(RTTNews) – Today’s dose gives you data on Applied Therapeutics’ ACTION-Galactosemia Kids trial partially suspended through the FDA, Novavax launches the COVID-19 vaccine trial in South Africa, Sanofi acquires Principia Biopharma for $100 per action in cash, FDA Slaps Clinical opinion on the trial of prostate cancer Poseida after the patient’s death matrix and the disappointing effects of unity Biotechnology’s osteoarthritis trial.
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1. Applied therapeutic action: study of children with galactosemia on partial waiting
The AT-007 Applied Therapeutics Inc. (APLT) pediatric Phase I/II trial of galactosemia, called ACTION-Galactosemia Kids, has been suspended through the FDA.
Galactosemia is a rare inherited disease of carbohydrate metabolism through a deficiency in the enzyme galactose-1-phosphate uridilyl transferase. (Source: NORD).
The company requested the provision of technical data related to the trial and clinical suspension does not respond to considerations regarding the at-007’s protection profile.
The action adult trial ACTION-Galactosemia, which is a phase I/II trial of AT-007 in healthy volunteers and adults with galactosemia, is ongoing and is affected by clinical suspension.
APLT closed on Monday at $25.71, 12.07% less.
Novavax Inc. (NVAX) has submitted a Phase IIb efficacy trial of its COVID-19 vaccine candidate NVX-CoV2373 in South Africa. This trial is funded by a $15 million grant from the Bill & Melinda Gates Foundation.
NVX-CoV2373 is a solid prefusion protein manufactured with a patented nanoparticle generation and includes Novavax’s patented Matrix-M adjuvant.
In Phase I of the Phase I/II clinical trial in Australia, NVX-CoV2373 was well tolerated and provoked numerically astonishing physically powerful antibody responses than those observed in convalescent human serums. Phase II of this trial is expected to begin this month in the United States and Australia.
The company is working with the UK government on the phase III trial of the vaccine, which is expected to begin in the UK this quarter.
NVAX closed on Monday at $155.53, up 6.16 per cent.
3. Principia Biopharma to be acquired through Sanofi
The shares of Principia Biopharma Inc. (PRNB) reached an all-time high on Monday, following the announcement of Sanofi’s proposed acquisition of the company.
Under the final agreement between the two companies, Sanofi will get all of Principia’s consistent notable percentages of $100 consistent with the cash-consistent percentage, which equates to an overall fairness of approximately $3.68 billion.
PRNB closed On Monday at $99.25, an increase of 9.38%.
4. Poseida prostate cancer trial conducted after patient death
Poseida Therapeutics Inc. (PSTX) collapsed more than 34% in out-of-hours operations on Monday, following the closure of the FDA’s phase I trial of the company for P-PSMA-101 in castration-resistant metastatic prostate cancer.
The regulator stopped the trial after the death of one of the patients enrolled in the trial.
Although the direct cause of hepatic impairment has not yet been confirmed, the patient has developed symptoms consistent with macrophage activation syndrome, related to CAR-T therapies, although it may have other reasons such as infection and autoimmune disease, the corporation added.
Poseida debuted on the Nasdaq Global Select Market as recently as July 10, 2020, providing its shares at a value of $16 each.
PSTX closed $13.00 on Monday, down 0.76 percent. Outside of hours, inventory fell 34.54% to $8.51.
5. United Therapeutics to face FDA in April
Tyvaso is already approved for the treatment of pulmonary arterial hypertension in order to improve training capacity.
Interstitial lung disease (PPE) is an organization of lung diseases characterized by significant scarring or fibrosis of the bronchioles and alveolar sacs of the lungs. Pulmonary hypertension related to interstitial lung disease, or PH-ILD, is a condition that affects approximately 30,000 other people in the United States.
Tyvaso, if approved for extended indication, would be the first and only approved cure for the PH-ILD remedy.
During the last quarter of the moment, Tyvaso generated a profit of $119.2 million, at $109.6 million in last year’s quarter.
6. Unity Biotech dives when osteoarthritis trial fails
Unity Biotechnology Inc. (UBX) reported disappointing effects of 12 weeks of its Phase II of UBX0101 in patients with moderate to severe painful knee osteoarthritis.
In the clinical trial, UBX0101 tested at doses of 0.5 mg, 2.0 mg or 4.0 mg and the effects of the trial revealed that there is no statistically significant difference between the arms of UBX0101 and placebo at the end point of 12 weeks for replacement compared to WOMAC-A, an established measure of pain in osteoarthritis.
Based on the results, Unity Biotech does not have to advance UBX0101 in fundamental studies, but should focus on its ongoing neurological and ophthalmological disease programs.
7. Actions that have had anything new
TFF Pharmaceuticals Inc. (TFFP) closed on Monday at $14.06, an increase of 21.73%.
Checkpoint Therapeutics Inc. (CKPT) closed on Monday at $2.49, up 21.12%.
Forma Therapeutics Holdings Inc. (FMTX) closed on Monday at $39.79, an increase of 20.76%.
Biofrontera AG (BFRA) closed on Monday at $13.86, down 13.86%.