FDA rejects BeyondSpring "First in class" innovative drug: Punabulin

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FDA rejects BeyondSpring “First in class” innovative drug: Punabulin

FDA rejects BeyondSpring “First in class” innovative drug: Punabulin.

The FDA rejected the listing application of BeyondSpring‘s innovative drug “Prenabulin”.

The FDA believes that the clinical research data of this drug is insufficient, and requires BeyondSpring Pharmaceutical to continue to carry out relevant clinical research to obtain sufficient approval evidence.

BeyondSpring’s stock price has once again gone a roller coaster. Although BeyondSpring’s Phase III lung cancer clinical data released in August amazed investors, the FDA found that it “didn’t like it” in another indication and rejected the drug on the grounds that the single registration trial was too thin to show the drug. Clinical benefits.

BeyondSpring’s FDA documents include the use of Plinabulin in chemotherapy-induced neutropenia (CIN), which is a key dose-limiting toxicities for cancer treatment.

Neutropenia is considered to be the main indication for pranabulin, but BeyondSpring linked its use to improving the overall survival rate of non-small cell lung cancer (NSCLC) in August, thus bringing the molecular drug hope.

Subsequent updates made investors stunned. When the data for non-small cell lung cancer participants declined, the company’s stock price soared 170% to more than $26, but when the FDA made a decision on the neutropenia file, the stock price fell back to around $13.

Subsequently, the letter of complete reply made BeyondSpring’s share price drop to near $4.

This sharp decline reflects the FDA’s request for BeyondSpring to conduct a second well-controlled trial to verify the efficacy achieved in the first trial. Nablin’s main indication) There is no shortcut.

The FDA’s request then raises a question as to why BeyondSpring (confidence) believes it can be approved on the basis of a phase 3 (non-small cell lung cancer) trial.

After talking with the company’s management, analysts from Jefferies believed that BeyondSpring and the FDA had negotiated at an earlier meeting.

“Our understanding is that after the pre-NDA meeting (pre-NDA mtg) and the directed w/ FDA meeting (mtg w/ FDA) held by BeyondSpring with the FDA in May, there are still some deviations in the expectations of both parties.

BeyondSpring seems to believe that the FDA will go all out. Considering all the data (6 studies), but the FDA only followed a Phase 3 (CIN) trial (ph.III).

BeyondSpring stated that the FDA did not include demographic data (participant data) in the clinical trial of pranabulin. As the main issue,” the analyst wrote.

BeyondSpring has not yet committed to a second study, but has stated that it will work with the FDA on possible future clinical pathways, which may include another trial.

After BeyondSpring’s meeting with the FDA, more details will emerge in the future, and Jefferies analysts expect this to happen early next year.

The FDA and BeyondSpring are also meeting to discuss potential applications for approval in NSCLC. The lung cancer indication is an important opportunity for BeyondSpring and can give it a chance to quickly recover from CIN rejection.

However, Jefferies analysts “see more uncertainties in non-small cell lung cancer” after the full response letter (CRL), noting that subgroups and long-term overall survival (OS) data are at a disadvantage.

FDA rejects BeyondSpring “First in class” innovative drug: Punabulin.

(source:internet, reference only)

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