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It was a week that saw Protagonist stock crashing on news of discontinuation of a phase IIb study, Amgen’s Reptha getting a positive CHMP opinion, Verona Pharma stock rallying on positive top-line data from COPD study and the FDA accepting sBLA for Bristol-Myers’ Opdivo.
Recap of the Past Week’s Most Important Stories
Protagonist Plummets on Study Results: Shares of Protagonist Therapeutics (PTGX - Free Report) plummeted on announcement of the discontinuation of phase IIb study — PROPEL — on its ulcerative colitis ("UC") candidate, PTG-100. The company decided to discontinue the study as a planned interim analysis of PROPEL study by an independent Data Monitoring Committee determined that the study will not be able to achieve its primary endpoint of clinical remission.
The interim analysis was done on data from first 65 patients who had completed the 12-week treatment with PTG-100. The total patient population of the study was 240. The company has notified that it will stop further treatment of patients currently in the study. Protagonist has also postponed its decision to initiate a phase II/III on PTG-100 in patients with chronic pouchitis, as it awaits full review of the interim data from the PROPEL study (Read more: Protagonist Therapeutics Stalls Ulcerative Colitis Study)
Amgen’s Repatha Gets Positive CHMP Opinion: Amgen (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) rendered a positive opinion on the company’s regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the European label of its PCSK9 inhibitor, Repatha.
The application seeks for a new indication in the Repatha label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. Concurrently, the CHMP gave a positive opinion for the marketing authorization to Amgen and Allergan’s , ABP 980, a biosimilar of Roche’s oncology drug Herceptin.
The biosimilar has been recommended for approval for the treatment of the same three types of cancer — HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. (Read more: Amgen's Repatha Gains CHMP Nod to Include Outcomes Data)
Verona Pharma Surges on Study Results: Shares of Verona Pharma plc (VRNA - Free Report) surged following positive top-line data from its phase IIb study evaluating pipeline candidate, RPL554. RPL554, a first-in-class, inhaled, dual inhibitor is being evaluated as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The study met its primary endpoint as RPL554 demonstrated clinically and statistically significant improvements in lung function at all dose levels.
Additionally, secondary endpoints were also met and support the potential clinical benefits of RPL554 for the treatment of COPD. The positive results from the study support the progression of RPL554 into later stage development as an inhaled treatment for COPD patients. Verona Pharma doesn’t have any approved product in its portfolio and the successful development and commercialization of the drug will significantly boost results.
Bristol-Myers’ Opdivo sbLA Accepted by the FDA: The FDA accepted Bristol-Myers Squibb Company’s (BMY - Free Report) supplemental Biologics License Application (sBLA) for blockbuster drug Opdivo in combination with Yervoy for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The agency has also granted the application priority review and set an action date of Jul 10, 2018. The combination is already approved for a variety of oncology indications.
Seattle Genetics Gets Breakthrough Therapy Designation for Enfortumab: Seattle Genetics, Inc. and partner Astellas Pharma Inc. announced that the FDA has granted Breakthrough Therapy Designation to antibody-drug conjugate (“ADC”) enfortumab vedotin, for the treatment of patients suffering from locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (“CPI”). The candidate is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). Both companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.
Biohaven Pharma Plunges Despite Positive Trial: Biohaven Pharmaceutical Holding Company Ltd. ’s (BHVN - Free Report) shares plunged significantly despite the company announcing positive top-line results from two phase III trials (BHV3000-301 and BHV3000-302) on migraine candidate rimegepant (formerly known as BHV-3000). Rimegepant is an oral CGRP receptor antagonist which is being evaluated for the acute treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine.
The results were statistically significant and clinically meaningful across multiple outcome measures as the candidate met the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom. The company is on schedule to submit an NDA for rimegepant in 2019. However, the investors were not much impressed with the data when compared to rival Allergan’s migraine candidate ubrogepant.
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 4.98% over the last five trading sessions. Among major biotech stocks, Biogen lost 14.5%%. Over the last six months, Celgene lost 39.98% while Vertex gained 7.56% (see the last biotech stock roundup here: Biotech Stock Roundup: ALXN & ARNA Up on Study Data, PRTA Teams Up With Celgene).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
Image: Bigstock
Biotech Stock Roundup: PTGX Down, VRNA Up, AMGN's Repatha Gets Positive Opinion
It was a week that saw Protagonist stock crashing on news of discontinuation of a phase IIb study, Amgen’s Reptha getting a positive CHMP opinion, Verona Pharma stock rallying on positive top-line data from COPD study and the FDA accepting sBLA for Bristol-Myers’ Opdivo.
Recap of the Past Week’s Most Important Stories
Protagonist Plummets on Study Results: Shares of Protagonist Therapeutics (PTGX - Free Report) plummeted on announcement of the discontinuation of phase IIb study — PROPEL — on its ulcerative colitis ("UC") candidate, PTG-100. The company decided to discontinue the study as a planned interim analysis of PROPEL study by an independent Data Monitoring Committee determined that the study will not be able to achieve its primary endpoint of clinical remission.
The interim analysis was done on data from first 65 patients who had completed the 12-week treatment with PTG-100. The total patient population of the study was 240. The company has notified that it will stop further treatment of patients currently in the study. Protagonist has also postponed its decision to initiate a phase II/III on PTG-100 in patients with chronic pouchitis, as it awaits full review of the interim data from the PROPEL study (Read more: Protagonist Therapeutics Stalls Ulcerative Colitis Study)
Amgen’s Repatha Gets Positive CHMP Opinion: Amgen (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) rendered a positive opinion on the company’s regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the European label of its PCSK9 inhibitor, Repatha.
The application seeks for a new indication in the Repatha label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. Concurrently, the CHMP gave a positive opinion for the marketing authorization to Amgen and Allergan’s , ABP 980, a biosimilar of Roche’s oncology drug Herceptin.
The biosimilar has been recommended for approval for the treatment of the same three types of cancer — HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. (Read more: Amgen's Repatha Gains CHMP Nod to Include Outcomes Data)
Verona Pharma Surges on Study Results: Shares of Verona Pharma plc (VRNA - Free Report) surged following positive top-line data from its phase IIb study evaluating pipeline candidate, RPL554. RPL554, a first-in-class, inhaled, dual inhibitor is being evaluated as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The study met its primary endpoint as RPL554 demonstrated clinically and statistically significant improvements in lung function at all dose levels.
Additionally, secondary endpoints were also met and support the potential clinical benefits of RPL554 for the treatment of COPD. The positive results from the study support the progression of RPL554 into later stage development as an inhaled treatment for COPD patients. Verona Pharma doesn’t have any approved product in its portfolio and the successful development and commercialization of the drug will significantly boost results.
Bristol-Myers’ Opdivo sbLA Accepted by the FDA: The FDA accepted Bristol-Myers Squibb Company’s (BMY - Free Report) supplemental Biologics License Application (sBLA) for blockbuster drug Opdivo in combination with Yervoy for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The agency has also granted the application priority review and set an action date of Jul 10, 2018. The combination is already approved for a variety of oncology indications.
Seattle Genetics Gets Breakthrough Therapy Designation for Enfortumab: Seattle Genetics, Inc. and partner Astellas Pharma Inc. announced that the FDA has granted Breakthrough Therapy Designation to antibody-drug conjugate (“ADC”) enfortumab vedotin, for the treatment of patients suffering from locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (“CPI”). The candidate is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). Both companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.
Biohaven Pharma Plunges Despite Positive Trial: Biohaven Pharmaceutical Holding Company Ltd. ’s (BHVN - Free Report) shares plunged significantly despite the company announcing positive top-line results from two phase III trials (BHV3000-301 and BHV3000-302) on migraine candidate rimegepant (formerly known as BHV-3000). Rimegepant is an oral CGRP receptor antagonist which is being evaluated for the acute treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine.
The results were statistically significant and clinically meaningful across multiple outcome measures as the candidate met the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom. The company is on schedule to submit an NDA for rimegepant in 2019. However, the investors were not much impressed with the data when compared to rival Allergan’s migraine candidate ubrogepant.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 4.98% over the last five trading sessions. Among major biotech stocks, Biogen lost 14.5%%. Over the last six months, Celgene lost 39.98% while Vertex gained 7.56% (see the last biotech stock roundup here: Biotech Stock Roundup: ALXN & ARNA Up on Study Data, PRTA Teams Up With Celgene).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>