Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Sesen Bio To Pause Clinical Development Of Its Lead Bladder Cancer Candidate In the U.S.
Based on a thorough reassessment, Sesen Bio Inc (NASDAQ:SESN) has decided to voluntarily pause further development in the U.S. of its lead asset, Vicineum, for non-muscle invasive bladder cancer.
The decision was based on a reassessment of the incremental development timeline and associated costs for an additional Phase 3 clinical trial following recent discussions with the FDA.
This decision enables Sesen Bio to conserve cash while assessing potential strategic alternatives. Additionally, the company intends to seek a partner to develop Vicineum further.
Sanofi To Stop Regulus-Partnered Midstage Alport Syndrome Study
Regulus Therapeutics Inc (NASDAQ:RGLS) received notification from Sanofi SA (NASDAQ:SNY) to terminate the Phase 2 study of lademirsen (RG-012) for Alport syndrome (the HERA study) for failure to meet Sanofi's pre-defined futility criteria.
Sanofi also notified the company that it is currently evaluating opportunities for RG-012.
Regulus had been eligible to receive a $25 million milestone in the event of successful completion of the HERA study. Under the agreement, Regulus will remain eligible for the milestone in the event of successful completion of a Phase 2 fibrosis proof of concept study.
RGLS shares are slipping 21.7% to $1.80 during the premarket session.
FDA Approves Eton Pharma's Zonisamide For Partial Seizures
The FDA has approved Eton Pharmaceuticals Inc's (NASDAQ:ETON) Zonisade (zonisamide oral suspension) for partial seizures in patients with epilepsy.
Zonisamide is one of Eton's three neurology-focused oral liquid product candidates submitted to the FDA.
Shares are up 14.7% at $3.20 during the premarket session.
Calliditas' Nefecon Approved In Europe For Autoimmune Kidney Disease
The European Commission conditionally approved Calliditas Therapeutics AB's (NASDAQ:CALT) Kinpeygo (developed under the name NEFECON) for primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio ≥1.5 g/gram.
In Europe, Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune kidney disease.
Bavarian Nordic Inks Multiple Supply Pact For Its Monkeypox Vaccine
Bavarian Nordic A/S (OTC:BVNRY) has signed several supply contracts with undisclosed countries for its liquid-frozen Jynneos, a non-replicating smallpox vaccine, the only FDA-approved vaccine against monkeypox.
Bavarian Nordic raises its expectations for 2022 financial results, with revenue now expected to be DKK 2.7 - 2.9 billion (previously between DKK 2.3-2.5 billion).
The U.S. government has ordered an additional 2.5 million doses of the Bavarian Nordic vaccine against monkeypox, bringing total deliveries in 2022 and 2023 to nearly 7 million.
Nabriva Therapeutics Expands Xenleta Distribution With An Exclusive Pact With Er-Kim Pharmaceuticals
Nabriva Therapeutics plc (NASDAQ:NBRV) has entered into an exclusive distribution agreement with Er-Kim for the oral and intravenous formulations of Xenleta (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia.
Under the terms of the agreement, Er-Kim gains exclusive rights to distribute Xenleta in several European countries.
Er-Kim may also distribute Xenleta to five countries through a Named Patient Usage program. Nabriva will be the exclusive supplier of Xenleta to Er-Kim.
Shares are up 26.5% at 24 cents during the premarket session.
Unicycive Inks Licensing Pact For Its Kidney Disease Candidate In China
Unicycive Therapeutics Inc (NASDAQ:UNCY) has entered into an agreement granting exclusive rights of Renazorb (lanthanum dioxycarbonate) to Lee's Pharmaceutical Holdings Limited in Mainland China, Hong Kong, and certain other Asian markets.
Under the terms of the agreement, Lee Pharm will be responsible for the development, registration filing, and approval of Renazorb in the licensed territories.
Unicycive will receive an upfront payment of $1 million upon signature and up to $1 million in milestone payments upon product launch in China.
Offering
Immunocore Holdings plc (NASDAQ:IMCR) will sell 3.7 million shares, including 2 million American Depository Shares and 1.7 million non-voting ordinary shares, via a private investment at $37.50.
Immunocore anticipates that gross proceeds will be approximately $140 million.
On The Radar
PDUFA Dates
Incyte Corporation (NASDAQ:INCY): Expanded use for ruxolitinib cream (Opzelura) for vitiligo, a condition in which the skin loses its pigment cells (melanocytes).
