Biotech & Life Sciences
Medicenna’s MDNA11 Shows a 40% Response Rate in a Small GI Cancer Cohort
Four of 13. That is how many patients whose gastrointestinal tumors had already outlasted checkpoint immunotherapy responded to Medicenna’s MDNA11, in data presented at a cancer immunotherapy meeting on November 7. The published benchmarks the company cites for comparable patients sit at roughly 11% to 13%. Thirteen patients, though, is a group small enough that…
Edesa Biotech Licenses Paridiprubart to Kyorin for $12 Million Upfront
Fifty percent. That is how much Faeth Therapeutics gave up on Monday after releasing cancer data it called positive. Edesa Biotech went the other way the same morning, climbing as much as 39% on a licensing deal in Japan. Edesa Biotech Signs $12M Upfront Japan Deal With Kyorin Edesa Biotech (Nasdaq: EDSA) signed an exclusive…
Kane Biotech’s revyve Gel Cut Chronic Wound Area 43.9% in a 17-Patient Study
The 17 patients in Kane Biotech’s newly published study had lived with their wounds for a median of 22 months, and every one of those wounds had already failed earlier care. After 12 weeks on the company’s revyve gel, average wound area was down by more than 40%. Kane booked $8,143 in revenue in its…
Inovio Wins First FDA Approval as VOCERYQ Clears the Accelerated Path
Inovio closed at about 60 cents on October 30, down 22% on the day. That evening the FDA approved its first product, and the stock more than tripled. Pulmonx needed only 6% sales growth to add a third to its share price. Inovio Wins Accelerated FDA Approval for RRP Therapy VOCERYQ Inovio Pharmaceuticals (Nasdaq: INO)…
Theralase Readies Health Canada and FDA Filings After Phase II Ruvidar Data
Sixty of 93 assessed patients had a complete response at some point after treatment. At three years, nine of 49 still did. Theralase Technologies published both figures on October 26, in what it calls an interim efficacy readout from a Phase II study it intends to put in front of regulators in Canada and the…
Theralase Reports 64.5% Complete Response in Phase II Bladder Cancer Study
Seven years. That is how long one patient in a Toronto company’s bladder cancer study has held a complete response after a single light-activated treatment. The rest of the data is less tidy, and so is most of what crossed the biotech wires on Monday and Tuesday. Theralase Reports 64.5% Complete Response in Phase II…
Devonian Health Group Gets Health Canada Authorization for Radiodermatitis Trial
Devonian Health Group’s last published cash balance was C$0.7 million, as of April 30. On Tuesday, Health Canada authorized the company to run a 150-patient, double-blind trial in women receiving radiotherapy for breast cancer. The US listing and public offering Devonian has pursued since July was once expected to start trading on August 21. It…
Fractyl Health Meets REMAIN-1 Pivotal Endpoint, Shares Plunge
Hitting a pivotal endpoint is supposed to be the good day. Fractyl Health hit its, with a p-value of 0.0023, and the stock still lost about half its value. Opus Genetics had its own odd Friday: an FDA approval a day early, and shares closed lower. Opus Genetics Wins FDA Approval for Presbyopia Eye Drops,…
Hemostemix Wins Full LARTA Approval for Commercial VesCell Phase 1 Study
Hemostemix sold its newest units for five Canadian cents apiece. The same October 7 release disclosed full approval from a regulator in The Bahamas to begin a commercial study of VesCell, the company’s stem cell therapy. One document carries both facts, and neither one cancels the other. Hemostemix Receives Full LARTA Approval for VesCell Phase…
First Tracks ANB033 Limits Gluten Damage in 32-Patient Celiac Trial
Two slices of bread a day, for 14 days. That was the gluten challenge 32 people with celiac disease signed up for, and the ones on First Tracks Biotherapeutics’ drug came through with their gut lining mostly intact. Caribou Biosciences spent the same stretch deciding it could no longer afford to finish what it started.…
