Bellerophon Therapeutics Inc (NASDAQ: BLPH) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced a regulatory update, exciting investors who are sending the stock for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from BLPH stock as a result; and
- what we’ll be watching for ahead.
BLPH Heads Up On Regulatory Update
As mentioned above, Bellerophon Therapeutics is having a great day in the market today after announcing regulatory news. The update was provided by way of press release early this morning.
In the release, the company said that it has reached an agreement with the FDA on the regulatory approval pathway for INOpulse. The product is being developed as a potential option for patients with Pulmonary Hypertension associated with Interstitial Lung Disease.
In the release, BLPH reminded investors of the positive results it releasedin January from Cohort 1 of an ongoing Phase 2b clinical trial. Patients on active treatment saw significant improvement of 34% in moderate to vigorous physical activity when compared to subjects on placebo.
The treatment also led to improvements in overall activity, oxygen saturation and additional functional measures. Based on this data, the FDA has agreed that the company may use MVPA as the primary endpoint of a piovatal Phase 3 clinical trial. The FDA also agreed that the company’s proposal that the Phase 2b trial be amended to a Phase 2/3 trial. This will act as the pivotal trial.
In a statement, Fabian Tenenbaum, CEO at BLPH, had the following to offer:
Reaching this critical agreement with the FDA for INOpulse in PH-ILD represents a significant milestone for Bellerophon as it confirms the validity of MVPA as a clinically meaningful endpoint, enables us to build upon the robust data generated to date from iNO-PF and substantially shortens the regulatory pathway for our therapy in a disease with a serious unmet need.
We appreciate the FDA’s support and their agreement on both the primary endpoint and the seamless pivotal Phase 2/3 design, creating the opportunity for INOpulse to become the first approved therapy in PH-ILD. We expect to complete Cohort 2 and initiate the pivotal Phase 3 trial in the second half of this year.
The above statement was followed up by Steven D. Nathan, M.D., F.C.C.P., Chair at the company’s Steering Committee. Here’s what he had to offer:
Compared to surrogate endpoints, such as six-minute walk distance or patient reported outcomes, change in MVPA provides a direct and continuous measure of physical activity in PH-ILD patients, who have limited ability to perform even the most basic daily tasks.
INOpulse is a selective vasodilator that can improve both cardiopulmonary circulation and oxygenation, increasing the ability to perform physical activities. The improvements in MVPA seen to date in iNO-PF support INOpulse’s potential to address this unmet medical need. I am excited by the acceleration of this program into Phase 3 and look forward to the further evaluation of this promising therapy in the clinic.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Bellerophon Therapeutics, the news proved to be overwhelmingly positive.
After all, the company is moving into pivotal trial phases, potentially opening the door to a coming NDA with the FDA. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:00), BLPH is trading at $0.76 per share after a gain of $0.11 per share or 16.88% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on BLPH. In particular, we’re interested in following the continued development of INOpulse as the asset is progressing well. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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