INDIANAPOLIS (dpa-AFX) - Today's Daily Dose brings you news about the progress in Flexion Therapeutics' pipeline; Immunome's coronavirus research program; Pfizer/BioNTech testing COVID-19 vaccine in pregnant women; and Rigel's deal with Lilly to develop RIPK1 inhibitors.
1. Flexion to Test High Dose of FX201 In Osteoarthritis
Flexion Therapeutics Inc. (FLXN) has decided to advance its gene therapy product candidate FX201 into the high dose cohort of the Phase 1 dose-escalation trial in osteoarthritis, following positive Data Monitoring Committee review of mid dose safety data.
The company has also expanded the trial to include up to 20 additional patients in both the low and mid dose treatment groups.
Longer-term data to assess safety and clinical activity in both the low and mid dose cohorts are still being collected, and these interim data are expected to be presented at a scientific meeting in the first half of 2021.
FLXN closed Thursday's trading at $11.13, down 2.45%.
2. Immunome Discovers Antibodies To Fight South African Covid Variant
Shares of Immunome Inc. (IMNM) touched a new high of $63.78 in intraday trading, following news that the company has isolated potent antibodies capable of neutralizing several SARS-CoV-2 variants, including the South African Variant (B.1.351), in pseudovirus testing.
The company's COVID-19 antibody research program is focused on developing a cocktail of antibodies targeting spike and non-spike proteins that can serve as a prophylaxis or a treatment for COVID-19.
At a time when there are reports that the South African Covid Variant reduces the efficacy of certain vaccines and antibody therapies, Immunome's discovery of antibodies that target multiple SARS-CoV-2 variants, including the South African Variant, is of significant importance.
Immunome, a preclinical stage biopharmaceutical company developing antibody therapies for cancer and infectious diseases, went public on the Nasdaq Capital Market on October 2, 2020, offering its shares at a price of $12 each.
IMNM touched a new high of $63.78 in intraday trading Thursday, before closing at $39.01, up 75.56%.
3. Pfizer/BioNTech To Test COVID-19 Vaccine In Pregnant Women
Pfizer Inc. (PFE) and BioNTech SE (BNTX) have dosed the first participants in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of their BNT162b2 vaccine in preventing COVID-19 in healthy pregnant women.
The Phase 2/3 trial is designed to enroll approximately 4,000 healthy pregnant women 18 years of age or older vaccinated during 24 to 34 weeks of gestation. The participants will be given two doses of BNT162b2 or placebo administered 21 days apart. Each woman will participate in the study for approximately 7 to 10 months, depending on whether she was randomized to receive the vaccine or placebo.
Pfizer and BioNTech expect to start additional studies with BNT162b2 vaccine in children between the ages of 5 and 11 over the next couple of months, and in children younger than 5 later in 2021.
In the U.S., BNT162b2 received FDA approval for emergency use in preventing COVID-19 in people 16 years of age and older on Dec.11, 2020. The vaccine is also authorized in the European Union under the brand name Comirnaty.
PFE closed Thursday's trading at $34.56, down 0.95%.
4. Rigel Teams Up With Lilly
Rigel Pharmaceuticals Inc. (RIGL) has inked a global exclusive license agreement and strategic collaboration with Eli Lilly and Co. (LLY) to co-develop and commercialize RIPK1 inhibitors for all indications including autoimmune and inflammatory diseases.
Rigel's lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials this year as part of the collaboration. Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.
While Lilly will be responsible for all costs of global commercialization for R552, Rigel will have the right to co-commercialize R552 in the U.S. Lilly will be solely responsible for all clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications.
The deal entitles Rigel to receive an upfront cash amount of $125 million from Lilly and also receive up to $835 million in potential development, regulatory and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens.
RIGL closed Thursday's trading at $4.76, up 5.08%. In after-hours, the stock was up another 4.83% at $4.99.
5. Stocks That Gained/Lost The Most In A Day
Motus GI Holdings Inc. (MOTS) closed Thursday's (Feb.18, 2021) trading at $2.46, up 38.20%.
Avinger Inc. (AVGR) closed at $2.10, up 24.26%.
VistaGen Therapeutics, Inc. (VTGN) closed at $2.48, up 20.39%.
MEDNAX Inc. (MD) closed at $20.82, down 24.73%.
ReWalk Robotics Ltd. (RWLK) closed at $3.60, down 23.40%.
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