Pfizer Inc. (NYSE: PFE) and  OPKO Health Inc. (Nasdaq: OPK) said that the  U.S. Food and Drug Administration  (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly treatment for pediatric patients with growth hormone deficiency (GHD), a rare disease characterized by the inadequate secretion of the growth hormone somatropin from the pituitary gland. 

This new longer-acting option reduces the need for daily injections. Without treatment, children with GHD may experience persistent growth attenuation, a significantly shorter height in adulthood, and potential delays in puberty. Additionally, they may encounter challenges related to their physical health and mental well-being.

NGENLA is expected to be available for prescribing in the U.S. starting in August 2023.

In 2014, Pfizer and OPKO formed a global partnership to jointly develop and commercialize NGENLA for the treatment of growth hormone deficiency (GHD). According to the agreement, OPKO took charge of overseeing the clinical program, while Pfizer assumed responsibility for the registration and commercialization of NGENLA specifically for GHD.

In pre-market, $OPK is trading at $2.07 (+24.70%) and $PFE at $36.52 (+0.27%)

In other news, Eton Pharmaceuticals, Inc (Nasdaq: ETON) has received a Complete Response Letter from the FDA regarding its New Drug Application for dehydrated alcohol injection to treat methanol poisoning. 

The issues raised in the letter primarily relate to Chemistry Manufacturing and Controls. However, the company is confident that these concerns can be addressed and it is committed to developing a comprehensive action plan to meet the FDA's requirements. 

$ETON is trading at $3.25, down $0.79 (19.55%) in pre-market, following the announcement.

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