The Daily Biotech Pulse: Limited Use Of JNJ's COVID-19 Shot, Myovant-Pfizer's Relugolix Application Delayed, Gain Therapeutics' Parkinson's Data

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

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FDA Limits Use of Johnson & Johnson's COVID-19 Vaccine to Certain Individuals

The FDA said it was limiting the use of Johnson & Johnson's (NYSE:JNJ) COVID-19 vaccine for adults due to the risk of a rare blood clotting syndrome.

The J&J shot can be administered in cases where authorized or approved COVID-19 vaccines are not accessible or if an individual is less keen on using the other two shots, the FDA said.

The FDA said the risk of thrombocytopenia syndrome warranted limiting the use of the single-dose shot after it investigated reported cases.

FDA Pushes Decision Date For Myovant-Pfizer's Endometriosis Candidate Into August

The FDA has extended the review period for Myovant Sciences Ltd (NYSE:MYOV) / Pfizer Inc's (NYSE:PFE) supplemental marketing application for Myfembree.

The companies seek approval for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg to manage moderate to severe pain associated with endometriosis.

The FDA requires extended time to review additional information regarding bone mineral density.

The extended Prescription Drug User Fee Act goal date is Aug. 6.

Gain Therapeutics Presents Preclinical Data From Parkinson's Disease Program

Gain Therapeutics Inc (NASDAQ:GANX) presented preclinical data from its GBA Parkinson's Disease program. The results were highlighted in a poster presentation at the XXVII World Congress on Parkinson's Disease and Related Disorders.

The data demonstrate the ability of lead compound GT-02287 to penetrate the brain, target, and bind with the beta-glucocerebrosidase protein, avoiding its degradation and allowing its transport to the lysosomes where the enzyme can carry out its biological function.

Shares are up 13.4% at $4.39 in premarket trading.