The Daily Biotech Pulse: F-Star Therapeutics Buyout, Orphan Drug Tag For VBI's Brain Cancer Vaccine, Xenon's Epilepsy Candidate Shows Promise

Zinger Key Points
  • F-star will form a key element of invoX's strategy to accelerate Sino Biopharm's pipeline development
  • All doses of XEN1101 rapidly reduced the frequency of focal onset seizures within one week

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

China-Based Sino Biopharma Buys Cancer-Focused F-Star Therapeutics

invoX Pharma, a wholly owned subsidiary of Sino Biopharmaceutical Limited, has agreed to acquire F-star Therapeutics Inc FSTX for $7.12 per share. 

The proposed acquisition values F-star at approximately $161 million. 

The invoX and F-star boards have unanimously approved the transaction. It is expected to close in the second half of 2022.

VBI Vaccines Brain Cancer Vaccine Candidate Gets Orphan Drug Status

The FDA has granted Orphan Drug Designation for VBI Vaccines Inc VBIV's VBI-1901, a bivalent gB/pp65 immunotherapeutic vaccine candidate for glioblastoma (GBM). 

In June 2021, the FDA also granted Fast Track Designation for VBI-1901 for recurrent GBM patients with first tumor recurrences.

Xenon's Epilepsy Candidate Rapidly Reduces Focal Onset Seizure Frequency

Xenon Pharmaceuticals Inc XENE announced new efficacy data supporting the Phase 3 development of XEN1101.

XEN1101 rapidly reduced focal onset seizure frequency within one week for all doses compared with placebo. 

"Additionally, within our analysis of the open-label extension (OLE) population, we are seeing seizure frequency continuing to improve after the double-blind period with patients experiencing increased periods of seizure freedom," said Christopher Kenney, Xenon's chief medical officer.

Rockwell Medical Receives Additional FDA Feedback On Anemia Candidate

Last week, Rockwell Medical Inc RMTI closed the second $7.5-million tranche of the previously announced DaVita Inc DVA stock purchase agreement of up to $15 million in convertible preferred stock in two tranches. 

The planned Phase 2 proof of concept study design for ferric pyrophosphate citrate in home infusion patients for iron deficiency anemia and maintaining hemoglobin requires three units of the existing FDA-approved IV product to be compounded into a single unit for each patient dose. 

As this is a necessary step, the FDA requested that Rockwell perform a microbial challenge study.

Radius Health Submits US Application For Breast Cancer Candidate

The Menarini Group and Radius Health Inc RDUS have submitted a marketing application to the FDA seeking approval for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

As part of the submission, the companies have requested a Priority Review with the FDA. If Priority Review is granted, the companies anticipate that the FDA will conduct an eight-month review.

Amryt's Skin Disease Treatment Scores European Approval

The European Commission (EC) has approved Amryt Pharma PLC's AMYT Filsuvez for partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients six months and older.

The EC approval of Filsuvez is supported by Phase 3 data from the EASE trial, the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

FDA Gives Nod To Fusion Pharma's Radiopharmaceutical Trial For Solid Tumors Expressing NTSR1

The FDA has signed off Fusion Pharmaceuticals Inc's FUSN Investigational New Drug (IND) applications for FPI-2059 and the corresponding imaging analog FPI-2058. 

FPI-2059 is a targeted alpha therapy that uses a small molecule to target and deliver actinium-225 to tumor sites expressing neurotensin receptor 1, a protein overexpressed in multiple solid tumors.

CDC Backs Merck's Vaxneuvance As Recommended Vaccine Option 

The Centers for Disease Control and Prevention's Advisory Committee unanimously voted to include Merck & Co Inc's MRK Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) as a recommended option for vaccination in infants and children, including routine use in children under two years of age. 

Yesterday, the FDA approved an expanded indication for Vaxneuvance to include children six weeks through 17 years of age, making it the first pneumococcal conjugate vaccine approved in almost a decade to help protect pediatric populations against invasive pneumococcal disease.

Offerings

Xenon Pharmaceuticals Inc XENE priced its underwritten public offering of 7.9 million shares and prefunded warrants to purchase up to 327,868 shares at $30.50, with gross proceeds of $250 million.

Shares closed 7.78% lower at $32 during the after-hours session.

Applied Therapeutics Inc APLT priced its underwritten public offering of 20 million shares, 10 million pre-funded warrants and accompanying warrants to purchase up to 30 million shares at a combined value of $1 each, with gross proceeds of $30 million.

Summit Therapeutics Inc SMMT approved a rights offering as a record date of July 5. Assuming that the rights offering is fully subscribed, Summit will receive gross proceeds of up to $100 million.

Earnings

RedHill Biopharma Ltd RDHL: Before the market open.

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