $SRPT.
Also: . Asked on a Wednesday investor call if the decision was driven by any safety concerns, CEO Doug Ingram said the company had made “a risk-adjusted net present value” calculation and determined the financial opportunity didn’t justify the costs of developing the limb girdle.
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And a final sideswipe from Padzur, who took $GSK to task for enrolling so few US patients into Dreamm-7 & 8: "If the drug is so good patients should be enrolled in the US.".
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So judging by panellists' comments the key issue was $GSK's refusal to investigate lower Blenrep doses. Pertinent slide from FDA:
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$SRPT now basically a debt vs equity story, but I guess it's always good news
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RT @raffcolo: INN Proposed List 133 is out!. Here are the International Nonproprietary Names (INN) for ADCs, along with their targets, payl….
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This is the kind of stuff that used to make Vinay apoplectic.
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. and more, this time from the FDA's Andrea Baines $BMY $JNJ $GSK $LEGN
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$JNJ first announced TAR-200 filing on 15 Jan, but never announced the acceptance. Today's PR likely result of mention of priority review dribbled out at GS conf in June & on yesterday's earnings call. Still no idea when filing was actually accepted!.
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Latest OS curves, from IA2 of Dreamm-7 and IA1 of Dreamm-8. Comment from FDA was that Dreamm-8 isn't sufficiently powered for OS, and might never show a benefit $GSK
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Based on the low-key comments from the FDA (nothing like the attacks we've heard at recent adcoms) I see $GSK Blenrep getting positive votes both for Dreamm-7 & 8.
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Admirable effort by FDA's Deepti Telajara to present the current treatment paradigm for multiple myeloma $JNJ $BMY $GSK
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$GSK Blenrep adcom briefing documents & Youtube link -> Starts 8am ET.
www.fda.gov
July 17, 2025: Meeting of the Oncologic Drugs Advisory Committee
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