Friday, December 4, 2020

Scholar Rock (SRRK) Trades at All-Time High After It Reports Positive SRK-015 Data from TOPAZ Phase 2 

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SRRK reached the all-time high after the close of the market on Tuesday as the stock skyrocketed on positive SRK-015 results. 

Scholar Rock Holding Corporation (SRRK) shares soared above 110% in yesterday’s trading breaking the all-time price mark. The stock surged with a high volume followed by the announcement of positive six-month interim analysis results of SRK-015 from the TOPAZ Phase 2 clinical trial.

Shares of Scholar Rock made a bullish move in the premarket on Tuesday and opened the trading session at $17.25 compared to the previous close of $13.72. The stock kept on rising before it closed the day at an all-time high of $30.02 up by a massive 118.80%. 

As we write this at before hours 7:43 A.M. EDT, SRRK was continuing the bullish momentum trading at $34.55 soaring up to 15%. 

The major reason behind Scholar Rock’s massive push came from its positive results of SRK-015 from the TOPAZ Phase 2 clinical trial. The interim analysis results obtained the primary efficacy endpoint which gained the attention of the market. 

Treating the patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA) with SRK-015 showed notable improvements in Hammersmith scale scores in all three cohorts at six-months. The company anticipates the top-line data from the 12-month treatment period in 2021. 

The 6-month data obtained ≥1 point improvement in Hammersmith scores among 67% of patients. While 35% of patients in all the three cohorts obtained a ≥3 point increase in Hammersmith scores. The Phase 2 results showed no safety signals from the interim analysis.

From a high-dose of 20 mg/kg) arm across all evaluated time points, the primary endpoint reflected greater, randomized, double-blind cohort; statistical improvements in HFMSE scores. 

The Chief Medical Officer of Scholar Rock, Yung Chyung highlighted that the interim data from the TOPAZ Phase 2 is a great achievement that will help them in engaging with the regulatory authorities for the registrational trial plans. Chyung said:

“This is an exciting and important step towards establishing SRK-015 as the potential first muscle-directed therapy for patients with SMA, while also providing important validation of our scientific approach of targeting the latent forms of growth factors.”

This was the first clinical data showing the potential therapeutic benefits of Scholar Rock’s innovative scientific platform of inhibiting the activation of latent myostatin. This is also the first time the company has tried to target the latent forms of growth factors through its proprietary approach. 

Scholar Rock Holding Corporation (SRRK) is very enthused from its Phase 2 results and is optimistic to report the top-line data of the 12-month study in the next year. The next step for the company is to talk with the regulatory authorities for the registration of SRK-015. 

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