Today’s Daily Dose brings you news about Sangamo’s deal with Novartis, Roche’s Tecentriq scoring another FDA nod, Lexicon realigning its business, Edesa Biotech joining the battle against the novel coronavirus, upcoming regulatory catalyst of Aimmune, rosy outlook of Vertex Pharma, and the giant stride of Precipio.
1. EMA to rule on Aimmune’s Peanut Allergy Drug in Q4
Aimmune Therapeutics Inc. (AIMT) expects the European Medicines Agency’s decision on peanut allergy drug Palforzia in the fourth quarter of 2020. Palforzia is also under review by the Swissmedic, with a decision expected in mid-2021.
In the U.S., Palforzia was approved in January of this year. It is the first drug for the treatment of peanut allergy for children.
The company is also developing a drug AR201 for egg allergy. A phase II trial of AR201 in patients with egg allergy is underway, with data expected in the first half of 2021.
AIMT closed Thursday’s trading at $14.04, up 1.74%.
2. Edesa Seeks Permission to begin COVID-19 Study in the U.S.
Edesa Biotech Inc. (EDSA) has sought FDA clearance to initiate a phase II/III clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
EB05, an investigational monoclonal antibody is believed to have the potential to regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.
The company recently received expedited approval to begin the phase II/III study in COVID-19 patients in Canada and is seeking government grants to accelerate site selection and initiate patient enrollment.
EDSA touched a high of $19.10 in intraday trading Thursday, before closing at $9.45, up 81.38%.
3. Eton Pharma on Track
Eton Pharmaceuticals Inc (ETON) has submitted a New Drug Application for Zonisamide oral suspension, previously known as ET-104, to the FDA for the treatment of partial seizures in patients with epilepsy.
Zonisamide is widely used as a capsule to treat partial seizures but is not FDA approved in liquid form.
ETON closed Thursday’s trading at $6.16, up 3.53%.
4. Lexicon Sells Rights to Carcinoid Syndrome Diarrhea Drug, Realigns Business
Lexicon Pharmaceuticals Inc. (LXRX) has sold its rights, title, and interest in XERMELO to TerSera Therapeutics LLC for approximately $159 million in cash at closing, which includes a $155 million upfront payment and approximately $4 million for existing inventory. The transaction is expected to close in the third quarter of 2020.
XERMELO is an approved drug to treat carcinoid syndrome diarrhea. The drug is also under a phase II study in biliary tract cancer patients, dubbed TELE-ABC. The sales of XERMELO in the U.S. were $9.0 million in the second quarter of 2020.
As per the deal with TerSera, Lexicon is also eligible to receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of XERMELO in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer.
The upfront proceeds of $155 million from the XERMELO sale will be used by Lexicon to substantially reduce its debt, including full repayment of its $150 million secured term loan.
The company is realigning its business around research and early-stage research and development programs, with a focus on LX9211 for neuropathic pain.
A phase II study of LX9211 for the treatment of diabetic peripheral neuropathic pain, dubbed RELIEF-DPN-1, has been initiated with an enrollment target of approximately 300 patients at 30 U.S. sites.
Lexicon is preparing for additional phase II studies of LX9211 in other areas of neuropathic pain.
LXRX closed Thursday’s trading at $2.00, up 14.94%.
5. Precipio Skyrockets As it readies For Rollout of COVID-19 Tests
Shares of specialty diagnostics company Precipio Inc. (PRPO) soared nearly 470% as it gears up for the rollout of its COVID-19 serology antibody tests that recently received Emergency Use Authorization from the FDA.
The company has entered into an agreement with ADS Biotec, a US company based in Omaha, Nebraska, to distribute the COVID-19 serology antibody tests in the U.S. and across the globe.
The antibody tests will be initially launched as a CLIA test run in its laboratory, probably in August, with further rollout (pending further FDA authorization) to physician offices as a POC (point-of-care) test and finally, through distribution via various retail channels for at-home, DTC (direct-to-consumer) use, the company noted.
PRPO closed Thursday’s trading at $7.00, up 469%.
6. Roche’s Tecentriq Scores another FDA Nod
The FDA has approved Roche’s (RHHBY.OB) Tecentriq plus Cotellic and Zelboraf for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
A combination of Cotellic and Zelboraf is already approved in the United States and Europe, as well as many countries around the world, for the treatment of people with melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation.
Levi Garraway, chief medical officer and head of Global Product Development, said, “When receiving cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening. The FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”
Tecentriq is already approved for the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and hepatocellular carcinoma.
The drug brought in annual sales of 1.88 billion Swiss francs for Roche in 2019, up 143% over the prior year.
RHHBY.OB closed Thursday’s trading at $44.39, down 0.80%.
7. Sangamo Inks Three-year Deal with Novartis
Sangamo Therapeutics Inc. (SGMO) has inked a three-year global licensing collaboration agreement with Novartis (NVS) to develop and commercialize gene regulation therapies for autism and other neurodevelopmental disorders.
Under the terms of the agreement, Novartis has exclusive rights to Sangamo’s engineered ZFP transcription factors (ZFP-TFs) targeted to three undisclosed genes that are associated with neurodevelopmental disorders, including autism spectrum disorder and intellectual disability. Novartis also has the option to license Sangamo’s proprietary adeno-associated viruses ( AAVs).
Sangamo will be funded by Novartis to carry out certain research and associated manufacturing activities. Additional research activities, investigational new drug-enabling studies, clinical development, related regulatory interactions, manufacturing, and global commercialization will all be the responsibilities of Novartis.
As part of the deal, Sangamo will receive a $75 million upfront licensing fee and is eligible to receive up to $720 million in potential milestones, as well as royalties on potential net commercial sales.
SGMO closed Thursday’s trading at $11.34, up 14.55%.
8. Vertex Boosts Revenue Outlook
Vertex Pharmaceuticals Inc. (VRTX) has reported impressive second-quarter financial results and has boosted its revenue outlook for the full year.
On a non-GAAP basis, the net income for the second quarter of 2020 was $686.8 million or $2.61 per share on total revenue of $1.52 billion. This compared with a non-GAAP net income of $327.3 million or $1.26 per share and revenue of $941 million in the year-ago quarter.
Looking ahead to full-year 2020, Vertex now expects total revenue to be in the range of $5.7 billion to $5.9 billion, up from its prior guidance of $5.3 billion to $5.6 billion.
A phase III study evaluating the use of TRIKAFTA in children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation or who have one F508del mutation and one minimal function mutation is underway, with data expected in the second half of 2020. The drug is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation.
VRTX closed Thursday’s trading at $279.40, up 0.24%.
9. Stocks That Moved on No news
Liminal BioSciences Inc. (LMNL) closed Thursday’s trading at $23.79, up 123.59%.
ThermoGenesis Holdings Inc. (THMO) closed Thursday’s trading at $6.21, up 35.89%.
Altimmune Inc. (ALT) closed Thursday’s trading at $26.06, up 15.72%.
AnPac Bio-Medical Science Co., Ltd. (ANPC) closed Thursday’s trading at $5.72, down 20.45%.
Adamis Pharmaceuticals Corporation (ADMP) closed Thursday’s trading at $1.23, down 15.17%.
Source: Read Full Article